DRUG SITUATION AND IN THE IERNATIONAL LEVEL
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- DRUG SITUATION AND IN THE IERNATIONAL LEVEL
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RF_DR_18_SUDHA
DRUGS*
THE cost of modern drugs is invariably so high that
an Overwhelming majority of the Third world <s
population cannot rifford to purchase them.
IN developed countries drug costs represent only 10-20%
of the total health care expenditure. IN MANY DEVELOPING
COUNTRIES PHARMACEUTICAL COSTo REPRESENT 40-60%. It is,
thereforef Important that ways and means be found to reduce
the cost of drugs in developing countries*
THE first thing for any country to do9 according to WHO,
is to prepare a list of essential drugs
vzhich they can
afford and which are needed to meet the basic health needs of
the majority of the population* But by restricting imports
to these drugs which meet most of the health needs, and
abolishing the use of brand names for drugs in favour of
generic non-proprletary names, countries can obtain large
savings in drug costs* WHO’s Basic Drugs List contains about
200 drugs, subject to modification for national needs, and
according
to the Mahler-Labouisse report to Alma-Ata, "the
number needed for primary health care may be lower than 2^0"*
UNCTAD (UN Conference on Trade and Development) has proposed
that developing countries should Increase their purchasing
power against the large drug companies. They should centralise
their drug Imports via a single state-controlled Drug Buying
Agency* Wherever possible9 UNCTAD proposes that Third world
countries should also try to Join one another and combine
their drug purchases. This will give them further bargaining
power*
*8ourcet PRIMARY HEALTH CARE i Earthscan Press
Briefing D^cyment No 9, July 1978 pp 33-34.
2
►
ti
2
SRI LANKA has tried such a strategy and obtained
con sid er able savings•
SUCH regional purchosing agencies will take time to
set up. In the meantime, UNICEF, which has a substantial
drug purchasing programme of its own, offers to buy drugs
on behalf of developing countries.
UNIDO (UN Industrial Development Organization) is
me inwhile
trying to help developing countries set up
their own basic drug induatiies^ at least for formulation
(tabletting, capsuling, etc) and packa ing drugs.
BOTH UNIDO and WHO feel that many druj needs can now be
met by the judicious use and production of tr ad it ion ally -
used herbs.
Many locally available medicinal plants
|—»WI T'- WW—»■»»*—
can also become the source for local production of drugs.
WHERE possible, the UN agencies also propose that developing
countries should cooperate to set up Cooper at iye^ Fharmaceu-
tical Production and Technology Centres to produce drugs
for regional markets ano help in pooled procurement of
drugs#
THESE ideas indicate the emergence of composite UN
strategy to mvct the pharmaceutical needs of 6 eye losing
countries.
THIS strategy is clearly in conformity with the New
International Economic Order. It will also advance appropriate
technology, and the process of technological cooperation
among developing countries (TCDC)»
\
■
COUNTRY PROFILE^
Vietnam
Growth of plant-basec5 pharmaceutic Is.
Herbal gardens in villages•
State farms for medicinal plants.
40 new drugs from local herbs.
Sri L^ka
Bulk purchasing through state Pharmaceutical
Corporation (1^71).
adopted limited list of drugs (6Ou).
Restricted prescribing to generic names.
(Multi-National Corporations (MNCs)
blew up plan - 127b).
Pakistan
Generic prescribing (failed)•
Bangladesh
1707 drugs banned (June 19b2) in three schedules:
Schedule I
I
Schedule II
305 banned immediately.
1?4 banned after 6 months.
Schedule I I :126b to be manufactured locally*
(Modifications on pressures from MNCs through
U.s.jBxitish) Dutchy German embassies).
Mozambique
Restricted Drugs in Market.
China
Traditional Medicine and Herbal remedies
promoted as part of drug policy*
50 herbal medicines included in pulley*
Accupuncture promoted.
Bare-foot doctors.
COMMUNITY health cell
47/1,(First FlooDSu. Marks Soad
BANGALOHE-biiOOOl
DIARRHOEA AND DRUG^*
IN the rich world , where the treatment of diarrhoea
aims to relieve inconvenience rather than save life,
a variety of drugs is used#
SINCE there are so many possible causes of diarrhoea,
it is often not possible to identify the cause, let
alone attack it directly with drugs® This is particularly
true in poor communities, where there are few expensive
diagnostic laboratories*
IN the Third world
drugs are therefore of limited value
in tackling diarrhoea®
WHO, in a Manual of the Tr atment of Diarrhoea, warns
WA number of medicines which are of no value and are
even dangerous, are often given to tr at diarrnoea* Money
and time are wasted in their use“®
THIS advice sometimes conflicts with the. hard sell of
the rich world *s drug companies® American pharmaceutical
firm G®D® Searle has encouraged its
representatives
to claim that its product lomotil has “an important
role in the treatment of such diarrhoeas to help
prevent dehydration. ”
The WHO manual on the other hand dismisses the drug
as of *no value %
2
♦source: PRIM ARY HEALTH CAR?: Earthscan Press
Briefing Document No 9, July 197b fp 3a*39
♦
<•
2
IN Britain and the UbA, it can only be obtained with
the prescription of a doctor* Yet in some poor countries^
Lomotil is freely available—over the counter without
warr ing of possible dangerous side effects, particularly
to children*
GOVERl MENT he-1th services still spend money on such
products* In Tanzania, fox instance, a doctor found recently
that *2S,OOQ (6 35,000 shillings) a year was being spent
on Lomotil and other anti-dlarxhoeal drugs of doubtful
effectiveness• The WHO’e list of essential drugs is intended
to exclude this sort of wasteful purchase*
T
The State Of The Philippine Drug Business*
by Nelia Cortes-Maramba, M.D.
This morning, I would Like to share
with you some knowledge about the drug
business in the Philippines and the
problems affecting the Third World as
far as drugs are concerned. The slogan,
"Health for All in The Year 2000,"
given by Dr. Mahler of the World Health
Organization (WHO) is familiar to us.
The Philippines as a signatory of the
United Nations agreed to implement this
thrust. But how are we going to
achieve this, when we as developing and
underdeveloped countries have Lots of
problems?
Whereas tn the developed countries the
expenditure for pharmaceuticals com
prise only 10% of the total health
expenditure, in the Third World it
varies from 63.8% to 18.3%.
In 1980,
the total drug expenditure in the
Philippines amounted to ?2.? billion
<US$ 330 milj. This comprises 50%
of the total health expenses
Now,
how much does the government spend? It
is only 16.5% because they do not have
enough money to buy drugs. Since 1968,
the Philippine government has alloted
J?150 million to purchase drugs every
year. You can imagine what P150 million
can buy m 1981.
It is probably 1/10
of the volume that we were buying m
1968. And if you analyse the drugs
that are being used in our primary
health care system, you will find out
that 45% of the drugs are for symptom
atic therapy. This means you never get
cured from the disease.
As far as drug usage is concerned, we
in the Third World are being mani
pulated by the drug companies. How is
this so? Instead of selling only those
drugs which are necessary to meet the
health demands of the country, they
create a demand for drugs which has no
relation to the actual needs of the
population through strong promotional
efforts. We can see that their sole
business is money. Saleability of the
product is the main gauge. They tell
4
Dr Nelia Cortes-Maramba, Chairman of
the Department of Pharmacology of the
University of the Philippine College
of Medicine> delivered this speech
us,
"Why should we not sell them when
doctors and even primary health care
workers like nurses and midwives pres
cribe them?" But that is not correct.
Part of their commitment as a drug in
dustry is to teach us to prescribe
properly.
Let us take a Look at how they promote
their drugs. Take for example, Diazepam
or Vaiium. There are 28 brand names of
Diazepam in the country. How much do we
need it? This drug is for anxiety.
But
we can get rid of anxiety through many
other means.
But what do the companies
do? They tell* the doctors,
"Para hinda
tumagal ang inyong panahon sa isang
pasyente, imbis na makipagkuwentuhan,
bigyan na Lang ninyo ng Valium, Pacitran
o ng ibang brand names ng Diazepam."
(To spend Less time with a patient, ]USt
give him Valium, Pacitran or other
brands of Diazepam instead of talking
with them.) Of course, the physician
who wants to earn more money would buy
this kind of salepiece hook, line and
sinker’ And who gets the problems? The
people.
But in the first place, how did
the doctors know Diazepam?
It is pro
moted like hell to the physicians.
Another problem that we face is the
number of active principles and drugs ot
formulation that are sold m the market
which vary from 2,000 to 20,000 in the
Third World countries. In Switzerland,
the total number of brand names is only
1,500. They have kept this for the last
15 years. Yet in an underdeveloped
country, the minimum that WHO found was
2,000. Does this mean that we have to
use more drugs? No, if we look at our
problems they are mainly those of pre
vention and infectious diseases, We
don't need most of those brands,
It has
been estimated that if we go generic and
that includes our own purchase of drugs
from the government, then we can actual
ly save J*70 million annually. If we buy
brand names, the prices are doubled.
For example. Chloramphenicol USP 250 mg
during the NEHCC-NCCP sponsored Herbal
Medicine Course3 Nov. 4/81. The. source
of this article is Health Concerns>
Vol. 2, No. 6, Nov/Dec. 1981.
COMMUNITY HEALTH CELL
«7/1.(First Floor)St. Marks f?oa<f
BAWGAl,oaE-5S0 0Q1
S. 1/4/82
(a generic) is sold at ^0.70 per
capsule but Neophenicol 250 mg (a brand
name) is sold at £1.40 per capsule.
Using generics is but one of the many
ways we can save.
In 1977, I joined the CIOMS Round Table
Conference on Drug Research and Develop
ment; Dr. Gahr, Minister of Health of
Egypt at that time, presented his fiveyear study of the drug industry through
out the world. He found out that the
net return from the drug industry (11%)
is greater than the net return from
oil. You can imagine how much all
these drug industries earn all over the
world and sad to say a big amount of
their earnings come from the Third
World countries. Why is this so?
The Philippines, for example, imports
95% of the active raw materials that
are required for the formulation and
compounding of drugs. At present, only
alcohol, sugar and starch are manu
factured locally. It has been estimated
that if symptomatic drug preparations
are replaced by medicinal plants which
have been found effective through basic
and clinical study, then we would save
about ?67.5 million every year. The
cost of importation of raw materials
was US$39 million in 1976. According
to former Minister Jose Leido, Jr.,
we can save as much as ?375 million
annually if raw materials come from
local plants. But then remember that
the multinationals are the ones that
are here and it is not easy to im
plement this. Let us look at who
controls the drug business in the
Philippines:
Drug Companies
1974
1978
Multinationals
70%
50%
United Laboratories
26%
45%
Filipino drug com
panies
4%
4%
Let us look at what the multinational
drug company owners do. Take the case
of the cost of importation of ampi ci 11 in
in 1976.
Companies
Date
Cost
per kilo
US$
Bristol/Mead Johnson
(from parent co.)
Jan. ’ 76
$177.47
Beecham
(from parent co.)
Feb.’76
$251.00
Doctors Pharmaceu
tical
- Filipino owned
(bought from world
market)
Jan.’76
$81.38
Zodiac (voluntary
licensor - Beecham)
- Filipino owned
Apr.'76
$115.00
United Labora
tories
Apr.'76
$141.00
I
The subsidiary pays more for the same
ampicillin from its parent company This
is one way of channeling the dollars
back to the parent company. They are
able to salt it out in the guise of highpriced raw materials because if they buy
ampicillin at US$141.00/kilo (United
Laboratories) they cannot have an addi
tional profit of US$80.OO fox every kilo
of ampicillin that they buy from their
own parent company. This is one way of
cheating the government.
For this reason, prices of drugs vary
from company to company. Among the
Third World countries, prices of drugs
are more expensive in the Philippines.
If we take a look at one drug, we can
get a picture of what is happening.
Ampicillin in the Philippines is 365%
more expensive than in Malaysia, 260%
more expensive than in Papua New Guinea,
300% more expensive than in the US, 40%
more expensive than in Afghanistan, It
is, therefore, no wonder that 50% of
our expenditures on health care go to
pharmaceuticals because we have one of
the highest-priced medicines in the
world.
It is high time that we use medicinal
plants especially because we have more
than 800 indigenous plants with medici
nal properties. But some people say,
"The use of medicinal plants is going
backward. How is that? We are already
underdeveloped, why don't we move
forward?" One thing I can say is that
even in a developed country like USA
in 1973'to 1979 the sales of drugs
coming from medicinal plants totalled
US$2.3 billion annually.
Crude Extract
Total no.of
Prescription
% of
total
Belladonna
10.4 million
0.68%
Ipecac
7 million
0.46%
Opium
6.9 million
0.45%
Rauwolfia
5.8 million
0.38%
Cascara
2.4 million
0.16%
Digitalis
2.4 million
0.16%
Citrus
Biflavonoids
1.4 million
0.09%
Veratrum
1.1 million
0.07%
Be Iladonna has 2 active principles:
scopolamine and atropine. For pre
anesthetic medication, nothing can re
place atropine to prevent respiratory
depression secondary to opiates, to
dry up the mucus membrane so that you
can induce general anesthetics without
vagal reflex and without secretion
clogging up the patient. Why can we
not use Belladonna? Can we not put up
an industry to extract atropine from
our own medicinal plants?
Syrup of Ipecac is the best drug to
induce emebis in cases of poisoning.
Of course, no one can deny that opiates
naturally are carrying Morphine and
Codeine for visceral and severe pain.
Rauwolfia serpentina is still one of
the drugs we can rely on for hyper
tension. We have two varieties that
does not need uprooting unlike Rauwolfia
serpentina which is used in India
because it is the roots that are used.
Here in the Philippines we have already
studied the active principles of the
bark extract of two rauwolfia plants -
R, samarensis and R. amsomnifolia.
All
we have to do is to remove a portion of
the bark and extract the active princi
ples. This procedure has been investi
gated at the U.P. College of Pharmacy.
We can therefore save the country from
the importation of reserpine.
Cascara is another medicinal plant and
this is mainly used as a cathartic. In
the Philippine General Hospital we are
using Cana fistula as cathartic, We
don't use Dulcolax, Bisacodyl or
Lactulose. We make our own suspension
of Cana fistula seeds. We have saved
for our own PGH by giving this for pre
operative preparation. So we are
already manufacturing our own cathartic
or laxative.
Let it not be said that we are going
backwards by using medicinal plants.
It is a way to counteract the strangle
hold that the multinationals have placed
on us and throughout the Third World.
It is about time that we appreciate our
own God-given bounty and make use of
our talent and our resources to manu
facture our own drugs and cut down on
importation of pharmaceuticals. In this
way we will provide health for all by
the year 2000.
HEALTH ACTION INTERNATIONAL (HAD
is an informal network of con
sumer> professionalj development
action and other public-interest
groups working on pharmaceutical
issues.
This supplement to HAI News, the
network^ newsletter3 comes to
you from the HAI clearinghouse
which is maintained at the Inter
national Organizatin of Consumers
Unions (IOCU) Regional Office fcr
Asia and the Pacific3 P,0. Box
1045Penangy Malaysia, Cable:
INTEROCU PENANG, Telex: MA 4016^
APIOCU, Tel: (04) 885072.
THE CHRISTIAN SCIENCE MONITOR
Wednesday, January 5, 1983
23
”'1
OPINION AND COMMENTARY
Out of step at the UN
By Ward Morehouse
The Reagan administration has once again
demonstrated its diplomatic ineptness at the
United Nations. Recently, by a vote of 146 to 1,
with no abstentions, it went down to glorious
defeat in the UN General Assembly over a
resolution on protection against harmful
products.
The resolution establishes for the first
time international procedures and standards
for trade in products harmful to health and
the environment. Administration apologists
would have us believe that by its resolute
stand America’s national honor was success
fully defended against an unprincipled as
sault by hot-headed radical third-world coun
tries aided and abetted by the Soviet bloc.
But this is a resolution that even our tradi
tional allies in international diplomacy, not to
mention the rest of the world community,
found acceptable enough to support. Japan,
West Germany, and Great Britain - hardly
bastions of radicalism - all voted for the
resolution.
This is not the first time the Reagan ad
ministration has stood isolated in multilateral
diplomacy with a position on an'issue on
which effective international coopeiauon is
clearly needed. In May 1981, the US govern
ment was the only country to vote in the
World Health Organization against the estab
lishment of an international code of standards
for marketing baby food. (Three countries
abstained.)
The US refusal earlier this month in Ja
maica to sign the Law of the Sea Treaty has
been widely publicized (46 other countries did
not sjgn but 117 did). Much less well known is
the fact that, alone among the major mari
time and industrial nations, the United States
refused to join the preparatory commission
for the treaty. Other nonsignatory countries
are participating because they want to be in
volved in the implementation of the treaty,
and many are expected, sooner or later, to
sign it.
