7547.pdf
Media
- extracted text
-
Lawyers Collective HIV/AIDS Unit
"ACCESS TO AFFORDABLE MEDICINES'
CAMPAIGN WORKSHOP
August 11, 12, 2001
BACKGROUND MATERIALS
I
Lawyers Collective HIV/AIDS Unit
"ACCESS TO AFFORDABLE MEDICINES' CAMPAIGN WORKSHOP
August 11, 12, 2001
BACKGROUND MATERIALS INDEX
DOCUMENT
Overview of Access Issues
A.
> "How can you get the medicines you need to survive?"
International Gay and Lesbian Human Rights Commission
PAGE
1
>
"Improving Access to Essential Medicines: Confronting the Crisis"
Medecines-sans-Frontieres, Health Action International, Consumer
Project on Technology
19
>
"Where are our rights?"- The Draft Declaration of Commitment and
its Gaps
Health Gap Coalition and the International Gay and Lesbian
Human Rights Commission
32
B.
The Agreement on Trade-Related-Intellectual-Property
(TRIPS)
"Globalization and Access to Pharmaceuticals"- TRIPS explained
World Health Organization
> Fact Sheet: TRIPS and Pharmaceutical Patents
World Trade Organization
>
"Compulscry Licensing and Parallel Importing: What Do They Mean?"
Margaret Duckett, International Council of AIDS Service
Organizations (ICASO)
37
41
58
C.
International Efforts
> Declaration of Commitment on HIV/AIDS
United Nations General Assembly Special Session on HIV/AIDS
70
> Global Health Fund:
> Communique, G8 Statement
> Statement of the Secretary General, Kofi Annan
87
96
A. Overview of Access Issues
> "How can you get the medicines you need to survive?"
International Gay and Lesbian Human Rights
Commission
> "Improving Access to Essentia! Medicines: Confronting
the Crisis"
Medecines-sans-Frontieres, Health Action International,
Consumer Project on Technology
> "Where are our rights?"- The Draft Declaration of
Commitment and its Gaps
Health Gap Coalition and the International Gay and
Lesbian Human Rights Commission
1
How can you get the
medicines you need to
survive?
TOO MANY PEOPLE ARE
INFECTED, TOO MANY
HAVE DIED
The HIV/AIDS epidemic has killed over 18
million people throughout the world in less than
two decades, and over 34 million people are
currently infected.
AND MEDICINES ARE TOO
EXPENSIVE
One-third of the world’s population lacks access
to essential drugs to treat life-threatening
diseases, including AIDS. In the most
impoverished parts of the world that number is
more than 50%. Serious illnesses such as
tuberculosis (TB), malaria, and meningitis
continue to claim millions of lives in the
developing world due to the lack of affordable
treatment. In the case of TB, most of the 100,000
people suffering from multi-drug resistant strains
are unable to afford the new standard
combination treatment, which costs
approximately US$15,000 per year. And
according to the World Health Organization, in
developed countries a course of one year’s
treatment for HIV infection costs the equivalent
of four to six months’ salary. Antiretroviral
drugs have become the standard of care in
treating HIV infection in developed countries—
but nearly 95% of the world’s 34 million people
with HIV live outside of those countries. In
developing countries one year's HIV treatmentif it were available—would consume 30 years of
the average person’s income.
PRICE IS NOT THE ONLY
FACTOR
There are many barriers to access to essential
medicines. Supply and storage problems,
substandard drug quality, irrational selection of
drugs, wasteful prescription and use, inadequate
production, insufficient drug research and
H
R
C
development (R&D) and prohibitive prices are
all barriers to access.
AND MEDICINES BY
THEMSELVES ARE NOT THE
SOLUTION
The struggle for access to affordable medicines
is one pan of a larger Hi V/AiDS public heal th
crisis. 95% of people with HIV live in poor
countries, and the vast majority of these do not
have access to very basic health care. Clean
water, nutrition, health care infrastructure, and/or
trained medical personnel are often not available
either.
BUT NO SOLUTION IS
POSSIBLE WITHOUT
AFFORDABLE MEDICINES!
FIVE WAYS TO GET THE
AFFORDABLE MEDICINES
YOU NEED
We will examine five strategies that may help
you get affordable medicines. Each one has pros
and cons and none of them offers a guaranteed
success.
These five strategies are:
• Getting the law on your side: your right to
health
• Getting the law on your side: monopolies don’t
make a “free market”
• Getting the prices of medicines down though
imponation from cheaper markets
• Getting the prices of medicines down through
cheaper manufacturing
• Getting medicines for free
Page 1
STRATEGY 1:
GETTING THE LAW
ON YOUR SIDE:
YOUR RIGHT TO HEALTH
What does it mean?
The right to health care is a basic human right. It is
recognized in international treaties and in the national
constitutions and laws of many countries.
Article 25 of the Universal Declaration of Human
Rights affirms that: “Everyone has the right to a
standard of living adequatefor the health and well
being of himself and of his family, includingfood,
clothing, housing and medical care and necessary
social services, and the right to security in the event of
unemployment, sickness, disability, widowhood, old age
or other lack of livelihood in circumstances beyond his
control. ”
Article 12 of the International Covenant on Economic,
Social and Cultural Rights recognizes "the right of
everyone to the enjoyment ofthe highest available
standard ofmental and physical health." It requires
governments, among other steps, to take necessary
measures for the "prevention, treatment, and control of
epidemic, endemic, occupational and other diseases."
as well as to create "conditions which would assure to
all medical service and medical attention in the event of
sickness."
Despite this clear mandate, in some countries the right
to health is not guaranteed in the constitution, or it is
not implemented by the government. Sometimes
governments say they recognize the right to health, but
still exclude or discriminate against people with
HIV/AIDS.
What can you do?
You can change the laws of your country or bring a
case to court (a national or sometimes international
court) in order to broaden the right to health care.
It is important to know your country’s laws and
constitution, and in particular what rights are
guaranteed there. The same applies for knowledge of
the international conventions that have been signed by
your country and the rights included in those. You can
find all major international human rights conventions,
as well as the lists of countries who signed them, at
http.7/www 1 .umn.edu/humanrts/treaties.htm.
It may also be good to review samples of laws from
other countries, international law in the field of the right
to health as well as the field of human rights for people
with HIV/AIDS. The documents can be useful because
of their persuasive value or even as drafts for legislation
in your own country.
Different countries follow different political and
legislative systems in the processes by which laws are
changed. It is best if you form alliances with other
sectors of civil society and work within the system in
your country in order to change the laws. Some
international human rights organizations, including the
International Gay and Lesbian Human Rights
Commission (IGLHRC), may be able to offer some
resources and technical assistance. A list of
organizations is attached at the end.
Pros and cons9
The right to health care is a basic human right. If it is
not recognized as such in your country, your
government may deny that they have a responsibility to
ensure that you have access to health care. If, on the
other hand, your government accepts that responsibility,
the remaining question is how it will provide health
care and medications—not whether it will provide them
or not.
The end result of your efforts may be more legal
protections for people with HIV/AIDS and a legal
recognition of their right to health care. If, however,
the case or legislation you are working on does not
yield a “good” court decision or an improvement in the
laws, you may end up worse off than when you started.
Or if you live in a country where the government
routinely disregards its own laws and the sentences of
the courts, then legal victories may set a good precedent
but remain ineffective.
Or the government may wish to implement laws
guaranteeing access to health care, but may claim it
lacks the money to do so, particularly when medicines
arc too expensive. Later on we will address ways to
bring down the price of medicines. It is certainly true
that the prices of medicines must come down. But your
government’s priorities in spending must be looked at
with a critical eye. Is the government continuing to buy
expensive military technology while people die of
AIDS? Misplaced priorities are not the same thing as a
lack of money, and are no excuse for inaction.
Example A:
Salvadorans and Costa Ricans
Get Medicines By Law
On April 28, 1999 Odir Miranda, President of the
Salvadoran Association of People Living with AIDS
(ATLACATL) filed a complaint with the Salvadoran
Supreme Court requesting that the Salvadoran Institute
Page 2
of Social Security, the nation’s health care provider,
give antiretroviral medications to people with AIDS.
Almost half a year had passed and the Supreme Court
had not yet issued a ruling.
Odir sent a letter in September to the Interamerican
Commission on Human Rights asking for immediate
intervention. Odir accused the Salvadoran government
of discrimination against people with AIDS in the
provision of health care.
The Interamerican Commission on Human Rights is a
commission that can rule on human right violations in
the Americas, and its rulings have legal weight over the
whole continent, from Argentina to Canada. The
Commission only acts in cases where all legal remedies
at the national level have been exhausted, in other
words, when every possible legal avenue at home was
tried and did not work. Odir argued that the
Commission should hear his case as an emergency, and
he cited the fact that the Supreme Court was delaying
its reply and that because of this delay more and more
people were dying.
The Interamerican Commission on Human Rights took
the case and issued a ruling on February 29, 2000,
ordering the government of El Salvador to begin
supplying antiretroviral medications to the 26 surviving
Salvadorans who appeared mentioned in the September
petition. The petition had contained the names of 36
people living with AIDS, out of which ten had died
between the September filing and the Commission’s
ruling. The emergency order was given for six months
while legal proceedings continue in El Salvador.
The Commission ordered the Salvadoran government
to: "provide medical attention necessary to protect the
life and health ofJorge Odir Miranda Cortez and the
other 25 aforementioned people.Jn particular the
Commission solicits that your illustrious government
provide antiretroviral medications necessary to avoid
the death of the aforementioned persons, as well as
hospital attention, other medications and nutritional
support which strengthen the immune system and
impede the development ofillnesses and infections."
Even though the case refers exclusively to the 25
people with AIDS mentioned in the claim, the decision
of the Commission sets an important precedent and may
be useful to others too.
A similar process had happened in Costa Rica three
years earlier. In 1997 the Costa Rican Supreme Court
had ordered the government there to provide
medications to 4 persons with AIDS. Shortly thereafter
the National Health Care system began to give the
medications to others too. At the moment 800 Costa
Ricans are reported to receive antiretroviral
medications
STRATEGY 2:
GETTING THE LAW
ON YOUR SIDE:
MONOPOLIES DON’T MAKE A
FREE MARKET
What does it mean?
Big drug companies defend their high prices in two
ways, by saying the “free market’’ sets these prices, and
by saying its prices are necessary to produce new and
better medicines. These claims are untrue. The prices
reflect privileges— privileges which some governments
assign to inventors. And the privileges do not always
reflect the real costs of researching and developing the
new medicines.
International law and the laws of many countries
recognize certain privileges for a company that has
invented a new product. These privileges, called
patents, generally give the inventor a temporary
monopoly to produce and market their new product.
This temporary monopoly is given to compensate the
inventor for research and development costs, and to
encourage the inventor to continue developing new
products. The ultimate goal of the patents has been
described in an international treaty, the Agreement on
Trade-Related Aspects of Intellectual Property Rights
(TRIPS). This treaty sets guidelines for countries to
establish patents, and respect each other’s patents.
Article 7 of TRIPS explains that the patents are granted
to: “contribute to the promotion oftechnological
innovation and to the transfer and dissemination of
technology, to the mutual advantage ofproducers and
users oftechnological knowledge and in a manner
conducive to social and economic welfare, and to a
balance ofrights and obligations. ” In other words, the
patents are a temporary reward to the inventor not
because of the invention per se, but because of the
promise that the benefits of that invention will be
“transferred and disseminated... in a manner conducive
to social and economic welfare.
Patents are temporary: inventing something does not
give you control over the invention forever. Patents do
usually last a long time, sometimes 20 years or more.
However, some inventions are urgently needed, and
cannot wait this long to be widely used and distributed.
That is why the same treaty (TRIPS) provides for
measures to overccme the patents, particularly in
order to protect public health and nutrition (article 8
Page 3
of TRIPS). Two of these measures are explained in the
next two sections:
They favor patents over patients, and over the right to
health.
Getting the prices of medicines down through
importation from cheaper markets
All these pressures may be heavier on countries that are
not designated “least developed,” because they have no
transitional period until 2006. “Least developed
countries” are also pressured to pass restrictive laws
now. before the required deadline of 2006.
Getting the prices of medicines down through cheaper
manufacturing
And For Which Countries?
Some countries grant and honor patents and others do
not. Each country can decide for itself how it wants to
treat the temporary monopolies that other countries give
to inventors. However, right now, all countries fall into
one of these two categories:
1 / Countries which have not signed the TRIPS
agreement. These countries do not have to respect the
patent system. They may suffer heavy political
pressure and even trade sanctions in order to force them
to change their domestic laws to include patent
protections (also called intellectual property rights
law).
2/ Countries which are members ofthe World Trade
Organization. These countries have signed the TRIPS
agreement, promising to change their domestic laws to
include patent protection. These countries are given a
period of time to change their laws. All of them, except
the ones designated “least developed countries,”
technically should have changed their domestic laws
already, but many have not done so yet. The “least
developed countries” have more time, a transitional
period, until 2006.
We have provided an attachment at the end with a list
of member countries of the World Trade Organization,
and of those members who have been designated “least
developed.” It is important to know the status of your
country. This information has an effect on the price of
medicines in your country.
If your country is a member of the World Trade
Organization and has not updated its patent laws (in
other words, they are not TRIPS compliant), it is
probably under intense pressure from the United States,
the European Union, and the pharmaceutical companies
Sometimes the United States, the European Union, and
the corporations pressure countries to pass patent
protections, which are even stronger than they need to
be under international law. •Such “stronger” patent laws
(sometimes referred to as "TRIPS-Plus") protect
international corporations by giving their patents extra
power. In the process they limit the measures that you
can take to get the affordable medicines you need.
What can you do?
Investigate what is the state of patent laws in your
country (are these laws in place? in progress? non
existent?). If your country is not a member of the
World Trade Organization, defend its right to decide for
itself about which patent protections it will enforce. If
your country is a member, then it is probably
developing new legislation about patents. If your
country is classified as “least-developed,” patent laws
should not be implemented in national legislation
before the required deadline of 2006.
When legislation is introduced in any country, ensure
that the laws that are being proposed meet only the
standard minimum requirements of TRIPS—that they
are not “TRIPS-Plus.” In other words, ensure that
when national laws are reviewed to include TRIPS
requirements, parallel imports and compulsory
licensing are included. (We will define these terms in
Strategies 3 and 4). The laws should include simple
administrative procedures for granting compulsory
licenses. You can seek the support of the World Health
Organization in this process.
Patent law may be complicated. The terms may be
foreign. Sometimes the details seem too technical and
intimidating. It is helpful to seek the assistance of a
lawyer or an organization that specializes in the field. A
list of resources is attached at the end.
It is important to remember that while the details may
seem complicated, the overall picture should not be.
Your goal is to ensure that patents for medicines are not
more restrictive than they need to be, because as a
general rule of thumb the stronger the monopoly is the
more restricted the access to the medications will be.
Pros and cons?
It is important to be vigilant about the development of
patent law in your country. As explained above,
restrictive patent laws will likely end up raising the
price and limiting the availability of medications.
There is enormous pressure on countries to become part
of the “global market” and play by rules set in the
global North. Because of this, it is unlikely that you
will succeed in making your country’s patent laws more
lenient than they are now. You can, however, help to
Page 4
keep the situation from getting worse, by building a
coalition of concerned citizens to help your government
preserve the legal status quo.
i
Such advocacy will probably not help you get new
medications on the market in your country. However,
you will be laying the legal groundwork to get the
prices of existing medications down through cheaper
manufacturing, or importing from countries where the
drug is cheaper.
STRATEGY 3:
GETTING THE PRICES OF
MEDICINES DOWN THROUGH
IMPORTATION FROM CHEAPER
MARKETS
What does it mean?
I
Example B:
Pressures Against Thailand
to Change the Law
In the global economy, companies sell the same item
for different prices in different places. A major
corporation may offer drugs in one country for a
significantly lower price than in another.
Under United States pressure, the Thai passed a bill that
restricts the use of compulsory licenses in Thailand.
This law offers conditions that are much more
restrictive than the rules set out in the TRIPS
agreement, the internationally accepted standard. One
of these conditions is the creation of the Safety
Monitoring Program (SMP).
In Thailand patent protection is effective only for
products invented after 1992. However, all new drugs
introduced to the Thai market must pass through a
Safety Monitoring Program (SMP) that usually lasts
four years. During that time no generic drug companies
can produce the medication (same drug, without the
brand name), so the drug remains monopolized.
A 1999 joint report of the World Health Organization
and Medecins Sans Frontieres (Doctors Without
Borders) concluded that the high cost of medications in
Thailand is linked to the monopolies caused by patent
protections or by the SMP.
Example C:
India Produces its Own Medicines
The Indian drug industry is a good example of what
happens when companies are given the authority to
produce drugs for the local market without paying
daunting licensing fees. Currently, Lariam, a treatment
for malaria, costs US$37 in the United States and $4 in
India, while the AIDS treatment AZT cost USS239 per
month in the United States and US$48 in India. If and
when India is forced to honor patents for medicines,
these lower prices may disappear. And India may be
pressuured to legislate a “TRIPS-Plus” law.
Suppose you could buy medicine in another country for
half the price that the same drug costs in your own
country. If you and others could shop around the
world, find the place where the medicine is cheapest,
and then bring it to your country—if you could import
the medicine from the least expensive supplier—you
could make medicine available to people who cannot
afford it now. But, because of market pressures, the
company would probably be forced to cut the price it is
charging for the medicine in your country, as soon as it
became available more cheaply.
This process is really no different than searching for
bargains at the market. It is how truly “free markets**
work. But there is a technical term for doing such
bargain-hunting on an international scale. It is called
parallel importing. In effect you are importing parallel
to the company which sells the medicines in your
country at a higher price- and doing so without that
company’s permission.
Parallel importing is very common around the world for
a variety ofproducts-pianos, automobiles,
motorcycles, chemicals, medicines, computers,
cameras, music CDs. In fact, most every country has
some trade in parallel imports. Many European
countries have significant trade in pharmaceutical
parallel imports, mostly within the European Union
itself-but also from outside the Union, from the United
States and other countries.
In general, parallel importing is legal under
international law (TRIPS), and can be an attractive
option when the same patented product is being sold for
different prices in different markets.
!
Parallel importing is an important option to increase
access to medicines, because there are in fact
substantial price differences for medicines in different
national markets. These price differences are due to
local market conditions, including the degree of
competition for a product. In some countries the
Page 5
I
■
G
medicine may be produced and sold by a number of
manufacturers, while in others only one company has
the right (or patent) to do so. For example, according to
a Medecins Sans Frontieres (Doctors Without Borders)
study, the price of a 200 mg capsule of fluconazole, an
anti-fungal drug, when sold as a brand-name drug under
patent and with no competition, range from USS9.34 in
South Africa to US$27.60 in Guatemala. The exact
same drug sold by the same company costs 300% in
Guatemala! If Guatemala “parallel imported” the
medicine from South Africa, it could substantially
reduce its price.
What can you do?
Governments, private health care groups, and non-profit
health agencies that buy bulk supplies of medicines
could engage in parallel importing of medicines to
lower national public health expenditures for life-saving
drugs. Since parallel importing is permitted under
international law (TRJPS), it is important that you make
sure that your governments, and other entities in your
country are aware of their right to exercise this price
reducing option, and make full use of it.
Even if your government is felly aware of the
advantages of parallel importing, and willing to make
use of this legal measure, there may be a great deal of
pressure from governments in the West (where the
major pharmaceutical drug companies reside) not to
exercise this option. Drug companies, which hold
patents to the medications, pressure their governments
to keep developing countries from shopping around the
world for the best drug prices. Western governments
threaten to use trade sanctions against states that use
parallel importing. The drug companies may establish
restrictive contracts with their distributors in each
country, prohibiting them from reselling the drug in
other countries.
Drug companies use many arguments to justify their
position; some of these are detailed in the pros and cons
section. Yet probably a major reason for their
opposition is based on the real fear that if every country
could search for the lowest price for a certain drug,
eventually prices would drop everywhere, and the drug
companies' profits would drop too. They will use their
political power to stop practices that threaten their
profits.
Parallel importing medicines requires some of the same
work that we outlined in the previous section. You can
help your government defend its own right to use
parallel importing, and help it stand up to international
pressure aimed at changing its practices and laws.
Depending on how cooperative your government is,
you can work with government officials to implement
the parallel importing of specific medicines. You can
support your government as it withstands pressure from
abroad, and you can organize a campaign to shame the
drug companies into allowing you and your government
to prioritize public health concerns and the full
enjoyment of the right to health.
Pros and cons?
Parallel importing helps to take advantage of different
global prices for medicines, and may ensure that you
are getting the medicines for the lowest price possible.
It also creates greater competition in your own country,
which forces local distributors to lower their prices to
match the best price internationally.
Drug manufacturers who oppose parallel imports make
a number of arguments against their use. For example,
they allege that parallel imports may be substandard or
even counterfeits, or that they may be difficult to
support or service. The issue of the quality of
medications is a valid and important concern. It is a
concern that should apply to all medications. The same
regulations and quality controls can and should be
applied consistently to all medications, whether parallel
imported or not.
Some drug companies argue that parallel trade should
be stopped to prevent developing countries from
marketing cheap drugs in rich countries. Rich countries
want to protect their own manufacturers and markets;
they do not want to lose the profits that come from
selling the medicines at a higher price in their own
markets. Europe, the United States, and Japan have
already passed legislation to prevent poorer countries
from marketing medications there. However, even if
one accepts the protectionism of the rich countries,
there is no reason why poor countries should not be
able to buy products in rich countries for their own use,
when prices are lower there due to competition in the
larger US and European markets.
Remember, though: even the lowest available price
worldwide for the patented medication may still be
beyond the reach of many poor countries! Parallel
importing only takes advantage of existing variations in
price. It cannot bring the price to a point that the
poorest countries can pay. You may need to look at
other, more time-consuming options, to manufacture
the medication at a price that is lower than any on the
market today. These options will be addressed in the
next section.
Page 6
Example D:
The Patented Price of Fluconazole
Wholesale prices of fluconazole
200 mg capsules in USS
in September 1999
South Africa...
USA..............
Kenya............
Guatemala
(public sector).
France.............
Spain...............
Guatemala
(private sector)
...$9.34
$10.00
$10.50
$11.90
SI 2.60
$13.37
S27.60
Source: Price Differences of Fluconazole, Differences
and Conclusions (MSF, November, 1999)
The prices on the table above represent price for the
brand-name version of the drug, as sold by the
manufacturer holding a patent.
STRATEGY 4:
GETTING THE PRICES OF
MEDICINES DOWN THROUGH
CHEAPER MANUFACTURING
What does it mean?
Imagine that you need a particular medicine to treat a
serious infection that you have. You go to your local
drug manufacturer and ask them if they produce this
medicine and distribute it to local hospitals and
dispensaries. They tell you that they would like to
produce this medicine but that only one company is
allowed to produce it because that company has a
patent (they have "monopoly rights” to make and sell
this medicine). You explain to the local drug-maker
that while it is true that only one company has a patent
on the medicine, there are some ways to get around
this—and that they are legal.
One way is by going to the drug company that holds the
patent (the patent-holder) and requesting that they issue
the local drug maker a voluntary license to produce a
generic version of the drug (the same drug, but without
the brand-name). The local manufacturer would offer
to pay the patent-holder some set amount (a royalty) for
the privilege of making the drug. The patent-holder
keeps its patent but voluntarily gives a license to the
local drug maker.
Then, the local manufacturer could make the drug,
using local workers, scientists, technicians, and
distributors, and sell it in your country. Most likely,
producing and distributing the generic version of the
drug locally would cost far less than the price charged
by the patent-holder.
Suppose that the patent-holder will not provide the local
drug maker with a voluntary license. There are still
some legal options available, and you can work with
your government to use these options. Under
international law, your government can compel the
patent-holder to license production of the drug to a
local manufacturer. If there is no drug company in your
country to make the drug —because it is too
complicated or because there are no manufacturers in
your country —your government could still compel the
patent holder to license production to some other
generic producer outside your country, and buy it from
them.
Either way. this is called compulsory licensing.
Compulsory licensing is the granting of a license to a
third party without the consent of the patent holder. The
patent holder in turn receives compensation for issuing
the license.
A compulsory license may be issued on various
grounds of general interest—including public health.
Compulsory licensing is legal under international law.
Article 31 of the TRIPS agreement states that countries
which are members of the World Trade Organization
may "use the subject ofa patent without the
authorisation ofa right holder, including use by the
government or third parties authorised by the
government" when justified by the public interest.
Article 31 also says "the right holder shall be paid
adequate remuneration... taking into account the
economic value ofthe authorisation. ”
Compulsory licensing also needs to be legal under
national legislation. As we said earlier, it is important
that the laws of your country are not “TRIPS-Plus,” in
other words, it is important that the laws of your
country do not have “stronger” patent laws than they
need to have under international law.
Historically, compulsory licensing has been used to
serve the greater good of society, by restricting the
monopoly rights of patent holders. Today countries
grant them in a wide range of fields such as computers,
nuclear energy, music recordings and biotechnology.
However, the use of compulsory licensing for
HIV/AIDS drugs or other life-saving medicines has
encountered heavy political opposition. Drug
companies and some governments in the industrialized
countries have opposed compulsory' licensing for these
Page 7
medicines. The United States’ government has applied
strong pressure to Thailand, South Africa, and other
countries to stop them from using compulsory
licensing.
What can you do?
Countries should ensure simple administrative
procedures for granting compulsory licenses. In many
countries, compulsory licensing is part of the patent
law. For example, France's law authorizes compulsory
licensing when patented drugs "are only made
available to the public in insufficient quantities or
quality or at abnormally high prices. ” In many
• countries, HIV/AIDS drugs for opportunistic infections
and antiretrovirals are maintained at such high prices
through the exclusive marketing rights granted to patent
holders. TRIPS clearly states that countries can use
compulsory licensing to defend themselves against
these prices.
Here, again, this strategy is similar to Strategy 2: you
need to ask what your country’s patent laws say.
Activists from developing countries can begin by
finding out what their countries’ laws say about
compulsory licenses and parallel imports. You can then
lobby to change the laws if they do not permit
compulsory licensing or if they are more restrictive than
international trade agreements demand. And you can
support your government in standing up to pressure
from the developed North.
Pros and cons?
Many international consumer advocacy groups are
urging developing countries to implement TRIPS
provisions for compulsory licensing so that their
populations can have access to essential medicines.
On the other hand any attempt at requesting a
compulsory license for medicines is likely to be met
with very strong opposition by the pharmaceutical
companies and the developed countries where they are
based. As of the writing of this document (July 2000)
we know of no HIV/AIDS drugs that have successfully
been licensed and produced in any country in the
developing world. Compulsory licensing remains a
possibility that is legal and should be used, but it
requires a concerted effort by local activists and
government, as well as international support, in order to
overcome the obstacles and pressures against it.
Example E:
The Generic Price ofFluconazole
Wholesale prices of fluconazole
200 mg capsules in USS
in September 1999
$0.60
Thailand..
Cambodia
(generic produced in India)..$1.50
Source: Price Differences of Fluconazole, Differences
and Conclusions (MSF, November, 1999)
Compare these prices with the patented prices in
Example D.
Example F:
Under Pressure, Thailand Drops
Compulsory Licensing
and Produces Other Generic Medicines
On November 1999 the Government Pharmaceutical
Organization of Thailand (GPO) initiated legal
proceedings to get a compulsory licensing for the
manufacture and sale of the drug ddl. Three months
later, and after intense pressure from the United States’
government and the drug manufacturer, the Ministry of
Public Health announced that it would not try to get the
compulsory license of ddl because they feared that the
enforcement of compulsory licensing under the Thai
patent law would result in trade sanctions. The pressure
on Thailand was most heavy because the
pharmaceutical interests did not want to set a
‘precedent’ of a case where the compulsory licensing of
medications actually worked.
Thai physicians and patients were particularly outraged
when they discovered that ddl was invented by the US
government and is licensed on an exclusive basis to the
US drug manufacturer Bristol-Myers Squibb.
Since in Thailand patent protection is effective only for
products invented after 1992, the GPO found a way out
of compulsory licensing. The GPO is producing at
present generic versions of d4T, ddl, and AZT.
However these productions are not under compulsory
licensing agreements. They are productions of drugs
or versions of drugs that were never patented in
Thailand.
In the case of ddl, the GPO is producing generically a
non-patented powder version, which it sells for 26 baht
per 100 milligrams (about 67 US cents). That is almost
half the price of the patented version of ddl, which sells
for 49 baht (about USS 1.26) per 100 milligram tablet.
Page 8
8
These generic productions outside of compulsory
licensing will not work in countries that have older
patent laws. But even for those countries, compulsory
licensing remains an option.
STRATEGY 5:
GETTING MEDICINES
FOR FREE
What does it mean?
Recently, multinational pharmaceutical companies have
announced plans for HIV drug donation programs as
part of their effort to address the AIDS epidemic in the
developing world. Here we will discuss the meaning of
AIDS drug donations and how they can be used to
improve access to medications for people living with
HIV/A1DS.
There are also many small-scale drug donation
programs run by individuals or organizations. Through
these, some people living with HIV/AIDS have
obtained drugs—although the rich and well-connected
have benefited most. But hundreds or thousands of
lives have been saved.
What can you do?
The pharmaceutical companies are under pressure to
lower the prices of life-sustaining medications. But for
them it is easier to give medicines away rather than face
fair pricing and a competitive generic markets. The
pharmaceutical companies will then increasingly offer
drug donation programs as an alternative to parallel
importing, compulsory licensing, and generic
competition. It is important to know how to negotiate
an effective donation program is worthwhile.
What does it take to start a campaign for meaningful
donations in your country? Broadly speaking, you
might:
1) Work with your government and the pharmaceutical
company to secure a sustainable and ethical donation.
Ensure that a guaranteed constant supply of quality
medicines (well before their expiration date), to be
distributed in an equitable fashion. Be careful of the
conditions set by the donor, which may unnecessarily
narrow the scope of the donation or create an undue
burden on the health care delivery system in your
country.
2) Help make sure donations adhere to drug donation
guidelines set by the World Health Organization.
3) Have a National Drug Donation Policy in place, to
help lower procurement prices
4) Work to adopt a national Essential Drug List, to
determine what drugs are needed according to the
disease patterns in your country.
5) Work to remove policies that create barriers to
access to medications.
Pros and cons?
The United States has seen a 60% decrease in AIDS
deaths since a triple drug combination, or Highly
Active Antiretroviral Therapy (HAART), became the
preferred treatment for HIV. In much of the world,
these therapies are virtually inaccessible. 92% of the
world’s population makes do with 8% of the money the
world spends on AIDS.
Drug donations are one way to get drugs to people.
Corporate donations however are only a stop-gap
solution. Drug companies may place unacceptable
conditions on the donations^ and they can cut them off
at any time.
A recent study by the World Health Organization
showed that many drugs donated to countries by
pharmaceutical companies were drugs deemed “nonessential” by the recipient country, and in one third of
donation cases, the drugs were either expired or did not
meet the World Health Organization’s guidelines for
shelf-life. Such donations are dangerous to health.
Donations can also burden on the recipient country’s
already overloaded distribution systems. “Donation
programs” are often a veiled excuse for pharmaceutical
companies to get tax breaks or to “dump” surplus
materials taking up space in their warehouses.
Reducing HIV-related drug prices to a fair rate, and
allowing fair competition from generic manufacturers,
is a better long-term answer to the need for affordable
medicines. However, as long as pharmaceutical
companies continue to use this as a response to the
global AIDS crisis, you should consider negotiating the
best possible drug donation programs—while still
pushing for permanent solutions, and for broader access
to treatment worldwide.
When you ask pharmaceutical companies to make their
products more affordable and accessible to people
dying in your country, you are also making a demand
for your right to health. Drug companies, like all other
subjects of all states, are obliged by human rights
standards to respect and promote the right to health.
Morally, they must answer positively to your demands.
By offers ofa drug donation, a company admits its
responsibility for ensuring this right. You should hold
Page 9
them accountable to follow through. Drug donations
are one more way to enjoy increased access to health
care.
Example G:
South Africa Gets
“Expensive” Gifts
With Many Strings Attached
Recently, Pfizer, Inc. offered to provide its patented
drug, fluconazole, to South Africans with cryptococcal
meningitis at no cost. Not long after its announcement
of the donation program, treatment activists learned that
the “gift” was so restricted as to be counterproductive.
Fluconazole’s effectiveness depends on a lifelong daily
dosing regimen: but Pfizer planned to offer the drug for
only 2.5 years. The time limit makes it impossible for
the South African government to develop a long-term
program for treating the disease. And Since the time
limit coincides with the expiration of Pfizer’s patent on
the drug, there are suspicions that Pfizer may be trying
to use the ‘donation’ to give samples of the drug away
in the hopes of getting South African doctors
accustomed to using the brand name version (Pfizer’s
version) of fluconazole even after the patent expires.
In addition, though fluconazole treats numerous lethal
infections in people living with HIV/AIDS, Pfizer
insisted on limiting its offer to one disease, and only in
one country. When activists in Central America
requested Pfizer duplicate their offer for HIV-positive
people there, they were flatly rejected. At this time,
Pfizer continues to negotiate the specifics of its
program with the South African Ministry of Health
General Resources
There are several non-governmental ad intergovemmental international organizations, some with
regional and local offices, working on campaigns,
advocacy and grassroots activism toward increasing
access to medicines global by challenging the negative
effects of international trade policies.
AIDS Empowerment and Treatment
International (AIDSETI)
International group of and for people living with
HIV/AIDS, to empower associations of PWAs in the
South by supporting their positive living and surviving
skills programs and by providing a medical safety net to
ensure the survival of members and leaders.
10
P.O. Box 27143
Washington D.C., USA 20038-7143
Fax:+1-(202) 614-0035
Email: DHOUSDEN@A1DSETI.ORG
http://www.aidseti.org
AIDS Treatment News
Internationally recognized newsletter with resources for
people with HIV/AIDS who are looking for information
on new therapies and different treatment options.
John S. James, Publisher
PO Box 411256
San Francisco, CA 94141
Tel:+1-415-255-0588
http://www.aidsnews.org/
Consumers International
A worldwide non-profit federation of consumer
organizations, dedicated to the protection and
promotion of consumer interests. The organization
promotes the rational use of essential drugs, universal
quality health care services and patients' rights.
Consumers International has co-founded three global
health networks: the International Baby Food Action
Network; the Health Action International (campaigning
for fairer health and drug policies) and The Pesticides
Action Network.
Head Office
Postal Address:
24 Highbury Crescent
London
N5 1RX
United Kingdom
Tel: +44 171 226 6663
Fax: +44 171 354 0607
E-mail: consint@consint.org
http://www.consumersintemational.org/
Consumers International Offices:
Regional Office for Africa (ROAF)
Postal Address:
11 Connaught Road
Avondale
Harare
Zimbabwe
Tel: +263 4 302 283
Fax: +263 4 303 092
E-mail: roaf@harare.iafrica.com
Sub-Regional Office for West & Central Africa
Postal Address:
Villa No. 9, Debut de la VDN x Bourguiba
Casier Postale No. 2
Dakar-Fann
Senegal
Page 10
■
Tel: +221 24 80 06
Fax: +221 24 80 06
E-mail: ci-pwca@ndar.enda.sn
Regional Office for Asia Pacific (ROAP)
Postal Address:
PO Box 1045
10830 Penang
Malaysia
. Tel:+60 4 229 1396
Fax: +60 4 228 6506
E-mail: ciroap@pc.jaring.my
Office Address:
250-A Jalan Air Itam
10460 Penang
Malaysia
South Pacific Consumer Protection Programme
(SPCPP)
Postal Address:
PO Box 43-148
Wainuiomata
New Zealand
Tel: +64 4 564 8317
Fax:+64 4 564 8317
E-mail: cispcpp@xtra.co.nz
http://www.spcpp.org.nz/
Regional Office for Latin America & the Caribbean
Postal Address:
Las Hortensias 2371
Providencia, Santiago
Chile
Tel: +56 2 335 1695
Fax: +56 2 231 0773
E-mail: consint@entelchile.net
http://www.consumersint-americalatinaycaribe.cl/
Sub-Regional Office for Central America
Postal Address:
Colonia Dolores
Pasaje Rosales No. 2 Casa 309
San Salvador
El Salvador
Tel: +503 242 2506
Fax: +503 242 2506
Programme for Developed Economies and Economies
in Transition
Postal Address:
24 Highbury Crescent
London
N5 1RX
United Kingdom
Tel: +44 171 226 6663
Fax: +44 171 354 0602
E-mail: progs@consint.org
http:/7/193,128.6.150/consumers/about/hi$tory,htn]|
11
Consumer Project on Technology
Extensive background and documents on intellectual
property and health care. This site includes recent and
archival information on general policy issues
(compulsory licensing, parallel imports, trademark
issues, Bolar and other research provisions, scope of
patents, data exclusivity, orphan drug legislation,
generic competition, etc.), as well as specific drug
pricing data and information on trade disputes related to
the pharmaceutical industry. Very thorough collection
of legal texts on the issues.
Consumer Project on Technology
P.O. box 19367
Washington DC 20036
Phone (202) 387-8030
Fax: (202) 234-5176
contact: cgavin@cptech.org
http://www.cptech.org
F»ttr»-//\ininv nr»tr»ro/ir»/h#*aIth/
Global Network of People Living with
HIV/AIDS (GNP+)
The Global Network of people living with HIV/AIDS
(GNP+) is a global network for and by people with
HIV/AIDS.
GNP+
P.O. Box 11726 Haarlemmerplein 17
1001 GS Amsterdam 1013 HP Amsterdam
Netherlands
Tel-31 20 423 4114
Fax-31 20 423 4224
E-mail : gnp@gn.apc.org
http://www.hivnet.ch/gnp/index.html
Health Action International (HAI)
HAI is a non-profit, global network of health,
development, consumer and other public interest groups
in more than 70 countries working for a more rational
use of medicinal drugs. HAI represents the interests of
consumers in drug policy and believes that all drugs
marketed should be acceptably safe, effective,
affordable and meet real medical needs. HAI campaigns
for increasing access to essential drugs in a globalized
economy
http://www.haiweb.org/
For Western and Eastern Europe, North America and
Africa
HAI-Europe Coordinating Office
Jacob van Lennepkade 334-T
1053 NJ Amsterdam
tel +31.20.6833684
fax+31.20.6855002
e-mail hai@hai.antenna.nl
Page 11
For Latin America
Coordinator AIS
Asociacion Accion Intemacional para la Salud
Aptdo. 41-128
Lima, Peru
tel +51.1.3461502
fax +51.1.3461502
e-mail ais@amauta.rcp.net.pe
http://ekeko2.rcp.net.pe/AIS-LAC/
For Asia and Pacific Region
HA1 /Action for Rational Drug Use (ARDA)
c/o Consumers International- Regional Office for Asia
Pacific (ROAP)
P.O.Box 1045 10830
Penang, Malaysia
tel +60.4.2291396
fax +60.4.2286506
e-mail ciroap@pc.jaring.my
http.7/www.consumersintemational.org/directory/region
s/roap4.html
For Africa
http://www.haiweb.org/regional/HAI-africa-info.html
Health Global Action Project (GAP)
Coalition
US - based coalition of AIDS treatment activists,
consumer groups, doctors, and social justice advocates.
This is a good site for information about grassroots
organizing and protests on US trade policies affecting
access to treatment. Press materials are extensive. This
is a volunteer-run coalition of AIDS treatment activists.
http://www.aids.org/healthgap/
http://www.durban2000march.org/
International Council of AIDS Service
Organizations (ICASO)
ICASO is a network of community-based AIDS
organizations. They have produced a background paper
on compulsory licensing and parallel importing, in
English, Spanish, and French.
“Compulsory Licensing and Parallel Importing: What
do They Mean? Will They Improve Access to Drugs for
People Living with HIV/AIDS? A Background paper
for NGOs.” (in Spanish, French and English),
International Council of AIDS Service Organizations
(July) at http://www.icaso.org/compulsory.html
ICASO
Central Secretariat
399 Church Street, 4th Floor
Toronto, ON
CANADA M5B 2J6
Tel: (1-416) 340-2437 (main reception)
IZ
Fax: (1-416) 340-8224
http://www.icaso.org
AfriCASO - African Regional Secretariat
ENDA Tiers Monde
54, rue Carnot, B.P. 3370
Dakar SENEGAL
Tel: (221) 823-1935
Fax:(221) 823-6615
Email: africaso@enda.sn
http://www.africaso.org
Contact: Moustapha Gueye
APCASO - Asia/Pacific Regional Secretariat
Malaysian AIDS Council
12 Jalan 13/48A
The Boulevard Shop Office
off Jalan Sentul 51000 Kuala Lumpur
Malaysia
tel: (603)4045-1033
fax:(603)4043-9178
Email: apcaso@pd.jaring.my
http://www.31stcentury.com/apcaso/
Contact: M. Puravalen/Susan Chong
EuroCASO - European Regional Secretariat
Groupe sida Geneve
17 rue Pierre-Fatio
CH-1204 Geneva, SWITZERLAND
Tel: (41-22) 700-1500
Fax: (41-22) 700-1547
Email: eurocaso@hivnetch
http://www.hivnet.ch/eurocaso/
Contact: Florian Hubner
LACCASO - Latin American and the Caribbean
Regional Secretariat
Accion Ciudadana contra el SIDA - ACCSI.
Av. Romulo Gallegos, Edif. Maracay, Apto. 21, El
Marques
CARACAS 1071 - VENEZUELA.
Tel: (58-2) 232 7938
Tel/Fax: (58-2) 235 9215
Email: laccaso@intemet.ve
http://www. laccaso.org
Contact: Edgar Carrasco
NACASO - North America Regional Secretariat
Canadian AIDS Society
900-130 Albert Street
Ottawa, Ontario
Canada, K1P 5G4
Fax: (1-613) 563-4998
Email: SharonB@cdnaids.ca
Page 12
International Gay and Lesbian Human
Rights Commission
IGLHRC is a US-based, non-profit, non-governmental
organization, whose mission is to protect and advance
the human rights of all people and in particular
communities subject to discrimination or abuse on the
basis of sexual orientation, gender identity, or HIV
status. IGLHRC maintains a Campaign for Access to
Treatment.
IGLHRC
C/o Human Rights Watch
350 Fifth Avenue, 34th Floor
New York, NY USA 10118
Tel.+(1-212)216-1256
FAX +(1-212)216-1876
email: karyn@iglhrc.org
http://www.iglhrc.org
http://www.iglhrc.org/campaigns/accesstotreatment/ind
ex.html
Medecins Sans Frontieres (MSF/Doctors
Without Borders)
MSF is an independent humanitarian medical aid
agency operating in 84 countries and committed to two
objectives: providing medical aid wherever it is needed,
regardless of race, religion, politics or sex; and raising
awareness of the plight of the people they help. MSF
has launched an Access to Essential Medicines
Campaign. The campaign is designed to mobilize
MSF’s volunteers and people who support MSF's vision
for improving the health of populations in danger. The
project has three pillars: health exceptions to trade
agreements, overcoming access barriers, and
stimulating research and development for neglected
diseases
International Office
Medecins Sans Frontieres
Rue de la Tourelle, 39
1040 BRUXELLES
Belgium
Tel:+32 (2) 280.18.81
Fax:+32 (2) 280.01.73
http://www.accessmed-msf.org
Panos Institute
The Panos Institute exists to stimulate debate on global
environment and development issues.
Publication: “Beyond Our Means? The Cost of Treating
HIV/AIDS in the Developing World”
Panos, Main Office
9 White Lion St
London N1 9PD
United Kingdom
13
tel +44 (0)20 7278 1111
fax +44 (0)20 7278 0345
email panos@panoslondon.org.uk
http://www.panos.org.uk
People’s Health Assembly
The goal of the People’s Health Assembly is to re
establish health and equitable development as top
priorities in local, national and international policymaking, with primary health care being the strategy to
achieve these priorities. The Assembly aims to draw on
and support people’s movements in their struggles to
build long-term and sustainable solutions to health
problems.
Publication: “Globalisation and Liberalisation of
Healthcare Services: WTO and the General Agreement
on Trade in Services,” K. Balasubramaniam at
http://www.pha2000.org/issue_bala 1 .htm
People’s Health Assembly
International Secretariat Secretariat
Gonoshasthaya Kendra
PO Mirzanagar, Savar
1344 Dhaka
Bangladesh
tel: 880-2-770 8316
fax: 880-2-770 8317
e-mail: phasec@pha2000.org
http://www.pha2000.org
The Third World Network
The Third World Network is an independent non-profit
international network of organizations and individuals
involved in issues relating to development, the Third
World and North-South issues.
Publication: “Pharmaceuticals, Patents and Profits:
South Deprived of Lifesaving Drugs,” Third World
Network,
Third World Network,
228 Macalister Road,
10400
Penang, Malaysia.
Tel: 60-4- 2266728 / 2266159
Fax: 60-4-2264505
E-mail: twn@igc.apc.org, twnet@po.jaring.my
http:// www.twnside.org.sg
Treatment Access Forum
This is an electronic listserve discussion group that
includes many issues of treatment access in developing
countries. Starting in late March 1999, there are many
reports, documents, and personal messages on
compulsory licensing and related issues of trade policy
and access to essential medical technology. You do not
Page 13
■
need to register to read the messages; you can,
however, register free of charge. If you have e-mail
access only, you can still participate; send a message to:
treatment-access@hivnet.ch.
communities to HIV/A1DS, and d) alleviate the impact
of the epidemic.
UNAIDS, 1211 Geneva 27, Switzerland
http://www.unaids.org
http://www.hivnet.ch:8000/treatment-access/tdm
Treatment Action Campaign
The Treatment Action Campaign (TAC)'s main
objective is to campaign for greater access to treatment
for all South Africans, by raising public awareness and
understanding about issues surrounding the availability,
affordability and use of HIV treatments. TAC
campaigns against the view that AIDS is a ‘death
sentence’. TAC aims to’(I) ensure access to affordable
and quality treatment for people with HIV/AIDS; (2)
prevent and eliminate new HIV infections; and (3)
improve the affordability and quality of health-care
access for all. TAC has launched a defiance campaign
to import generic medication into South Africa.
TAC
PO Box 31104
Braamfontein 2017
South Africa
e-mail: info@tac.org.za
Ph: 27 11403 7021
Fax: T1 11 403 2106
email: info@tac.org.za
http://www.tac.org.za
http://www.durban2000march.org/
Treatment Action Group (TAG)
The Treatment Action Group (TAG) is a US-based
organization dedicated to fighting in order to find a cure
for AIDS and to ensure that all people living with HIV
receive the necessary treatment, care, and information
they need to save their lives. TAG focuses on the AIDS
research effort, both public and private, the drug
development process, and the health care delivery
systems.
Publication: “Exploring the American Response to the
Global AIDS Pandemic,” by Derek Link with Mark
Harrington, at
www.aidsinfonyc.org/tag/activism/global.html
Contact: ggonsalves@msn.com
http://www.aidsinfonyc.org/tag/
UNAIDS
As the main United Nation^ advocate for global action
on HIV/AIDS, the Joint United Nations Programme on
HIV/AIDS (UNAIDS) is responsible for leading,
strengthening, and supporting an expanded response to
a) prevent the transmission of HIV, b) provide care and
support, c) reduce the vulnerability of individuals and
The following documents can be found at:
http://www.who.int/medicines/docs/pagespublications/h
iv_relatedpub.htm
“Patent Situation of HIV/AIDS-related Drugs in 80
Countries” (UNAIDS/WHO)
(also:
http://www.unaids.Org/publications/documents/health/a
ccess/patsit.doc)
“Pharmaceuticals and the WTO TRIPS Agreement:
Questions and Answers” (UNAIDS/WHO)
"Essential drugs used in the care of people living with
HIV: sources and prices," Joint UNAIDS-UNICEF SDWHO/EDM Project, (2/2000)
Other relevant UNAIDS/WHO documents:
“Access to Drugs: UNAIDS Technical Update (March
2000)
http://www.unaids.0rg/publicati0ns/d0cuments/health/a
ccess/accestue.pdf
“UNAIDS Initiative on Accelerated Access to
HIV/AIDS Care”
“HIV/AIDS and Human Rights: International
Guidelines” (United Nations, 1998)
Office of the United Nations High Commissioner for
Human Rights, 1211 Geneva 10, Switzerland or,
UNAIDS, 1211 Geneva 27, Switzerland
"Guidelines for Drug Donations," World Health
Organization (WHO) (1999) at
http://www.drugdonations.org
“NGO Perspectives on Access to HIV-Related Drugs in
13 Latin American and Caribbean Countries
(UNAIDS)” at
http://www.unaids.0rg/publications/documents/health/a
ccess/una98e25.pdf
vso
VSO is an international development charity that works
through volunteers. VSO is responding the HIV/AIDS
crisis with the Treatment for Life campaign, which
aims to increase the availability of medicines and by
working with overseas partners to help prevent further
spread of infection.
Page 14
Hj.
IS
See their report, ‘‘Drug Deals: Medicines, Development
and HIV/AIDS,” at
http://www.vso.org.uk/campaign/drugdeals.pdf
http://www.vso.org.uk/
Women’s Environment and Development
Organization (WEDO)
WEDO is an international advocacy network actively
working to transform society to achieve a healthy and
peaceful planet with social, political, economic and
environmental justice for all through the empowerment
of women, in all their diversity, and their equal
participation with mdn in decision-making from
grassroots to global arenas.
Publication: “A Gender Agenda for the WTO,” WEDO
Primer, Women and Trade (Nov. *99) at
http://www.wedo.org/global/wedo_primer.htm
WEDO
355 Lexington Avenue, 3rd Floor
New York, New York 10017, USA
Tel: 212-973-0325
Fax: 212-973-0335
E-mail: wedo@igc.org
gopher://gopher.igc.apc.org/11/orgs/wedo
http://www.wedo.org/
Information Specific to Drug Donations
Aid for AIDS
Aid For AIDS is a US-based non-profit organization
founded to support the clinical care of HIV-infected
Latin Americans living in the United States and
throughout Latin America through a small-scale drug
donation program.
Aid for AIDS
515 Greenwich St
New York, NY 10013
USA
Tel: (001) (212) 337-8043
Fax: (001) (212) 337-8045
info@aid4aids.org
http://www.aidforaids.org
AIDS Empowerment and Treatment
International (AIDSETI)
Contact them (see address in first section) for more
information on their program, “The African AIDS
Network (AAN),” which is a program of AIDSETI that
collects surplus medications from across the United
States and closely monitors their distribution to AIDS
patients in six African countries. The AAN also
provides support referrals for HIV/AIDS patients and
technical support for doctors in Africa.
Global Network of People Living with
HIV/AIDS (GNP+)
Contact them (see their address in previous section) and
ask for their “Guidelines for the Donation of
Medication”
Wemos Foundation
Wemos is a Dutch NGO that addresses international
health issues through policy advocacy and education
activities They maintain a web site on drug donations,
in seven languages: http://www.drugdonations.org
Wemos Foundation, PO Box 1693
1000 BR Amsterdam
The Netherlands
Fax:+31-20-468-6008
Phone+31 20-468-8388
Pharmaceuticals@wemos.nl
http://www.wemos.nl
http://www.drugdonations.org
Other Resourcesfor Reference
World Trade Organization
See the full text of the Trade Related Aspects of
Intellectual Property (TRIPS) Agreement at the World
Trade Organization’s website:
http://www.wto.org/
Pharmaceutical Manufacturers’
Association
Pharmaceutical industry lobbying group.
http://www.phrma.org
Page 15
We gratefully acknowledge the invaluable assistance and input provided
by Mobilization Against AIDS (MAA).
If you have any comments additions or edits, please contact us:
International Gay and Lesbian Human Rights Commission (IGLHRC)
1360 Mission St., Suite 200
San Francisco, CA 94103 USA
Tel. +1-(415) 255-8680 FAX +l-(415) 255-8662
Satellite Office:
C/o Human Rights Watch
350 Fifth Avenue, 34th Floor
New York, NY 10118 USA
Tel. 4-1 -(212) 216-1256 FAX +1-(212) 216-1876
iglhrc@iglhrc.org
http://www.iglhrc.org
Page 16
ITAPPENDIX : WTO Member Countries As of June 14, 2000
137 members on 14 June 2000, with dates of membership
(see in http://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm)
Angola...........................
Antigua and Barbuda.....
Argentina......................
Australia
Austria
Bahrain
Bangladesh
Barbados
Belgium
.
Belize
Benin
Bolivia
Botswana
Brazil
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cameroon
Canada
Central African Republic
Chad
Chile
.....................
Colombia
Congo
Costa Rica
Cote d'Ivoire
Cuba
Cyprus
Czech Republic
Democratic Republic
of the Congo..................
Denmark........................
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Estonia
European Communities ..
Fiji
Finland
France
Gabon
The Gambia
Georgia
Germany
Ghana
.
Greece
Grenada
Guatemala
Guinea Bissau
Guinea
Guyana
Haiti
. 23 November 1996
. 1 January 1995
. 1 January 1995
1 January 1995
1 January 1995
I January 1995
1 January 1995
1 January 1995
1 January 1995
1 January 1995
22 February 1996
12 September 1995
31 May 1995
1 January 1995
1 January 1995
1 December 1996
3 June 1995
23 July 1995
13 December 1995
1 January 1995
31 May 1995
19 October 1996
1 January 1995
30 April 1995
27 March 1997
1 January 1995
1 January 1995
20 April 1995
30 July 1995
1 January 1995
. 1 January 1997
. 1 January 1995
.31 May 1995
1 January 1995
9 March 1995
21 January 1996
30 June 1995
7 May 1995
13 November 1999
1 January 1995
14 January 1996
1 January 1995
1 January 1995
I January 1995
23 October 1996
14 June 2000
I January 1995
I January 1995
1 January 1995
22 February 1996
21 July 1995
31 May 1995
25 October 1995
1 January 1995
30 January 1996
Honduras ........................... . 1 January 1995
Hong Kong, China,............ . I January 1995
Hungary............................. . I January 1995
Iceland ................................ . 1 January 1995
India................................... . 1 January 1995
Indonesia ............................ . I January 1995
Ireland................................. . 1 January 1995
.21 April 1995
Israel
Italy.................................... . 1 January 1995
.9 March 1995
Jamaica
Jordan................................. . 11 April 2000
Japan................................... . 1 January 1995
Kenya ................................. . 1 January 1995
Korea, Republic of.............. . 1 January 1995
Kuwait ............................... . 1 January 1995
.20 December 1998
The Kyrgyz Republic
Latvia.................................. . 10 February 1999
.31 May 1995
Lesotho
Liechtenstein ...................... . 1 September 1995
Luxembourg ....................... . 1 January 1995
Macau, China....................... . 1 January 1995
.17 November 1995
Madagascar
.31 May 1995
Malawi
Malaysia............................. . 1 January 1995
.31 May 1995
Maldives
.31 May 1995
Mali
Malta .................................. . 1 January 1995
.31 May 1995
Mauritania
Mauritius
...... 1 January 1995
Mexico
;......................... 1 January 1995
29 January 1997
Mongolia
1 January 1995
Morocco
26 August 1995
Mozambique
1 January 1995
Myanmar
I January 1995
Namibia
Netherlands
For the Kingdom in Europe
and for the Netherl. Antilles 1 January 1995
New Zealand
1 January 1995
Nicaragua
3 September 1995
Niger
13 December 1996
Nigeria
1 January 1995
Norway
1 January 1995
Pakistan
1 January 1995
Panama
6 September 1997
Papua New Guinea
9 June 1996
Paraguay
1 January 1995
Peru
1 January 1995
Philippines
1 January 1995
Poland
......... I July 1995
Portugal
1 January 1995
Qatar.................................... 13 January 1996
Romania
1 January 1995
Rwanda
Saint Kitts and Nevis
Saint Lucia
22 May 1996
21 February 1996
1 January 1995
Page 17
18
Saint Vincent
& the Grenadines
Senegal...............
Sierra Leone
Singapore
Slovak Republic .
Slovenia
Solomon Islands..
South Africa
Spain
Sri Lanka
Suriname
Swaziland
Sweden
Switzerland
. I January 1995
. 1 January 1995
.23 July 1995
I January 1995
I January 1995
30 July 1995
26 July 1996
1 January 1995
I January 1995
1 January 1995
1 January 1995
I January 1995
1 January 1995
1 July 1995
Tanzania .................
Thailand...................
Togo
Trinidad and Tobago
Tunisia
Turkey
Uganda ...............
United Arab Emirates
United Kingdom.......
United States ...........
Uruguay...................
Venezuela.................
Zambia
Zimbabwe
.. 1 January 1995
.. I January 1995
..31 May 1995
.. 1 March 1995
.29 March 1995
.26 March 1995
. 1 January 1995
.10 April 1996
. 1 January 1995
. 1 January 1995
. 1 January 1995
. 1 January 1995
1 January 1995
5 March 1995
WTO Least-Developed Member Countries As of June 14, 2000
http:/7www. wto.org/english/thewTo_e/whatis_e/tif_c/org7_e.htm
The WTO recognizes as least-developed countries (LDCs) those countries which have been designated as
such by the United Nations. There are currently 48 least-developed countries on the UN list, 29 of which to
date have become WTO members.
Angola, Bangladesh, Benin, Burkina Faso, Burundi, Central African Republic, Chad, Congo, Democratic
Republic of the, Djibouti, Gambia, Guinea, Guinea Bissau, Haiti, Lesotho, Madagascar, Malawi, Maldives,
Mali, Mauritania, Mozambique, Myanmar, Niger, Rwanda, Sierra Leone, Solomon Islands, Tanzania,
Togo, Uganda, Zambia,
Six additional least-developed countries are in the process of accession to the WTO. They are: Cambodia,
Laos, Nepal, Samoa, Sudan and Vanuatu.
There are no WTO definitions of “developed” or “developing” countries. Developing countries in the WTO
are designated on the basis of self-selection although this is not necessarily automatically accepted in all
WTO bodies.
Page 18
Drug policy at the 53rd World Health Assembly
Medecins Sans
Frontieres
HA
Page 1 of 11
piW
Consumer Project
on Technology
Health Action
International
Drug Policy at the 53rd World Health Assembly
May 2000
(
Improving Access to Essential Medicines:
Confronting the Crisis
One-third of the world’s population lacks access to essential drugs. In the most
impoverished parts of Africa and of Asia that number is more than 50%.[i]
Because of that fact, many effective medicines remain out of reach to people in
developing and Eastern and Central European countries. Long-time killers such
as tuberculosis (TB) and malaria continue to claim millions of lives in the
developing world. Very few people in this region have access to medicines that
are the standard in industrialised countries. The AIDS epidemic is also
exacerbated by lack of access to medicines-95% of the 34 million people with
HIV/AIDS remain without access to treatment.[ii]
Many factors contribute to the problem of limited access to essential medicines.
