RF_DR_38_SUDHA.pdf
Media
- extracted text
-
RF_DR_38_SUDHA
Main Identity
From:
To:
Cc:
Sent:
Attach:
Subject:
’Naveen’ <navthom@gmail,com>
<aidanindia@yahoogroups.com>
--chc@sochara.org>: *ravl' <ravf@phmovement.org>
Monday, June 26,2006 6:16 PM
AIDAN Response_Data Exclusivity.doc
Data exclusivity
Dear friends,
Ire’d that the PMO has called the Ministries of Health, Commerce, Chemicals and Fertilisers, Science and
Tt .iclogy and the Centre for Scientific and Industrial Research (CSIR) on July 12,2006 for a meeting to decide
about amending the Drug and Cosmetics Act.
The purpose of the amendment is to include 'data exclusivity1 which would make it mandatmy for generic
companies in India to conduct their own clinical trials before marketing a drug during the period of the data
exclusivity. The other possible impacts are listed in the attached document.
Shouldn't we send out comments to the respective ministries and PMO as AIDAN? I have attached a draft letter
with comments on the issue. Please give your comments/ or modify it suitably. We can also send it from our
respective organisations.
Looking fonAiard to your responses.
Best wishes,
Naveen
CHC
July 3, 2006
Comments on the
Proposed Amendment to the Drug and Cosmetics Act,
and the issue of Data Exclusivity
by Jan Swasthya Abhiyan (ISA)
The Jan Swasthya Abhiyan (JSA) is the Indian circle of the People's Health Movement, a worldwide
movement to establish health and equitable development as top priorities through comprehensive primary
health care and action on the social determinants of health. The JSA coalition consists of over 20 networks
and 1000 organisations as well as a large number of individuals that endorse the Indian People's Health
Charter a consensus document that arose out of the Jan Swasthya Sabha held in December 2000.
We are writing this letter to share our strong concerns on the issue of ‘Data Exclusivity’ and its inclusion in
the proposed amendment to the Drug and Cosmetics Act. We consider ‘data exclusivity’ to be another
attack on peoples’ health. We urge you to consider these concerns and stop any move to amend the above
Act, or to include ‘Data Exclusivity’ in any legislation. Looking forward to your early action in this regard.
In case you need more information, we would be happy to provide the same.
OUR CONCERNS ON THE ISSUE OF DATA EXCLUSIVITY
1) The TRIPS agreement does not refer to any period of data protection, nor does it
refer to data exclusivity.
2) This move to include ‘data exclusivity’ is a ‘TRIPS-plus’ agenda which is anti
people and against people’s interest. It is being pushed by vested interests
including large Multi-National Corporations and certain foreign governments.
3) Data exclusivity has become a means of preventing competition from Indian
manufacturers which greatly restricts access to medicines.
4) It is unethical to conduct clinical trials on drugs which have already been proven
effective.
5) The cost of generic drugs and the costs of health care are bound to increase, which
is a wasteful expenditure which a country like ours can ill-afford.
6) The civil society in the country and even experts from within the Government have
opposed the amendment because of the impact it will have on people and people’s
access to medicines.
i
Compliance with TRIPS
In complying with the TRIPS norms, India amended the Indian Patents Act, 1970 for the second time as
recently as two years back against much public opposition. This move to further alter Indian legislation to
supposedly comply with TRIPS requirements is an unwarranted step. In fact, the TRIPS agreement does
not refer to any period of data protection, nor does it refer to data exclusivity.
Article 39.3 of TRIPS says that WTO Members should protect "undisclosed test or other data" against
"unfair commercial use" and "disclosure". Nowhere does TRIPS state that countries should provide exclusive
rights to the originator of the data for a given period. Rather, TRIPS simply refers generally to the need for
“data protection”.'
Data protection against unfair commercial misuse as mentioned in TRIPS is totally different from data
exclusivity. The use of data by the Drug Controller to compare bioavailability and bioequivalence data is a
legitimate, non-commercial use and is TRIPS compliant.
TRIPS plus - An Anti-People Agenda
Preventing comparative use of data submitted for getting marketing license from the Drug Controller is
definitely a TRIPS PLUS measure. Such measures are being forced on developing countries as part of many
of many Free Trade Agreements and Bilateral Trade Agreements.
In fact, the Report of the Commission on Intellectual Property Rights, Innovation and Public Health
(CIPRIPH), of which Dr. R. A. Mashelkar was the Vice-Chairperson has clearly cautioned countries from
placing unnecessary data protection norms. In page 143, it clearly says “Article 39.3, unlike the case of
patents, does not require the provision of specific forms of rights. [...] It does not create property rights, nor
a right to prevent others from relying on the data for the marketing approval of the same product by a third
party, or from using the data except when unfair (dishonest) commercial practices are involved." In page
144, it states, “
developing countries should not impose restrictions for the use of or reliance on such data
in ways that would exclude fair competition or impede the use offlexibilities built into TRIPS".11
Access to Drugs
It is clear that data exclusivity could prevent the registration of generic versions of medicines even when
there is no patent on a medicine. For instance when a pharmaceutical does not meet the standards for
patentability or when no patents are granted for pharmaceuticals, the data could still come under ‘data
exclusivity’ norms."1 Data exclusivity has thus become a means of preventing competition from Indian
manufacturers which greatly restricts access to medicines.