The principle that the government nas an
obligation to protect its citizens and the envi
ronment from harmful products is well estab
lished. Furthermore, the US has done more
than any other country to create some proce
dures, though limited, to prevent US compan
ies from dumping hazardous products that
cannot be sold in the US on unsuspecting for
eign countries;
This is not the first time the
Reagan administration has
stood isolated on an issue
on which international
cooperation is clearly
needed.
The UN resolution takes a small step to
ward bringing the rest of the world into con
formity with the US position by creating a
consolidated international list of drugs, pesti
cides, and other hazardous products. It also
embraces the sensible principle that such pro
ducts should not be exported without the in
formed consent of the importing country.
It is clearly in the US national interest and that of the US business community - to
have all countries play by the same rules. But
even more direct self-interest is involved
through the “boomerang effect.”
Pesticides banned in the US but freely ex
ported come back to the US embedded in im
ported foodstuffs. For example, a 1978 Food
and Drug Administration study of coffee en
tering the US showed that 45 percent of the
samples tested had pesticide residues illegal
by US standards.
Public outrage over the dumping by US
manufacturers on third-world countries of 2.4
million baby garments treated with a chemi
cal said to be carcinogenic and banned in the
US led President Carter in the waning days of
his administration to sign an executive order
to strengthen US policy on export of hazard
ous substances. Thirty-four days later, Presi
dent Reagan summarily revoked the Carter
executive order, branding it as “excessive
regulation.”
No country likes to have products banned
or severely restricted in the country of origin
dumped on it. Indignation over the Reagan
revocation of the Carter executive order was
an important factor in pushing through this
resolution at the UN. Here is another case of
chickens coming home to roost.
Ward Morehouse is president of the
Council on International and Public Af
fairs, a nonprofit policy research, educa
tion, and publishing group in New York,
' and directs its toxic exports project.
UNITED
NATIONS
General Assembly
Distr.
LIMITED
A/C.2/37/L.65/Rev.1
7 December 1982
ORIGINAL:
3 •
ENGLISH
ma
ESI
EBM
Ihirty-seventh session
SECOND COMMITTEE
Agenda item 12
REPORT OF THE ECONOMIC AND SOCIAL COUNCIL
Algeria, Argentina, Bangladesh, Colombia, Cuba, Ethiopia, Ghana, Guyana,
Honduras, India, Iran (Islamic Republic of), Nicaragua, Nigeria,
Pakistan, Saudi Arabia, Senegal, Sudan, Trinidad and Tobago, Tunisia,
Uganda, Venezuela, Viet Nam and Zimbabwe: revised draft resolution
Protection against products harmful to health and the environment
The General Assembly,
Aware of the damage to health and the environment which the continued
production and export of products which have been banned and/or permanently
withdrawn on grounds of human health and safety from domestic markets is causing in
the importing countries.
Aware that some products, although they present a certain usefulness in
specific cases and/or under certain conditions, have
have bee
been severely restricted in
their consumption and/or sale due to their toxic effects
------------ > on health and the
environment.
Aware of the harm to health being caused in importing countries by
by the
the export
export
of pharmaceutical products ultimately intended also for consumption and/or sale in
there0^
°f the exPortin9 country, but which have not yet been approved
Considering that many developing countries lack the necessary information and
expertise to keep up with developments in this field.
Considering the need for countries that have been exporting the
above-mentioned products to make available the necessary information and assistance
to enable the importing countries to adequately protect themselves.
HEALTH CELt
82-35535
0833Z (E)
CON1WiCN,TV
-3or)St. Marks
47/1, (First
A/C.2/3 7/L.65/Rev. 1
Eng 1 i s h
Page 2
Cognizant of the fact that almost all of these products are at present
manufactured and exported from a limited number of countries.
Taking into account that the primary responsibility for consumer protection
rests with each state,
Recalling its resolution 36/166 of 16 December 1981 and the report on
Transnational Corporations in the Pharmaceutical Industry of the Developing
Countries", 1/ and acting in pursuance of Economic and Social Council
resolution 1981/62 of 23 July 1981,
4
Bearing in mind in this context the work of the Food and Agriculture
Organization of the United Nations, C
the World Health Organization, the International
Labour Organisation, the United Nations Environment Programme,, the General
Agreement on Tariffs and Trade, the Centre on Transnational Corporations and o ,r
relevant intergovernmental organizations,
1.
Agrees that products which have been banned for domestic consumption
and/or sale because they have been judged to endanger health and the environment
should be sold abroad by companies, corporations or individuals only when a request
for such products is received from an importing country or when the consumption of
such products is officially permitted in the importing country;
2.
Agrees that all countries that have severely restricted or non-approved
the domestic consumption, and/or sale of specific products,, i..
in particular
pharmaceuticals and pesticides, should make available full information
----- 1 on these
products with a view to safeguarding the health and environment < ^ ’
of the importing
country, including clear labeling in a language acceptable to the importing country;
3.
Requests the Secretary-General .to continue tto’ ensure the provision of the
necessary information and assistance by the United Nations system in order to
strengthen the national capacities of developing countries to protect themselves
from the consumption and/or sale of banned, withdrawn, severely restricted and ‘n
the case of pharmaceuticals, non-approved products;
4.
Requests the Secretary-General, 1based upon the work already being done
within the Food and Agriculture Organization ofJ the United Nations, the World
Health Organization, 1the
•
-International
Labour Organisation, the United Nations
Environment Programme, the General Agreement: on Tariffs and Trade, the United
Nations Centre on Transnational. Corporations and other relevant intergovernmental
organizations, to the maximum extent -possible within
--- existing
------ g resources, to prepare
and
an regularly
regu ar y update a consolidated list of products whose consumption and/or sale
have been banned, withdrawn, severely restricted or, in the case of
pharmaceuticals, non-approved by governments, and to make this list available as
early as possible, and in any case , not later than December 1983;
1/
E/C.10/85, 15 July 1981.
A/C.2/37/L.65/Rev.1
English
Page 3
5.
Agrees that the consolidated list referred to in paragraph 4 should be
easy to read and understandable and contain both generic/chemical and brand-names
in an alphabetical order, as well as the names of all manufacturers and a short
reference to the grounds and decisions taken by governments that have led to the
banning, withdrawal or severe restriction of such products;
Decides on the basis of the above—agreed criterion, to keep under review
the format of the consolidated list with a view to its possible improvement;
7.
Requests governments and relevant organs, organizations and bodies of the
United Nations system to provide all the information and assistance necessary for
the prompt and effective fulfilment of the task entrusted to the Secretary-General.
CC.
<^:^3
f^e^>
/y^yr-)
i &
j/donted by the Second Committee
132-1-0, on 8 December 1982
/TA
Ar -~
UNITED
NATIONS
General Assembly
Distr.
LIMITED
A/C,2/37/L.65/Rev.1
7 December 1982
ORIGINAL:
ENGLISH
Thirty-seventh session
''ECOND COMMITTEE
^enda item 12
REPORT OF THE ECONOMIC AND SOCIAL COUNCIL
Algeria, Argentina^ Bangladesh, Colombia, Cuba, Ethiopia, Ghana, Guyana,
Honduras, India, Iran (Islamic Republic of), Nicaragua, Nigeria,
Pakistan, Saudi Arabia, Senegal, Sudan, Trinidad and Tobago, Tunisia,'
Uganda, Venezuela, Viet Nam and Zimbabwe: revised draft resolution
Protection against products harmful to health and the environment
The General Assembly,
Aware of the damage to health and the environment which the continued
production and export of products which have been banned and/or permanently
withdrawn on grounds of human health and safety from domestic markets is causing in
♦-He importing countries,
-
Aware that some products, although they present a certain usefulness in
specific cases and/or under certain conditions, have been severely restricted in
their consumption and/or sale due to their toxic effects on health and the
environment.
Aware of the harm to health being__caused_in importing countries by the export
of pharmaceutical products ultimately intended also for consumption and/or sale in
the home market of the exporting country, but which have not yet been approved
there,
Considering that many developing countries lack the necessary information and
expertise to keep up with developments in this field.
z
Considering the need for countries that have been exporting the
above-mentioned products to make available the necessary information and assistance
to enable the importing countries to adequately protect themselves.
Z
82-35535
0833Z (E)
coMMOM.sv
C..y
A7H (First FlaorlSt. Mar—
BAKGALOafc-560 00l
1/
z
zVC. 2/37/L.6 5/RCV.1
English
Page 2
Coor^zant of the fact that almost all of these products’ are at present
manufactured and exported from a limited number of countries,
lnto account that the primary responsibility for consumer protection
rests with each state.
Recalling its resolution 36/166 of 16 December 1981 and the report
report on
on
■Transnational Corporations in the Pharmaceutical Industry of the tevelopina
Countries", 1/ and acting in pursuance of Economic and Social Council
resolution 1981/62 of 23 Julv 1981,
jLeJ.r-lnc? Ln 171 inG ln this context the work of the Food and Agriculture
r0X"/ntlOn'°hthe Vnited N5ti°ns' the world Health Organization, the International
L-k,ou. Organisation, the I nited Nations Environment Programme, the General
Agreement on Tariffs and Trade, the Centre on Transnational Corporations and oth=r
relevant intergovernmencai organizations.
Agrees that products which have been banned for domestic consumption
and/or sale because they have been judged
to endanger health and the environment
should be sold abroad by companies, corporations or individuals only when c ---a request
rorsucn products is received from an importing country or when the consuinDticn"cf
sucn products is officially permitted in the importing country;
2.
Acrees that all countries that have severely restricted or non-approved
the domestic consumption, <and/or
' '
sale of specific products, in particular
pharmaceuticals and pesticides,, should make available full information on these
products with a view to «safeguarding
"
the health and environment of the importing
country, including clear labeling in_i a language acceptable to the importing country;
3.
~eqUeSt5 the £ecretary-General to continue to ensure the provision of the
necessary information and assistance by 1'
the United Nations system in order to
strengthen
the national capacities
c
. ,
* of
— developing
—------ countries to protect themse^VA<^
from the consumption and/or sale of banned, withdrawn,
severely restricted and, in
the case of pharmaceuticals, non-approved products;
Requests
4.
Requests the Secretary-General, based upon the work already being done
o-ii? thG FO°d Snd A5riculture Organization of the United Nations, the World
Health Organization, the International Labour Organisation, the United Nations
ironment Programme, the General Agreement on Tariffs and Trade, the United
Nations Centreon Transnational Corporations and other relevant intergovernmental
rganizationsAto the maximum extent possibleXwithin existing resources, to prepare
and regularly update a consolidated list of products whose consumption and/or sale
have been banned, withdrawn, severely restricted or, in the case of
pharmaceuticals, non-approved by governments, and to make this list available
as
early as possible, and m any case, not later than December 1983;
V
E/C.10/85, 15 July 1981.
A/C.2/37/L.65/Rev.l
Eng 1i s h
Pag e 3
5.
Agrees that the consolidated list referred to in paragraph 4 should be
easy to read and understandable and contain both generic/chemical and brand-names
in an alphabetical order, as well as the names of all manufacturers and a short
reference to the grounds and decisions taken by governments that have led to the
banning, withdrawal or severe restriction of such products;
Decides on the basis of the above-agreed criterion, to keep under review
6.
the format of the consolidated list with a view to its possible improvement;
Requests governments and relevant organs, organizations and bodies of the
7.
United Nations system to provide all the information and assistance necessary for
the prompt and effective fulfilment of the task entrusted to the Secretary-General.
♦
REPUBLICA DE VENEZUELA
MISION PERMANENTE
ANTE LAS NACIONES UNIDAS
'
PRESS RELEASE
110
COf’^oo
ad
For Immediate Release
16th December 1982.
Date:
For further information, contact:
Mr. Enrique ter Hors’t
838.28.00 (Mission of Venezuela)
U. N . TO -ADOPT RESOLUTION PROHIBITING EXPORT
OF HAZARDOUS PRODUCTS
The United Nations General Assembly is expected tomorrow
to adopt overwhelmingly a resolution calling upon countries to
prohibit the export of banned hazardous products such as phar
maceuticals and pesticides, unless request for such products
are explicitly endorsed or allowed by importing countries.
This
resolution was passed last week in the Second Committee of the
General Assembly by a margin of 132 to 1, with no abstentions.
The sole negative vote was cast by the United States, which was
not in
position to go along with a modified consensus resolu-
tion which was worked out in lengthy negotiations between repre
sentatives of the industrialized countries and the representative of Venezuela acting on behalf of the 23 developing countries
that cosponsored the resolution.
The problem of the export of hazardous products, which have
been banned or severely restricted for domestic sale and consump
tion, has recently become the focus of intense debate and contention at several international fora.
The United Nations General
. . /
2
Assembly had, in the past three years, adopted two other resolu
tions which set the stage for information exchange between coun
tries engaged in the import and export of hazardous products.
The present resolution, inter alia agrees
1 :
"that products which have been banned for domestic
consumption and/or sale because they have been
judged to endanger health and the environment should
be sold abroad by companies, corporations or indivi
duals only when a request for such products is recei
ved from an importing country or when the consumption
of such products is officially permitted in the import
ing country,
and requests,
"the Secretary General.... to prepare and regularly
update a consolidated list of products whose consump
tion and/or sale have been banned, withdrawn, severe
ly restricted or, in the case of pharmaceuticals,
non-approved by governments, and to make this list
available as early as possible, and in any case, not
later than December 1983."
Mr. Enrique ter Horst, the Venezuelan negotiator of the resolution expressed the hope that the United States would soon change
its position, thus permitting unanimous agreement in this important
question of vital interest to the Third World.
J
AND PUBUC INTERNA™NAL
AFFAIRS
777 United Nations Plaza
New York, NY 10017
(212) 972-9877
Natural Resources Defense Council
122 East 42nd Street
New York, New York 10164
PRESS RELEASE
Fbr Immediate Release
December 17, 1982
For further information, contact:
Karim Ahmed, (212) 949-0049
(914) 723-0517
UNITED STATES NEGATIVE VOTE ON UN RESOLUTION
ON EXPORT OF HAZARDOUS PRODUCTS SEVERELY CRITICIZED
The Natural Resources Defense Council and the Council on
International and Public Affairs sharply criticized the role of the United
States in casting the only negative vote on the U.N. General Assembly’s
resolution prohibiting the export of banned, hazardous products without
the knowledge and consent of importing countries.
The General Assembly
today overwhelmingly adopted the resolution on a vote of 146-1, with no
abstentions.
This resolution, passed last w?ek in the Second Ccmmittee of
the General Assembly (132-1, 0 abstentions), was the result of many weeks
of intense negotiations bet\\een representatives of developing countries
(who cosponsored the resolution) and delegates from the major Western
industrialized and Eastern bloc countries. The resolution also calls upon
the Secretary General to prepare a report on a consolidated list of
products which had been banned, severely restricted, withdrawn, or —for
druqs— not approved by December 1983.
COMMUNITY HEALTH Ct-.L
47/1, (First FlooOSt. Marks Road
47/1 > (First Floor)St
BANGALORE - 560 001
"The United States had, until recently, been the world's leader in
addressing the problem of the dumping of banned, hazardous products in
developing regions of the world", said Jacob Scherr, Senior Staff Attorney
for the Natural Resources Defense Council. "It is ironic that while other
nations were beginning to follow the U.S.’s lead, the present
Administration is making an about face on this critical international
problem."
Ward Morehouse, President of the Council on International and Public
Affairs, stated "The present Administration, in standing alone in
opposition to this resolution clearly appears to be more interested in
adhering to a 19th century free-market ideology than in responding to the
growing consensus worIdwide regarding the export of banned, dangerous
products in the global market-place".
"This is the kind of problem," Morehouse added, "which requires
international cooperation if action is to be effective.
It is very much
in our national interest—and that of the U.S. business community—that
all countries play by the same rules."
Mr. Enrique ter Horst, Venezuela’s U.N. delegate, speaking on behalf
of the cosponsors today at the General Assembly after the vote vzas
recorded, expressed his hope that, in spite of United States’ opposition
to the adopted resolution, "it will fully cooperate with the United
Nations in the establishment of the consolidated list of banned products,
as called for in the resolution."
Public attention to the probl ens of dumping had been first
highlighted in 1977 over the export by U.S. manufacturers of some 2.4
million baby garments treated with the carcinogenic chemical. Tris, after
the product had been banned for domestic sale.
This issue eventually led
to the signing of an Executive Order by President Carter in 1980 which
would have strengthened U.S. policy on the export of hazardous
substances.