Unavailability can be caused by logistical supply and storage problems,
substandard drug quality, irrational selection of drugs, wasteful prescribing and
use, inadequate production, insufficient drug research and development (R&D)
and prohibitive prices.
WHO’s response
The Revised Drug Strategy (RDS) was adopted by the World Health Assembly
(WHA) in 1986 (WHA39.27). The RDS is a comprehensive policy designed to
ensure equitable access to essential drugs of acceptable quality. It promotes the
development of national drug policies including such elements as drug
legislation, independent drug information, control of unethical promotion and
inappropriate drug donations, safety, efficacy, quality of drugs and rational use
of drugs. The Essential Drugs Concept is the cornerstone of such a policy. 1 he
WHO Model List of Essential Drugs is a key element of the RDS and applies to
both the private and public sectors.
In a series of resolutions, the WHA has reaffirmed its commitment to the RDS
http://www.haiweb.org/news/WHA53en.html
6/9/00
Page 2 of 11
Drug policy at the 53rd World Health Assembly
and has adapted the strategy to enable WHO to address current issues relating to
pharmaceuticals. WHO uses the RDS to support countries as they develop
national drug policies.
International trade and WHO
Last year's Assembly ended with a resounding show of support for the RDS
(resolution WHA52.19). The resolution gave WHO the firm mandate to expand
its work on a range of trade-related issues affecting access, quality, and rational
drug use. It specifically asked the WHO to study the effects of international tra'de
regulations on'health and to assist countnes in impiementing trade regulations
while addressing public health needs and priorities.)iii]
"WHO has a mandate to make public health a priority in trade agreements, but
has been relegated to the background in the WTO decision-making process said
a recent letter published in The Lancet .[i\ ] WHO’s Director General confirmed
this fact when she stated that WHO was invited to attend the recent trade
ministerial in Seattle "not as a participant, but as an active and vocal
observer")' J The WHO Director General’s progress report on the RDS (A53/10)
made to the Executive Board in January paints a picture of a cautious approach
regarding pharmaceuticals and trade.
Since last year’s Assembly, the WHO has expressed the need to implement the
TRIPs taking health concerns into consideration and has advocated using the
safeguards that are offered in the TRIPs agreement. The WHO has also come out
Dr Gro Harlem Brun
strongly in favour of policies that encourage the production and use of generic
medicines, [vi] Although WHO has developed clear policy statements in recent
In her address to the
months on strategies related to trade that help increase access to medicines, it
“Access
can do much more to fulfil its mandate.
to HIV drugs is part o
system. ”
WHO needs to be a pro-active participant in global trade issues that affect access
to medicines. The market fails when it comes to providing for the poor. Strong
public commitment and government intervention are needed to ensure access
i---------and
equity in health care. In the international arena the WHO should be a strong
leading force "not an observer".
[viii]
Translating the Essent
today rs
reality
Since 1977, the
WHO’s
Essential Drugs Com.
Global trade regulation and access to drugs
Globalisation and the international regulation of trade are becoming increasingly
linked to health policy. Concerns about the consequences of globalisation and
international trade agreements on access to drugs were first raised during the
1996 World Health Assembly in a resolution on the RDS[ixJ.
The World Trade Organization's (WTO) agreement on trade-related aspects of
intellectual property rights (TRIPs) is the most important international agreement
on the protection of patents, copyright and trademarks. TRIPs obliges all WTO
http://www.haiweb.org/newsAVHA53en.html
6/9/00
Drug policy at the 53rd World Health Assembly
Page 3 of 11
member states to provide 20 years of patent protection for medicines.
Industrialised countries should have implemented the TRIPs by 1996,
developing countries had to introduce national regulation on intellectual property
by the year 2000, and least developed countries have until 2006. Intellectual
property (IP) protection provides clear benefits. However, there are also costs. A
Trade disputes invo
good IP system extends IP protection in some areas, but provides exceptions or
limitations on IP rights in others. For each country, the best IP regime will
Concerns about the
depend upon its own situation, including its level of income, stage of
development and its own legal traditions.
The Bangui Agreem
Patent protection plays a role in stimulating drug research, but most of the global
In francophone A frice
R&D is focused on the health needs of the developed world. In addition, the
market monopoly conferred by patents leads to higher prices for new medicines.
What is compulsory
There are concerns that the implementation of TRIPs will lead to further drug
price increases and will have harmful effects on developing countries capacity to
Compulsory licensinc
produce affordable, generic versions of life-saving drugs.
Why is the WHO’s input needed in trade policy?
Globalisation and new international trade rules demand new approaches to
protect and advance the basic human right of access to health care. As the
international organisation mandated to protect public health, the WHO s input is
needed now as countries create national laws that are consistent with the TRIPs
and because the WTO will be interpreting TRIPs provisions. Strong public
health input is needed at both national and international levels. The DirectorGeneral’s report HIV/AIDS: confronting the epidemic (WHA53/6) and draft
resolution (EB105.R17) refer to member states’ need for WHO’s advice on
options allowed within the TRIPs to increase access to HIV/AIDS-related
medicines.
The objectives and principles of the TRIPs agreement (articles 7 and 8) provide a
strong public interest framework for the interpretation and implementation of
intellectual property rights. Developing countries in particular should be actively
encouraged to use this framework to the fullest. In reality, 51st the opposite is the
casej.w iii | Countries that attempt to use TRIPs provisions to increase
availability of essential drugs have come under tremendous pressure to change
their legislation, even when the proposed legislation did not violate international
Parallel imports
agreements. Developing countries do not receive technical assistance that
enables them to use safeguards to counterbalance the negative effects of patent
Parallel imports are c
protection.
WHO's support is vital to withstand such pressure. For example, there are a
number of country disputes currently taking place which invol ve legislation on
compulsory licensing of essential medicines, generic competition and other
related issues. WHO has an important role to play in these discussions. It should
assist countries and other stakeholders by providing briefing documents
outlining policy options and by giving technical assistance. The joint WHOUNAIDS missions to Thailand and Western Africa that looked into the patent
situation of HIV/AIDS-related drugs are good examples of how the WHO can
http://www.haiweb.org/news/WHA53cn.html
The lack of R & D fo
world's
most common disei
Infectious diseases k
In developing countn
month's
wages. In many poor
6/9/00
Drug policy at the 53rd World Health Assemury
support member states.[.xix]
years'
income. Ixvu]
Recommendations for Action:
For WHO:
• Provide pro-active measures and strong public health leadership in the area
of access to essential drugs.
• Actively support differential pricing policies that lead to a dramatic price
reduction for drugs in developing countries. WHO should develop
strategies for differential pricing policies and actively advocate for
implementation.
• Issue technical briefings on the following issues:
* the role of generic competition in increasing affordability of drugs
and policy options to speed up the introduction of generic products;
* how to issue a compulsory license in general, and on public health
grounds;
* drug price control options for developing countries;
* the effects of financial requirements such as tariffs and taxes that
inappropriately increase drug prices.
• Review the Essential Drugs List to ensure that the Essential Drugs
Concept responds to current epidemiological trends. This can be done by
including a second group of drugs—not included now because of cost
consideration—with guidance on how to increase affordability and how to
ensure the rational use of these drugs.
• Provide member states with advice and technical guidance to ensure that
international trade agreements, including TRIPs, do not have a detrimental
effect on public health and to ensure that safeguards of the TRIPs to
address the negative effects of patents are used to the fullest. One way to
do this would be to take part in WIPO missions and trainings on TRIPs
implementation.
• In cooperation with WIPO, develop a model law for intellectual property
protection for use by developing countries.
- Encourage the development of a working group on access to essential
medicines at the World Trade Organisation as called for in the Amsterdam
statement (see
http://www.haiweb.org/campaign/novseminar/amsterdam_statement.html ).
• Support the need for inclusion of health concerns in trade negotiations.
• Monitor systematically the effects of TRIPs on access to drugs, drug
prices, technology transfer and pharmaceutical research and development.
• Develop, in co-operation with other relevant organisations, an essential
research agenda for neglected diseases.
• Take a leading role in devising new and innovative approaches to
stimulating research in essential medicines, including:
f
* increased public and donor funding of research and development with
assurances of guaranteed public access;
http://www.haiweb.org/ncws/WHA53cn.htmI
6/9/00
Drug policy at the 53rd World Health Assembly
Page 5 of f 1
* compulsory research obligations, such as requirements that companies
reinvest a percentage of pharmaceutical sales into R&D for neglected
diseases, either directly or through public or private sector R&D
programmes;
* development of neglected disease legislation that stimulates public
investment for communicable disease vaccines and medicines.
• WHO in cooperation with international organisations, national
governments and drug companies needs to actively support developing
countries to increase drug development capacity. This includes proactive
technology transfer projects.
By member states:
• Reaffirm commitment to developing, implementing, and monitoring
national drug policies and take all necessary steps in order to ensure
equitable access to essential drugs.
• Ensure that when national laws are reviewed to include TRIPs
requirements, parallel imports and compulsory licensing are included.
Seek support from the WHO in this process.
• Ensure that national drug policies include mechanisms to make needed
medicines affordable, including means to remove inappropriate taxes.
• Assure the provision of affordable drugs through implementation of a
strong generic drug policy, bulk purchasing, negotiations with
pharmaceutical companies and adequate financing.
• Least developed countries should not implement TRIPs in national
legislation before the required deadline of 2006.
• Ensure that national patent laws include the possibilities for compulsory
licensing and parallel import. This should include simple administrative
procedures for granting compulsory licenses.
• National governments and organisations will have to address the market
failure that has led to the abandonment of R&D for neglected diseases.
This requires political will, a strong commitment to prioritise health
considerations and the enforcement of rules, regulations and other
mechanisms to effectively stimulate drug development for neglected
diseases.
What is compulsory licensing?
Compulsory licensing is one of the TRIPs provisions that can help address the
negative effects of patent monopolies. Compulsory licensing is the granting of a
license to a third party without the consent of the patent holder. It is a legal or
administrative procedure and should be set out in national legislation. A
compulsory license may be issued on various grounds of general interest
including public health. The patent holder receives adequate remuneration for
the license. Compulsory licensing is a legal option, consistent with the TRIPs
agreement (article 31). Countries should ensure simple administrative procedures
http://www.haivveb.org/ncvvs/WHA53en.html
6/9/00
Drug policy at the 53rd World Health Assembly •
Page 6 of 11
for granting compulsory licenses. In many countries, compulsory licensing is
part of the patent law. For example, France's law on this issue authorises
compulsory licensing when patented drugs “are only made available to the
public in insufficient quantities or quality or at abnormally high prices”.! \h|
Translating the Essential Drugs Concept into today’s reality
Since 1977, the WHO’s Essential Drugs Concept has been a major contribution
to improving access to medicines in developing countries. Essential drugs arc
“those that satisfy the health care needs of the majority of the population; they
should therefore be available at all times in adequate amounts and in the
appropriate dosage forms”.| \ i i ] The inclusion criteria are proven safety and
efficacy, well-understood therapeutic qualities and cost. Without the cost criteria
the list would be longer. Presently fewer than 20 drugs on the list are patentprotected products.
Twenty-three years after the publication of the first Essential Drugs List, the
WHO’s model list remains one of the most important public health tools
available. The list suggests a limited number of drugs with a good benefit/risk
ratio and an affordable price which help health care providers make rational
choices and meet the majority of medical needs.
Since its first edition, the WHO’s model list has been updated many times; the
eleventh edition was published in December 1999. Today WHO's Essential
Drugs List faces many pressures. Because cost is one of the list’s inclusion
criterion, the latest list cannot respond to new epidemiological trends. This is the
case, for example, with diseases such as Shigellosis and TB that can no longer be
treated with first-line treatment because of drug resistance. In some countries,
HIV/AIDS is the most pressing public health problem. However, antiretroviral
therapies are not included on the WHO model list except for the very limited
indication of mother-to-child transmission.
Critics argue that second-line drugs such as new and expensive antibiotics and
antiretrovirals should not be added to the WHO list because they would
undermine the Essential Drugs Concept, are too expensive, or are difficult to use.
But can the list continue to ignore so much suffering? Clearly this dilemma
needs to be addressed.
Adding such drugs to the WHO Essential Drugs List calls for caution: this
second group of drugs must be clearly distinguishable from the first-line
treatment drugs which are more affordable and easy-to-use. They should be
included with published guidance on how to use them and how to ensure their
affordability.
The lack of R & D for the world’s most common diseases
Infectious diseases kill 17 million people every year, 90% of whom live in
developing countries.] xiv] In the absence of effective, affordable and easy-to-use
medicines to fight these diseases, respiratory infections, malaria, and
http://www.haiweb.org/nevvs/WHA53cn.html
6/9/00
Drug policy at the 53rd World Health Assembly
Page 7 of 11
tuberculosis (TB) remain the leading causes of death and illness in African,
Asian and South American countries. These regions are home to four-fifths of
the world population.
Today, science and technology arc sufficiently advanced to provide the
necessary medicines to control these leading killers. However, research and
development (R&D) for new medicines for so-called tropical diseases, which
correspond largely to the diseases affecting poor countries, has come to a
standstill. Only a few percent of the world-wide expenditure on health R&D
(estimated at a total of USS50-60 billion a year) is devoted to the development of
such medicines. For example, 0.2% of the global pharmaceutical research budget
is spent on acute respiratory infections, TB and diarrhoea, while 18% of the
deaths are attributable to these diseases.| w J
Current R&D priorities are set by an increasingly consolidated multinational
drug industry, and are based on economic priorities (i.e. maximising return to
shareholders) rather than on global health needs. As a result, drug development
is focused on the health requirements of the wealthiest population, shifting
increasingly from life-threatening diseases towards life-style 'diseases'.
The results for the global drug development outcome are severe: of the 1,233
new drugs (new chemical entities) that came on the market between 1975 and
1997, only 13 were targeted specifically at tropical, infectious diseases.!x\ i j
Meanwhile, resistance renders many infections unresponsive to older, cheaper
anti-infectious drugs, and in some instances large pharmaceutical companies
have simply discontinued production of "old", cheap, and effective tropical
disease drugs because of insufficient profit margins. Communicable diseases
justifiably warrant the term 'Neglected Diseases'.
Drug development costs are substantial. Dedicated expenses for development of
a given drug can range from less than US$1 million to tens of millions of dollars.
If one includes adjustments for risk and the costs of financing the investments,
the cost is higher, but how much higher is a matter of controversy.
Representatives of the pharmaceutical industry claim development expenses,
including risk and capital costs, are hundreds of millions of US dollars. There are
questions about the accuracy of the assumptions used in the industry estimates as
well as the relevance. For example, the industry estimates assume companies
fund all of the clinical and pre-clinical research, and for many important drugs,
the government's role in funding research is significant. O’
(For more information, see
http://www.cptec_h,org/ip/liealtli/econ/howmuch.html )
Parallel imports
Parallel imports are cross border trade in a product without the manufacturer's
permission. It can be an attractive option when the same product is being sold for
different prices in different markets For example, a pricing study carried out by
Health Action International in 1999 showed that Glaxo Wellcome's acyclovir
http://wvvw.haiwcb.org/news/WHA53cn.html
6/9/00
Drug policy at the 53rd World Health Assembly
Page 8 of 11
800 mg in Malaysia costs US$316. The same product was being sold by the
same company in India for US$89. This is a result of generic competition in
India. Prices for Smithkline Beecham’s amoxycillin (Amoxil) range from: US$6
in Pakistan, US$13 in Canada, US$8 in New Zealand, USS25 in The Philippines,
US$22 in Malaysia, and US$14 in Indonesia. | xni| Parallel imports are the
global version of shopping around for the best value and are permitted under the
TRIPs agreement. Clearly it is not in the interest of developing countries at this
point to restrict parallel imports of pharmaceuticals. Many European countries
already benefit from significant parallel trade in order to reduce the overall cost
of medicines.
Some drug companies say that parallel trade should be stopped to prevent
inexpensive drugs from developing countries from entering the markets of rich
countries. Already, this is not permitted by national legislation in Europe, the
United States, Japan and other developed countries. Moreover, there is no reason
to prevent poor countries from engaging in parallel trade. In particular, there is
no reason why poor countries should not be able to buy products in rich
countries, when prices are lower due to competition in the larger US and
European markets.
Trade disputes involving access to drugs
In 1997 South Africa decided to amend its 1965 Medicines Act to include
compulsory licensing and parallel imports in accordance with the provisions of
the TRIPs. The multinational pharmaceutical industry brought legal action
against the South African State claiming that the new law was unconstitutional.
In addition, the US government issued trade sanctions against South Africa to
pressure the country to change its proposed medicines law. The European
Commission added its voice to the US complaints. The United States Trade
Representative even went as far as to cite unwelcome views expressed by South
Africa at the World Health Assembly as a basis for sanctions(see
http://www.cptech.org/ip/health/sa).
In Thailand the right to issue compulsory licenses for pharmaceuticals was
limited by the Thai government following a US threat to increase tariffs on
imported Thai wood products and jewellery.| x] The US policy came under fierce
attack from AIDS activists, public health activists, consumer groups and
international NGOs. In response to the pressure the US was forced to declare a
change in US policy with regard to intellectual property rights and access to
medicines. Under the new policy the US Trade representative (USTR) and the
Department of Health and Human Services (HHS) will work together to
establish a process to analyse health issues that arise in the application of US
trade-related intellectual property law and policy.
In 1999, the US had disputes regarding intellectual property and health care in 42
countries of which 37 were developing countries) \i j. u
http://www.haiweb.org/ncws/WHA53en.htnil
6/9/00
Drug policy at the 53rd World Health Assembly
Page 9 of 11
(sec also www.cptcch.org/ip/health/country/ajlcountncs.html).
Concerns about the effects of TRIPs
• Increased patent protection leads to higher drug prices. The number of new
essential drugs under patent will increase but the drugs will remain out of
reach to people in developing countries because of their high prices. As a
result, the access gap between developed and developing countries will
grow.
• Enforcement of the WTO rules will have an effect on local manufacturing
capacity and will remove a source of generic, innovative, quality dmgs on
which poorer countries depend.
• It is unlikely that the TRIPs agreement will encourage adequate research
and development in developing countries for diseases such as malaria and
TB. There are also inadequate incentives for the research-based
pharmaceutical industry to invest its increased revenues towards the
development of essential medical technologies.
• Developing countries are under pressure from industrialised countries and
industry to implement patent legislation that goes beyond the obligations
of the TRIPs agreement. This is called “TRIPs plus” protection. “TRIPs
plus” is patent legislation that provides stronger protection of intellectual
property than the TRIPs agreement requires or does not include safeguards
such as compulsory licensing that are provided in TRIPs to counteract the
negative effects of patent protection. An example of a “TRIPS plus” patent
law is a law that does not allow for the issuing of a compulsory license or
parallel imports.
• Industrialised countries and the World Intellectual Property Organization
(WIPO) offer expert assistance to help countries become TRIPs compliant.
This technical assistance however does not take into account the specific
needs of the health sector of developing countries and both of these
institutions are under strong pressure to advance the point of view of large
companies that own patents and other intellectual property rights.
The Bangui Agreement:"TRIPs plus” in Western Africa
In francophone African countries, patents are granted through a regional patent
office called the African Intellectual Property Organization or OAPI, which acts
as a national patent office for all OAPI member states. Patents are granted and
regulated according to the Bangui Agreement which constitutes the patent law of
all these countries. Although the majority of OAPI members are least-developed
countries, the Bangui Agreement was recently revised to comply with the TRIPs
before the year 2000. Despite the unaffordability of many essential drugs in
Western Africa, the new Bangui Agreement is more stringent than the TRIPs
Agreement and provides little manoeuvring room in case of patent abuse.
Compulsory licences arc only available provided that the patented drug can be
http://www.haiwcb.org/news/WHA53en.html
6/9/00
Drug policy at the 53rd World Health Assembly
Page 10 of 11
2.8
manufactured locally when in reality there is little manufacturing capacity in the
region. Parallel imports are only possible between OAPI member states whereas
lower prices might be found in other parts of the world. As a result, patent
holders enjoy greater protection than the public interest in OAPI member states.
References
vV H()
S’ntog*' 2000 2003: F.~...~.vork for action in essentia*
aiiu ■iicuicinea |»ulk.y. Department of Essential
Drugs and Medicines Policy.World Health Organization, p. 28.
.njlbid.
: i Revised Drug Strategy. WHA52.19. 24 May 1999.
“Trade agreements and public health: role of WHO" The Lancet 2000; 355:580, 12 Feb 2000.
Brundtland, GH. International trade agreements and public health:WHO’s role. Presented by video at the Conference on
Increasing Access to essential drugs in a globalised economy. Amsterdam, 25-26 Nov 1999.
^^dt,an<1’ G H oPcning remarks: Parliamentary Commission on Investigation of Medicines. Brasilia, Brazil, 4 April
1' “The usc of essential drugs: Model list of essential drugs (seventh list)". Fifth repon of the WHO expen committee, WHO
Technical Report Scries, 825, World Health Organization, Geneva, p. 4.
r> i.. . Towards a strategic agenda for the WHO secretariat: Statement by the Director-General to the Executive Board at its 105sfi
session" (EB105/2) 24 January 2000, p. 7.
:'' Revised Drug Strategy resolution (WHA49.14) 25 May 1996, World Health Organization, p. 3.
i \ ; Wilson, D. et al “Global trade and access to medicines: AIDS treatment in Thailand. The Lancet, Vol. 345, pp. 1893-1895.
; \ < j Data collected by Consumer Project on Technology: http://www.cptech.org/ip/health/country/allcountrics.html
’xh! Art. 613 Du Code de la Proprietc intellectuelle.
I'.mj Bala, K. et al. “Retail drug prices: The law of the jungle" HAI News, No. 100, April, 1998.
: \ . , Fifty facts from the World Health Report 1998, World Health Organization, Geneva;
http://www.who.int/whr/1998/factse.htm.
i'■' i The Human Development Report 1999, United Nations Development Programme.
! V.Pecoul, B. et al. “Access to essential drugs in poor countries: a lost battle?” The Journal of the American Medical
Association (JAMA), Vol. 281, no. 4, pp. 361-67, 27/1/99.
1999 W°rld Hca,th Assembly gives resounding support to WHO technical programmes," WHO press release WHA/I8, 25 May
hv Hi.: ’t Hoen, E. "Dying of market failure: MSFs campaign for access to essential medicines, EPHA Update, Jan/Feb 2000, p.
| xis: WHO/UNAIDS Joint mission: Access to HIV/A1DS - related drugs in Thailand. Bangkok, 22-25 February 2000. WHO,
UNAIDS, and Report of a UNAIDS/WHO Fact finding mission in Thailand 23 August 2 September 1999 (in collaboration with
Medecins Sam Frontieres).
About the organisations
Health Action International (HAI) is a network of more than 200 consumer, health,
development action and other public interest groups involved in health and
pharmaceutical issues world-wide.
Health Action International - European Office
Jacob van Lennepkade 334-T
1053 NJ Amsterdam
The Netherlands
Tel: (+31-20) 683 3684
Fax: (+31-20) 685 5002
E-mail: hai@hai.antenna.nl
Website: http://www.haiweb.org
HA
Medecins Sans Frontieres (MSF) offers assistance to populations in distress, to
victims of natural or man-made disasters and to victims of armed conflict without
discrimination and irrespective of race, religion, creed or political affiliation. MSF was
awarded the 1999 Nobel Peace Prize.
http://www.haiwcb.org/nevvs/WHA53cn.htnil
6/9/00
Drug policy at the 53rd World Health Assembly
Page 11 of 11
M6decins Sans Frontieres
Access to Essential Medicines Project
Rue du Lac 12
C.P. 6090
1211 Geneva 6
Switzerland
Tel: +41 22 849 8405
Fax: +41 22 849 8404
E-mail: access@geneva.msf.org
Website: http://www.accessmed-msf.org
Consumer Project on Technology (CRT) is a US-based, non-profit research and
advocacy organisation created by consumer advocate Ralph Nader. Its activities focus
on information technologies, intellectual property and research and development.
Consumer Project on Technology
P.O. Box 19367
Washington, DC 20036
United States of America
Tel: (+1-202) 387 8030
• Fax: (+1-202) 234 5176
E-mail: love@cptech.org
Website: httfx/Awwyy.cptech.org
http://www.haiwcb.org/news/WHA53cn.html
6/9/00
WTO | Intellectual property (TRIPS) - fact sheet - pharmaceuticals - 1
search
WORLD TRADE
Organization
Page I of2
on this site
register
contact us
Illi W1O i WTO NEWS i TRADE TOPICS l RESOURCES i DOCIIMLNIS | COMMUHIT Y/EORUMS
espanol
ON THIS PAGE
Ehe balance
The basic right
frangais
Not a permit to market
home - trade topics > trips > pharma fact sheet > philosophy
FACT SHEET: TRIPS AND PHARMACEUTICAL PATENTS
Philosophy: TRIPS attempts to strike a
balance
The WTO’s Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS) attempts to strike a balance between the
long term social objective of providing incentives for future
inventions and creation, and the short term objective of allowing
people to use existing inventions and creations.
The agreement covers a wide range of subjects, from copyright
and trademarks, to integrated circuit designs and trade secrets.
Patents for pharmaceuticals and other products are only part of
the agreement.
April 2001
Contents
> Philosophy: striking a balance
> Obligations and exceptions
> What does "generic" mean?
> Developing countries
Tnis fact sheet has been prepared
oy the intottnation ana Media
delations Division of (he WTO
secrctanat to help public
i.Ttd”'si<!iidin§. It is not an official
interpretation ot the WTO
aerecnicnts or mcnibers’ positions
The balance works in three ways:
• Invention and creativity in themselves
should provide social and technological
benefits. Intellectual property protection
encourages inventors and creators because
they can expect to earn some future
benefits from their creativity. This
encourages new inventions, such as new
drugs, whose development costs can
sometimes be extremely high, so private
rights also bring social benefits.
• The way intellectual property is protected
can also serve social goals. For example,
patented inventions have to be disclosed,
allowing others to study the invention even
while its patent is being protected. This
helps technological progress and
technology dissemination and transfer.
After a period, the protection expires,
which means that the invention becomes
available for others to use. All of this
avoids "re-inventing the wheel”.
• The TRIPS Agreement provides flexibility
for governments to fine tune the
protection granted in order to meet social
goals. For patents, it allows governments
to make exceptions to patent holders’
hltp.7/www. wto.org/english/tratop_e/trips_e/factsheet_phamiO l_e.htm
The TRIPS Agreement
Article 7
Objectives
The protection and
enforcement of
intellectual property
rights should contribute
to the promotion of
technological innovation
and to the transfer and
dissemination of
technology, to the
mutual advantage of
producers and users of
technological knowledge
and in a manner
conducive to social and
economic welfare, and to
a balance of rights and
obligations.
Article 8
Principles
1. Members may, in
formulating or amending
their laws and
regulations, adopt
measures necessary to
5/23/01
J | liHCilUUluai pi UpCl ly
I IVll oy ~ luti
~ puat
SI
rights such as in national emergencies,
anti-competitive practices, or if the right
holder does not supply the invention,
provided certain conditions are fulfilled.
What is the basic patent right? n . k t*. top
Patents provide the patent owner with the legal
means to prevent others from making, using, or
selling the new invention for a limited period of
time, subject to a number of exceptions.
A patent is not a permit to put a
product on the market back to top
A patent only gives an inventor the right to
prevent others from using the patented
invention. It says nothing about whether the
product is safe for consumers and whether it can
be supplied. Patented pharmaceuticals still have
to go through rigorous testing and approval
before they can be put on the market.
< Previous
protect public health and
nutrition, and to promote
the public interest in
sectors of vital
importance to their
socio-economic and
technological
development, provided
that such measures are
consistent with the
provisions of this
Agreement.
2. Appropriate
measures, provided that
they are consistent with
the provisions of this
Agreement, may be
needed to prevent the
abuse of intellectual
property rights by right
holders or the resort to
practices which
unreasonably restrain
trade or adversely affect
the international transfer
of technology.
Next >
CONTACT US : World Trade Organization, rue de Lausanne 154, CH-1211 Geneva 21. Switzerland
http://www.wto.org/english tratop_e/trips_e/factsheet_pharmO l_e.htm
5/23/01
Page 1 of 5
3X
Main Identity
From:
To:
Sent:
Subject:
Daniel Lee <daniel@iglhrc.org>
<aidscaw@bom5.vsnl.netin>
Monday, August 06, 2001 2:56 PM
HealthGAP/IGLHRC Statement
WHERE ARE OUR RIGHTS?
THE DRAFT DECLARATION OF COMMITMENT AND
ITS GAPS
A statement by the Health GAP Coalition
and the International Gay and Lesbian Human Rights Commission
The draft Declaration of Commitment on HIV/AIDS acknowledges the value of human rights
in the struggle against the pandemic. Yet it does so only partly and in piecemeal fashion
Commitment is no help without consistency. The draft’s extensive promises are silent about the
principles which might motivate and sustain them. When it comes to the values undergirding action
there is a gap. Our rights are missing.
6
Under Leadership," the draft urges States to "fully protect and promote human rights and
undamental freedoms for all, including the right of enjoyment of the highest attainable standard of
p tysical and mental health." We agree. Both the language and the action steps of the rest of the
ocument, however, still do not fully envision the concrete responsibilities this entails,
he Declaration is a crucial opportunity for the global community to endorse and further a
comprehensive rights-based response to HIV/AIDS. Only such a response will make the right to
health a lived reality rather than convenient rhetoric. Only such a response will guarantee the
dignity, and lengthen the lives, of all those affected by HIV/AIDS.
PART ONE: THE RIGHT TO HEALTH
We begin with the section on Care , Support, and Treatment. By detaching itself dangerously
from the right to health, this section fails to recognize three crucial points:
1) Treatment is prevention. Treatment strengthens prevention efforts, provides an incentive to HIV
°Ca hea,lth lnf'rastructure’ addresses stigma and discrimination against people living
with HIV, and improves delivery of care and response. The first sentence should read:
Care, support and treatment are inextricably linked to prevention and are fundamental
elements of an effective response.
2) Treatment is a right. It is not a privilege accorded to the advantaged, nor a mere means to another
end It is an aspect of the universal right to the highest attainable standard of health. Governments
can take steps toward implementing this right immediately-without waiting till 2003 or 2005 This
section should express States' commitments:
8/7/01
Page 2 of 5
To outlining and implementing immediate and clear action steps for increasing access to
treatment and care, with express and concrete standards. Steps toward this end should address
interrelated issues including: treatment for STDs and opportunistic infections; palliative care;
nutrition; diagnostics; ’’best practice” clinical management of HIV disease; education of
communities about HIV treatment through culturally appropriate materials; and training of
physicians and health-care professionals.
Support, treatment, and care are an aspect of the right to the highest attainable standard of
physical and mental health. Strategies on the national level should begin immediately to work
toward implementation of that right. States can begin immediately to train physicians, health
care advocates, and community professionals in appropriate strategies for managing
HIV/AIDS; can identify and take concrete steps to enhance existing health infrastructure for
introduction and delivery of HIV-related medicines and care; can identify and establish
national programs and successful community-based models of HIV treatment; and can
immediately establish mechanisms to prioritize care and support for individuals with
symptomatic late-state HIV or late-stage AIDS, and their families.
Similarly, the DeclaiatiOu should call, at the international level, for.*
Strategies to research and promote best practices for providing anti-retroviral treatment in
resource-limited settings, including publishing and disseminating models.
3) The barriers to effective treatment are international. Developing countries cannot overcome
them on their own. The section on treatment irresponsibly calls only for national strategies, without
addressing the four major international barriers to treatment:
<- debt
<- pricing
<- intellectual property standards
<- global trade practices and systems.
The Declaration should reinstate language included in its previous draft, and cut from this one,
calling for strategies to
Address factors affecting the provision of essential drugs, including technical and system
capacity, prices, international trade rules and intellectual property rights.
The Declaration should state, in language drawn from the resolution unanimously adopted this year
by the UN Commission on Human Rights:
All States should:
a) Refrain from taking measures which would deny or limit equal access for all States and for
all persons to preventive, curative, or palliative pharmaceuticals or medical technologies used
to treat pandemics such as HIV/AIDS or the most common opportunistic infections that
accompany them;
b) Ensure that their actions as members of international organizations take due account of the
right of everyone to the enjoyment of the highest attainable standard of physical and mental
health, and that the application of international agreements promotes broad access to such
pharmaceuticals or technologies;
c) Adopt legislation or other measures to safeguard access to such preventive, curative or
palliative pharmaceuticals or medical technologies from any limitations by third parties;
d) Adopt all appropriate positive measures to maximize the resources allocated for this
purpose.
8/7/01
Page 3 of 5
The World Health Organization and the World Intellectual Property Organization, in
cooperation with other agencies, should assist countries in developing patent and other
legislation aimed at implementing the right to health. To this end they should develop a library
of model legislation and other resources for technical assistance.
This section of the Declaration should also affirm that States:
Support the establishment of a special fund which will, among other activities, purchase
medicines, raw materials, and other competitively available commodities-including medical
technologies and prophylaxis and palliative care-at best world prices through a transparent
bidding process, from multiple suppliers including generic manufacturers. The program must
provide its services for regional entities and governments, but also for other providers
including non-governmental organizations and charitable and workplace programs. Medicines
for tuberculosis, malaria, and other life-threatening diseases affecting developing countries
should be eligible for purchase, as well as medicines for HIV and its opportunistic infections.
Medicines purchased should be made available for free distribution to the peoples of non
OECD countries. Decision-making with regard to the procurement program must be
transparent, and governed by international health experts and representatives from civil
society, including representatives of people living with HIV/AIDS, with full representation of
developing countries.
This program should also assist countries to expedite and harmonize both drug registration
and quality assurance. The program should work with suppliers to create and maintain a
common dossier of product information, including information typically required for drug
registration.
6
I
The description of this fund, in the section on Resources, must contain clear guidelines for its
governance. The section on Resources should state:
The fund should be housed within the United Nations system, drawing upon the expertise in
bulk procurement within United Nations agencies. Governance and advisory bodies of the
Fund should be drawn from international health experts; representatives of civil society,
including people living with HIV/AIDS; and representatives of the governments of developing
countries. Decision-making should be fully transparent, and contributors to the fund should
not impose conditions upon donations. Steps, including compulsory recusal, should be taken to
prevent conflict of interest, and commercial interests should not be represented on the
governance board.
The section on Resources should also state:
Recognizing the interrelatedness of treatment and prevention, the fund should strive for parity
in allocating resources to both areas.
PART TWO: STIGMA, VULNERABILITY, AND HUMAN RIGHTS
In the section on HIV/AIDS and Human Rights, the draft rightly states that "Respect for
human rights reduces vulnerability to HIV/AIDS," and calls for "respect for the rights of people
living with HIV/AIDS." The concrete steps envisioned, however, fall far short of an effective
' response.
I
8/7/01
Page 4 of 5
The draft sees discrimination overwhelmingly in terms of discrimination against people living
with HIV/AlDS-and thus neglects or evades those other forms of discrimination and abuse which
contribute to the spread of the epidemic. This is conspicuous in the transition from this section to the
following section on Reducing Vulnerability. The draft indicates that States must protect the rights
of people living with HIV/AIDS, but must protect the health of vulnerable populations. Yet
vulnerable populations demand to be regarded in a rights-based framework. Their health cannot be
furthered unless their rights are expressly recognized and respected.
In the section on HIV/AIDS and Human Rights, the Declaration should call on States to:
Enact or strengthen legislation offering protection against all forms of discrimination,
consistent with the Universal Declaration of Human Rights, the International Covenant on
Civil and Political Rights and their interpretations; and implement programs to educate
against discriminatory treatment of vulnerable groups in all aspects of government and society,
including but not restricted to the health care and criminal justice systems.
In the section on Reducing Vulnerability, the Declaration should call on States to:
Ensure that all measures taken to promote and protect the health of vulnerable populations are
inclusive and educational, rather than restrictive or punitive; that they are devised,
implemented, and evaluated with full regard to States’ obligations with respect to human
rights; and that communities affected are fully consulted in their development and
implementation.
The Declaration should also state, in the same section:
All proposed or existing strategies or policies with regard to HIV/AIDS--at local, national, or
international levels, and in prevention, care, treatment, research, and other areas-should be
examined with a view to their differential impact on populations made vulnerable by
discrimination, and with a view to ensuring that they are non-discriminatory in intent,
implementation, and impact.
The draft segregates gender into a few short paragraphs, without seeing it as an essential,
structuring factor in the spread of the epidemic. In the section on Human Rights and HIV/AIDS,
the Declaration should affirm that States will immediately:
Recognize that women are particularly affected by and burdened by the AIDS pandemic,
brom young girls to grandmothers, they are disproportionately affected by the breakdown of
family, social, and civic structures. They are sources of care and support within the family;
they are subjected to violence both within and outside it; they are breadwinners in stilldiscriminatory economic situations; they are often deprived of political rights which would
enable them to voice their needs. Women’s inequality in political, economic, social, cultural,
civil, private and other fields further contributes to the spread of HIV/AIDS. Moreover, the
particular situations of women are often neglected in considerations of research, prevention,
treatment and care. The very lives of women are sometimes treated as secondary in decisions
about treatment, or ignored in the course of research.
States should take all necessary measures to eliminate all forms of discrimination against
women and the girl child, and to remove all obstacles to gender equality and the advancement
and empowerment of women. States should ensure women’s full participation on the basis of
equality in all spheres of society, including participation in the decision-making process and
access to power. States should ensure the full enjoyment by women and the girl child of all
8/7/01
Page 5 of 5
human rights and fundamental freedoms, and take effective action against violations of these
rights and freedoms. The human rights of women include their right to have control over and
decide freely and responsibly on matters related to their sexuality, including sexual and
reproductive health, free of coercion, discrimination and violence.
The Declaration should also state:
All proposed and existing strategies and policies with regard to HIV/AIDS—at local,
national, or international levels, and in prevention, care, treatment, research, and other areas—
should be examined from a gender perspective and with a view to their differential impact on
men and women, including the human rights of women.
Gender-disaggregated data should be produced in evaluating all strategies and policies.
In this spirit, in the section on Prevention, the roles and needs of women must be expressly
acknowledged. The Declaration should affirm that States will:
Establish programs to create and improve prevention tools allowing greater options and
greater control of decision-making to women, in the realm of their own sexuality and
HIV/AIDS. Both political will and resources, including the resources of developed countries,
must be devoted to developing such tools, which include availability of, and education in the use
of, microbicides and barrier forms of contraception.
This paper was prepared by the Health GAP (Global Access Project) Coalition and the International Gay and Lesbian
Human Rights Commission (IGLHRC).
The Health GAP Coalition is a network of US-based AIDS activists, public health experts, human rights groups, fair
trade advocates, and concerned individuals dedicated to eliminating barriers to global access to affordable life-sustaining
medicines for people living with HIV/AIDS. It can be reached at: PO Box 22439, Philadelphia PA 19143 USA
Tel.+01 215.731.1844 Fax+01 215.731.1845 Web www.healthgap.org
IGLHRC's mission is to document and advocate against human rights abuses based on HIV status, sexual orientation, or
gender identity. IGLHRC cooperates with the efforts of thousands of activists and organizations worldwide. It can be
reached at: 1360 Mission St., Suite 200, San Francisco CA 94103 USA
Tel. +01 415.255.8680 Fax +01 415.255.8662 Web www.iglhrc.org
*************************************************************************
Daniel J. Lee
Senior Program Officer for Asia and the Pacific
International Gay and Lesbian Human Rights Commission
1360 Mission Street, Suite 200, San Francisco, CA 94103 USA
Tel: 1-415-255-8680, Fax: 1-415-255-8662
Check out our website at http://www.iglhrc.org/
The mission of IGLHRC is to protect and advance the human rights of all people and communities
subject to discrimination or abuse on the basis of sexual orientation, gender identity or HIV status.
8/7/01
B. The Agreement on Trade-RelatedIntellectual-Rroperty (TRIPS)
> "Globalization and Access to Pharmaceuticals"
TRIPS Explained
World Health Organization
> Fact Sheet: TRIPS and Pharmaceutical Patents
World Trade Organization
> "Compulsory Licensing and Parallel Importing: What Do
They Mean?''
Margaret Duckett, International Council of AIDS Service
Organizations (ICASO)
I
Box 2.
Articles of the TRIPS Agreement of greatest relevance to pharmaceuticals
Key phrasing from TRIPS agreement
(Note that a number of artides contain further specific conditions, exceptions and exemptions which are spelh.-d
Topic
(TRIPS Article)
Nondiscrimination (Articles 3
and 4)
out in TRIPS or other referenced agreements.)
____________________________
'National Treatment...Each Member shall accord to the nationals of other Members treatment no less
favourable than that it accords to Its own nationals with regard to the protection of intellectual property. .’
'Most-Favoured-Nation Treatment...'With regard to the protection of intellectual property, any advantage,
favour, privilege or immunity granted by a Member to the nationals of any other country shall be accorded
immediately and unconditionally to the nationals of all other Members..________________________________
‘Exhaustion For the purposes of dispute settlement under this Agreement, subject to the provisoes of Articles
3 [National Treatment] and 4 [Most-Favoured-Nation Treatment], nothing in this Agreement shall be used to
Parallel importation
(“exhaustion of patent
address the issue of the exhaustion of intellectual property rights *
rights") (Article 6)
_______________________________
‘Obiect/ves The protection and enforcement of intellectual property rights should contribute to the promotion
of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of
producers and users of technological knowledge and in a manner conducive to social and economic welfare,
Objectives of TRIPS
(Artide 7)
Protection of public health
(Article 8)
Process ana proaucx patents
(Article 27)
Subject matter which may be
excluded from patentability
and to a balance of rights and obligations."
____ ______________ ________________________
‘Principles...Members may. in formulating or amending their laws and regulations, adopt measures necessary
to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socioeconon vc and technological development, provided that such measures are consistent with the provisions of this
Agreemt nt"
_ _________________________________ __________________________ :——
‘Patentable Subject fJattar..patents shall be available for any inventions, whether products or processes, in all
fields of technology, provided that they are new. involve an inventive step and are capable of industrial
application...[PJatents shall be available and patent rights enjoyable without discrimination as to the place of
invention, the field of technology and whether products are imported or locally produced.__________________
‘Patentable Subject Matter...Members may exdude from patentability inventions, the prevention within their
territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to
protect human, animal or plant life or health..."
(Artide 27)
"Members may also exclude from patentabdity.
(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;
(b) plants and animals other than micro-organisms, and essentially biological processes for the production of
plants or animals other than nombidogical and microbiological processes.
However. Members shal provide for the protection of piarrt varieties either by patents or by an effective sur geoens
system or by any combination thereof. The provisions of this subparagraph shal be reviewed four years after the
Exceptions which facilitate
prompt marketing of generic
drugs ("Bolar" provisions)
(Artide 30)__________________
Compulsory licensing
(Artide 31)
•
20-year minimum term of
protection (Artide 33)_______
Reversal of burden of proof
for process patents
(Artide 34)
Data protection and
Exclusivity (Artkde 39)
Transitional arrangements
for developing country WTO
Members (Artides 65 and 66)
Transfer of technology and
technical cooperation
(Artides 66 and 67)
Mailbox filings (Article 70:8)
Review (Article 71:1)
date of entry into force of the WTO Agreement'
__________________ ___ _______________
"Exceptions to Rights Conferred..Members may provide limited exceptions to the exclusive nghts conferred by
a patent provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and
do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate
interests of third parties."______________________________________ ____________ ______________________
•Other Use Without Authorization of the Right Hoider-Mhere the law of a Member allows for other use of the
subject matter of a patent without the authorization of the right holder, inducting use by the government or thi rd
parties authorized by the government the [twelve] provisions shall be respected."
Term ofProtection...The term of protection avalabte shall not end before the expiration of a period of twenty
years counted from the fSng date."
_
_
_
•Process Patents..£urden of Proof..JFcr the purposes of ervi proceedings in respect of the infringement of the
rights of the owner...! the subject matter of a patent is a process for obtaining a product, the jucfictal authorities
shal have the authority to order the defendant to prove that the process to obtain an identical product is different
from the patented process."
___________________________________ _______ ______ _______
"Protection of undisclosed information...In the course of ensuring effective protection against unfair
competition...Members shal protect undisclosed information...and data submitted to governments or
governmental agencies...'
______________________________ ___________________________
Specific transitional arrangements are provided for developing and least-developed countries (see TRIPS text).
•Developed country Member* shall provide hoentives to enterprises and institutions in their territories for the
purpose ol promoting and encouraging technology transfer to taast-rievetoped country Members in order to
enable them to create a sound and viable technological base...[and] trial provide, on request and on mutual/
country Membe “___________ __________________ _______________
_____________________________
“Where a Member does not make avaiade as of the date of entry into force of the WTO Agreement patent
» i, . - -ji proojas
. -» commw»uiw» with ks wy
obfioations
ixrder
protection for pharmaceutical and agnaAraia cnenxca
0
Artide 27. that Member shat
(a) notwithstanding the provistons of Part VI. provtoe as from the dated entry into force of the WTO Agreement
a means by which apptications for patents for such invanbons can be filed . / ____
“The Council for TRIPS shal review the imptementtoon of this Agreement after the expiration of the transrtionai
period referred to in paragraph 2 of Artide 65. The Counci sha^ having regard to the experience gained n rts
implementation, review it two years after that date, and at identical intervals thereafter. The Council may also
undertake reviews in the bght of any relevant new devefopments which might warrant modification or amendment
of this Agreement.*
_
_
htga 3: WB8 HUcj FwsMOfrM oa MedfciBM- 6J«taflnfls«.nun nd wcsn ta gtanncwticaJi Trade
...
.
■
’
-
•Perspective^
on medicines
liionanzauon, i Kirs
and
access
to
**■“»••****** ■■•5
I
Mi. 3 tondiMI
Wiril Itatlii IrganizaUifl
Umi
A new era in global trade
Creation of the World Trade Organization
The World Trade Organization (WTO) is the
international organization dealing with rules of
trade between nations. Although the WTO
became officially operational only in January
1995. it is the successor to the GATT multilateral
trading system founded in 1947. In becoming
Members of the WTO, countries undertake to
abide by its rules. As of 30 November 2000, the
WTO counted 140 Members.
The WTO is charged with setting the legal
ground rules for international trade. Its objectives
are
to
promote:
(1)
non-discrimination
(2) progressive liberalization of barriers to trade (3)
predictable policies and transparency (4)
competition and (5) special provisions for
developing countries.
WTO Agreements
In joining the WTO, Members adhere to 18 specific
Qnnexed to the Agreement
establishing the WTO. They cannot choose to be
party to some agreements but not others (with
the exception of a few “plurilateral” agreements
^at are not obligatory). Of greatest relevance to
the health sector are: the Agreement on TradeEct t^P!CtS Of lntellec,ual Property Rights
(TRIPS), the Agreement on the Application of
Sanitary and Phytosanitary Measures (SPS): the
Agreement on T
—L
~Barriers to Trade (TBT)’
Technical
the
General
Agreement
(cATT,.
C-c-.c.-.t on Tariffs and Trade
LATT ' ,^d he General Agreement on Trade in
Services (GATS).
Of these agreements. TRIPS is expected to
sector The t^T' ,mpact On ,he ptlarmaceutical
sector. The TBT Agreement should be of particular
concern to producing countries, since °s
implementation may affect export markets.
Implementation and dispute settlement
The WTO Agreement is a treaty that creates
international obligations among its Members
Sns0fhot0,i0nS inC'Ude refrQinin9 from ,3kin9
actions that are inconsistent with the agreement
and implementing certain provisions via national
legislation.
The various parts of the WTO Agreement,
including the TRIPS Agreement, require that such
national legislation embodies certain specific
standards. However, in many areas, the WTO
Agreement affords considerable discretion in how
its obligations are implemented. This discretion,
combined with the potential health impact of
national legislation, make it imperative that,
health officials work closely with other parts of
government, such as the trade department, and
use top-level legal, trade and pharmaceutical
expertise when legislation is being drafted. (See
Box 1. Points for policy-makers
v*A/-rrJRIPS establ'shes intellectual property standards for
WTO Members, historically based on the standards of
developed countries.
• TRIPS requires patent protection for all products and
processes, with a minimum duration of 20 years from the
original date of filing, without any special consideration for
pharmaceuticals.
•
The TRIPS Agreement permits Members some
discretion in enacting and amending their laws and
regu ations, which can help promote public health goals.
• When establishing standards of patentability for
pharmaceutica15 countries should consider the implications
for health of those standards. Standards which are too bmad
pen^ requi'X7TTSeX,enSi°n °f Paten'
free.trade Provisions can stimulate generic
TRIPS ma" T
UCre the priCeS for off-Patent drugs, but
TRIPS may also significantly delay the Introduction of new
genenc drugs, depending on the way national legislation Is
designed and implemented.
legislation is
•
Developing countries should be cautious about
enacting legislation more stringent than the TRIPS
| requirements (‘TRIPS-plus'),
S
int J?ISP^,e? canIarise when countries differ in the^
interpretation of the WTO Agreement. The WTO
o ocSQr
PU'e Se,,,ement Pr°ce” 'hat may
proceed from a consultation phase, to the
es ablishment of and decision by a dispute
settlement panel, and appeal to the Appellate
Body Trade sanctions may only be imposed if the
dispute settlement process has run its course and
the losing country has failed to comply with the
decision
ecision made.
made. For
For this
this reason. WTO Members
(
may not unilaterally impose trade sanctions
based on alleged failures to comply with TRIPS.
Key requirements of the
TRIPS Agreement
The TRIPS Agreement introduced global minimum
standards for protecting and enforcing nearly all
forms of intellectual property rights, including
those for pharmaceuticals. The Agreement’s 73
Articles cover basic principles, standards and use
of patents, enforcement, dispute settlement and
a range of other subjects. The key requirements
for pharmaceuticals are described below and
summarized in Box 2.
Patent protection
Members must provide patent protection for a
minimum of 20 years from the filing date of a
patent application, for any invention, including of
a pharmaceutical product or process, that fulfils
the criteria of novelty, inventive step and usefulness
(subject to certain exceptions X see Box 2).
Rights conferred
TRIPS specifies the rights conferred on a patent
owner, but allows for limited exceptions and
. compulsory licensing, subject to specified
conditions. The Agreement also contains
- provisions on: protection of undisclosed
information (including test data): actions to
address anti-competitive practices: protection of
trademarks (relevant to generic substitution and
combating counterfeit drugs); and enforcement.
Transitional arrangements
TRIPS provides transitional periods during which
countries are required ^o bring their national
legislation and practices into conformity with its
provisions. The latest dates for WTO Members
were/are: 1996 for developed countries; 2000 for
developing countries (as a general rule); 2005 for
developing countries who had not introduced
patents before joining the WTO; and 2006 for
least-developed countries.
TRIPS specifically recognizes the economic,
financial, administrative and technological
constraints of the least-developed countries. It
therefore provides the possibffity for further
extension of the transitional period.
Public health and TRIPS
International conventions before TRIPS did not
specify minimum standards for patents. Over 40
countries provided no patent protection for
pharmaceuticals, many provided only process and
not procuct patents, and the duration of patents
was much less than 20 years in many countries.
From the health sector's perspective,
intellectual property standards, including those
specified in TRIPS, should take protection of public
health into account. However, current standards
X historically derived from those of developed
countries X are not necessarily appropriate for
countries struggling to meet health and
development needs. Developing countries can
therefore use the flexibility of TRIPS provisions and
its safeguards to protect public health.
3S
Patentability
What can be patented? TRIPS specifies patents
must be available for all discoveries which "...are
new, involve an inventive step and are capable
of industrial application (Article 27)."
The difference between the number of new
drugs ("new chemical entities"), that are
developed globally each year, and the number
of patents awarded for. new uses of a drug,
processes, dosage forms, formulations and
different forms of the same molecule, including
patents on genes and genomic sequences is
enormous. The latter is influenced by national
legislation and practices
Yet because "new” and "inventive" are not
defined, countries must establish their own criteria
for these terms. They should remember that
patentability standards which are too broad can
contribute to "evergreening”. This means that the
effective patent life for a new medicine is
extended beyond the 20-year TRIPS minimum.
Therefore. Ministries of Health must work closely
with other ministries’ to formulate and/or revise
national patent legislation to ensure that it takes
public health needs into account.
Generic drugs
Promotion of generic drugs requires appropriate
legislation and regulations, reliable quality
assurance capacity, professional and public
acceptance of generic drugs, and economic
incentives and information for both prescribers
and consumers. The TRIPS Agreement does not
prevent Members from requiring generic labelling
and allowing generic substitution.
Trade liberalization can increase competition .
and reduce prices.for generic drugs that are
already on the market. But if the wording and
implementation of TRIPS-compliant national
legislation and regulations are inappropriate, the
introduction of new generic drugs can be
delayed. The economic cost to governments,
^useholds and public health can be enormous.
Prompt introduction of generic drugs can be
facilitated by: drafting appropriate legislation and
regulations on patentability; use of exceptions to
exclusive rights which permit early testing and
approval of generics ("Bolar” provision) (including
allowing access to pre-registration test data); and
compulsory licensing.
Pago 2: W10 Policy Peapecttves m Medtetow - Gtoballzatfoa. TUPS aad access to plwmaceoticals
?
f
i Perspectiues
3SA on medicines
V' t
$
\l
1
monanzauon, i mt's
and
access
to
4* aw Mt* ** 4mm ■ ■ • ■ 4m
I
Mi 3 Marot Ml
Wrtf luitii Iqpniutjin
Sinn
A new era in global trade
Creation of the World Trade Organization
The World Trade Organization (WTO) is the
international organization dealing with rules of
trade between nations. Although the WTO
became officially operational only in January
1995, it is the successor to the GATT multilateral
trading system founded in 1947. In becoming
Members of the WTO. countries undertake to
abide by its rules. As of 30 November 2000. the
WTO counted 140 Members.
The WTO is charged with setting the legal
ground rules for international trade. Its objectives
are
to
promote:
(1)
non-discrimination
(2) progressive liberalization of barriers to trade (3)
predictable policies and transparency (4)
competition and (5) special provisions for
developing countries.
WTO Agreements
In joining the WTO. Members adhere to 18 specific
agreements annexed to the Agreement
establishing the WTO. They cannot choose to be
party to some agreements but not others (with
the exception of a few “plurilateral” agreements
that are not obligatory). Of greatest relevance to
the health sector are: the Agreement on TradeRelated Aspects of Intellectual Property Rights
(TRIPS); the Agreement on the Application of
Sanitary and Phytosanitary Measures (SPS); the
Agreement on Technical Barriers to Trade (TBT);
the General Agreement on Tariffs’and Trade
(GATT); and the General Agreement on Trade in
Services (GATS).
Of these agreements, TRIPS is expected to
have the greatest impact on the pharmaceutical
sector. The TBT Agreement should be of particular
concern to producing countries, since its
implementation may affect export markets.
implementation and dispute settlement
The WTO Agreement is a treaty that creates
international obligations among its Members.
These obligations include refraining from taking
actions that are inconsistent with the agreement.
and Implementing certain provisions via national
legislation.
The various parts of the WTO Agreement,
including the TRIPS Agreement, require that such
national legislation embodies certain specific
standards. However, in many areas, the WTO
Agreement affords considerable discretion in how
its obligations are Implemented. This discretion,
combined with the potential health impact of
national legislation, make it imperative that,
health officials work closely with other parts of
government, such as the trade department, and
use top-level legal, trade and pharmaceutical
expertise when legislation is being drafted. (See
Box 1.)
Boxl. Points for policy-makers
•
TRIPS establishes intellectual property standards for
WTO Members, historically based on the standardsxof
developed countries.
• TRIPS requires patent protection for all products and
processes, with a minimum duration of 20 yearf from the
original date of filing, without any special consideration for
pharmaceuticals.
•
The TRIPS Agreement permits Members some
discretion In enacting and amending their laws and
regulations, which can help promote public health goals.
•
When estabishing standards of patentability for
pharmaceuticals countries should consider the Implications
for health of those standards. Standards which are too broad
may lead to inappropriate extension of patent life beyond the
period required by TRIPS.
•
WTO free trade provisions can stimulate generic
competition and reduce the prices for off-patent dn igs, but
TRIPS may also significantly delay the Introduction of new
generic drugs, depending on the way national legislation is
designed and implemented.
•
Developing countries should be cautious about
enacting legislation more stringent than the TRIPS
requirements ("TRIPS-plus").
Disputes can arise when countries differ in their
interpretation of the WTO Agreement. The WTO
provides a dispute settlement process that may
proceed from a consultation phase, to the
establishment of and decision by a dispute
settlement panel, and appeal to the Appellate
Body. Trade sanctions may only be imposed if the
dispute settlement process has run its course and
the losing country has failed to comply with the
decision made. For this reason, WTO Members
be authorized predominantly for the supply of the
domestic market of the Member authorizing such
use (Article 3If).
Box 3. Checklist for policy-makers
Government process and resources:
□
Identify trade-and-pharmaceuticals focal point
within Ministry of Health.
□
Establish contacts, perhaps a working group,
with trade and other key ministries.
!
Compulsory licenses must be granted on a
non-exclusive basis. Since the TRIPS Agreement
provides for non-discrimination between locally
produced and imported products (Article 27:1). a
compulsory license may be granted for
importation to satisfy local needs (Article 31).
□
Obtain reliable specialized legal advice.
Parallel Imports
□
Develop a mechanism to monitor the health
impact of new trade agreements.
Parallel importation is importation, without the
consent of the patent-holder, of a product legally
marketed in another country by the patent-holder
or by another authorized party. The aim of parallel
importing is to promote and assure price
competition for patented products by allowing
importation of equivalent patented products
marketed at a lower price in another country by
or with the consent of the patent-holder. In TRIPS
terminology, the potent-holder’s rights to control
the international movement of a pharmaceutical
have been "exhausted" when the product has
been placed on a market by or with the consent
of the patent-holder.
National patent and related legislation should:
□
Promote standards of patentability that take
health into account.
□
Establish process and product patents for 20
years.
□
Incorporate exceptions, trademark provisions,
data exclusivity and other measures to support
generic competition.
□
Permit compulsory licensing, parallel
importation and other measures to promote
availability and ensure fair competition.
□
Permit requests for extension of transitional
period for TRIPS implementation, if needed and
if eligible.
□
Carefully consider national public health
interests before instituting TRIPS-plus provisions
(see text).
The TRIPS Agreement does not prohibit
Members from applying the principle of
international exhaustion - that is. allowing parallel
importation of patented pharmaceuticals once
they have been placed on the market in any
country. Article 6 explicitly states that disputes
relating to exhaustion are not subject to the WTO
dispute settlement process.