2
As the Global AIDS Alliance and the others working on ‘access to drugs’ have pointed out, such
amendments will have adverse effects on the global availability of affordable essential medicines meant
to treat HIV/AIDS, hypertension, diabetes, asthma and many other diseases. If ‘data exclusivity’ is applied,
then companies would be prevented from taking marketing approval even if they have been granted
compulsory license to use a patented substance during the period the data exclusivity is in operation.
Unethical Practice
In addition to all the above problems, data exclusivity raises very important ethical questions. Entities
desirous of making a generic drug would have to repeat clinical trials, which would be unethical as they
would be conducting efficacy trials with compounds which have already been proven effective, while
denying effective drugs to certain other people.
Health Care Costs
In a country where most of the spending on health is through out-of-pocket expenditure and the provision of
government services is limited, any increase in cost of drugs is bound to adversely affect people’s access to
drugs. A duplication of clinical trials is bound to increase the cost of drugs and is a wasteful expenditure
which a country like ours can ill-afford. As the Report of the CIPRIPH states, the United Nations Special
Rapporteur on the Right to Health commented on the possible additional health-care costs relating to the
introduction of data exclusivity in the Free Trade Agreement between the United States and Andean Pact
countries.
Mismatched Responsibilities
The drug regulatory authority is a body set up as a public authority. Its function is to ensure, in public
interest, that drugs that are provided with marketing approval meet the criteria of safety, efficacy and good
quality. Drug Regulatory Authorities need be concerned with safety and efficacy of a drug, and are not
supposed to involve themselves with the patent status of a drug. By amending the Drugs and Cosmetics Act,
Drug Regulatory Authorities will be required to look at the Patent status of a drug, which does not fall
under their domain. Under the guise of Data Exclusivity, what is really being sought is that drug regulatory
authorities should act on behalf of pharmaceutical companies to safeguard their monopoly right.*7
The recent WHO Briefing Note on Access to Medicines emphatically states that efforts to integrate the
intellectual property system and the drug regulatory system via data exclusivity, “linkage” or other means are
3
likely to have negative implications for access to medicines. It calls on countries to keep these systems
separate, and to reject any and all efforts to make connections between them.
Opposition from Within
Experts on the issue, including experts from civil society, the Parliament Standing Committee on Commerce
and the Ministries of Commerce and Health have opposed the amendment because of the impact it will
have on people’s access to drugs and agro-chemical products. These views should be taken into account
while taking a decision of such far-reaching impact.
What is the Alternative?
Instead of seeking to further expand the scope and duration of ‘exclusive rights’ of drugs and agro-chemical
products, India should seek to encourage competition from Indian manufacturers.
A minor addition to the Drugs and Cosmetics Act which says ‘test data provided by a company will not be
made public or shared with its potential competitors for five years’ is enough to meet the requirements of
TRIPS. This does not prevent the Drug Regulatory Authorities from relying on the data to license a generic
version of a new drug.
The urgent need of the hour is to improve people’s access to drugs and to make drugs affordable. We
hope these issues will be taken up strongly in the new Drug Policy.
1 Data exclusivity in international trade agreements: What consequences for access to medicines? MSF
Technical Brief - Campaign for Access to Essential Medicines, 2004.
ii
Public health, Innovation and Intellectual Property Rights - Report of the Commission on Intellectual
Property Rights, Innovation and Public Health, WHO, 2006.
iii
Briefing Note - Access to Medicines, World Health Organisation (WHO Regional Office for South East
Asia and WHO Western Pacific Region), 2006.
,v Data Exclusivity: Implications for Public Health, Amit Sen Gupta, 2006.
4
29 June 2006
Draft Comments on the
Proposed Amendment to the Drug and Cosmetics Act,
and the issue of Data Exclusivity
by Community Health Cell (CHC)
Community Health Cell (CHC) is a technical resource group in health. We have been involved in community
health, public health and health policy issues for the past twenty-two years. Promoting community health
based on the social paradigm, through policy action, training, mainstreaming, networking and the people’s
health movement is CHC’s core thrust. CHC recognises that peoples’ health is deeply influenced by
determinants that are deeply embedded in the social, political, economic, cultural and ecological fabric of
life.
We are writing this letter to share our concerns on the issue of ‘Data Exclusivity’ and its inclusion in the
proposed amendment to the Drug and Cosmetics Act.
OUR CONCERNS ON THE ISSUE OF DATA EXCLUSIVITY
1) The TRIPS agreement does not refer to any period of data protection, nor does it
refer to data exclusivity.
2) This move to include ‘data exclusivity’ is a ‘TRIPS-plus’ agenda which is anti
people and against people’s interest. It is being pushed by vested interests
including large Multi-National Corporations and certain foreign governments.
3)
Data exclusivity has thus become a means of preventing generic competition which
greatly restricts access to medicines.