However, shortly after taking office. President Reagan
summarily revoked the Executive Order, branding it as "excessive
regulation”.
The action of the United States in the U.N. General Assembly
last week indicated, according to spokesmen of both organizations, further
i
retreat by the present Administration, on this serious international
problem.
Between 1970 and 1978 worldtrade in chemical products rose from $22
to $96 billion, while export of these products (including drugs.
pesticides and industrial chanicals) from industrialized to developinq
countries increased from $5 billion to $24 billion, a five-fold growth in
an eight year period.
In recent years, numerous examples of the export of
banned, withdrawn or non-approved products have come to light, including
marketing of banned drugs (such as combination antibiotics), pesticides
(such as aldrin and mirex, withdrawn by the U.S. EPA), other consumer
products (such as unsafe medical devices), and shipments abroad of
hazardous wastes.
The Natural Resources Defense Council is a nonprofit membership
organization dedicated to protecting America’s natural resources and to
improving the quality of the human environment. With offices in New York
City, Washington, D.C., and San Francisco, and a full-time staff of
lawyers, scientists, and environmental specialists, NRDC combines legal
action, scientific research, and citizen education in a highly effective
environmental protection program.
The Council on International and Public Affairs, established in 1954,
is a non-profit, policy, research, education and publishing group, which
seeks to pronote citizen understanding of critical econcmi'?, social,
environmental and other public issues.
p-10.341
SS:k/31.12.81
INTERNATIONAL FEDERATION OF PHARMACEUTICAL
MANUFACTURER^ AoSOCIATldEte (tP&MAy " " "
CODE OF PHARMACEUTICAL MARKETING PRACTICES
MB
•»
••••
w
*»«»•»<*«•«• w
—
i i «■» IM, I— aM
Preamble
The Statute of the Federation article 3 states that one of the
objects of the Federation is "to promote and support continuous
development throughout the pharmaceutical industry of ethical
principles and practices voluntary agreed on and "to coordinate
the efforts of its members towards the realization of the above
objects ".
It is believed that in keeping with the pharmaceutical industry's
international responsibilities, the members of the Federation
will be prepared to accept certain obligations, insofar as their
marketing practices are concerned, and to ensure respect for
them.
IFPMA recommends a Code of Marketing Practices to its member
associations, recognizing the difficulty of setting out a simple
Code which will be applicable in all parts of the world. It
seems clear that national and regional conditions and legal
restrictions will continue to vary to such an extent as to make
a simple world Code impractical. Nevertheless, the Federation
believes that it has a duty to encourage its member associations
to1 either introduce
such Codes
or where
where such
such Codes
Codes
,
- of
— Practices
•—J or
already.exist, to continually re-examine and where necessary
revise them so that a voluntary
---- system 'based
____ 1 on such a Code
keeps, pace with modern medical knowledge
... —and
—_ changing
—- *. —g lie a 1th
services and conditions.
It is recognized that many individual member associations of
IFPMA have laid down their own Codes of Marketing Practices and
this recommended Code is not intended to replace similar Codes
or instruments already in force by members of the Federation.
The following-voluntary Code is therefore put forward as a
model for IFPMA’s member associations.
A Code of Marketing Practices of this sort should be the res
ponsibility of member associations who should also provide
guidance to their members on matters of compliance and inter
pretation.
Obligations of the industry
The obligations of the industry may be identified as follows:
The pharmaceutical industry, conscious of its special position
arising from its involvement in public health, and justifiably
eager to fulfil its obligations in a free and fully responsible
manner, undertakes:
to ensure that all products it makes available for
prescription purposes to the public are backed by
the fullest technological sefvice and have full
regard to the needs of public health;
to produce pharmaceutical products under adequate
procedures and strict quality assurance;
9
to base the claims for substances and formulations
on valid scientific evidence, thus determining the
therapeutic indications and conditionsriQf use;
BANGALORE- 560 001
. . ./
D^IQ.341
S^:k/31•12.81,
: 2 :
k
I
t
to provide scientific information with objectivity
• and 'good taste, with scrupulous regard for truth,
and with clear statements with respect to indications,
contra-indications, tolerance and toxicity;
tb use complete candour in dealings with public health
officials, health care professionals and the public.
Suggested Code of Marketing Practices
we hereby declare our intention to voluntarily conform to the
following Code of Marketing Practices:
I.
General Princinles
1.
The term “pharmaceutical product*’ in this concept
means any pharmaceutical or biological product
intended for use in the diagnosis, cure, mitiga
tion, treatment or prevention of disease in humans,
or to affect the structure or any function of the
human body, which is promoted and advertised to
the medical profession rather than directly to the
lay public .
2.
Information on pharmaceutical products should be
accurate, fair and objective, and presented in
■ such a way as to conform not only to legal require
ments but also to ethical standards and to
standards of good taste.
3.
Information should be based on an up to date
evaluation of all the available scientific evidence,
and should reflect this evidence clearly.
4.
No public cocaraunication shall be made with the
intent of p^’^oting a pharmaceutical product as
safe and effective for any use before the required
approval of the pharmaceutical product for market
ing for such use is obtained. However, this pro
vision is not intended to abridge the right of the
scientific community and the public to be fully
informed concerning scientific and medical
progress. It is not intended to restrict a full
and proper exchange of scientific information
concerning a pharmaceutical product, including
appropriate dissemination of investigational find
ings in scientific or lay communications media,
nor to restrict public disclosure to stockholders
and others concerning any pharmaceutical product
as may be required or desirable under law, rule
or regulation.
5.
Statements in promotional communications should be
based upon substantial scientific evidence or
other responsible medical opinion. Claims should
not be stronger than such evidence warrants.
Every effort should be made to avoid ambiguity*
6.
Particular care should be taken that essential
information as to pharmaceutical products’ safety,
contradictions and side effects or toxic hazards is
appropriately and consistently conmunicated subject
to the legal, regulatory and medical practices of'
each nation. The word "safe" must not be used
without qualification.
t
*
D-10.341
&S:k/31.12.81
: 3 :
7.
II.
Promotional communications should have medical
clearance, or where appropriate, clearance by the
responsible pharmacist, before their release.
Nediral Reur^sentatjve
Medical representatives must be adequately trained
and possess sufficient medical and technical knowledge
to present information on their company’s products in
an accurate and responsible manner.
III.
Symposia Congresses and other Means of Verbal Communi
cation.
Symposia, congresses and the like are indispensable
for the dissemination of knowledge and experience.
Scientific objectives should be the principal focus
in arranging such meetings, and entertainment and
other hospitality shall not be inconsistent with
such objectives.
IV.
Printed Promotional Material
Scientific and technical information shall fully dis
close the properties of the pharmaceutical product as
approved in the country in question based on current
scientific knowledge including:
-
The active ingredients, using the approved
names where such names exist.
-
At least one approved indication for use
together with the dosage and method of use,
-
A succinct statement of the side-effects,
precautions and contraindications.
Except for pharmaceutical products where use entails
specific precautionary measures, reminders need not
necessarily contain all the above information providing
that a form of words is used which indicates clearly
that further information is available on request.
Promotional material, such as mailings and medical
journal advertisements, must not be designed to dis
guise their real nature and the frequency and volume
of such mailings should not be offensive to the health
care professionals .
V.
Samples
Samples may be supplied to the medical and allied
professions to familiarize them with the products, to
enable them to gain experience with the product in
their practice, or upon request.
******
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area
New Delhi-110016
w
\
%
Telegrams : VOLHEALTH
>v
/V
New Delhi-110016
Phone : 652007, 652008
D-10/545
LOW COST DRUGS AND RATIONAL DRUG THERAPY
INTERNATIONAL CODES AND LYON .«
Last year the WHO was instrumental in passing an International Code of
Conduct of Marketing Practice of Baby foods*
This not only focussed the attention of the public, the health professionals
on the baby food issue, but placed the concept of breast feeding from
a ’rustic, old fashioned practice1 to scientifically sound and recommended
one. What this will do to the commercial interests of the milk food
industry is anybody’s guess? It is up to the aware public, the consumer
associations, the journalists to ensure that the code of conduct of which
India was a signatury - is firmly adhered to.
The contents of this code are being circulated for awareness and action
of the health personnel and the public.
Along with it is a copy of the International Code of Pharmaceutical
Marketing Practice, proposed by IFPMA (international Federation of
Pharmaceutical Manufacturers Associations).
A copy of this provisional code was given to the participants of our
Drug Workshop at Poona, for discussion and comments.
The code is being circulated along with extracts from the discussion
document prepared by Health Action International on the code.
You are requested to read it carefu' ly, share it with your colleagues
and pass it on. Your comments and suggestions regarding the international
code of pharmaceutical marketing practice are requested.
You are request ,d also to bring to our notice, cases of malpractice by
drug companies which may be,by way of misinformation, selling of spurious
drugs, unethical marketing practices, commissions for prescriptions, cut
backs etc. Your participation is not only requested but is NEEDED for
us and other groups and organisations to take any legal action, for
malpractices to be curtailed before it is too late.
What is IFPMA ?
IFPlvU is an International Federation of Pharmaceutical Manufacturers
Association, a Zurich-based trade organisation, set up and supported by
a number of national.associations of manufacturers of prescription drugs.
Altogether there are 50 affiliated national associations plus 12
affiliated through the Latin American Association of the Pharmaceutical
Industry.
Why the IFPMA Code was introduced and what it aims to he?
"The Paris-based International Chamber of Commerce has published codes of
advertising and marketing practice - which are meant to apply to business
of all kinds. However, the IFPMA Code (which makes no reference to the
requirements of the International Chamber of Commerce) is believed to be
the first ever attempt to introduce an international code of marketing
practice for pharmaceutical companies.
health cell
47/1,(First FlQor)St. Marksekxg/BANGALOHE - 500 001
9
D-10/343
MS-cb/23.582
2
The preamble of the IFPMA Code (Appendix) explains how its terms of
reference extend to the drawing up of a voluntary code of pracbice. Though
the IFWA does not state why it decided to introduce a code at this timd,
the following factors would certainly have been important!
1. There has been considerable criticism of the activity of the international
pharmaceutical industry, anu it appears to be increasing. The industry
has given little evidence he suggest that it accepts such criticism - but
would certainly be aware, at least, that health-care professionals increasingly
find it legitimate and to the point. The relative success of the campaign
coordinated by the International Baby Pood Action Network (IBPAN) has
demonstrated the potential for international action by media, consumer,
public interest and development and health action groups - particularly
where developing countries are concerned.
2. The need to avoid further statutory regulation of the industry at
either national or international level. The indications are that the
IFPMA proposed its Code in response to the threat of a move by the World
Health Assembly to work towards the setting up of a formal international
code of pharmaceutical marketing practice. In the event, the threat did not
materialise at the Summer 1981 World Health Assembly - but there remains
the possibility of future initiative,9 if not throughihe World Health
Organisation or UNCTAD, tfeen possibly through the UN Centre on Transnational
Corporations.
The credibility of the industry - now clearly under threat - is a vital
commercial asset. Lack of confidence in the drug industry by those who
regulate, prescribe or use pharmaceutical products could be commercially
disastrous. It is clearly critical that the industry generally, as well
as individual drug companies , is trusted and seen to ’care’.
3.
The IFPMA has responded to these (and perhaps other) imperatives by first,
issuing a-statement of ’the obligations’ of the pharmaceutical industry;
and secondly, by suggesting a number of ’general principles’ by which
these obligations might be fulfilled.
It is important to recognise that, in doing so, the IFPMA is not trying to
introduce its own ’simple world code’. The IFPMA specifically says this
would be ’impractical’ because of differences in local conditions. All
IFPMA b trying to do with its Code is ’to encourage’ national member
organisations either to introduce or to revise their own voluntary codes.”
What stage of imple-mentation is the Code in?
,lThe document has not yet been formally adopted or published: it is
reproduced here in the form in which it was circulated for comment to
IFPMA member associations, in March 1981. Since thq^., the Code has been
agreed by the IFPMA Council and, by the end of June 1981, it had been
approved also by all of the major associations within IFPMA.”
What is the purpose of the discussion document circulated by HAI?
”The purpose of this paper is
1. to draw attention to the existence and provisions of the IFMA Code;
I;
D-10/345
MS-cb/25.5.82
- 5 -
2.
to discuss briefly its significance in relation to controls that are
needed and which might be applied5 and
3.
to suggest options for action by HAI participating groups. ”
According to the discussion document, what are the three essential
ingredients of any code of practice omitted in this IFPMA’s Code?
1.
Need for interpretation.
Reference to the need to ensure that the industry makes products which
have full regard to the needs of public health - appears a statement
so vague that it is hard to accept it as anything much more than an
advertising or public relations slogan.
2.
Need for monitoring
The question raised is *what assurance is there,that the code will be
adhered to?1 Is the Code to operate on the basis of a complaints
procedure? The mechanism for complaints handling and monitoring,
which are fundamental to a code have not been referred to.
3.
Need for enforcement
What happens if the Code is violat.d?
who Judges? industry (through its association or otherwise) or
truly independent bodies.
whether enforcement decisions are published - or this is kept
a secret? Could it be possible to establish, on the basis of past
decisions, what practices are acceptable or unacceptable? And what
is the record of individual companies- where complying with the
Code is concerned.
what sactions would be applied if companies break the provisions
of the Code?
what incentive is there for firms to observe the requirement of
the Code?
What are the implications and significance of this for the HAI groups?
This is useful to ifefer to the obligations of the industry identified
by IFJMA;
Individual groups may think alternative or additional requirements which
might be needed to control abuse in pharmaceutical marketing, and to
consider how such requirements might effectively be enforced at both
national and international level;
...4/-
B-10/343
Ms-cb/23.5.82
4
Groups might also wish to collect exmaples of apparent malpractice5
Collectively, groups may find it useful to exchange information or the
design and enforcement of standards under different voluntary (self
tegulatory) systems operating in their countries. Groups might also wish to
compare and pool the evidence they obtain about apparent malpractice
and to publish and publicise this evidence both locally and internationally
through HAI•
!
HAI would like to' know whether it should press for introduction of an
international code of pharmaceutical marketing practice which ha^’ teeth,’*
and which can reasonably be expected to work through WHO/UNCTAD and
national governments.
YOUR RESPONSE IS NEEDED URGENTLY
/
\
INTERNATIONAL ORGANIZATION OF CONSUMERS UNIONS
Regional Office for Asia and the Pacific
Phone: (04) 20391
P.O. Box 1045
Cable: Interocu Penang
Telex: MA 40164 APIOCU
Penang, Malaysia.
o
5/ or
O co
30th November 1984
•' 7 o
CONTACT PERSON : Eva Lachkovics, Tel No :
(04) 20391
o .
CONSUMER WELCOME - WITHDRAWAL OF PROBLEM DRUG
The President of IOCU, Anwar Fazal, today welcomed the news that Ciba-Geigy
is abandoning the worldwide supply of its clioquinol containing and related
drugs by the end of March next year.
Clioquinol and related drugs - the group of hydroxiquinolines - have been
proved responsible for a serious nerve disease "SMON
(subacute—myelo—optic
neuropathy) which often leaves people severely crippled, blind or both.
There have been more than 10,000 "SMON" victims in Japan alone in the late
1960s.
"We hope that this marks the beginning of a new assertiveness on the part of
Ciba-Geigy to have nothing but the highest ethical standards in the marketing
of its products," says Anwar Fazal.
The IOCU President added that there is a clear moral responsibility on all
manufacturers of oral clioquinol and other hydroxiquinoline containing drugs
to follow Ciba-Geigy's example and stop the production and sale of these
"We will insist on the recall of
products without any further hesitation.
such drugs already distributee io retailers and there is no excuse whatso-
ever for governments to allow this drug to be in circulation .
Note : Malaysia has banned this drug.
It is however, widely available and
used in Indonesia, Thailand and India.
The International Organization of Consumers Unions (IOCU) links the activities of some 120 groups that serve the consumer interest
in over 50 countries worldwide. An independent, non-profit-making and non-political foundation, IOCU promotes international
cooperation in consumer protection and education, represents the consumer interest at the global level, furthers the dissemination
and documentation of consumer-related information and facilitates the comparative testing of consumer goods and services. The
headquarters of IOCU are at 9 Emmastraat, The Hague, Netherlands. Phone: (3170) 476331. Cable: Interocu Haag. Telex: 33561.