Compulsory licensing
TRIPS-plus provisions
w Compulsory licensing enables a competent
government authority to license the use of an
invention to a third party or government agency
without the consent of the patent-holder. The
pateht-holder, however, retains intellectual
property rights and “shall be paid adequate
remuneration” according to the circumstances of
the case (Article 31). In the pharmaceutical
sector compulsory licenses have been used to
stimulate price-lowering competition and to
ensure availability of needed medicines. Most
developed countries and many developing
countries now provide for compulsory licensing
through national legislation.
’TRIPS-plus" is a non-technical term which refers to
efforts to: extend patent life beyond the 20-year
TRIPS minimum: limit compulsory licensing in ways
not required by TRIPS: and limit exceptions which
facilitate prompt introduction of generics.
A comprehensive patent regime should
include adequate provision for the granting of
compulsory licenses. Grounds for compulsory
licensing may include public interest, problems
linked with national emergencies such as
epidemics, public non-commercial use. or anti
competitive practices (Article 31)' Whether or not
compulsory licenses are issued, national legislation
which provides for compulsory licensing allows
governments to provide the medicine in the case
of abuse of rights by the patent-holder, or
commercial non-availability. Any such use should
Page 4: WIO PaUcy Persoecthes
Since the public health impact of TRIPS
requirements have yet to be fully assessed. WHO
recommends that developing countries be
cautious about enacting legislation that is more
stringent than the TRIPS requirements.
Non-WTO Members
As of December 2000, over 50 WHO Member
States were either not WTO Members or had
observer status only at the WTO. From a public
health perspective, countries which are not
bound by TRIPS should evaluate TRIPS
requirements, and incorporate into national
legislation and trade-related practices those
elements which clearly benefit national public
health interests.
MetfidiM-Glatattzitfofl. TBIPS md access to pbannaceutfcals Trade
33
5^
Evaluating impacts of trade
agreements
foils'1 when'T0' °f 'r°PiCQl diSeaSeS' The mo'
tails when it comes to ensuring adequaK
(R&D?foCeU,l<;al /esearch and development
(R&D) for neglected diseases such as malaria a
range of other tropical diseases and tuberculosis
S rang public sector involvement, including
through public-private partnerships, is necessar?
to ensure development of new drugs for
developing country priority health problems.
Protection of intellectual property rights aims to
promote innovation by providing an incentive to
Hives* m research and development. Yet the TRIPS
Agreement, which seeks to' fulfil this aim has
proven to be one of the most controvers^ WTO
agreements. At least four questions are commonly
vfew oMh Q PUb"'C heQ"h perspec"ve (Box 4). In
,evy of the impact that the TRIPS Agreement
wh HVe On pharmaceuticals. WHO (in accord
with World Health Assembly Resolution WHA52 19)
s using these four questions to monitor and
analyse the effects of globalization and trad^
AfforctebHity of essential drugs Is a public
health priority
innHr' /in?nciQl resources
are woefully
inadequate for meeting the health care and
medicine needs of the world's poorest
populations. Governments, donor agencies and
development banks all have a vital role to play in
increasing those resources. But affordable prices
are also very important.
agreements on the pharmaceutical sector.
Concurrently, having been awarded observer
status on an
1—
_ ’ by ,he WTO Council for
b°P ■ bQSis
TRIPS. WHO is able to monitor
oil relevant issues
under discussion
. ---------1 at WTO that may have
implications for the health sector.
Among the four elements needed to ensure
access, the affordability of essential drugs X
bT^ffem h° h S,i" °n Pa,en' X is most
Box 4. Key questions for m
onitoring the public
health impact of TRIPS
1.
2.
3.
4.
»•" «>.,
SA’"""?1 d,u”
,o
orntn
ed by ,rade a9reements. Patent
protection awards exclusive rights to an invention
and prevents generic competition. But poorer
populations in developing countries should not be
®xpecled ,0 pay ,he same price as do the
mlchn
neWef essential drugs. TRIPS-compliant
mechanisms can be used to lower drug prices.
Other options to improve affordability include
would have been if not under patent?
7
Aremnr^0110? °f 9enSriC drU9S boin9 sl°wod?
n'S"“" a~““ “"I
Are transfer of technology and direct
foreign
Investment in developing countries Increasing
decreasing?
and n 096 ° PnC® information: Price competition
and pnce negotiation within public procurement
and insurance schemes: price controls; reduced
duties and taxes; improved distribution efficiency
educed distribution and dispensing costs and
reduced marketing expenses.
WHO perspectives on
access to drugs
Access to health is a human right
Essential drugs are i
'
*
not simply another
commodity X TRIPS safeguards
»are
So hlrih^LTto^ssenS d^ugsde'pZds
crucial
WHO supports countries in the use of WTO/TRIPS
ZdabT^H*’ 05 Qppropria,e. fo enhance
X
avanability of existing medicines,
paces and (4) reliable health and supply systems
Since most poor people in developing countries
curren ly pay for health care. including9drugs out
of their own pockets, access to medicfnles i
family0'^ nenS"!Ve ,O COSt- Governmenfs. the UN
famdy. the private sector and civil society each
ave vital roles and responsibilities in achievina
universal access to essential drugs. (See Box 5?
.
discouraging the development of
settina stcXt m®dl^ines'These safeguards include
sethng standards for patentability which reflect
public health concerns, legislative provision for
compulsory licensing, exceptions to exclusive
Patents are an effective stimulator of
research and development
also be authorized by governments
Memb^s9belom:th^TeaHh JmpaXZ
deveioped between .975 o'd l^only . .were
do|ng have been fully-assessed.
Pm 5: WHO Policy PoHooctlvos oo Modlcloo, - filollalkaUotl
aC(
xeu to Dhannaceatlcaft
?P
■ o
Box 5. WHO perspectives on access to drugs
1 Access to essential drugs Is a human right.
Essential drugs are not simply another commodity.
2.
■
! an effective incentive for
3. Patent protection has been
irch
and development for new drugs.
reseat
—---------4. Patents should be managed' 'ini an impartial way.
protecting the interests of the patent-holder, as well
as safeguarding public health principles.
5. WHO supports measures which improve access to
essential drugs, including application of TRIPS
safeguards. __________ __________________
Countries
must
develop
approaches to health and trade
informed
Countries with least capacity for interpreting and
acting on international trade agreements have
most at risk in terms of access to medicines. WHO
will continue to provide independent data and
technical assistance to countries to help them
develop informed approaches to trade and
health at national, sub-regional and regional
levels. Countries are advised to carefully monitor
the implementation of the TRIPS Agreement in
order to formulate comprehensive proposals for
the future review of the TRIPS Agreement as
provided for in Article 71:1. A network of legal
experts who have specialized knowledge and
understanding of international trade agreements,
pharmaceuticals and public health is also being
developed as a resource for developing
countries.
6: WM roun hwwecttMJ m MmUtaw-GlsliiUaUotTBlrt and acceMta Btaraacnntlcais
Page 1 of6
WTO | Intellectual property (TRIPS) - fact sheet - pharmaceuticals - 2
search
WORLD TRADE
Organization
ON THIS PAGE
unuoi t.s
General
rm wio
Exceptions
W IO HF WS
TRADE TOPICS
Bolar exception
register
contact us
DOCUMttHS : COMMIlrlll VffORIIMS
HI SOUKCI s
Anti c oiimetilion
home • trade topics > tups
on this site
espanol
franqais
Compulsoiv licensing
Pai aliet
pnarnia fact sheet
obligations and exceptions
FACT SHEET: TRIPS AND PHARMACEUTICAL PATENTS.
ip
April 2001
Contents
> Philosophy: striking a balance
> Obligations and exceptions
> What does "generic” mean?
> Developing countries
This tact sheet has been prepared
bv the Information and Media
Relations Division of the WTO
Secretariat to help public
understanding. It is not an official
interpretation of the WTO
jp.reements or members’
positions
Obligations and exceptions
Under TRIPS, what are member governments’ obligations on
pharmaceutical patents?
IN GENERAL (see also
"exceptions”) back to top
Patenting: WTO members have to
provide patent protection for any
invention, whether a product (such as a
medicine) or a process (such as a
method of producing the chemical
ingredients for a medicine), while
allowing certain exceptions. Article 27.1.
Patent protection has to last at least 20
years from the date the patent
application was filed. Article 33
Non-discrimination: Members cannot
discriminate between different fields of
technology in their patent regimes. Nor
can they discriminate between the place
of invention and whether products are
imported or locally produced.
Article 27.1
Three criteria: To qualify for a patent,
an invention has to be new ("novelty”),
it must be an "inventive step” (i.e. it
must not be obvious) and it must have
"industrial applicability” (it must be
useful). Article 27.1
Disclosure: Details of the invention have
to be described in the application and
therefore have to be made public.
Member governments have to require the
patent holder to disclose specifications
of the patented product or process and
they may require the patent holder to
reveal the best method for carrying it
http://www.wto.org/cnglisli/tratop_c/trips_e/factshcct_phann02_c.htni
The TRIPS Agreement
Article 27
Patentable Subject Matter
1. Subject to the provisions of
paragraphs 2 and 3, patents shall be
available for any inventions, whethe
products or processes, in all fields oi
technology, provided that they are n
involve an inventive step and are
capable of industrial application (5).
Subject to paragraph 4 of Article 65,
paragraph 8 of Article 70 and paragr.
3 of this Article, patents shall be
available and patent rights enjoyable
without discrimination as to the plac
of invention, the field of technology
whether products are imported or
locally produced.
2. Members may exclude from
patentability inventions, the prevent
within their territory of the common
exploitation of which is necessary to
protect ordre public or morality,
including to protect human, animal <
plant life or health or to avoid serioi
prejudice to the environment, provic
that such exclusion is not made men
because the exploitation is prohibite
by their law.
3. Members may also exclude from
patentability:
(a)
diagnostic, therapeutic and sun
5/23/01
Page 2 of 6
WTO | Intellectual property (TRIPS) - fact sheet - pharmaceuticals - 2
out. Article 29.1
methods for the treatment of humar
animals;
Exceptions n,K t to top
(b) plants and animals other than
micro-organisms, and essentially
biological processes for the product!of plants or animals other than nonbiological and microbiological
processes. However, Members shall
provide for the protection of plant
varieties-either by patents or by an
effective sui generis system or by an
combination thereof. The provisions
this subparagraph shall be reviewed
years after the date of entry into for
of the WTO Agreement.
ELIGIBILITY FOR PATENTING o <• >■ o- t.,P
Governments can refuse to grant patents
for three reasons that may relate to
public health:
• inventions whose commercial
exploitation needs to be
prevented to protect human,
animal or plant life or health Anicle 27.2
• diagnostic, therapeutic and
surgical methods for treating
humans or animals - Article 27.3a
Article 29
Conditions on Patent Applicants
1. Members shall require that an
applicant for a patent shall disclose
invention in a manner sufficiently cl<
and complete for the invention to be
carried out by a person skilled in the
and may require the applicant to
indicate the best mode for carrying (
the invention known to the inventor
the filing date or, where priority is
claimed, at the priority date of the
application.
• certain plant and animal
inventions - Article 27.3b.
Under the TRIPS Agreement,
governments can make limited
exceptions to patent rights, provided
certain conditions are met. For example,
the exceptions must not "unreasonably”
conflict with the "normal” exploitation
of the patent. Article 30.
2. Members may require an applica
for a patent to provide information
concerning the applicant’s
corresponding foreign applications ai
grants.
Continue >
Article 30
Exceptions to Rights Conferred
Members may provide limited
exceptions to the exclusive rights
conferred by a patent, provided that
such exceptions do not unreasonably
conflict with a normal exploitation o
the patent and do not unreasonably
. prejudice the legitimate interests of
patent owner, taking account of the
legitimate interests of third parties.
Article 33
Term of Protection
The term of protection available sha
not end before the expiration of a
period of twenty years counted from
http://www.wto.org/cnglish/tratop_c/trips_e/factsheet_phann02_e.htm
5/23/01
WTO | Intellectual property (TRIPS) - fact sheet - pharmaceuticals - 2
Page 3 of 6
filing date. (8)
Footnote:
(5) For the purposes of this Article,
terms "inventive step” and "capable
industrial application” may be deem
by a Member to be synonymous with
terms "non-obvious” and "useful”
respectively.
> back to inference
(8) It is understood that those
Members which do not have a systen
original grant may provide that the t
of protection shall be computed fron
the filing date in the system of origir
grant.
> h<i( to teteicocc
back to top of section
RESEARCH EXCEPTION AND HBOLAR”
PROVISION back to lop
The TRIPS Agreement
Many countries use this provision to
advance science and technology. They
allow researchers to use a patented
invention for research, in order to
understand the invention more fully.
Article 8
Principles
In addition, some countries allow
manufacturers of generic drugs to use
the patented invention to obtain
marketing approval - for example from
public health authorities - without the
patent owner’s permission and before
the patent protection expires. The
generic producers can then market the-r
versions as soon as the patent expires.
This provision is sometimes called the
"regulatory exception" or "Bolar"
provision. Article 8
2. Appropriate measures, provided
that they are consistent with the
provisions of this Agreement, may b<
needed to prevent the abuse of
intellectual property rights by right
holders or the resort to practices wh
unreasonably restrain trade or adver
affect the international transfer of
technology.
SECTION 8: CONTROL OF ANTI
COMPETITIVE PRACTICES IN
CONTRACTUAL LICENCES
Article 40
This has been upheld as conforming with
the TRIPS Agreement in a WTO dispute
ruling. In its report adopted on
7 April’2000, a WTO dispute settlement
panel said Canadian law conforms with
the TRIPS Agreement in allowing
manufacturers to do this. (The case was
titled "Canada — Patent Protection for
Pharmaceutical Products")
1. Members agree that some licensi
practices or conditions pertaining to
intellectual property rights which
restrain competition may have adver
effects on trade and may impede the
transfer and dissemination of
technology.
ANTI-COMPETITIVE PRACTICE,
2. Nothing in this Agreement shall
prevent Members from specifying in
their legislation licensing practices o
conditions that may in particular cas
ETC ba< t !<• t-H
http://www.wto.org/cnglish/tratop_c/trips_e/factsheet_phann02_c.htm
5/23/01
WTO | Intellectual properly (TRIPS) - fact sheet - pharmaceuticals - 2
The TRIPS Agreement says governments
can also act, again subject to certain
conditions, to prevent patent owners and
other holders of intellectual property
rights from abusing intellectual property
rights, ’’unreasonably” restraining trade,
or hampering the international transfer
of technology.
tides 3 and 40
Page 4 of 6
constitute an abuse of intellectual
property rights having an adverse efl
on competition in the relevant mark<
As provided above, a Member may
adopt, consistently with the other
provisions of this Agreement,
appropriate measures to prevent or
control such practices, which may
include for example exclusive grantt
conditions, conditions preventing
challenges to validity and coercive
package licensing, in the light of the
relevant laws and regulations of that
Member.
[...]
• bac*- to tup ot section
COMPULSORY LICENSING oack io top
The TRIPS Agreement
Compulsory licensing is when a
government allows someone else to
produce the patented product or process
without the consent of the patent owner.
In current public discussion, this is
usually associated with pharmaceuticals,
but it could also apply to patents in any
field - and the TRIPS Agreement does
prohibit discrimination between fields of
technology.
Article 31
Other Use Without Authorization of
Ri$ht Holder
The agreement allows compulsory
licensing as part of the agreement’s
overall attempt to strike a balance
between promoting access to existing
drugs and promoting research and
development into new drugs. But the
term ’’compulsory licensing” does not
appear in the TRIPS Agreement. Instead,
the phrase ’’other use without
authorization of the right holder”
appears in the title of Article 31.
Compulsory licensing is only part of this
since ’’other use” includes use by
governments for their own purposes.
Compulsory licensing and government
of a patent without the authorization of
its owner can only be done under a
number of conditions aimed at protecting
the legitimate interests of the patent
holder.
For example: Normally, the person or
company applying for a licence must
http://www. wto.org/cnglish/tratop_e/trips_e/factshect_pharm02_e. him
Where the law of a Member allows f<
other use of the subject matter of a
patent without the authorization of ■
right holder, including use by the
government or third parties authoriz
by the government, the following
provisions shall be respected:
[...]
(b) such use may only be permitted
prior to such use, the proposed user
made efforts to obtain authorization
from the right holder on reasonable
commercial terms and conditions an<
that such efforts have not been
successful within a reasonable perio<
time. This requirement may be waiv<
by a Member in the case of a nation^
emergency or other circumstances o
extreme urgency or in cases of publinon-commercial use. In situations of
national emergency or other
circumstances of extreme urgency, t
right holder shall, nevertheless, be
notified as soon as reasonably
practicable. In the case of public noi
commercial use, where the governm
or contractor, without making a patf
search, knows or has demonstrable
grounds to know that a valid patent
will be used by or for the governmer
5/23/01
U5
Page 5 of 6
WTO | Intellectual property (TRIPS) - fact sheet - pharmaceuticals - 2
have first attempted, unsuccessfully, to
obtain a voluntary licence from the right
holder on reasonable commercial terms
- Ai tide 3 lb. If a compulsory licence is
issued, adequate remuneration must still
be paid to the patent holder Article 3lh.
However, for "national emergencies”,
"other circumstances of extreme
urgency” or "public non-commercial
use” (or "government use”) or anti
competitive practices, there is no need
to try for a voluntary licence Article 31 b.
Compulsory licensing must meet certain
additional requirements. In particular, it
cannot be given exclusively to a single
licensee, and usually it must be granted
mainly to supply the domestic market.
Compulsory licensing cannot be
arbitrary.
WHAT ARE THE GROUNDS FOR USING
COMPULSORY LICENSING? back to top
The TRIPS Agreement does not
specifically list the reasons that might be
used to justify compulsory licensing. In
Article 31, it does mention national
emergencies, other circumstances of
extreme urgency and anti-competitive
J practices - but only as grounds when
some of the normal requirements for
compulsory licensing do not apply, such
as the need to try for a voluntary licence
first.
the right holder shall be informed
promptly;
(c) the scope and duration of such i
shall be limited to the purpose for
which it was authorized, and in the (
of semi-conductor technology shall c
be for public non-commercial use or
remedy a practice determined after
judicial or administrative process to
anti-competitive;
[•••I
(f) any such use shall be authorized
predominantly for the supply of the
domestic market of the Member
authorizing such use;
[-]
(h) the right holder shall be paid
adequate remuneration in the
circumstances of each case, taking ii
account the economic value of the
authorization;
[•••]
(k) Members are not obliged to app
the conditions set forth in
subparagraphs (b) and (f) where sucl
use is permitted to remedy a practic
determined after judicial or
administrative process to be anti
competitive. The need to correct an
competitive practices may be taken
account in determining the amount c
remuneration in such cases. Compel
authorities shall have the authority t
refuse termination of authorization i
and when the conditions which led t<
such authorization are likely to recui
• back to rop or jcctton
PARALLEL IMPORTS, GREY IMPORTS AND
'EXHAUSTION' OF RIGHTS d.u . b- top
Parallel or grey-market imports are not
imports of counterfeit products or illegal
copies. These are products made and
marketed by the patent owner (or
trademark- or copyright-owner, etc) in
one country and imported into another
http://wvvw.wto.org/english/tratop_c/trips_e/factsheet_phami02_c.htni
The TRIPS Agreement
Article 6
Exhaustion
For the purposes of dispute setttemc
under this Agreement, subject to th<
provisions of Articles 3 and 4 nothing
this Agreement shah be used to addr
5/23/01
1
4^
Page 6 of 6
WTO | Intellectual property (TRIPS) - fact sheet - pharmaceuticals - 2
country without the approval of the
patent owner.
For example, suppose company A has
patented a drug, which it makes under
patent in the Republic of Belladonna and
the Kingdom of Calamine, but sells at a
lower price in Calamine. If a second
company buys the drug in Calamine and
imports it into Belladonna at a price that
is lower than company A's price, that
would bo z parallel or grey import.
the issue of the exhaustion of
intellectual property rights.
Ill 111
The legal principle here is "exhaustion”,
the idea that once company A has sold its
product (in this case, in Calamine), its
patent is exhausted and it no longer has
any rights over what happens to that
product.
The TRIPS Agreement simply says that
none of its provisions, except those
dealing with non-discrimination
("national treatment” and "mostfavoured-nauon treatment”), can be
used to address the issue of exhaustion
of intellectual property rights in a WTO
dispute. In other words, even if a country
allows parallel imports in a way that
might violate the TRIPS Agreement, this
cannot be raised as a dispute in the WTO
unless fundamental principles of non
discrimination are involved. Article 6
< Previous
Next >
CONTACT US : World Trade Organization, rue de Lausanne 1S< CH i211. Geneva 21, Switzerland
http://www.wto.org/cnglish/tratop_c/trips_e/factsheet_phami02_e.htm
5/23/01
Page 1 of 6
WTO | InlQ*Icctual property (TRIPS) and pharmaceuticals - technical note
search
world Trade
Organization
[HI W1O
•.v in Ml w
TRADE TOPICS
id souRcrs
on this site
contact us
register
DOCIIMI MIS
COMMUNI 1 Y/rORIIMS
espariol
ON THIS PAGE
Conclusioii
Balance
paicn( abu:t.
Pa’»-T.; fights
Tei rn
Except ions
Othei s
frariQdis
Transition
home • trade topics ■ trips > drug patents
TRIPS: DRUG PATENTS, TECHNICAL NOTE
Pharmaceutical patents and the TRIPS
Agreement
The purpose of this note is to describe those provisions of the
Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS Agreement) that relate to the standards of patent
protection to be accorded to inventions in the area of
pharmaceuticals.
11 July 2000
See also:
> Fact sheet: TRIPS and
pharmaceutical patents (includes
extracts of the TRIPS Agreement/
To set this discussion in context, it is useful to recall three basic
features of the TRIPS Agreement:
« that, together with some 25 other legal texts, it is an
integral part of the Agreement Establishing the World
Trade Organization (and therefore subject to the WTO
dispute settlement system);
• that it covers not only patents but all the other main areas
of intellectual property rights; and
• that it lays down not only the minimum substantive
standards of protection that should be provided for in each
of these areas of intellectual property, but also the
procedures and remedies that should be available so that
rights holders can enforce their rights effectively.
The basic balance in the TRIPS Agreements u
Finding a balance in the protection of intellectual property
between the short-term interests in maximizing access and the
long-term interests in promoting creativity and innovation is not
always easy. Doing so at the international level is even more
difficult than at the national level. Perhaps nowhere do these
issues excite stronger feelings than in regard to pharmaceutical
patents, where tension between the need to provide incentives
for research and development into new drugs and the need to
make existing drugs as available as possible can be acute.
Footnotes:
(1) The effe
patent protf
inventions o
chemical en
less than th<
because a lc
that period •
expired befc
approval is c
the public h
regulatory b
reason, mos
developed c
introduced s
whereby a p
period of pr<
be obtained
compensate
part, for thi
effective pe
protection.
(2) Thirteen
Members (Ai
Brazil, Cuba
Kuwait, Mor
The TRIPS Agreement attempts to find an appropriate balance. Its
Article 7 entitled "Objectives” recognizes that the protection of
intellectual property should contribute to the promotion of
technological innovation and to the transfer and dissemination of
technology, to the mutual advantage of users and producers of
http://www.wto.org/englisli/tratop_e/trips_e/pharnia_atol86_c.htni
Pakistan, Pa
Tunisia, Tur
Arab EmiratUruguay) ha
"mailbox” s;
TRIPS Counc
5/23/01
technological knowledge and in a manner conducive to social and
economic welfare and to a balance of rights and obligations. It is
not an Agreement about simply maximizing the level of protection
for intellectual property; rather, it emerged from a genuine
negotiating process where the need for balance was very much to
the fore.
What pharmaceutical inventions must be patentable
under the TRIPS Agreement? bad' to top
The main rule relating to patentability is that patents shall be
available foi any invention, whether a product or process, in all
fields of technology without discrimination, where those
inventions meet the standard substantive criteria for patentability
- namely, novelty, inventive step and industrial applicability. In
addition, Members are required to make grant of a patent
dependent on adequate disclosure of the invention and may
require information on the best mode for carrying it out.
Disclosure is a key part of the social contract that the grant of a
patent constitutes since it makes publicly available important
technical information which may be of use to others in advancing
technology in the area, even during the patent term, and ensures
that, after the expiry of the patent term, the invention truly falls
into the public domain because others have the necessary
information to carry it out.
indicating tf
not grant pa
protection t
pharmaceut
Some of the
Argentina, E
Turkey, hav<
introduced <
protection,
excluded th.
few other W
who should l
but have no
(3) The "pip
to the backl
inventions o
pharmaceut
that were n<
patentable (
because dist
yet on the n
because per
marketing a
Three types of exception to the above rule on patentable subject
matter are allowed. These may be of interest from a public health
perspective:
• inventions the prevention of whose commercial
exploitation is necessary to protect ordre public or
morality, including to protect animal or plant life or
health;
• diagnostic, therapeutic and surgical methods for the
treatment of humans or animals; and
• certain plant and animal inventions.
What are the rights conferred by a patent under the
TRIPS Agreement? back to tup
The minimum rights that must be conferred by a patent under the
TRIPS Agreement follow closely those that were to be found in
most patents laws, namely the right of the patent owner to
prevent unauthorized persons from using the patented process
and making, using, offering for sale, or importing the patented
product or a product obtained directly by the patented process.
http://www.wto.org/english/tratop_e/trips_e/pharma_atol86_e.htm
5/23/01
WTO | Intellectual property (TRIPS) and pharmaceuticals - technical note
Page 3 of 6
MT
Term of protection bat. k to top
Under the TRIPS Agreement, the available term of protection
must expire no earlier than 20 years from the date of filing the
patent application. It should be noted that, although the issue of
patent term extension to compensate for regulatory delays in the
marketing of new pharmaceutical products was raised in the
Uruguay Round negotiations, the TRIPS Agreement does not
contain an obligation to introduce such a system. (1)
Limitations/exceptions to these rights back to top
Under the TRIPS Agreement, patent rights are not absolute but
can be subject to limitations or exceptions. These can be put into
three categories:
• the Agreement allows limited exceptions to be made by
Members provided that such exceptions do not
unreasonably conflict with a normal exploitation of the
patent and do not unreasonably prejudice the legitimate
interests of the patent owner, taking account of the
legitimate interests of third parties. Thus, for example,
many countries allow third parties to use a patented
invention for research purposes where the aim is to
understand more fully the invention as a basis for
advancing science and technology. The WTO Panel in
Canada — Patent Protection for Pharmaceutical Products
decided that this provision, allowing limited exceptions,
covered a provision of Canadian law which permits the use
by generic producers of patented products, without
authorization and prior to the expiry of the patent term,
for the purposes of seeking regulatory approval from public
health authorities for the marketing of their generic
version as soon as the patent expires. (This provision is
sometimes referred to as the "regulatory exception” or as
a "Bolar” provision.) The Panel Report was adopted by the
WTO Dispute Settlement Body on 7 April 2000;
• the Agreement also allows Members to authorize use by
third parties (compulsory licences) or for public non
commercial purposes (government use) without the
authorization of the patent owner. Unlike what was sought
by some countries in the negotiations, the grounds on
which this can be done are not limited by the Agreement,
but the Agreement contains a number of conditions that
have to be met in order to safeguard the legitimate
interests of the patent owner. There is not space to discuss
all of these here, but two of the main such conditions are
that, as a general rule, an effort must first have been made
to obtain a voluntary licence on reasonable commercial
te. ms and conditions and that the remuneration paid to the
right holder shall be adequate in the circumstances of each
case, taking into account the economic value of the
http://www.wto.org/cngl ish/tratop_e/trips_e/pharma_ato 186_e.htm
5/23/01
■ | kilxv t
"pi
j/v,*VJ y k
j'
x
.
SO
licence;
• the Agreement recognizes the right of Members to take
measures, consistent with its provisions, against anti
competitive practices and provides more flexible
conditions for the grant of compulsory licences where a
practice has been determined after due process of law to
be anti-competitive. For example, each of the conditions
specifically referred to above for the grant of compulsory
licences may be relaxed in these circumstances. The
Agreement also provides for consultation and cooperation
between Members in taking action against anti-competitive
practices;
• the TRIPS Agreement makes it clear that the practices of
WTO Members in regard to the exhaustion of intellectual
property rights (e.g. a Member’s decision to have a
national exhaustion regime, under which right holders can
take action against parallel imports, or an international
exhaustion regime, under which they cannot) cannot be
challenged under the WTO dispute settlement system,
provided that they do not discriminate on the grounds of
the nationality of right holders.
Other policy instruments back to too
It should be remembered that governments have a range of public
policy measures before them outside the field of intellectual
property to address issues of access to and prices of drugs. For
example, many countries use price or reimbursement controls.
Article 8 of the TRIPS Agreement makes it clear that WTO
Members may, in formulating or amending their rules and
regulations, adopt measures necessary to protect public health
and nutrition, provided that such measures are consistent with
the provisions of the Agreement.
Transition provisions
.w;
The TRIPS Agreement lays down some rather complicated
transition provisions which give countries periods of time in order
to adapt their legislation and practices to their TRIPS obligations,
which periods differ according to the type of obligation in
question and the stage of development of the country concerned.
Here we will limit the discussion to those transition provisions
which relate to the application of the obligations on substantive
standards for the protection of pharmaceutical inventions. For
these purposes, the obligations should be divided into two
categories*
(i) the obligations relating to the introduction of product
patent protection for pharmaceutical products in those
http://www.wto.org/english/tratop_e/trips_c/phamia_atol86_e.htm
5/23/01
Page 5 of 6
WTO | Intellectual property (TRIPS) and pharmaceuticals - technical note
developing and least developed countries which do not yet
grant it. Since most developing and least developed
country Members of the WTO already provide for product
patent protection for pharmaceuticals, a relatively small
number of countries are concerned (2);
(ii) obligations regarding process patents for this group of
countries and all patent protection obligations for other
developing and least developed countries.
With respect to the second category above, the basic rule is that
developing country Members had until 1 January 2000 and least
developed country Members have until 1 anuary 2006 to meet the
obligations in question. At that time, the rules of the TRIPS
Agreement will apply not only to new patent applications but also
to patents still under protection in their territories.
With respect to the first category of situations referred to above,
the developing countries in question have until 1 January 2005 to
apply product patent protection to pharmaceutical products and
the least developed countries until 1 January 2006.
Notwithstanding proposals to the contrary, the TRIPS Agreement
does not require the bringing under protection of pharmaceutical
inventions that were in the "pipeline” in these countries at the
time of entry into force of the WTO. (3) However, with effect
from the entry into force of the WTO (1 January 1995), these
countries have been under an obligation to provide a system
whereby applications for patents for pharmaceutical product
inventions can be filed (often referred to as a "mailbox” system).
These applications do not have to be examined until after 1
January 2005 (or 1 January 2006 in the case of least developed
countries). If found to be patentable by reference to their filing
(or priority) date, a patent would have to be granted for the
remainder of the patent term counted from the date of filing. In
the event that a pharmaceutical product that is the subject of a
"mailbox” application obtains marketing approval prior to the
decision on the grant of a patent, an exclusive marketing right of
up to five years will have to be granted provided that certain
conditions are met.
Concluding remarks back io tup
It will be noted that most developing and least developed
countries already grant patent protection for pharmaceutical
products. In .these countries, the TRIPS Agreement will therefore
not lead to fundamental changes in this regard, although a certain
amount of adjustment in legislation, for example in respect of
patent term and compulsory licencing, may be necessary. With
respect to the fairly limited number of countries that did not
provide patent protection for pharmaceutical products at the
time of entry into force of the WTO Agreement, some, including
Brazil and Argentina, have decided to bring such protection into
effect more quickly than is required under the TRIPS Agreement.
5/23/01
ht(p.7/vvww. vvto.org/cnglisli/tratop_e/trips_e/pharma_ato 186_e.htm
'o f
A ooc’ :;
' ’^41
07547
>V
W10 | Intellectual property (TRIPS) and pharmaceuticals - technical note
Page 6 of 6
5Z
It will also be noted that the TRIPS Agreement pays considerable
attention to the need to find an appropriate balance between the
interests of rights holders and users and that this was an
important theme in the negotiations. This is not only reflected in
the basic underlying balance related to disclosure and providing
an incentive for R&D, but also in the limitations and exceptions to
rights that are permitted and in the transition provisions.
It should also be appreciated that the protection of
pharmaceutical inventions is one aspect of a much wider
agreement, covering not only the protection of intellectual
property in general in a coherent and non-discriminatory way but
also further liberalization and strengthening of the multilateral
trading system as a whole. While it is true that some countries put
particular emphasis on TRIPS matters in the Uruguay Round
negotiations, it is also true that other countries attached great
importance to other areas, for example textiles and agriculture. It
is our belief, and a belief shared by all WTO Members, that a
strong and vibrant multilateral trading system is essential for
creating conditions for economic growth and development
worldwide. This in turn provides for the generation of the
resources required to tackle health problems.
CONTACT US : World Trade Organization, rue de Lausanne 154. CH-1211 Geneva 21. Switzerland
http://www.wto.org/cnglish/tratop_e/trips_e/phanna_atol86_e.htm
5/23/01
I
Page 1 of2
WTO | Intellectual property (TRIPS) - fact sheet - pharmaceuticals - contents
S3
search
WORLD TRADE
Organization
11 fl WTO ' w TO rlf ws
TRADE TOPICS
RfSOURCLS
on this site
contact us
register
DOCUMINIS
COMMIJNITY/fORUMS
espanol
ON THIS PAGE.
Contents
francjais
Foi more informatm
home • trade topics - tups
pharma fact sheet
TRIPS and pharmaceutical patents: fact
sheet
The WTO's Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS) attempts to strike a balance between the
long term social objective of providing incentives for future
inventions and creation, and the short term objective of allowing
people to use existing inventions and creations.
The agreement covers a wide range of subjects, from copyright
and trademarks, to integrated circuit designs and trade secrets.
Patents for pharmaceuticals and other products are only part of
the agreement.
April 2001
This fact sheet has been prepared
by the Information and Media
Relations Division of the WTO
Secretariat to help public
understanding. It is not an official
interpretation of the WTO
agreements or members’ positions
Contents back to top
Philosophy: TRIPS attempts to strike a balance
What IS the basic patent right?
Prefer to d
fact sheet i
out?
> Download
(7 pages, If
A patent is not a permit to put a product on the market
See also:
> Pharmaceutical patents and the
TRIPS Agreement
A more technical explanation.
Under TRIPS, what are member governments’ obligations on
pharmaceutical patents?
Need help on c
> guide to dowi
IN GENERAL (see also "exceptions”)
Exceptions
ELIGIBILITY FOR PATENTING
RESEARCH EXCEPTION AND "BOLAR” PROVISION
ANTI-COMPETITIVE PRACTICE, ETC
COMPULSORY LICENSING
WHAT ARE THE GROUNDS FOR USING COMPULSORY
LICENSING?
PARALLEL IMPORTS, GREY IMPORTS AND ’EXHAUSTION’ OF
RIGHTS
What does "generic” mean?
Developing countries’ transition periods
hup.7/www.wto.org/cnglish/tratop_e/trips e/factshcct_phannOO_e.htni
5/23/01
v i ixir
jaci biicui - piiarniaccoucais - contents
Hage2 of2
514
GENERAL
PHARMACEUTICALS AND AGRICULTURAL CHEMICALS
For more information
:
> Gateway to TRIPS materia! on the WTO website
< Previous
Next
CONTACT US : World Trade Organization, rue de Lausanne 154. CH-1211 Geneva 21. Switzerland
!
I
iI
II
hnP//'v'vw. wto.org/english/tratop_e/trips_e/factsheet_pharmOO
c.htm
5/23/01
I
«
i </ fnncnuciuai property < i mra; - laci sneei - pharmaceuticals - 4
search
world trade
Organization
11II WT 6
w ro Nf ws
TRADE TOPICS
Rf sot was
Page 1 of3
on this site
register
espanol
ON THIS PAGE
General
contact us
DOCUMfNIS I COMMUNI I Y/1ORUM’.>
frdnQais
Pharmaceuticals and agricultural chemicals
home ' trade topics • trips • pharma fact sheet > developing countries
FACT SHEET: TRIPS AND PHARMACEUTICAL PATENTS
Developing countries’ transition periods
Provisions for developing countries, economies in transition from
central planning, and least-developed countries
April 2001
t
Contents
> Philosophy: striking a balance
> Obligations and exceptions
> What does "generic” mean?
> Developing countries
1,1 • tael sneci has Deen pi epared
o< the informal ion and Media
^eladorA
f,< th(, wtq
Secretariat to help public
understanding. It is not an official
interpretation ot the WTO
agreements or members' positions
GENERAL back to lop
The TRIPS Agreement
Developing countries and economies in
transition from central planning did not
have to apply most provisions of the
TRIPS Agreement until 1 January 2000.
The provisions they did have to apply
deal with non-discrimination.
Article 65.2 and 65.3
Least-developed countries have at least
until 1 January 2006 — this may be
extended. Article 66.1
(Developed countries had until 1 January
1996, one year after the TRIPS
Agreement took effect. Article 65.1)
Most new members who joined after the
WTO was created in 1995 have agreed to
apply the TRIPS Agreement as soon as
they joined. Determined by each new
member's terms of accession
PHARMACEUTICALS AND AGRICULTURAL
CHEMICALS back id top
Some developing countries are delaying
patent protection for pharmaceutical
products (and agricultural chemicals)
until 1 January 2005.
This is allowed under provisions that say
a developing country that did not provide
product patent protection in a particular
area of technology when the TRIPS
Agreement came into force (on
Article 65
Transitional Arrangements
1. Subject to the provisions of
paragraphs 2, 3 and 4, no Member sh
be obliged to apply the provisions of
this Agreement before the expiry of
general period of one year following
date of entry into force of the WTO
Agreement.
2. A developing country Member is
entitled to delay for a further perioc
four years the date of application, a:
defined in paragraph 1, of the provis
of this Agreement other than Article
4 and 5.
3. Any other Member which is in th*
process of transformation from a
centrally-planned into a market, fre<
enterprise economy and which is
undertaking structural reform of its
intellectual property system and fac
special problems in the preparation .
implementation of intellectual propc
laws and regulations, may also benel
from a period of delay as foreseen ir
paragraph 2.
4. To the extent that a developing
country Member is obliged by this
Agreement to extend product patent
protection to areas of technology no
protectable in its territory on the
general date of application of this
i
http.7Avww.vvto. org/englisli/tratop_e/trjps_c/factshect_phann04_e.htm
5/23/01
5-6
1 January 1995), has up to 10 years to
introduce the protection. Article 65.4
However, for pharmaceuticals and
agricultural chemicals, countries eligible
to use this provision (i.e. countries that
did not provide protection on
1 January 1995) have two obligations.
They must allow inventors to file patent
applications from 1 January 1995, even
though the decision on whether or not to
grant any patent itself need not be taken
until the end of this period —
Article 70.8. This is sometimes called the
"mailbox” provision (a metaphorical
"mailbox” is created to receive and store
the applications). The date of filing is
significant, which is why the mailbox
provisions were set up. It is used for
assessing whether the application meets
the criteria for patenting, including
novelty ("newness”).
And if the government allows the
relevant pharmaceutical or agricultural
chemical product to be marketed during
the transition period, it must - subject
to certain conditions — provide the
patent applicant an exclusive marketing
right for the product for five years, or
until a decision on a product patent is
taken, whichever is shorter. Article 70.9
Which countries are using the extra
transition period? The answer is not
entirely straightforward. Thirteen WTO
members - Argentina, Brazil, Cuba,
Egypt, India, Kuwait, Morocco, Pakistan,
Paraguay, Tunisia, Turkey, United Arab
Emirates and Uruguay — have notified
"mailbox” systems to the TRIPS Council,
indicating that at that time they did not
grant patent protection to
pharmaceutical products. It is also
possible that there are a few other WTO
Members who should have notified but
have not done so.
Some of these have now introduced
pharmaceutical patent protection - such
as Argentina, Brazil, Guatemala, Morocco
and Turkey.
< Previous
Next >
http://www.wto.org/english/tratop_e/trips_e/factshcetj>harm04 e.htm
Agreement for that Member, as defir
in paragraph 2, it may delay the
application of the provisions on prod
patents of Section 5 of Part II to sucl
areas of technology for an additional
period of five years.
5. A Member availing itself of a
transitional period under paragraphs
2, 3 or 4 shall ensure that any chang
in its laws, regulations and practice
made during that period do not resul
a lesser degree of consistency with t
provisions of this Agreement.
Article 66
Least-Developed Country Members
«.
In tnnti/ nT
—_ — J_ _____ _f
in ncn Ml LHC special IICCUS alia
requirements of least-developed
country Members, their economic,
financial and administrative constrai
and their need for flexibility to creai
viable technological base, such Mem
shall not be required to apply the
provisions of this Agreement, other t
Articles 3, 4 and 5, for a period of 1(
years from the date of application a:
defined under paragraph 1 of Article
The Council for TRIPS shall, upon dul
motivated request by a least-develo|
country Member, accord extensions <
this period.
Article 70
Protection of Existing Subject Matte
(...)
8. Where a Member does not make
available as of the date of entry intc
force of the WTO Agreement patent
protection for pharmaceutical and
agricultural chemical products
commensurate with its obligations
under Article 27, that Member shall:
(a) notwithstanding the provisions (
Part VI, provide as from the date of
entry into force of the WTO Agreem<
a means by which applications for
patents for such inventions can be fi
(b) apply to these applications, as (
the date of application of this
Agreement, the criteria for
5/23/01
Page 3 of3
patertability as laid down in this
Agreement as if those criteria were
beinj applied on the date of filing in
that Member or, where priority is
availtcie and claimed, the priority d
of the application; and
(c) p ovide patent protection in
accordance with this Agreement as f
the giant of the patent and for the
remander of the patent term, count
from rte-filing date in accordance w
Article 33 of this Agreement, for tho
°f thrxe applications that meet the
criteru for protection referred to in
subpa agraph (b).
9. Were a product is the subject o
paten: application in a Member in
accordance with paragraph 8(a),
exclude marketing rights shall be
grantee, notwithstanding the provisi
of Pan VI, for a period of five years
after retaining marketing approval ii
that Member or until a product patei
grantee or rejected in that Member,
whichr-er period is shorter, provide,
that, siosequent to the entry into fc
of the wTO Agreement, a patent
applicxion has been filed and a patr
grantee for that product in another
Membe and marketing approval
obtained in such other Member.
CONTACT US: Wo„d Tlade Organ,zat,„.
ae
r
'1tiP^/www*wlo-org/Cnglisli/iralop_c/,nps_e/factsheeij,hann04 e.hlni
5/23/01
1
I
t age i ui
Compulsory Licensing
58
Compulsory Licensing and Parallel Importing
What do they mean?
Will they improve access to essential drugs for
people living with HIV/AIDS? •
Background Paper
International Council of AIDS Service Organizations (ICASO)
July 1999
Acknowledgements
Margaret Duckett, author
Author's Note: This paper draws substantially on material prepared and distributed from a
number ofsources including the Consumer Project on Technology’, and postings on
the Treatment Access Forum, an electronic listserve discussion group.
Grateful Thanks are also extended to Richard Burzynski, David Patterson and
David Gannaisefor their editorial comments.
1. Introduction
Since 1998, treatment activists have increasingly been talking about the effect of
international trade laws on access to essential drugs, especially HIV-related medications.
Recently, these issues have been the subject of considerable debate among treatment
activists, pharmaceutical companies, governments and academics.
This document aims to provide people with sufficient information to participate fully in
the debate, and to help people better understand the potential lor advocacy work on these
matters in their own countries and with their own governments. If this is the first time
you have considered some of the issues covered in this paper, please treat this document
as a starting point; collect more information, read further, and talk about the issues with
other individuals and groups.
2. Background
http://www.icaso.org/compulsory_englisli.htm
8. i 01
Compulsory Licensing
Page 2 of' 12
S5
'
Thanks to new drug therapies, many people living with HIV/AIDS in most developed
countries are now able to live relatively healthy lives. Combination anti-retroviral
therapies allow HIV-positive people to reduce their viral load significantly, in some
cases to undetectable levels, thus enabling many individuals to return to the workplace.
In developing countries and countries in transition, however, these and many other
therapies used to treat HIV infection and related illnesses are unavailable for a simple
reason: they are not affordable. Even for those few who may be able to afford them,
sometimes pharmaceutical companies conclude that the potential market is loo small to
bother with licensing and distribution arrangements.
The issue of the cost of drug therapies is of immense importance in relation to
HIV/AIDS. Over 89% of people currently living with HIV/AIDS reside in countries
ranked in the lowest 10% in the world in terms of gross national product. Even in
slightly wealthier countries in Southeast Asia, there are major cost constraints. Al the
Bamrasnaradura hospital in Bangkok. Thailand, for example, only 20 of the 2000
patients who seek treatment each month can afford the triple drug cocktails that have
become the standard of care in developed countries.
Ways to lessen or remove the gap in access between developed countries and developing
countries are increasingly being explored. This paper describes two strategies that are
being considered to bring down the price of drug therapies:
• parallel importing, which involves bringing drugs in from another country
and
• compulsory licensing, which involves using a legal intervention to restrict
the monopoly rights of existing patent holders and make generic drugs more
available.
This paper also provides a list of other strategies to reduce the costs of essential drugs
It should be noted that in the developing world the specific access to treatment needs of
each country may be different. Only countries with more developed medical
infrastructures have the widespread capacity to use combination anti-retroviral drugs.
For other countries, it may be more important to obtain greater access to anti-microbial
and other prophylactic (disease preventing) drugs.
3. Parallel Importing
Parallel importing consists of purchasing proprietary drugs from a third party in another
country, rather than directly from the manufacturer, and taking advantage of the fact that
pharmaceutical companies sometimes charge significantly lower prices in one country
than in another. For instance, in Britain, where parallel importing is common, the list
price for Glaxo Wellcome's Retrovir is £125, but consumers can purchase the same
proprietary drug imported from other European countries for as little as £54.
Price for the same product can vary widely among countries because of many factors.
http://www.icaso.org/compulsory _english.htm
8/1/01
Page 3 of 12
Compulsory Licensing
60
such as differences in intellectual property rules, differences in local incomes, and the
degree of competition among producers. For example, a 1998 study by the Consumer
Project on Technology found prices for SmithKlinc Beechman's version of Amoxil was
$8 in Pakistan, S14 in Canada, $16 in Italy. $22 in New Zealand, $29 in The Philippines,
$36 in Malaysia. $40 in Indonesia, and $60 in Germany.111
By permitting some form of parallel imports, countries can shop around and get belter
prices, using market forces to lower national expenditures on a range of goods, including
pharmaccuficals. In the European Union (EU), parallel importing of patented products is
widely used and is seen as very effective at equalizing prices.
Since the creation of the World Trade Organization' -1 (WTO), the United States
Government has been extremely aggressive in attacking parallel imports by other
countries. Nevertheless, parallel imports of a range of goods routinely flow into the
United States itself.
Parallel importing of generic drugs is also possible.
For many countries, particularly in Africa, parallel importing may well be the best way
to improve access to essential drugs because of limited local capacity to produce raw
materials and undertake drug manufacturing.
4. Compulsory Licensing
To understand the concept of compulsory licensing, one has to first understand what a
patent is. A patent is a legal title granted by government allowing a temporary monopoly
(for a specified number of years) for the production and sale of an invention or
discovery. Compulsory licensing is the term given to a legal approach that permits the
manufacture and use of generic drugs without the agreement of the patent holder.
The issue of patent protection has received increasing attention internationally since the
establishment of WTO in 1995. In deciding to become a member of WTO..a country
must agree to follow its rules. A certain number of treaties are therefore binding oh all
WTO member countries.
One such treaty is the TRIPS Agreement (Trade-Related Aspects of Intellectual Property
Rights), which sets out minimum standards in relation to intellectual property. All WTO
member countries have to comply with these standards by changing their national
regulations (where necessary) to follow the provisions of the agreement. With respect to
drugs, the major difference between TRIPS and previous multilateral agreements is that
TRIPS requires countries to grant patent protection to pharmaceutical products tor a
minimum period of 20 years.
Nevertheless, the TRIPS Agreement does leave WTO member countries with a certain
amount of freedom. Countries are allowed, under certain conditions, to issue compulsory
licenses against the will of the patent holder. For example, for a country with high HIV
seroprevalence, the government could decide that it is in the public interest to ensure that
http://www.icaso.org/compulsory_english.htm
8/1/01
Tagc 4 ol I J
Compulsory Licensing
appropriate drugs arc manufactured locally and made available at a cheaper price. Such
action should be legal under the TRIPS Agreement (though lawyers may argue about the
exact requirements). (It should also be noted that the TRIPS Agreement does not
prohibit parallel importing.)
However, many countries arc under strong pressure (particularly from the United Slates
and the multinational pharmaceutical industry) to adopt legislation that provides a higher
dcvel of patent protection than is required by TRIPS and international trade law. A
number of countries have adopted (or are considering) legislation that is far more
restrictive than required, including not allowing compulsory licensing.
Complete patent protection - i.e., for 20 years from date of filing - would certainly
increase the access gap between the North and the South, particularly in relation to the
treatment of HIV/AIDS.1 1,1 1'
5. The Consumer Perspective
Price should not be the sole or main determining factor for access to any drug.
ICASO and other international non-governmental organizations (NGOs) acknowledge
that effective patent protection is a prerequisite for a successful, innovative
pharmaceutical industry. But effective patent legislation should balance all interests and
provide protection against abuse by the patent holder. The present international trade
rules, which permit compulsory licensing, offer sensible ways of doing this.
The Indian drug industry is a good example of what happens when companies are given
the authority to produce drugs for the local market without paying exorbitant licensing
fees. India operates under an unregulated system (at time of writing). Lariam, a
treatment for Malaria costs $37 in the United States, but only $4 in India. AZT, an AIDS
treatment, costs $239 per month in the United States, but only $48 in India. The lower
prices in India still deliver a very high return to the Indian pharmaceutical company
(CIPLA) and its stockholders.
Under TRIPS, compulsory licenses could be granted to produce essential medicines to
treat life-threatening diseases. This would produce results that are similar to the
unregulated system in India.
6. Commonly Asked Questions
Would increased use by developing countries of compulsory licensing and parallel
importing be a serious threat to research and development funding for new drugs?
The International Federation of Pharmaceutical Manufacturers Associations (IFPMA),
which represents the research-based pharmaceutical industry and other manufacturers ol
prescription medicines, argues that compulsory licensing discourages research and
http://www.icaso.org/compulsory_english.htm
8/1/01
Compulsory Licensing
Page 5 of 12
62
development. IFPMA suggest that compulsory licensing will slow the search for
effective new medicines that are needed to address existing and emerging public health
challenges. Specifically, IFPMA states that use of compulsory licensing will lessen
development of new AIDS drugs and other drugs for infectious diseases.
There is no doubt that research and development (R&D) for new drugs is expensive.
R&D costs should be recovered during the initial years of marketing. Currently, most of
the R&D costs are recovered from sales in industrialised countries where most of the
patients have health insurance. The main question is whether patients in poor countries
should also pay for these costs.
Although the majority of the world's population live in developing countries, these
countries represent only a small proportion of the global pharmaceutical market. Africa,
for example, accounts for only 1.3 percent of that market. Consequently, lower prices for
essential drug therapies in developing countries should not be a serious threat to R&D
funding.
The very small size of the global pharmaceutical market represented by developing
countries is the reason why only extremely limited investments are made into the
diseases that mainly or solely affect people in developing countries.
Richard Laing, Associate Professor, Department of International Health, Boston
University School of Public Health, has argued^ that the global pharmaceutical market
is so large (over $400 billion per year) and the proportional contribution of Africa,
Southeast Asia, and the Commonwealth of Independent States to both turnover and
profit so small, that these markets could be completely isolated from the global total and
pharmaceutical manufacturers would not be affected in any measurable way.
In addition, universal or widespread health insurance in most industrialised countries
ensures that the burden of drug costs is rarely substantial for any individual. This is in
marked contrast to the situation in most developing countries/61
How much return on R&D is required to ensure further drug development?
There is considerable debate about what level of return (i.e., profit) is required for
marketed drugs, to compensate both for the R&D done for that product and for the R&D
done in unsuccessful attempts to develop other drugs.
IFPMA states that the risks with R&D are largely borne by the research-based
pharmaceutical, biotechnology and vaccine industries, which invest tens of billions of
dollars annually in research and development. Thus, IFPMA argues, the only feasible
model for promoting innovation in the high-risk and resource-intensive pharmaceutical
industry is to guarantee the companies that invest in research an adequate period of
exclusive rights for their products.
■
IFPMA also states that research-based pharmaceutical companies are socially
responsible, and that Merck, Pfizer, Glaxo-Wellcome, SmithKIine Beecham and other
companies have made major financial and corporate commitments to addressing diseases
that affect developing countries through product donation programmes and price
http://www.icaso.org/compulsory_english.htm
8/1/01
I
Compulsory Licensing
Page 6 of 12
63
concessions.
The costs of drug development are not small. One of the most detailed studies of the
costs of clinical trials was reported in a 1991 Journal of Health Economics paper.1 ' The
authors found that the total cost of drug development can be as high as $500 million per
drug. However, with respect to HIV-related drug therapies, it has usually been
.governments (rather than drug companies) that have paid for initial development, preclinical research and clinical research. For the pharmaceutical companies, this
significantly lowers the costs of bringing these products to market. For example, the
costs of securing Federal Drug Authority (FDA) approval in the United States for
HIV/AIDS drugs have been estimated to be only about $25 million per drugJ'S|
Many people’9' have argued that the industry does not in fact engage in any significant
effort to find cures to illnesses - i.e., that the efforts are superficial and primarily
restricted to the refinement of government-produced products (e.g., T-20, ddl) or the
development of alternative copycat drugs to government-sponsored efforts (e.g., the
protease inhibitors, new nucleoside analogues). This is particularly obvious in the case
of HIV disease where every class of drug was discovered, tested and developed by
government agencies. Among these drugs are ddl, AZT, d4t, Ritonavir (including the
structure of the proteinase enzyme), and T-20.
Some support for the position that drug prices are not related to replacement of R&D
costs is provided by the current price for Pentamidine. Pentamidine was a cheap
treatment developed to treat sleeping sickness. However, when it was found to be
effective in the treatment of AIDS-related PCP (pneumocystis carinii pneumonia), the
price of Pentamidine increased 500%. A recent survey of 20 African and Southeast
Asian Countries conducted by UNAIDS found that Pentamidine is now available in only
one of these countries.
i
!
How will compulsory licensing and parallel importing affect the quality of drugs?
Some people argue that compulsory licensing and parallel importing will lead to cheaper
but poorly performing drugs and that these drugs will then enter the markets of both
developing and developed countries. They point out that with pater ted products,
pharmaceutical manufacturers allocate significant resources to developing trustworthy
sources of raw materials; building manufacturing facilities that can be counted on for
consistent and high quality products; using and maintaining distribution systems that
allow every government or individual buying the drug access to products upon demand;
and refining products to remove substances that cause side effects.
There are issues around drug quality, but they are not related to compulsory licensing or
the production of generic drugs. With or without compulsory licensing; sub-standard,
expired and counterfeit drugs are increasingly found in international and local markets.
Control of production, importing and exporting of drugs varies greatly among countries.
Hundreds of people have died as a result. Paradoxically, although global standards for
drugs are becoming more demanding, 10 to 20% of sampled drugs in developing
countries fail quality control tests. Only one developing country in six has a fully
functional drug regulation system. The Revised Drug Strategy adopted by the 52nd
http://www.icaso.org/compulsory_english.htm
8/1/01
Compulsory Licensing
1
1
Page 7 of 12
World Health Assembly commits all countries to ensure that all aspects of national drug
policy, including quality control of available drugs, receive increased attention.
i
7. Other Means of Lowering Drug Prices
To lower the cost of HI V/AIDS drug therapies in developing countries, a number of
approaches have been tried or are currently being used, of which parallel importing and
compulsory licensing are but two. The following is a brief description of some of the
other approaches:
Therapeutic value pricing. This approach has been adopted in Australia. The
Pharmaceutical Benefit Pricing Authority (an official, independent body) determines the
drug price on the basis of therapeutic value. When a new drug becomes available for
marketing, the benefits and health outcomes of the new drug are carefully compared
with similar, existing drugs and a comparative price is estimated. For example, a new
drug may provide a small benefit compared to an existing drug, so the Pricing Authority
may declare that the government will be willing to purchase the new drug at a 10%
increase over the price of the existing drug. The manufacturer then determines if it
wishes to sell its drug at this price. Sometimes, negotiation for a mutually acceptable
price can take months.
Pooled procurement. For countries with small national populations, pooled procurement
may be an option. This has been tried in the Caribbean, where seven different countries
have joined together to purchase drugs. This approach, which started in the 1980s, has
enabled these countries to reduce prices by around 50%. In addition, this combined
operation has allowed the countries involved to develop a single multi-country unit with
expertise in drug evaluation and price negotiation.
*
Negotiated procurement. Large organizations buying drugs in large amounts can also
bring down prices. For instance, some large health maintenance organisations in the
United States have been able to negotiate significantly lesser prices than the official
price of a drug (i.e., more than official discounts for bulk orders).
Planned donations. In the past, many countries have received donations of about-toexpire stocks of drugs. The World Health Organization (WHO) is now encouraging
planned donation programmes for drugs that are still in use. For example, Johnson and
Johnson now have a planned giving programme (addressing a range of diseases), with
three years of donations planned three years in advance.
Lobbying Pharmaceutical Companies. UNAIDS has lobbied pharmaceutical companies
to lower the prices*of their drugs in developing countries. Their current four-country
treatment pilot initiative has resulted in slightly lower initial prices for retroviral and
other drugs bought through the pilot program. In addition, treatment activists in many
countries have been lobbying many pharmaceutical companies directly for some years.
One result was the decision by GlaxoWellcome in 1997 to halve the then cost of an
annual course of AZT — the price is still substantial, however.
r
htlp://w ww.icaso.org/compulsory_english.htm
8/1/01
i.
ra^c o v»i
Compulsory Licensing
a
8. Future Action
1
In May 1999, the 52nd World Health Assembly in Geneva passed a resolution' "" which
urges countries to "explore and review their options under international agrectnents,
including trade agreements, to safeguard access to essential drugs, t c targes
„
with, "monitoring and analysing the pharmaceutical and public health miphcat.ons of
these agreements.
essential drugs.
In a statement to delegates at the 52nd World Health Assembiy, iGASO called on
aovernments, the United Nations and other development agencies, and NGOs active in
the health sector, to ensure that access for essential medications rece.ves pnoruy in a.,
societies.