4) It is unethical to conduct clinical trials on drugs which have already been proven
effective.
5) The cost of generic drugs and the costs of health care are bound to increase, which
is a wasteful expenditure which a country like ours can ill-afford.
6) The civil society in the country and even experts from within the Government have
opposed the amendment because of the impact it will have on people and people’s
access to medicines.
1
Compliance with TRIPS
In complying with the TRIPS norms, India amended the Indian Patents Act, 1970 for the second time as
recently as two years back against much public opposition. This move to further alter Indian legislation to
supposedly comply with TRIPS requirements is an unwarranted step. In fact, the TRIPS agreement does
not refer to any period of data protection, nor does it refer to data exclusivity.
Article 39.3 of TRIPS says that WTO Members should protect "undisclosed test or other data" against
"unfair commercial use" and "disclosure". Nowhere does TRIPS state that countries should provide exclusive
rights to the originator of the data for a given period. Rather, TRIPS simply refers generally to the need for
“data protection”.'
TRIPS plus - An Anti-People Agenda
The Report of the Commission on Intellectual Property Rights, Innovation and Public Health (CIPRIPH), of
which Dr. R. A. Mashelkar was the Vice-Chairperson has clearly cautioned countries from placing
unnecessary data protection norms. In page 144, it states, “
developing countries should not impose
restrictions for the use of or reliance on such data in ways that would exclude fair competition or impede the
use offlexibilities built into TRIPS . It further states in page 147 that “facilitating the entry of generic
competition after the expiry of a patent is one means ofpotentially bringing down the price of health-care
products ”.z/
Access to Drugs
It is clear that data exclusivity could prevent the registration of generic versions of medicines even when
there is no patent on a medicine. For instance when a pharmaceutical does not meet the standards for
patentability or when no patents are granted for pharmaceuticals, the data could still come under ‘data
exclusivity norms. Data exclusivity has thus become a means of preventing generic competition which
greatly restricts access to medicines.
As the Global AIDS Alliance and the others working on ‘access to drugs’ have pointed out, such
amendments will have adverse effects on the global availability of affordable essential medicines meant to
treat HIV/AIDS, hypertension, diabetes, asthma and many other diseases. If ‘data exclusivity’ is applied,
then companies would be prevented from taking marketing approval even if they have been granted
compulsory license to use a patented substance during the period the data exclusivity is in operation.
2
Unethical Practice
In addition to all the above problems, data exclusivity raises very important ethical questions. Entities
desirous of making a generic drug would have to repeat clinical trials, which would be unethical as they
would be conducting efficacy trials with compounds which have already been proven effective, while
denying effective drugs to certain other people.
Health Care Costs
In a country where most of the spending on health is through out-of-pocket expenditure and the provision of
government services is limited, any increase in cost of drugs is bound to adversely affect people’s access to
drugs. A duplication of clinical trials is bound to increase the cost of drugs and is a wasteful expenditure
which a country like ours can ill-afford. As the Report of the CIPRIPH states, the United Nations Special
Rapporteur on the Right to Health commented on the possible additional health-care costs relating to the
introduction of data exclusivity in the Free Trade Agreement between the United States and Andean Pact
countries.
Opposition from Within
Experts on the issue, including experts from civil society and the Ministries of Commerce and Health have
opposed the amendment because of the impact it will have on people’s access to drugs and agro-chemical
products. These views should be taken into account while taking a decision of such far-reaching impact.
What is the Alternative?
Instead of seeking to further expand the scope and duration of ‘exclusive rights’ of drugs and agro-chemical
products, India should seek to encourage generic entry on patent expiry. One such norm which is presented
in CIPRIPH, and practiced in countries like Canada is the "early working" exception. This is consistent with
the TRIPS Agreement and allows prospective generic producers to make use of a patented product within the
patent period for the purposes of obtaining regulatory approval of their product as soon as the patent expires.
The “early working” exception constitutes jointly, with parallel imports and compulsory licenses, one of the
flexibilities-that the TRIPS agreement.
**********
3
1 Data exclusivity in international trade agreements: What consequences for access to medicines? MSF
Technical Brief - Campaign for Access to Essential Medicines, 2004.
ii
Public health, Innovation and Intellectual Property Rights - Report of the Commission on Intellectual
Property Rights, Innovation and Public Health, WHO, 2006.
111 Briefing Note - Access to Medicines, World Health Organisation (WHO Regional Office for South East
Asia and WHO Western Pacific Region), 2006.
4
— Original Message---From: Naveen
To: pha-ncc@vahooqroups.com
Sent: Thursday, June 29, 2006 11:57 AM
Subject: Defeat the anti-generics move of the Govt.
Dear friends,
The Prime Minister's Office has called the Ministries of Health, Commerce, Chemicals and
Fertilisers, Science and Technology and the Centre for Scientific and Industrial Research (CSIR)
on July 12, 2006 for a meeting to decide about amending the Drug and Cosmetics Act.
The purpose of the amendment is to include 'data exclusivity' which would make it mandatory for
generic companies in India to conduct their own clinical trials before marketing a drug during the
period of the data exclusivity. This is another gimmick of the pharma companies to extend their
protection and to prevent generic competition. They are using the TRIPS agreement as the basis
of their demand.