PRESS RELEASE BY Cl BA-GEIGY, NOVEMBER 26, 1984
IN OCTOBER 1982, CIBA-GEXGY HAD PUBLISHED A NEW POLICY
ON CONTROL OF DIARRHOEAL DISEASES. THIS POLICY INCLUDED
(
THE ANNOUNCEMENT OF THE WORLWIDE GRADUAL PHASING OUT OF
ALL ORAL CLIOQUINOL-CONTAINIMG PRODUCTS OVER A PERIOD OF
THREE TO FIVE YEARS. THE DRUGS IN CONSIDERATION HERE, R
EHTEPOVIOFORM, R MEXAFORM AND OTHERS, ARE DRUGS WHICH HAVE
BEEN USED FOR THE CONTROL OF DIARRHOEAL DISEASE FOR DECADES.
HOWEVER, IN CONNECTION WITH A SERIES OF SMON-CASES IN JAPAN,
THESE DRUGS BECAME THE OBJECT OF A PUBLIC, CONTROVERSIAL
DISCUSSION CONCERNING DRUG BENEFIT/RISK.
WITHIN KEEPING OF THE ANNOUNCED POLICY, SALES OF THE PRODUCTS
CONERNED HAVE BEEN DISCONTINUED SINCE OCTOBER 1982 IN SOKE
90 COUNTRIES. THE GRADUAL PHASING OUT OF THESE DRUGS HAS
TAKEN PLACE WITH THE APPROVAL OF THE NATIONAL HEALTH AUTHORI
TIES. THE WORLD HEALTH ORGANIZATION IN GENEVA WAS REGULARLY
INFORMED OF THE PRESENT STATE OF DEVELOPMENTS.
TODAY, THE METHOD OF ORAL REHYDRATION OFFERS A SIGNIFICANT
ALTERNATIVE THERAPY IN THE CONTROL OF DIARRHOEAL DISEASES.
PARTICULARLY IN THE FIELD OF INFANT DIARRHOEAL DISEASES.
CIBA-GEIGY HAS DECIDED TO ACCOUNT THE PRESENT CONCEPTS
AND DEVELOPMENTS IN THIS FIELD INTO A NEW POLICY, THEREBY
ABANDONING THE USE OF CLIOQUINOL-CONTAINI NG AND -RELATED
DRUGS.
CONSEQUENTLY, CIBA-GEIGY WILL ACCELERATE ITS ORIGINAL POLICY
ON CONTROLLING DIARRHOEAL DISEASES, WHEREBY THE SUPPLY
OF THE ANTI-DIARRHOEAL PRODUCTS WILL BE STOPPED BY THE
END OF THE FIRST QUARTER OF 1985.
EVENTHOUGH THE CONTINUED AVAILABILITY OF THE PRODUCTS HAS
OCCURRED WITH THE FULL KNOWLEDGE OF THE NATIONAL HEALTH
AUTHORITIES, THIS HAS BEEN GREATLY CRITICIZED BY VARIOUS
CONSUMER ORGANIZATIONS. WITH THE SPEEDED-UP PHASING OUT
OF CLIOQUINOL-CONTAINING DRUGS, CIBA-GEIGY HOPES TO ADDRESS
THE CONERNS OF THESE CONSUMER GROUPS.
TO HELP CREATE AN ALL-AROUND BETTER CLIMATE BETWEEN CONSUMERS
AND CIBA-GEIGY., DR VON PLANTA MET WITH DR OLLE HANSSON
IN GOTHENBURG, SWEDEN. AT THE MEETING, BOTH PARTIES AGREED
THAT INDUSTRY AND CONSUMERS HAVE MANY PARALLEL INTERESTS
AND SHOULD ESTABLISH AN OPEN DIALOQUE. THE DISCUSSION COVERED
A BROAD SPECTRUM OF TOPICS OF MUTUAL INTEREST. ALSO DISCUSSED
WAS CIBA-GEIGY'S POLICY CONCERING DRUGS WHICH CONTAIN CLIOQUINOL.
FOLLOWING THE MEETING DR HANSSON AND DR VON PLANTA CONFIRMED
THAT IT WAS IMPORTANT TO CONTINUE THE DIALOGUE BEGUN IN
GOTHENBURG.
-- - -
END
STATEMENT ON CLIOQUINOL
All the participants at the IOCU Seminar on Health, Safety
and the Consumer, held in Ranzan, Japan, from 5 to 9 April
1983, representing consumer organisations from 23 countries
and including all the consumer organisations in Japan,
make the following STATEMENT:
“Although clioquinol can severely damage the nervous system
and has injured more people than any other drug, it is
still being sold in about 100 countries around the world.
CIBA-GEIGY, the biggest producer of clioquinol has at
last decided to phase it out from the world market within
3 to 5 years.
But this exposes large populations to
unacceptable risks for yet another 3 to 5 years and offers
no benefits.
We urge all national drug regulatory authorities and the
World Health Organisation to ensure that the production
and sale of oral preparations containing clioquinol or
any hydroxyquinoline is stopped now."
Ranzan, 9 April 1983
INTERNATIONAL ORGANIZATION OF
CONSUMERS UNIONS (IOCU)
• Regional Office for Asia & the Pacific
P.O. Box 1045, Penang. Malaysia
Tel:
Telex: MA40164 APIOCU
Cable: INTEROCU PENANG
• 9 Emmastraat, The Hague,
Netherlands.
Tel: (3170) 476331, Telex 33561
Cable: INTEROCU HAAG
New Scientist 15 November 1984
Secret deal gives all clear for Japan’s whalers
§
ill
y
/ T AST
Sunday,
____
Japanese
Jeremy Cherfas
I
whalers returned home with
two sperm whales, the first
confirmed catch of the 1984/85
season. The catch should lay the
Japanese open to trade sanc
tions from the United States.
However, these sanctions are
unlikely to be implemented
because of an “understanding”
reached between the US and
Japan within the last few days.
The terms of this understanding
are not yet public.
The International Whaling
Commission (IWC) decided, in
effect, to suspend sperm whaling
Orrv!!r .
in the northwest Pacific in 1981.
It set no quota for whaling, and
in a footnote suspended whaling
until a quota had been set.
However, Japan objected to the
footnote and obtained special
A whale by its tail: Japan won’t let go
quotas for the 1982-83 and
1983-84 seasons. Once again, at this year’s understanding.
meeting in Buenos Aires no quota was set.
Jack LaCovev, _a spokesman
for
- theAlthough the IWC has no power to Department of Commerce,
told New
enforce its decisions, moves in the United
States, senate threatened Japan’s fishing
trade if it did not stop whaling. Two
amendments would stop the US from 'T’HE WORLD’S smallest bat, the
importing fish from any country under A Sumatran rhino, the Hawaiian tree
mining conservation agreements and snail, a six-metre-long crocodile and a
reduce quotas for fish taken within the 360- tortoise that feeds on faeces all have one
kilometre fishing limit around the US thing in common. They are all on a list of
coast.
the 12 animals most likely to become
Japan’s fishing agreements with the US extinct. The list was drawn up by the Inter
are worth many times more than the national Union for the Conservation of
whalingk industry.
Japan takes 74 per cent
♦♦
r u
— Nature (IUCN) at its annual meeting in
of the bottom fish caught by foreign fleets Madrid this week.
off Alaska. This amounts to about 10 per
oii
The bumble bee bat weighs only two
cent oi Japan s total catch.
grammes, and was discovered in 1974. The
15°^• halerS
caves where ** ,ives in Thailand are
around the beginning of October. This threatened by hydro-electric projects.
year the fleet did not leave port until late
There are only about 100 Sumatran rhino
October. A week later, the ships were left. They are threatened by poaching, as is
recalled because of the threat of US the Northern White Rhino. There are ten
sanctions. Conservationists say that the left, all in a national park in Zaire.
fleet had already taken seven whies, but
The 19 species of Hawaiian tree snail are
dumped them at sea.
now confined to one island. Their multi
The fleet set out again and returned with coloured shells are sought by collectors.
the two sperm whales on Sunday, only a
The Orinoco crocodile, grows up to six
short time after the US and Japan had metres long. It lives in Columbia and
apparently reached agreement on their Venezuela, but its population is down to
Scientist: “It appears as though
we may have arrived at an
understanding whereby if Japan
were to take some specific
actions they would avoid certifi
cation for continued sperm
whaling”. He declined to give
further details on the grounds
that the agreement had not yet
been finalised.
Greenpeace, the international
conservation organisation, says
that the agreement will allow
Japan to continue whaling until
1987. “We are absolutely
opposed to this,” its spokesman
Mark Cheater said, “because it
effectively would negate the
commercial moratorium.”
Last Thursday Greenpeace
filed a suit against both the
State Department and the
Department of Commerce. The
aim was designed to prevent the
US government from making an agreement with Japan and forcing it to apply the
fishing sanctions.______________
Almost as dead as a dodo
200.
The agonoka is a large tortoise which
lives in Madagascar. Its population is also
down to about 200. No nests have been
found in the wild, but it is kept in people’s
back gardens to eat faeces.
The other animals on the list are:
• The kagu, a flightless bird that lives in
New Caledonia
• The Queen Alexandra’s bird wing butter
fly, which with a wingspan of 25 centi
metres is the world’s largest butterfly
• The murukui, the woolly spider monkey
which lives in Brazil
• The kouprey, a wild ox which lives in
Indo-China
• The Mediterranean monk seal, which is
persecuted by fishermen because it
occasionally damages nets.
The IUCN also announced a list of the 12
most endangered plants, which includes the
world’s largest flower, the rafflesia arnoldii
in Sumatra, along with the 11 most
endangered national parks.
Valium banned from NHS in drugs overhaul
COME 300 branded medicines will be
O banned from National Health Service
prescriptions from next April, as the
government attempts to cut its £1400
million medicines bill. Most of the drugs
are for minor ailments and are usually
available in chemists’ shops—at a price. A
study of the 31 medicines listed by the
health minister Kenneth Clarke last week
as replacements for the banned brands
reveals, for the first time, the emergence of
a government medicines policy.
Twenty-eight of the 31 approved medi
cines are pharmacopoeial preparations,
that is medicines for which composition
and standards are laid down in the British
Pharmacopoeia (BP) or the British
Pharmaceutical Codex (BPC). The other
three are benzodiazepines, such as Valium,
for which no standard yet exists.
Nearly 100 cough medicines with names the pharmacists’ bible, MIMS.
that tell nothing will disappear from NHS
Five aspirin and paracetamol prepara
prescriptions. They will be replaced bv six tions replace the 34 brand-named mild
medicines with such simple titles as analgesics listed in MIMS, though some
Diamorphine Linctus BPC or Methadone doctors think they will be able to go on
Linctus BP. Alkaline Gentian Mixture prescribing the branded products for
BP alone will replace the various “tonics” arthritis. Ministers’ opposition to benzo
to improve the appetite.
diazepines will remove the money-spinner
The numerous multivitamin prepara Valium from NHS prescriptions in favour
tions with fancy names will give way to of plain diazepam, Mogadon as
straightforward Vitamin Capsules BPC, or nitrazepam.
to single substance preparations such as
A score of other brand-named “sedatives
Ascorbic Acid Tablets BP (Vitamin C) or and tranquillisers” will also disappear,
Pyridoxine Hydrochloride Tablets BP including bluzodiazepine bypaotics. Last
(Vitamin
B6)
or
Vitamin
BP week’s The Lancet reported once again
(cyanocobalamin) for the treatment of on the inappropriate prescribing of
pernicious anaemia.
prochlorperazine as.a tranquilliser, particu
Two BP laxatives and five antacids will larly for the elderly suggesting that nondo NHS service for the 65 brands and more bluzodiazepine tranquillisers should also
than 100 proprietary preparations listed in be considered.
Frank Lesser
CELL
47/1,(First FloorjSt. r^rksKced
BAMGALOaE-560 001
3^
A
UNITED
NATIONS
General Assembly
Distr.
LIMITED
T
A/C. 2/38/L. 28/Rev. 2
25 November 1983
ORIGINAL/
:r
ENGLISH
Thirty-eighth session
SECOND COMMITTEE
Agenda item 12
REPORT OF THE ECONOMIC AND SOCIAL COUNCIL
Algeria, Bangladesh, Egypt, Ghana, Nigeria, Pakistan, Sudan,
Trinidad and Tobago and Venezuela/ revised draft resolution
Protection against products harmful to health and the environment
The General Assembly/
Recalling its resolutions 36/166 of 16 December 1981 and 37/137 of
17 December 1982,
Bearing in mind the oral report presented by the Secretariat with regard to
progress made in the implementation of resolution 37/137, 1/
1.
Takes note of the report of the Secretary-General on the exchange of
information on banned harzardous chemicals and unsafe pharmaceutical products, 2/
and the work being carried out by the United Nations system of organizations;
2.
Notes with satisfaction that the work carried out in consultation with
organizations of the United Nations system on the consolidated list of products
whose consumption and/or sale have been banned, withdrawn, severely restricted or,
in the case of pharmaceuticals, not approved by Governments, is in the process of
being completed;
3.
Requests the Secretary-General to make available the consolidated list,
as established on the basis of information supplied up to now, in accordance with
the objectives of General Assembly resolution 3 7/13 7, and to update it on a regular
basis;
1/
See A/C. 2/38/SR.2 7.
2/
A/38/190.
83-32259
1287Z (E)
! CEtt
56 ’ 0
/...
A/C.2/38/L.28/Rev.2
English
Page 2
I•?
4.
Urges the relevant organs# organizations and bodies of the United Nations
system# particularly the Food and Agriculture Organization of the United Nations#
the. World Health Organization# the International Labour Organisation# the United
. Nations Environment Programme# the General Agreement on Tariffs and Trade and the
United Nations Centre on Transnational Corporations# and other intergovernmental
organizations# to continue to co-operate fully in providing information for the
consolidated list and for its updated versions;
5.
Appreciates the co-operation extended by Governments and urges all
Governments# in particular those which have not done so yet# to provide the
necessary information for inclusion in the consolidated list and its updated
versions# as well as comments and views Governments may deem relevant;
6. ■ Urges non-governmental organizations to extend co-operation to the
Secretary-General regarding the preparation of the consolidated list# particularly
in the identification of potential sources of information among national
Governments and in obtaining governmental information on relevant regulatory
actions;
7.
Requests the Secretary-General# for purposes of review by the General
Assembly at its thirty-ninth session# to submit a report on the implementation of
Assembly resolution 37/137# including the consolidated list# taking into account
the latest'information and-comments collected for possible improvement of the list#
as envisaged in paragraph 6 of resolution 37/137/
8.
Requests the Secretary-General to submit to the General Assembly at its
thirty-ninth session# through the Economic and Social Council# a report on the
exchange of information on banned harzardous chemicals and unsafe pharmaceutical
products identifying elements for possible further work in this area in regard to
the needs and capabilities of developing countries to monitor and control those
substances in the light of the relevant observations in the report of the
Secretary-General; 2/
9.
Requests the Secretary-General and the organs# organizations and other
competent bodies of the United Nations system to continue to provide# within
available resources# the necessary technical assistance to the developing
countries# at their request# for the establishment or strengthening of national
systems for a better use by those countries of the information provided with regard
to banned harzardous chemicals and unsafe products, as well as for an adequate
monitoring of the importation of those products.
DEVELOPMENT FORUM
Jan-Feb
PAGE 8
1982
COMMUNITY HEALTH CELL
47/1,(First Floor) St. Marks BoatS
BAMGAlO JE - 560 001
Published by the United Nations University and the Division of
Division of Economic and Social Analysis
Trade
Health
Toxic
Chemicals
A poisonous trade
Dumping on other countries products banned where they are
is fast becoming the major international environmental
—ri consumer protection issue of the 1980s. Fueled by recent
dbdouures in print and on film (see box), the issue is the focus
of renewed public attention in several countries-and a source
of growing conflict between consumer, public health, and
environment groups on one side and industry and government
on the other.
the growth in exports of chemical pro
ducts from the industrialized countries
to the Third Worid-from $5 billion in
Principal sources of pesticide exports
1970 to $24 billion in 1978, an increase
are Germany (25 per cent). United
of 480 per cent.
States (20 per cent). United Kingdom
(15 per cent), Switzerland (15 per
A similar picture emerges if we look
cent), France (13 per cent), Japan
at international trade in pesticides.
(5 per cent), and Italy (3 per cent).
Third World imports soared over a
five-year period (1974 through 1978) These countries provide virtually all of
from $641 million to almost $1 billion. i Third World imports of pesticides.
By 1978, developing country imports
“ _
*
"1
constituted’ 39
per cent of‘ the
world
trade in pesticides, obviously a big and
rapidly growing business for tbe major
<
.
transnational chemical companies
dominating the world trade scene.
rphe (nm it sot •■b'
> M c if Me «tti. Became of tbe
OBonMNM BtakM ImroHed, effort! to
cwt export! of protect! coodtered
■Mfe at bow are befog foogbt bitter
ly by Intertry. Mort of tbeee protect!