This discussion paper aims to provide people with a greater knowledge of the role that
!
[CASO encourages all NGOs and PWA groups to inquire about the status of their
domestic law provisions covering compulsory licensing and parallel importing an o
lobby for changes in these laws if they are more restrictive than the requirements ot
TRIPS Agreement. If domestic governments request it, technical assistance to frame
their laws to meet the requirements of TRIPS is available from the World Intellectual
Property Organization. Decision makers in the health sector can obtain us^l
information from Globalization and access to dmgs: perspectives on the WTO/TBJP^
agreement, a WHO/DAP publication that discusses the impact of trade agreements in the
pharmaceutical field and offers guidance on how to interpret the requirements. See the
section on Further Information for more details.
Similarly the ICASO document Stories from the Frontlines (see the section on Further
Information) may provide ideas on how to mobilise interest and support among key
decision-makers in improving treatment access.
Some things that you can do at the local and national levels include.
. set up a study group of key NGOs to review this document and discuss the
issues for your country;
• copy this document and pass it out at local meetings,
. translate it in your local language (ICASO has initially distributedI it in
English, French and Spanish; if you make a translation please let ICASO
know so that it can pass on your translation to others);
. speak to your national AIDS programme manager (if appropriate) about the
issues;
<
hitp://www. icaso.org/compulsory_english.htm
8/1/01
Cosp.ipulsory Licensing
. start a dialogue with a pharmaceutical company (if there :s one in your
country) about the issues from your perspective, and tn to find some
common ground.
9. Further Information
Websites and E-Mail Discussion Forums
Treatment Access Forum
hmy/7www hivnct.cli:8000/trcatment-acccss/tdm
This is an electronic listserve discussion group that includes many issues of treatment
access in developing countries. Starting in late March 1999. there are many reports,
documents and personal messages on compulsory licensing and related issues ot trade
policy and access to essential medical technology. You do not need to register to read
fhe messages; you can, however, register free of charge. If you have e-mad access only,
.... .. Jli narticipate; send a message to: <treatment-access^hivnet.ch>.
Consumer Project in Technology Website
ForeXXXckground anddocuments, see the pages on intellectual property and
health care maintained by James Love of the Consumer Project on Technology. This
well-designed site includes sections on the 1999 Geneva meeting. South Africa disputes,
compulsory licensing, parallel imports, data exclusivity, and other issues of intellectual
property and access to essential medicines.
Health Action International
nTahh”^^
(HAI) was one of the main NGO players involvedjn the
WHO revised drug strategy recommendations. See particularly Globaltzatton and
Pharmaceuticals: Implicationsfor Public Health, a policy paper prepared by HAI (full
text or summary). From the home page, select News and scroll down to Policy Papers.
Medecins sans frontieres (Doctors Without Borders)
http://www.msf.org/adyocacy/accessmed/
.
rpviced
Medecins sans frontieres (MSF) is another NGO that was involved in the WHO revised
drug strategy recommendations. The website listed above contains a number of articles
on access ^essential drugs. MSF lawyers and doctors are frequently called upon to
respond to media inquiries on international AIDS issues, specifically around compulsory
licensing issues.
WTO/TRIPS Agreement
hitp://www.wto.org/wto/intcllec/intellec.htm.
World Health Organization Publications
For distribution and sales of all WHO publications contact WHO at 1211 Geneva 27,
hup:/, www.icaso.org/compulsory_english.htm
8/1/01
■z
Page 10 of 12
Compulsory Licensing
Switzerland: Tel: +41.22.791 2476 or via the Internet on http://www.who.ch
Essential Drugs Monitor, Double Issue No. 25 and 26 (1998) World Health
Organization Action Programme on Essential Drugs and Vaccines. (This issue focuses
on managing drug supply.) The Essential Drugs Monitor is published in English, French,
Spanish and Russian and is provided to appropriate personnel free of charge.
' Managing Drug Supply. The Selection, Procurement, Distribution, and Use of
Pharmaceuticals. 2nd Edition. Management Sciences for Health in collaboration with
the World Health Organization Action Programme on Essential Drugs. Kumarian Press
1997 ISBN 1-56549-047-9.
WHO Model Prescribing Information: Drugs used in HIV-related Infections. World
Health Organization 1999 WHO/DMP/DS1/99.2.
Other Sources
Correa CM. The GATT Agreement on Trade-Related Aspects of Intellectual
Property Rights: new standards for patent protection.European Intellectual. Propglty
Review, 1994, 16 (8): 327-335. Analysis of the main provisions of the TRIPS
Agreement on patents, and in particular the extension of patentability, criteria for
patentability, the non-discrimination clause, the rights conferred by a patent and the
exceptions, conditions for patent applications, compulsory licences, the reversal of the
burden of proof and transitional provisions.
Globalization and Access to Drugs. Perspectives on the WTO/TRIPS Agreement
Health Economics and Drugs. DAP Series No. 7, (1999) World Health Organization,
2nd edition. An overview of the limitations on pharmaceutical patents provided by the
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Contact:
Documentation Centre, Essential Drugs and Other Medicines, World Health
Organization, 1211 Geneva 27, Switzerland. E-mail: <darec@who.ch>.
I
HIV/AIDS and Human Rights: Stories from the Frontlines. International Council of
AIDS Service Organizations (ICASO). June 1999. Among other subjects, this document
describes how NGOs have improved access to treatments for persons living with
HIV/AIDS by fighting in the courts, by lobbying politicians, by using the media, by
organizing public actions, and by setting up distribution pipelines. This and other
ICASO documents can be accessed via the ICASO website: <http://www.icaso.org>.
10. Glossary
Compulsory License. Authorisation for a government or company to make and sell a
product (such as a drug, for example) without the permission of the patent holder.
Compulsory licenses are generally issued on the basis of public interest - e.g., public
health or defence.
http://vvww.icaso.org/compulsory_english.htm
>
8/1/01
I
Compulsory Licensing
Page 11 of 12
flexiWe and adaptable to many different situations; exactly which drugs are regarded as
essential remains a national responsibility.
'Generic Drue A pharmaceutical product usually manufactured without a license alter
the expiry of patent or other exclusivity rights. For example, Aspirin is a widely
available generic drug.
Parallel Importing: Products that are imported into a country without authorisation of
Che patent holder in that country and that have been made available in another country by
the patent holder or under license.
Patent. A title granted by the public authorities conferring a temporary monopoly (up to
20 years) for the production and sale of an invention or discovery.
Proprietary drug: A pharmaceutical product made and sold under a brand name
TRIPS: The Agreement on Trade-Related Aspects of Intellectual Property Rights (or
TRIPS) covers a new field in multinational trade law. The agreement describes
minimum standards that member countries of the World Trade Organisation (WTO)
must adopt in order to ensure that new products, including drugs, are protected by
oatents These new standards should be integrated into national laws by specified
deadlines, which depend on the current patent laws and development status of any given
country.
ENDNOTES
1. 1. S indicates US dollar in all cases in this paper.
2 2 The World Trade Organization (WTO) developed out of the General Agreement on
Tariffs and Trade (GATT). GATT was a treaty signed in 1947 by 23 countries aimed at
promoting and regulating international trade. Various "rounds- of imenrattonal trade
negotiations eventually developed into the agreement to create the WTO, with all
matters relating to international trade being placed within its legal responsibility Prior
the creation of the WTO, the GATT did not address the issue of the level of protection
that should be given to intellectual property; countries had adopted a range ot
approaches to drug patents.
3 3 According to Health Action International, a number of drugs considered essential
from a health point of view are not on the WHO Essential Drugs List because of their
current costs.
4 4 See Pecoul et al (JAMA Jan 27 1999 Vol 281,4: 361-367) who argue that removal
of compulsory licensing and other means to manufacture generic drugs would remove a
source of essential drugs on which poorer countries depend, and would also have
http://www.icaso.org/coiTipulsory_english.htm
8/1/01
£
Page 12 of 12
’
Compulsory Licensing
detrimental long term effect on local manufacturing capacity.
s 5 Laine R Global Issues of Access to Pharmaceuticals and Effect of Patents.
PrfsenSn at the AIDS and Essential Medicines and Compulsory L.censmg Mect.ng,
Geneva, March 26-27, 1999.
6 6. "The inequities are striking," says Dr Jonathan Qu.ck, D'rcct«r
ahd Other Medicines at WHO. "In developed countries a course of antibiotics can b
bought for the equivalent of two or three hours' wages. One-year s treatment for I
X'ReuLTwH^lTzl'w ^999^0 to A^ess Trade and Pharmaceuticals.
7. 7. DiMasi, JA. Hansen, RW, Grabowski, HG & Lasagna, LJ Health Econ 10. 107142 (1991).
8. 8. Love, J Nature 397, 202 (1999) 21 January 1999.
9. 9. Multiple postings on
(1999).
the Treatment Access Forum electronic discussion group
10. 10. Resolution EB103/1999/R1 Revised Drug Strategy.
http://www.icaso.org/compulsory_english.htm
8/1/01
I
C.
International Efforts
> Declaration of Commitment on HIV/AIDS
United Nations General Assembly Special Session on
HIV/AIDS
> Global Health Fund:
> Communique, G8 Statement
> Statement of the Secretary General, Kofi Annan
> Contributions Pledged to the Global AIDS Health
Fund
> Press Releases, Medecines-sans-Frontieres
> Inspiring Country Efforts:
> 'frequently Asked Questions^x^\x^^\X. Action
Campaign, South Africa
> "Look At Brazil''Rosenberg
> "NationalAIDS Drug Policy", Ministry of Health of
Brazil
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 1 of 17
70
UNITEDgNATIONS
SFECIAKiSSION
ON MlDS
Global Crisis-Global Action
25-27 June 2001 New York
»
t
r\ r\
z i June zuu i
DECLARATION OF COMMITMENT ON HIV/AIDS
"Global Crisis - Global Action"
1. We, Heads of State and Government and Representatives of States and
Governments, assembled at the United Nations, from 25 to 27 June 2001, for the
twenty-sixth special session of the General Assembly convened in accordance
with resolution 55/13, as a matter of urgency, to review and address the problem
of HIV/AIDS in all its aspects as well as to secure a global commitment to
enhancing coordination and intensification of national, regional and international
efforts to combat it in a comprehensive manner;
2. Deeply concerned that the global HIV/AIDS epidemic, through its devastating
scale and impact, constitutes a global emergency and one of the most formidable
challenges to human life and dignity, as well as to the effective enjoyment of
human rights, which undermines social and economic development throughout
the world and affects all levels of society — national, community, family and
individual;
3. Noting with profound concern, that by the end of the year 2000, 36.1 million
people worldwide were living with HIV/AIDS, 90 per cent in developing countries
and 75 per cent in sub-Saharan Africa;
4. Noting with grave concern that all people, rich and poor, without distinction of
age, gender or race are affected by the HIV/AIDS epidemic, further noting that
people in developing countries are the most affected and that women, young
adults and children, in particular girls, are the most vulnerable;
5. Concerned also that the continuing spread of HIV/AIDS will constitute a serious
obstacle to the realization of the global development goals we adopted at the
http://www.unaids.org/whatsnew/others/un_special/Declaration2706_en.htm
8/8/01
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 2 of 17
Millennium Summit;
6. Recalling and reaffirming our previous commitments on HIV/AIDS made
through:
• The United Nations Millennium Declaration of 8 September 2000;
• The Political Declaration and Further Actions and Initiatives to Implement
the Commitments made at the World Summit for Social Development of 1
July 2000;
• The Political Declaration and Further Action and Initiatives to Implement the
Beijing Declaration and Platform for Action of 10 June 2000;
• Key Actions for the Further Implementation of the Programme of Action of
the international Conference on Population and Development of 2 July
1999;
• The regional call for action to fight HIV/AIDS in Asia and the Pacific of 25
April 2001;
• The Abuja Declaration and Framework for Action for the Fight Against HIV/
AIDS, Tuberculosis and other Related Infectious Diseases in Africa, 27 April
2001;
• The Declaration of the Ibero-America Summit of Heads of State of
November 2000 in Panama;
• The Caribbean Partnership Against HIV/AIDS, 14 February, 2001;
• The European Union Programme for Action: Accelerated Action on HIV/
AIDS, Malaria and Tuberculosis in the Context of Poverty Reduction of
14 May 2001;
• The Baltic Sea Declaration on HIV/AIDS Prevention of 4 May 2000;
• The Central Asian Declaration on HIV/AIDS of 18 May 2001,
7. Convinced of the need to have an urgent, coordinated and sustained response
to the HIV/AIDS epidemic, which will build on the experience and lessons learned
over the past 20 years;
8. Noting with grave concern that Africa, in particular sub-Saharan Africa, is
currently the worst affected region where HIV/AIDS is considered as a state of
emergency, which threatens development, social cohesion, political stability, food
security and life expectancy and imposes a devastating economic burden and that
the dramatic situation on the continent needs urgent and exceptional national,
regional and international action;
http://www.unaids.org/whatsnew/others/un_special/Declaration2706_en.htm
8/8/01
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 3 of 17
9. Welcoming the commitments of African Heads of State or Government, at the
Abuja Special Summit in April 2001, particularly their pledge to set a target of
allocating at least 15 per cent of their annual national budgets for the
improvement of the health sector to help address the HIV/AIDS epidemic; and
recognizing that action to reach this target, by those countries whose resources
are limited, will need to be complemented by increased international assistance;
10. Recognizing also that other regions are seriously affected and confront similar
threats, particularly the Caribbean region, with the second highest rate of HIV
infection after sub-Saharan Africa, the Asia-Pacific region where 7.5 million
people are already living with HIV/AIDS, the Latin America region with 1.5 million
people living with HIV/AIDS, and the Central and Eastern European region with
very rapidly rising infection rates; and that the potential exists for a rapid
escalation of the epidemic and its impact throughout the world if no specific
measures are taken;
11. Recognizing that poverty, underdevelopment and illiteracy are among the
principal contributing factors to the spread of HIV/AIDS and noting with grave
concern that HIV/AIDS is compounding poverty and is now reversing or impeding
development in many countries and should therefore be addressed in an
integrated manner;
12. Noting that armed conflicts and natural disasters also exacerbate the spread
of the epidemic;
13. Noting further that stigma, silence, discrimination, and denial, as well as lack
of confidentiality, undermine prevention, care and treatment efforts and increase
the impact of the epidemic on individuals, families, communities and nations and
must also be addressed;
14. Stressing that gender equality and the empowerment of women are
fundamental elements in the reduction of the vulnerability of women and girls to
HIV/AIDS;
15. Recognizing that access to medication in the context of pandemics such as
HIV/AIDS is one of the fundamental elements to achieve progressively the full
realization of the right of everyone to the enjoyment of the highest attainable
standard of physical and mental health;
16. Recognizing that the full realization of human rights and fundamental
freedoms for all is an essential element in a global response to the HIV/AIDS
pandemic, including in the areas of prevention, care, support arid treatment, and
that it reduces vulnerability to HIV/AIDS and prevents stigma and related
discrimination against people living with or at risk of HIV/AIDS;
17. Acknowledging that prevention of HIV infection must be the mainstay of the
national, regional and international response to the epidemic; and that prevention,
care, support and treatment for those infected and affected by HIV/AIDS are
http://www.unaids.org/whatsnew/others/un_special/Declaration2706_en.htm
8/8/01
i
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 4 of 17
mutually reinforcing elements of an effective response and must be integrated in
a comprehensive approach to combat the epidemic;
18. Recognizing the need to achieve the prevention goals set out in this
Declaration in order to stop the spread of the epidemic and acknowledging that all
countries must continue to emphasize widespread and effective prevention,
including awareness-raising campaigns through education, nutrition, information
and health-care services;
19. Recognizing that care, support and treatment can contribute to effective
prevention through increased acceptance of voluntary and confidential
counselling and testing, and by keeping people living with HIV/AIDS and
vulnerable groups in close contact with health-care systems and facilitating their
access to information, counselling and preventive supplies;
20. Emphasizing the important role of cultural, family, ethical and religious factors
in the prevention of the epidemic, and in treatment, care and support, taking into
account the particularities of each country as well as the importance of respecting
all human rights and fundamental freedoms;
21. Noting with concern that some negative economic, social, cultural, political,
financial and legal factors are hampering awareness, education, prevention, care,
treatment and support efforts;
22. Noting the importance of establishing and strengthening human resources
and national health and social infrastructures as imperatives for the effective
delivery of prevention, treatment, care and support services;
23. Recognizing that effective prevention, care and treatment strategies will
require behavioural changes and increased availability of and non-discriminatory
access to, inter alia, vaccines, condoms, microbicides, lubricants, sterile injecting
equipment, drugs including anti-retroviral therapy, diagnostics and related
technologies as well as increased research and development;
24. Recognizing also that the cost availability and affordability of drugs and
related technology are significant factors to be reviewed and addressed in all
aspects and that there is a need to reduce the cost of these drugs and
technologies in close collaboration with the private sector and pharmaceutical
companies;
25. Acknowledging that the lack of affordable pharmaceuticals and of feasible
supply structures and health systems continue to hinder an effective response to
HIV/AIDS in many countries, especially for the poorest people and recalling
efforts to make drugs available at low prices for those in need;
26. Welcoming the efforts of countries to promote innovation and the
development of domestic industries consistent with international law in order, to
increase access to medicines to protect the health of their populations; and noting
that the impact of international trade agreements on access to or local
http://www.unaids.org/whatsnew/others/un_special/Declaration2706_en.htm
8/8/01
*3
UN Special Session Declaration of Commitment on H1V/AIDS, 27 June 2001
Page 5 of 17
manufacturing of, essential drugs and on the development of new drugs needs to
be further evaluated;
27. Welcoming the progress made in some countries to contain the epidemic,
particularly through: strong political commitment and leadership at the highest
levels, including community leadership; effective use of available resources and
traditional medicines; successful prevention, care, support and treatment
strategies; education and information initiatives; working in partnership with
communities, civil society, people living with HIV/AIDS and vulnerable groups;
and the active promotion and protection of human rights; and recognizing the
importance of sharing and building on our collective and diverse experiences,
through regional and international cooperation including North/South, South/South
cooperation and triangular cooperation;
28. Acknowledging that resources devoted to combating the epidemic both at the
national and international levels are not commensurate with the magnitude of the
problem;
29. Recognizing the fundamental importance of strengthening national, regional
and subregional capacities to address and effectively combat HIV/AIDS and that
this will require increased and sustained human, financial and technical resources
through strengthened national action and cooperation and increased regional,
subregional and international cooperation;
30. Recognizing that external debt and debt-servicing problems have substantially
constrained the capacity of many developing countries, as well as countries with
economies in transition, to finance the fight against HIV/AIDS;
31. Affirming the key role played by the family in prevention, care, support and
treatment of persons affected and infected by HIV/AIDS, bearing in mind that in
different cultural, social and political systems various forms of the family exist;
32. Affirming that beyond the key role played by communities, strong partnerships
among Governments, the United Nations system, intergovernmental
organizations, people living with HIV/AIDS and vulnerable groups, medical,
scientific and educational institutions, non-governmental organizations, the
business sector including generic and research-based pharmaceutical
companies, trade unions, media, parliamentarians, foundations, community
organizations, faith-based organizations and traditional leaders are important;
33. Acknowledging the particular role and significant contribution of people living
with HIV/AIDS, young people and civil society actors in addressing the problem of
HIV/AIDS in all its aspects and recognizing that their full involvement and
participation in design, planning, implementation and evaluation of programmes is
crucial to the development of effective responses to the HIV/AIDS epidemic;
34. Further acknowledging the efforts of international humanitarian organizations
combating the epidemic, including among others the volunteers of the
International Federation of Red Cross and Red Crescent Societies in the most
http://www.unaids.org/whatsnew/others/un_special/Declaration2706_en.htm
8/8/01
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 6 of 17
affected areas all over the world;
35. Commending the leadership role on HIV/AIDS policy and coordination in the
United Nations system of the UNAIDS Programme Coordinating Board; noting its
endorsement in December 2000 of the Global Strategy Framework for HIV/AIDS,
which could assist, as appropriate, Member States and relevant civil society
$ actors in the development of HIV/AIDS strategies, taking into account the
particular context of the epidemic in different parts of the world;
36. Solemnly declare our commitment to address the HIV/AIDS crisis by taking
action as follows, taking into account the diverse situations and circumstances in
different regions and countries throughout the world;
Leadership
Strong leadership at all levels of society is essential for an effective
response to the epidemic
Leadership by Governments in combating HIV/AIDS is essential and their
efforts should be complemented by the full and active participation of civil
society, the business community and the private sector
Leadership involves personal commitment and concrete actions
At the national level
37. By 2003, ensure the development and implementation of multisectoral
national strategies and financing plans for combating HIV/AIDS that: address the
epidemic in forthright terms; confront stigma, silence and denial; address gender
and age-based dimensions of the epidemic; eliminate discrimination and
marginalization; involve partnerships with civil society and the business sector
and the full participation of people living with HIV/AIDS, those in vulnerable
groups and people mostly at risk, particularly women and young people; are
resourced to the extent possible from national budgets without excluding other
sources, inter alia international cooperation; fully promote and protect all human
rights and fundamental freedoms, including the right to the highest attainable
standard of physical and mental health; integrate a gender perspective; and
address risk, vulnerability, prevention, care, treatment and support and reduction
of the impact of the epidemic; and strengthen health, education and legal system
capacity;
38. By 2003, integrate HIV/AIDS prevention, care, treatment and support and
impact mitigation priorities into the mainstream of development planning, including
in poverty eradication strategies, national budget allocations and sectoral
development plans;
At the regional and subregional level
http://www.unaids.org/whatsnew/others/un_special/Declaration2706_en.htm
8/8/01
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 7 of 17
39. Urge and support regional organizations and partners to: be actively involved
in addressing the crisis; intensify regional, subregional and interregional
cooperation and coordination; and develop regional strategies and responses in
support of expanded country level efforts;
40. Support all regional and subregional initiatives on HIV/AIDS including: the
International Partnership against AIDS in Africa (IPAA) and the ECA-African
Development Forum Consensus and Plan of Action: Leadership to Overcome
HIV/ AIDS; the Abuja Declaration and Framework for Action for the Fight Against
HIV/AIDS, Tuberculosis and Other Diseases; the CARICOM Pan-Caribbean
Partnership Against HIV/AIDS; the ESCAP Regional Call for Action to Fight HIV/
AIDS in Asia and the Pacific; the Baltic Sea Initiative and Action Plan; the
Horizontal Technical Cooperation Group on HIV/AIDS in Latin America and the
Caribbean; the European Union Programme for Action: Accelerated Action on
HIV/AIDS, Malaria and Tuberculosis in the context of poverty reduction;
41. Encourage the development of regional approaches and plans to address
HIV/AIDS;
42. Encourage and support local and national organizations to expand and
strengthen regional partnerships, coalitions and networks;
43. Encourage the United Nations Economic and Social Council to request the
regional commissions within their respective mandates and resources to support
national efforts in their respective regions in combating HIV/AIDS;
At the global level
44. Support greater action and coordination by all relevant United Nations system
organizations, including their full participation in the development and
implementation of a regularly updated United Nations strategic plan for HIV/AIDS,
guided by the principles contained in this Declaration;
45. Support greater cooperation between relevant United Nations system
organizations and international organizations combating HIV/AIDS;
46. Foster stronger collaboration and the development of innovative partnerships
between the public and private sectors and by 2003, establish and strengthen
mechanisms that involve the private sector and civil society partners and people
living with HIV/AIDS and vulnerable groups in the fight against HIV/AIDS;
Prevention
Prevention must be the mainstay of our response
47. By 2003, establish time-bound national targets to achieve the internationally
agreed global prevention goal to reduce by 2005 HIV prevalence among young
http://www.unaids.org/whatsnew/others/un_special/DecIaration2706_en.htm
8/8/01
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 8 of 17
men and women aged 15 to 24 in the most affected countries by 25 per cent and
by 25 per cent globally by 2010, and to intensify efforts to achieve these targets
as well as to challenge gender stereotypes and attitudes, and gender inequalities
in relation to HIV/AIDS, encouraging the active involvement of men and boys;
48. By 2003, establish national prevention targets, recognizing and addressing
$ factors leading to the spread of the epidemic and increasing people’s vulnerability,
to reduce HIV incidence for those identifiable groups, within particular local
contexts, which currently have high or increasing rates of HIV infection, or which
available public health information indicates are at the highest risk for new
infection;
49. By 2005, strengthen the response to HIV/AIDS in the world of work by
establishing and implementing prevention and care programmes in public, private
and informal work sectors and take measures to provide a supportive workplace
environment for people living with HIV/AIDS;
50. By 2005, develop and begin to implement national, regional and international
strategies that facilitate access to HIV/AIDS prevention programmes for migrants
and mobile workers, including the provision of information on health and social
services;
51. By 2003, implement universal precautions in health-care settings to prevent
transmission of HIV infection;
52. By 2005, ensure: that a wide range of prevention programmes which take
account of local circumstances, ethics and cultural values, is available in all
countries, particularly the most affected countries, including information,
education and communication, in languages most understood by communities
and respectful of cultures, aimed at reducing risk-taking behaviour and
encouraging responsible sexual behaviour, including abstinence and fidelity;
expanded access to essential commodities, including male and female condoms
and sterile injecting equipment; harm reduction efforts related to drug use;
expanded access to voluntary and confidential counselling anc-testing; safe blood
supplies; and early and effective treatment of sexually transmittable infections;
53. By 2005, ensure that at least 90 per cent, and by 2010 at least 95 per cent of
young men and women aged 15 to 24 have access to the information, education,
including peer education and youth-specific HIV education, and services
necessary to develop the life skills required to reduce their vulnerability to HIV
infection; in full partnership with youth, parents, families, educators and health
care providers;
54. By 2005, reduce the proportion of infants infected with HIV by 20 per cent,
and by 50 per cent by 2010, by: ensuring that 80 per cent of pregnant women
accessing antenatal care have information, counselling and other HIV prevention
services available to them, increasing the availability of and by providing access
for HIV-infected women and babies to effective treatment to reduce mother-tochild transmission of HIV, as well as through effective interventions for HIV-
http://www.unaids.org/whatsnew/others/un_special/Declaration2706 en.htm
8/8/01
t
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 9 of 17
infected women, including voluntary and confidential counselling and testing,
access to treatment, especially anti-retroviral therapy and, where appropriate,
breast milk substitutes and the provision of a continuum of care;
Care, support and treatment
Care, support and treatment are fundamental elements of an effective
response
55. By 2003, ensure that national strategies, supported by regional and
international strategies, are developed in close collaboration with the international
community, including Governments and relevant intergovernmental organizations
as well as with civil society and the business sector, to strengthen health care
systems and address factors affecting the provision of HIV-related drugs,
including anti-retroviral drugs, inter alia affordability and pricing, including
differential pricing, and technical and health care systems capacity. Also, in an
urgent manner make every effort to: provide progressively and in a sustainable
manner, the highest attainable standard of treatment for HIV/AIDS, including the
prevention and treatment of opportunistic infections, and effective use of qualitycontrolled anti-retroviral therapy in a careful and monitored manner to improve
adherence and effectiveness and reduce the risk of developing resistance; to
cooperate constructively in strengthening pharmaceutical policies and practices,
including those applicable to generic drugs and intellectual property regimes, in
order further to promote innovation and the development of domestic industries
consistent with international law;
56. By 2005, develop and make significant progress in implementing
comprehensive care strategies to: strengthen family and community-based care
including that provided by the informal sector, and health care systems to provide
and monitor treatment to people living with HIV/AIDS, including infected children,
and to support individuals, households, families and communities affected by HIV/
AIDS; improve the capacity and working conditions of health care personnel, and
the effectiveness of supply systems, financing pl ms and referral mechanisms
required to provide access to affordable medicines, including anti-retroviral drugs,
diagnostics and related technologies, as well as quality medical, palliative and
psycho-social care;
57. By 2003, ensure that national strategies are developed in order to provide
psycho-social care for individuals, families, and communities affected by
HIV/AIDS;
HIV/AIDS and human rights
Realization of human rights and fundamental freedoms for all is essential to
reduce vulnerability to HIV/AIDS
Respect for the rights of people living with HIV/AIDS drives an effective
http://www.unaids.org/whatsnew/others/un_special/Declaration2706_en.htm
8/8/01
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 10 of 17
response
58. By 2003, enact, strengthen or enforce as appropriate legislation, regulations
and other measures to eliminate all forms of discrimination against, and to ensure
the full enjoyment of all human rights and fundamental freedoms by people living
with HIV/AIDS and members of vulnerable groups; in particular to ensure their
access to, inter alia education, inheritance, employment, health care, social and
health services, prevention, support, treatment, information and legal protection,
while respecting their privacy and confidentiality; and develop strategies to
combat stigma and social exclusion connected with the epidemic;
59. By 2005, bearing in mind the context and character of the epidemic and that
globally women and girls are disproportionately affected by HIV/AIDS, develop
and accelerate the implementation of national strategies that: promote the
advancement of women and women’s full enjoyment of all human rights; promote
shared responsibility of men and women to ensure safe sex; empower women to
have control over and decide freely and responsibly on matters related to their
sexuality to increase their ability to protect themselves from HIV infection;
60. By 2005, implement measures to increase capacities of women and
adolescent girls to protect themselves from the risk of HIV infection, principally
through the provision of health care and health services, including sexual and
reproductive health, and through prevention education that promotes gender
equality within a culturally and gender sensitive framework;
61. By 2005, ensure development and accelerated implementation of national
strategies for women’s empowerment, promotion and protection of women’s full
enjoyment of all human rights and reduction of their vulnerability to HIV/AIDS
through the elimination of all forms of discrimination, as well as all forms of
violence against women and girls, including harmful traditional and customary
practices, abuse, rape and other forms of sexual violence, battering and
trafficking in women and girls;
Reducing vulnerability
The vulnerable must be given priority in the response
Empowering women is essential for reducing vulnerability
62. By 2003, in order to complement prevention programmes that address
activities which place individuals at risk of HIV infection, such as risky and unsafe
sexual behaviour and injecting drug use, have in place in all countries strategies,
policies and programmes that identify and begin to address those factors that
make individuals particularly vulnerable to HIV infection, including
underdevelopment, economic insecurity, poverty, lack of empowerment of
women, lack of education, social exclusion, illiteracy, discrimination, lack of
information and/or commodities for self-protection, all types of sexual exploitation
http://www.unaids.org/whatsnew/others/un_special/Declaration2706_en.htm
8/8/01
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 11 of 17
SO
of women, girls and boys, including for commercial reasons; such strategies,
policies and programmes should address the gender dimension of the epidemic,
specify the action that will be taken to address vulnerability and set targets for
achievement;
63. By 2003, develop and/or strengthen strategies, policies and programmes,
which recognize the importance of the family in reducing vulnerability, inter alia, in
educating and guiding children and take account of cultural, religious and ethical
factors, to reduce the vulnerability of children and young people by: ensuring
access of both girls and boys to primary and secondary education, including on
HIV/AIDS in curricula for adolescents; ensuring safe and secure environments,
especially for young girls; expanding good quality youth-friendly information and
sexual health education and counselling service; strengthening reproductive and
sexual health programmes; and involving families and young people in planning,
implementing and evaluating HIV/AIDS prevention and care programmes, to the
extent possible;
64. By 2003, develop and/or strengthen national strategies, policies and
programmes, supported by regional and international initiatives, as appropriate,
through a participatory approach, to promote and protect the health of those
identifiable groups which currently have high or increasing rates of HIV infection
or which public health information indicates are at greatest risk of and most
vulnerable to new infection as indicated by such factors as the local history of the
epidemic, poverty, sexual practices, drug using behaviour, livelihood, institutional
location, disrupted social structures and population movements forced or
otherwise;
Children orphaned and made vulnerable by HIV/AIDS
Children orphaned and affected by HIV/AIDS need special assistance
65. By 2003, develop and by 2005 implement national policies and strategies to:
build and strengthen governmental, family and community capacities to provide a
supportive environment for orphans and girls and boys infected and affected by
HIV/AIDS including by providing appropriate counselling and psycho-social
support; ensuring their enrolment in school and access to shelter, good nutrition,
health and social services on an equal basis with other children; to protect
orphans and vulnerable children from all forms of abuse, violence, exploitation,
discrimination, trafficking and loss of inheritance;
J
66. Ensure non-discrimination and full and equal enjoyment of all human rights
through the promotion of an active and visible policy of de-stigmatization of
children orphaned and made vulnerable by HIV/AIDS;
67. Urge the international community, particularly donor countries, civil society, as
well as the private sector to complement effectively national programmes to
support programmes for children orphaned or made vulnerable by HIV/AIDS in
http://www.unaids.org/whatsnew/others/un_special/Declaration2706_en.htm
8/8/01
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 12 of 17
affected regions, in countries at high risk and to direct special assistance to subSaharan Africa;
«l
Alleviating social and economic impact
v To address HIV/AIDS is to invest in sustainable development
68. By 2003, evaluate the economic and social impact of the HIV/AIDS epidemic
and develop multisectoral strategies to: address the impact at the individual,
family, community and national levels; develop and accelerate the implementation
of national poverty eradication strategies to address the impact of HIV/AIDS on
household income, livelihoods, and access to basic social services, with special
focus on individuals, families and communities severely affected by the epidemic;
review the social and economic impact of HIV/AIDS at all levels of society
especially on women and the elderly, particularly in their role as caregivers and in
families affected by HIV/AIDS and address their special needs; adjust and adapt
economic and social development policies, including social protection policies, to
address the impact of HIV/AIDS on economic growth, provision of essential
economic services, labour productivity, government revenues, and deficit-creating
pressures on public resources;
69. By 2003, develop a national legal and policy framework that protects in the
workplace the rights and dignity of persons living with and affected by HIV/AIDS
and those at the greatest risk of HIV/AIDS in consultation with representatives of
employers and workers, taking account of established international guidelines on
HIV/AIDS in the workplace;
Research and development
With no cure for HIV/AIDS yet found, further research and development is
crucial
70. Increase investment and accelerate research on the development of HIV
vaccines, while building national research capacity especially in developing
countries, and especially for viral strains prevalent in highly affected regions; in
addition, support and encourage increased national and international investment
in HIV/AIDS-related research and development including biomedical, operations,
social, cultural and behavioural research and in traditional medicine to: improve
prevention and therapeutic approaches; accelerate access to prevention, care
and treatment and care technologies for HIV/AIDS (and its associated
opportunistic infections and malignancies and sexually transmitted diseases),
including female controlled methods and microbicides, and in particular,
appropriate, safe and affordable HIV vaccines and their delivery, and to
diagnostics, tests, methods to prevent mother-to-child transmission; and improve
our understanding of factors which influence the epidemic and actions which
http://www.unaids.org/whatsnew/others/un_special/Declaration2706_en.htm
8/8/01
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 13 of 17
address it, inter alia, through increased funding and public/private partnerships;
create a conducive environment for research and ensure that it is based on
highest ethical standards;
71. Support and encourage the development of national and international
research infrastructure, laboratory capacity, improved surveillance systems, data
collection, processing and dissemination, and training of basic and clinical
researchers, social scientists, health-care providers and technicians, with a focus
on the countries most affected by HIV/AIDS, particularly developing countries and
those countries experiencing or at risk of rapid expansion of the epidemic;
72. Develop and evaluate suitable approaches for monitoring treatment efficacy,
toxicity, side effects, drug interactions, and drug resistance, develop
methodologies to monitor the impact of treatment on HIV transmission and risk
behaviours;
73. Strengthen international and regional cooperation in particular North/South,
South/South and triangular cooperation, related to transfer of relevant
technologies, suitable to the environment in prevention and care of HIV/AIDS, the
exchange of experiences and best practices, researchers and research findings
and strengthen the role of UNAIDS in this process. In this context, encourage that
the end results of these cooperative research findings and technologies be owned
by all parties to the research, reflecting their relevant contribution and dependent
upon their providing legal protection to such findings; and affirm that all such
research should be free from bias;
74. By 2003, ensure that all research protocols for the investigation of HIV-related
treatment including anti-retroviral therapies and vaccines based on international
guidelines and best practices are evaluated by independent committees of ethics,
in which persons living with HIV/AIDS and caregivers for anti-retroviral therapy
participate;
HIV/AIDS in conflict and disaster affected regions
Conflicts and disasters contribute to the spread of HIV/AIDS
75. By 2003, develop and begin to implement national strategies that incorporate
HIV/AIDS awareness, prevention, care and treatment elements into programmes
or actions that respond to emergency situations, recognizing that populations
destabilized by armed conflict, humanitarian emergencies and natural disasters,
including refugees, internally displaced persons and in particular, women and
children, are at increased risk of exposure to HIV infection; and, where
appropriate, factor HIV/AIDS components into international assistance
programmes;
76. Call on all United Nations agencies, regional and international organizations,
as well as non-governmental organizations involved with the provision and
http://www.unaids.org/whatsnew/others/un_special/DecIaration2706_en.htm
8/8/01
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 14 of 17
delivery of international assistance to countries and regions affected by conflicts,
humanitarian crises or natural disasters, to incorporate as a matter of urgency
HIV/AIDS prevention, care and awareness elements into their plans and
programmes and provide HIV/AIDS awareness and training to their personnel;
77. By 2003, have in place national strategies to address the spread of HIV
among national uniformed services, where this is required, including armed forces
and civil defence force and consider ways of using personnel from these services
who are educated and trained in HIV/AIDS awareness and prevention to assist
with HIV/ AIDS awareness and prevention activities including participation in
emergency, humanitarian, disaster relief and rehabilitation assistance;
78. By 2003, ensure the inclusion of HIV/AIDS awareness and training, including
a gender component, into guidelines designed for use by defence personnel and
other personnel involved in international peacekeeping operations while also
continuing with ongoing education and prevention efforts, including predeployment orientation, for these personnel;
Resources
The HIV/AIDS challenge cannot be met without new,
sustained resources
additional and
79. Ensure that the resources provided for the global response to address
HIV/AIDS are substantial, sustained and geared towards achieving results;
80. By 2005, through a series of incremental steps, reach an overall target of
annual expenditure on the epidemic of between US$ 7 billion and USS 10 billion
in low and middle-income countries and those countries experiencing or at risk of
experiencing rapid expansion for prevention, care, treatment, support and
mitigation of the impact of HIV/AIDS, and take measures to ensure that needed
resources are made available, particularly from donor countries and also from
national budgets, bearing in mind that resources of the most affected countries
are seriously limited;
81. Call on f*the international community, where possible, to provide assistance for
HIV/AIDS prevention,, care and treatment in developing countries on a grant
basis;
82. Increase and prioritize national budgetary allocations for HIV/AIDS
programmes as required and ensure that adequate allocations are made by all
ministries and other relevant stakeholders;
83. Urge the developed countries that have not done so to strive to meet the
targets of 0.7 per cent of their gross national product for overall official
development assistance and the targets of earmarking of 0.15 per cent to 0.20
per cent of gross national product as official development assistance for least
http://www.unaids.org/whatsnew/others/un_special/Declaration2706 en.htm
8/8/01
i
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 15 of 17
developed countries as agreed, as soon as possible, taking into account the
urgency and gravity of the HIV/ AIDS epidemic;
84. Urge the international community to complement and supplement efforts of
developing countries that commit increased national funds to fight the HIV/AIDS
epidemic through increased international development assistance, particularly
those countries most affected by HIV/AIDS, particularly in Africa, especially in
sub-Saharan Africa, the Caribbean, countries at high risk of expansion of the
HIV/AIDS epidemic and other affected regions whose resources to deal with the
epidemic are seriously limited;
85. Integrate HIV/AIDS actions in development assistance programmes and
poverty eradication strategies as appropriate and encourage the most effective
and transparent use of all resources allocated;
86. Cali on the internationai community and invite civil society and the private
sector to take appropriate measures to help alleviate the social and economic
impact of HIV/AIDS in the most affected developing countries;
87. Without further delay implement the enhanced Heavily Indebted Poor Country
(HIPC) Initiative and agree to cancel all bilateral official debts of HIPC countries
as soon as possible, especially those most affected by HIV/AIDS, in return for
their making demonstrable commitments to poverty eradication and urge the use
of debt service savings to finance poverty eradication programmes, particularly for
HIV/AIDS prevention, treatment, care and support and other infections;
88. Call for speedy and concerted action to address effectively the debt problems
of least developed countries, low-income developing countries, and middle
income developing countries, particularly those affected by HIV/AIDS, in a
comprehensive, equitable, development-oriented and durable way through
various national and international measures designed to make their debt
sustainable in the long term and thereby to improve their capacity to deal with the
HIV/AIDS epidemic, including, as appropriate, existing orderly mechanisms for
debt reduction, such as debt swaps for projects aimed at the prevention, care and
treatment of HIV/AIDS;
89. Encourage increased investment in HIV/AIDS-related research, nationally,
regionally and internationally, in particular for the development of sustainable and
affordable prevention technologies, such as vaccines and microbicides, and
encourage the proactive preparation of financial and logistic plans to facilitate
rapid access to vaccines when they become available;
90. Support the establishment, on an urgent basis, of a global HIV/AIDS and
health fund to finance an urgent and expanded response to the epidemic based
on an integrated approach ^o prevention, care, support and treatment and to
assist Governments inter alia in their efforts to combat HIV/AIDS with due priority
to the most affected countries, notably in sub-Saharan Africa and the Caribbean
and to those countries at high risk, mobilize contributions to the fund from public
and private sources with a special appeal to donor countries, foundations, the
http://www.unaids.org/whatsnew/others/un_special/Declaration2706_en.htm
8/8/01
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 16 of 17
business community including pharmaceutical companies, the private sector,
philanthropists and wealthy individuals;
t
91. By 2002, launch a worldwide fund-raising campaign aimed at the general
public as well as the private sector, conducted by UNAIDS with the support and
collaboration of interested partners at all levels, to contribute to the global HIV/
AIDS and health fund;
92. Direct increased funding to national, regional and subregional commissions
and organizations to enable them to assist Governments at the national,
subregional and regional level in their efforts to respond to the crisis;
93. Provide the UNAIDS co-sponsoring agencies and the UNAIDS secretariat with
the resources needed to work with countries in support of the goals of this
Declaration;
Follow-up
Maintaining the momentum and monitoring progress are essential
At the national level
94. Conduct national periodic reviews involving the participation of civil society,
particularly people living with HIV/AIDS, vulnerable groups and caregivers, of
progress achieved in realizing these commitments and identify problems and
obstacles to achieving progress and ensure wide dissemination of the results of
these reviews;
95. Develop appropriate monitoring and evaluation mechanisms to assist with
follow-up in measuring and assessing progress, develop appropriate monitoring
and evaluation instruments, with adequate epidemiological data;
96. By 2003, establish or strengthen effective monitoring systems, where
appropriate, for the promotion and protection of human rights of people living with
At the regional level
97. Include HIV/AIDS and related public health concerns as appropriate on the
agenda of regional meetings at the ministerial and Head of State and Government
level;
98. Support data collection and processing to facilitate periodic reviews by
regional commissions and/or regional organizations of progress in implementing
regional strategies and addressing regional priorities and ensure wide
dissemination of the results of these reviews;
http://www.unaids.org/whatsnew/others/un_special/Declaration2706 en.htm
8/8/01
MS'
UN Special Session Declaration of Commitment on HIV/AIDS, 27 June 2001
Page 17 of 17
99. Encourage the exchange between countries of information and experiences in
implementing the measures and commitments contained in this Declaration, and
in particular facilitate intensified South-South and triangular cooperation;
At the global level
100. Devote sufficient time and at least one full day of the annual General
Assembly session to review and debate a report of the Secretary-General on
progress achieved in realizing the commitments set out in this Declaration, with a
view to identifying problems and constraints and making recommendations on
action needed to make further progress;
101. Ensure that HIV/AIDS issues are included on the agenda of all appropriate
United Nations conferences and meetings;
102. Support initiatives to convene conferences, seminars, workshops, training
programmes and courses to follow up issues raised in this Declaration and in this
regard encourage participation in and wide dissemination of the outcomes of: the
forthcoming Dakar Conference on Access to Care for HIV Infection; the Sixth
International Congress on AIDS in Asia and the Pacific; the XII International
Conference on AIDS and Sexually Transmitted Infections in Africa; the XIV
International Conference on AIDS, Barcelona; the Xth International Conference
on People Living with HIV/AIDS, Port of Spain; the II Forum and III Conference of
the Latin American and the Caribbean Horizontal Technical Cooperation on
HIV/AIDS and Sexually Transmitted Infections, La Habana; the Vth International
Conference on Home and Community Care for Persons Living with HIV/AIDS,
Changmai, Thailand;
103. Explore, with a view to improving equity in access to essential drugs, the
feasibility of developing and implementing, in collaboration with non-governmental
organizations and other concerned partners, systems for voluntary monitoring and
reporting of global drug prices;
We recognize and express our appreciation to those who have led the effort
to raise awareness of the HIV/AIDS epidemic and to deal with its complex
challenges;
We look forward to strong leadership by Governments, and concerted
efforts with full and active participation of the United Nations, the entire
multilateral system, civil society, the business community and private
sector;
And finally, we call on all countries to take the necessary steps to implement
implement this Declaration, in strengthened partnership and cooperation
with other multilateral and bilateral partners and with civil society.
http://www.unaids.org/whatsnew/others/un_special/Declaration2706_en.htm
8/8/01
G8' Statement
Page 1 of9
G8 Statement
8}
COMMUNIQUE
Genoa, 22 July 2001
1. We, the Heads of State and Government of eight major industrialise.,
democracies and the Representatives of the European Union, met in Genet ,
foi the first Summit or the new miilenmum. In s spn'C of co op. mh?
discussed the most pressing issues on the international agenda.
2. As democratic leaders, accountable to our citizens, we believe in th<fundamental importance of open public debate-on the key challenges facing
our societies. We will promote innovative solutions based on a broac
partnership with civil society and the private sector. We will also seek
enhanced co-operation and solidarity with developing countries, based on a
mutual responsibility for combating poverty and promoting sustamablr
development.
1
3. We are determined to make globalisation work for all our citizens ano
especially the world's poor. Drawing the poorest countries into the globai
economy is the surest way to address their fundamental aspirations. We
concentrated our discussions on a. strategy to achieve this.
A Strategic Approach to Poverty Reduction
4. The situation in many developing countries - especially in Africa - calls to'
decisive global action. The most• effective poverty reduction strategy is to
maintain a strong, dynamic, open and growing global economy. We oledge t(
do that.
5. We will also continue to provide effective development assistance, to help
developing countries' own efforts to build long-term prosperity. Consistent
with the conclusions of the LDC III Conference and the Millennium
Declaration, we support a strategic approach centred on the principles cr
ownership and partnership. In the common interest of donors and recipieri...
of aid, we shall ensure the efficient use of scarce resources.
6. Open, democratic and accountable systems of governance, based or
respect for human rights and the . rule of law, are preconditions fo;
sustainable development and robust growth. Thus, we shall help developing
countries promote:
. accountability and transparency in the public sector
. legal frameworks and corporate governance regimes to fight corruption
http://www.esteri.it/eng/archives/arch_press/miscpapers/do210701ee.htm
8/3/01
I
8S
G8 Statement
Page 2 of 9 |
< safeguards against the misappropriation of public funds and thei: I
diversion into non-productive uses
• access to legal systems for all citizens, independence of the judiciary,
and legal provisions enabling private sector activity
• active involvement of civil society and Non Governmental Organisations i
(NGOs)
• freedom of economic activities.
We, for our part, will:
implement fully the OECD Bribery Convention
support efforts in the UN to pursue an effective instrument againw
vru pt ion
* encourage Multilateral Development Banks (MDBs) to help recipient
countries strengthen public expenditure and budget management.
Debt Relief and Beyond
7. Debt relief - particularly the Enhanced Heavily Indebted Poor Countries
(HIPC) Initiative - is a valuable contribution to the fight against poverty, but
it is only one of the steps needed to stimulate faster growth in very poor
countries. We are delighted twenty-three countries have qualified for an
overall amount of debt relief of over $53 billion, out of an,initial stock of debt
of $74 billion. We must continue this progress.
8. In particular we look to countries affected by conflict to turn away from
violence. When they do, we confirm that we will strengthen our efforts to
help them take the measures needed to receive debt relief. We confirm that
HIPC, in conjunction with reforms by the countries to ensure strong domestic
nolicies and responsible lending by donors, is designed to lead bo a lasting
exit from unsustainable debt.
9. Beyond debt relief,
reinforcing elements:
we focussed our discussion
■
r
on three mutually '
• greater participation by developing countries in the global trading
system
• increased private investment
u initiatives to promote health, education and food security.
I
10. Open trade and investment drive global growth and poverty reduction.
That is why we have agreed today to support the launch of an ambitious new
Round of global trade negotiations with a balanced agenda.
11. While opening markets through global negotiations provides the greatest
economic benefit for developing countries, we fully endorse measures already
taken to improve market access for the least developed countries (LDCs),
such as Everything But Arms, Generalised Preferences and all other initiatives
that address the same objectives. We confirm our pledge made at the UN !
ittp://www.esteri.it/eng/archives/arch_press/miscpapers/do210701ee.htm
8/3/01
I
I
I
sB
8 Statement
Page 3 of 9
LDC III Conference to work towards duty-free and quota-free access for ail
products originating in the least developed countries. We support efforts
made by LDCs to enter the global trading system and to take advantage of
opportunities for trade-based growth.
12. Increased market access must be coupled with the capacity to take
advantage of it. Thus, to help developing countries benefit from open
markets, we will better co-ordinate our trade related assistance to:
. provide bilateral assistance on technical standards, customs systems,
legislation needed for World Trade Organisation (WTO) membership, the
protection of intellectual property rights, and hu man resoi rodevelopment
support tile work of th
Integra ted Framework for I r a d e - R e I a t
Technical Assistance
« encourage the international financial
institutions to help remove
oostacicS to traue and irivestmeril, and establish the institutions and
policies essential for trade to flourish
urge countries to mainstream trade expansion by including it in their
poverty reduction strategies.
13. Increased private sector investment is essential to generate economic
growth, increase productivity and raise living standards. To help developing
countries improve the climate for private investment, we urge MDBs and
other relevant international bodies to support domestic reform efforts,
including the establishment of public-private partnerships and investmentrelated best practices, as well as codes and standards in the field of
corporate governance, accounting standards, enhanced competition and
transparent tax regimes. We call on the World Bank to provide additional
support for programmes that promote private sector development in the
poorest countries. To promote further investments in the knowledge-based
economy, we call on the WTO and the World Intellectual Property Rights
Organisation, in collaboration with the World Bank, to help the poorest
countries comply with international rules on intellectual property rights.
i
I
I
.14. Official development assistance (ODA) is essential. We will work with
developing countries to meet the International Development Goals, by
strengthening and enhancing the effectiveness of our development
assistance. We commit ourselves to implement the landmark OECD-DAC
Recommendation on Untying Aid to LDCs which should increase aid
effectiveness and achieve more balanced effort-sharing among donors.
15. At Okinawa last year, we pledged to make a quantum leap in the Tight
against infectious diseases and to break the vicious cycle between disease
and poverty. To meet that commitment and to respond to the appeal of the
UN General Assembly, we have launched with the UN Secretary-General a
new Global Fund to fight HIV/AIDS, malaria and tuberculosis. We are
determined to make the Fund operational before the end of the year. We
have committed $1.3 billion. The Fund will be a public-private partnership
ittp.//www.esteri.it/eng/archives/arch_press/miscpapers/do210701 ee.htm
8/3/01
F
■
I
I
i
G8 Statement
^0
Page 4 of9
and we caii on other countries, the private sector, foundations, and academic
institutions to join with their own contributions - financially, in kind ano
through shared expertise. We welcome the further commitments already
made amounting to some $500 million.
16. The Fund will promote an iintegrated
’
’ approach emphasising prevention in
a continuum of treatment and care. It will operate according to principles of
proven scientific and medical effectiveness, raoid resource transfer, low
transaction costs, and light governance with a strong focus on outcomes, whope that the existence or the Fund will pro
:e improved cu-ordinaiiuh
among donors and provide further incentives for private sector research anc
development, it will offer additional financi-g consistent with existmc
nroorammes to be integrated into the national health Dians of parme-.ic engagement of uevelop.ag co. ntries in the purpu;,t c..u
operation of the Fund will be crucial to ensure ownership and commitment tc
results.
-------- Local partners, including NGOs, and international agencies, will be
instrumental in the successful operation of the K.na.
17
national health
JW Strong
auuny nauonai
neairn systems will continue to play
piay a key role in the
delivery of effective prevention, treatment and care and in improving access
to essential health services and commodities without discrimination, An
effective response to HIV/AIDS and other diseases will require society-wide
action beyond the health sector. We welcome the steps taken by the
pharmaceutical industry to make drugs more affordable. In'the context of the
new Global Fund, we will work with the pharmaceutical industry and with
affected countries to facilitate the broadest possible provision of drugs in an
affordable and medically effective manner. We welcome ongoing discussion in
the WTO on the use of relevant provisions in the Trade-Related Intellectual
Property Rights (TRIPs) agreement. We recognise the appropriateness of
affected countries using the flexibility afforded by that agreement to ensure
that drugs are available to their citizens who need them, particularly those
are unable to afford basic medical care. At the same time, we reaffirm
our commitment to strong and effective intellectual property rights protection
as a necessary incentive for research and development of life-saving drugs.
18. Education is a central building block for growth and employment. We
reaffirm our commitment to help countries meet the Dakar Framework Co
Action goal of universal primary education by 2015. We agree on the need to
improve the effectiveness of our development assistance in support of
iocally-owned strategies. Education - in . particular, universal primary
education and equal access to education at all levels for girls - must be given
high priority both in national poverty reduction strategies and in our
development programmes. Resources made available through the HIPC
Initiative can contribute to these objectives. We will help foster assessment
systems to measure . progress, identify best practices and ensure
accountability for results. We will also focus on teacher training. Building m
the work of the G8 Digital Opportunities Task Force (dot.force), we’will work
to expand the use of information and communications technology (ICT) to
train teachers in best practices and strengthen education strategies. We
:p://www.esteri.it/eng/archives/arch_press/miscpapers/do2 10701ee.htm
!
8/3/01
I
8 Statement
Page 5 of 9
especially encourage the private sector to examine new opportunities for
investment in infrastructure, ICT and learning materials. We encourage MDBs
to sharpen their focus on education and concentrate their future work orcountries with sound strategies but lacking sufficient resources and to report
next year to the G8. We support UNESCO in its key role for universa;
education. We wiil also work with the International Labour Organisation /ILO
to support efforts to fight child labour and we wiil develop incentives tc
increase school enrolment.
we wiii estaoiisn a task force of senior G8 officials to advise us on hov.
best to pursue the Dakar goals in co-operation with developing countries
relevant international organisations and other stakeholders. The task forcr
will provide us with recommendations in time for our next meeting.
20. As the November 2001 "World Food Summit: Five Years Later'
approaches, food security remains elusive. Over 800 million peooie remair >
seriously malnourished, including at least 250 million children. So a centra;
objective of our poverty reduction strategy remains access to adequate food
supplies and rural development. Support to agriculture is a crucial instrument
of ODA. We shall endeavour to develop capacity in poor countries, integratinc
programmes into national strategies and increasing training in agricultural
science. Every effort should be undertaken to enhance agricultural
productivity. Among other things, the introduction of tried and tested new
technology, including biotechnology, in a safe manner and adapted to local
conditions has significant potential to substantially increase crop yields ir •
developing countries, while using ' fewer pesticides and less water than
conventional methods. We are committed to study, share and facilitate the
responsible use of biotechnology in addressing development needs.
21. We shall target the most food-insecure regions, particularly Sub-Saharan
Africa and South Asia, and continue to encourage South-South co-operation.
We will support the crucial role international organisations and NGOs play ir
relief operations. We believe national poverty reduction and sectoral
. strategies should take due account of the nutritional needs of vulnerable
■groups, including new-borns and their mothers.
Digital Opportunities
22. ICT holds tremendous potential for helping developing countries
accelerate growth, raise standards of living and meet other development
priorities. We endorse the report of the Digital Opportunity Task Force
(dot.force'' and its Genoa Plan of Action that successfully fulfilled the Okinawa
mandate. The direct participation of representatives from public, private and
non-profit sectors, as well as that of developing countries' governments,
presents a unique formula for ensuring that digital technologies meet
development needs. We will continue to support the process and.encourage
ad stakeholders to demonstrate ownership, to mobilise expertise and
resources and to build on this successful co-operation. We will review the
implementation of the Genoa Plan of Action at our next Summit on the basis
ittn-//www.esteri.it/eng/archives/arch_press/miscpapers/do210701 ee.htm
8/3/01
38 Statement
Page 6 of 9
or a report by the G8 Presidency. We also encourage development of ar
Arhnn Plan on how e-Government can strengthen democracy and the rule of
law by empowering citizens and making the provision of essentia'
government services more efficient.
A Legacy for the Future
Environment
W
confirm our ctetei i Di i id ti or, to f.nd giobai
endangering the planet. We recognise that climate change is a pressing issue
that requires a global solution. V\/e are committed to providing srr.j. <
leadership. Promp:, effective and sustainable action is needed, consisted ',
with the ultimate objective of the UN Framework Convention on Climate
Change of stabilising greenhouse gas concentrations in the atmosphere. Wc
are determined to meet our national commitments and our obligations unde!
■
Convention through a variety of flexible means, drawing on the power of
markets and technology. In this context, we agree on the importance of
intensifying co-operation on climate-related science and research. We shall
promote co-operation between our countries and developing countries on
technology transfer and capacity building.
24. We all firmly agree on the need to reduce greenhouse gas emissions.
While there is currently disagreement on the Kyoto Protocol and its
ratification, we are committed to working intensively together to meet our
common objective. To that end, we are participating constructively in the
resumed Sixth Conference of the Parties in Bonn (COP6) and will continue to
do so in all relevant fora. We welcome the recent deepening of discussions
among the G8 and with other countries.
1
j
I
i
25. We reaffirm that our efforts must ultimately result in an outcome that
protects the environment and ensures economic growth compatible with our
shared objective of sustainable development for present and future
generations.
26. We welcome Russia s proposal to convene in 2003 a global conference on
climate change with the participation of governments, business and science
as well as representatives of civil society.