India already passed the Patent's Amendment Act to comply with the TRIPS agreement Now,
this amendment in the Drug and Cosmetics Act wants to include clauses which goes even
beyond the agreement. In fact the TRIPS agreement does not refer to data exclusivity. The WHO
Commission on Intellectual Property Rights, Innovation and Public Health (CIPRIPH), of which
Dr. R. A. Mashelkar was the Vice-Chairperson has also reiterated this fact. The civil society in the
country and even experts from within the Government have opposed the amendment because of
the impact it will have on people and people’s access to drugs.
As JSA we must strongly protest this move of the Government. It will be useful if we can send
letters to the concerned ministries expressing our concern.
Looking forward to your responses.
Best wishes,
Naveen
Naveen I. Thomas
Community Health Cell (CHC)
No. 359 (Old No. 367), Srinivasa Nilaya
Jakkasandra, 1st Main
1st Block, Koramangala
Bangalore - 560 034. India
Tel: +91-(0) 80-25531518
Telefax: +91-(0) 80-25525372
Email: navthom@vahoo.co.uk
Website: www.sochara.org
Hr
s.
3/7 job
: ' i U.
6on lo-U"
&!■
A O
y
’i/l jX^ciiA
feLee•ep>
I
7---
C 2^30IS^>
/-7c7A7
due-
Pu^SPlbn .
’pi'G^dcw
^Ci f-)(fz/t >(r
fvd^Actova^xxLca31wia_z ^2)CZ^\
mx^alcf^
Cj
d
-i-jj
S • 22^1^^I
Ajn
, fytTlOt<*V3
M4UISH
M^U-’
f-
t) •
t
S Iv-
li
VoGi'^^S CcAtsvVi.
^^-VcilcJ X^K- •
K^no.
cjttrrTva-k/Sftv
M •
/ oJ’O
yc» VMSt.
Pk.‘
fYxO^d ’
t4'5 ‘^/^Lvf
. ./7
j • Ch^trlCi
J3-
) -^£2^^.
• 7 ^^3 /.2£^63&
Vi’c^UitUK
/ A.
L\
)
,4c
IzCi
J. u<\^AV),
\J
6V
"a
/OCcf// ,
r^. £. gU 11 S+o^L-et/
\) i-'irx t •
c
. G| s L^
a, c h e. Lj 2. v
^6 3 W
.
q 2,2
i^i'ip T~
i 6
1 c( Ciy~l-
V^u>-hot •
ycvv^ a., e
cjQ/u <Pd cjfr^uA /<2m
/„ct!..'cw:x.j
(O\
Pt~A/>c<Kv~Zx_
NciV&lo
iG
As^.
Th©po<x<)
A59 '
twlhom® yciAcr).Co.ul<- ',
(iXM Co/^cXtVU-
n.
h
»?
jQ4aA^vv
i
^9-
.*)
— Original Message---From: Amitava Guha
To: Naveen ; Amit Sen Gupta ; mirashiva@Yahoo.com
Sent: Friday, June 30, 2006 1:11 PM
Subject: Re: Data Exclusivity
Dear Navin,
Thank you for your mail. You have pointed out an important issue where we need to go for an
immediate action. I personally feel that data exclusivity should not be allowed, whatever
expenses the MNCs make for safety, efficacy and toxicology study is extracted out by keeping
the prices of patented medicines very high. Thus they recover the expensed within two years
maximum of introduction of new medicine.
In some countries data exclusivity is allowed till the patent period lasts but is not applicable for
early working of a patented molecule.
I am not very sure how Indian industry is reacting but in their recent actions they are found to be
useless. I am contacting the National Working Group, if they are planning some actions
FMRAI would like to join actions with pothers. I shall talk with our Bangalore unit
friends requesting them to jointly work with you. Our Bangalore unit is not very strong since most
of the field workers here are very new.
You may contact our unit secretary in the following address.
A.K Suresh
1530, 11th Main, Vijayanagar
Bangalore-560 040 Phones: 080-23404179; 9448858897
Best Wishes,
Amitava
\
Briefing Note
Access to Medicines
.
'z
■
z
:
'
■
-
.........
March 2006
DATA EXCLUSIVITY AND
OTHER “TRIPS-PLUS”
MEASURES
entirely new pharmaceuticals, since there will be no
similar existing medicines with which to compare them.
Thus, in practice, only generic manufacturers can
demonstrate the safety and efficacy of their products via
bio-equivalence tests.
REG! IL A r I NG M EDICIN I S
This latter point is important, since bio-equivalence tests
are much smaller in scale than full-fledged clinical and
pre-clinical trials. Thus, they can be conducted faster,
and are considerably less expensive.
The pharmaceutical market is highly regulated. Two sets
of laws and regulations play a crucial role in this market.
These are i) the intellectual property laws and ii) the
laws and regulations about drug registration. These two
sets of laws have different objectives, and are
administered by different government agencies.