•re ■ade fo tbe devefoped coratrice
and told to developing coratriee. b
i______
‘
‘
‘
■■Mt
caam, fotertry
has racceeted fo
.
radeteg tbe —pgnrt M developed
corabTgoverwrabtorotetrayoBta
on foternatloMd trade fo toxic enbrtancee. WbBe developfog coratriee
need to fortforte raxe effective procedare! for wndtoring rad control of tbe
practice, traaraatfonal corporatfow
and tbeir borne govenunenti have by
far tbe greatert capacity for dealing
with tbe problem. They abo bear tbe
■miJor responribffity for fafling tbna far
to do ao.
Because of its complicated charactei
and growing significance, the interna
tional trade in toxic substances b cer
tain to be a major and continuing
source of conflict throughout the current decade. The issue itself is, of
course, not new. New are its size and
complexity as a factor in international
relations generally but especially in
North-South relations.
The 1970s witnessed an exponential
growth in the international trade of
chemical substances. From 1970 to
1978, for example, worldwide trade in
chemical products increased well over
four times from US$22 billion to $96
billion. Even more significant has been
by Karim Ahmed,
Ward Morehouse
and Rashid Shaikh
i
fol
A druggist in Bangladesh who sells medicines restricted in the United States. (From "Pesticides
and Pills: For Export Only ”, see box).
Resistance to regulation
The US pesticide industry is rapidly
becoming more export-oriented, in
creasing industry’s stake in overseas
markets and its resistance to efforts to
regulate products for export. During
the last decade, domestic production of
pesticides has increased by about 50
per cent, but exports have grown by
200 per cent. In 1978, the US exported
$1 billion of pesticides, up from $625
million just two years earlier.
Thirty per cent of these exports were
pesticides not registered for use within
the US. Of these unregistered pesti
cides, some 20 per cent were products
that the US Environmental Protection
Agency had suspended or cancelled
because of their hazardous character.
The remaining 80 per cent were pesti
cides which presumably had never been
registered with the EPA.
Comparable data on other major
pesticide exporting countries are not
available. However, it seems not un
reasonable to assume a somewhat simi
lar pattern of export of unregistered
and potentially hazardous products. If
anything, the proportions may be high
er, at least in those exporting countries
are not as
where domestic regulations
i
stringent as in the
ic US.
Almost all of this traffic, further
more, is one way. The Third World
generated only four per cent of interna
tional exports of pesticides in 1978.
Similarly, they are responsible for
20 per cent of world imports of antibio
tics but only eight per cent of exports.
Over the past decade, spending on
drugs has been increasing at the rate of
about 20 per cent a year in the Third
World. Most of these drugs come from
transnational pharmaceutical com
panies based in the industrialized coun
tries. The 50 largest TNCs account for
two-thirds of worldwide pharmaceuti
cal sales, and the top 110 supply 90 per
cent of world production.
The rapid growth and enormous size
of TNCs make them a co-equal fourth
category of actors in the international
political economy. The traditional
tripartite division of the world’s nations
into Group D or centrally planned
economies. Group B or industrialized
market economy countries, and the
Group of 77 (now actually 123), com
posed of Third World or developing
countries, is no longer adequate to
categorize the major actors on the
world scene.
The world’s largest corporation, Ex
xon-* nujor Httnufacfnrer of petrodbemical products-had in 1979 gross
incoMe of $70 billion, larger than the
gross national products of all but three
Third World countries and three Group
D countries. Taken together, the annu
al sales of the five largest US chemical
firms (DuPont, Dow, Union Carbide,
Monsanto, and W. R. Grace) in 1980
came to $47 billion. This auaount is
larger than the gross national products
of every African nation and some
Aston nations, including Indonesia.
Pakistan, Malaysia, and the Phil
ippines. The smallest of the top five
chemical TNCs, W. R. Grace, had
annual sales of $6 billion, exceeding the
GNPs of Bolivia, Costa Rica, Jamaica,
and Ecuador.
Not only have the stakes in exports
to the Third World of potentially
dangerous products such as pesticides
and pharmaceuticals increased enorm
ously in the last decade, along with the
size and economic power of the trans
national corporations making these
products. The number of products has
also grown, vastly complicating the task
of monitoring the impact of these pro
ducts on public health and the environ
ment and regulating them effectively.
Even though most medical experts
agree that the number of generic drugs
needed to maintain good public health
is vastly less (in the range of 100-2000,
depending upon the sophistication of
the health care delivery system), the
pharmaceutical
companies
have
brought about an explosion in the
number of brand-name variations of
these generic drugs in their efforts to
capture a bigger piece of the market for
a given pharmaceutical product. Thus,
there are over 30,000 branded drugs on
sale in the UK, 24,000 in the FRG,
21,000 in Italy, and 14,000 in the US.
These countries find it difficult
enough to maintain effective regulation
of such a large number of products,
even with substantial technical and ad
ministrative capacity. Imagine the
problem for developing countries, even
the more advanced ones, with much
more limited resources. In Brazil,
14,000 brand-name drugs are sold on
the market, in Argentina 7,000, and in
India 15,000. In the last-named in
stance, a major government commis
sion studying the pharmaceutical indus
try estimated that one per cent of that
number would be adequate to meet the
country's basic health needs.
Nordic abstemiousness
While the enormous number of such
products clearly increases the complex
ity of regulating them, there is little
evidence that these large numbers of
products are necessary. In Sweden and
Norway, there are, respectively, only
2,000 and 2,500 drugs on sale. These
countries have some of the lowest mor
tality rates and most sophisticated
health care systems in the world.
Pesticides and drugs are the two
major categories of potentially hazard
ous products being exported by indus
trialized countries to the Third World,
but they are certainly not the only ones.
The infant formula case, in which sub
stitutes for breast feeding actively pro
moted by TNCs in developing countncs
and used under unsanitary conditions
there, is well known. The first step^
toward a real international response to
the problem were taken in 1981 with
the adoption by the Member States of
the World Health Organization of a
voluntary international code for mar
keting infant formula.
Other consumer products have fared
less well. One of the most celebrated
cases in recent years involved children's
sleep wear treated with a carcinogenic
chemical known as Tris. In April 1977,
the US Consumer Products Safety
Commission banned the sale of Tris
treated sleep wear. Before the Com
mission, after months of waffling, ban
ned their export a year later, 2.4 mil
lion garments treated with this hazard
ous product were exported, primarily
to unsuspecting the Third World.
A new and particularly troublesome
aspect of the movement of toxic sub
stances from one country to another
involves the disposal of toxic waste.
This is likely to asmme increasing im
portance in the 1960s as industrialized
countries accumulate more such waste
and, in response to public outcries
when the health of their citizens is
adversely affected, begin to impose
tighter standards for disposal of these
wastes by industry.
As industrialized country regulations
become stricter, the costs to industry of
disposing of these wastes increase, and
the incentive of trying to find lower cost
alternative sites free of these regula
tions also grows. Several cases have
already come to light of US enterprises
approaching Third World countries
; with the promise of substantial finan
cial payments if they would accept toxic
wastes. In one instance, the President
of Sierra Leone was offered $25 mil
lion. After the proposition became
known in December 1979, there was
such an adverse reaction from within
I the country and in neighbouring na
tions that he called the deal off.
In another instance, Mexico disco
vered that an American businessman
was dumping toxic waste from the US
in Mexico. The Mexican Government
arrested him in March 1981 for doing
so, although it has refrained thus far
from asking the United States to clean
up the dump he was operating.
Where such initiatives have become
public, there has been a sufficient pub
lic outcry to stop them. But of course
we have no way of knowing whether
other initiatives which have not become
public may have succeeded.
Third World resentment against this
kind of “chemical colonialism” from
the industrialized countries is under
standable. It is also justified. There are
enough well-documented cases of the
adverse impact of banned or severely
restricted substances from indus
trialized countries on people in the
Third World.
In 1972 and 1973, to give one illus
tration, the death rate was very high
during an extensive typhoid epidemic
in Mexico. It was found that the bac
teria responsible for this epidemic were
resistant to an antibiotic known as
chloramphenicol. Although this anti
biotic has been restricted in the US
since the early 1950s to the treatment
of a few life-threatening infections be
cause of its serious side-effects such as
aplastic anaemia, it has been freely
exported to and extensively promoted
in a number of developing countries,
including Mexico. The result has been
excessive misuse of the antibiotic, and
when the typhoid epidemic struck, it
was no longer effective.
Another illustration involves Phosvel (Leptophos), an organo-phosphorous pesticide. In a study sponsored by
the US company manufacturing it and
completed in 1969, Phosvel was shown
to cause demyelination, a serious
pathological condition of the nervous
system. Phosvel was never registered
for US use, but more than 14 million
pounds were exported to 30 countries ,
from 1971 to 1976.
Almost half of these exports went to '
Eppt, where Phosvel was heavily used
00 cotton, Egypt's largest agricultural i
export. During the early 1970s, Phosvel was hnphated in the death of ose
farmer, the poboning of 65 farm workera, and the deaths of several hundred |
water buffalos. The US manufacture of
Phosvel was finally halted in 1976, not !
because of its impact overseas but be- !
cause the US Government found many
workers employed at the plant where it
was made were suffering from bhirred
vision, dizziness, partial paralysis, and
other disorders of the nervous system.
As the number of chemical com
pounds and other formulations used in
pesticides, pharmaceuticals, and other
products grows, the task of monitoring
thfcir impact on the environment and
human beings also grows. The iUustrations just given, and many others like
them, are almost certain to increase in
the 1980s far beyond what occurred in
the past decade unless there are effec
tive counter measures.
In the ideal world, each nation state
would take responsibility for setting its
own environmental and public health
standards, conduct its own studies of
the possible pathological and other ad
verse effects of all of the pesticides,
drugs, and other products used within
the country, make its own assessment
in each instance of whether the risks of
using a given product outweighed the
benefits or vice versa, promulgate regu
lations regarding use of each product,
and then implement those regulations
comprehensively and systematically.
Effective performance of these tasks
would also involve resisting the
pressures and blandishments of major
transnational corporations which, with
all of their scientific and technical re
sources, would come forward with
soothing and persuasive assurances that
a product they were trying to market
was safe and harmless if used properly
or, even if it might occasionally cause
some minor adverse results, produced
such astounding benefits that it was
well worth the small risk involved.
Of course, this is not an ideal world.
For the better part of this century, and
in some cases longer, the industrialized
countries have been accumulating ex
perience in trying to make more effec
tive their efforts to deal with toxic
substances so as to protect their own
environment and health of their citi
zens. (The US Food and Drug Admin
sitration, for example, was established
in 1906). While their record is far from
perfect, and in many years has required
the prodding of non-governmental en
vironmental, public health, and con
sumer safety groups for governments to
resist industry pressure, the indus
trialized countries have come a long
way in learning how to cope with the
problem of toxic substances within
their own borders.
Virtually all countries, whatever
their level of development, recognize in
principle the obligation of government
protect its citizens and the environ
ment against the adverse consequences
of use of toxic substances. But the
cajMicity of govemmente to fulfill this
obligation varies enormously. Yet it is
dear that governments must act. The
experience of the developed countries
over many decades has shown that,
even with the best of intentions, volun
tary guidelines and self-regulation by
industry are insufficient.
The obvious solution turns out not to
be so obvious. Given the widely varying
capacity for monitoring and regulating
toxic substances in the real world, why
not let those countries which have this
capacity-i.e. the major industrialized
countries-perform this function for
those which do not yet have it? While
no country wants to be the dumping
ground for toxic products and wastes
considered unsafe where they arc man
ufactured, environmental and public
health conditions are not the same
throughout the world.
A specific case
Take the celebrated case of Depo
Provera, a contraceptive drug. While
the drug is not approved for use as a
contraceptive in the US, it is used for
that purpose in more than 82 countries,
mostly in the Third World, where rapid
population growth makes contracep
tion a public health priority. Many
developing countries and international
agencies promoting the use of the drug
take the position that, even if there is a
possibility of occasional adverse side
effects from the drug, the urgency of
lowering the birth rate in these societies
is far more important. They would
clearly not be happy with having US
standards imposed upon them in this
instance.
TW ao-caBed “boomeraag effect”,
i ill Min It docameiited In the recent
iMtfmte for Food awd Development
' Policy rtndy. Ode at Faison, is pro
ducing contrary results. On the one
|t b canaing Industrialized coun-
PUBLIC DEBATE
ON TOXIC EXPORTS
INTENSIFIES
T»ii
<*rrMk
firrWr vt-nfrfrJ
M Nufih Atftnim td nitotJIc piMic tirhn*f>M export of toxk MAMmmr io afer TkirJ
Wtrrid. The fim a the hmaAoO over the
US Public Bototkoxtion Srttrof of tt ovirpon tiottonefoorv serin. "n^XTKTDES
AND riU^S: For Expttri Ooty". The
teievisioo thu umeoiory serin hw pro
duced by Robert Richtrr of RubierMcBride Prodtutiow. tdmdy tnB-kotnvu
for his tneurd-triuninn Novo pruductutns.
"A Phtpur oo Our ChUtrs". ood “Ineident ut Brosru's Ferry". The prugnorttnes
ore rttne tooikdde Ort fibu fur edunrtiurtul
use.
The secttrtd neot b hr ptddicurtort of
Pilk. PcMickfc* and Profit*. The tMcmatkmal Trade in Toaic SuhaatKc*. o rttujor
study trf uherv iuduBriuiized murttrybused MNCs ore seUirtR hozorduus drops
und pesticidn in Rte Third World. The
bottk. which irtciudn trurtscripts of the
television serin, hns been prepared by A.
Kttrifu Ahmed. Senior Stuff Scientist, uud
S. Jacob Schcrr. Senior Sluff Attorney,
btuh of the Natural Resources Defense
Council, under the ftenerul edbonhip of
Ruth Nttrrir , Associated Editor. Audubon
Magazine. The Council mt Iniematioiud
and Public Affairs prtnided ussistamv with
buckprtntml research for the book. '
Further information on these and related
material designed to promote public dis
cussion and actum on thd impmutm ques
tion is available fnon the Coomil. 777
United Naturns Pinza. New Vttrk. Neu
York 10017. USA (2I2/V72-W177)
tries to took more doeefy at the export
9l pertiddM baaued at botot tort sued
artiuBfidy «i erupt grown for export
to the UM Worid. Evidence mounts
Aat theae toxic aubrtancet are coming
back to Mdr point of ortgto when food
ctocm are tomortod and reureaent the
mmektedofrtakto
‘beatth which
d or severely
cawed them to be
mrtrkkd to the fbrt place.
On the other hand, developing coun
tries where these pesticides are widely
used are resistant to placing restrictions
on them because of their need to main
tain high levels of agricultural produc
tivity for major cash crops which are
important earners of foreign exchange.
The problem is further compounded
by the fact that some of the more
industrially advanced developing coun
tries such as India and Brazil are now
themselves significant exporters of
chemical produrts, including pesticides
which may be toxic. Here again, these
exports are seen as important sources
of earning scarce and badly needed
foreign exchange. Any effort to try
to reach real international agreement
will have to come to grips with the real
possibility that some developing coun
tries, being exporters as well as impor
ters, may be less than enthusiastic
about setting high limits on the toxicity
of pesticides and other products traded
internationally.
Most industrialized countries, which
are the principal exporters of toxic
substances, take the position that it is
none of their business to enforce their
environmental and public health stan
dards on other countries. Their govern
ments are actively encouraged to adopt
this position by industry which under
standably has no desire to see its over
seas activities subject to the same kind
of regulations as are applied domesti
cally. To attempt to apply indus
trialized country utkndards in the Third
World, industry representatives argue, I
would involve the practice of paternal- i
ism, inappropriate in today’s world.
|
Furthermore, the industry argument j
runs the attempt by one exporting
country to apply m domestic standards
ebewhere by prohibiting the export
■ubstances banned at home would be
aetf-defeating unleaa all exporting
countries agree to the same standards.
If an Importing country were unable to .
get what it wanted from a source in one ;
country, it would simply turn io a
source in another country where export
of toxic substances was not limited. The
only result would be loss of export
markets, with an adverse impact on
trade balance.