2 7. We recognise the importance of renewable energy for sustainable
development, diversification of energy supply, and preservation of the
environment. We will ensure that renewable energy sources are adequately
considered in our national plans and encourage others to do so as well. V7e
encourage continuing research and investment in renewable energy
technology, throughout the world. Renewable energy can contribute to
poverty reduction. We will help developing countries strengthen institutional
capacity and market-oriented national strategies that can attract private
sector investment in renewable energy and other clean technologies. We call
on MDBs and national development assistance agencies to adopt an
r//www.esteri.it/eng/archives/arch_press/miscpapers/do2 10701ee.htm
8/3/01
i
95 Page 7 of 9
38 Statement
innovative approach and to develop market-based financing mechanisms for
:uiClvaL,c imeiyy. .be ulye the Globa. Environment Facility (GEF) to continue
supporting environmental protection on a global scale and fostering good
practices to promote efficient energy use and the development of renewable
energy sources in the developing world, and stress the need to commit
adequate resources to its third replenishment. We thank all those who
participated in the work of the.Renewable Energy Task Force established in
Okinawa. G8 energy ministers will hold a meeting in -■.< coming veai tc
discuss these and other energy-related issues.
28. We are looking forward to the World Summit on Sustainable
Development (WSSD) in Johannesburg in 2002, an important milestone ir.
the Rio process. The three dimensions of sustainable development enhancing economic growth, promoting human and social development ano
protecting the environment - are interdependent objectives requiring ou:
concerted action We will work in partnership with developing countries for ar
inclusive preparatory process with civil society or a forward looking ..me
substantial agenda with action-oriented results. We welcome the recent
adoption of the Stockholm Convention on Persistent Organic Pollutants
(POPs) and will strongly promote its early entry into force.
;
.
i
29. We are committed to ensuring that our Export Credit Agencies (EGAs)
adhere to high environmental standards. We therefore agreed in Okinawa to
develop common environmental guidelines for EGAs, drawing on relevant
MDB experience. Building on the progress made since last year, we commit
to; reach agreement in the OECD by the end of the year on a
Recommendation that fulfils the Okinawa mandate.
Food safety
30. Fully aware of the paramount importance of food safety to our peoples,
we will continue to support a transparent, scientific and rules-based approach
and will intensify our efforts to achieve greater global consensus on how
precaution should be applied to food safety in circumstances where available
’scientific information is incomplete or contradictory. We value the ongoing
diaioyue between governments, scientists, consumers, reguiatcrs, and
relevant stakeholders in civil society. This must be based on the principle of
openness and transparency. We recognise our responsibility to promote a
clear understanding by the public of food safety benefits and risks. We shall
strive to provide consumers with relevant information on the safety of food
pioducts, based on independent scientific advice, sound risk analysis and the
latest research developments. We believe an .effective framework for risk
management, consistent with the science, is a key component in maintaining'
consumer confidence and in fostering public acceptance.
31. We welcome the outcome of the recent Bangkok conference on new
biotechnology food and crops and the ad hoc meeting of regulators from
OECD countries and Russia. We encourage the relevant international
organisations to follow up the conference, as appropriate, within their own
hiL|j://www,esteri.it/eng/archives/archpress/miscpapers/do2 10701 ee.htm
8/3/01
I
G8 Statement
Page 8 of 9 |
respective mandates. Furthermore, we welcome the establishment of the
joint FAO / WHO Global Forum of Food Safety Regulators. We also appreciate
. <. a . r. ■ u.e iiii_emAcacei11y Oouiicii hi puUiicisiiig uaiaiiced pi ores^io:iai I
views on the science of food safety. All these meetings demonstrate our
commitment to a process of dialogue aimed at strengthening public
confidence in food safety.
Increasing Prosperity in a Socially-Inclusive Society
employment.
32. io the tirm belief that economic performance and social inclusion an
mutually dependent, we commit to implement policies in' line with the
recommendations of the G8 Labour Ministers Conference held in Torino las*
year. We welcome the increased activity of older persons who represent, as
stated in the G8 Turin Charter "Towards Active Ageing", a great reservoir of
resources for our economies and our societies.
Combatinq transnational organised crime and drugs
33.We reaffirm our commitment to combat transnational organised crime. To
this end, we strongly endorse the outcome of the G8 Justice and Interior
Ministers Conference held in Milano this year. We encourage further progress
in the field of judicial co-operation and law enforcement, "and in fighting
corruption, cyber-crime, online child pornography, as well as trafficking in
human beings.
34. Following up on the G8 ad hoc Meeting of Drug Experts held in Miyazaki
last year and the recent London Conference on the global economy of illegal
drugs, we will strengthen efforts to curb the trafficking and use of illegal
drugs.
To the citizens of Genova
35. We are grateful to the citizens of Genova for their hospitality, and deplore
the violence, loss of life and mindless vandalism that they have had to
endure. We will maintain our active and fruitful dialogue with developing
m--d othe- stakeholders. And we will defend the right of peaceful
protestors to have their voices heard. But as democratic leaders, we cannot
accept chat a violent minority should be allowed to disrupt our discussions on
the critical issues affecting the world. Our work will go on.
Next Summit
36. We accept the invitation of the Prime Minister of Canada to meet again
next year in the province of Alberta, Canada on 26-28 June.
p.7/www.esteri.it/eng/archives/arch_press/miscpapers/do2 10701 ee.htm
8/3/01
i
'
^SECRETARY-GENERAL STATEMENT AT PRESS EVENT, Genoa, 20 July, 2001
THE SECRETARY-GENERAL
Page l.of2
96
STATEMENT AT PRESS EVENT
Genoa, 20 July, 2001
Mr. Prime Minister,
Distinguished Heads of State and Government,
Ladies and Gentlemen,
Thank you, Prime Minister, for that extraordinary expression of support for the global fight against HIV-AIDS. The
commitment and resources of the G-8 countries are indispensable if we are to win this battle. By joining it as
vigorously and comprehensively as you have today, you - all of you - have given new meaning to leadership and
solidarity in the 21st century, and I salute you for it. In this effort, there is no us and them, no developed and
developing countries, no rich and poor — only a common enemy that knows no frontiers and threatens all peoples.
Our meeting today is the culmination of a year-long process of awareness, engagement and mobilization on the issue
of HIV-AIDS. For the first time, we are seeing the emergence of a response to this deadly disease that begins to
match the scale of the epidemic itself. Governments, multilateral organizations, the private sector and civil society
are all engaged in an unprecedented effort to defeat an epidemic that to date has infected an estimated 36 million
people and claimed 22 million lives. At the Abuja Summit in April, African leaders made clear their commitment to
the fight against AIDS. And at the United Nations General Assembly Special Session in June, the world came
together to set common targets for reducing the spread of AIDS and alleviating its impact.
Our priorities should be clear: First, to ensure that people everywhere - particularly the young - know what to do to
avoid infection. Second, to stop perhaps the most tragic form of HIV transmission - from mother to child. Third, to
provide treatment for all those infected. Fourth, to redouble the search for a vaccine, as well as a cure. Fifth, to care
for all whose lives have been devastated by AIDS, particularly the orphans - and there are 13 million of them today and their numbers are growing.
The battle against AIDS will not be won without the necessary resources. We need to mobilize an additional seven
to ten billion dollars a year to fight this disease world-wide. Part of these funds will be found in increased domestic
budgets in countries in every part of the world. In Africa, leaders are rising to the challenge, and African
Governments have pledged to increase their health budgets significantly. This is laudable, but it is not enough.
African and other developing countries will need substantial assistance to meet the needs of their peoples. That is
why the United Nations General Assembly endorsed the establishment of a Global AIDS and Health Fund, which all
sides now agree must become operational by the end of this year. The Fund has already received more than $ 1
billion in contributions - from Governments, foundations, businesses and private citizens. This is a very good
beginning. But much, much more is needed. I therefore call on Governments, civil society, foundations and
individuals to contribute to the fight against AIDS in any way they can.
Mr. Prime Minister,
Excellencies,
I see the contributions by your Governments as evidence of your determination to follow through on the Millennium
Declaration issued at the United Nations last year. Let me recall today three of its most pressing commitments: your
http://www.un.org/News/dh/latest/sg_genoa.htm
8/3/01
^RETARY-GENERAL STATEMENT AT PRESS EVENT, Genoa, 20 July, 2001
Cj
Page 2 of 2
pledges to "have halted and, begun to reverse, the spread of HIV/AIDS" by 2015; to halve, by the same date, the
proportion of the world's people living in extreme poverty; and to spare no effort to free humanity "from the threat
of living on a planet irredeemably spoilt by human activities."
The magnitude and the urgency of the AIDS epidemic has created an extraordinary global response to one of these
challenges, based on partnership, solidarity and enlightened leadership. We must all remember that while HIV/AIDS
affects both rich and poor, the poor are much more vulnerable to infection, and much less able to cope with the
disease once infected. Your leadership and commitment today will serve to give new strength and inspiration to the
thousands of health-care workers, teachers and community leaders fighting this disease in the poorest parts of the
world, and the millions suffering from its effects. They will know that the world is finally summoning the will — and
committing the resources - to win this war for all humanity.
Thank you.
I
http://www.un.org/News/dh/latest/sg_genoa.htm
8/3/01
Page 1 of2
Global AIDS and Health Fund
9s
..
CONTRIBUTIONS PLEDGED TO THE GLOBAL AIDS AND HEALTH FUND
CONTRIBUTOR
DATE
Donations by private individuals
|7 August 2001
|30 July 2001
[25 July 2001~
|25 July 200r~
21 July 200f~
20 July 200r~
Kuwait_____________________
■
Stupski Family Foundation
Cheng Design & Construction
Price Systems, LLC___________
Italy
Russia______________________
18 July 2001~ Canada_____________________
18 July 2001~ European Commission________
13 July 2001~ Germany
____________
11 July 2001~ Byers Choice, Ltd.____________
5 July 2001 ~ Niger_______________________
3 July 2001 ~ Japan______________________
27 June 20qF Andorra____________________
27 June 2001" Luxembourg_________________
26 June 2001
Austria
26 June 2001 Liberia
25 June 2001" Zimbabwe_______________________
25 June 2001" Uganda_________________________
25 June 2001" Nigeria
19 June 2001
Bill and Melinda Gates Foundation
8 June 2001 ~ Winterthur Insurance (Credit Suisse)
31 May 2001~ France
31 May 2001
United Kingdom
11 May 200f~ United States
8 May 2001 ~ International Olympic Committee
3 May 2001 ~ Secretary-General Kofi Annan*
PLEDGES
_____ USS
115,423
1,000,000
40,000
145
500
200,000,000
20,000,000
98,000,000
100,000,000
131,000,000
10,000
50,000
200,000,000
100,000
2,500,000
1,000,000
25,000
1,000,000
2,000,000
10,000,000
100,000,000
1,000,000
127,000,000
200,000,000
200,009,000
100,000
ICO,000
TOTAL USS
1,395,041,068
1,394,925,645
1,393,925,645
1,393,885,645
1,393,885,500]
1,393,885,000]
1,193,885, OOP]
1,173,885,000]
1,075,885,OOP]
975,885,000]
844,885,000]
844,875,000]
844,825,000]
644,825,000]
644,725,000]
642,225,000]
641,225,000]
641,200,000]
640,200,OOP]
638,200,OOP]
628,200,000]
528,200,000]
527,200,000]
400,200,000]
200,200,000]
200,000]
100,000
*The Secretary-General pledged the proceeds of the Philadelphia Liberty Medal he was awarded on
http://www.un.org/News/ossg/aids.htm
8/8/01
Global AIDS and Health Fund
Page 2 of 2
4 July 2001.
Figures provided by the United Nations Fund for International Partnerships.
For background information on the Fund, click here.
Contributions to the Fund can be made through the United Nations Foundation.
USEFUL LINKS:
UNAIDS
UNICEF
UNDP
UNFPA
UNDCP
UNESCO
WHO
WORLD BANK
Last Updated: 7 August 2001
Office of the Spokesman for the Secretary-General
United Nations, S-378
New York, NY 10017
Tel. 212-963-7162
Fax. 212-963-7055
Back to the Spokesman's Page
Back to UN homepage
http.7/www.un.org/News/ossg/aids.htm
8/8/01
MSF: U.S. at odds with Europe over rules on world drug pricing<BR><BR>
Page 1 of 4
loo
A MEDEONS
FRONTIERES
11
MSF Article
Advocacy
RELATED LINKS
I-’found Liu:: davcd "C
■.2001
Mental Health
K°tuoee ■ Di^olared
inv and Sa’^tat 01
Issues
Medicines
U.S. at odds with Europe
over rules on world drug
pricing
Other Issues
?=
Contact
Si
□
□
By DONALD G. McNEIL Jr
This article first appeared in The New York Times
Before the United Nations has even raised up to $10
billion for its new fund to fight AIDS, the Bush
administration and the European Union are engaged in
a behind-the- scenes struggle over how that money
will be spent, particularly on pharmaceutical drugs.
Communications between the United States trade
representative and his European Union counterpart,
obtained by The New York Times, show starkly
opposing views on several key issues.The Bush
administration, like the giant pharmaceutical
companies, opposes the creation of any system to
regulate world drug prices, or the creation of a
database where prices could simply be posted. The
administration, while it has dropped moves against
Brazil's production of cheap generic drugs, emphasizes
that patent rights must be protected and wants the
companies left alone to offer discounts when they see
fit.
f
i
I
The Europeans appear to be siding with poor countries
and campaigners for cheaper drugs.
No unified European position has yet been laid out, but
different leaders and European Council resolutions ,
favor a "tiered pricing system," endorse the right of
poor countries to shop for cheap generic drugs from
countries that ignore Western patents, and favor the
creation of a worldwide database to show prices for all
drugs from any supplier and to indicate whether the
supplier is considered reliable.While acknowledging
that patents are important, the Europeans often note
that they are blamed for driving up the cost of health
care, and emphasize the exceptions to patent rights
contained in world trade treaties.
http://217.29.195.76/content/page.cfm?articleid=C 16DEB17-B17D-4F69-80F37106C4C67188
8/3/01
MoF: U.S. at odds with Europe over rules on world drug pricing<BR><BR>
"Basically, the European Union is saying that it doesn't
want the fund to turn into a subsidy for Big Pharma,
and the U.S. is saying the reverse," said Ellen't Hoen,
a drug price specialist at Doctors Without Borders, a
medical charity that has led the fight for lower-priced
drugs.The United Nations' global fund to fight AIDS
was proposed by Secretary General Kofi Annan at a
special General Assembly in June. He asked donors to
contribute $7 billion to $10 billion a year. So far, only
about $1 billion has been committed.
Page 2 of 4
lol
The rules governing the new fund are expected to be
one topic discussed when President Bush meets the
leaders of the world's seven wealthiest nations and
Russia this week in Genoa, Italy.The Europeans - to
the frustration of the Bush administration - have not
defined what they mean by a tiered pricing system,
although the assumption is that it would mean low
prices for poor countries, high prices for rich ones and
some sort of system for verifying that it was working.
Some leading members of the European Parliament
appear to favor a system like that used for getting
vaccines and contraceptives to the third world. For
those, the pharmaceutical multinationals and their
generic competitors in countries like India submit bids
to international agencies like Unicef or the United
Nations Population Fund, which handle distribution
costs. The vaccines or contraceptives sell for a fraction
- sometimes as little as one two- hundredths - of their
prices in developed countries, and the makers still turn
a small profit.Price cuts by the multinational companies
have been voluntary, in response to public indignation
and counteroffers from generic producers.
!
The most obvious targets of the drive are anti
retroviral AIDS drugs, which 18 months ago cost as
much as $10,000 a year per patient, and now are
offered by generic makers for as little as $350 per
year.But AIDS also makes the body susceptible to
secondary diseases like malaria, tuberculosis,
pneumonia, meningitis, fungal infections and cancer.
Pressure on pharmaceutical companies to offer poor
countries discounts on virtually all therapeutic drugs is
thus expected to mount.The extent of the EuropeanAmerican debate is outlined in a letter sent in late June
by Robert B. Zoellick, the United States trade
representative, to Pascal Lamy, his counterpart on the
European Commission.
i
i
In the letter, a copy of which was obtained by The
Times, Mr. Zoellick expressed his distress that the
commission was endorsing a tiered system. The Bush
administration is "opposed to the creation of an
international institution or convention to regulate drug
prices," Mr. Zoellick wrote. "I also would question
establishment of a verification process." Further, he
stated that "we have practical and legal concerns with
http ://217.29.195.76/content/page.cfm?articleid=Cl 6DEB17-B17D-4F69-80F37106C4C67188
8/3/01
MSF: U.S. at odds with Europe over rules on world drug pricing<BR><BR>
Page 3 of 4
the concept of maintaining a database on drug prices."
The database, he wrote, would be "difficult to keep
accurate" and "the sharing of drug pricing information
can at times present problems under U.S. antitrust
laws."
lox
An official in Mr. Zoellick's office said the letter had two
purposes. "One, we're challenging them to be specific
about what they mean by a tiered pricing system," he
said. "And, two, we're communicating that we're pretty
skeptical."
Mr. Zoellick wrote that he was troubled by the reasons
that Mr. Lamy's colleagues had offered for tiered
pricing, including the argument that cheap drugs were
still not available in Africa. Repeating an argument
often made by spokesmen for the drug industry, he
wrote that it was "more likely the result of the
enormous infrastructure problems plaguing this region,
rather than drug prices."
Millions of AIDS-infected Africans live in cities with
hospitals or within walking distance of rural clinics, and
have enough clean water to take pills. Many African
countries now treat tuberculosis, which involves
essentially the same regimen as AIDS requires - a daily
handful of pills and occasional lab tests. Standard
"first-line" tuberculosis drugs, however, are priced
much lower than anti-retrovirals; recently, drug
companies began voluntarily lowering the prices of
their "second-line" tuberculosis drugs, which are
prescribed if other drugs are ineffective.
Mr. Zoellick's letter concluded by saying that the drug
companies ought to be trusted. "We should expect
companies to sell at the lowest possible prices," he
wrote. "However, it appears to me that many
companies are now doing so; there is no indication that
their pricing commitments are short-term or of such
limited quantity that we should doubt their sincerity."
■
Doctors Without Borders argued at a drug price
conference in April that relying on the good will of
pharmaceutical companies was not a sound approach
for battling AIDS. The companies, the charity argued,
deeply slashed their prices last year "only after
immense international public pressure began to
jeopardize the industry's image."
The official in Mr. Zoellick's office confirmed that the
Bush administration still backed the policy started
under the Clinton administration of not seeking trade
sanctions on African countries that legitimately used
patent-nullifying provisions under World Trade
Organization treaties to get AIDS drugs. "And," he
added, "about three weeks ago, we settled our W.T.O.
dispute with Brazil. That's gone down fairly poorly with
the pharmaceutical companies."
http://217.29.195.76/content/page.cfm?articleid^g 16DEB17-B17D-4F69-80F37106C4C67188
jo !
< I ‘./)C >
I
07547
Ooi
8/3/01
MSF: U.S. at odds with Europe over rules on world drug pricing<BRxBR>
Page 4 of 4
103
Related Links
For more information about
MSF at the Genoa G8
This article first appeared in
The New York Times
*
I
i
http://217.29.195.76/content/page.cfm?articleid=C 16DEB17-B17D-4F69-80F37106C4C67188
8/3/01
ft
MSF: Global Health Fund must not be a subsidy for the drug industry
Page 1 of2
!oq
k Gedeons
FRONTtERES
I' M Ifn] ijiii’i41 |i|'ffl^lWlili i t
MSF Article
RELATED LINKS
Advocacy'
: ■Y-.ta re
Refugee / Displaced
Water and Sanitation
Other Issues
As theGS announces details of Global Health
Fund, access to affordable medicines for the
poor must be a priority.
die a.'
i
C o nta ct
Register
Global Health Fund must
not be a subsidy for the
drug industry
□
□
Genoa, Italy - This afternoon at 5pm, the G8 heads of
state will announce the constitution of the Global
Health Fund. But there is no clear plan for how the
fund are to be used. MSF is particularly concerned
about the lack of policy to ensure the purchase of the
most affordable medicines and other health
commodities.
An article in today's New York Times today raises
concerns over a split between the US and EU over how
the money should be spent.
"Without a deliberate strategy to ensure the funding
can be used to purchase from generic producers,
including those in the South, the fund will be mainly a
subsidy to the European and American drug
industries," says MSF's Ellen't Hoen. "We are here at
the G8 to demand that the government of the richest
countries in the world put people’s lives over profits of
industry. An equitable pricing system and restarting
research and development for neglected diseases are a
key part of improving access to life-saving medicines in
the developing world."
Fourteen million people die of infectious diseases every
year. 90% of them live in developing countries. Many
of the victims of these diseases die because they have
no access to the medicines they need.
Related Links
Read the New York Times article:
U.S. at odds with Europe over rules on world drug
pricing
Visit:
http://217.29.195.76/content/page.cfm?articleid=90EC1273-80E3-4D63-86A0ABBlBC083B85
8/3/01
MSF: G8 window dresses while poor die from lack of medicines
Ttosy*
A MEDEONS
t'- SANS FRONTIERES
Page 1 of2 [
/os-
I 4
Ilf-.
tri I
dd.l i^
tt i1H
ft ilMll£»ll(i|ii|ll
MSF Article
3
Advocacy
Mental Health
Refugee
D.spiaccd
:'f di’icl San'tatiOr
Other Issues
Information
23.07..'
G8 window dresses while
poor die from lack of
medicines
"The richest countries of the world refuse to
address more fundamental solutions to the
access to medicines crisis", says an MSF
spokesperson.
£
i
RELATED LINKS
£ onia ct
□
Register
□
Genoa, Italy, July 21, 2001 - The G8 governments
and the UN Secretary-General announced the
constitution of a global health fund designed to tackle
infectious diseases in developing countries.
More money and new money are needed in the fight
against diseases of the poor, but the amount
committed is nowhere near what is required. Pledges
to the fund, currently at $1.2 billion, are shamefully
low. Governments call upon multinationals and the
private sector to contribute. Among these are the
pharmaceutical companies whose pricing policies are a
fundamental part of the problem.
The G8 governments have been preparing a global
health fund for a year. In that time, 14 million people
will have died from infectious and parasitic disease;
90% of these deaths will have occurred in developing
countries.
p
"There are serious organisational concerns with the
fund. There is still no clear statement regarding who
makes the decisions, on what the funds are to.be
spent, and no policy to ensure that the fund will be
used to purchase medicines at the lowest possible
cost," says Ellen *t Hoen from the medical aid
organisation M&eaacute;decins Sans Frontie:res.
"Without these basic commitments, it will be a long
time before the fund contributes to saving lives. In its
current state, it is little more than window dressing."
The crisis of lack of access to essential medicines faced
by developing countries is much greater than can be
solved by a global fund. A fundamental change in the
medicines market is needed, embracing multiple
http://217.29.195.76/content/page.cfm?articIeid=5A05508A-AAD9-474E-AEDA9C6F6A3D5 AAA
8/3/01
F
i
MSP: G8 window dresses while poor die from lack of medicines
Page 2 of 2
strategies that will lead to equitable drug prices. Such
strategies should include:
• a flexible interpretation of the WTO agreements on
intellectual property to ensure that pharmaceutical
patents do not stand in the way of producing and
purchasing affordable medicines
• the promotion of the production and use of generic
medicines
• a tiered pricing system to ensure that medicines in
developing countries are affordable
• public investment in research and development for
neglected diseases.
"The richest countries of the world refuse to address
more fundamental solutions to the access to medicines
crisis," says Ellen't Hoen. "The current fund makes the
richest countries look good, but will have very little
impact on the lives and health of people.
Related Links
As the G8 announces details of Global Health Fund,
access to affordable medicines for the poor must be a
priority.
Global Health Fund must not be a subsidy for tne drug
industry
For more information about:
MSF at the Genoa G8
!
http://217.29.195.76/content/page.cfm?articleid=5A05508A-AAD9-474E-AEDA9C6F6A3D5 AAA
8/3/01
Frequently Asked Questions
Frequently Asked Questions
Contents
• Questions about FAC
o When was TAC started?
o What are the objectives of TAC?
How is TAC trying to achieve its objectives?
o
.
o How do Ijoin TAC?
Is
TAC
concerned
only
with
HIV
health-care
issues.
o
• Questions about HIV/AIDS
o How do we know that HIV causes AIDS.
o How serious is the HIV epidemic in South Africa.
o Is HIV a death sentence?
o What are the anti-retroviral medications?
o Whatjs triple-drug therapy?
o Are anti-retroviral drugs dangerous?
o What is drug resistance?
• ’"XZ*
“fa and Cher poor ™n,nes
have access ,o aa.i-rc.ro.M
medication or the treatments for opportunistic inlections.
o Why_are rnany.essemiaLHiy medicatjonsjSQ.cxpetisiyj.
o Are their cheaper generic versions of HIV medications.
o What is patent abuse?
o What can be done about patent abuse.
O What is compulsory Ijcgnsing?
°o ^diSXSgXe^^bcZZg ^'ZlXl trade agreements by issuing
„
SSJ&. «•us "’d E“ goverw's
press“ns,ng “
»..... ................
o
o
o
o
Is TAC against patent laws?
......... ......
o
o w SKZ?
£££
l,ws ” rc“vcr,cs“rv"
3/2/01
V http://www.tac.org.za/faq.htm
rcqucntly Asked Questions
Page 2 of 16
/os
development costs false?
o What is wrong with the argument that the US and EU arc justified in protecting their industries,
because the cost of developing drugs has been borne entirely by these countries.
o Is it true that major drug company research and development is increasingly focused on
developing non-essential recreational drugs?
o Won't compulsory licenses result in job losses for South Africans?
• Questions about the Defiance Campaign
‘ o What is the Christopher Moraka Defiance Campaign Against Patent Abuse?
o Who was Christopher Moraka and why was the campaign named after him?
o What is the point of the defiance campaign?
o Is TAC planning to supply generic fluconazole to the entire country?
o Docs the Defiance Campaign break the law?
o How long will the Defiance Campaign continue?
o How will the generic medication be distributed?
o How docs TAC know that the generic fluconazole it is importing is of good quality?
o What has happened to Pfizer's offer to donate fluconazole?
o What are the drugs that TAC intends to target?
• Questions about preventing mother-to-child transmission of HIV
o Do all pregnant mothers with HIV transmit the virus to their children?
o Howmany mother-to-child transmissions occur yearly in South Africa?
o How can mother-to-child transmission be prevented?
o Isn't infant formula milk associated with higher infant mortality rates in poor countries? What
about 'Breast is Best'?
o How long do HIV-positive infants live?
o Should the government afford to implement a country-wide mother-to-child transmission
prevention (mtctp) programme.
o Isn't the government only obligated to implement mother-to-child transmission prevention if it is
within its available resources?
o Won't implementing an mtctp programme result in a large number of orphans?
o What other spin-offs are there to an mtctp programme?
o Why hasn't the government implemented a country-widejrntctp programme?
o Is it true that TAC is takingjegal action against the government: for pot implementing an mtctp
programme?
o Does taking legal action against the uovemment mean that TAC is anti-government or antiANC?
o The government has announced that it will implement pilot mother-to-child transmission
programmes using Nevirapine. What is this all about?
o Does the Democratic Alliance have a good record on HIV?
Questions about TAC
When was TAC started?
TAC was started on the 1st of December 1998, Human Rights Day.
What are the objectives of TAC?
http://www.tac.org.za/faq.htm
3/2/01
frequently Asked Questions
♦
Page 3 of 16
TAC's objectives are as follows:
1.
2.
3.
4.
Highlight disparities and problems in access to treatment and campaign to have them eliminated, with
particular emphasis on HIV/AIDS.
Highlight problems with South Africa's health-care infrastructure and campaign to have them
eliminated.
Educate ourselves and the public about treating HIV.
Educate people about how to live healthier and better with HIV/AIDS.
How is TAC trying to achieve its objectives?
TAC is conducting a number of campaigns. You can find out more about these on the
activity.htmActivities web page.
How do I join TAC?
TAC does not have an official membership list. However, the organisation is in constant need of volunteers
to help with the enormous workload. See the Contact Uscontact. htm web page for details on how to contact
one of the TAC offices.
Is TAC concerned only with HIV health-care issues?
TAC's primary focus is definitely health-care issues affecting people with HIV in South Africa. However, the
organisation is concerned about other epidemics as well, such as Tuberculosis (TB). At the moment, the
extent of the HIV epidemic consumes all our resources, but in the future we will make an effort to highlight
other issues.
Questions about HIV/AIDS
How do we know that HIV causes AIDS?
The evidence is overwhelming. Over a period of time, usually between 2 and 10 years, the Human
Immunodeficiency Virus (HIV) destroys an infected person's immune system. Once the immune system
becomes sufficiently weak, the infected person is prone to being attacked by opportunistic diseases. There are
many opportunistic diseases, including, but not limited to, TB, cryptococcal meningitis, PCP and Karposi
Sarcoma. The immune systems of healthy people can fight off many of the diseases which attack people with
HIV, but if left untreated, they can often be fatal or de-habilitating for people with HIV. When the immune
system has deteriorated very badly and the infected person regularly falls ill with opportunistic diseases, the
person is said to have Acquired Immune Deficiency Syndrome (AIDS). For an excellent explanation of the
evidence that HIV causes AIDS, sec Scientific American Article sciam.htm. For a detailed and more
complicated explanation, see NIH article nihart.doc.
Someone who claims that HIV does not cause AIDS is referred to as an AIDS denialist or dissident. The
arguments of the denialists have been discredited.
http://www.tac.org.za/faq.htm
ft
ft.
3/2/01
. A . Questions
requently Ask^
Page 12 of 16
118
c active ingredient is supplied by a Swiss company and has been certified.
Tb i he WHO has inspected Biolab's premises and found them to be of good quality.
. Biolab has an ISO 9001 certificate for its production facilities.
• Biozole is registered and used in Thailand. It is used in many Asian countries.
• Medicins Sans Frontieres (Doctors Without Borders), the 1999 Nobel Peace Prize Winners, uses
Biozole. They have recommended Biozole to us.
• TAC has visited the Biolab site. It was clean and the company's labour practices were acceptable.
What has happened to Pfizer's offer to donate fluconazole?
This is a good question and should be directed to Pfizer. The offer was made in mid-2000. Not a single
capsule of donated fluconazole has reached a patient yet. Pfizer is negotiating the offer with the government
but despite persistent rumours no agreement has been reached. TAC was party to the early stages of the
negotiations and was witness to the bad faith negotiating style of Pfizer. In July the company released a false
press statement aimed to coincide with immense activist pressure they were experiencing at the International
AIDS Conference in Durban South Africa. The statement announced that Pfizer had reached an agreement
with the South African government. The Minister of Health stated that she was furious at this premature
announcement at the Global March for Treatment Access organised by TAC and Health-GAP on 9 July 2000.
1 •
Thus far it has been clear that the offer of the donation was a mere publicity stunt, but one that has been at the
expense of people's lives.
What are the drugs that TAG intends to target?
TAC is focusing on the following essential medications which are the source of excessive profits:
• fluconazole under patent to Pfizer
• ddl and d4T under patent to Bristol Myers Squibb
• ABC, 3TC and AZT under patent to Glaxo Wellcome.
• nevirapine under patent to Boehringer Ingleheim
At the moment TAC is only importing fluconazole. In the future we will investigate importing anti
retrovirals.
Questions about preventing mother-to-child
transmission of HIV
Do all pregnant mothers with HIV transmit the virus to their
children?
No. There is some debate as to the precise transmission rate, which seems to differ within about a 20% range
from study to study. It seems that 30% is a reasonable figure to use, but a recent study in Zimbabwe found a
transmission rate ofjust over 40%.
http://www.tac.org.za/faq.htm
3/2/01
9
r
r
/equently Asked Questions
Page 13 of 16
H9
Assuming a 30% rate, transmission occurs as follows in a typical sample of 100 births:
• 5 infections occur in early pregnancy
• 15 infections occur in late pregnancy and during birth
• 10 infections occur as a result of breast-feeding
Howmany mother-to-child transmissions occur yearly in South
Africa?
The prevalence of the virus is not stable, so from year to year the numbers have been increasing. In 1999, it
was estimated that over 60,000 mother-to-child HIV infections occurred.
How can mother-to-child transmission be prevented?
By giving the mother and child anti-retroviral treatment and encouraging mothers to use infant formula milk,
mother-to-child transmission can be reduced substantially. There are a number of possible anti-retroviral
regimens that can be used: (1) long-course AZT, (2) short-course AZT and (3) Nevirapine, among others.
Long-course AZT is the most expensive, but also the most effective. TAG is advocating that short-course
AZT or Nevirapine are minimum appropriate solutions for South African public antenatal clinics.
Short-course AZT requires the mother to take AZT from the 36th week of pregnancy. The Nevirapine
regimen is much simpler and requires the mother to take Nevirapine once during labour and for a Nevirapine
syrup to be given to the child once after birth.
Using the transmission rate of 30%, the number of infections that can be prevented using the latter two
regimens coupled with infant formula milk is estimated to be at least 15, but probably closer to 20, per 100
births. Using the numbers discussed in Question [*]:
• 5 infections that occurred early in pregnancy cannot be prevented
• approximately 10 of the 15 infections that occur in late pregnancy or just before birth will be prevented
• 10 infections due to breast-feeding will be prevented.
Isn’t infant formula milk associated with higher infant mortality
rates in poor countries? What about 'Breast is Best’?
Breast is normally best and infant formula milk is associated with higher infant mortality rates for mothers
who are HIV-negative. However, for mothers who are HIV-positive the overall effect is to substantially
reduce mortality by reducing the number of transmissions.
It is easiest to understand the effect of transmission rates by looking at the numbers. If 100 HIV-positive
breast-feeding mothers are given Nevirapine or short-course AZT, then using the numbers discussed in
Question [*]then:
• 5 infections that occurred early in pregnancy cannot be prevented
• 10 babies who were HIV-negative at birth even without the anti-retroviral treatment will still contract
HIV through breast-feeding
http://www.tac.org.za/faq.htm
3/2/01
/requently Asked Questions
Page 14 of 16
IXO
• approximately 5 of the 10 babies whose infection was prevented through the anti-retrovirals will now
become infected through breast-milk
This comes to a total of approximately 5 infections averted as opposed to the 15 to 20 that would be averted
if infant formula milk was used.
How long do HIV-positive infants live?
Assuming HIV-positive babies do not receive anti-retroviral therapy, they live on average 2 years.
Should the government afford to implement a country-wide motherto-child transmission prevention (mtctp) programme.
By not implementing a country-wide programme, the following clauses in the South African constitution are
being infringed by the government:
1.
2.
3.
4.
right of mothers to make reproductive choices
right to health-care
right to dignity and equality
best interests of the child.
Isn’t the government only obligated to implement mother-to-child
transmission prevention if it is within its available resources?
Yes, but it is within the government’s resources. A number of independent studies published in prestigious
peer-reviewed medical journals have shown that an mtctp programme is affordable. For a detailed analysis
see this document mtctcost. Actually an mtctp programme would probably save the state money, because of
the cost saved on not having to treat HIV-positive children?
Won’t implementing an mtctp programme result in a large number
of orphans?
It is not ethical to let children to die so that they don’t become orphans. This is not even an ethic used in
warfare. Besides, TAC is campaigning for all people, including mothers, to have access to HIV treatments.
What other spin-offs are there to an mtctp programme?
There is evidence that the counselling that mothers get with an mtctp programme results in a reduction of
unsafe sex practices. In addition, by finding out their HIV status, mothers are in a better position to plan for
the future and to make decisions that can help them live healthier, longer lives.
Why hasn’t the government implemented a country-wide mtctp
programme?
http.7/www.tac.org.za/faq.htm
3/2/01
frequently Asked Questions
Page 15 of 16
This is a question that should be put to the government. TAC has done this and received vague answers
which avoid the issue.
Is it true that TAC is taking legal action against the government for
not implementing an mtctp programme?
Yes. However, preparation for the court case has taken longer than expected. In addition, when TAC
announced its intentions, the government announced that it would implement a pilot programmes in all
provinces which has affected our preparation. Unfortunately, TAC has few resources and most of the TAC
activists involved in the court case preparation do so on a part-time basis without any pay, and have full-time
job commitments.
TAC is therefore taking the following approach. The legal action is being prepared meticulously and in
detail. Civil society organisations are being solicited to join us in the court case against the government.
Does taking legal action against the government mean that TAG is
anti-government or anti-ANC?
No. TAC is not aligned to any political party. Actually, most, but not all, TAC activists are ANC members or
supporters. However, the government is failing to combat the HIV problem appropriately and it is necessary
for the TAC to do everything we can to change the government’s attitude to the disease. Ideally, TAC would
like the government to lead us in the fight against HIV.
The government has announced that it will implement pilot motherto-child transmission programmes using Nevirapine. What is this all
about?
In response to public pressure, the government has announced that it will implement a mother-to-child
transmission pilot projects. We understand the details of this implementation to be the following:
• The Nevirapine regimen will be used.
• Each province must implement at least two sites, where a site is defined as a set of clinics or hospitals
that handles at lea Kt 3000 pregnancies a year.
• Provinces may implement more than 2 sites if they wish.
Superficially, this pilot programme might seem to be substantial progress, but on careful examination one
discovers that if the provinces implement the minimum requirement, then:
9 provinces X 2 sites X 3000 pregnancies = 54,000 pregnancies
There are approximately 1,000,000 births in public antenatal clinics in South Africa a year. Therefore, the
pilot programme ensures that a small minority, approximately 6%, of mothers will be part of the mtctp
programme.
Therefore TAC has decided to write to every provincial MEC for health to determine precisely what each
http://www.tac.org.za/faq.htm
3/2/01-
Frequently Asked Questions
Page 16 of 16
province is intending to implement. We will also wirite to the Department of Health requesting a precise
explanation of the details of the pilot programme.
Does the Democratic Alliance have a good record on HIV?
No. The DA, which is composed of the old National Party and the Democratic Party has a terrible track
record when it comes to fighting HIV. The DP opposed the legislation introduced by government to make the
importation of generic medication easier. The National Party's track record against HIV when they were in
power was worse than the current government. They ignored the disease for the most part and a minister of
health under the National Party stated that HIV is a disease of people with poor morals.
It is quite concerning that just over a month before the local elections the DA's Tony Leon took an
unprecedented interest in HIV. It suggests that the DA is using HIV purely for election propaganda purposes.
On the other hand, the government has not helped the situation by releasing confusing messages on HIV not
implementing a country-wide mtctp programme and giving credence to AIDS denialists.
About this document...
Frequently Asked Questions
This document was generated using the LaTeX2htm translator Version 98. Ipl release (March 2nd, 1998)
Copyright © 1993, 1994, 1995, 1996, 1997, NikpsDrakos, Computer Based Learning Unit, University of
.L/vCClS.
The command line arguments were:
latex2htm -split 0 -ascii_mode -address TAC faq.tex.
http:/Avww.tac.org.za/faq.htm
3/2/01
TAG UP- DA i E-
https://www. mail. yalc.edu/cgi-bin/wcbcxprcss.cgi/Read/' 9807
Date: Thu, 2 Aug 2001 09:37:00 -0400 (EDT)
From: "Sharonann Lynch" <salynch00@earthlink .net>
Reply-To: <healthgap@CritPath.Org>
To: "Multiple recipients of list" <healthgap@CritPath.Org>
Subject: NEWS: TAC threatens to sue SA gov't over Nevirapine
/2S
<snip>
In an attempt to force the government to move more quickly, an AIDS
activist group, the Treatment Action Campaign (TAC), has threatened
to file-a lawsuit against the government this week. If the government
doesn't promise in writing to provide Nevirapine to all HIV-positive
pregnant women, the group will file suit, claiming that the
constitutional right to reproductive freedom has been violated.
I snip
South Africa faces suit over cheap AIDS drug Activists say the
government is slow to provide a drug doctors say cuts the risk of
AIDS for babies.
Nicole Itano Special to The Christian Science Monitor
08/02/2001
Christian Science Monitor
Twice a month, Nora Motshelanoka travels across the sprawling
metropolis of Johannesburg. Her destination: a tiny concrete wing of
Soweto's Chris Hani Baragwanath Hospital. She is 4-1/2 months
pregnant, diagnosed as HIV-positive, and very much alone. No one in
her community knows about her HIV-status, and she lives in fear that
she may pass the deadly virus to her unborn child.
Mrs. Motshelanoka's one source of support is her bimonthly visit to
the hospital, where she receives counseling and routine prenatal
care. When she nears her delivery date, she will be given a single
dose of Nevirapine, an antiretroviral drug that tests have shown can
halve the likelihood of AIDS being transmitted to her child.
"When I first found out, I cried every night. I asked God why this
had to happen to me," Motshelanoka says. "Now I think maybe my baby
will be healthy."
Baragwanath Hospital is one of only a handful of hospitals in Sbuth
Africa that treats HIV-positive pregnant women, such as Motshelanoka.
AIDS groups say the government has been slow to make the drug widely
available to the estimated 25 percent of pregnant women in South
Africa who are HIV-positive.
In the wake of the highly publicized lawsuit by international drug
companies earlier this year to block generic drugs, the German
pharmaceutical Boehringer Ingelheim, the producers of Nevirapine,
offered to provide the drug free for the next five years. But the
South African government hasn't accepted the offer.
One AIDS group is now threatening to sue the government if Nevirapine
is not made more widely available, but the government says that
concerns about the drug's safety still need to be addressed.
An estimated 2.5 million South African women of child-bearing age
have been diagnosed as HIV-positive. Without treatment, the South
African government calculates that more than 100,000 HIV-positive
babies will be born in the country this year.
1 of 3
8/3/01 12:24 PM
https://www.mail.yale.edu/cgi-bin/webexpress.cgi/Rcad/l9807 I
At Baragwanath Hospital, the world's second-largest maternity
hospital, nearly 30 percent of the 16,000 women who give birth here
are diagnosed as HIV-positive.
The Department of Health has pledged to implement Nevirapine pilot
programs in two sites in each of the country's nine provinces, which
they say would reach an estimated 90,000 pregnant women each year.
But only two provinces now have pilot programs up and running.
At Baragwanath, the inexpensive Nevirapine therapy is privately
funded and run through an independent unit of the University of the
Witwatersrand. Another province, controlled by the opposition
Democratic Alliance Party, is running its own program - using a
different, more expensive drug.
The government says the pilot programs are needed to answer questions
of drug resistance and toxicity.
"We believe the drug has proved effective in preventing intrapartum
transmission at the time of birth, but it's the practices thereafter
and sustainability that require looking at," says Jo-Anne Collinge, a
spokeswoman for the Department of Health.
She says Nevirapine is only a small part of a successful motherand-chiId program, and that other essential components - HIVcounseling, prenatal health care, and the provision of formula to
newborns - are complicated and expensive to implement, especially in
rural areas.
But Boris Jivkov, an obstetrician in the Perinatal HIV Research Unit,
says, "We have shown them a model of how mother-to-child transmission
can be reduced." He argues that providing HIV-positive women with
Nevirapine, at an estimated cost of $3 per woman, is far more cost
effective than treating HIV-positive children.
He says that 95 percent of the pregnant women at Baragwanath now
choose to take a voluntary HIV test. Money from international donors
is paying for all women who test positive to have access to
Nevirapine.
"Basically, what the they're [the health department] doing is
repeating what research we’ve already done," says Dr. Jivkov.
In an attempt to force the government to move more quickly, an AIDS
activist group, the Treatment Action Campaign (TAC), has threatened
to file a lawsuit against the government this week. If the government
doesn't promise in writing to provide Nevirapine to all HIV-positive
pregnant women, the group will file suit, claiming that the
constitutional right to reproductive freedom has been violated.
"If a mother wants to have a child, and there is Nevirapine available
that can prevent the transmission from the mother to the baby, the
government has the obligation to provide that to the mother, " says
Mandla Majola, Western Cape coordinator for TAC. (c) Copyright 2001.
The Christian Science Monitor
Sharonann Lynch
Health GAP Coalition
212-674-9598
2 of 3
8/3/01 12:24 PM
1
Look al Brazil
Page 1 of20
/2lS
eljc^du l|ork Eimes Hlapaane
Home
I
Stte Index
| Site Search
Forums
Archives
Marketplace
Home Equity Ones and Loans
I*7 Home improvement
r Debt consolidation
I- Income tax bills
F Major appliances
I- Tuition payments
r Vacation expenses
Fc.
Look at Brazil
Con?
Paicm laws arc malleable. Patients arc educable. Drug
companies are vincible. The world’s AIDS crisis is solvable
(
By TINA ROSENBERG
Forum
• Should fi^eigiigoveiwi^
AIDS drugs?
manufacture their own
V,
Cw omeday, we
may look
back on the year
2001 with nostalgia
for a time when
AIDS was merely a
health catastrophe.
Soon, AIDS in
Africa will be
doing more than
killing millions
every year. It will
destroy what there
is of Africa's
economy and cause
furthe’- instability
and, perhaps, war.
In the year 2010,
the country of
South Africa will
be almost one-fifth
poorer than it
would have been
had AIDS never
existed.
Throughout Africa,
the disease has
ravaged the young,
urban and mobile.
. I
Trinidad,
Poland
♦
http://www.nytiincs.com/library/magazine/home/20010128mag-aids.html
8/1/01
I-
Page 2 of20
It has robbed
schools of their
teachers and
hospitals of their
doctors and nurses.
Businesses arc
depleted by the
need to cope with
sick and dying
employees. AIDS
takes the
breadwinner,
leaving millions of
destitute elderly
and orphans who
TRINIDAD: LYNNE SLADKY/ ASSOCIATED PRESS; POLAND^
W£JJEK STE,N/REpORTER; BRAZIL. DOUGLAS ENGLE/
will grow up
ASSOCIATED PRESS; HAITI: DANIEL MOREL/ASSOCIATED
without going to
PRESS.
school, many on
the streets. As they lose their productive citizens, the nations
themselves face collapse.
At the moment, however, AIDS in Africa is only a plague of a
severity not seen since the Black Death killed at least a quarter of
Europe in the 14th centuiy. A 15-year-old in South Africa has a
better than even chance of dying of AIDS. One in five adults is
infected with H.I.V. Hospitals are filled with babies so shriveled by
AIDS that nurses must shave their heads to find veins for
intravenous tubes. Seventeen million people have died prolonged
and miserable deaths from AIDS, and that number is dwarfed by
what lies ahead.
While Africa is the region most ravaged, the disease is exploding
elsewhere as well. India says it has four million infected; it may
well have five times as many. Its AIDS epidemic bears a terrifying
resemblance to South Africa's a few years ago — AIDS is
widespread in every risk group, and health care is inadequate. The
Caribbean has the second-highest rate of infection after sub-Saharan
Africa. More than one in 50 adults is H.I.V.-positive, and because
the epidemic is primarily spread heterosexual ly there, most of the
population is at risk. In Eastern Europe and the former Soviet
Union, the number of infected nearly doubled in the last year.
Tina Rosenberg writes
editorials for The Times. Her
last article for the magazine
was about children abducted
during El Salvador's civil war.
Until a year ago, the triple therapy that
has made AIDS a manageable disease
in wealthy nations was considered
realistic only for those who could
afford to
S10,000 to $ 13,000
15,000 a year
aiiuiu
io pay diu,uuu
or lived in societies that could. The most that poor countries could
hope to do was prevent new cases of AIDS through educational
programs and condom promotion or to cut mother-to-child
http://www.nytimes.com/library/magazine/home/20010128mag-aids.html
8/1/01
Look at Brazil
Page 3 o f 20
transmission and, if they were very lucky, treat some of AIDS’s
opportunistic infections. But the 32.5 million people with H.I.V. in
the developing world had little hope of survival.
This was the conventional wisdom. Today, all of these statements
arc false.
TT" he Raphael de Paula Souza hospital sits on the outskirts of Rio
I de Janeiro. It is a one-story plaster building with peeling blue
paint and barefoot boys playing in the parking lot. Nothing in its
appearance suggests that it might serve as a model for treating ’
- AIDS worldwide.
The AIDS clinic is run by Ademildes Navarini, who spends her
days seeing patients like Rogerio. He is 26, has tuberculosis as well
as AIDS and suffers from an AIDS-related brain infection,
toxoplasmosis. The infection has affected his speech, and now he
gropes for words. He removes his T-shirt using only his left arm.
His right arm and his right leg hang limp.
Of all the tools
available to poor
countries,
compulsory
licensing is what
the drug
companies fear
the most, since it
represents the
most direct
assault on
control of their
patents.
Rogerio is followed by Jerdinete, a 46year-old middle-class woman who came in
for tests a year ago because of stomach
problems -- and was stunned to find she
had AIDS. The only way she could have
got it, she says, was from her husband,
whom she had presumed faithful. When
she told him that she was sick, he left her.
Jerdinete is followed by Maura, H.I.V.positive but asymptomatic, and her 7-yearold son, Emerson, whose H.I.V. was
diagnosed 10 months ago but has
undoubtedly been infected since birth.
Emerson, a handsome, curly-haired boy,
kisses his mother's cheek, puts his arm
around her neck and caresses her face as
she sits on a stool. A year ago, Emerson's
hair started to fall out. He got diarrhea and started losing weight.
The family went in for testing, and their fears were confirmed.
Maura, whose husband also has AIDS and tuberculosis, stopped
working to stay home with Emerson. "He's the reason for my life,"
she says, squeezing her son.
If Rogcrio, Jerdincte and Emerson lived in any other poor nation,
their future would be achingly foreseeable. But here's the news from
Raphael de Paula Souza hospital: each of these patients will walk
out with a plastic bag filled with bottles of antiretrovirals — AZT
and ddl and the protease inhibitors and other components of the
I
http://www.nytimcs.com/library/magazine/home/20010128mag-aids.html
8/1/01
1
w
rage
Look at Brazil
orzu
/zs
triple cocktail that, for the lucky, have turned AIDS into a chronic
disease. Rogcrio, who started taking triple therapy three weeks
before I met him, has gotten much better. He will be scarred by
toxoplasmosis, Navarini says, but will improve a little more.
Jcrdinctc and Emerson, on triple therapy for months, are doing fine.
And Adcmildcs Navarini is the happy exception in third-world
medicine, an AIDS doctor who can make her patients healthy again
instead of merely holding their hands and watching them die.
Since 1997, virtually every AIDS patient in Brazil for whom it is
medically indicated gets, free, the same triple cocktails that keep
rich Americans healthy. 0n Western Europe, no one who needs
AIDS treatment is denied it because of cost. This is true in some
American states, but not all.) Brazil has shredded all the excuses
about why poor countries cannot treat AIDS. Health system too
fragile? On the shaky foundation of its public health service, Brazil
built a well-run network of AIDS clinics. Uneducated people can t
stick to the complicated regime of pills? Brazilian AIDS patients
have proved just as able to take their medicine on time as patients in
the United States.
Ah, but treating
AIDS is too
expensive! In fact,
Brazil's program
almost certainly
pays for itself. It
has halved the
death rate from
AIDS, prevented
hundreds of
thousands of new
hospitalizations,
cut the
transmission rate,
helped to stabilize
the epidemic and
improved the
overall state of
public health in
Brazil.
f-
h
‘F
i
J
J
__
w
.
/.
Eloan Pinheiro, who copied AIDS drugs for the
government. Photograph by Claudio Edinger/SABA.
for The New York Times.
Brazil can afford to treat AIDS because it does not pay market
prices for antiretroviral drugs — the most controversial aspect of the
country's plan. In 1998, the government began making copies of
brand-name drugs, and the price of those medicines has fallen by an
average of 79 percent. Brazil now produces some triple therapy for
$3,000 a year and expects to do much better, and the price could
potentially drop to $700 a year or even less.
http://www.nytimes.com/library/magazine/hoinc/20010128mag-aids.html
8/1 01
Look at Brazil
Brazil is showing that no one who dies of AIDS dies of natural
causes. Those who die have been failed -- by feckless leaders who
sec weapons as more alluring purchases than medicines, by wealthy
countries (notably the United States) that have threatened the
livelihood of poor nations who seek to manufacture cheap medicine
and by the multinational drug companies who have kept the price of
antiretroviral drugs needlessly out of reach of the vast majority ol
the world's population.
But one major reason that only Brazil
offers free triple therapy is that, until
now, there was no Brazil to show that it
is possible. A year and a half ago,
practically nobody was talking about
using triple therapy in poor countries.
Today, it is rare to find a meeting of
international leaders where this idea is
not discussed. International
organizations like the United Nations
AIDS agency. Unaids, and
nongovernment groups like Medecins
Sans Frontieres are starting to help
countries try to replicate Brazil's
program. Brazil has offered to transfer
all its technology and provide training in
the practicalities of treating patients to
other countries that want to make drugs
and will supply them to patients free.
Even the drug companies, hoping to
head off more damaging assaults on
their patent rights and improve their
tattered image, have acknowledged the
need to charge less for their products in
poor nations. They have begun to make
limited offers of cheap drugs.
In other words, the debate about whether
poor countries can treat AIDS is over.
The question is how.
Also in This Issue
Survival of the Pushiest
Mark Burnett, the
nF’Sl’n/ivnr '
has not only created the
mother of all reality
shows; he may also
have revolutionized
how the business of
television is done.
Hong Kong’s Queen of
Pulp Moves On
Having played to the
crowds for years,
Maggie Cheung tries
paring it down.
Stronger Than Steel
Next week Three
Rivers Stadium is being
blown up. But it will
live on as a testament to
those four Super Bowls
the Steelers won a
generation ago -- and to
all the things Pittsburgh
still wants to be.
Index to this week's
Pharmaceutical manufacturers argue that New York Times
many countries are very far from able to
Magazine
administer a program of triple therapy,
and they are right. But Brazil shows that poor nations can do it.
Others will be able to follow if they get substantial international
help.
f
http://www.nytimcs.coni/library/magazine/liome/20010128niag-aids.html
8/1/01
Look at Brazil
Page 6 or 20
'B©
The drug companies are wrong, however, on how to make AIDS
drugs affordable. Their solution — limited, negotiated price cuts -- is
slow, grudging and piecemeal. Brazil, by defying the
pharmaceutical companies and threatening to break patents, among
other actions, has made drugs available to everyone who needs
them. Its experience shows that doing this requires something
radical: an alteration of the basic social contract the pharmaceutical
companies have enjoyed until now.
By the terms of that contract, manufacturers, in return for the risks
of developing new drugs, receive a 20-year monopoly to sell them
in some nations at whatever prices they choose. The industry has
thrived under this contract. And so have we, the rich. The system
has conquered an unimaginable range of diseases. But for billions of
people the medicines have remained out of reach. Poor countries, it
is now clear, must violate this contract if they are to save their
people from AIDS.
Brazil has been able to treat AIDS because it had what everyone
agrees is the single most important requirement for doing so:
political commitment. At the beginning of 1999, Brazil's economy
was skidding into crisis. President Fernando Henrique Cardoso was
under great pressure to cut the budget by abandoning the AIDS
program. He rejected that advice, deciding that treating AIDS was a
priority.
Such commitment has its roots in the gay community. Although
AIDS is now a disease of the poor in Brazil, the first Brazilians
infected were gay men. In a country famously open about matters
sexual, gays were much more activist and better organized than in
most other nations, and AIDS carried less of the stigma that has
elsewhere led people simply to deny its existence.
Then the movement found an unlikely ally in Jose Samey, Brazil’s
first civilian president after the country emerged from military rule
in 1985 and a conservative who led a pro-military party during the
dictatorship. In 1996, scientists at the world AIDS conference in
Vancouver announced that triple therapy with a protease inhibitor
could reduce viral load to undetectable levels. Finally, there was a
treatment for AIDS. "A doctor friend informed me about what was
going on in Vancouver," Samey told me. "1 saw that most of the
medicine in the cocktail would not be available to the poor, and I
felt that we were talking about the survival of the species."
Sarney proposed a law that guaranteed every AIDS patient state-ofthe-art treatment. It passed. At the same time, Brazil was carrying
out an aggressive AIDS prevention program, financed by the World
Bank. Activist groups were the keystone, distributing millions of
http://www.nytimes.corn/library/magazinc/homc/20010128rnag-aids.html
8/1/01
Look a! Brazil
Page 7 of 20
P5U
free condoms.
Surveys show that there are about 530,000 H.I.V.-positive people in
Brazil. Four-fifths do not know they arc infected. Of those who
have been identified as needing antiretroviral therapy, however
(some 90,000 at the moment), virtually all can get it, even homeless
people, even people in the middle of the Amazon, says Paulo
Teixeira, who runs Brazil's AIDS program. A slim, elegant man of
52, Teixeira has been an AIDS doctor since 1983 and director of the
country's AIDS efforts for a year.
The treatment and prevention programs complement each other -another powerful reason to begin treating AIDS in poor countries.
Treating AIDS helps to limit its spread, as people with a lower viral
load are less contagious. The availability of lifesaving treatment is
also a powerful lure for people to get an AIDS test.
"Treatment brings people into the hospital, where you can talk to
them," says Serafim Armesto, a psychologist who works with AIDS
patients at the General Hospital of Nova Iguazu, a major hospital in
a working-class town a short drive from Rio. "You can work with
them to prevent the spread of AIDS and further disease.
The programs have paid off. In 1994, the World Bank estimated that
by 2000 Brazil would have 1.2 million H.I.V.-positive people. In
fact it had half that many. The epidemic has stabilized, with some
20,000 new cases each year for the last three years. The treatment
program has cut the AIDS death rate nationally by about 50 percent
so far, and each AIDS patient is only a quarter as likely to be
hospitalized as before.
Treating AIDS also
fights other
diseases. The
incidence of
tuberculosis in
H.I.V.-positive
patients has
dropped by half.
AIDS has also
helped to mobilize
people to fight for
better health care.
"In 1999, the
Health Ministry
had problems
getting its budget
passed for AIDS,
Dr. Adcmildes Navarini at the Raphael de Paula Souza
TB and other
hiip://www.nytimes.com/library/magazine/home/20010128mag-aids.html
8/1/01
-
Page 8 ol 2u
Look at Brazil
nuspimi. rnuiugrapn oy v^iauuio cuingcr/o/\D/\. lur
The New York Times.
131
diseases," says
Pedro Chequer,
Teixeira's predecessor as head of the AIDS program and now the
Unaids director for the southern part of South America. "There are
now 600 nongovernmental groups that work on AIDS. They
demonstrated in the street for a higher budget for all diseases, not
just for AIDS, and these protests were covered in the press." The
money was restored.
The Health Ministry spent S444 million on AIDS drugs in 2000 -- 4
percent of its budget. The only study of the program's benefits so far
shows that the decline in hospitalizations from opportunistic
infections from 1997 to 1999 saved the Health Ministry $422
million. But the tally of benefits should also take into account the
savings from treatment's contribution to a halving of the expected
infection rates and the productivity of those who no longer need to
stay home or care for the sick.
hen we started with triple therapy," Teixeira says, "the
W W main criticism from developed countries was that we
didn't have the conditions for antiretroviral treatment. They said it
would be dangerous for other countries, that we would create
resistance."