Intellectual property rights, notably patents (on which
this briefing note will focus, since they have the most
profound implications on access to medicines) are meant
to reward innovation by providing inventors with
temporary monopoly rights. Patents, however, confer
negative rights: a patent on a certain pharmaceutical
product means that the patent holder can prevent others
from producing or selling that product. But it does not
give the patent holder the right to actually sell that
medicine. In order to be allowed to sell a medicine, it has
to be registered by the national Drug Regulatory
Authority.
The drug regulatory system, or registration system, seeks
to ensure that only medicines of assured safety, quality
and efficacy are available on the national market. This is
important, since consumers do not normally have
sufficient information and knowledge about a
pharmaceutical product to make their own assessment
about its quality, safety and efficacy. In addition,
medicines that are ineffective or of poor quality can be
dangerous, both for the patient and for public health.
In order to assess the quality, safety and efficacy of a
product, the Drug Regulatory Authority will normally
require the manufacturer to provide relevant information.
For instance, in order to assess the quality of the product,
samples will have to be tested, the production procedures
will have to be documented and validated, and the
production facility may have to be inspected.
Meanwhile, the safety and efficacy of pharmaceuticals is
demonstrated mainly via pre-clinical and clinical trials.
Safety and efficacy can also be demonstrated by
Data Exclijsivi i y
The clinical and pre-clinical trial data that originator
companies submit to the Regulatory Authority are at the
centre of the debate on “data exclusivity”.
Because bio-equivalence data only prove that a generic
medicine behaves in (he body in the same way as the
original product (the safety and efficacy of which have
already been established), one could say that the generic
company and the Regulatory Authority indirectly rely on
the clinical trial data provided by the originator
company.
Originator companies argue that, since they made
substantial investment in these trials, they deserve a
period of “data exclusivity”; a certain length of time
during which the Regulatory Authority cannot rely on
the originator’s data in order to register a generic version
of the same product.
By implication, as long as the exclusivity lasts, generic
producers would have to submit their own data to prove
safety and efficacy, which would oblige them to repeat
the clinical trials and other tests. This is something that
would cause significant delay, and that many generic
manufacturers cannot afford. Moreover, it would raise
serious ethical questions, since it would mean that
clinical trials will have to be repeated, purely for
commercial reasons.
Alternatively -and in practice much more likely- generic
producers would have to delay the launch of their
product until the end of the exclusivity period1. Thus,
data exclusivity diminishes the likelihood of speedy
marketing of generics, and delays competition and price
reductions.
showing that a product is chemically and biologically
equivalent to an existing medicine (the safety and
efficacy of which are already known). However, by
definition, ‘bio-equivalence’ can not be demonstrated for
In the United States, data exclusivity lasts five years for new
chemical entities and three years for new indications. In the
European Union, it is 10 years with a possible one year extension
in case the drug is registered for a significant new indication.
Implications of Data Exclusiv ity
Proponents of data exclusivity at times point out that
data exclusivity docs not have major implications, since
the period of data exclusivity would normally be shorter
than the patent duration (see Figure la).
Figure La.: “standard” situation
Patent
granted
Registration;
market entry
♦—
♦
End patent
term
•
|
Data exclusivity
Yet, there are some questions as to whether data
exclusivity could prevent the registration of medicines
produced under a compulsory license (see Figure lb). If
so, data exclusivity would effectively render the
compulsory license useless.
Figure Lb.: “standard" situation
Patent
granted
Registration'
market ency
End patent
term
C
Data exclusivity
q
During this peiitxl. generics nwy
not be able to enter the market,
even when a (X has been issued
Secondly, if a period of data exclusivity is also granted
when an existing medicine obtains marketing
authorization (or registration) for a second or new
indication, data exclusivity could (be used to) extend the
period of exclusivity of the originator product (see
Figure 2).
Figure 2: Second indication
Patent
granted
Registration;
market entry
It has at times been argued that Article 39.3 of the
TRIPS Agreement makes it mandatory for countries to
grant data exclusivity. However, careful reading of
Article 39.3 (see Box 3) does not warrant this
conclusion; the text of the Article does not make any
reference whatsoever to exclusivity or exclusive rights.
Article 39.3 requires countries to protect undisclosed
registration data about new chemical entities i) against
disclosure and ii) against unfair commercial use. Thus,
regulatory authorities may not publish registration data3,
or share them with third parties (e.g. generic
competitors). This is a clear requirement. But there is
some debate as to what exactly is meant by ‘unfair
commercial use’. Does the use of bio-equivalence
studies instead of full clinical trials represent ‘unfair
commercial use’?
Clearly, there is no ‘unfair commercial use’ by the
generic company. The generic manufacturer never uses
the originator's data, and does not even have access to
them. Meanwhile, the regulatory authorities also do not
normally use the originator’s data - though, as
mentioned above, they may (indirectly) rely on them.
But even if the regulators would use those data, this is
not commercial use. since the regulatory agency is not a
commercial organization. Legal experts have also
pointed out that, in the context of Article 39 of TRIPS,
the term ‘unfair commercial use’ refers to, and prohibits,
practices such as industrial espionage, but was not meant
to provide exclusive rights (Correa, 2002). Nor was it
meant to interfere with the work of a government body
tasked with protecting the public.