The exporting country which has
struggled the most with this intractable
problem is the United States. US policy
has thus far avoided the extremes of
doing nothing and actually banning the
export of hazardous substances. The
Tris incident in which over two million
children’s garments treated with a
hazardous chemical were dumped on
Third World countries created an
enormous furor in the US. Congres-
sjanal hearings were held and some
new legislation adopted, requiring that
importing countries be notified when
The recent controversy in Britain
toxic substances were being exported.
with the shipment of toxic wastes from
Procedures and substantive contents Holland disposed near a residential
of notifications under existing legisla community in England, the marketing
tion, however, differed, and some evi of PCB-contaminated eels from Cana
dence emerged that notification regula da and the US in Holland and Federal
tions Were not working well. In an Germany, or the inadvertent release of
effort to develop a more coherent and 100,000 supposedly sterile but in fact
systematic approach, the Carter ad fertile
Mediterranean fruit flies imministration established in 1978 an
Inter-Agency Working Group on
Hazardous Substances Export Policy.
After many months of complex : ported from Peru last year in California
illustrate the point. But while the prob
negotiations and several drafts of a
lem may be international in character,
policy statement, which was revised to
reaching international agreement will
respond to industry concerns. President
not be easy, for all of the reasons we
Carter signed an executive order imple
have suggested.
menting the Working Group’s policy
The United Nations system is al
recommendations on 15 January 1981.
ready engaged in a limited way in
The Carter policy had four elements:
coping with the problem. The World
- Mure uniform procedures for notifying
Health Organization, the Food and
foreign governments, already required under
some existing legislation, would be instituted
Agricultural Organization, and United
und would require that certain minimal infor
Nations Environmental Programme all
mation about banned or restricted products
are concerned with documenting toxic
be provided to the government of the import
substances and their use, although the
ing country.
dissemination of this information still
- An annual list of all products banned or
leaves much to be desired.
restricted by various US Government agen
cies would be prepared and provided to
foreign governments.
- International agreements would be sought
to help create a worldwide system of controls
and to keep US industry from suffering a
competitive disadvantage with enterprises
producing the same product in other export
ing countries.
- The most controversial element of the
policy involved the creation of a procedure
whereby export controls could be imposed
"only in exceptional cases" on "extremely
hazardous substances" that represented a
significant threat to human health, safety or
the environment or that would cause substan
tial harm to US foreign policy interests.
Thirty-four days later, on 17 Febru
ary 1981, inconting President Ronald
Reagan revoked the Carter policy with
a one-sentence Executive Order enti
tled “Federal Exports and Excessive
Regulation”. Given indnstry opposi
tion to the Carter Executive Order
establishing a Hazardous Substances
Export Poifcy (which many environ
mental, consumer and public health
groups on the other dde of the issue feh
was too weak to be effective) and the
pro buffriesi orientation of the Reagan
odndnbtration, Ae Reagan revocation
of the Carter Executive Order was
perhaps Inevitable. But the problem
wfll not go away, and the Reagan
characterizatioo of the Carter policy as
“excessive regulation” Is far from the
last word on the subject.
While some form of notification
would appear to be a minimal first step
at the national level by the major
exporters of toxic substances, the prob
lem is a genuinely international one
requiring international solutions. It is
important to remember that this is not
just a North-to-South problem but a
South-to-South, a South-to-North, and
a North-to-North problem as well.
The UNEP Governing Council in
1978 called both upon developed coun
tries to prevent the export of banned,
unregistered, or restricted products
without the fully informed consent of
importing countries and upon develop
ing countries to strengthen their own
capabilities to make decisions on such
imports. The UN General Assembly
has also passed resolutions in 1979 and
1980, calling upon all Member States
to discourage the export of toxic sub
stances. While these actions help to
bring the issue to world attention, not
much has happened, certainly not at
the national level.
Continuing vigilance
More concrete was the adoption at
the World Health Assembly in May
1981 of a code of marketing practices
for infant formula. (The US, reflecting
the Reagan administration’s distaste
for anything which would impede the
free and untrammeled conduct of busi
ness regardless of the social conse
quences, cast the sole dissenting vote
against adoption of the code!) The
code, however, is voluntary and non
binding, and its impact will depend
upon the continuing vigilance of de
veloping country governments and
non-governmental organizations in
both developing and developed coun
tries. Nonetheless, the Infant Formula
Code of Marketing Practices is impor
tant as a symbol, representing the first
major step taken by the world’s nations
toward recognizing their ethical re
sponsibilities to each other as traders in
toxic or potentially hazardous products.
A variety of other initiatives are
underway involving the UN system,
including codes of conduct for transna
tional corporations and for the transfer
of technology which involve respective
ly the UN Commission on Transnation
al Corporations and the UN Confer
ence on Trade and Development (UN-
CTAD). Both codes include provisions
related to toxic substances or tech
nologies which produce such sub
stances. Both also have been under
negotiation for many years and have
been stoutly resisted by transnational
corporations and the major indus
trialized country governments, certain
ly in forms that would have any teeth.
Nonetheless, action at the most recent
session of the UN Commission on
Transnational Corporations suggests
the possiblity of a more active role for
its executing arm, the UN Center on
Transnational Corporations, in dealing
with this complex issue in which trans
national corporations play a major role.
Other international organizations such
as OECD have also been grappling
with the problem for several years.
OECD efforts show some promise but
they have had little impact as yet.
Non-governmental
organizations
which pushed for the infant formula
code are becoming increasingly active
on other aspects of the toxic substances
export problem, reflecting its growing
importance as a major international
issue for the 1980s. In May of last year,
at the same time that the World Health
Assembly was adopting the infant
formula code, a new international
coalition of consumer, professional, de
velopment action and other groups was
formed “to resist the ill-treatment of
ILO’s Hazard Alert Syste II
<>7bea the Caaadiaa Cestre for
W Occopatiooal Healtli aod Safety
(CCOHS) la HaMMoa, (Mario receatly received a wanriag from the
lotematiooal Labowr Office la Geaeva
oa the poteatial carciBogenic proper
ties of 2-Nftropropaae (2NP) - a
dmakal widely aaed as a eolveat la
adhesives, prtatiag iaks, paints for
street rigas aad marine coatiagi
the
agency immediately transmitted thto informatioa to the 2,600 organization
and h^Mdaab on its asaUng Hat. In
tarn, two of the notified agencies cobh
amnicated the “hazard alert” to their
members. Within a two-nraath period,
the CCOHS received some SO inqniries
concerning 2-NP from businesses and
Individual workers.
This Canadian experience shows
how the multiplier effect of networks
within networks is being achieved by
ILO’s International Occupational Safety
and Health Hazard Alert System.
Prevention is the main aim of the
ILO’s hazard alert system, which was
set up in 1977 to provide a network
through which newly-discovered safety
and health dangers can be signalled to
the ILO for urgent world-wide trans
mission. Through the rapid dissemina
tion of information, the system pro
motes immediate preventive action at a
national level. It deals with all aspects
of safety and health in the working
environment.
The system consists of a network of
government-designated bodies, such as
the CCOHS, which are expected to
build up two-way communication with
other interested national establish
ments such as government institutions,
industries, workers’ and employers’ or
ganizations, professional associations,
and teaching and research centres.
These designated bodies are respon
sible for the internal dissemination of
hazard alerts and it is through them
that the ILO is notified when new
occupational hazards are identified in
their respective countries. The fact that
98 governments have designated a
competent body to be part of the global
network indicates that the system re
sponds to a real need.
There is a long way to go, however,
before it can function at its maximum
level. So far only five hazard alerts have
been signalled to the ILO and all of
these came from the US. This situation
reflects, among other things, the need
to strengthen co-operation among the
interested parties in individual coun
tries. For it is these various interest
groups that are the vital links to ensur
ing mandatory action and encouraging
voluntary action to protect the life and
health of workers against potential
occupational hazards.
no
consumers by multinational drug com
panies”. Called Health Action Interna
tional (see DF, December 1981), the
new coalition plans to set up an inter
national clearing house for information
on hazardous drugs, pharmaceutical in
dustry marketing practices and related
initiatives.
Closely related is the action of the
International Organization of Consum
ers Unions, one of the groups behind
Health Action International, at its
world congress in the Netherlands in
June 1981. IOCU, which is composed
of some 80 consumer organizatknis
from 50 developed and developing
countries, is establishing a '^Consumer
Interpol” network to exchange intemational hazardous warning information
More recently, some 150 physicians
and scientists from more than 25 de
veloped and developing nations, or
ganized through the International Plas
mid Conference in Santo Domingo,
Dominican Republic, issued a joint
appeal to curb the misuse of antibiotics.
The statement contends that these
drugs are losing their effectiveness
through indiscriminate overuse, leading
to the spread and persistence of drug
resistant organisms. Unless steps are
taken to curtail their use, the scientists
contend, we will be faced with a serious
world-wide public health problem in
which antibiotics will no longer be
effective in combating many infectious
diseases. The statement concludes that:
... it is imperative to increase awareness
of the dangerous consequences of antibiotic
misuse at all levels of usage: consumers,
prescribers, dispensers, manufacturers and
government regulatory agencies. Only then
can we begin to institute measures to curb the
unnecessary use and flagrant misuse of these
drugs."
While these and other initiatives rep
resent encouraging beginnings in inter
national recognition of the problem,
much more needs to be done before the
world’s environment and the human
community are effectively protected in
all countries from toxic substances. As
the problem itself continues to grow
through the 1980s, so will efforts at all
levels to deal with it.
Clearly, no single action will be suffi
cient. National governments, of course,
bear primary responsibility for protect
ing their own citizens and environment.
Industrialized countries with far more i
extensive experience and technical re- ■
sources can certainly play a construe- !
bye role in helping developing coun
tries strengthen their own capacity for
dealing with toxic substances.
While developed country experience
has clearly demonstrated that voluntary
compliance by industry is not enough,
the chemical, pharmaceutical and other
industries engaged in manufacturing
toxic substances or generating toxic*
waste should be encouraged to deal
responsibly with the problem as a
handful of companies are now begin
ning to do. They can provide complete
A Malaysian farmer using 245 T-a brush killer pesticide banned in the US. Half the 40,000
compounds in the UN Environment Programme's (UNEP) International Register of
Potentially Toxic Chemicals (IRPTC) art pesticides. One way developing country govern
ments can keep track is to take the “ Bulletin ” of the IRPTC which has also just produced the
first data profiles covering 330 chemicals in detail. Recognizing the limitation* of national
research facilities and the need to co-ordinate efforts on an international level, UNEP, the
International Labour Organisation (ILO) and the World Health Organization (WHO) are co
operating in the joint International Programme on Chemical Safety. This scheme is designed to
promote international co-operation among national research centres dealing with health
implications in such areas as industrial chemicals, pesticides, cosmetics and water pollution.
(Photo from "Pesticides and Pills: For Export Only", see box).
‘
<
and comprehensible information about
the possible adverse consequences of
their products and follow truly safe
procedures for disposal of toxic wastes.
Given the international character of
the problem, the UN system has a
major role to play. Current efforts by
WHO, FAO, UNEP, ILO and other
international agencies need to be
strengthened and expanded, as national
governments struggle to achieve con
sensus on meaningful international
norms and procedures for dealing with
toxic substances.
Finally, non-governmental organiza
tions at both the national and interna
tional levels have a crucial role to play.
They must monitor the performance of
their national governments and of in
ternational agencies to see that they
perform effectively the task assigned to
them and admihister fairly and fully
relevant legislation. Where serious
shortcomings exist, NGOs can help to
bring those shortcomings to public
attention, seeking corrective action.
Medical and other professional
bodies, particularly in developing coun
tries, can assist in informing health
practitioners about
the potential
hazards in misuse of some products.
They and environmental and consumer
groups can do much to increase public
understanding of the potentially harm
ful effects of drugs, pesticides and other
products which may at the same time
be beneficial if properly used.
‘
_
___________
Cradal NGO networks
International NGO networks to pro
vide rapid dimeinmation of information
on international trade in toxic sub
stances, TNC marketing practices and
related developments are crucial. The
recent initiatives in pharmaceuticals
■nd consumer products need to be
paralleled by comparable develop
ments related to pesticides and Kara rd ous waste disposal.
edds np to a dhalenging
■genda for
IMOa. For natioMl
yrrnmtnti, both devrioped nad deUN system and NGOs,
ease are many tasks to be performed
in deafag with a complex problem. But
whoa everything b said nd done,
the amjor role in
ovrfjt the problem and industrialized
emmtry governments which have the
grentmt techatad and admiaiKi all re
enpadty for dealing with the problem
^ve prfasmry responsftflky for acting.
Ody If they tackle these tasks with
mrgency and deterndnatioa w0 it be
pomttte for the world community to
enpe with the fast growing problem
•<
brtemationai trade
in toxic
mbstances.
g
p,71Ahmed is Senior Staff Scientist and
^orch Director at the Natural Resources Defense
Councd and Ward Morehouse is President of the
^^^/^^fuional and Public Affairs in New
YOr^ RaStUd 5haikh
Research Fellow in the
Interdcmpbnary p^rarns in Heallh of
Har_
vard School of Public Health in Boston.
I
* • -- •
CSE
CENTRE FOR SCIENCE AND ENVIRONMENT
807 Vishal Bhawan, 95 Nehru Place, New Delhi-110019
Phone: 683394
INFORMATION SERVICE ON
Science and Society-Related Issues
Selling Dangerous Wares
BY DR RASHID SHAIKH
Third World countries are being used as a dumping ground for .unsafe chemicals
and hazardous pharmaceuticals. With President Reagan in charge, the United
States is reversing even the half-hearted decisions that former President Carter
had taken to prevent this dangerous trade. Other developed countries are also
taking few measures. The Internaltional Organisation of Consumers Union is set
ting up a “Consumers Interpol” to keep consumer groups in the Third World
regularly informed about imports of hazardous products.
Dr Rashid Shaikh, an Indian biochemist, is a fellow of the Harvard School of Public Health,
Boston.
71 CELL
t^iarks Road
. 560 GDI
Copyright CSE 1981
1500 words
The Centre for Science and Environment is a non-profit, non-governmental, quasi-academic research organisation that has been set up to increase public
awareness of the role of science and technology in national development. The Information Service issues news and feature items in six languages
English, Hindi, Marathi, Bengali, Malayalam and Punjabi—prepared by a research team consisting of professionals qualified in science and technology.
Director: P. Dasgupta
Director of Research : Anil Kumar Agarwal•»
CSE 2
Boston (CSE) — The International Organisation of Consumer Unions (IOCU) is
setting up a “consumer’s interpol”—a loose network of consumer groups across the
world — to inform each other of imports of dangerous products. Exports to Third World
countries by multinational companies will be an important focus of lOCU’s work, espe
cially after President Reagan’s decision to remove all barriers to export of hazardous
products from USA.
\
The Hague-based lOCUj — an international organisation representing consumer
associations across the world, — was at the forefront of the campaign against the indis
criminate marketing of artificial baby milk in. the Third World. The campaign finally resulted
in a universal condemnation ^xcepftJfR^e US, of course) of infant formula manufacturers
in the World Health Assembly last May’and each government is now expected to draw up
legislation to control marketing! and import of that product.
Most developed country have laws to protect the health of their citizens and the
environment from unsafe^iemioals, pesticides, pharmaceuticals, consumer products,
toxic wastes and other prod.uctsy4ut developing countries have only rudimentary laws to
protect health and environment from injuries from hazardous products, and have practi
cally non-existent mechanisms for enforcingrthem. Over the last decade, the export of
chemicals, pesticides, and pharmaceuticals from the developed countries to the Third
World has grown at an exponential rate. This has led to a temptation among the
manufacturers to simply export products whose domestic market has been affected due
to adverse regulatory decisions.
Several disastrous effects of such exports have come to public knowledge. For
example, use of the antibiotic Chloramphenicol has been restricted in the developed
world since the early 50s to the treatment of a few life-threatening infections like typhoid
and whooping cough because of its serious, sometimes lethal, side-effects, such as
aplastic anemia. Only recently have the marketing practices of the multinationals selling
Chloramphenicol improved in some developing countries. Prior to this, Chloramphenicol
was sold without proper warnings about side-effects and marketed for more routine
infections for which its effectiveness had not been proven. In 1972-73 during an exten
sive epidemic of typhoid fever in Mexico, the death rate was very high. It was then
found that the bacteria responsible for this epidemic were resistant to Chloramphenicol,
presumably as a result of the over use and indiscriminate prescribing of the antibiotic.
A similar problem occurred in Calicut, Kerala during the 1970s.
Phosvel (Leptophos), a toxic organophosphate pesticide, was never registered for
use in the United States, but more than 10 million pounds of the pesticide were shipped
by the American manufacturer to some 50 countries during 1972-76. Almost half of the
exports went to Egypt, where Phosvel was heavily used on cotton, Egypt’s major agri
cultural export. It caused the death of one farmer, the poisoning of 65 farm workers, and
the deaths of several hundred water buffaloes. The manufacture and export of Phosvel
was halted in 1976 only because a number of workers at the US plant manufacturing the
pescticide were suffering from blurred vision, partial paralysis, dizziness, and other
disorders.