Antiretrovirals, if taken incorrectly, can indeed create a more
resistant strain of virus in the patient — and in anyone to whom it is
transmitted. Patients must stick to a rigorous and complicated
schedule of pills, some taken with food, some without, and they
must keep to this program (at least this is the current thinking) every
day for the rest of their lives.
Yet the worries of rich countries that the poor and uneducated will
mess things up for the rest of us have proved unfounded. Any nation
that provides its AIDS patients with antiretrovirals must also
provide them with help and training to take the medicine correctly.
Brazil is doing just this, although it has meant turning nurses into
organizers of nature hikes and clinics into baby-formula
warehouses.
In Ademildes Navarini's clinic at Raphael de Paula Souza hospital, a
nurse's aide, Denise Feliciano, spends a large part of her day
drawing suns and moons with a purple marker. Today she is
preparing Rogerio, the patient recovering from toxoplasmosis, to go
home with a bag of medicine. Rogerio has been taking
antiretrovirals for three weeks, and he may or may not be taking
them correctly. "What time do you take your pills?" she asks. She
waits while he counts. He stops at 6, groping for the next number.
Seven? she supplies. Eight?
http://wwwjiytimes.com/library/magazinc/homeZ20010128mag-aids.html
8/1/01
I
Look at Brazil
Page 9 of 20
'33
Rogerio makes a noise at 8.
How many pills do you take at 8 at night?
"Three," he says, but he is holding up two fingers. It is not clear
whether Rogerio is confused or merely has trouble expressing
himself. The toxoplasmosis has also affected his eyesight; he knows
how to read, but he can't see.
Feliciano sits down next to him and takes out his bag of medicine, a
sheet of paper and her marker. ’’O.K., how do you take Biovir?" she
says.
They go through each drug, with Feliciano drawing suns and moons
on the boxes of pills and making a list on a separate sheet in a large
purple hand. She estimates that 30 percent of patients have trouble
keeping to their schedules, the same figure I heard from doctors and
health workers at other hospitals. Most patients, everyone agreed,
eventually understand how to take their medicine.
But that doesn't mean they take it. "Many don't understand the need
for treatment, and they abandon it at the first side effects," says
Armesto, the psychologist in Nova Iguazu's clinic. "It can become a
vicious circle -- no food, no money - so they can't take their
medicine properly, so they get opportunistic diseases, so they can't
work, they get depressed, and that leads them further away from
treatment."
In 1999, the AIDS program conducted a survey of more than 1,000
patients in Sao Paulo. It found that 69 percent achieved 80 percent
adherence, which means they took their medicine properly 80
percent of the time. According to Margaret Chesney, a professor of
medicine at the University of California at San Francisco who
studies behavioral factors in AIDS treatment, this rate is not
sufficient to control the virus - which can kill even people who take
their medicine faithfully - but it is no different from adherence rates
in the United States. A study in San Diego showed that 72 percent
of patients took their medicine 80 percent of the time.
The Sao Paulo study found that the most important factor in patient
falloff was missing a doctor's appointment. Next came the level of
instruction and support available at the clinic, followed by a
patient's income and education. "Patient adherence depends directly
on the quality of the services provided," Teixeira says. "People in
bad economic situations have more difficulties, but we can
overcome them if we provide good service."
The study reinforced Brazil's attempt to offer patients more
http://www.nytimes.com/library/magazinc/home/20010128mag-aids.html
8/1 01
Look al Brazil
sustained and varied help. AIDS officials expanded their training
programs for people who work with patients. AIDS sufferers get
free bus passes. Clinics ask local churches and Lions Clubs for food
and baby formula. They recruit patients to sit in the waiting room
and talk with other patients about their problems and to run
Alcoholics Anonymous-style groups. The nurse at Nova Igua&#u
recently look one group on a nature hike to a waterfall, because the
patients seemed to be getting depressed.
- 1
*• V
1•
<34
"When we realize the patient is no longer coming to appointments,
we send a telegram to ask them to come in and tell us why they
slopped," says Rosa Maria Rezende, the social worker in Nova
Iguazu's clinic. "Then we try to overcome that. We want them to be
more interested in the struggle to live. It is not their attitude toward
medicine that matters; it is their attitude toward life."
At first glance, it would seem that brazil has advantages that are
hard to duplicate. It has a well-organized network of civic groups,
which were essential to building support for the program, designing
it and making it work. It is a big country, with a large market for
drugs. It has a health care system, however patchy. And while it is a
poor country, it is a rich poor country.
Some countries will be unable to follow - they are too corrupt or
war-tom or venally governed or not governed at all. In many of the
African nations most ravaged by AIDS, the annual health budget
comes to less than $10 per capita. This reflects the twisted priorities
of leaders, many of whom can find sufficient money when they
need to buy weapons. And health care is worsening thanks to AIDS
itself, as doctors and nurses are among those most ravaged by the
disease. But millions and millions of AIDS patients live in countries
that could emulate Brazil, although they would need international
help. These include virtually all the countries of Latin America and
Eastern Europe, most of Asia and the former Soviet Union and at
least 10 countries in sub-Saharan Africa. Pilot programs in Ivory
Coast and Uganda show that at well-run clinics, patients have the
same rate of adherence as in Europe and the United States.
Brazil shows how a nation can create an AIDS infrastructure atop
an unstable foundation. Fairly good in Brazil's rich regions, health
care is bad to nonexistent in poor ones. The country has one of the
lowest rates of life expectancy and highest rates of infant mortality
in Latin America. "When we passed the bill, we had to rely on a
distribution network that didn't exist," former President Sarney says.
It seems absurd to suggest that countries that will not spend 10 cents
to cure an infant with diarrhea should spend thousands of dollars on
her mother's AIDS drugs. But in Brazil, there has been no trade-off.
The program has very likely saved the Health Ministry money.
http://www.nytinies.com/library/magazine/home/20010128mag-aids.html
8/1/01
Page H of 20
155
Look at Brazil
workers who might also be able to cure diarrhea.
Sowbyhaveottarceumne^d^SSS""1,
or even hostile, leadersh.p Kenya s p esio
AIDS
only very recently reversed°PP™ ofsome African leaders has.
carries such a stigma that th
vernments are too corrupt
been to deny there is a problem. O her 8°
much less
started.
respons.bledeader. who tas
J it has becc,me p„lit,cally
I
AIDS priorities, delayed the institution of even a progr
mother-to-child transmission..
he could make a triple therapy for 1500 per year^p
"S^^ldelu sick wl^MOS
treatment? It does not.
Bui treating AIDS is gradoaUy -'P^X^bu^
are he.n^ clamor —"'X
pr'ogmmtwhS Si theySeked possible to do. Now «>ey
http://www.nytimes.com/library/magazine/home/20010128mag-aids.html
8/1/01
Look at Brazil
Page 12 of20
rse
starting to think about treatment as well.
bile Brazils ability to reach patients encourages other
“ nations, far more important is its success in lowering the
cost of medicine. This is the news that can now allow other
countries to dream about treating AIDS.
Eloan Pinheiro is a soft-spoken, ever-smiling 55-year-old chemist
who spent the first part of her career as chief of formulation for the
Brazilian subsidiaries of two multinational drug companies. Now
Pinheiro is tormenting her former colleagues. She is the director of
, Far-Manguinhos, a government pharmaceutical research lab and
factory named for the industrial neighborhood of Rio where it is
located. In 1998, with the costs of importing brand-name drugs
mounting, Brazil s health minister asked Pinheiro to analyze and
Cfinv
va.w
\vr*rl/4’c moinr A TFSC
r?--- W 4_____ K _ _ . __ I r->
•».
uiugd. i ai-iviaiiguiniius anu orazii s
six other state pharmaceutical factories now make seven of the 12
antiretrovirals taken by Brazilians with AIDS. Pinheiro buys raw
materials from India and Korea.
From the drug companies’ point of view, the assembly lines below
Pinheiro’s second-floor office are humming with the violation of
intellectual property rights, 40,000 times an hour. Brazil’s 1996 law
recognizing patents on medicine, passed to comply with the rules of
the World Trade Organization, specifies that anything
commercialized anywhere in the world by May 14, 1997, would
forever remain unpatented in Brazil. That covers a lot - all the firstgeneration antiretrovirals like AZT, ddl, d4T, 3TC. It covers
nevirapine, one of the nonnucleoside reverse transcriptase
inhibitors, which, like protease inhibitors, make up the third drug in
the triple cocktail. And by a few weeks, it covers the protease
inhibitor indinavir. And at the end of last year, Brazil was causing
tremors in the pharmaceutical industry by preparing to produce
copies of Stocrin, a Merck antiretroviral that came out after 1996,
which is patented in Brazil. Since Brazil started making generics of
AIDS drugs, their cost has plummeted. The price of AIDS drugs
with no Brazilian generic equivalent dropped 9 percent from 1996
to 2000. The price of those that compete with generics from
Brazilian labs dropped 79 percent. But just the credible threat of
generic competition is enough to get manufacturers to lower their
prices.
■
There is no legal reason that other countries cannot do the same.
Most drugs, including antiretrovirals, have never been patented in
most sub-Saharan African countries, so those countries are free to
make or import generics. Even countries that do respect patents on
medicines have this possibility. This is important, because every
country joining the World Trade Organization must pass laws
respecting medical patents - the reason Brazil did. But there is a
W.T.O. loophole that allows countries to make copies of patented
http://www.nytimes.com/library/magazine/homc/20010128mag-aids.html
871/01
Look at Brazil
Page 13 6120 '
IM
items in certain situations, including that of a national emergency.
According to a W.T.O. official, governments could also choose to
import generic drugs instead of making them. They can get what is
called a compulsory license - in effect, they seize a patent - and
manufacture or import a generic copy of a drug, paying the
patentholder a reasonable royalty. Of all the tools available to poor
countries, compulsory licensing is what the drug companies fear the
most, since it represents the most direct assault on control of their
patents. The United States has issued compulsory licenses in
situations far less dire than those of AIDS-ravaged poor nations.
Recent ones have been for tow trucks, stainless-steel wheels andcom seeds. Such licenses are common remedies in antitrust cases.
But although trade rules provide legal ways for poor nations to get
cheap medicine, there are other obstacles. Many do not even know
it is legal. Countries that have tried to manufacture generic medicine
have fallen under debilitating pressure from pharmaceutical
companies and from Washington.
In Thailand, such pressure kept the government from making cheap
antiretrovirals until last year. Thailand has long made zidovudine,
the knockoff of Glaxo Wellcome's AZT. But two drugs are needed
to slow AIDS, and Thailand was blocked from making the other
components of dual therapy - ddl, d4T and 3TC. Bristol-Myers
Squibb sells ddl and d4T under the brand names Videx and Zerit.
Glaxo sells 3TC under the name Epivir. None of the three were
patented in Thailand because they came out before 1992, when the
nation passed patent protections for medicine. Thailand's state drug
factory was preparing to produce generic ddl when Bristol obtained
a patent on the antacid buffer used to pack Videx into pill form.
Krisana Kraisintu, the head of the factory, told me that Bristol also
prevented the producers of the raw materials for ddl from selling to
her. She was only able to make a generic ddl - in powder form recently. (Bristol failed to respond to questions despite repeated
requests over the course of a montn.)
With Zerit and Epivir, Bristol and Glaxo took advantage of a
controversial safety monitoring period passed in 1993 at American
urging. It gives drugs up to five or six years of market exclusivity
while generics undergo special safety tests - a law the World Health
Organization and Unaids says "unnecessarily delays generic
competition." Thailand was able to make generic d4T only when
Zerit exited the program last year and is only new beginning to
make generic 3TC.
The drug companies’ actions are particularly distasteful because
neither Bristol nor Glaxo invented these drugs or discovered their
use in AIDS therapy. Glaxo’s 3TC was discovered and patented for
AIDS use by BioChem Pharma, a Canadian company, which
licensed the drug to Glaxo. d4T was synthesized by the Michigan
http://www.nytimes.com/library/magazine/home/20010128mag-aids.html
8/1/01
Look at Brazil
Page 14 of 20
Canccr Foundation in 1966, using public funds. Its application for
AIDS was discovered at Yale University, which holds the patent,
using grants from the federal government and Bristol. In the United
States, Bristol’s Zerit sells for $4.50 for 40 milligrams.
Pharmaceutical manufacturers never disclose their costs, but one
indication of Bristol’s markup is that Pinheiro can sell her version
for 30 cents - and it is possible her costs are higher than Bristol's,
since the multinationals have access to cheaper raw materials.
The National Institutes of Health discovered ddl’s use as an AIDS
therapy. The N.I.H. then licensed the drug to Bristol for a 5 percent
royalty, with the stipulation that Bristol's pricing take into account
the health and safety needs of the public. But Bristol sells Videx for
$ 1.80 in the United States for a 100-milligram tablet, while FarManguinhos in Brazil can sell the generic equivalent for 50 cents.
The contract has a fair-pricing clause, but it has never been
enforced.
The drug companies’ influence has been greatly magnified because
the United States trade officials have put the full weight of
American trade pressures to work on their behalf. And one official
told me that until very recently, "it was pretty rare" that his agency
ever considered the health consequences. The statements in the
trade representative’s annual reports and trade watch lists document
a shameful history of successful American efforts to get Thailand to
pass patents on medicine, to abolish the pharmaceutical review
board that monitored drug prices, to pass the safety monitoring
period of market exclusivity and to refrain from issuing compulsory
licenses. Here is one example from the trade representative s 1997
national trade estimate for Thailand: "The Thai legislature is
expected in 1997 to consider a bill abolishing the pharmaceutical
review board. This measure would advance objectives of American
manufacturers."
I
Numerous countries have been placed on
the trade representative’s Special 301
It seems absurd
Watch List because of pharmaceutical
to suggest that
patent disagreements. The list is a
countries that
precursor to trade sanctions, but simply
will notspend 10 appearing on it is
i a form of sanction
because it discourages investment. It turns
cents to cure an
a
country's business sector and commerce
infant with
ministry against generic production - and
diarrhea should
with such powerful opposition, local
spend thousands
health officials lose. "When 1 wanted to
of dollars on her produce generics, I was told, 'Don't move,
mother’s AIDS
because we're afraid of trade retaliation,
drugs. But in
Kraisintu says. "All of us know that the
reason for all these things is pressure from
Brazil, there has
the United States and multinational
been no trade-
h(tp://www.nytimcs.coni/library/magazinc/home/200 10128mag-aids.html
8/1/01
Page 15 of 20
• Look at Brazil
off.
companies." Thailand sells a fifth of its
exports to the United States.
IM
The drug industry's dominance over American trade policy on
pharmaceuticals finally crashed over South Africa. In 1997, South
Africa, which does respect pharmaceutical patents, amended its
laws to allow compulsory licensing of essential medicines,
including AIDS drugs. Pharmaceutical companies sued. The suit is
still going on.
Although Clinton administration officials acknowledged that what
■ South Africa proposed was legal under the World Trade
Organization, it declared war. President Clinton and Vice President
Gore lobbied their counterparts. Nelson Mandela and Thabo Mbeki,
then the deputy president. Friends of the drug companies in
Congress passed a requirement that the State Depanment report on
Washington's efforts to stop South Africa before the country could
receive American aid. It reported in February 1999, that "all
relevant agencies of the U.S. government... have been engaged in
an assiduous, concerted campaign to persuade the government of
South Africa to withdraw or modify" the relevant parts of the law.
This was a bizarre policy for an administration that claimed a
special relationship with South Africa. But there was no role in the
process of decisions about trade pressures for voices that countered
those of industry. This resulted in egregious blind spots. In August
1998,1 talked with an American trade official who worked on South
Africa's medicines act. He told me that until a few months before I
spoke to him, he was unaware of the dimensions of South Africa's
AIDS problem. "Nobody brought it to my attention that it was a
major health crisis," he said.
Today, this official is better informed. The administration changed
its policy after activist groups began heckling Vice President Gore
at his campaign appearances. When reporters, and later Gore aides,
began to take notice, the administration told South Africa it could
issue compulsory licenses for essential medicines as long as it
stayed within world trade rules. Over the next year, the
administration announced that health officials would participate in
decisions about pharmaceutical disputes and pledged not to block
compulsory licenses in the rest of sub-Saharan Africa and Thailand
and in other countries on a case-by-case basis.
But pressure from other parts of the administration continued. In
February 2000, William Daley, then the commerce secretary,
traveled to Brazil and Argentina with Raymond Gilmartin, the
C.E.O, of Merck, and a vice president of Pfizer in tow. Before he
went, Daley told students that one purpose of his trip to Brazil was
to talk about "serious concerns our companies have" with medical
http://www.nytimes.com/library/magazine/honie/20010128mag-aids.html
8/1/01
Page 16 of 20
Look at Brazil
/^o
patent laws. In Argentina, he threatened trade sanctions over the
issue.
Overall, however, the Clinton administration went through a real
conversion. Countries that displease American pharmaceutical
manufacturers no longer land on a trade watch list if the trade
representative believes they have a health emergency. But this could
be reversed in five minutes by President Bush - and probably will
be, since the industry is likely to be even more influential in the
Bush administration than it has been under President Clinton. ,
Pharmaceutical manufacturers give money to both political parties $23 million in the last election cycle, according to the Center for
Responsive Politics - but 69 percent of it went to Republicans. The
drug industry also spends $75 million or so on lobbying every year.
C" rom the beginning of the aids epidemic, the major drug makers
■ clung to the idea of one planet, one price. Or worse -some
drugs cost more in Kenya than in Norway. The strategy has earned
them a public image almost as malignant as that of tobacco
companies. By last year, they were also facing the growing t reat o
generics and the loss of Washington’s automatic trade support, ar y
in 2000, several companies began to discuss the idea of lowering
their prices in the third world.
In May 2000, Glaxo Wellcome, Merck, Boehringer-Ingelheim, F.
Hoffmann-La Roche and Bristol announced a program called
Accelerating Access, promising to sell drugs at deep discounts to
poor countries that met certain standards. The price cuts the drug
companies fought until last year have now become their solution to
the world's AIDS crisis.
The companies have restricted their discounts, demanding that
recipient countries properly administer the medicine. But the
restrictions also keep the program small, controlled and largely
secret. Each price cut for each drug in each country is negotiated
separately. Glaxo was the only company to specify a price reduction
publicly, announcing it would cut Combivir from $16 to $2 a day.
And while about 20 countries are talking to the drug companies,
only Senegal and Uganda have so far signed agreements to receive
cut-price antiretrovirals. The discounts are impressive - Senegal will
be able to buy triple therapy for as low as $1,000 per year per
person. But just a few hundred people will benefit, most of them
rich enough to pay themselves. In Uganda, about a thousand people
will get the drugs, but they will all pay for them.
The pharmaceutical industry argues that collaborative efforts like
this one are the way to make AIDS medicine affordable in the third
world. But the program is too crabbed. "Why don't they just lower
their prices in poor countries?" asks Ellen't Hoen, who works in the
http://www.nytimes.com/library/magazine/home/20010128mag-aids.html
8/1/01
Look at Brazil
Page 17 of 20
Medecins Sans Frontieres campaign to help poor countries get
needed medicines. "Having country-by-country confidential
negotiations is not justified. This way, it stays in the charity comer
and it hampers the development of more sustainable ways to get
medicines to people." The industry's control over the program
serves another purpose: the companies can use it to head off the
practices they fear most, chiefly compulsory licensing. The
document announcing the plan calls on the recipients of their largess
to "respect intellectual property" - code for "stay away from
compulsory licensing." And countries are complying, many of them
out of ignorance.
Every single drug company executive I spoke with argued that if
countries turn to compulsory licensing, new discoveries could
eventually slow. "If we are to continue with research and
development, then countries that participate in the program must
provide conditions basic to innovation," Tadeu Alves, the chief of
Merck's Brazil subsidiary, said during a panel at an AIDS
conference in Rio. Those conditions, he said, included a free
market, price structures that provide incentive to innovation and
respect for intellectual property.
The drug companies' argument is in essence a defense of high
profits. Even in the United States, the cost of drugs is provoking
questions about whether continued research and development really
depends on giving companies a 20-year monopoly to charge
whatever price they choose, especially since they are often
marketing other people's discoveries. The manufacturers generally
spend twice as much on marketing and administration as they do on
research and development. The real threat that third-world generics
pose to pharmaceutical companies is that of blowback in rich
nations. They worry that publicity about generic prices will fuel the
American demand for cheap imports or price controls. They fear
that patent seizures in the third world could loosen intellectual
property rights in the first world.
Innovation would certainly suffer if pharmaceutical manufacturers
could not charge high prices in their primary markets, although how
high is open to debate. But applying this argument to Ukraine or
Uganda is a scare tactic. No manufacturer depends on profits in
Africa, which will account for 1.3 percent of worldwide drug sales
next year, to motivate the search for new medicines. And companies
can sell their AIDS drugs at very steep discounts - some at 90
percent or more off the American price - and still profit.
Once they realized that Brazil was solidly behind its generic drug
program, the pharmaceutical companies have made the best of it,
and they have not suffered. In fact, the government is buying 20,000
daily doses of Crixivan (Merck's brand of indinavir), a tenth of the
drug's worldwide sales. Merck had to meet Pinheiro's price for
http://www.nytimcs.com/library/magazine/home/20010128mag-aids.html
8/1/01
Look al Brazil
Hi3l
indinavir, the generic. But the company can do this and still profit.
"The half-million infected today arc patients of tomorrow," Tadeu
Alves told me.
The same thing may soon happen with Merck’s Stocrin, which is
patented in Brazil. Pinheiro is threatening to gel a compulsory
license to make the generic. The threat will most likely force Meick
to drop the price or voluntarily license Pinheiro to make the generic
or sell Stocrin. And this arrangement will be profitable for Merck,
which shows no sign of shutting its labs because of Brazil. Yet the
pharmaceutical industry continues to paint the ongoing battle .
against generics in impoverished nations as Armageddon. Glaxo has
even stopped the Indian generic manufacturer Cipla from selling.a
knockoff of a Glaxo AIDS drug in Ghana. Ghana's share of the
international antiretroviral market is virtually zero.
I f wealthy countries and the united nations agencies they
I influence chose to make AIDS treatment available to every
citizen of the earth in the most efficient and cost-effective manner
possible, the program would look very much like Unicefs global
system of vaccination. When Unicef began a campaign to vaccinate
the world's children in the early 1980’s, many scoffed. But today
vaccination rates top 80 percent, saving three million lives a year
and preventing crippling diseases in tens of millions more. This is
one of the world's most significant public health victories.
Who pays to vaccinate a child in Angola? We do, without much
complaint. Antiretrovirals, of course, do not cost pennies per dose.
But they would be a lot cheaper than they are today if the World
Health Organization or Unaids used a Unicef-like system, which has
dropped the price of vaccines to a thirtieth of their American price
in some cases. The W.H.O. could buy antiretrovirals for third-world
use from reliable generic suppliers like Cipla in India or brand-name
manufacturers if they were willing to lower their prices. The
economies of scale and guaranteed markets could drop the price of a
year's triple therapy to below the $700 that Cipla could muster
today.
This is a price many countries could afford, especially when
balanced against the savings in hospitalizations. But everyone
agrees that AIDS treatment will require North America and Europe
to purchase the medicines and to help set up the necessary health
care network. In my calculus, applying the Unicef system to AIDS
would cost $3 billion a year in antiretrovirals alone, assuming five .
million patients at $600 a year. And the cost will increase as
countries reach more patients. This is a large sum of money. It
seems somewhat smaller, however, next to the wards of shavenhead babies - or the collapse of a continent.
!■
i
http://www.nytimes.com/library/magazine/lioiTie/20010128mag-aids.html
8/1'01
1^3
It is difficult to imagine the Bush administration endorsing such a
global plan. There arc, however, smaller, worthwhile steps the
administration could take if it were so inclined. At minimum, it
should bury forever the bad old policy of intimidating countries that
want to make or buy generics, especially through compulsory
licensing. The administration should also encourage agencies like
the World Health Organization and Unaids to facilitate these
purchases and the necessary training to make them work.
There are also laws already on the books, which the Clinton
administration chose not to carry out, that could promote the cheap
■ production of at least some antiretrovirals. One such law allows the
government to seize patents of drugs that were discovered at
government labs or with substantial public funds if the patent holder
is not meeting public health needs - for example, by charging too
much. James Love, who runs the Consumer Project on Technology,
a Ralph Nader-affiliated advocacy group, argues that it applies to
five antiretrovirals. Love would like to see the government license
them to a nonprofit corporation that would produce the drugs
cheaply for both the first- and third-world markets.
But the Bush administration is unlikely to be so inclined, because
the drug companies have other ideas. "Merck and other companies
appreciate that our products need to be more affordable in the
developing world," Jeffrey Sturchio, a Merck spokesman, told me,
echoing every pharmaceutical maker. "We are willing to sit down
and be a constructive partner. Compulsory licensing is
unnecessary." But compulsory licensing seems very necessary.
Merck would have little interest in constructive partnership in Brazil
- or anywhere - if that threat did not exist.
This is the larger lesson of Brazil: AIDS can become a manageable
disease in the third world, but it takes power, in addition to other
things. The ability to pull the price of A.DS drugs within reach of
those who need them may someday come from the backing of some
international organization, or the pharmaceutical industry might
find religion. But at the moment, it arises only from the threat to
make or buy generic drugs. AIDS is turning the third world's human
landscape into a parched wasteland. Brazil has shown that, armed
with the power of competition, a government can do more than sit
and watch the desert encroach.
Tabic of Contents
January 28, 2001
http://www.nytimes.com/library/magazine/liome/20010128mag-aids.html
8/1/01
UOUK dl DI UZH
V-"-
Home | Site Index | Site Search | Forums | Archives | Marketplace
Quick News | Page One Plus | International | National/N.Y. | Business | Technology |
Science | Sports | Weather | Editorial | Op-Ed | Ans | Automobiles | Books | Diversions
| Job Market | Real Estate | Travel
Help'Feedback j Classifieds | Sen ices | New York Today
Copyright 2001 The New York Times Company
http://wvvw.nytimes.com/library/magazine/honie/20010128mag-aids.html
8/1/01
!
Ministry ot Health of Brazil
■ •w
>S'
J£
/■
#■
. AWg
Xr
••
X
x
X /
f
national aids Drug Policy
’
Ministry of Health - Brazil
National AIDS Drug Policy
Brazil
May 2001
I
I
/44
Foreword
The Brazilian HIV/AIDS drug policy has been highly debated and criticised,
particularly at the time of its implementation by the national authorities in the early 90s
Tre dearth of trained health professionals and the poor structure of the health services,
the lack of laboratories capable of monitoring the infection, and the patients’ capacity
of adhering to treatment were hotly questioned. National and international experts and
health professionals, managers of programs of prevention and care of people living
with HIV/AIDS, staff responsible for the budgetary and financial execution of public
monies and international organisations argued amid reports of treatment assessment
and cost-benefit studies and projections both favourable and contrary to the
imolementation of a such a costly policy for the State.
However, fortunately, reality not only corroborated our policy; over and above,
the statements of its most optimistic defenders were outdone by their remarkably positive
results. The quality of the government-provided services is reflected by the significant
improvement in the health status and in the control of the infection among people
living with HIV/AIDS. To this more immediate consequence of the antiretroviral regimens
recommended by the Brazilian Ministry of Health one must add several social, economic
and political benefits, both palpable and yet to be achieved, without precedent in the
history of Public Health in our country.
At the present time, the success of the program for the free and universal
distribution of these drugs to every patient who needs them cannot be doubted. In
addition, its repercussion may contribute to the global debate on the access of people
living with HIV/AIDS to antiretroviral treatment, with strong priority to the poorest
countries, which bear the heaviest brunt of an epidemic that, according to UNAIDS
data, was responsible for 5.3 million new infections and 3 million AIDS deaths in 2000
alone.
The so-called developing countries suffer from the lack ?f public resources,
social problems and political oppression. AIDS has shown, in bright and sharp colours,
all the contrasts unveiled by the epidemic in these countries when its threat does not
elicit a response or is not tackled with the responsibility, competence and a humanist
and solidary planning that are necessary.
This document retraces the most recent history of the unquestionable advances
in laboratory care and in the treatment of HIV infection and assesses its development
from the perspective of the unique Brazilian experience in the efforts for the prevention
and control of the epidemic.
Paulo R. Teixeira
Co-ordinator
Brazilian Program of Sexually Transmissible Diseases and AIDS
AIDS drugs policy in Brazil
Background
The Brazilian population is estimated at 169,5 million people. From 1980 until
December 2000, 203,353 AIDS cases were reported to the National STD and AIDS
Program (NAP) of the Ministry of Health (MoH). 151,298 of them are males and 52,055
females; 7,086 are children. It is estimated that 536,000 Brazilians are infected with
HIV. Since 1996, the incidence rate has stabilised around 14 cases per 100.000
population. The number of new cases reported in the last five years was approximately
22,000 per year.
The Ministry of Health’s policy for the care of people living with HIV/AIDS
includes, among several other initiatives, the creation of the Laboratory Network for
the Quantification of Viral Load and CD4+ and CD8+ cell counts, the organisation of
health care services, the support to the organisation of People Living with HIV/AIDS
and to projects carried out by Non-Governmental Organisations, and the creation of a
program for the free and universal access to antiretroviral drugs through the public
health network.
This program, begun in the early 90s with the distribution of AZT capsules, was
expanded and consolidated in 1996 by Congressional Bill 9113, of 13 November 1996,
that guarantees every patient the access, free of direct costs, to all the medication
required for his/her treatment, including protease inhibitors (since December 1996),
following treatment criteria and guidelines set forth by the MoH. The Ministry thus
created two advisony committees, with the mandates to define a Consensus on the
Recommendations and Guidelines for the Use of Antiretroviral Therapy in Adults and
Adolescents and a second similar consensus on treatment for children. The committees
meet periodically at least once a year, to review the recommendations and adjust them
i
to the updated scientific knowledge and the availability of new drugs.
According to the current recommendation, the use of antiretroviral drugs is
indicated for all symptomatic HIV-infected patients, asymptomatic patients with
significant laboratory changes, for HIV+ pregnant women, aiming at the reduction of
vertical transmission, and for the prophylaxis of HIV infection in health professionals
after exposure to potentially contaminated biological material.
I
Infrastructure of the system for HIV+ patient care
In the past 5 years, the MoH has adopted the strategy of offering modalities of
care that favour outpatient care, such as Specialised Care Services (148), Day Hospitals
(69) and Therapeutic Home Care (52). which complement the care provided by the
362 Accredited Hospitals for HIV/AIDS care. The availability of these care modalities
khas enabled a higher quality of life for the patient and lower costs of care. It is important
to highlight that these figures do not include all services available for HIV+ patients,
reflecting only those that have the infrastructure defined by the MoH as a requirement
of a specialised care service and have requested their accreditation as such.
A study of the direct costs of AIDS care in Brazil in 1996, carried out by the
Foundation Institute of Economic Research - FIRE, with the support of NAP. comparing
the average costs per day of hospital stay, proved that the cost of conventional
hospitalisation (US$ 97.31) was twice that of Day Hospital admission (USS 4/.02) and
almost nine fold higher than Therapeutic Home Care (USS 11.31).
The Brazilian policy of acess to antiretroviral therapy has resulted in a shift of
• i and thus in the profile of service
the morbidity and mortality profile of- HIV infection
the demand for outpatient services has grown significantly
utilisation. In the past years,
demand for
with a decrease in tthe
--------------- Home Care, Day Hospital and Conventional
Hospitalisation.
Distribution of specialized care
services (SCS) on HIV/AIDS.
1
3
2
1
2 •.
5
2
1
1-
2
3
-
4
N° SCS = 148
a
2
8
10 • 3
49
9
Projects fundeo out not actually
implemented yet are not shown.
’8
m'l
Distribution of Day Hospitals (DH)
for HIV/AIDS care.
2 •'*
N° DH = 69
5 •'
9
Projects funded but not actually
implemented yet are not shown.
Distribution of Home Therapeutic
Care Projects (HTC) on HIV/AIDS.
2
N° HTC = 52
i
Projects funded but not actually
implemented yet are not shown.
t
r'
iso
Distribution of Accredited
Hospitals (AH) for HIV/AIDS care.
N° AH = 362
12>'
22
Concomitant to the drug distribution policy. NAP has endeavoured to strengthen
the public laboratories and implement the National Network of Laboratories (or T C
Lymphocyte Counts (70) and for HIV Viral Load Quantification (63) This network cames
out the tests required for the Indication of antiretroviral therapy and chemoprophylax
of opportunistic Infections, as well as for the appropriate monitoring °fPa"en®
treatment In 2001.422 thousand viral load tests and 422 thousand
• *
counts are expected, corresponding to a totai expenditure of approxima ely US$ 18
million (unitary costs of USS 1S per CD4» test and USS 29 per viral load test)
National network of laboratories
for TCD4+ lymphocyte counts and
viral load quantification - 2001
0 '.
01
Ul<.' QL
01
01
■ 01
•
01
ot
.
0
01
0*
.z'?--. .. "02_
'-J’-iOl
.'
■r
03
03
ra
01
oi
O'
04
0:
2F ■
01
17
Viral load - 63 Lab.
02
’
.^03
Q-j
Source: MOH/Brazil
..
06
-
<»
3oV
ISI
AIDS Drugs Logistic System
Logistics of AIDS Drugs - Ministry of Health
SECRETARIAT FOR
HEALTH POLICIES
EXECUTIVE
SECRETARIAT
>
I
DIRECTORATE OF
STRATEGIC ,
PROGRAMS
NATIONAL STD AIDS
PROGRAM
Zj
n
SUBSECRETARIAT FOR
> ... ADMINISTRATION
PUBLIC
MANUFACTURERS
PRIVATE
MANUFACTURERS -
A
STATE STD AIDS
PROGRAMS
STATE WAREHOUSE
—
REGIONAL HEALTH
DIVISION
A
>
MUNICIPAL STD AIDS
PROGRAMS
MUNICIPAL
WAREHOUSE
:•
AIDS drug* procuremewt
flow
AIDS drugs flow
infoowatioa flow on ACS
drugs us«
UNITS DISPENSING AIDS DRUGS
Dratributxxi programmmg
PATIENT
This flowchart shows the functioning of the AIDS drugs logistic system. Brown
arrows indicate the procurement flow within the MoH, which starts with the programming
• i
of needs, done by NAP; green arrows demonstrate distribution programming; blue
arrows, the different drug flows from delivery by the manufacturers to dispensation to
the patient; and red arrows, the flow of information from the patient to NAP, including
data essential for the distribution and procurement programming.
The current list of antiretrovirals provided by the MoH includes 13 drugs (5
nucleoside analog reverse transcriptase inhibitors-NRTI, 3 non-nucleoside analog
reverse transcriptase inhibitors-NNRTI, and 5 protease inhibitors-PI), in 27
pharmaceutical presentations.
&
07547
0|
8(
153.
Antiretroviral drugs
Year of first distribuition
zidovudine capsule 100 mg
1991
zidovudine oral solution
1992
didanosine 25 and 100 mg tablets
1993
' zalcitabine 0.75 mg tablet, injectable zidovudine, ,arp'vu^e 15°
mg tablet, saquinavir 200 mg capsule and ntonavir 100 mg
1996
' indinavir 400 mg capsule, lamivudine oral solution, stavudine 30
1997
1998
and 40 mg capsules----------- -- --------------------- - ------------------------‘ ritonavir oral solution, didanosine pediatric po^er
zidovudine+lamivudine 300+150 mg tablet, nelfinavir 250 mg
tablet and pediatric powder, nevirapme .20° mg table ,
stavudine pediatric powder and delavirdme 100 mg tablet-------
1999
’ efavirenz 200 mg capsule
" efavirenz 50 and 100 mg capsules for pediatric patients and
2000
nevirapine oral suspension_________________ __________ _—
” amprenavir 150 mg capsule and ora! solution
2001
J
It is important to highlight that while the Federal Government is responsible for
ARV drugs, the procurement and distribution of drugs for treating opportunistic diseases
is decentralised to the states and municipalities.
AIDS drugs needs are estimated according to the following data.
• Historical series of the total number of adult and paediatric patients on ARV therapy
• Historical series of the number and percentage of patients using each ARV drug and
each therapeutic regimen
• New recommendations on ARV therapy
Number of HIV+ patients on ARV in the Brazilian
Public Health System (Jan/97 - dec/00)
100.000 7
90,000 •
I
80,000 ■*
70,000 -i
60,000 '
50,000 J
40,000 -
30,000
20,000
10,000
0 -
Source: Ministry of Health/Brazil
*
153
There are currently 98,000 infected individuals on antiretroviral treatment; 95%
of which are adults and adolescents and 5% children (<13 years old). As a comparison,
in January 1997, approximately 23,000 people benefited from the free access policy.
% distribution of NRTI use.
Brazil. Jan/97 - Dec/2000
100%
80% -
60%
40%
1
20% -
0% ■,a
/ /
■/ X z /
///
jaAZT ■ddl QddC
X X° /
o&
■ 3TC ■d4T !
Source: Ministry of Health/Brazil
% distribution of PI use.
Brazil. Jan/97 - Dec/2000
100% -j|
80%
60%
40%
Hliia I I I
I
20%
0%
J
i
0 ID V E3NFV C3 RTV EESQV
Source: Ministry of Health/Brazil
e
i
ISM
% distribution of NNRTI use.
Brazil. Jan/99 - Dec/2000
100%
I
I
80%
-
I
.
60%
40%
20%
0%
--
-
-
-
-
-
■
■
A
-A
*4-
////// /XZ
—
>'' S
J?
/•
/
r
■ DLV KEFZ BNyP j
Source: Ministry of Health/Brazi!
% of patients by ARV regimen.
Brazil, Jan/97 - Dec/2000
RR «RRR
100%
hlih
80%
80%
4i
40%
20%
0%
/
o*'
o&
/
<S
z/ /
■ S?
o&
o°
J
OG
E2Nt ■ 2N + PI q2N 4- NN «4 ARV !
Source: Ministry of Health/Brazil
"Estimated data
9
L
/ST
Drug procurement is usually carried out once a year and complies with the
Brazilian laws governing public bidding. Deliveries are usually divided in three to four
consignments.
AIDS drugs dispensing units.
Brazil, 2001
i
1
3
3
: 2 —
9
3
-1
32.-^-
3
i
30
io
10
.-^129
23 ?.
>^95
—^31.
31 F
TOTAL = 424
Patients receive ARV drugs in the Units Dispensing AIDS Drugs, which usually
are the pharmacies of HIV/AIDS outpatient services. Currently there are 424 such
units throughout the country.
NAP has developed a Computerised System for the Control of Drug Logistics
(SICLOM), with the following main characteristics:
• Nation-wide patient register
• Registration linked to the individual drug dispensing unit
• Validation of the register and dispensation, using MoH criteria.
• Computerisation of the dispensing units
• Certification of the ARV prescription through a magnetic card
• Patient information on the appropriate use and storage of drugs
• Daily transfer of data to the NAP by telephone data transmission
SICLOM has been implemented in the 111 largest Dispensing Units, which
account for approximately 65% of patients on ARV therapy in Brazil. A managerial
module for SICLOM is now being developed by NAP.
Computerized System for the
Logistical Control of Drugs
Civil Rights
Q ua lity of L
10
I;
I5G
National production of antiretroviral drugs
Domestic production started in Brazil in 1993, with AZT by the private company.
In the following year, AZT production in the public sector was begun by LAFEPE,
Laboratorio do Estado de Pernambuco. Domestic AIDS drugs production comprises 7
ARVs: zidovudine (AZT), didanosine (ddl), zalcitabine (ddC), lamivudine (3TC),
stavudine (d4T), indinavir and nevirapine, and by the association zidovudine+lamivudine
(AZT + 3TC). Three ARV drugs distributed by the MoH - amprenavir, efavirenz and
nelfinavir - are under patent protection.
The national production of zalcitabine and stavudine started in 1997, that of
didanosine in 1998, lamivudine and zidovudine+lamivudine in 1999 and of indinavir
and nevirapine in 2000.
Public laboratories manufacturing ARVs are: Far-Manguinhos/FIOCRUZ/MoH,
Fundagao para o Remedio Popular/SP, Laboratorio Farmaceutico do Estado de
Pernambuco, Fundagao Ezequiel Dias/MG, Industria Quimica do Estado de Goias,
and Institute Vital Brasil/RJ. In 2000, Far-Manguinhos provided approximately 30% of
the ARV drugs used in Brazil, corresponding to 45% of the funds spent in purchases
from national manufacturers. Eight Far-Manguinhos products — zidovudine capsules,
didanosine tablets, lamivudine tablets, zidovudine+lamivudine tablets, zalcitabine
tablets, stavudine capsule, indinavir capsule and nevirapine tablet - have been approved
in bioequivalence tests and thus are eligible for licensing as a generic drug.
The quality control of the antiretrovirals distributed by the MoH is done by: (1)
mandatory statement from the competent health authority in the country of manufacture,
certifying that the plant complies with the Good Manufacturing Practices (GMP); (2)
preliminary inspection of the pharmaceutical plant before the first delivery of the product;
(3) monitoring of the production of the first batches; (4) in the early phases of the
procurement contract, analysis of batches purchased at laboratories accredited by
the National Health Surveillance Agency/MoH; and (5) starting in 2001, mandatory
bioequivalence testing of all drugs purchased. Bioequivalence tests, certifying drug
interchangeability, are a recent achievement of the Brazilian National Drug Policy,
guaranteed by the 1999 Generic Drugs Bill. The Brazilian bioequivalence process
comprises pharmaceutical, clinical, analytic and statistical testing. Clinical studies are
carried out mainly by the quantification of the drug or its active metabolite in the
circulation (most commonly in blood, plasma or serum samples) of healthy volunteers,
who receive the drugs being tested and the reference drugs at different times, in single
or multiple dose regimens. This is a complex study and it requires the submission of a
research project, experimental protocol, free and informed consent form, and approval
by the Committee of Ethics in Research.
/STDrug expenditures and decrease of ARV therapy costs
The Federal Government's expenditures with the purchase of antiretrovirals
was approximately USS 34 million in 1996, USS 224 million in 1997, USS 305 million in
1998, USS 336 million in 1999 and USS 303 million in 2000; it is estimated that they
will reach USS 422 million in 2001. Between 1999 and 2000, in spite of increased
numbers of patients on treatment and of the proportion of patients on more complex
<
and expensive regimens, there was a reduction in the overall costs of drug procurement.
These expenditures corresponded to 0.2% of the MoH budget in 1^96, 1.2% in 1997,
1.8% in 1998, 3.2% in 1999, and 2.9% in 2000, with an estimated 2.9% in 2001. In
terms of GDP, they have ranged between 0.004% in 1996 to 0.06% in 1999.
MOH expenditures on ARV drugs (1996-2001)
I
Average
n° patients
%MOH
budget
Year
I Million USS }
1996
34
1997
224
35,900
1.2
1998
305
55,600
1.8
1999
336
73,000
3.2
2000
303
87,500
2.9
2001
422
105,000
2.9
* estimated data
0.2
Source: NAP/McxH
The prices of antiretroviral drugs purchased by the MoH have shown a declining
trend over the past few years, largely due to the MoH investments to foster the production
by public manufacturers and to the policy of price negotiation in the case of single
exclusive manufacturers. The most significant drops are seen in the prices of drugs
that are domestically produced, both by private national companies and especially by
public manufacturing laboratories, and in prices negotiated with multinational companies
that have adopted the system of differentiated^ prices, according to the Human
Development Index and rate of HIV infection in the country’s adult population.
Price evolution (in US5) of ARV for adult use with
domestic production.
Brazil, 1996 - 2001
0 .00 -i
T.00
Mean Reduction:
4.00
78%
4
4"
5.00
4.00
r
i
[■ 1 996 1 1997 ■ 1 9 98 0 1999 12000
IZOOlH
Source: Ministry of Health/Brazil
‘Estimated data
K,.. v
.a USS) Of ARVs, with negotiation
Price evolution
(in
i differenciated
prices (HDI and HIV
based
on <-----prevalence in the country).
Brazil, 1996-2001
T.#0-
Mean
4.00 -
Redaction: 70%
4
4
5.00
4.j
I
1.00 -
EFZ cap 200mg
IDV cap 400mg
i ■ $996 1 1 997 11998 01999
■ 2000 12001' j
Source: Ministry of Health/Brazil
'Estimated data
Price evolution (in USS) of imported ARVs for adult use.
Brazil, 1996 -2001
I.Ofl -i
I
7.00 -]
s.oo J
Mean Reduction:
25%
$.00 -i
4.00
I
J 00 -
2.0 0 -<
j.ooJ
o.oo-*-
SQVcap 200mg
NF V tablet 250m g
□ 1 9 9 9 12000 g2001'|
-Source: Ministry of Heattti/Brazil
■ Estimated data
Prices of ARV drugs. Brazil. 1996 a 2001
Unit price USS01
DRUG
I
1996
1997
1998
1999
j 2001121
2000
DIDANOSINE 25 mg Tab
0.52
olT
036
0.23
0J9j
DIDANOSINE 100 mg Tab
135
T39
132
"^076
0.50
0J6
0^49
60.19
37.81
38.15
33.48
0.34
DIDANOSINE POWDER FOR BOTTLE/ORAL
SOLUTION 4g_____________________________
LAMIVUDINE 150 mg Tab
Taj
2.90
2.70
2.39
1.51
0.81
LAMIVUDINE ORAL SOLUTION 240ml BOTTLE/IO
mg/ml_____________________________________
ESTAVUDINE 30 mg Tab
(F~
45.57
31.18
12.05
12.54
_____ I
1.75
1.03
0.46
2.32
1.02
"0?64
0.211
0.27[
W~
41.79
35.10
ESTAVUDINE 40 mg Cap
ESTAVUDINE POWDER FOR ORAL SOLUTION
200mg BOTTLE_____________________________
ZALCITABINE 0.75 mg Tab
(a)
(a)
(a)
ZIDOVUDINE 10 mg/ml ORAL SOLUTION 200 ml
BOTTLE___________________________________
INJECTABLE ZIDOVUDINE 10 mg/ml 20 ml vial
EFAVIRENZ 50 mg Cap
EFAVIRENZ 100 mg Cap
EFAVIRENZ 200 mg Cap
DELAVIRDINE 100 mg Tab
NEVIRAPINE 200 mg Tab
NEVIRAPINE 10 mg/ml ORAL SUSPENSION 240 ml
BOTTLE____________________________________
AMPRENAVIR 150 mg Cap
AMPRENAVIR 15 mg/ml ORAL SOLUTION 240 ml
BOTTLE____________________________________
INDINAVIR 400 mg Cap
(d)
0.1 st
4.47!
0.15
(bj
2.46
2.11!
1.75
2.01
0.70!
0.68
0.65
0.65|
(a)
L3
13j
(a)
2.32
2.32 i
0.56
053
0.58,
0?45
10.22
947
8^47
630
13.40
11.93
11.07
328
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
2.00
2.00
(bj
0.081
0.18
1.08
ZIDOVUDINE+LAMIVUDINE 300 mg + 150 mg Tab
0.19
0.27
______ i_
1.55
ZIDOVUDINE 100 mg Cap
34.451
(b)
021
0.48
0.48
(d)
3.04
3.02
(a)
1.28|
55.87f
(a)
(a)
(a)
(a)
(a)
(a)
;
lb)
(b)
0.84
Tdj
1.25
(bj
0.72
99.76
1.94
1.91
1.34|
0.47
1.53
1.45
130
1.08
52.40
52.40
(bTF
(c)
NELFINAVIR 250 mg Tab
(aFj
NELFINAVIR POWDER FOR ORAL SOLUTION 7.2 g
BOTTLE_______________________________ ■
RITONAVIR 100 mg Cap
(a)
0.90
0.90
0.88
0.88
0.88:
(c)
RITONAVIR 80 mg/ml ORAL SOLUTION 240 ml
BOTTLE____________________________________
SAQUINAVIR 200 mg Cap
W'
222.41
168.94
168.94
168.94!
(b)
1.31
1.31
1.19
1.19
0.75!
(c)
(a)
(a) ARV not offered by the MoH in the year
(b) procurement not programmed in the year
(c) procurement in progress
(d) ARV no longer purchased by the MoH
Source: NAP and Directorate for Strategic Programs/MoH
Notes: (1) ARV purchased in R$ converted in USS using the mean year exchange rate, except for 2001
(2) preliminary data
(3) 2000 data estimated by Far-Manguinhos
iGo
A study designed to assess the impact of the domestic ARV production on the
cost of treatment between 1997 and 2000. using the average cost per patient/day m
1997 as a baseline and taking into account the increase of the number of patients on
treatment, estimated that, had the 1997 cost remained constant, the expenditure wou
have been between USS 200 million and USS 250 million higher, and total ARV therapy
costs would have exceeded USS 400 million in 2000. Considering only mdmavir and
nevirapine, drugs that.are part of the triple therapy, whose domestic production was
started in 2000, it was estimated that savings were greater than USS 80 million,
accounting for approximately 30% of the total costs in the year.
In a second moment, the study assessed the economic impact of domestic
AIDS drug production, by comparing average patient/day costs calculated for 2000
with prices in the pnvate US sector and in the public Canadian sector (Bntish Columbia).
In relation to Canadian prices, the economy was calculated as approximately USS 200
million; in relation to US prices, of 540 million dollars.
The same study assessed the impact of annual costs of ARV therapy in the
years 2001-2004, in case of continuing patent protection of nelfinavir and efavirenz,
using as baseline data:
• The proportion of nelfinavir and efavirenz in the period 2001-2004, estimated by
statistical methods, assuming that ARV use will keep its current rate of increase
until the first semester of 2001 and stabilise in early 2003.
• The projected average costs of ARV therapy per patient/day in 2001-2004, based
on the trend of variation of drug costs in 1997-2000. Two different projections were
made for nelfinavir and efavirenz. The first assumes the beginning of domestic
production in the second semester of 2001, and costs for 2001 -2004 were projected
with the same declining trend observed in 1999-2000 after the start of national
production of triple therapy drugs. The second assumes continuing import of the
drugs with prices unchanged.
According to this study, if domestic production of both drugs is started, the
average cost of ARV therapy by patient/day will fall by approximately 30% in 2001 and
the cost of ARV drugs will remain close to USS 300 million in the following years, in
spite of the expected increase in the number of patients in treatment to 160,000 by the
end of 2004.
On the other hand, if both drugs continue to be imported, with no price reduction,
there would be an additional cost of USS 425 million in the period 2001-2004.
In 1999, 47% of antiretroviral drugs, accounting for 19% of the expenditures,
were purchased from national companies (92.5% from public and 7.5% from pnvate
manufacturers); 53%, corresponding to 81% of the expenditures, were purchased from
multinational pharmaceutical companies. In 2000, 56% of ARVs (41 □ o
expenditures) were purchased from national companies and 44/o (59/□ of
e
expenditures), from multinational pharmaceutical companies. It is interesting to point
out that, some drugs that were domestically produced were still provided by multinabona
companies, which lowered their prices and won governmental bids^
ARV procurement: Distribution of resources and
amount by type of manufacturer.
Brazil, 2000
Amount
Resources
44%
59%
fi!
■■■'■
\
1
4
4
41%
56%
■ Generic Drugs □ Branded Drugs
This reduction of ARV prices in Brazil led to a considerable decrease in the
costs of AZT chemoprophylaxis for the control of HIV vertical transmission (complete
ACTG 076) from USS 660 in 1996 to USS 170 in 2001 (74% vacation).
Itt-
Costs of ZDV chemoprophylaxis (in US$) for th
reduction fo vertical transmission - ACTS 07b.
Brazil, 1996 -2001
•J56O
620.:,
~ -
530
240
74% reduction7 ■,y.
210
170
'
-A-?' -
2001*
2000
1999
1998
1997
1996
Source: Ministry of Health/Brazil
•preliminary data
The mean weighted cost of double NRTI therapy dropped from US$ 3,810 per
patient/year in 1996 to USS 630 in 2001 (preliminary data), with a 84% reduction.
Mean cost (in US$) of double NTRI therapy per
patient/year.
Brazil, 1996 - 2001
.810
••
3.070
r
i
2.370
84% reduction
T
7H0
630
1997
1996
1998
1999
2000
2001*
Source: Ministry of Health/Brazil
•Preliminary data
t
165
The reduction of the mean weighted cost of triple regimens including Pls or
NNRTIs is estimated at 57% and 66%, respectively.
Mean cost (in US$) of triple therapy (2 NTRI + PI) per
patient/year.
Brazil, 1996 - 2001
7.340
6.490
- 5.690
4.530
57% reduction
^3.180
: - ''y ;
••
:
'
1997
2001"
2000
1999
1998
Source: Ministry of Health/Brazil
•Preliminary data
Mean cost (in US$) of triple therapy (2 NTRI +
NNRTI) per patient/year.
Brazil, 1998 -2001
4.580
I
I
3.720
2.740
66% reduction
1.540
i
1998
'Preliminary data
1999
2000
2001*
Source: Ministry of Health/Brazil
I6<f
The mean weighted cost per patient/year on ARV therapy showed an increase
between 1996 and 1997, associated with the beginning of PI distribution. In 2001, this
cost should be 48% lower (USS 4,860 in 1997; USS 2,530 in 2001, according to
preliminary data), in spite of the proportional increase in the number of patients using
more complex and expensive therapeutic regimens.
Mean cost (in US$) per patienVyear on ARV therapy.
Brazil, 1996 -2001
4.860
4.540
*3.810
4.240
PI use started
3.320
2.530
1997 - 2001
I
i
1996
1997
48% reduction
1998
1999
2.000
2001*
Source: Ministry of Health/Brazii
•Preliminary data
Impact of the antiretroviral therapy
The policy of providing ARV drugs policy guarantees a longer survival for HIV+
individuals, minimising the impact of the epidemic on the population groups infected,
particularly those in productive age ones. Moreover, the universal access program,
together with other initiatives, such as the more widespread use of chemoprophylaxis
for the main opportunistic infections and the different types of care available (Day
Hospital and Home Care), has allowed a decrease in the need for hospital admissions,
with a consequent reduction of costs, as well as a fall in the frequency of opportunistic
infections. As for the decrease in deaths, a marked reduction in AIDS-related mortality
has been observed in recent years. In 1995, the AIDS death rate was 12.2 per 100,000
population; in 1999, it had dropped to 6.3/100,000 population, a reduction of
approximately 50%. In large urban centres such as Sao Paulo and Rio de Janeiro
(which account for more than 31 % of the known AIDS cases in the country), the decrease
in mortality has been even more marked, of approximately 70% (SP - 54%, Rio - 73%)
in the period 1995-2000 (data up to August 2000).
Trend of aids death rates.
Brazil, 1990-1999
14^
1210Q-
i °
Io
8l
■ o"
5.
! O
I O
2
12S
4n
2H
oJ--90
91
92
93
94
95
Year of death
96
97
’ 98
99
R2 = .8156
166
>•
As to costs, some studies have shown that the price of antiretroviral therapy is
I
largely offset by the reduction of costs with drugs for the treatment of opportunistic
infections and with the ensuing hospitalisations. The analysis of data at the MoH has
shown a significant drop in the number of hospitalisation/patient; it estimated that
approximately 234,000 AIDS-related hospital admissions were prevented in the penod
4
1997-2000, with USS 677 million savings for the Unified Health System. In the case of
CMV infection, for instance, a condition affecting individuals at an advanced stage of
HIV infection and that may cause blindness, data on the use of ganciclovir for its
treatment show a 69% decrease in the period 1997—1999; in the past two years, this
meant a savings of approximately USS 34 million.
4
Bi
Adherence to antiretroviral therapy
Combined antiretroviral therapy not only contributes to a longer life span for
HIV+ individuals but also to a better quality of life, directly related to a better physical
and emotional status. These individuals, mostly in the economically active age group,
remain productive and tpus do not divert Social Security funds with illness aid, retirement
pensions for disability reasons, and other such benefits.
It is clear that patient adherence to multiple doses therapeutic regimens is
crucial to the clinical management of this disease, since non-adherence to antiretroviral
treatment is directly linked to the development of viral resistance, the consequent therapy_J
failure and the emergence of multiresistant viral strains.
A study carried out in Sao Paulo has shown that certain characteristics of users
groups are risk factors for non-adherence, particularly less than 4 years^oLschooling-^
and lack of personal income.
The history of HIV+ individuals registers the overcoming obstacles, mainly those
related to adjustments of lifestyle and issues pertaining to the stigma of the disease.
One critical moment is the beginning of treatment, when the need to accept the condition
and to establish a reliable rapport with the physician and the health services is clearly
seen.
The health services have an extremely important role in overcoming treatment-
related difficulties, and their dialogue and negotiation abilities are crucial.
Antiretroviral adherence in Brazil seems very similar to that seen in First-world
countries. However, the rates achieved everywhere are still far from the desired levels.
A study on adherence that defined it as taking 80% or more of the total prescribed
■ doses has shown 69% adherence among more than one thousand patients interviewed.
Similar studies carried out in Baltimore (202 patients), London (114 patients) and San
Francisco (388 patients) demonstrated similar rates (60%, 75% and 78%, respectively).
Comparative results of ARV therapy adherence studies.
N° patients
% compliance
Adherence
rate
Sao Paulo/Brazil
1141
80
69
Baltimore/USA
202
80
60
London/UK
114
80
75
San Francisco/USA
388
80
78
Madrid/Spain
366
90
57,6
Site
I6S
«
Co-operation between Brazil and other developing countries
A considerable part of the success achieved by the Brazilian drug
distribution program is due to the development of quality generic antiretroviral drugs
1
4
by Brazilian manufacturing laboratories, at costs significantly below those practised in
the international market. The Brazilian expertise in AIDS drug manufacturing was offered
to developing countries, particularly in Africa, during the XIII International AIDS
conference held in Durban, South Africa, in July 2000. In a spirit of co-operation and
international solidarity, Brazil can currently promote the transfer of technology for the
establishment of industrial ARV production poles. Such transfer includes technical
support for the design and construction of the production plant, manufacturing of drugs
as capsules and tablets (all produced in Brazil), training in quality control of raw materials
and transfer of analytic methods. Some countries, like South Africa and Uganda, have
shown an interest in obtaining the Brazilian technology and others, like Chile, Burkina
Faso, Barbados and Guatemala, in direct drug purchase, through point co-operation
actions.
Brazil has signed co-operation agreements with four Portuguese-speaking )
African countries (Angola, Mozambique-Guine-Bissau and Sao Tome and Principe). /
Seven other African countries have shown an interest in exchanges with Brazil - y
Portuguese-speaking Cape Verde and English-speaking Namibia, Zimbabwe, South
Africa, Kenya, Nigeria and Botswana.
/W
<■
n
c
1
D.