Thus, legal and public health experts believe that TRIPS
requires data protection, but not data exclusivity - and
national laws do not need to be more stringent or more
restrictive than TRIPS.
Box 3: Article 39.3 of TRIPS
End patent
Members, when requiring, as a condition of approving
the marketing of pharmaceutical or of agricultural
chemical products which utilize new chemical entities,
the submission of undisclosed test or other data, the
origination of which involves a considerable effort,
shall protect such data against unfair commercial_use.
In addition, Members shall protect such data against
disclosure, except where necessary to protect the
public, or unless steps are taken to ensure that the data
are protected against unfair commercial use.
term
Data exclusiv tty
Finally, data exclusivity could prevent the registration of
generic versions of medicines even when there is no
patent on a medicine, for example when a
pharmaceutical does not meet the standards for
patentability (e.g. because it is not new), when a country
has no patent law, or when no patents are granted for
pharmaceuticals. The latter situation can arise in least
developed World Trade Organization (WTO) Member
2
TRIPS OOFS NO I REQUIRE Da TA
EXC1,1 SIX ITY
Registration
■’"''mdication
— •
Data exclusivity
Countries, which do not have to grant patents for
pharmaceuticals until 2016.2
' According to the Declaration on the TRIPS Agreement and
Public I Icalth. WTO Ministerial Conference, Doha, Nov. 2001
(or the “Doha Declaration”).
’ Though it is important to note that they may do so when this
is necessary to protect the public.
It is also worthwhile to note that in developing countries,
regulatory authorities often rely on data that are already
published or otherwise in (he public domain - and that
therefore do not fall within the scope of Article 39.3
(which only imposes protection for undisclosed data).
Mitigating the Impact
As mentioned above, from the perspective of public
health and access to medicines, it is preferable not to
grant data exclusivity. Moreover, there is no requirement
under international law that countries grant data
exclusivity; countries only have to provide for data
protection.
But if a country, for some reason (see below), does grant
data exclusivity or otherwise provides data protection
beyond that mandated by TRIPS, it is important to limit
its potential negative implications on access to
medicines. This can for example be done by limiting its
duration and/or scope (e.g. only for new chemical
entities) and by providing that reliance on the
originator’s safety and efficacy data is allowed in case of
compulsory licensing.
Other “TRIPS-pliis” Provisions
Requirements to offer exclusive rights to originator
products that go beyond what is mandated by the TRIPS
Agreement are sometimes referred to as “TRIPS-plus”
requirements. Data exclusivity is an important example.
But it is not the only example. Other “TRIPS-plus”
requirements are for instance:
•
•
•
Patent term extensions, i.e. provisions to extend the
duration of a patent beyond the 20 years required by
TRIPS, in order to compensate for delays in
granting the patent or in registering the medicine. It
is important to note that there is no obligation, from
an intcrnational/legal perspective, to grant such
extensions4.
Limitations of the grounds for compulsory licenses.
which may preclude issuing a compulsory license
for reasons of public health. Requirements to limit
the grounds (or reasons) for issuing a compulsory
license go directly against the Doha Declaration",
which has unambiguously confirmed that countries
are free to determine the reasons for granting
compulsory licenses.
Linkage between patent status and generic
registration, meaning that the Regulatory Authority
may not register generic versions of a
pharmaceutical that is under patent. This would be
problematic, since the Regulatory Authority would
probably lack the resources and manpower to check
the patent status of each product. Moreover, in case
there is a patent, regulators may not have the
1 Moreover, it should also be noted that at times the patent
holder is responsible for those delays.
5 Declaration on the TRIPS Agreement and Public Health, see
footnote 2.
expertise to assess whether the patent is valid and
would be infringed6. As a result, it is likely that they
will enforce all patents, even invalid ones - and
thus create additional and unnecessary hurdles for
generic competition . “Linkage” is also problematic
in view of the fact that patents are private rights; as
such, they should be enforced by the right holders,
not by the government.
Other “TRIPS-plus” requirements deal with the
administrative procedures related to patent applications
and/or the granting and revocation of patents. The
common feature of all “TRIPS-plus” provisions is that
they have the effect to complicate and/or delay the
marketing of generics, and thereby reduce access to
medicines.
Yet, while these requirements are going beyond the
TRIPS Agreement -or, in other words, are not required
by TRIPS- in recent years, “TRIPS-plus” requirements
have at times been incorporated in bilateral or regional
free trade negotiations, in bilateral investment
agreements and in other international agreements and
treaties. From the perspective of access to medicines,
this is a worrying trend; countries should therefore be
vigilant and should not ‘trade away’ their people’s right
to have access to medicines.
Box 4; Expanding data exclusivity requirements
Initially, requirements for data exclusivity focused on
undisclosed data that have been submitted to regulatory
authorities. However, more recently, there have been
cases where such demands just referred to
‘information’ - which could potentially expand the
scope of data exclusivity significantly by preventing
regulators from relying on data that are in the public
domain in order to register a generic medicine.