«;
CSE 4
national organizations when the US government agencies ban or restrict the use of a
product.(Reagan’s rescission of the Carter policy has led a few Congressmen to intro
duce bills in the Congress to deal with the exports issue. However, given the conserva
tive orientation of the present Congress, the bills may not find many supporters.
Third World countries are showing increasing concern that they are being used as a
dumping ground and testing arena for unsafe chemicals and hazardous pharmaceuticals.
On May 6, 1981, during an address to the World Health Assembly, Mrs Indira Gandhi
said “...sometimes dangerous new drugs are tried on populations of weaker countries
although their use is prohibited within the countries of manufacture.’’ In 1977 and 1978
the 58 nation United Nations Environment Programme Governing Council adopted deci
sions urging exporting nations to ensure that potentially harmful chemicals, which are
unacceptable for domestic use, are not permitted to be exported without the knowledge
and consent of the importing countries. In December 1979, the United Nations General
Assembly passed its first resolution on the exchange of information on banned hazard
ous chemicals. The resolution calls upon exporting nations to discourage, in consultation
with the importing countries the export of banned hazardous chemical products.
Non-governmental organizations are also becoming active in this area. Last summer,
an international coalition of consumer, professional, developmental and other agencies
was formed. The coalition, called Health Action International, with IOCU as its lead
agency, plans to set up an international clearing house on hazardous drugs,
pharmaceutical industry and their marketing practices. In August, 150 scientists from 25
countries who participated in the International Conference on Plasmids, called attention
to the ever-increasing number of organisms resistant to antibiotics, which is causing a
world-wide threat to human health; and called for international controls to halt the indis
criminate marketing and prescribing of antibiotics.
Although these efforts on the international scene are an encouraging sign, much
remains to be done. Given the present mood in Washington, no new initiatives to correct
the situation are likely to emerge from there. Other developed countries have largely
followed the US lead in this area, and are unlikely to play a leading role.
Therefore, initiative from the Third World countries is essential to bring this issue for
ward. In countries where official interest is lacking, pressure from public interest groups
and professional groups will be required to force the governments to raise this issue at
international assemblies.
L
• Centre for Science and Environment
CSE 3
However, these, and many other, incidents of large-scale suffering did not receive
much public attention in the US. One notable exception was the case of the export of
childrens’ sleepwear treated with the flame-retardant, Tris. In 1977, Tris was found to
cause cancer in experimental mice. Since animal carcinogens are suspected to be car
cinogenic in humans as well, the US Consumer Products Safety Commission (CPSC)
banned the use of Tris. Manufacturers and dealers, with large inventories of Tris-treated
garments, began to export them. Initially, the CPSC ruled that it had no authority to
control exports. After several months of debate over law and policy, and after 2.4 million
Tris-treated sleepwear had already been exported, the CPSC finally banned the export
of the garments.
The Tris controversy generated a furore in the United States and led to Congres
sional hearing. It became apparent that the government had practically no control over
the export of banned or severely restricted products. Such goods could be legally sold
to overseas customers. Subsequently, Congress incorporated into several regulatory
laws procedures for informing importing countries when a hazardous product is to be
exported. However, the Congress decided not to impose American standards on other
countries, and so left the assessment of the potential benefits and hazards of a particular
product to the importing nation. Since then certain minimal information about the legal
status and the commercial transaction is provided by the US government once a year to
each country importing a specific product. Such notification requirements are in opera
tion for chemicals, pesticides and consumer products. However, adulterated and mis
branded drugs are exported from the United States without any notice, since the law
covering such drugs has not been changed yet.
The debate over the Tris-exports also put pressure on the Carter administration to
develop a comprehensive policy on the export of hazardous products. An interagency
working group was set up, which, after 2V2 years of negotiations, recommended that the
notification system be left essentially as it is, that a list of products be prepared and
updated annually, that efforts to reach international agreements be intensified, and that
an export licence be introduced for the export of extremely hazardous products. While
the first three provisions were not likely to have any immediate impact on hazardous
exports, the last provision could stop the export of some commodities. However, the
administrative procedure for including substances in the extremely hazardous products
list was cumbersome, therefore, the fourth provision could not have been used fre
quently. Thus, the policy was not likely to have a significant impact on hazardous
exports, and, at best, was a foreign policy statement. Four days before leaving office,
Carter approved this policy in an Executive Order.
Thirty-four days later, Reagan revoked the Carter policy, allegedly to reduce regu
latory burden” and “excessive regulation.” But this has left the United States with its
previous laws, with their once a year notification requirement, as the principal mecha
nism for dealing with hazardous exports. It now appears that the Reagan administration
may propose to change such laws to remove the notification requirement, and replace it
with a brief information which would either be sent to foreign governments or inter-
P^^TiCiD£St PROBLEMS AND PROGRESS
The Bhopal tragedy illustrates only one aspect of how the
overuse and misuse of pesticides endangers the health and the
environment of the Third World Poor. Deaths by accidental poison
ing in the Third World are estimated conservatively at 10,000
per year - four Bhopals.
In addition, some 375,000 people are
injured and this does not take into account the longer term
effects such as cancer and birth defects*
Deaths and injurjjy caused by pesticides abuse are the direct
result of using dangerous chemicals in conditions where safe
use is almost impossible due to ignorance of posible problems.
lack of safety gear, inadequate labelling and packaging.
This
is not to say that pesticides are unnecessary; they are still
needed to maintain agricultural production.
But they should be
used as a part of integrated pest managemental
systems which
also include mechanical?biological, and other means of pest
□w &
control.
X « o
o
Above all, they should be used only where safety
can be assured.
Costs and benefits of chemical pesticides
use must be more evenfcly distributed At present. the benefits
'O
U1 to
X
>- co
h: .2 i
m ..3
accrue to the agrochemical companies, the larger farmers and
plantation owners.
The costs, especially the non-quantifiable
s
6 r-'
ones, are largely borne by the Thtird World Poor.
Further problems arejrelated to residues and resistance.
There have been notable cases(for example cotton in Sudan and
Central America) where largescale agricultural production has
had to be abandoned because chemicals have failed to contain
the increase in pest species.
The number of resistant •species
worldwide has increased phenomenally over the last 20 years from
around 100 in 1960 to well over 400 in 1980.
Resistance is the root cause of thetecent dramatic in
crease in malaria.
Resistance to chloroquine, th^most widely
used drug against malaria has now built up in the northern
part of Latin America, West and East Africa and a very large
part of Asia.
The alternative Fmsidar, is no longer as effective
in many places where it once was and there are few available
alternatives.
As resistance among crop pests increases# farmers are tempted
to mix pesticides and increase do<ses, both with potentially dis-
astrous consequences.
They become trapped in a treadmill situa-
tion of increasing costs and decreasing yields.
Execessive use of pesticides can also lead to residue pro
blems which can have far-reaching consequences.
In the industria-
Used countries which, by an large, have strict regulations on
the more hazardous pesticides# residue levels may be so high
that the products are unacceptable.
The international trade in pesticides is enormous, largely
unregulated and increasing.
Total pesticides sales increased
from 8.1 billion US dollars in 1972 to 12.8 billion dollars
(1983 dollars) in 1983.
Most pesticide production takes
place in the industrialised countries of the north# which account
for 96% of pesticide exports; and most of it is in the hands of
a score of large corporations.
16.5%
In 1978# the USA accounted for
of that trade and the EEC countries for a massive 61.5%
surely the most compelling reason for regulatory action within
the Community.
Many of the pesticides which are marketed in the Third
World are banned or severly restricted in EEC countries (EEC
Directive 79/117).
Others have never been registered for use in
their country of origin or have been withdrawn from use.
In an
ideal world# every country should have its own structure for
testing and regulating pesticides.
However# at present 41
countries have no regulations at all an<^nany of those which do
lack the resources to make their system effective.
EXPORT CONTROLS
Worldwide concern about pesticides grew during the late
1970s as more and more cases of abuse came to light.
An increas-
ing number of environmental# development and consumer organi
sation became involved and in 1982 formed the pesticides
Action Newwork (PAN). PAN participants have made collaborative
input to several international initiatives^esigned to achieve a
degree of regulation of the international pesticide trade.
of the first such initiatives was the European parliament
One
..3.
f
3
Resolution of October 1983
which called upon the Commission to
make a new directive which would ban the export of a hazardous
pesticide unless the importing country gave its consent to receiv
ing it.
The Resolution was passed unanimously but the EEC has
been very slow to respond with a Directive.
The Netherlands government repeated the call for action by
the Community a year ago but very little has happend.
Such a
system of export control has wide support among the developing
countries and has been reflected in a Resolution of the UN
General Assembly (December 1982)t in a Resolution of the Inter
national Union for the Conservation of Nature and Natural Re
sources ( IUCN)
(November 1984), as well as being embodied in the
latest draft of the FAO
International Code on the Use and Distri-
bution of pesticides (still under consultation).
The United states operates a limited notification system
which became a model for the interim Notification Scheme adopted
by the United Nations Environment Programme (UNEP) in May 1984
and for a Recommendation of the Council of the Organisation for
Economic Cooperation and Development (OECD).
Both these initia
tives are useful steps on the way to export controls but do not
go far enough.
It is nevertheless important that they be imple
mented immediately and monitored closely.
National governments have been slow to respond to international calls for information exchange and controls.
The United
States is alone in operating a notification system.
In the United Kingdom, a Bill currently going through parlia-
ment enables ministers to call for information from exporters to
fulfil their international commitments but the government has so
far resisted pressure to hav^esticide export controls written
in to the Bill.
In the Netherlands, chemicals for export are
subject to the same testing and notification procedures as those
for domestic use.
In Denmark, powers exist to enable a minister
to ban exports if he/she choose to do so.
In Germany, the trend
in the Bundesrat is towards taking steps to protect health and
environment.
••••4.
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■
I
L
PAN activities have played a vital part in increasing global
awareness of the issues involved in pesticide abuse and in the
However,
development of national and international initiatives.
much remains to be done, especially in the area of concerted
Europe is the leading exporter; surely it
Eurppean action.
should also be the leader in taking responsible action on export
controls.
’V^'T-oiy My^TT& ,
n'CA
Sp&cic^l repcrl- <■
ppfl,
r^lo.y'c Al ,
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.
8e l>c.^
PHARMACEUTICALS FOR THE THIRD WORLD: PROBLEMS AND PROSPECTS
By
DR. KUMARIAH BALASUBRAMANIAM, M.B.B.S. Ph.D
PHARMACEUTICAL ADVISER
0
Caribbean Community Secretariat
Georgetown
Guyana
The views expressed in this paper are the author's and do not
necessarily reflect those of the Caribbean Community Secretariat.
Presented at: HEALTH POLICY INTERNATIONAL, Princeton, N.J. 08540
27-28 October 1985
— 1 CH-5(FirstF'o°r)St
. fc/larKs Boad
560 001
ABSTRACT
This paper analyaaa the problama and proapacca
related to quality assurance and biooquivalence of
phamaceuticala marketed in Third World countries,
Socio*
economic and other relevant characteristics of these countries
which impose constraints on their capacity to control the
quality of drugs are indicated.
The background for the call
by many Third world governments for generic prescribing, the
reasons for generic substitution being widely practised in
these countries end procedures they adopt to procure drugs
with potential bioavailability problems are examined.
1
I.
INTRODUCTION
Traditionally pharmaceuticals involved only two parties the prescriber/dispenser and the patient.
This was a fairly simplistic
arrangement and presumably there were no problems.
At a later point
in time a third and important party - the pharmacist - joined the scene
and the pharmaceutical sector was becoming more complex.
At present,
this vital sector has attracted the attention not only of technical
personnel in many disciplines but also of authoritative economic and
social forces.
The pharmaceutical sector in every country is beset
with many problems which are being discussed at national, regional and
international levels.
In the advanced industrialised countries, there is concern
over escalating health care costs.
There is also evidence of over
prescribing, of drug wastage, of the ineffectiveness of many drugs and
of the excessive use of tranquillisers end other psychotropic agents.
In view of these there has been a call for controls on prescribing by
doctors.^
In the Third World the problems are different,
It has been
estimated by international agencies that a majority of the population,
up to about 70-80 percent, particularly those living in rural areas
and urban slums have no access to even the few basic and essential
drugs, in spite of the fact that a majority of these countries allocate
a significant portion of their health budget, ranging from 40-50 percent t
for the purchase of pharmaceutical®.
These countries procure their
pharmaceuticals from external Bourses and most of their requirements
by international tendering,
but a majority of these countries do not
have adequate laboratory facilities to assure the quality and
bioequivalence of the imported drugs.
-2-
This paper will attempt to survey the problems and prospects
with regard to quality assurance and bioequivalence of drugs in the
Third World.
The problems and possible solutions to quality assurance
of pharmaceuticals in ths Third World cannot be considered without an
understanding of the socio-economic and other relevant characteristics
of these countries.
Therefore* before we proceed to analyse the
problems and prospects associated with quality assurance* it would be
useful to look at some relevant characteristics of Third World countries.
II.
THIRD ttORlD COUNTRY* SOME RELEVANT CHARACTER
Majority of the Third World countries are young nations which
started managing their own affaire within the last 20 to 40 years.
They
■
are organizing systems suited to their political* cultural and socio
economic peculiarities and within the available human* financial and
technological resources.
Tabla 1 shows 157 Third World countries divided into appropriate
groups according to their population sizes and per capita gross national
product (GNP).
A majority of these countries are small| more than
50 percent of tham have less than three million people each and more
than 50 percent have per capita income of less than US51*000 each,
In
contrast, only one out of IB advanced industrialised countries (Table la)
has e population of less than a million^ the other 17 have populations
of over three million each.
The per capita GNPs of these countries are
savoral times higher.
What are not revealed in Table 1 but ere of great relevance
to pharmaceutical supply systems are the facts that out of the 157
countries, 27 are small islands, some of them far removed from international
sea lanes and another 20 are land-locked.
A..
TABLE X
ONE HUNDRED AND FIFTY-SEVEN THIRD UQRLD COUNTRIES GROUPED
ACCORDING TO THEIR POPULATIONS AND PER CAPITA GROSS NATIJNAL PRODUCTS
(J-97?)
(.
>
Greater than:
Per
Population
(Millions)
Capita
<
Legs thgn)
Gross National Product
> 200
> 500
< 500
< 1000
US
dollar
> 1000
> 2000
< 2000
< 5000
No. of
Countries
Not
Available
< 0.005
9
7
1
1
> 0*005
< 0.05
11
2
3
3
1
2
> 0.05
< 0.1
9
5
2
1
1
> 0.1
< 0.5
28
6
5
2
8
5
> 0*5
< 1*0
8
1
1
2
> 1.0
< 3.0
19
1
5
3
4
3
> 3*0
< 5.0
13
3
3
3
3
1
> 5.0
<10.0
24
1
4
8
3
5
2
> 10.0
<20.0
15
1
1
6
1
2
4
> 20.0
<50.0
13
1
2
2
4
2
2
> 50.0
< 100.0
5
1
1
1
1
1
> 100.0
< 200.0
2
1
1
1
> 200.0
No. of Countries
157
< 200
1
1
15
14
34
>
5000
4
2
1
1
30
Sources: (1) "Gross National Product and Growth Rates" - 1981, World Dank Atlas
(2) United Nations Conference on Trade and Development, Supplement 1981,
Handbook of International Trade and Development Statistics
25
28
11
-4«
TABUE la
EIGHTEEN ADVANCED INDUSTRIALISED COUNTRIES
GROUPED ACCORDING TO THEIR POPULATION AND
PER CAPITA GROSS NATIONAL PRODUCTS 1979
>
(
Population
(Millions)
Greater thfrn:« Lgss than)
No. of
Countries
Per Capita Gyc s National
Product
US Dpllar
> 5000
< 10000
> ioouo
>
o.i
<
0.5
1
>
3
<
5
3
2
1
>
5
< 10
5
1
4
> 10
< 20
2
1
1
> 20
< 50
1
> 50
<100
4
2
> 100
<200
1
1
> 200
1
1
2
1
1
TOTAL:
.18
Sources; (1)
"Grobs National Product and Growth Rates”
1931, World Bank Atlas
(2)
7
11
United Nations Conference on Trad© and Development,
Supplement 1901, Handbook of International Trade
and Development Statistics.
-5-
Ths size of the Third World countries and thair limited
financial resources are reflected in the small pharmaceutical markets
in a majority of thee© countries.