The HIV/AIDS Context
> "Community-based approaches to HIV treatment in
resource-poor settings"
Paul Farmer, F Laendre, J Mukerjee, M Sidonise Claude,
P Nevil, MC Smith-Fawzi, S Koenig, A Castro, M Becerra,
J Sachs, A Attaran J Yong Kim; The Lancet
> "Preventing antiretroviral anarchy in sub-Saharan Africa "
AD Harries, DS Nyangulu, NJ Hargreaves, 0 Kaluwa, FM
Salaniponi; The Lancet
> "Friend or Foe? Looking to International Law in the
Struggle ofAccess to Treatment for HIV/AIDS"
Jonathan Berger, Paper Presented at the "Post UNGASS
Meeting: Social and Economic Rights in Global HIV/AIDS
Epidemic", hosted by the Centre for Economic and
Social Rights
Page 1 of 13
The Journal : Current Issue
The Journal
I he jour nal
Discussion Groups
CyberSessions
eResearch Ai ciuve
Editorial and
Home > The Journal > Current Issue > review
Promo
Helo »• eedback
Volume 358, Number 9279
04 August 2001
■ Cuifi^it Issue
Contents in full
Talking points
Original research
News
Editorial and review
Correspondence
Clinical picture
Dissecting room
Department of error
Supplements
Back Issues
Viewpoint
Community-based approaches to HIV treatment in
resource-poor settings
Paul Farmer, Fernet Lendre, Joia S Mukherjee, Marie Sidonise Claude, Patrice
Nevil, Mary C Smith-Fawzi, Serena P Koenig, Arachu Castro, Mercedes C
Becerra, Jeffrey Sachs, Amir Attaran, Jim Yong Kim
\ Search Journal
• „ Subscribe
•K Log Out
Jobs
Awards and
Announcements
Conferences
Press Services
General Info
Free Sample
Info for Authors
Contact Us
Imectiojs Diseases
Lancet 2001;358:404-09
Partners in Health and Department of Social Medicine, Harvard Medical
School, Boston, MA 02115, USA (P Farmer MD, J S Mukherjee MD, M C
Smith-Fawzi ScD, S P Koenig MD, A Castro PhD, M C Becerra ScD, J Y Kim
MD); Centre Thomas J White, Zanmi Lasante, Cange, Haiti (F Lendre MD, M
S Claude RN, P Nevil BSc); and Center for International Development,
Harvard University, Boston, MA, USA (J Sachs PhD, A Attaran JD)
Correspondence to: Dr Paul Farmer (e-mail:p^!_^rner@hm^ha!yardie^
Why AIDS prevention alone is insufficient
One community's experjence:Jhe HLV Equity Initiative
Expanding the HIV Equity Initiative
Objections to HAARTJn.resource-poor settings
Rethinking costs and benefits
References
Last year, HIV surpassed other pathogens to become the world's leading
infectious cause of adult death. More than 90% of deaths occur in poor
countries, yet new antiretroviral therapies have only led to a drop in AIDS deaths
in industrialised countries. The main objections to the use of these agents in
less-developed countries have been their high cost and the lack of health
infrastructure necessary to use them. We have shown that it is possible to carry
out an HIV treatment programme in a poor community in rural Haiti, the poorest
country in the western hemisphere. Relying on an already existing tuberculosis
control infrastructure, we have been able to provide directly observed-therapy
with highly-active antiretroviral therapy (HAART) to about 60 patients with
advanced HIV disease. Inclusion criteria and clinical follow-up were based on
basieJaboratory data available in most rural clinics. Serious side-effects have
been rare and readily managed by community-health workers and clinic staff.
We discuss objections to the widespread use of HAART, and suggestlhat
directly-observed therapy of chronic infectious disease with multidrug regimens
can be highly effective in settings of great privation as long as there is sustained
commitment to uninterrupted care that is free to the patient.
Why AIDS prevention alone is insufficient
http://www.lancet.com/journal/joumaLisa
8/6/01
Page 2 of 13
The Journal : Current issue
1^0
The dimensions of the global HIV crisis are such that predictions termed alarmist
a decade ago are now revealed as sober projections.1 In 2000, HIV overtook
tuberculosis as the world's leading infectious cause of adult deaths. HIV has, in
fact, overtaken the 1918 influenza epidemic as the most devastating
communicable cause of adult death since the bubonic plague of the 14th
century.2 The social impact of HIV has been particularly severe in Africa, where
an estimated 14 million children have been orphaned by AIDS; if trends hold, 40
million African children will be orphaned by the close of this decade 3 4 Because
poverty and social inequalities are leading co-factors in HIV transmission, the
virus promises to wreak similar havoc in India and other parts of Asia.5 At the
same time, AIDS mortality has dropped precipitously in affluent countries, in
large part because of access to highly-active antiretroviral therapy (HAART).6,7,8
This ever-widening outcome gap is evident globally.
The response of the affluent countries and their institutions—from aid agencies,
non-governmental organisations, and the pharmaceutical industry--has been
insufficient. (The death toll and increasing HIV incidence are the most eloquent
rebuke to contrary assessments.) The quasitotality of AIDS assistance to the
heavily-burdened countries has consisted of the promotion of education and
condom distribution to prevent HIV transmission. It has taken two decades to
acknowledge the central irony of AIDS prevention: "Towards the end of the
second decade of the AIDS_pandemic^ve_still have no good evidence that
primary prevention works."9 Many of those at greatest risk already know that HIV
isTsexually transmittedTpathogen and that condoms could prevent
transmission. Their risk stems less from ignorance and more from the precarious
situations in which hundreds of millions live; gender inequality adds a special
burden, and is the main reason that, globally, HIV incidence is now higher
among women than among men.10,11
r Clearly, the prevention strategies currently in use will not inflect HIV incidence
/ among the poorest populations, even though these prevention strategies have
I proven effective in settings from San Francisco to Thailand and merit greater
support. Other complementary strategies, including vaccines protective against
clades prevalent in Africa, are needed if the most vulnerable are to be protected.
The acknowledgment that there is the need for better prevention is important,
and it is also time to turn our attention to the more than 30 million individuals
already living with HIV.12 They need more than palliative care. The programmes
extolled as "community-based care" or "home care" are inadequate whenever
these terms are euphemisms to describe what amounts to hospice, and not very
good hospice at that: no real analgesia, no antifungals, too few antibacterials,
and no parenteral lines for rehydration.
There is an unmentioned elephant in the conference rooms of many scientific
meetings: the prospect of providing HAART to those living with both poverty and
HIV. Even though this describes 90% of the potential beneficiaries of recent
therapeutic developments, use of HAART in poor countries is rarely the primary
topic of discussion in scientific congresses. Access to treatment is, however, the
primary topic of discussion in communities beset by HIV, just as it is the primary
topic of discussion among AIDS activists. Some groups in sub-Saharan Africa
already express hostility to humanitarian organisations and funders who express
interest only in education ar.d condom promotion. We report our experience of
treating HIV disease in a poor community in rural Haiti and examine the main
objections to making HAART available in resource-poor settings.
top
>
. ♦k/A Lll\/
http://www.lancet.com/joumal/joumal.isa
8/6/01
The Journal : Current Issue
Page 3 of 13
ITI
VZIIO KxV/IIIIIIUI my o CApCI IUI 1UU. IIIC7 HIV
ft_ljMliy IIHUailVC
Haiti is by all conventional criteria the poorest country in the western hemisphere
and one of the poorest in the world:13 per capita gross national product (GNP) is
around US$400; unemployment exceeds 70%; and fewer than one in 50
Haitians have regular employment.14 Not coincidentally, Haiti is also the
hemisphere’s most HIV-burdened country.15 In 1999, UNAIDS reported national
HIV seroprevalence as 5% among women attending antenatal clinics--and rates
were twice as high in urban slums.11 The latest estimates of life expectancy at
birth are 475 years for men and 492 years for women, with HIV considered the
chief contributor to premature adult death.16
Initially an urban epidemic, HIV prevalence is lower in rural Haiti, where we have
worked for more than 15 years. Most of the local inhabitants in the lower Central
Plateau are peasant farmers working small plots of infertile land. Many are
sharecroppers. Local health indicators are worse than national estimates.
Our clinical facility, founded in 1985 in the middle of a settlement of individuals
displaced by a hydroelectric dam, documented its first case of HIV disease in
1986. Following international convention, prevention efforts were tightly linked to
education and condom promotion.17 These efforts have been hampered by
political violence and resulting migration, and by gender inequality and poverty,
which conspire to make the male condom an imperfect prevention measure.
Thus, HIV transmission continued in spite of aggressive prevention
campaigns.18
Our modest therapeutic efforts have been aggressive when compared with other
clinics in poor, rural regions of the less-developed world. Shortly after the
publication of the ACTG-076 trial,19 we began offering zidovudine to pregnant
women to block mother-to-child transmission. More than 90% of women offered
HlVlestina-accepted it after zidovudine was made available free of charge;
dramatic declinesjr^vertical HIV transmission^iisued. jn 1997- we-began
offeringj^osLexposiHe prophylaxisTvi^ a three-drug regimen (usually
zidovudine, 3TC, and a protease inhibitor) to victims of rape o^professional
injury. Beginning in late 1998, a small number of patients with long-standing
HIV disease who no longer responded to syndromic treatment ofnpporti in istic.
infectionsjvere^offerecLdirectly-obseiYextHAART.
Inclusion criteria for HAART have not been codified rigidly, but follow a certain
log* - *n the absence of CD4 lymphocyte counts and viral-load testing.,Patients
assessed for HAART are those with chronic enteropathies or other forms ofrHIVassociated wasting; patients with presumed neurological complications of HIV
(encenhaiopathyrdlstal- sensory, or other polyneuropathies); those with
repeated_opportunistic infections unresponsive to antibacterials and antifungals;
and patientswith severe leukopaenia, anaemia, orthrombocytopaenia (panel 1).
Assessments are done by two physicians, one with infectious-disease training.
Panel 1: Guidelines for inclusion in DOT-HAART project, Clinique Bon
Saveur
♦ Absence of active tuberculosis
♦ Recurrent opportunistic infections difficult to manage with antibacterials or
antifungals
♦ Chronic enteropathy with Wasting
♦ Otherwise unexplained and significant weight loss
♦ Severe neurologic complications attributable to HIV
http://www.lancet.com/journal/journal.isa
8/6 01
Page 4 of 13
The Journal: Current Issue
v severe leuKopaema, anaemia, or inromDocyropaenia
Patients diagnosed with active tuberculosis are not-pfferecLHAART-because
nTost resporiJto^antituberculous4herapy^and-are-subsequently symptom-free for
long perjodsjoflime^ften-years. It is significant, then, that most patients
diagnosed with HIV infection present with active tuberculosis, as figure 1
shows.21
Figure 1: Presenting diagnoses in 200 patients with HIV disease, Clinique
Bon Sauveur, 1993-95
From reference 21.
In our clinic, directly observed therapy with HAART (DOT-HAART) is modelled
on successful tuberculosis-control efforts. That is, each HIV patient has an
accompagnateur (often a community-health workerfwlTO observes ingestion of
pills; responds to patienfand family concerns; and offers moral support (figure
2). Social support-including assistance with children's school fees-is included
imsemces-offered. Monthly meetings, in which patients discuss their illness and
other concerns, are notable for high attendance (figure 3).
J*5
Figure 2: Accompagnateur training, Thomonde, Haiti
/
Figure 3: Medical and human-resources infastructure necessary to
implement DOT-HAART
Top: Thomas J White Center, Cange, Haiti.Bottom: monthly patient meetings
notable for high attendance.
Response to HAART in an initial cohort of 60 patients has been dramatic (panels
2-4). Side-effects have been rare and readilyjnanaged (only six patients have
required a change in regimen). As elsewhere, patients receiving HAART are far
lessJikely_tQ_reauire admission to hospital than are patients with untreated HIV
disease.22 In the event that ambulatory care is not feasible for the initiation of
HAART or for the treatment of an acute illness, patients with HIV are admitted to
http://www.lancet.com/joumal/joumal.isa
8/6/01
The Journal : Current Issue
Page 5 of 13
i >3
the general ward, which is in a facility separate from the tuberculosis ward.
Panel 2: Enna, 26-years-old
Enna has already had six children. Born to an impoverished family in
Savanette, she was sent to Port-au-Prince as a restavft-a child servant--at 10
years of age: "I used to mop the floor and cook. I also used to babysit." Enna
was not paid but "they gave me food to eat." At age 14, she was raped: "A man
who was a friend of the family where I was staying raped me. He waited until no
one was home, then he jumped on me. I was just a child; I did not know what
was happening. This happened four times, and then I was pregnant. The family
[in Port-au-Prince] sent me away." Enna returned to Savanette, where she
almost died in childbirth. She later sold produce in regional markets and in Portau-Prince. At 18 years of age, while sleeping in a communal market depot,
Enna was raped by three men. "I didn't see them, so what could I tell the
police? Besides, I was afraid of the police." Enna regards "my entire life as a
disaster. I had three children for two different men, but neither of them would
help me [financially]." In 1997, sapped by recurrent fevers and chronic
diarrhoea, she was diagnosed with tuberculosis and HIV co-infection. Treated
for tuberculosis, she gained weight but later developed oropharyngeal
candidiasis and mental slowing. She lost weight and had intermittent diarrhoea. '
Enna received zidovudine during her sixth pregnancy, but the newborn baby
died of severe jaundice. When her weight dropped to 108 lb, she was started
on a regimen of zidovudine, 3TC, and efavirenz. She gained 9 lb in the first 6
months of therapy and now has no symptoms.
Panel 3: St Ker, 41-years-old
$5
St Ker, is from the village of Savanette. After completing 4
years of primary school, his parents could no longer pay
i
tuition. "I went to Port-au-Prince to learn how to become a
welder. I worked in factories." He lost his first job when the
company he worked for was sold. He has since been
intermittently employed. St Ker fathered two children, but his
marriage foundered: "We used to argue about money. Then
"'■i I became sick and she left me." He later struck up a
_ relationship with another woman, who bore him another
child, but by then, the summer of 1998, he was too sick to
work. He had chronic diarrhoea and weight loss.
"I wandered from clinic to clinic [in Port-au-Prince], but no one could tell me
what was wrong. So I came back here." St Ker was diagnosed with HIV in June
1999, when he presented to our clinic with cachexia, chronic enteropathy,
anaemia, and mucocutaneous candidiasis. He was treated with broad
spectrum antibacterials and loperamide, but continued to lose weight. He
suffered cognitive decline and by May 2000, was too weak to stand. When his
weight dropped to 90 lb, St Ker was started on a regimen of zidovudine, 3TC,
and efavirenz.
"I feel that these drugs have been miraculous. My diarrhoea stopped and I
started to gain weight." His candidiasis and odynophagia disappeared by
December 2000, when St Ker weighed 140 lb. He is ready to resume his work
as a welder.
Panel 4: Adeline, 34 years old
nttp://www.lancet.corn/joumal/journaLisa
8/6/01
Page 6 of 13
The Journal : Current Issue
Adeline, 34 years old, was born in the village of Kay Epin. Of
Adeline's eight siblings, five are living. Her parents are
peasant farmers, although her father supplements his
income by helping to run a local school. Adeline grew up in
the village, leaving rarely except to accompany her mother
to market. When she was 18, she left for Port-au-Prince to
continue her primary education. Adeline didn’t remain in
school for long-- her grades were poor; the cost of tuition,
high-and she ended up in a part-time vocational school,
where she learned to sew and embroider. She lived with a
sister in Cite Soleil, a slum on the northern edge of the city. Finding enough to
eat was a constant struggle. Not long after her arrival, Adeline married Joel, a
young man from the Central Plateau. Joel fell ill shortly after their son was born,
and Joel died only a year later. Adeline does not know what killed him, but now
assumes it was HIV. When Adeline's son was about 2 years old, she met
Ronald, the father of her second child. He's still around, she notes, "but I'm no
longer with him. He doesn't help me at all with feeding these children. I never
see him."
During her early twenties, Adeline had an episode of pneumonia, which led her
back to our clinic. She was also diagnosed with herpes zoster, which led to her
diagnosis of HIV infection. For almost 10 years, Adeline's therapy was limited to
treatment of opportunistic infections. By early 1999, Adeline's chronic
enteropathy no longer responded to antimotility agents. By October, she
weighed 79 pounds and could no longer get out of bed. In November 1999,
Adeline began therapy with zidovudine, 3TC, and indinavir. Her diarrhoea
disappeared within 2 weeks; she gained 26 pounds in the first 5 weeks of
treatment.
top
Expanding the HIV Equity Initiative
We believe that if DOT-HAART can be implemented in the devastated Central
Plateau of Haiti it can be implemented anywhere. Our experience further
suggests that HIV therapy can reinvigorate flagging prevention efforts. Although
AIDS remains a stigmatised disease in Haiti, we believe that access to effective
therapy_has_lessened AIDS related-stigma. ThejjemandTor HIV, testing, and the
opportunity for counselling, has risen since^HAART was made available.
During the next 3 years, we hope to expand the HIV Equity Initiative to better
meet the needs of the population of Central Haiti. Another nurse, an archivist,
and a second social worker would represent the first full-time employees of the
initiative. A part-time HIV prevention and care clinician will also work with the
team based in Haiti.
Even though we initially enrolled only_about 60 patients in theJD_QT4jAART
programme, we achieved nearly full coverage in parts of the catchment area:
using the enrolment criteria notedin_panel 1, we haye_be.en_ableJolreat most
patients_with_signs-and-symptoms-suggestive_oJ_adyanced_Hiy_dise§se. If the
catchment area served consists of 250 000 individuals, the seroprevalence of
HIV is about 5% among sexually active adults, and sexually active adults aged
15-40 years comprise 30% of the population, some 3750 HIV-positive individuals
would live within the catchment area. If 10% of these patients meet enrolment
criteria, then about 375 patients would need HAART. With additional staff, the
treatment of 375 patients is well within the capacity of many district hospitals ig
less-developed countries. WithmationaLanclinternational support, a larger
number of patients could be enrolled in life-saving therapy.
http://w\vw. lancet.com/joumal/joumal.isa
8/6/01
The Journal : Current Issue
Page 7 of 13
HqwjTiighXpalientsJ^e4uitably_ang_eff^^
project? They must of course want to be treated, but we have yet to meet one
who does not. Until tests of viral load, CD4c.ount._Qr other surrogate ma rkers a re
available, simple clinical criteria can identify those most likely..to_benefit from
HAARTTThemost important-weight loss or decreased body-mass index-has
been shown to-predict survival and disease progression in HIV infection.23,24
Other criteria include the presence of a wasting enteropathy; severe neurological
complications of HIV; severe leukopaenia, anaemia, or thrombocytopaenia; or
recurrent opportunistic infections unresponsive to antibacterial or antifungal
therapy.25-27 In collaboration with colleagues at the Association Frangois-Xavier
Bagnoud, we are developing more formal inclusion criteria, but these need not
be based on tests and measures unavailable in rural clinics in poor countries.
Many have expressed concern that HAART is too complicated for settings
without specialists to guide therapy. It is true that rifamycins decrease blood
concentrations of protease inhibitors; as noted, however, most patients who
present with tuberculosis do not need j;oncurrent_antj-retroviral therapy.
Furthermore, HAART in resource-pQ_or_sottings need not relyon protease
inhibitors. Given adequate financing^we plan-to base nurJnitial regimen on a
combination of two reverse-trAnsnriptaso inhibitors Anri a_nnn-nnc.rpnside
r^ef^transcriptasejnhihiiQEu^OQtbeiLprQmisu^
in
the U8A, is the triple-nucleQsideranaLQgue_pill"Zidovudine and 3TC together
with abacavir, the most potenLdruqJn-itsxlass. Such a fixed-dose combination
would make DQT-HAART significantly simpler than tuberculosis treatment and
would preserve protease inhibitors and non-nucleosides for cases of suspected
bTdocumented treatment failure.
Some have expressed alarm regarding the spread of drug-resistant virus if
HAART is used where health infrastructure is weak. Just as it is possible to
exaggerate the complexity of these regimens, so too is it possible to confound
the main causes of acquired resistance. Most are to be found in settings such as
the USA, where HIV patients face concurrent problems such as housing
instability, lack of medical insurance, drug addiction, and lack of access to
addiction-treatment programmes. Furthermore, there is in resource-poor settings
no history of the widespread use of monotherapy with nucleoside reverse
transcriptase inhibitors. The use of monotherapy, once the rule in HIV therapy in
the USA and Europe, is a leading contributor to the widespread existence of
pdrug-resistant strains there. If tuberculosis offers an instructive example, drug
} resistance is far less likely to emerge where DOT is used from the outset and
where drugs are made available to those who need them most.
Funding for expansion of this pilot project was sought from a number of
international agencies charged with responding to AIDS; all declined to support
this effort on the grounds that the drug costs were too high to meet so-called
sustainability criteria. Pharmaceutical companies were approached for
contributions or concessional prices but referred us back to the same
international agencies that had already termed the project unsustainable.
top
Objections to HAART in resource-poor settings
The two primary objections to use of HAART in poor communities have been the
high costs of the medications and the lack of infrastructure necessary to deliver
them effectively. The debate regarding pricing of antiretrovrals has been
reviewed elsewhere.28,29 As noted, there is little science to drug pricing. Several
firms, including one based in India, have developed very low-cost formulations of
zidovudine, 3TC, D4T, ddl, and nevirapine. The monthly retail cost of three
drugs is already as low as US$83, as compared with US$768 per month from
http://www.lancet.com/journal/journaLisa
8/6/01
The Journal: Current Issue
Page 8 of 13
1^6
manufacturers in the USA.OU
The second chief objection has been that poor countries lack the infrastructure
necessary to deliver HAART. Much is made of the complexity of HIV
management, which would defeat, according to conventional wisdom, the
overburdened and undertrained health personnel in the countries most affected
by HIV. In poor countries, HIV therapy is the privilege of local elites (who have,
almost invariably, far lower rates of infection than the poor majority) and of a
small number who live in capital cities and have access to specialty clinics
partnered with first-world research universities.
There is merit to observations regarding weak implementation capacity, since
health infrastructures are manifestly deplorable in most HIV-endemic areas. But
there is reason to believe that minor modifications could improve local capacity
to care for those sick with advanced HIV disease. One is the fact that we have
piloted a DOT-HAART project in one of the poorest parts of the poorest country
in the western hemisphere. Another is that other chronic infections have been
well managed in equally poor settings.
Tuberculosis offers important lessons. Although tuberculosis remains a ranking
cause of premature death, some extremely poor countries with high burdens of
tuberculosis have low tuberculosis mortality rates. These countries have often
been those adopting the DOTS strategy (directly observed therapy, short
course).31 Since prompt diagnosis and effective therapy mean less
transmission, treatment is prevention.
Tuberculosis treatment is easily as complex as HIV therapy, since both consist
of a multidrug regimen (most initiate tuberculosis therapy with four drugs).
Although fixed-dose combinations can reduce pill burden, the number of pills is
not the primary determinant of outcome. The chief innovations have been
directly-observed therapy; treatment that is without interruption and free of
charge to the patient; and good case holding. Adjuvant social services further
boost adherence and thus outcomes, which can be excellent in settings of
enormous privation.32,33 These innovations require political will at high
government levels.
Some argue that the way in which tuberculosis is treated is not relevant to HIV
care, since tuberculosis treatment lasts only 6-8 months whereas HIV therapy
must be ongoing. For sceptics, the effective treatment of multidrug-resistant
tuberculosis (MDR-TB) in impoverished regions may offer a more compelling
example. MDR-TB treatment is more than three times as long as short-course
therapy. The same arguments now heard in policy discussions of AIDS-high
drug prices and complexity of management render antiretroviral therapy
impracticable for use in resource-poor settings-were advanced to dissuade
those seeking to treat MDR-TB in poor countries. Working in rural Haiti and in a
slum in Lima, Peru, our group pioneered a community-based strategy to treat
MDR-TB. Using strict DOT and the same standards of care as in tertiary medical
centres in the USA or Europe, we achieved results better than those reported in
industrialised countries.34 Patients tolej^ted dQjg.Legiinens_niOLe_complex and
farjnore toxic than HAART/with low rates of abandonment. We called this
approach "DOTS-Plus,” because it incorporates the managerial strengths of the
DOTS strategy but relies on drug-susceptibility testing to determine treatment
regimens appropriate for each patient.35,36 This strategy is now being replicated
in the former Soviet Union, where MDR-TB constitutes a growing problem.
Furthermore, the WHO, humanitarian groups such as Medecins Sans
Frontieres, and partners in the pharmaceutics-, industry developed a coordinated
strategy of pooled procurement and distribution of second-line antituberculosis
druos. Concessional orices were offered to aoencies able to demonstrate to a
http://www.lancet.com/journal/journal.isa
8/6/01
The Journal : Current Issue
Page 9 of 13
Green Light Committee their capacity to use these drugs prudently and to work
under the aegis of a national tuberculosis programme.37 This mechanism offers
a concrete example of how coalitions can promote the prudent use of antibiotics
while at the same time lowering drug prices by as much as 90%.
Tuberculosis offers examples of what needs to be done once the international
community acknowledges that HIV is an international public-health emergency.
Tuberculosis control, considered a public good, is by_conyentLon_financed
publicly. Patiehts/dd not payTpr7 their own treatment, since those unable to .pay
remain sick and often infectious, perpetuating the epidemic; patients unable to
pay regularly acquire resistance to firstjjne d rugs agij, subsequently,Transmit
drucpresistant strains of Mycobacterium tuberculosis. With tuberculosis, good
treatmentlspreventionof both-tcansmissioriand^rugjesistance.
Again, HIV offersJmpertant-parallels. Although few would have predicted
otherwise, we now have proof that high viral load is a strong predictor of HIV
transmission.38 HAART drops viral load to undetectable levels in most patients,
and should be considered central to the AIDS-prevention arsenal.
Finally, tuberculosis offers a cautionary note. Reviewing published work reveals
confident claims that rifampin would prove too expensive for use in lessdeveloped countries; rifampin is now central to DOTS, advanced by the WHO
and the World Bank as one of the most cost-effective interventions available.39
The spread of MDR-TB across national boundaries makes different standards of
care--treatment for the affluent, no treatment for the poor-unacceptable on
epidemiological grounds. For some, double standards of care have long been
objectionable on moral grounds.40
top
Rethinking costs and benefits
We believe that much of the policy debate regarding the role of HAART in
responding to AIDS has been misguided. The belief that treatment may be
reserved for those in wealthy countries whereas prevention is the lot of the poor
might be less repugnant if we had highly effective preventive measures. We do
not. We have argued that we need better preventives, including vaccines, and
also a campaign to make HAART available to those who need it most. Where
HIV is the leading cause of adult death, a basic minimum package that does not
include antiretrovirals is not worthy of the name. We have instituted a very
different basic minimum package in one of the poorest parts of the world (panel
5), and believe that policy makers should take note. DOT-HAART is a safe way
to provide a minimum package that includes HAART.
Panel s: Basic minimum package for HIV in endemic settings
i ♦ Post-exposure prophylaxis for rape and professional accidents
Aggressive AIDS prevention programmes, including barrier methods
Maternal-child transmission package (including milk supplements)
♦ Social assistance to HIV-affected families, including orphans
♦ Diagnosis and treatment of opportunistic infections and sexually transmitted
diseases
U HAART with DOT
___
-----We also argue that it is wise to avoid confident claims regarding "appropriate
technology". Brazil has introduced sophisticated assays of viral load costing a
email fraction of toet ooctc in tho I IQ A- it hac mtani iftaofi iroH mon\/ ant irotrox/imle
http://www.lancet.com/journal/journal.isa
8/6/01
The Journal : Current Issue
Page 10 of 13
I
■ twit >« MVrliyyi I ssi SSssJS
III si ISZ SS SSI
IS I IVis* I I IS^I IS4IS4SSSS4I
IllVIlljr
S4I ISII S^SI sy V II Ulls>
locally. Cipla, the Indian pharmaceutical company, has introduced a substantial
formulary of antiretrovirals at a small fraction of the cost in Europe and North
America. These developments lead us to a consideration of the economics of
intervening to slow the spread of HIV and to diminish the death toll.
In settings of affluence, it seems as if no expense is too great in order to prolong
life, even when patients are elderly and have irreversible conditions. In subSaharan Africa and Haiti, where HIV is the reason for plummeting life
expectancies and for increasing numbers of orphans, we discern fairly overt
obstructionism to the use of HAART. Leaving aside all moral arguments, any
economic logic that justifies as acceptable the orphaning of children is unlikely to
be sound, since the cost to society, though difficult to tabulate, is far higher than
the cost of prolonging parents’ lives so that they can raise their own children.
Furthermore, HAART causes a dramatic drop not only in mortality, but also in
the number of opportunistic infections and consequent number of admissions to
hospital 22 HAART has already been declared cost-effective in Europe, North
America, and even Brazil, where HIV has become, for many, a chronic
infection.41,42
Health economists suggest that a life-saving intervention that costs between two
to three times the gross national product (GNP) per year-of-life saved represents
a reasonable expenditure.4^ Even by this crude calculus, it should be clear that
in South Africa or Botswana, for example, a three-drug HAART regimen at
generic prices would prove a sound investment by any criteria as long as drugs
are used correctly. Even in Haiti, where GNP is about US$400 per annum, a
regimen that costs US$800 per year-again. well within our grasp even now--will
be a wise expenditure even before considering favourable impact on
transmission.
We conclude by acknowledging that our DOT-HAART project is a humble
enough example. A small, effective pilot project might not warrant mention in the
international medical literature if widespread paralysis had not led to a near
universal absence of DOT-HAART projects in regions such as rural Haiti, with
minimum health infrastructure but high rates of both HIV and poverty. We know
from experience that repeated claims of unfeasibility are simply not true. Multiple
research projects carried out in sub-Saharan Africa have shown that moredeveloped world diagnostic tests can be used to follow viral load and to reveal
the genotype of drug-resistant strains of HIV. It is time that more-developed
world therapeutics follow.
We thank Thomas J White, the Association Frangois-Xavier Bagnoud,
FOKAL/Open Society Institute, Cambridge Cares about AIDS, OASIS, the Dunn
family, and the Infectious Disease division of the Brigham and Women's
Hospital. Photographs and case histories are used with patient's permission.
top
References
1 Mann JM, Tarantola DJM, Netter T. AIDS in the world. Cambridge: Harvard
University Press, 1992.
2 Garrett L. Of epidemic proportions/ UN report: AIDS deaths to surpass plague,
Spanish flu. Newsday. Nov 29, 2000 (AOS News).
3 International Federation of Red Cross and Red Crescent Societies. World
Disaster Report 2000. Geneva: International Federation of Red Cross and Red
Crescent Societies, 2000.
http://www.lancet.com/joumal/journal.isa
8/6/01
The Journal: Current Issue
Page 11 of 13
1^
4 Joint United Nations Programme on HIV/AIDS. AIDS epidemic update:
December 2000. Geneva: Joint United Nations Programme on HIV/AIDS, 2000.
. $
5 Farmer PE, Walton DA, Furin JJ. The changing face of AIDS: implications for
policy and practice. In: Mayer KH, Pizer HF, eds. The emergence of AIDS: the
impact on immunology, microbiology, and public health. Washington, DC:
American Public Health Association, 2000: 139-61.
6 Mocroft A, Vella S, Benfield TL, et al. Changing patterns of mortality across
Europe in patients with human immunodeficiency virus infection.
Lancet 1998; 352: 1725-30. [PubMed]
7 Moore RD, Chaisson RE. Natural history of HIV infection in the era of
combination antiretroviral therapy. AIDS 1999; 13: 1933-42. [PubMed]
8 Palella FJ, Delaney KM, Moorman AC, et al. Declining morbidity and mortality
among patients with advanced human immunodeficiency virus infection. N Engl
J Med 1998; 338: 853-60. [PubMed]
9 Mayaud P, Hawkes S, Mabey D. Advances in control of sexually transmitted
diseases in developing countries. Lancet 1998; 351 (suppl 3): S29-32.
10 Farmer PE, Connors M, Simmons J, eds. Women, poverty, and AIDS: sex,
drugs, and structural violence. Monroe, Maine: Common Courage Press, 1996.
11 Joint United Nations Programme on HIV/AIDS. Report on the global
HIV/AIDS epidemic, June 2000. Geneva: Joint United Nations Programme on
HIV/AIDS, 2000.
12 Farmer PE. Prevention without treatment is not sustainable. National AIDS
Bulletin (Australia) 2000; 13: 6-9. [PubMed]
13 United Nations Development Programme. Human Development Report 2000.
New York: Oxford University Press for UNDP, 2000.
14 World Bank. Poverty reduction and human development in the Caribbean: a
cross-country study. Washington, DC: World Bank Discussion Paper, 1997
(WDP 366).
i
15 Deschamps MM, Pape JW, Williams-Russo P, Madhavan S, Ho J, Johnson
W. A prospective study of HIV-seropositive asymptomatic women of childbearing
age in a developing country. J Acquir Immune Defic Syndr 1993; 6: 44651. [PubMed]
16 Central Intelligence Agency. The world factbook 2000. http:www.odci.gov/cia/
publications/factbook/geos/ha.html, accessed April, 2001.
17 Farmer PE. Ethnography, social analysis, and the.prevention of sexually
transmitted HIV infection. In: Inhorn M, Brown P, eds. The Anthropology of
Infectious Disease. Amsterdam: Gordon and Breach, 1997: 413-38.
18 Farmer PE, Walton DA. Condoms, coups, and the ideology of prevention:
facing failure in rural Haiti. In: Keenan J, ed. Catholic ethicists in HIV/AIDS
prevention. Maryknoll, NY: Orbis Books, 2000: 108-19.
19 Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant
http://www.lancet.com/joumal/joumal.isa
8/6/01
The Journal : Current Issue
Page 12 of 13
transmission of human immunodeficiency virus type 1 with zidovudine treatment.
N Engl J Med 1994; 331: 1173-80. [PubMed]
20 Centers for Disease Control and Prevention. Update: provisional Public
Health Service recommendations for chemoprophylaxis after occupational
exposure to HIV. MMWR Morb Mortal Wkly Rep 1996; 45: 468-72. [PubMed]
21 Farmer PE. Letter from Haiti. AIDS Clinical Care 1997; 9: 83-85. [PubMed]
22 Gebo KA, Chaisson RE, Folkemer JG, Bartlett JG, Moore RD. Costs of HIV
medical care in the era of highly active antiretroviral therapy.
AIDS 1999; 13: 963-69. [PubMed]
23 Wheeler D, Gilbert C, Launer C, et al. Weight loss as a predictor of survival
and disease progression in HIV infection. J Acquir Immune Defic
Syndr'IQQQ; 18: 80-85. [PubMed]
24 Graham NMH, Munoz A, Bacellar H, Kingsley LA, Visscher BR, Phair J.
Clinical factors associated with weight loss related to infection with human
immunodeficiency virus in the multicenter AIDS cohort study. Am J
Epidemiol 1993; 137: 439-46. [PubMed]
25 Blatt SP, McCarthy WF, Bucko-Krasnicka B, et al. Multivariate models for
predicting progression to AIDS and survival in human immunodeficiency virusinfected persons. J Infect Dis 1995; 171: 837-44. [PubMed]
26 Fuchs D, Zangerle R, Artner-Dworzak E, et al. Association between immune
activation, changes of iron metabolism and anaemia in patients with HIV
infection. Eur J Haematol 1993; 50: 90-94. [PubMed]
27 Chan ISF, Neaton LD, Saravolatz LD, Crane LR, Osterberger J. Frequencies
of opportunistic diseases prior to death among HIV-infected persons.
Community Program for Clinical Research on AIDS. AIDS 1995; 9: 114552. [PubMed]
28 The Panos Institute. Beyond our means? The cost of treating HIV/AIDS in the
developing world. London: Panos, 2000.
i
29 Pecoul B, Chirac P, Trouiller P, Pinel J. Access to essential drugs in poor
countries: a lost battle? JAMA 1999; 281: 361-67. [PubMed]
30 McNeil DG Jr. Selling cheap ’generic' drugs, India's copycats irk industry.
New York Times. Dec 1, 2000: 1(A).
31 Raviglione MC, Dye C, Schmidt S, Kochi A. Assessment of worldwide
tuberculosis control. Lancet 1997; 350: 624-29. [PubMed]
32 Sumartojo E. When tuberculosis treatment fails: A social behavioral account
of patient adherence. Am Rev Respir Dis 1993; 147: 1311-20. [PubMed]
33 Farmer PE, Robin S, Ramilus SL, Kim JY. Tuberculosis, poverty, and
'compliance': lessons from rural Haiti. Sem Respir Infect 199 <; 6: 25460. [PubMed]
34 Farmer PE, Furin JJ, Shin SS. The clinical management of multidrug
resistant tuberculosis. J Resp Dis 2000; 21: 53-56. [PubMed]
http://www.lancet.com/joumal/journal.isa
8/6/01
Page 13 of 13
The Journal : Current Issue
l&l
35 Farmer PE, Kim JY. Community-based approaches to the control of
multidrug-resistant tuberculosis: introducing 'DOTS-Plus'. BMJ 1998; 317: 67174. [PubMed]
36 Farmer PE, Kim JY, Mitnick C, Timperi R. Responding to outbreaks of
multidrug-resistant tuberculosis: introducing 'DOTS-Plus'. In: Reichman LB,
Hershfield ES, eds. Tuberculosis: a comprehensive international approach, 2nd
edn. New York: Marcel Dekker, 2000: 447-69.
37 Gupta R, Brenner JG, Henry CL, et al. Procurement of second-line anti
tuberculosis drugs for DOTS-Plus pilot projects. WHO Working Group on DOTSPlus for MDR-TB. Proceedings of a meeting, Cambridge, MA July 5-6, 1999.
Geneva: World Health Organization; 2000 (WHO/CDS/TB/2000.276).
38 Quinn TC, Wawer MJ, Sewankambo N, et al. Viral load and heterosexual
transmission of human immunodeficiency virus type 1. N Engl J
Med 2000; 342: 921-29. [PubMed]
39 Anonymous. Rifampicin or ethambutol in the routine treatment of
tuberculosis. BMJ 1973; 4: 568.
40 Farmer PE, Bayona J, Becerra M, et al. The dilemma of MDRTB in the global
era. Int J Tuberc Lung Dis 1998; 2: 869-76. [PubMed]
41 Gellman B. An unusual calculus of life and death; as millions perished in
pandemic, firms debated access to drugs; players in the debate over drug
availability and pricing. The Washington Post, Dec 16, 2000; Section A:1.
42 Freedberg KA, Losina E, Weinstein MC, et al. The cost effectiveness of
combination antiretroviral therapy for HIV disease. N Engl J
Med 2000; 344: 824-31. [PubMed]
43 Garber AM. Advances in cost-effectiveness analysis of health interventions.
In: Culyer AJ, Newhouse JP, eds. Handbook of Health Economics, Volume 1.
Amsterdam: Elsevier Science, 2000: 182-221.
* top
«
The Journal
Discussion Groups
http://www.lancet.com/joumal/joumaLisa
CyberSessions
eResearch Archive
Profile
Help
Feet
8/6/01
Page 1 of 10
The Journal : Current Issue
MS fl
T'le Journal
rHscussion •’.> ouo
Cvnei Scss
Editorial
Home > The Journal > Current Issue > and review
Volume 358, Number 9279
04 August 2001
;->sut
Contents in full
Talking points
Original research
News
Editorial and review
Correspondence
Clinical picture
Dissecting room
Department of error
Preventing antiretroviral anarchy in subSaharan Africa
Supplements
Back Issues
A D Harries, D S Nyangulu, N J Hargreaves, O Kaluwa, F M Salanipom
Viewpoint
Lancet 2001: 358: 410-14
Search Journal
Subscribe
Log Out
Jobs
Awards and
Announcements
Conferences
Press Services
General Info
Free Sample
Info for Authors
Contact Us
Irfecbous Diseases
LANCET,
■ -->
5,;<:
Tlaiional Tuberculosis Control Programme, Community Health
Science Unit, Lilongwe, Malawi (Prof A D Harries FRCP, D S
Nyangulu MB, N J Hargreaves MRCP, F M Salaniponi PhD); Liverpool
School of Tropical Medicine, Liverpool, UK (N J Hargreaves); and
National AIDS Control Programme, Lilongwe (O Kaluwa PhD)
Correspondence to: Prof A D Harries, c/o British High Commission,
PC Box 30042, Lilongwe 3, Malawi (e-mail:adharries@malawi.net)
Use of antiretroviral therapy in suthSahai^Africa
Dangers of antiretroviral therapy in sub-Saharan Africa
National tubercjJlpsjs^ntroLprogi^mes
Framework _fpr.an antiretroviral programmejn subrSa ha ran. Africa
Why have ajoint^ogramme?
Keyop^ratigns^of^pintjirogramme
Conclusion
References
Combination antiretroviral therapy has dramatically improved the
survival of patients living with HIV and AIDS in industrialised
countries of the world. Despite this enormous benefit, there are
some major problems and obstacles to be overcome.1 Treatment
of HIV-infection is likely to be lifelong.2 Unfortunately, many HIVinfected individuals cannot tolerate the toxic effects of the drugs,
or have difficulty complying with treatment which involves large
numbers of pills and complicated dosing schedules. Poor
adherence to treatment leads to the emergence of drug-resistant
viral strains that need new combinations of drugs or new drugs
altogether.
Use of antiretroviral therapy in sub-Saharan Africa
About 70% of the estimated 361 million people in the world with HIV
and AIDS live in sub-Saharan Africa, and 84% of all the estimated
deaths due to HIV and AIDS since the start of the pandemic have
occurred in this region.3 Africa is the epicentre of this pandemic, yet
http://www.lancet.com/joumal/joumal.isa
8/6/01
Page 2 of 10
The Journal : Current Issue
iiuiiiudiiy is uit; leyiun ledst auie tu uuei ciny uiidiieiiye ui opposition to
185
the devastation caused by the virus. With a few exceptions, strategies to
prevent the spread of HIV have been unsuccessful. Good quality HIV
counselling and testing services are few and far between, clinical care
and the resources to treat opportunistic infections are minimal, and for
most people with HIV and AIDS, there is no access to antiretroviral
drugs.
This state of affairs might change. Five large pharmaceutical companies
agreed in May, 2000, to significantly reduce the cost of antiretroviral
drugs to create better access for people in poor countries. An Indian
drug company, Cipla, has created a three-tiered pricing offer to make
antiretroviral drugs more accessible to resource-poor countries, and has
offered to produce a combination of lamivudine, stavudine, and
nevirapine at an annual cost of US$350 for Medecins Sans Frontieres,
US$600 for governments, and US$1200 for individuals 4 There is even
talk that the G8 countries might pay for antiretroviral drugs for resource
poor countries.
Access to antiretroviral drugs could be an important component of a
strategy to support people living with HIV and AIDS as well as
preventing transmission of infection. People may be more willing to
undergo voluntary counselling and testing and disclose their HIV status
if there is the possibility of getting effective treatment. By reducing viral
load, antiretroviral drugs might also reduce the risk of sexual
transmission.5 Sick people will be able to return to work. Parents will
stay alive longer, thus delaying the time when children become orphans.
The rate of mother-to-child-transmission will be reduced.
top
Dangers of antiretroviral therapy in sub-Saharan
Africa
Widespread, unregulated access to antiretroviral drugs in sub-Saharan
Africa could lead to the rapid emergence of resistant viral strains,
spelling doom for the individual, curtailing future treatment options, and
leading to transmission of resistant virus. There are few physicians
skilled in the use of antiretroviral drugs. The health infrastructure is
incapable of monitoring viral load, immune status, or side-effects of the
drugs. Drug procurement and distribution systems are weak, and drug
interruptions are likely. Theft of drugs from health institutions for sale in
markets, shops, private clinics, and across national borders is a real
concern. There are no monitoring systems in place to check on drug
■ adherence or drug effectiveness. Horton cites a recent report from
I Harare, Zimbabwe, where introduction of antiretroviral drugs has
' resulted in a situation of antiretroviral "anarchy" and chaos.6
Thus, it.is not just a matter of providing antiretroyjr^.drugs,_but.a!sp that
they must be provided withirta structured framework. There has.to be a
system to ensure regular procurement and distribution,_goadj3.atient
manaqement.ThomtonnqT^nd assessment. Is this possible? We believe
that it is feasible to put such a system in place in the public-health sector
based on the successful model adopted for tuberculosis control, the
national tuberculosis control programme, to initiate a combined
tuberculosis and antiretroviral drug programme.
top
Klfi ihnrri ilncic rnnfrnl nrnHrommnc
http://www.lancet.com/journal/journal.isa
8/6/01
The Journal: Current Issue
Page 3 of 10
I 1C4LIVI IC4I IUMUIVUIVOIO WIUIVI
VJ I C4I Illi l«^O
I8t>
The overall objective of tuberculosis control is to reduce mortality,
morbidity, and transmission of the disease until it no longer poses a
threat to public health. The strategy is simple. Standardised combination
chemotherapy is provided to, at least, all sputum smear-positive
tuberculosis patients. This treatment cures the disease and prevents
future transmission of infection within the community. Targets for
tuberculosis control include curing 85% of detected new smear-positive
tuberculosis cases and detecting 70% of the existing cases. To achieve
a high cure rate is the highest priority because tuberculosis programmes
with high cure rates are thought to attract a large number of existing
cases within their catchment areas.
The success of this strategy depends on the implementation of a
tuberculosis control policy package, so called Directly Observed
Treatment, Short course (DOTS).7,8 DOTS has a five-point policy
package (panel 1), associated with nine key operations (panel 2).
DOTS-tuberculosis programmes have better data on case finding, more
smear-positive pulmonary tuberculosis cases, and better treatment
outcomes than tuberculosis programmes which do not use DOTS.9,10 In
1997, for example, the treatment success rate for smear-positive
tuberculosis patients treated under DOTS-programmes was 78%
globally.10 Rates of treatment completion are lower in DOTS
programmes in high HIV-prevalent countries in sub-Saharan Africa. This
is not because the delivery of DOTS is worse, but principally because of
high case fatality rates due to HIV coinfection.11
i
Panel 1: Tuberculosis control policy package
♦ Government commitment
♦ Case detection through passive case finding
♦ Administration of standardised short-course chemotherapy to at
least all confirmed sputum smear positive cases of tuberculosis
under proper management conditions
♦ Establishment of a system of regular drug supply
♦ Establishment and maintenance of a monitoring system
Panel 2: Key operations of a national tuberculosis control
programme
♦
Establish a national tuberculosis programme with a central
unit
♦
Prepare a tuberculosis programme manual
♦
Establish the recording and reporting system
♦
Initiate a training programme
♦
Establish microscopy services
♦
Establish treatment services within the health care system
♦
♦
Secure a regular supply of drugs and diagnostic material
Design a plan of supervision
♦
Prepare a programme development plan especially for funding
Although DOTS is a successful strategy, its implementation is not easy.
By 1998, only 21% of all smear-positive tuberculosis cases globally had
•
.
.
..
http://www.lancet.com/joumal/joumal.isa
--------- -- .
.
.
m . .
....
8/6/01
The Journal: Current Issue
Page 4 of 10
been treated by a uu I b-tubercuiosis programme Adequate funding
is essential, and it is important to note that most large DOTStuberculosis programmes which have done well have been supported
by international donor agencies, the World Bank, or WHO.12
->• top
Framework for an antiretroviral programme in subSaharan Africa
Tbe_OYeialLpbjective of an antiretroviral programme would be to reduce
mortalityjnQ[bidity, and transmission of HIV. The strategywouTd be to
use standardised, combination antiretroviral therapy for HIV seropositive
patients with symptoms. The targets for antiretroviral therapy would be
lifelong treatment once the patient has started on therapy and drug
adherence rates of 90% orjreater. Achievement of excellent adhere nee
rates is the highest priority because this is the best way of reducing the
emergence of drug-resistant HIV infection.
We suggest five key elements in our proposed antiretroviral policy
package, similar to that adopted for tuberculosis control:
Government commitment
The aim should be nationwide coverage, similar to a permanent health
system activity, with technical leadership from a central antiretroviral unit
that is integrated with the national tuberculosis control programme.
Regional or provincial units with dedicated personnel should also be set
up in order to facilitate the work of the central unit. Antiretroviral drugs
should not be introduced in isolation, but must be part of an essential
package of care that includes voluntary counselling and testing
psychosocial support, palliative care, home based care, essential drugs
for thejreatment and preventiorFof-opportunisdin-Wer.tinns including
sexually transmitted infections, and nutritional support
I
Case detection through passive case finding
The focus should be on HIV seropositive patients with symptoms, who
should undergo voluntary counselling and HIV testing. The spectrum of
illness and the clinical features allowing access to antiretroviral drugs
would need to be worked out. For example, patients fulfilling the WHO
case definition for AIDS in Africa,13 or patients with common systemic
diseases such as tuberculosis, pneumonia, chronic diarrhoea,
bacteraemia, or systemic fungal infections could be considered
candidates for antiretroviral drugs if they tested HlV-positiveJn.
countries with limited resources, it is not feasible to offer symptom-free
l^4nfectedJndividuaJs_antireiEQviraLthejiapy. Experience in
industrialised countries has shown that early therapy is associated with
cumulative side-effects, poor adherence, and the development of
multidrug resistance, and these factors probably outweigh the net
benefits of lengthening life.2
Standardised antiretroviral regimens
The drug combination needs to be simple and have the least number of
side-effects. Protease inhibitors are associated with many side-effects,
and because of interactions with anti-tuberculosis drugs,14 are probably
hact ai/nidad in ci ih_Qohoror» African nni intn'ac
http://www.lancet.conVjoumal/joumaLisa
o hinh MI\/_
8/6/01
Page 5 of 10
The Journal : Current Issue
avUIUGU III OUU’VUI ICII QI I /-XIIIOOII
I I u ItiO
«VIUI O I I'y I • •' *
/sc
tuberculosis burden. The choice of the most appropriate regimen
depends on efficacy, cost, and safety issues,15 and would require
expert consultation. It would also be prudent to decide what drugs might
be used for salvage antiretroviral therapy when drug resistance, side
effects, or both become a problem.
Proper case management ensures patient adherence by supervised
administration of tablets (directly observed therapy). However, there are
some important differences from the supervision of antituberculosis
treatment. Antiretroviral therapy is lifelong and there is at present no
once-a-day regimen. DOT for antiretroviral drugs therefore has to be
flexible, and will probably only work if the site of supervision is in or
close to home and the supervisor or supervisors are trusted and
reliable.
Establishment of a regular drug supply
A mechanism needs to be set up for regular and uninterrupted
procurement, distribution, and safe storage of antiretroviral drugs,
building on the structures used in national tuberculosis control
programmes.
Establishment and maintenance of a monitoring system
In each antiretroviral treatment unit an antiretroviral register should be
maintained to record individual patient information. There should be
regular reporting on a quarterly basis of the cumulative as well as the
quarterly results of case finding and follow-up.
top
Why have a joint programme?
In most of sub-Saharan Africa there have been repeated requests for
tuberculosis control and AIDS control programmes to work together. A
joint tuberculosis and antiretroviral initiative could provide a real focus
for collaboration. An independent and parallel antiretroviral treatment
and delivery system could be implemented, but we believe that such a
step would be counter-productive.
It would be more cost-effective to build on the infrastructure already on
the ground for tuberculosis control. Good national tuberculosis control
programmes have the experience of providing, monitoring, and
supervising care of patients for long periods of time, and are in a
position to develop and implement a structure within which antiretroviral
drugs can be effectively and safely administered. Given that HIV is the
main driving force behind the current epidemic of tuberculosis, an
integrated programme has a greater chance of affecting the tuberculosis
burden in Africa than any course of action embarked on by tuberculosis
control programmes alone. Further, tuberculosis is the main
opportunistic infection resulting from HIV, and therefore many of the
patients will be common to both programmes. How will adverse side
effects be managed when patients are on both antituberculosis
treatment and antiretroviral drugs if patients are treated by two different
programmes? Will DOT for antituberculosis treatment and for
antiretroviral drugs be administered by different DOT providers if the
programmes run in parallel? Accessing a dedicated antiretroviral drug
unit may still be a stigmatising event for many people, whereas an
http://www.lancet.com/joumal/joumal.isa
8/6/01
Page 6 of 10
The Journal: Current Issue
integrated service could neip to reduce mis stigma.
One potential risk of a joint programme is that nosocomial tuberculosis
might be acquired by HIV-positive patients when accessing antiretroviral
therapy. This concern needs to be addressed in the physical design of
the joint programme offices and the logistics of how infectious
tuberculosis patients and non-tuberculosis patients access the services.
top
Key operations of a joint programme
We believe that an integrated tuberculosis and antiretroviral drug
programme is the best way forward. Various key operations need to be
established and sustained:
A central unit should be established that has an overall programme
manager, with two deputy managers (one in charge of a national
tuberculosis programme and one in charge of antiretroviral therapy)
reporting to the programme manager. The central unit is responsible for
the operational running of all aspects of the programme. Regional
(provincial) tuberculosis and antiretroviral therapy officers should be
established and maintained in each region: this would be a matter of
retraining the present regional tuberculosis officers in the management
of antiretroviral drugs. External technical assistance may be needed for
the initial setting up of the central unit.
One important function of the central unit will be to regularly monitor
antiretroviral drug resistance, possibly through surveys_£arn££Lout-every
1 to^years. This will inform the programme about appropriateness of
tliecurrenFdrugs, and will help to indicate when a change in drug
combinations is needed. Given the technical complexities of drug
resistance monitoring, there would need to be external support for this
activity.
The tuberculosis and antiretroviral programme should repor£on a famonthly basis, and whenever required, to a programme steering group
consisting of senior Ministry of Health personnel, director of the national
AIDS control programme, technical experts, and donors.
A joint programme manual should be prepared. This manual becomes
an expansion of the national tuberculosis programme manual. In
addition to the manual on tuberculosis control, the manual should
contain information about the structure and function of the joint
programme. The manual should be updated regularly.
A recording and reporting system should be established. Separate
registers need to be developed for recording case finding and follow-up
status: these should be based on the registers used for tuberculosis
control. Treatment cards and patient identity cards similar to tho^e used
for patientswithtuberculosis-need to-be_created for the recording of
antiretroviral DOT. Forms need to be made for quarterly reporting.
Registers, cards,^ndjjeporting forms-allow-inforination on the number
ofTases starting treatment within a quarter, the cumulative number of
cases on treatment, and their current follow-up status to be collected in
a standardised way at tach treatmenLunit. The information can be
compiled and collated at the central unit, and is vital for assessing the
use and effectiveness of antiretroviral drugs, and for planning drug
ire>mor»+ otaoHo
http://www.lancet.coni/journal/joumal.isa
8/6/01
The Journal: Current Issue
Page 7 of 10
IO
pi UV/UI Ul I ICI II IIGCUO.
At each treatment unit there should be a number of individuals
responsible for implementing the programme. There should be at least
two coordinators responsible for the registration, recording, and
reporting of tuberculosis cases and patients taking antiretroviral drugs.
With specific regard to antiretroviral treatment, this would involve
registration of patients, maintenance of confidentiality, administration of
I drugs, patient education, recording and reporting on cases, drug
ordering, and drug security. There should also be a doctor or clinical
officer who is responsible for doing ward rounds on tuberculosis wards,
for ensuring care of HIV-related complications, for referring patients for
the treatment of sexually transmitted infections, for monitoring the
efficacy of antiretroviral therapy, and for recognising and managing side
effects associated with antiretroviral treatment. In the industrialised
’ world, antiretroviral drug efficacy is monitored by regular measurements
oTvirano
ad and CD4^lymph6cyte
countsTsupplemented
oTviraHoad
CD4-lymph6cyfecounts7s
uppiemented by assays of
viTaTT^istariceTThis would be impossible for most hospitaldaboratories
in Africa. Efficacy can realistically only be monitored by measurements
ofweight and clinical examination. However, a system could be set up
that annual or 6-monthly blood tests be taken for_measurements of
plasmaTHral load in a specjaneference-laboratory. Recognising and
managing adverse drug-effects in a resource-poor environment will also
not be easy. Principal toxicities include mitochondrial dysfunction,
hypersensitivity, lipodystrophy, as well as more drug-specific side
effects.16 A system of systematically monitoring patients_dinically, with a
referral system for more detailed laboratoiv examination will need to be
explored.
I
I
There should also be a team of trained counsellors, to provide HIV
counselling and psycho-social support, referral to home-based care
groups, and linkage between hospital services and the community.
Tliese staff need to be appropriately traineUTTt is essential that
personnel can effectively deliver the care, and training should therefore
be linked to an examination system so that officers can only use
antiretroviral drugs when they can demonstrate that they know how to
use them, how to recognise side-effects, and when to institute referral
for more detailed investigation.
Voluntary HIV counselling and testing services must be established.
AntiretroyiraLdrugs should-notbe-allowed to start in any treatment unit
u nlessjhere is access to voluntary_counselling-and-testing .These
services also need to monitor their own activities using a confidential
system. Regular quality control of HIV testing, as is done with sputum
smear examination, should be put in place. There should also be
supervision of the quality of counselling services, and the central unit
might consider a central unit counsellor whose main role is to supervise
and monitor quality of services in each treatment unit. If nationwide
coverage is envisaged then treatment units, with the tuberculosis and
antiretroviral therapy team, are best set up within all central, provincial,
district, and mission hospitals. •
A regular supply of antiretroviral drugs and diagnostic material must be
secured. Antiretroviral drugs and HIV testing kits, along with anti
tuberculosis drugs and reagents and consumables for tuberculosis
diagnosis, should be procured centrally, and distributed on a regular
basis to treatment units. Knowledge of previous notification of AIDS
cases in a quarter and the.cumulative number of AIDS cases on
treatment will allow a rational system of drug ordering. A rigorous
system of monitoring drug use is also essential in order to safeguard
http://www.lancet.com/joumal/journaLisa
8/6/01
The Journal : Current Issue
Page 8 of 10
ai mi cu uvii cii uiuyo aitu pic vein duuoc.
Plans of supervision need to be prepared on an annual basis by central
and regional unit staff. Supervision of treatment units should be
undertaken on a quarterly basis. Case finding and follow-up, and up-todate data on drug supplies should be collected into structured proforma.
A long-term programme development plan should be drawn up with all
stakeholders laying out the vision, strategy, activities, reporting
mechanisms, and above all the budget and sources of funding.
Nationwide coverage cannot be done at once and a phased approach to
antiretroviral therapy will be necessary. The chosen_triple^combination
th^rap_y_shoulcLb&jlgQ£Qusly_piLotedJrLthafirst-phase with-intensive
clinical and laboratory monitoring to ensure that the regimen is safe_and
well tolerated. The aim will be to define simple and robust clinical
management algorithms for the monitoring of treatment and
complications, because in most districts laboratory monitoring will not be
f realistic. Additionally the difficult problem of defining antiretroviral
Q treatment failure will be tackled.