CO\( I.USION
Medicines fall under two separate legal and regulatory
systems: the intellectual property system and the drug
regulatory system. These systems have different
objectives, are administered separately and function
independently. Recent efforts to integrate these two
systems via data exclusivity, “linkage” or other means
are likely to have negative implications for access to
medicines. Thus, (developing) countries would be well
advised to keep these systems separate, and to reject any
and all efforts to make connections between them.
6 For these reasons. Regulatory Agencies in the EU have so far
refused to implement such “linkage" between patent status and
registration of medicines.
In 2002, the US Federal Trade Commission found that when
generic companies initiate patent litigation, they prevail in a
significant number of cases.
3
References and Further Reading
i.
d”dD,e ai
2.
3.
4.
4
ContadktorvTrend'in^
°n 'he TR'PS A8ree'^« “"d Public Health and the
CAMPAIGN FOR
ACCESS
ESSENTIAL
MEDICINES
& MfOfCMS
Data exclusivity in international trade agreements:
What consequences for access to medicines?
(MSF technical brief)
"Data exclusivity” is a term covering measures some governments
especially the US, are seeking to include in bilateral and regional trade
agreements. The implications of such measures need to be understood,
because they could have far-reaching ramifications for access to medicines. ’
Data exclusivity refers to a practice whereby, for a fixed period of time
drug regulatory authorities do not allow the registration files of an
originator to be used to register a therapeutically equivalent generic version
of that medicine. Data exclusivity is completely separate from patents. In
fact, the strongest impact may be felt in a country where there is no patent
for a medicine - if data exclusivity is granted this will provide a monopoly
for a set period (e.g. five years).
This short briefing paper outlines the consequences of data exclusivity for
access to medicines and explains why countries are not obliged to agree to
What kind of data are we talking about?
"Data exclusivity” refers to test and other data that a pharmaceutical
company must provide to a drug regulatory authority (DRA) in order to get
first-time registration for any new medicine it wishes to market in a
country. This test data is necessary to demonstrate the efficacy and safety
of the drug. Registration - or marketing approval - by the DRA is needed
before a medicine can be marketed in a country.
When generic manufacturers later apply to register another version of an
already-registered medicine, they only have to demonstrate that their
product is therapeutically equivalent to the original. To fulfil the efficacy
and safety requirements, the drug regulatory authority relies on the
registration file of the original manufacturer.
So what kind of exclusivity is it?
In order to delay competition from generic manufacturers, multinational
companies have been pushing hard to obtain exclusive rights over their test
data. During this period of "data exclusivity”, the DRA is not authorised to
rely on information in the originator dossier to approve/register generic
- I -
versions of a medicine. This period of exclusivity may vary from five years in
the US to eight years in the EU and can be found in developed countries
mostly in medicines legislation. Such legislation also exists in a limited
number of developing countries.
Practically, data exclusivity prevents DRAs from registering generic versions
of a medicine during a limited period, unless the generic manufacturer
independently carries out its own tests showing the safety and efficacy of
the medicine.
What are the consequences of data exclusivity for access to generic
medicines?
The biggest impact of data exclusivity is on medicines that are not patented
in some countries, as a result of pre-TRIPS patent laws excluding
pharmaceutical patents. This is the case of most antiretroviral medicines in
Guatemala for instance1, where generic manufacturers will now have to
wait five years from the date of approval of the original medicine in
Guatemala before obtaining registration of their own version of the
medicine2. In other words, even when a medicine is not protected by any
patent, multinational pharmaceutical companies are assured a minimum
period of monopoly in countries that provide data exclusivity. This is clearly
going beyond the TRIPS Agreement (see further below).
In other situations, where a medicine is protected by patents,
patents data
in
exclusivity may constitute a barrier to the use of compulsory licenses. If a
generic manufacturer is granted a compulsory license to overcome the
patent, it will not be able to make effective use of the license if it has to
wait for the expiry of data exclusivity before it can get its generic version
approved by DRA and put on the market. Therefore, countries will need to
ensure that the use of compulsory licences are not restricted by data
exclusivity.
Data exclusivity is a means of impeding generic competition, and
maintaining artificially high prices, thereby restricting access to medicines.
Moreover, it could be considered unethical to require generic manufacturers
to conduct their own safety and efficacy trials with proven effective
compounds. Clinical trials could expose patients to sub-optimal treatment.
Proof of therapeutic equivalence should be sufficient.
What is the relationship between data exclusivity and patents?
' This is because Guatemala only introduced patent protection for pharmaceuticals in
November 2000. Consequently, all medicines which were applied for patent protection
before this date cannot be patented in Guatemala (except for new improved versions that
meet the patentability criteria). See MSF report Dru^ patents under the spotlight - Sharing
practical knowledge about pharmaceutical patents, May 2003.
2 In accordance with Decree 09-2003, and the recently signed Central America Free Trade
Agreement (CAFTA) with the United States.
-2-
Patent application is made well before the application for drug registration,
at the stage of basic research, but since patents now last for 20 years, they
usually expire after the data exclusivity period.