Fifteen out of 141 countries
have markets of less than one million a yearj mors than 50 percent
have markets under 25 million each.
(Table 2).
0
One of tha essential resources needed for the various
activities associated with quality assurance is the availability of
sufficient number of young persons with a background of science education.
Table 3 gives the number of students, per 100,000 of the population,
graduating per year in natural sciences, medical and related health
sciences and engineering in 72 countries® for which data was available.
The graduates Include the following:
(i)
Diploma® and Certificate® not equivalent to a
first University Degr®ej
(ii)
first University Degree or equivalent
qualifications! and
(iii)
post-graduate University Degree or equivalent
qualifications•
In 22 out of the 26 African countries, the number of such
graduates is less than 10 per 100,□□□ of the population.
The situation
in Asia is slightly better though in more than 50 percent of ths 22
Asian countries the corresponding figurs is less than 25 per 100,000.
In contrast, in all the 13 advanced industrialized countries the figure
is over 50 end in 70 percent of these countries more than 100 students
per 100,000 of the population graduated in one year.
A..
TAPI.E ?
ESTIMATES OF PHARMACEUTICAL MARKETS IN 1979
(C.I.F. PRICES) FOR 141 THIRD WORLD COUNTRIES
( >
Grpater thnn:
Estimates of Pharmaceutical
Markets (C.I.F. Prices).
US S Millions
Number of Third V/orJd
Countries
<
1
15
1
<
5
15
5
< 10
14
>
10
< 25
36
>
25
< 50
20
>
50
<100
11
> 100
<200
8
> 200
<500
12
> 500
< 1000
7
>
> 1000
Source:
Lpfs than )
3
Ea1ssubramaniam , K., ’‘Pharmaceuticals fcr the Third World;
Strategy for Collective SeIf-Relir-nce” , Consumers Association
of Penang, Malaysia, November 1984 (Mimeograph).
-7-
NUMBER OF STUDFNTSrPER 100>000 OP POPULATION;£RADUA.HrjG*
PER YEAR IN W TURAL SC lEI-lEES, MEDICAL AND HE Al TH RELATED
SCIEK EES AND ENGINEERING IN 1979 OR 1980
(
>
Number Graduating
per 100,000 of the
Population
<
Greater Than?
Advanced
Industrial
ised (13
Countries)
<
Less Than)
Asia
Latin
America
(22
(11
Countries) Countries)
Africa
(26
Countries)
10
8
22
4
2
7
6
1
4
2
1
>
10
25
>
25
50
>
50
<
75
3
>
75
< 100
1
1
> 100
< 150
5
1
4
> 150
* Graduates include the following:
(i)
Diplomas and Certificates not equivalent to a first
University Degree;
(ii)
First University Degree or equivalent qualifications; and
(iii)
Post graduate University Degree or equivalent qualifications.
Source :
Statistical Yearbook 1983, UNESCO, Table 3,14.
-8-
The common causes of morbidity and mortality in the Third
World are bacterial infections and parasitic disoesss linked to
poverty, malnutrition and ignorance,
On the other hand, chronic and
degenerative diseases are the common causes of morbidity and mortality
in the advanced industrialized countries.
These differences, in turn,
give an altered pattern of need end use of drugs, exemplified in the
market breakdowns of the commonly used pharmaceuticals in Pakistan a Third World country — and federal Republic of Germany *• an advanced
industrialized country.
(Table 4).
Antibiotics and vitamins accounted
for over a third of the market in Pakistan, whereas drugs for
cardiovascular disorders, psychopharmaceuticals and hormones made up
a little over a third of the market in the federal Republic of Germany.
A number of Third World countries, particularly the smaller
territories, have no national medical schools, nor do they have
sufficient resources to train an adequate number of their students in
foreign medical schools.
As a result all such countries are served by
many expatriate doctors from several countries.
More important is the
fact that in any such single country there would be doctors trained in
different medical schools in many countries.
Each of these doctors
would take with him/her ths prescribing habits learned in the different
institutions and be familiar only with certain brand names of
pharmaceuticals manufactured in laboratories based in the countries
they underwent their training and continue to use those brand names.
Many of these doctors work for periods of about three to five years;
consequently, there is a large turnovar of expatriate doctors in many
of the smeller Third World countries.
/...
-9T A SU. 4
MARKET 3REAKBDWR OF THE COmC^LY U^ED,_mmCLUT^^
PAKISTAN AhD FOEfrAU REPUaVlC 3F GERMANY (FR5)
PLPXENT
PAKISTAN
or
FRG
MARKET
PLRCINT
OF
MARKET
Systemic Antibiotics
25
Cardiac Agents
11
Vitamins
13
Psychopharmacauticala
6
Cold Preparations
S
Peripheral Vasodilators
5
Analgesics
5
Cold Preparations
5
Antienae®ics
3
Analagesica
4
An tidiarrhoeels
3
Vasoprotactivas
4
Antacids
3
Systemic Antibiotics
4
Tuberculosisties
3
Antihyperteneives
4
Spasmolytics
3
Sexual hormonoa
3
Tonica
3
Antidiabetics
3
66
Sources Professor Haisgeorg Carets and Or* Clave &• Raepnack
of Hoechst AG quoted in Scrip &©• 66T» February
1982, F. 12.
49
-10-
•'hen discussing problems and prospects related to quality
assurance in the Third World, one of the essential data needed is the
availability and competence of quality control laboratories in theso
countries.
Unfortunately, whatever is available is anecdotal data.
-A
number of the smaller countries do not have their own quality control
laboratories.
Many others have set up laboratories which are equipped
to carry out □ limited number of chemical tests.
The more developed
countries do have fully equipped quelity control laboratories.
The reasons why many Third World countries do not hove fully
equipped quality control laboratories of their own are clear.
The
basic scientific infrastructure essential for the establishment and
operation of a high technology institution like a quality control
laboratory does not exist in these countries,
To set up and maintain
a quality control laboratory, a country would need:
(i)
to invest large sums of foreign exchange to meet
ths high capital expenditure and maintenance
costs, including ths imports of highly purified
and expensive reagents and for the heavy use of
energy to maintain efficient temperature and
humidity control in tropical climates whers the
atmosphere is hot and humid;
(ii)
technicians for the maintenance of the complex
automated electronic equipment which perform
reliably only when expertly maintained; and
(iii)
qualified analytical scientists trained in the
various disciplines.
£
-11-
The above resources are not available in a largo number of
Third World countries.
In this context, I seriously doubt ths validity
of the recommendation that every country, regardless of its stage of
development, should consider the need for investment in an independent
national drug quality control laboratory. A poorly equipped laboratory
would tend to give ths authorities a false sense of security.
Considering the small pharmaceutical markets in many Third World
countries, and the limited resources available, investment of considerable
financial and technical outlay on a quality control laboratory doss not
appear to be a viable proposition,
A two-tiered scheme would be more
advantageous to those countries which do not have the resources to set
up a fully equipped laboratory.
Depending on their own resources they
could set up laboratories to carry out the less demanding basic tests
for commonly used drugs.
A group of countries could join together to
set up a regional laboratory fully equipped to carry out the more
sophisticated tests.
The Caribbean Regional Drug Testing Laboratory
(CRDTL) is an example of such a joint venture.
This laboratory was
established in 1979 by the Caribbean Community Secretariat with
assistance from the Canadian International Development Agency and the
Pan American Health Organization to serve 14 countries in the Caribbean
Region with a total population of about 5.5 million.
Located in
Jamaica, this regional laboratory is equipped to carry out micro
biological and pharmacological teste, perform biological availability
on selected types of drugs, investigate the stability of drugs under
conditions of storage prevailing in the Region and establish liaison
with all appropriate agencies interested in drug testing and provide
information and advisory services to support the activities of the
drug control officials in the Region.
-12-
III.
DUALITY A5SURANC£ Ih THIRQ wfJRLg COUNTRIES
How da governments make
certain that each drug reaching a
patient is safe, effectiva wnd acceptable?
Ideally, each country
should have a national drug registration syetem embodied within a
legislative framework which, among others, contains provisions to
assure the quality of ell marketed drugs.
The drug registration system
is operated by a national drug regulatory authority which corries out
a comprehensive quality assurance programme that includes both technical
and managerial or administrative activities.
The capacity of a drug
regulatory authority to carry out th© technical ©ctlvities essential
for quality ©Bsurencs ia directly related to the operational capability
of th© national quality control laboratory.
How do countries without domestic facilities for carrying
out the wore sophisticated teste including bioavailability studies
assure the quality and bioequivalar.ee of drugs?
«orld countries do not have thtse facilities.
A majority of Third
These countries msk©
use of an offshore laboratory but, more important, they rely on
managerial or administrative procedures to esaure that all drugs
marketed in the country are safe, effective and acceptable.
The
managerial activities related to controlling the quality of drugs
include eupplier Belaction, preparation of contract terms and
monitoring supplier performance.
Intarnational agencies including the World Health Organisation
(WHO), Unitad Nations Conference on Trade end development (UWCTAD)
and United Nations Industrial Organization (UNIDO) have edvicod
Third World countries to centralism their drug requirements and
buy them in bulk through international tendering.
tendering can only be done in generic n^mee.
International
Almost all Third world
countries follow this procedure fox most of their large volume drug
requirements.
-13-
There has been arguments for and against generic drugs and
generic prescribing.
Generic prescribing, it has been argued,
restricted the clinical freedom of doctors.
But it must be understood
that doctors serve the public and ths amount of clinical freedom they
enjoy would depend on how much freedom the public want them to enjoy.
The public, of course, cannot make a choice on how much clinical
freedom should be given to the doctors.
The public passes on this
responsibility to experts in the relevant disciplines of medicine,
pharmacy and pharmacology to sit in committees and arrive at an
informed consensus.
The WHO Expert Committae on the use of essential
drugs is such an authoritative international Committee which has
indicated that a limited number of essential drugs would satisfy the
health care needs of the majority of the population.
This Committee
has also recommended that generic names for drugs should be used whan-
ever available.
2/
All Third World countries have accepted this advice.
Doctors in these countries are requested to use generic names for drugs
in prescribing.
The training an average doctor in many Third World countries
undergo would enable him, among other things, to select the appropriate
drug - active ingredient - to manage a particular patient.
Howevsr,
he/she would have limited competence to evaluate the quality aspects
□f dosage formulations.
This is an important task which is the
responsibility of the drug regulatory authority.
In addition to doctors,
many Third World countries employ paramedical personnel to deliver
health care including prescribing of drugs.
Those paramedical
personnel would not be competent to assess the quality and bioequivalencc
of drugs.
They have to prescribe generic drugs.
Furthermore, many
Third World countries employ expatriate doctors trained in various
A
-14-
medical schools in different countries.
If these doctors prescribs
by brand names there would perhaps be as many different brends of a
particular drug prescribed as tha number of doctors in that country!
All these factors lead to the conclusion that generic prescribing is
the only rational way of prescribing in these countries.
However, if
the doctors continue to prescribe brand name drugs, generic substitution
is the only alternative.
There ic no antisubstitution lew in any Third
World country and generic substitution is regularly carried out.
In
this context it is relevant to note that generic substitution is widely
practised in hospitals in the United Kingdom but is not permitted by
retail pharmacists who dispense the prescriptions of general
3/
practitioners.
Obviously, substitution by generic drugs of inferior
quality and bioequivalence should not be allowed.
Drug regulatory
authorities would be foiling in their duty if they allowed substandard
generic drugs to be marketed in a country.
Problems with quality and
bioavailability have occurred in the past with both generic and brand
name products and they can be eliminated by relatively simple teats.
There is a certain amount of fear among some doctors that a
generic drug policy would result in substandard drugs being marketed
in a country.
It has been contended that generic equivalents may
differ in absorption end solubility as a function of time.
However,
most studies find such differences minimal and conclude that generic
products manufactured by laboratories adhering to good manufacturing
practicss (GMP) do meet governmental pharmaceutical standards and
further find that brand narnos and associated high cost prodcuts do
not assure better quality.*^
/...
-15-
*
Professor Paul Turner of the Department of Clinical
Pharmacology , 5t. Bartholomew Hospital, University of London, writing
in the Lancet, has stated "In
In a large proportion of clinical situations, there
is no need for assurance of therapeutic bioequivalence
and there is thus no reason to use an expensive brand
name when a (cheaper generic equivalent is available.
This was confirmed by a four-year generic prescribing experiment in
the United Kingdom.
During the four-year experiment with genei-ic
prescribing, no bioequivalence problems were reported with generic
drugs.
The author of the experiment concluded -
"The charge of inadequete bioavailability and
therapeutic effect of generic drugs so often levelled
by the Association of the British Pharmaceutical
Industry (ABPI) has not been proved in practice.
An authoritative manual on drug supply management^ has been
prepered by a team of experts in collaboration with the WHO.
This
menus! has been written to assist health decision-makers, particularly
those in the Third World, to design and implement improvements in
their drug supply systema and has served as a background document for
WHO sponsored regional and intsrnational workshops on drug supply
management.
In discussing quality assurance, this manual states, among
other things -
0
"... In practice most drug preparations are sufficiently
bioequivalent for routine medical practice? that is, the
bioavailability of most drugs - whether bought by their
generic name or by a brand name - is adequate enough to
assure that thd patient receives the intended affect
from the drug. ••• Fortunately, for simple antibiotic
preparations, bioavailability is almost never a problem."
-16-
*
Though bioequivalencB is not s problem for a majority of
drugs needed for health care delivery in the Third World, yet it ia
an important factor in the selection of certain drugs.
In addition
to deciding which drugs have bioavallability problems, it is also
important to determine what potential harm could befell tha pstient
if he were administered a drug with bioavailability problems.
With
regard to certain drugs given to obtain symptomatic relief including
minor analgesics and cold remedies^ there is very little likelihood
of harm being done by the alow or incomplete absorption of the drug.
On the other hand, bioavailsbility would be extremely important for
drugs with s narrow therapeutic index such es dlxogin or anticoagulants
or for drugs whose blood levels should always be maintained within a
narrow therapeutic range such as entiseizure drugs.
It is also
important for certain dosage forms such as time-release preparations,
enteric coated forms and slowly disintegrating compressed tablets.
The majority of drugs used in the Third World do not have
bioavailability problems unlike those commonly used in the advanced
industrialised countries (Table 4).
Third World countries cannot
request bioevailability studies for all drugs they impart nor can
they do these studies themselves.
Therefore, it ie essential to
decide which of the drugs procured by these countries have a potential
bioavailability problem.
This would be feciliteted if tha WHO Expert
Committee on essential drugs in addition to periodically updating the
list of essential drugs would also indicate all drugs in their list
which have potential bioavailability problems.
Third World countries
could then pay particular attention in procuring these drugs which
would include the following:
(i)
these drugs would not be purchased by worldwide
international tender but from a restricted
number of manufacturers of both brand and
generic drugs?
/
-17-
(ii)
request bioavailebility studies from the
manufacturer and also from the national
drug regulatory authority of the country
where the manufacturer is based;
(ill)
have an independent offshore laboratory
to carry out these tests; and
(iv)
having idsntified reliable manufacturers
for the supply of the drugs with potential
bioavailability problems, continue to
restrict future purchases of these drugs
from them.
Ian Kennedy - BBCfs 1981 Reith Lecturer et a Symposium,
M Presser ibinq Drugs J The need for greater control", held at
the Poyal Society of Medicine in London on 29 May 1932• quoted
in 5CRIP ^o. 597, p. 2.
"The Use of Cssential Drugs”, Report of a WHO txpert Corrsnittee.
Technical Report Series 635, World Health 3rgenizetian, Geneva,
1983, p. a.
J/
Hichael 0. Rawiina, "Th® Case for Generic iubetilotion”, World
r>
Health Forum, 1934, Vol. 5, No. 4, pp 329-330.
4
Michael D. R awl ins, JLLii*
Slum and Kevin Kxeitraan, "fectore affecting Individual
Usa of Medicines*, in Ph^rm-^c^utickle and Hgelth Policy edited
by Hichard Blum, Andrew Herxhoimer, Catherine btenzl and
Jsspar *oodcoek. Published by Croom Helm Ltd., 2-10 St. Jchn,n
'•*oad, London S'w 11, 1991.
i/
Paul Turner, Lancet (1979), Vol. II, p. 75.
V
J.V. Tapster, "Generic Substitution", Pharmaceutical Journal,
London, 12 February 1983, pp 150-151.
&
Managing .UxuO-^MOPlyt ''anag^mynt sciences fox Health, Boston,
^assar-husetts, USA. Supported by reaearch fund® of
Sciences for Health and a Technical Service Agreement with the
World Health Urgenixation, Second Printing, March 1982*
- Media
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