While this study is taking place, the pilot districts earmarked for
feasibility studies should be strengthening their infrastructure and
expanding their staff to make a basic essential package of care for
people wing with AIDS available in preparation for the arrival of
antiretroviral drugs. Once these pilot districts are ready, the feasibility of
using antiretroviral drugs integrated into the national tuberculosis control
programme structure and activities will have to be tested. To test this
integration will not be easy because the population will soon know
where feasibility studies are taking place, and it is likely that there will be
huge demand from patients outside the district. Strict criteria for
including HIV-infected patients in district feasibility studies will be
needed. These feasibility studies should include social science and
health systems input to ensure that programmes are designed as
equitably as possible and to monitor the social impact of taking these
regimens long-term, especially on the poorest sectors of society. If the
feasibility studies are successful, then the programme could be
expanded and used throughout the country.
A resource-poor country itself will be unable to support an antiretroviral
programme, and long-term donor support will be needed. This support is
more likely to come if the AIDS control programme and the tuberculosis
and antiretroviralJhempy_£>r-QgramrrieJiave developed a workingcosted, development pla n.
top
Conclusion
(j We believe that such a structure may enable antiretroviral drugs to be
' used effectively and safely within sub-Saharan African countries. Having
this framework in place, integrated with a tuberculosis control
programme, might appeal to donors who otherwise might be reluctant to
embark on support for such care. The details of how the structure is
implemented need to be worked out, and will no doubt vary from country
to country.
However, there is an important caveat to this viewpoint. Many countries
in sub-Saharan Africa are embarking on the process of health-sector
reform, which incorporates among other things a sector-wide approach
to health and decentralisation of services to district level. Vertical
http.7/www. lancet.com/journal/journal.isa
8/6/01
The Journal : Current Issue
Page 9 of 10
HC
disease control programmes, such as DOTS tuberculosis programmes,
do not fit well into this new approach to the way health services are
delivered, and there have been examples of tuberculosis control efforts
floundering when health sector reform is introduced.17 It is important for
control programme staff and health planners to work closely together in
this reform process to ensure that regular drug supplies, supervision,
monitoring, and recording are maintained and continued in an
uninterrupted fashion.
The structure we propose also needs to take account of other
approaches to antiretroviral therapy. In Brazil, nearly 20% of HIVinfected individuals receive antiretroviral therapy at no cost through the
public health system,15 and lessons need to be learnt about how this is
working in practice. Elsewhere, small numbers of patients receive drugs
at subsidised cost through donor supported projects. SrnalLtr.eatment
units based^ammid community-care groups and supported by non.governmental organisations are already springing up in needy areas.
’More information needs to be gathered about the role of private
pharmacies and the private sector in managing antiretroviral therapy,
and decisions will need to be made about whether the private sector
should be regularised and come into line with the structure used in the
public-health institutions. Whatever approach is used, it is vital that the
emergence of drug resistance is minimised and drug efficacy protected.
The costs of such an antiretroviral programme will be large. UNAIDS
has estimated that the most basic HIV prevention and care package in
Africa would cost about US$3 billion annually.18 With the addition of
provision of antiretroviral therapy and palliative treatment at a cost of
US$500 per person per year for 5 million people with symptoms the
budget rises to about US$75 billion annually. According to Attaran and
Sachs,18 this could be afforded by the international community. The
benefits which could be reaped in Africa are potentially enormous.
There is the possibility that the wise and judicious use of antiretroviral
therapy could begin to reverse some of the appalling health and
development indicators that have become associated with HIV and
AIDS in the last few years. In South Africa, it has been estimated that
triple-combination antiretroviral therapy for 25% of the HIV-1 -positive
popylation could prevent a 3-year decline in life expectancy and more
than 400 000 incident AIDS cases.19
w
An antiretroviral programme would introduce the most advanced level of
care for people with HIV and AIDS who in most countries are not
receiving even the minimum standard. Thus, such a programme may be
criticised right from the start. However, antiretroviral drugs are already
being provided in many countries in a chaotic fashion.6 We believe that
a structured system of antiretroviral provision is urgently needed in subSaharan Africa. If this is combined with an essential package of care,
the lot of patients living with AIDS could improve and drug resistance be
curtailed.
* top
References
1 Fauci AS. The AIDS epidemic. Considerations for the 21st century. N
Engl J Med 1999; 34: 1046-50. [PubMed]
2 Harrington M, Carpenter CCJ. Hit HIV-1 hard, but only when
i
http://www.lancet.com/joumal/journal.isa
onnn- occ
eo-i oe rn..uR4^^ii
8/6/01
The Journal : Current Issue
Page 10 of 10
iicucoddiy. t-a/iuci 4uuu, ouu .^ouppi;
191
1-4.U. [r~uuivicuj
3 UNAIDS. AIDS epidemic update. Geneva: WHO, December 2000.
4 Kumar S. Indian company offers low cost AIDS drugs. Lancet 2001;
357: 616.
5 Quinn TC, Wawer MJ, Sewankambo N, et al. Viral load and
heterosexual transmission of human immunodeficiency virus type. N
Engl J Med 2000; 342: 921-29. [PubMed]
6 Horton R. African AIDS beyond Mbeki: tripping into anarchy. Lancet
2000; 356: 1541-42. [Text]
7 WHO. WHO Tuberculosis Programme. Framework for effective
tuberculosis control. Geneva: WHO, 1994 (WHO/TB/94.179).
8 Maher D, Chaulet P, Spinaci S, Harries AD. Treatment of tuberculosis:
guidelines for national programmes, 2nd edn. Geneva: WHO, 1997
(WHO/TB/97.220).
9 Raviglione MC, Dye C, Schmidt S, Kochi A, for the WHO Global
Surveillance and Monitoring Project. Assessment of worldwide
tuberculosis control. Lancet 1997; 350: 624-29. [PubMed]
10 WHO. Global Tuberculosis Control WHO Report 2000.
Communicable Diseases. Geneva: WHO, 2000
(WHO/CDS/TB/2000.275).
11 Mukadi YD, Maher D, Harries A. Tuberculosis case fatality rates in
high HIV prevalence populations in sub-Saharan Africa. AIDS
2001; 15: 143-52. [PubMed]
12 Volmink J, Matchaba P, Garner P. Directly observed therapy and
treatment adherence. Lancet 2000; 355: 1345-50. [PubMed]
13 Harries AD, Maher D. TB/HIV A clinical manual. Geneva: WHO,
1996 (WHO/TB/96.200).
14 Pozniak AL, Miller
http://www.lancet.com/journal/journal.isa
i
8/6/01
Friend or foe? Looking to International law in the
Struggle for Access to Treatment for HIV/AIDS
Prepared by Jonathan Berger, University of Toronto Faculty of Law
Post-UNGASS Meeting: Social and Economic Rights in the Global HIV/AIDS
Epidemic, Hosted by the Center for Economic and Social Rights
New York City: Thursday, June 28th 2001
Two claims dominate discussions of access to essential treatments for HIV/AIDS and the World
Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPS). First, TRIPS permits sufficient regulatory flexibility to deal with crises such as the
AIDS pandemic. Second, TRIPS is too restrictive. As a lawyer, I see the reality as lying
somewhere between these two positions. As an activist, I see merit is pursuing both arguments.
There can be no doubt that TRIPS has strengthened the international protection of intellectual
property (IP) so as effectively to narrow the scope of national patent policies. Nevertheless, the
agreement does not prevent—and indeed contemplates and permits—the taking of certain legal
steps to ensure meaningful reductions in drug prices. Properly interpreted in accordance with
recognized principles of international law and in the light of the Universal Declaration of Human
Rights (UDHR) and the ICESCR, TRIPS permits countries such as South Africa to take certain
regulatory steps to ensure the accessibility of essential drugs, which include but are not limited to
compulsory licensing, early working provisions and exclusions from patentability.
Meaningful reductions in prices are achievable in two distinct ways. First, the co-operation of
the patent holder may be sought either by governments seeking to enter into agreements for the
supply of affordable medicines, or by manufacturers seeking voluntary licenses for the
production, marketing and sale of generic alternatives, subject to a royalty payment. Second, the
state may regulate prices, either directly or indirectly. Direct regulatory mechanisms include
price controls on the sale of pharmaceutical products and the parallel importation of patented
products from where they are sold at the lowest international price, with indirect price regulatory
mechanisms seeking to take full advantage of market processes by ensuring the introduction of
real competition in the form of generic manufacturers, intended to result in sustainable price
reductions as the brand name pharmaceutical industry is forced to compete for its market share.
While TRIPS does not regulate price controls and parallel importation, it has much to say
regarding indirect price regulatory mechanisms, probably the most effective and sustainable
regulatory options. It would be a mistake to see the two approaches to price reductions as
separate. While the manners of regulation may be distinct, their operation will often be
cumulative. The very existence of coercive regulatory measures may serve as an incentive for
patent holders to negotiate meaningful price reductions, of voluntary licenses on terms
favourable to both generic manufacturers and the public.
The issues I am addressing today relate to two relationships: first, the relationship between
international trade law and international human rights law; second, the relationship between
international law and domestic law. Let me begin with the first.
2
As the WTO’s Dispute Settlement Body’s primary function is to interpret trade agreements, and
given that it is a creature of a treaty, its jurisdiction is primarily limited to applying the
provisions of agreements such as TRIPS.1 Nevertheless, the Vienna Convention on the Law of
Treaties (Vienna Convention) requires that interpretation take account of “any relevant rules of
international law applicable in the relations between the parties”.2 Indeed, the Appellate Body in
the Hormones case recognized that the “direction [in Article 3.2 of the Dispute Settlement
Understanding] reflects a measure of recognition that the [GATT] is not to be read in clinical
isolation from public international law.”3 Flowing from this finding, it is not difficult to argue that
where possible, TRIPS is to be interpreted in accordance with international law more broadly. It
therefore follows that TRIPS is to be read in the light of international human rights instruments
such as the UDHR and the ICESCR, the latter of which recognizes a right to the highest attainable
standard of health as well as limited intellectual property rights.
But not everything can be solved by legal gymnastics and creative interpretation. Sometimes
language is clear. Sometimes doors are shut. And when this happens, human rights activists
may wish to argue that international human rights law takes precedence of international trade
law. I am not convinced that even the most progressive and liberal in erpretation of international
law supports such a finding.
The second relationship—international law and domestic law—is more complex. When it
relates to international economic law, many of us become strident defenders of national
sovereignty. Not so in relation to international human rights law. The international
law/domestic law relationship has two interrelated legs. First, to what extent is international law
binding? Second, to what extent should international dispute settlement bodies defer to national
interpretations of international obligations?
To the extent that international treaties are binding, they are generally only binding as between
nations. In South Africa, for example, it seems to be the case that binding treaties that have not
been incorporated into domestic law cannot be “applied directly by South African courts”, but
rather “might be employed as a guide to the interpretation of an ambiguous statute or as evidence
of a customary rule of international law”.4 'This appears to be the consensus position amongst
leading authorities on the subject. Oppenheim’s International Law, for example, states that—
[a] national law which is in conflict with international law must in most states be applied
as law by national courts, which are not competent themselves to adapt the national law
so as to meet the requirements of international law . . . Furthermore, if a state’s internal
law is such as to prevent it from fulfilling its international obligations, that failure is a
matter for which it will be held responsible in international law.5
1 James Cameron & Kevin R. Gray, “Principles of International Law in the WTO Dispute Settlement Body”, (2001)
50 lnt’1 Comp. L.Q. 248 at 264.
2 Article 31 (3)(c).
3 EC—Measures Concerning Meat and Meat Products, Report of the Appellate Body, WT/DS26 and 48/AB/R (16
January 1998) at 17 [hereinafter Hormones].
4 John Dugard, “Public International Law”, in Matthew Chaskalson et al, eds. Constitutional law of South Africa
(Revision Service 5, 1999) (Kenwyn, South Africa: Juta & Co., Ltd., 1999) at 13-3.
5 R. Jennings & A. Watts (eds.), Oppenheim's International Law, 9th ed., Vol. I (Longman, 1992) at 84.
Hl
3
HQ
The degree to which such treaties are binding in domestic law varies across jurisdictions. Under
the South African Constitution, for example, TRIPS is only binding in so far as it does not
violate the Constitution. But under international law, the position is not so clear. Article 46(1)
of the Vienna Convention provides that “[a] State may not invoke the fact that its consent to be
bound by a treaty has been expressed in violation of a provision of its internal law regarding
competence to conclude treaties as invalidating its consent unless that violation was manifest and
concerned a rule of its internal law of fundamental importance.” Quite clearly, states are not
bound by those provisions of treaties that are in clear conflict with their constitutions.6 But what
exactly constitutes a manifest breach remains unclear.
This leads me to my next point: deference. When the European Court of Human Rights applies
the margin of appreciation in deference to national laws, many of us are outraged. When the
Dispute Settlement Body of the WTO refuses to do so, the same people are outraged. Is this a
question of wanting to have our cake and to eat it too?
Customary international law supports the deferential approach to treaty interpretation. The
principle of in dubio mitius requires that if more than one possible term can be ascribed to an
ambiguous term, preference be given to the meaning that is less onerous on the party assuming
an obligation.7 This is a useful argument to make regarding the interpretation of TRIPS, but
perhaps not so desirable in connection with broader issues of access to health care under
domestic law, where international law provides greater levels of protection for poor people. On
what basis, therefore, should deference proceed?
Recognizing that “effective international cooperation depends in part upon the willingness of
sovereign states to constrain themselves by relinquishing to international tribunals at least
minimum power to interpret treaties and articulate international obligations”, Croley and Jackson
argue that some deference to national decisions may be necessary—even in relation to treaty
interpretation—provided there is a “focus on an appropriate allocation of power between
international and national governments, and if one is willing to recognize that nation-states ought
still to retain powers for effective governing of national (or local) democratic constituencies in a
variety of contexts and cultures.”8 In essence, they argue, “[s]ome trade-off is necessary.”9
6 In countries where the legal system is based on the principle of constitutional supremacy, a national constitution is
clearly an “internal law of fundamental importance.”
7 Cameron & Gray, supra note 1 at 256. Recognized in Hormones as a “supplementary means of interpretation”
(Hormones, supra note 3 at para. 165), the principle is described as follows:
The principle of in dubio mitius applies in interpreting treaties, in deference to the sovereignty of
states. If the meaning of a term is ambiguous, that meaning is to be preferred which is less onerous
to the party assuming an obligation, or which interferes less with the territorial and personal
supremacy of a party, or involves less general restrictions upon the parties. ’
(Oppenheim's International Law, supra note 5 at 1278, cited in Hormones, supra note 3 at para. 165, n.154.)
8 Steven P. Croley & John H. Jackson, “WTO Dispute Procedures, Standard of Review, and Deference to National
Governments”, (1996) 90 Am. J. Int’l L. 193 at 211. The DSU itself is silent on the appropriate standard of review,
“but there are some clauses that might support a cautious approach by the WTO panels.” (John H. Jackson, “The
Great 1994 Sovereignty Debate: United States Acceptance and Implementation of the Uruguay Round Results”,
(1997) 36 Colum. J. Transnat’l L. 157 at 182, referring to Article 3(2).•
9 Croley & Jackson, supra note 8 at 212.
:•
4
Heifer provides an interesting approach to the issue of deference and standard of review,10
arguing in the context of copyright law that “states should enjoy the most deference when they
seek to strike a balance between the exclusive rights of authors and the rights and interests of the
public and future authors in obtaining access to copyrighted works.”11 In particular, he argues,
TRIPS jurists should “recognise that they cannot stand in the shoes of national actors and re* balance these competing goals. They should thus permit courts, legislatures and administrative
bodies a wide margin of appreciation to set the balance they consider appropriate.”12
Seeing the tension in copyright issues as a clash between free expression and IPR protection,
Helfer cautions that if “TRIPs jurists [were] to constrain states’ use of IPR exceptions and
limitations to achieve free expression goals, they might well be asking states to act in
contravention of their own constitutional or human rights obligations and to place the interests of
foreign intellectual property owners over the civil and political liberties of their own citizens.”13
The difficuhy in developing principles according to which such “deference” should take place is
reduced by referring to Article 46(1) of the Vienna Convention. As mentioned above, states are
not bound by those provisions of treaties that are in clear conflict with their constitutions. Faced
with a choice between various possible inteipretations, a treaty interpreter should therefore prefer
the interpretation that is consistent with the relevant national constitution to any alternative
interpretation that is inconsistent with that constitution. Where a national constitution is silent on
issues such as access to health care, for example, no reason for deference would exist. Where a
country had failed to provide access to health care, it would be very difficult to justify the failure
on the basis of a constitutional obligation.
A principled approach to deference would also consider the purpose for which the particular
national policy was intended. A great degree of deference would be required when a member
state is discharging its constitutional or other international law duties, or, for example, when it is
legislating in respect of TRIPS-recognized public policy goals, such as public health and
technology transfer. Less deference would be justified in other circumstances, such as practices
that which do not give effect to internationally recognized public policy goals.
The recent victory against the brand-name drug industry in South Africa provides food for
thought. Arguably, South Africa’s regulatory framework for accessing essential treatments is
now in place. What we need now is action—the issuing of compulsory licenses,14 the local
manufacture or importation of generic antiretroviral drugs and drugs such as fluconazole (to
target opportunistic infections such as cryptococcal meningitis and oesophageal and vaginal
thrush), and the parallel importation of acyclovir (to treat shingles and herpes). Just getting the
regulatory' framework in place dos not necessarily translate into action.
Laurence R. Helfer, “A European Human Rights Analogy for Adjudicating Copyright Claims Under TRIPs”.
(1999) 1 E.I.P.R. 8. The author suggests that jurisprudence developed by the European Court of Human Rights
under the European Convention of Human Rights would serve as a useful guide to the approach to interpretation
under TRIPS.
"ibid, at 14.
12 Ibid.
"Ibid, at 15.
14 In terms of section 4 of the Patents Act, 57 of 1978, either the Minister of Health or the Minister of Trade and
Industry could issue a compulsory license.
5
In the context of TRIPS, barriers to access are not limited to intellectual property issues.
Affordability is a necessary but not sufficient condition for accessibility. A number of
interesting questions arise.
• How do we force governments to comply with their international human rights
t
obligations in the absence of a real enforcement mechanism? International trade law
works because the WTO dispute resolution mechanism has teeth.
• How do we assure that governments take advantage of whatever regulatory flexibility
exists under TRIPS, understanding that in the context of the HIV/AIDS pandemic, direct
challenges against developing countries at the WTO may very well give way to more
“subtle” forms of coercion?
• How do we ensure that a progressive, rights-based understanding of TRIPS serves as the
staring point for any discussions regarding regulatory flexibility? How do we ensure that
increased flexibility is expressly included in TRIPS?
• How can we use domestic constitutions (where applicable) and international human
rights law to force reluctant governments not only to put the requisite regulatory
frameworks in place, but also to use such frameworks?
• How do we force such governments to provide antiretroviral therapy when it is costeffective to do so?
Particularly in the developing world, access to treatments for HIV/AIDS is reliant on political
will. Where it does not exist, it will have to be forced.
114
E,
Other
> 'Pharmaceutical Research and Development Myths: The
Case Against The Drug Industry's R&D Scare Card"
ix Report By Public Citizen, July 23, 2001
> Questions and Answers. The Drug Pricing and Control
Order
The National Pharmaceutical Pricing Authority
public^
(jtizeri
Rx R&D Myths: The Case Against
The Drug Industry’s R&D "Scare Card"
July 23,2001
(Click Here for PDF Versions of the Report, Appendix A-Officc of Technology Assessment Studyand Appendix C-National Institutes of Health Report)
(Click Here for the Press Release)
Executive Summary
This new Public Citizen report reveals how major U.S. drug companies and
their Washington, D.C. lobby group, the Pharmaceutical Research and
Manufacturers of America (PhRMA), have carried out a misleading
campaign to scare policy makers and the public. PhRMA’s central claim is
that the industry needs extraordinary profits to fund expensive, risky and
innovative research and development (R&D) for new drugs. If anything is
done to moderate prices or profits, R&D will suffer, and, as PhRMA’s
president recently claimed, "it’s going to harm millions of Americans who
have life-threatening conditions." But this R&D scare card - or canard - is
built on myths, falsehoods and misunderstandings, all of which are made
possible by the drug industry’s staunch refusal to open its R&D records to
congressional investigators or other independent auditors.
Using government studies, company filings with the U.S. Securities and
Exchange Commission and documents obtained via the Freedom of
Information Act, Public Citizen’s report exposes the industry’s R&D
claims:
• The drug industry’s claim that R&D costs total S500 million for each
new drug (including failures) is highly misleading. Extrapolated from
an often-misunderstood 1991 study by economist Joseph DiMasi, the
S500 million figure includes significant expenses that are tax
deductible and unrealistic scenarios of risks.
• The actual after-tax cash outlay - or what drug companies really
spend on R&D - for each new drug (including failures) according to
the DiMasi study is approximately $110 million. (That’s in year 2000
dollars, based on data provided by drug companies.) (See Section I)
http.7/www.citizen.org/congress/drugs/R&.Dscarccard.hlml
8/1/01
The Case Against The Drug Industry's
R&D ’’Scare Card”
. A simpler measure - aisc^vcd irg^from $57 million to $71
.......... .
including failures. (See Section II)
. Industry R&D risks and
^^‘Xlpedlaunch^h^ most
taxpayer-funded research, wh ch ;md nwny of the best-
^Kps^»r-^fi“sc"cls',’oncrc“mvcar
surveyed (1995).
. An internal National lns‘^tcS
by Public Citizen through.the
'ZXa,»^
d^
onnfomationAct, shows
topselling drugs.
-w5-(see se“,on ’
. The industry toughl. and “XcXXXVngOffice from
congressional investigators
records. (See Section IV)
seeing the industry’s comp e e
do sQ That might
Congress can
industry Spent $262 million
owe to the fact that in 1999:^tnbut£ns and ads for cand.dates
On federal lobbymg, campaign c°s^abccompanying report, "The Other
X’wurXVXVs 625 Washmg.on Lobby.s.s")
. Drug industry R&D does
’^“X'.ndustry has been the most
claim. In every Year slJceJ98 ^ording to Fortune magazine’s
profitable in the United States acco
§
remms on revenue
rankings. During
raged ab°ut three times the
S:SXSSes re.esent.im ^Wlt
,s“eM*(s“
Section V)
. Dtue industry R&D isiess^M5= « ^on^ou, 22
percent of the new drugs ro g
ed impOrtant therapeutic gains
I^XngdX
"ere -meRoo-drugs. which often repute
listing successful drugs. (See seenon VI)
. In addition to 'ueeivtuB reeemh sutadr» the drag^.^
is
XZemSaX average for ail other industries. (See
Section VII)
8/1/01
|1ttp//www.citizcn.org/congress/drugs/R&-Dscarecard.htnil
. he Case Against The Drug Industry's R&D ’’Scare Card"
Page 3 of 11
Hl
• Drug companies also receive a huge financial incentive for testing the
effects of drugs on children. This incentive called pediatric
exclusivity, which Congress may reauthorize this year, amounts to
$600 million in additional profits per year for the drug industry - and
that’s just to get companies to test the safety of several hundred drugs
for children. It is estimated that the cost of such tests is less than $100
million a year. (See Section VI11)
• The drug industry’s top priority increasingly is advertising and
marketing, more than R&D. Increases in drug industry advertising
budgets have averaged almost 40 percent a year since the government
relaxed rules on direct-to-consumer advertising in 1997. Moreover,
the Fortune 500 drug companies dedicated 30 percent of their
revenues to marketing and administration in the year 2000, and just
12 percent to R&D. (See Section X)
Introduction
Major U.S. drug companies and their trade association, the Pharmaceutical
Research and Manufacturers of America (PhRMA), have carried out a
campaign to scare policy makers and the public. The central claim of
PhRMA’s campaign is ominous: if anything is done to restrain high U.S.
prescription drug prices, then research and development (R&D) to find new
drugs for life-threatening diseases will suffer.
Alan Holmer, president of PhRMA, recently played this "R&D scare card"
while on National Public Radio’s "Talk of the Nation" program.
"Believe me," Holmer warned, "if we impose price controls on the
pharmaceutical industry, and if you reduce the R&D that this industry is
able to provide, it’s going to harm my kids and it’s going to harm those
millions of other Americans who have life-threatening conditions.”!
Later in the program, to reinforce his argument, Holmer made the claim that
research costs "$500 million just to get one medicine to market."
The drug industry’s "R&D scare card" is built on the premise that drug
companies need extraordinary profits - about three times those of the
average Fortune 500 company - in order to conduct expensive and risky
research on innovative new drugs. But evidence shows the research isn t as
expensive, risky oi innovative as the industry claims.
Instead, the evidence shows that such research may cost far less than $500
million for every new drug - and may be less than $100 million for every
new drug (including failed drugs). The evidence also shows that the drug
industry isn’t all that innovative, as it produces far more "me-too" or
copycat drugs of little medical importance than life-saving medicines.: And,
the evidence suggests that drug industry research isn’t all that risky because
http://www.citizen.org/congress/dnigs/R&Dscarecard.html
8/1/01
i he Case Against The Drug Industry’s R&D ''Scare Card"
Page 4 of 11
the industry is awash in profits while lightly taxed and heavily subsidized.
In fact, an internal National Institutes of Health (NIH) study obtained by
Public Citizen shows that taxpayer-funded scientists and foreign universities
conducted 85 percent of the published research studies, tests and trials
leading to the discovery and development of five blockbuster drugs. = It’s no
wonder the drug industry fought all the way to the Supreme Court to keep
its R&D records hidden from congressional investigators.
In all, the evidence shows that the drug industry’s R&D scare card is, in
reality, an R&D "canard" - that is "an unfounded or false, deliberately
misleading story."
I. Deconstructing the $500 Million Myth
The story of PhRMA’s R&D canard starts with the drug industry’s repeated
— and unchallenged — claim that it costs $500 million to develop a new drug,
including money spent on failures. The $500 million figure has become
ubiquitous and widely accepted. Unfortunately, it is misleading at best and
inaccurate at worst.
Public Citizen calculated more realistic R&D costs using methodology
modeled after that employed by the congressional Office of Technology
Assessment (OTA) in its 354-page report, "Pharmaceutical R&D: Costs,
Risks and Rewards," published in 1993. (See Appendix A)
These are our findings:
• As the OTA noted, "the industry’s collective response to charges that
drug prices are too high or are increasing too fast has been to point to
the high and increasing cost of pharmaceutical R&D." Specifically,
"industry representatives have pointed to academic studies of the
average cost of bringing a new pharmaceutical compound to the
marketJ'j
• This decade, industry representatives have pointed to one academic
study above all for the S500 million figure. That is a 1991 study by
Joseph DiMasi of the Tufts Center for the Study of Drug
Development. PhRMA representatives have acknowledged that the
$500 million figure is an extrapolation, adjusted for inflation and
changes in research and development, based on the Tufts Center
study.? DiMasi estimated the pretax cost of developing certain new
drugs, including failures, at $231 million in 1987.<<
• OTA later revised DiMasi’s $231 million figure with significantly
higher opportunity cost of capital. (Opportunity cost of capital is a
calculation of what a R&D expenditure might be worth had the
money been invested elsewhere. DiMasi used a 9 percent annual rate
of return to calculate the cost of capital. OTA used a rate that went
from 10 to 14 percent over time.) OTA put the "upper bound of the
hup.7/www.citizen.org/congrcss/drugs/R&Dscarecard.html
8/1/01
1 he Case Against The Drug Industry’s R&D "Scare Card"
Page 5 of 11
id
full capitalized cost" of R&D per new drug at $359 million in 1990
dollars. Inflated to year 2000 dollars, this estimate becomes $473
million, and it has been rounded up to $500 million by the industry.
• The Tufts Center for the Study of Drug Development is a self
described "independent research group affiliated with Tufts
University." The center’s sponsors include some of the world’s largest
drug companies such as Merck, Pfizer and Baycr.> According to the
Tufts Center, corporate sponsors get to "help shape strategic
objectives" and "influence key Center activities."-
• DiMasi’s study relied on data provided by 12 drug companies, m This
information has not been independently verified, nor checked for
accuracy. The OTA issued this warning about DiMasi’s data: "Any
company that understood the study methods and the potential policy
uses of the study’s conclusions could overestimate costs without any
potential for discovery. Thus, the motivation to overestimate costs
cannot be discounted."! i
• It’s important to note that DiMasi’s study only focuses on the cost of
developing "new chemical entities" (NCEs), which he defines as
drugs that have never been tested before in humans. 12 (His definition
of NCE differs only slightly from the Food and Drug Administration
definition of a new molecular entity, or NME.i i) Furthermore, DiMasi
focuses only on "self-originating" NCEs, which are new entities
developed by companies as opposed to those they acquire from other
research organizations. Many new drugs approved for market are not
NCEs, but are new dosage forms or new combinations of existing
drugs.i4 Thus, DiMasi focuses only on the most expensive new drugs,
not all new drugs, resulting in a higher cost estimate.
• DiMasi’s original $231 million figure does not represent what
companies actually spend to discover and develop new molecular
entities. Rather, it includes the cost of all failed drugs and the expense
of using money for drug research rather than other investments. It also
does not account for huge tax deductions that companies get for
R&D. Therefore, it substantially overestimates net expenditures on
R&D.
• According to the OTA, ’’The net cost of every dollar spent on R&D
must be reduced by the amount of tax avoided by that expenditure.
Like all business expenses, R&D is deductible from a firm’s taxable
income."
• The OTA revised DiMasi’s calculation, subtracting the expenses that
are tax deductible under Section 174 of the federal tax code and the
opportunity cost of capital.
• The tax deduction reduces the cost of R&D by the amount of the
http://www.citizen.org/congress/drugs/R&Dscarecard.html
8/1/01
rhe Case Against The Drug Industry’s R&D "Scare Card"
Page 6 of 11
zm
corporate marginal tax rate (currently 34 percent). This means in
ettect, that every dollar spent on R&D costs $0.66.. The OTA
concluded that DiMasi’s original $23 1 million figure (in 1987 dollars)
was $171 million (in 1990 dollars) after accounting for the R&D tax
deduction.
The opportunity cost of capital accounts for slightly more than half
(51 percent) of DiMasi’s total figure. After subtracting tax deductions
and the opportunity cost of capital, OTA found that DiMasi’s after-tax
R&D cash outlay fora new NME was $65.5 million (in 1990 dollars).
That is the estimate of how much the drug companies in DiMasi’s
study actually spent on new chemical entities, including failures.
It should be noted that five of the seven previous R&D cost studies
that DiMasi references did not include opportunity cost of capital in
their calculations.io
• Public Citizen inflated this figure to year 2000 dollars and found that
aCt^a after-tax ca$h outlay for NCEs (including failures) was SI 10
million - based on DiMasi’s data.
(See Table 1)
• It s important to stress that this is the R&D cost for new chemical
entities - which require the most expensive type of research - not all
new drugs brought to market. The R&D costs for all new drugs
brought to market, based on PhRMA’s own data, is detailed in
Section II.
• Several additional points about DiMasi’s estimate: First, it does not
account for R&D tax credits available to the drug industiy (these are
different from the R&D deductions). DiMasi estimated that R&D tax
1072? am^nted t0 3 6'8 perCCnt Subsidy for R&D expenditures from
l^/o to 19oo.
. Second, DiMasi assumes an FDA review time of 30 months in his
calculations. FDA review time has dropped dramatically since 1991
and now averages 11 to 17 months. DiMasi said a one-year decrease
m review time would cut his R&D estimate by $19 million (in 1987
dollars, or $29 million in year 2000 dollars).
• Third, evidence suggests that the time required to conduct clinical
tnals^on new drugs is also decreasing - particularly for the most
eft‘cient companies. A January 2000 report by the Tufts Center fo
r
ie Study of Drug Development stated that clinical testing time
declined by 19 percent fordrugs approved in 1996-1998 when
compared with drugs approved in 1993-1995.17 In addition the five
quickest pharmaceutical companies shaved, on average, more than
one-year off the i ndustry-wide median time (5.7 years) for clinical
research, ix
http.7/wwW.citizen.org/congress/drugs/R&Dscarecard.html
8/i/Ol
I
fhe Case Against The Drug Industry’s R&D "Scare Card"
Page 7 of 11
• Fourth, the advent of new technologies such as genomics and
combinatorial chemistry, has led, according to investment analysts at
Lehman Brothers, "to a growing school of thought that the cost of
discovering new biological targets and the cost of creating drug leads
is falling."ri
• Finally, it should be stressed that DiMasi's estimate of R&D costs
was far higher than in previous studies, including one published by
the pharmaceutical industry in 1987. That study by S.N. Wiggins put
the pre-tax cash outlay per NCE at $65 million (in 1986 dollars).>
After-taxes, the figure becomes $67 million in year 2000 dollars.
Table 1
Comparative Analysis of Pharmaceutical R&D Costs
($ millions per New Chemical Entity)
Study (Year)
Expressed in
Pre-tax
Dollars for Including Cost
Which Year of Capital (9%)
Pre-tax
Excluding
Cost of
Capital
After-tax
Actual Cash
Outlay*
DiMasi Original
(1991)
1987
$231
$114
$61.6
Office of
Technology
Assessment
(1993)
1990
$259
$127
$65.5
Public Citizen
(2001)
2000
$341
$167
$110.2***
* Excludes the opportunity cost of capital. **DiMasi did not calculate after-tax costs;
the $61.6 million figure was calculated by Public Citizen based on the 46 percent
corporate tax rate in effect at the time of the expenditures DiMasi studied. *** The
$110 million figure is calculated using the current corporate tax rate of 34 percent;
this is the rate used to deduct R&D expenses from taxable income.
II. PhRMA’s Own Data Contradicts the $500 Million Claim
Not all R&D is created equal. DiMasi studied the most expensive of all new
drugs. Only 36 percent of drugs the FDA approved for market in the 1990s
were NMEs (similar to DiMasi’s NCEs). The others were mostly new
combinations of drugs or new formulations of existing drugs. (For example,
from pill to syrup form.)
The drug industry’s own data about this larger universe of new drugs reveal
that the actual cash outlay for a new drug is far less than S500 million - and
perhaps as low as $57 million per drug in recent years (including failures).
Here’s how Public Citizen arrived at this conclusion:
attp://www.citizen.org/congress/drugs/R&Dscarecard.html
8/1/01
fhc Case Against The Drug Industry’s R&D "Scare Card"
Page 8 of 1 1
2 ©H
PhRMA’s annual survey lists aggregate R&D spending by year in two
categories: domestic (spending in the U.S. by both foreign and domestic
companies) and abroad (spending overseas by U.S.-based companies.)
Public Citizen uses PhRMA’s domestic spending for its analysis, in part,
because that’s what DiMasi did when he ran a check on his study using
aggregate data. His reasoning: "We include only domestic expenditures in
our analysis under the assumption that the foreign expenditures of U.S.owned firms will be directed primarily to non-U.S. introductions."'. (Public
Citizen has calculated R&D costs with combined domestic-overseas
spending in Appendix B. Spending in the last decade ranges between $69
million and $87 million per drug.)
According to PhRMA, U.S. and foreign drug companies spent $139.8
billion on domestic R&D in the 1990s.. ? During that same period, the U.S.
Food and Drug Administration approved 857 new drugs for market.. <
Simple division suggests that drug companies spent $163 million on R&D
for every new drug approved for market in the U.S. in the 1990s (expressed
in year 2000 pre-tax dollars).
This measure is very generous to the industry. It counts total R&D
expenditures - which include salaries, equipment, overhead, lab tests (preclinical) and clinical trials.24 And it counts all failed drugs as well as
successful drugs. In addition, it uses PhRMA s own R&D figures, which
have not been independently verified and may be inflated with marketing
research costs.25 Finally, it uses pre-tax figures; in fact, R&D expenses are
tax deductible and every dollar spent on R&D has a net cost of only $0.66.
A more accurate measure — according to pharmaceutical experts such as
Stephen Schondelmeyer, director of the PRIME Institute at the University of
Minnesota — would account for R&D tax deductions and the approximate
seven-year lag between R&D spending and drug approval. (DiMasi said
"approvals in one year should be associated with R&D expenditures lagged
2 to 12 years."26) Therefore, a more accurate measure would compare R&D
spending for 1994 to new drug approvals for the year 2000.
To be even more accurate, the measure should account for years in which
R&D spending on new drugs was extraordinarily high or low. In other
words, it should smooth out the peaks and valleys. Thus, this measure would
compare R&D spending over seven-year periods with new drug applications
(NDAs) approved over corresponding seven-year periods. /Xn annual
average should be calculated for each period, which has the effect of
smoothing out peaks and valleys. (See Appendix B for more detailed
methodology)
The results? From 1984-1990, PhRMA reported that R&D spending totaled
$32.8 billion. (That’s domestic R&D spending by U.S. companies and
foreign-based companies.2-) Adjusted for inflation, that total is $48.2 billion
http://www. citizen. org/congress/drugs/R&Dscarecard. him!
8/1/01
Page 9 ol 11
The Case Against The Drug Industry’s R&D "Scare Card”
Divide that amount by the number of new drugs (563)
in year 2000 dollars,
1990-1996 and it appears that $85.6 million was the average
approved from 1 —
drug approved in that period (in pre-tax dollars).
R&D cost for every new
deductions, worth 34 cents on the dollar, the actual
After subtracting tax g_
cost plummets to $56.5 million.
For new drugs approved in the more recent seven-year NDA period 19942000" the Jmge pre-m e»s. ol R&D was S107.6^hors Adjusong for
R&D tax deductions makes the figure $71.0 million. (See Table 2)
Table 2
1990s
Average R&D Cost per New Drug Approved During the
(Rolling 7-Year Average with 7-Year Lag,
$ in millions, all in year 2000)
Domestic R&D Spending Only
7-Year
R&D
Period
Average
Annual
R&D
Spending
1988-1994
$10,255?" 1994-2000
$9,3877? 1993-199?
7-Vear NDA
Period
Average
Annual
NDA's
Approved
95?]|
1986-1992
1985-199?
$8,4733
1992-1998
$7,6133
1991-1997
91.3
9Z4
80
1984-1990
$6,887? 1990-1996
804
1987-1993
After-Tax
Pre-Tax R&D
R&D
Spending per Spending per
New Drug
New Drug
$107?]
$71.0
$677?
$91.7
$60^5
$86.0
$85.6
$567
$56.5
based pharmaceutical companies.
Two additional notes:
with the seven-year lag, arguing that in accounting
Some might quarrel
-,-s are paid by today’s revenue. Thus, R&D
terms, today’s R&D expenses
• t to be compared with drugs brought to market
spending in any year ought t_
tha7s"am°e ’year This study rejects that argument. It doesn’t reflect the reality
that R&D^spending invariably precedes the marketing of a drug and ou
that
R&D spending
invariably
numost?s
o ^efstand
wha? itprecedes
costs to bring a drug to market not how
purpose
mTR&D s oaid for in accounting terms. In addition, as noted earher,
111C4V UV***** j - ---------
»
~
DiMasi agrees that spending should be lagged two to 1
years.
Nevertheless Public Citizen calculated R&D spending for current drug
approvals and current research expenditures in Appendix B and1 found h
spending remained close to $100 million per drug, with costs in
ranging from $99 million to $118 million per drug.
hitp://www.citizen.org/congress/drugs/R&Dscarecard.html
8/1/01
Page 10 of 11
/The Case Against The Drug Industry’s R&D "Scare Card"
2O&
$
1
Finally, it has also been suggested that our analysis should focus only on
NCEs or NMEs because that’s what DiMasi studied, and that’s where the
bulk of industry R&D is spent, and those new compounds are the drugs that
make the industry risky. That analysis is below (see Table 3) although our
intent was not to mirror DiMasi in this section. Rather, this section aims to
point out that there are many kinds of drugs approved each year - not just
the elite group in DiMasi’s study. More important, PhRMA's R&D
spending figures - the figures that it constantly touts - are for all drugs, not
just NMEs or NCEs. So it's only fitting to compare PhRMA’s spending for
all drugs to all drugs approved for market. (That said, an all-NME analysis
shows R&D spending of SI 14 million to $150 million per drug.)
Table 3
Average R&D Cost per New Molecular Entity During the 1990s
(Rolling 7-Year Average with 7-Year Lag, $ in millions)
Domestic R&D Spending Only
7-Year
R&D
Period
Average
Annual
R&D
Spending
7-Year
NME
Period
Pre-Tax R&D
Average
Annual NME*s Spending
per NME
Approved
1988-1994
$7,588.9 |pl 994-2000
334
$227.02
1987-1993
1986-1992
$6,947.01| 1993-1999
$6,270.2|| 1992-1998
33.7|
$209.61
31.9]
$5,633.6|[ 1991-1997
1985-1991____________
1984-1990 || $5,096.4[| 1990-1996
31.9]
29.6][
$196.82
$176.84
$172.34
After-Tax
R&D
Spending
per NME
$149.8
$138.3|
$129.9|
$116.7|
$113.7|
Source: Spending data comes from Pharmaceutical Research and Manufacturers
of America, PhRMA Annual Survey, 2000; NDA data comes from U.S. Food and
Drug Administration, Center for Drug Evaluation and Research, December 31,
2000. (All spending figures have been inflated to year 2000 dollars.)
Note: Domestic R&D includes expenditures within the United States by research
based pharmaceutical companies.
III. U.S. Taxpayers Play A Crucial Role in Pharmaceutical
R&D
Drug companies stress how difficult it is to discover new drugs particularly innovative life-saving drugs. But the evidence suggests it’s not
all that risky because the federal government is doing much of the crucial
research. The National Institutes of Health (NIH) budget reached $20.3
billion in fiscal year 2001 (a 14 percent increase over FY 2000) with much
of that money going to research that ultimately helps with the discovery and
development of pharmaceuticals - how much exactly is hard to say. The
NIH admits it doesn’t track its spending on drug development. NIH officials
claim it’s a tough task because so much NIH work is basic research into
diseases that is converted years later - often through several other related
http://www.citizen.org/congress/drugs/R&Dscarecard.html
8/1/01
flic Case Against The Drug Industry’s R&D Scare Card
Page 11 of 11
discoveries that build on one another - into a marketed drug...>
What we do know is that several studies have shown that many important
and popular drugs were developed with taxpayer support. 1 hat s why
publicly-funded researchers have 90 Nobel Prizes compared to just lour by
industry scientists, although the industry spends more on R&D..:-. For
instance:
. A study by a Massachusetts Institute of Technology (MIT) scholar of
the 21 most important drugs introduced between 1965 and 1992 found
that publicly funded research played a part in discovering and
developing 14 of the 21 drugs (67 percent).-"
. 45 of the 50 top-selling drugs from 1992-1997 received government
funding for some phase of development, according to an investigation
by The Soslan Globe. In all, taxpayers spent at least SI75 million
helping to develop these 50 drugs.si
Publicly-funded Researchers Conducted Most Studies Behind
Blockbuster Drugs
An NIH internal document obtained by Public Citizen through the Freedom
of Information Act ("NIH Contributions to Pharmaceutical Development,
February 2000, see Appendix C) reveals much more detail about the
importance of taxpayer-funded research to drug companies.
The NIH report looked closely at the role of public research in developing
the most popular drugs in the U.S. To avoid well-known NIH success
stories, such as the agency
http://www.citizen.org/congress/drugs/R&Dscarecard.html
8,1/01
ivairoirdi rii'aruraccu’iica’i-i riving
-o- -
2.08
tjfcFAa
A) Drug Pricing and Objectives
Q.l What are the Objectives of the Drug Policy7
Q.2 What is the "Drugs (Prices Control) Order (DPCO,
1995)"?
DPCO is issued under Essential Commodities
Q.3 Why the
i
(EC) Act?
Q.4 Are all the drugs marketed in the country under price
control?
Q.5 What is NPPA and its role?
.
B) Features of DPCO
Q.6 How are the prices of drugs in the controlled category
regulated?
Q. 7 What is "Ceiling Price"?
Q.8 What is "Non-Ceiling Price"?
Q.9 Whether NPPA has any role to regulate prices of nonscheduled drugs?
Q.10 What margins are allowed to a Wholesaler and a
Retailer as per DPCO, 1995?
C) Punishment for Violation
____
punishmentb for violating the DPCv>,
Q.ll What are the
t
1995?
Q.12 What happens if a manufacturer sells a medicine
above the price approved by the Government?
HOME
Message from Chairman
Resolution
Functions ot N P P A
From the Member Secretary's Desk
Drugpolicy 1986
Modifications in Drug Policy 1986
Drugs (Prices Control) Order 1995
List of Controlled Bulk Drugs
Exemption Order
Norms for CC/PC/PL
Production Data
What's Hew
Archive
list of Officers
Price Notifications
Press Releases
Prorata Price • Notification
Issues for your Comments
Feedback
Q.13 Who are the national level, state level and district
level authorities that are responsible for enforcement of
fixed prices?
Q.14 Who are the local level authorities to whom the
compliant can be made?
Q.15 Where can a consumer lodge a complaint regarding
overcharging and quality of drugs sold?
Q.16 What is a retail price?
Q.17 What is the essential/ mandatory information that is
required to be printed on the label of the medicine pack?
Q.18 Labels of the medicines carry words 'local taxes
extra'; which are these and what are the rates7
Q.19 What is the total amount required to be.paid for a
medicine?
Q.20 If a retailer sells medicines by breaking packing,
what price can he charge?
Q.21 Can consumer ask for the price list of medicines
being sold by a chemist/retailer?
Q.22 Is it mandatory for a chemist/ retailer to issue cash
receipt for sale of medicines?
http://www.nppaindia.com/frequcnt.html
10/6/00
' r
v/i 'r
2O<?
F) General reasons for price increases in medicines
Q.23 Why are the prices of medicines rising?
G) Price Fixation procedures
Q.24 What is the methodology for fixation of bulk drug
price?
Q.25 What is the methodology for fixation of price of
formulation?
Q.26 What is Suo-motu pricing?
Q.27 What is Pro-rata Pricing7
A) Drug Pricing and Objectives
Q.l What are the Objectives of the Drug Policy ?
Ans. As per the Modifications in Drug Policy, 1986 announced in September, 1994, the
main objectives of the Drug Policy are as under :
a. ensuring abundant availability, at reasonable prices of essential and life saving
and prophylactic medicines of good cuality;
b. strengthening the system of quality control over drug production and promoting
the rational use of drugs in the country;
c. creating an environment conducive to channelising new investment into the
pharmaceutical industry with a view to encourage cost-effective production with
economic sizes and introducing new technologies and new drugs;
d. and strengthening the indigenous capability for production of drugs.
Q.2 What is the "Drugs (Prices Control) Order (DPCO, 1995)" ?
Ans. The Drugs Prices Control Order, 1995 is an order issued by the Government of
India under Sec. 3 of Essential Commodities Act, 1955 to regulate the prices of drugs.
The Order interalia provides the list of price controlled drugs, procedures for fixation of
prices of drugs, method of implementation of prices fixed by Govt., penalties for
contravention of provisions etc. For the purpose of implementing provisions of DPCO,
powers of Govt, have been vested in NPPA.
Ans. Drugs are essential for health of the society. Drugs have been declared as
Essential and accordingly put under the Essential Commodities Act.
Q.4 Are all the drugs marketed in the country under price control ?
Ans. No, Only 74 out of about 500 commonly used bulk drugs are kept under statutory
price control. All formulations containing these bulk drugs either in a single or
combination form fall under price controlled category. However, the prices of other
drugs can be regulated, if warranted in public interest.
Q.5 What is NPPA and its role ?
Ans. National Pharmaceutical Pricing Authority (NPPA), was established on 29th August
1997 as an independent body of experts as per the decision taken by the Cabinet
committee in September 1994 while reviewing Drug Policy. The Authority, interalia, has
http://www.nppaindia.com/frequent.html
10/6/00
.ational Pharmaceutical Pacing Authority : wnaxs inew
been entrusted with the task of fixation/revision of prices °f Pha2"a“fXs ConSl)
B) Features of DPCO
n fi Hnw are the orices of drugs in the controlled category regulated ?
Ant As per the provisions of DPCO, NPPA fixes two types of prices viz. Ceiling prices
and Non-ceiling prices for medicines in the controlled category.
?ra7 K
IS -0- price cenrro, . «e —
selling price is fixed that is applicable throughout the country.
~in
notified as exclusive of excise duty, local tax, etc.
local taxes are not included in the Non-ceiling pace.
Q.9 Whether NPPA has any role to regulate prices; of^"'^^^'^jcecontrol)
I
ls
I
Q.10 What margins are allowed to a Wholesaler and a Retailer as per DPCO,
“s9” scheduled (centrohed) drugs the margin is hxed at 16% as per para 19 et the
DPCO, 1995 which is reproduced below .
1.
"A Manufacturer, distributor or.wholesaierseN a^fo
unless otherwise permitted under the pr
order made
specified by an order or notified
Simeon per cent thereat
2.
by a general or special order fix, in P^b''c'"Emulation the price of which has
to the wholesaier or retaiier '" respect. f
y
h du|ed formulations the
^^"Xe
mjgin. However. It is repoHed h, the
10/6/0C
http://www.nppaindia.com/frequent.html
.ational Pharmaceutical Pricing Authority : Whats New
Page 4 of 7
xn
industry that the prevailing normal trade margin in respect of some decontrolled
formulations is 20% for retailers and 10% for wholesalers.
C) Punishment for Violation
Q.ll What are the punishments for violating the DPCO, 1995 ?
Ans. Contravention of any of the provisions of DPCO, 1995 is punishable in accordance
with the provision of the Essential Commodities Act, 1955. As per Sec. 7 of Essential
Commodities Act, the penalty for contravention of DPCO is minimum imprisonment of 3
months, which may extend to seven years and the violator is also liable to a fine.
Q.12 What happens if a manufacturer sells a medicine above the price
approved by the Government ?
Ans. If a manufacturer sells a medicine at a price higher than the price approved/ fixed
for the product the manufacturer is liable for prosecution under Essential Commodities
Act and also liable to deposit the amount with the Government accrued due to charging
of prices higher than those fixed or notified by the Government.
D) Enforcement Agencies
Q.13 Who are the national level, state level and district level authorities that
are responsible for enforcement of fixed prices ?
Ans. The National Pharmaceutical Pricing Authority, the FDA/ Drugs Controller of the
State, and Drugs Inspector of the District are the enforcing authorities at National /
State/ District Levels.
Q.14 Who are the local level authorities to whom the compliant can be made ?
Ans. The area State Drug Controller/Joint Drug Controller/ Deputy Drug
Controller/Assistant Drug Controller / Drugs Inspector etc. of the state concerned.
Complaints can be lodged with anyone of these.
Q.15 Where can a consumer lodge a complaint regarding overcharging and
quality of drugs sold ?
Ans. Charging more than printed MRP of a medicine attracts the penal provisions of
Drugs Price Control Order, 1995. Qua'ity aspects of a medicine attract the provisions of
Drugs and Cosmetic Act, 1940. The FDA/ Drugs Control Organisation of the State is the
enforcing agency of Drugs and Cosmetics Act and DPCO at state level. Therefore, all
complaints on prices as well as quality of medicines can be lodged with the Drugs
Inspector of the District or the State Drug Controller. Complaints regarding violation of
prices can be lodged with NPPA directly also.
E) Retail price and labeling requirements
Q.16 What is a retail price ?
Ans. A retail price is a price at which a formulation / medicine is sold to a
consumer/user. The manufacturer of the formulation is required to print such a price on
the label of the product. In case of controlled formulations the retail price is a price
arrived at or fixed in accordance with the provisions of Drugs (Prices Control) Order,
1995.
http://www.nppaindia.coni/frequent.html
10/6/00
ational Pharmaceutical Pricing Authority : Whats New
Page 5 of 7
11
Q.17 What is the essential/ mandatory information that is required to be
printed on the label of the medicine pack ?
Ans. The following information is required to be printed on the label of a medicine under
the Drugs and Cosmetics Act and DPCO, 1995.
a. Name of the formulation
b. Composition of the formulation
c. Pack Size
d. Address of the manufacturer
e. Manufacturing License Number
f. Date of manufacture
g- Expiry Date
h. Maximum Retail Price (Excluding Local Taxes) etc.
Q.18 Labels of the medicines carry words 'local taxes extra'; which are these
and what are the rates ?
Ans. They generally include Sales Tax and Octroi. Whenever the manufacturer pays the
Central Sales Tax (CST) the same is also included. They are to be paid by the customer.
Q.19 What is the total amount required to be paid for a medicine ?
Ans. The printed MRP (Maximum Retail Price) plus local taxes is the maximum payable
amount. However, a medicine can be sold below this price.
Q.20 If a retailer sells medicines by breaking packing, what price can he
charge ?
Ans. If a retailer sells loose quantity (unpacked) the price of such medicine should not
exceed pro-rata amount of the price printed on the label of the container, plus 5%
thereof.
Q.21 Can consumer ask for the price list of medicines being sold by a
chemist/retailer ?
Ans. Yes. Every retailer is required to display the price list and the supplementary price
list furnished by the manufacturer/ importer on a conspicuous part of the premises
where he carries on business in a manner so as to be easily accessible to any person
wishing to consult the same.
Q.22 Is it mandatory for a chemist/ retailer to issue cash receipt for sale of
medicines ?
Ans. Yes. Every chemist/ retailer is required to issue a receipt for sale of medicines and
maintain the copies of cash/ credit memos.
F) General reasons for price increases in medicines
Q.23 Why are the prices of medicines rising ?
Ans. The reasons for rise in the prices of medicines are :
i. rise in the price of bulk drugs;
ii. rise in the cost of excipients used in the production of medicines like Lactose,
Starch, sugar, glycerine, solvent, gelatine capsules etc.;
iii. rise in the cost of transport, freight rates;
http://www.nppaindia.com/frequent.htinl
10 6/00
aiional Pharmaceutical Pricing Authority : Whats New
Page 6 of 7
21^
iv. rise in the cost of utilities like fuel, power, diesel, etc.;
v. for imported medicines, rise in the c.i.f. price and depreciation of the Rupee;
vi. changes in taxes and duties.
G) Price Fixation procedures
Q.24 What is the methodology for fixation of bulk drug price ?
Ans. Methodology for fixation/revision of bulk drug prices is as under :
As per para 3 of DPCO, 1995, bulk drug prices are fixed by the NPPA to make it
available at a fair price from different manufacturers. These prices are, fixed from time
to time by notification in the official gazette.
The following steps are involved in fixation/revision of bulk drug prices
1. Collection of data by issuing questionnaire/Form I of DPCO, 1995 to the
companies and from cost-audit report etc.
2. Verification of data by plant visits, when required.
3. Preparation of actual cost statement.
4. Preparation of technical parameters to be adopted for working out fair price of the
bulk drug.
5. Preparation of estimated cost based on actual cost and technical parameters. Fair
price is calculated by providing returns as specified in sub para (2), para 3 of
DPCO, 1995 as opted by the individual manufacturer.
6. Fixation of fair price of bulk drug by considering weighted average cost, °rd cut
off level of production studied.
7. Notification of bulk drug price in official Gazette.
8. The fair prices may be further revised, if asked for by the manufacturers, based
on escalation formula for change in major raw materials and utilities rates.
Ans. Para 8 of DPCO, 1995 lays down the rules and procedure for fixing prices of
formulations. Para 7 of the DPCO lays down the formula for calculation of retail price of
formulation.
The circumstances that warrant price fixation of formulation are :i.
ii.
iii.
iv.
Revision in the prices of bulk drugs(Sub-Para(2) of para 8 of DPCO, 1995)
Introduction of new packs ( Sub -Para (6) of para 8)
Change in various norms etc. notified by Government under para 7.
Other reasons which may be cited by the manufacturer.
In order to seek price approval , the firm manufacturing the pack has to make an
application in Form -III appended to the DPCO, if it is locally manufactured; or Form-IV
appended to the DPCO, 1995, if it is imported.
Applications received in NPPA from manufacturers in Form III for indigenous
formulations and from importers in Form IV (as prescribed under DPCO, 1995) are
considered for price fixation/revision. The retail prices of indigenously produced
formulations are worked out as per the formula given in para 7 of the DPCO, 1995. For
indigenously manufactured formulations, the Maximum Allowable Post-manufacturing
Expenses 'MAPE) is allowed upto 100%. For imported formulations MAPE is upto 50%
of landed cost.
http://www.nppaindia.com/frcquent.html
10/6/00
.ational Pharmaceutical Pricing Authority : Whats New
Page 7 of 7
Q.26 What is Suo-motu pricing ?
Ans. The NPPA also fixes/revises prices of both bulk drugs and formulations on suomotu basis, where it is felt that manufacturers are not filing their applications as per the
provisions of the DPCO, 1995 after the decrease in bulk drug prices and statutory
duties, etc. Hence, with a view to passing on the benefits of such decreases to the
consumers, suo-motu price is fixed. For example, as per para 8(2) of DPCO, 1995, the
manufacturers are to apply for price revision of formulations within a period of thirty
days of price fixation/revision of bulk drug(s). If they fail to comply with this during the
prescribed time, suo- motu action is taken as per para 9(2) of DPCO, 1995 for ceiling
prices, and as per para 8(2) and para 11 of DPCO, 1995 for non-ceiling packs.
Q.27 What is Pro-rata Pricing ?
Ans. NPPA has issued notification on pro -rata pricing on 27.01.98. According to this
notification, the manufacturers of all the scheduled formulation pack sizes different from
the notified pack sizes under sub- paragraphs (1) and (2) of the paragraph 9 of the
DPCO, 1995, shall have to work out the price for such pack sizes, in respect of tablets
and capsules of the same strength or composition packed in different strips or blisters,
on pro-rata basis of the latest ceiling price fixed for such formulations under sub
paragraphs (1) and (2) of para 9 of the DPCO, 1995. This was done to ensure that :i. manufacturers are not forced to approach frequently for price approvals for
different pack sizes and
ii. the manufacturers do not change the pack sizes in a bid to remain out of price
control.
Every formulation of a bulk drug included under schedule 1 of DPCO, irrespective of
pack size, strength, dosage form must be marketed only at price fixed by Government,
with adjustment for pro-rata price wherever required. However, the manufacturers in
the Small Scale Industry (SSI) category may avail exemption from seeking price
fixation from NPPA in respect of Scheduled Formulations not covered under ceiling
prices provided they have submitted a declaration to NPPA as per S.O.No. 134(E) dated
2nd March, 1995 and obtained approval for the same from NPPA.
Top of the Page | Home
http://www.nppaindia.com/frequent.html
10/6/00
Position: 2630 (2 views)