The schematic graph below illustrates the interference of patents and data
exclusivity.
basic
research
preclinical
clinical
application
drug
research
research
for registration
approval
end of 20-year patent
I
2-4 years |
4-5 years j______ 2-3 years
start of 2()-year patent
-year data exclusivity
t—r-
Is data exclusivity another kind of intellectual property right?
Compared to more traditional intellectual property rights such as patents
and copyrights, data exclusivity is very unusual since it does not require any
inventive activity for it to be granted. Data exclusivity protection is instead
only based on the fact that an investment has been made by the originator
in carrying out the necessary tests to demonstrate the safety and efficacy of
their new medicine. Although the TRIPS Agreement now requires some
protection for this sort of data, it does not require that exclusive rights be
granted in the same way as patents or copyright.
What does TRIPS say about test data?
Developed countries pushed very hard during the TRIPS negotiations to have
data exclusivity included in the TRIPS Agreement as a new kind of IPR. They
succeeded in part, as test data are mentioned in Section 7 of the TRIPS
Agreement, but not entirely, as TRIPS does not talk about "exclusivity" as
such.
There is only one article in the TRIPS Agreement that talks about test data:
Article 39.3, which states that
"Members, when requiring, as a condition of approving the marketing of
pharmaceutical or of agricultural chemical products which utilize new chemical entities,
the submission of undisclosed test or other data, the origination of which involves a
considerable effort, shall protect such data against unfair commercial use. In addition,
Members shall protect such data against disclosure, except where necessary to protect the
public, or unless steps are taken to ensure that the data are protected against unfair
commercial use."
In simple words, what TRIPS says is that WTO Members should protect
"undisclosed test or other data" against "unfair commercial use" and
"disclosure". Nowhere does TRIPS state that countries should provide
exclusive rights to the originator of the data for a given period. Rather,
TRIPS simply refers generally to the need for "data protection”, without
answering the question of how such protection should occur.
As for other forms of IP, Article 39.3 of the TRIPS Agreement only provides a
minimum international standard for the protection of the submitted
-3-
>
undisclosed information required for market approval of a pharmaceutical
product. Since the wording of Article 39.3 is very general, Members
maintain substantial flexibility when determining how submitted test data
should be protected. WTO Members do not have an obligation under Art
39.3 to confer exclusive rights to test data, whether it is for three years
rive years, or 10 years, as pointed out by many experts3.
Data exclusivity is no more than "TRIPS-plus” and is designed to delay the
introduction of generic competition, creating a barrier to access of
medicines, in particular where there are no patent barriers.
What will be the effect of data exclusivity in bilateral
and/or regional
trade agreements given TRIPS flexibility?
Countries that are members of the WTO do not have to grant data
exclusivity, as specified under TRIPS Article 39.3. However, if they agree to
grant data exclusivity in a trade agreement signed after the TRIPS
Agreement, they are bound by the later agreement, in accordance with the
rules of international law, and will have to implement this obligation at
national level.
Countries that have agreed to data exclusivity provisions in free trade
agreements with the US include: Chile, Costa Rica, Dominican Republic El
Salvador, Guatemala, Honduras, Mexico, Morocco, Nicaragua and Singapore.
3 See Carlos Correa, Protection of Data Submitted for the Registration of Pharmaceuticals:
Implementing the Standards of the TRIPS Agreement, South Centre 2002. Available at
bllBlZ/^ww^outhcentre.org/pu
See also the Report of the Commission on Intellectual Property Rights, Integrating
Intellectual Property Rights and Development Policy, London, September 2002 pp 50-51
and 163.
’
-4-
10-July-2006
To.
Dr. Manmohan Singh,
Prime Minister of India,
South Block, Raisina Hill.
New Delhi, India-110 011.
Fax: 91-11-23019545 / 91-11-230168
Re: Proposed amendments to the Drugs and Cosmetics Act, 1940
and
Re: ‘Data Exclusivity’
Dear Prime Minister.
We, the Affordable Medicines and Treatment Campaign (AMTC), a national campaign
aimed at creating an environment that will ensure sustained accessibility and affordability
of medicines and treatment for every individual in India, write to express our grave
concerns over the proposed amendments to the Drugs and Cosmetics Act, 1940 (the
DC A) to introduce ‘data exclusivity’ that are currently being discussed by the
government.
The Common Minimum Programme of the UPA government has committed to the
people of India that:
'The UPA Government will take all steps to ensure availability of lifesaving drugs at reasonable prices. Special attention will be paid to the
poorer sections in the matter ofhealthcare. ”
However, the proposed amendment of the DC A to introduce data exclusivity would have
the opposite effect. The introduction of data exclusivity will seriously compromise
accessibility and availability of essential medicines, one of the primary components of
Right to Health. We strongly feel that the introduction of such a provision is
unnecessary under India’s existing international obligations, and would come
directly at the cost of the health of millions of India’s poorest and most needy.
Data exclusivity measures are likely to have the following impact on the right to health:
> Prevents the drug regulatory authorities themselves from relying on test data
already in their possession for subsequent approval of generic versions of the
medicine;
> Data exclusivity impedes the use of compulsory licenses. A compulsory license is
granted to a generic manufacturer by the government to overcome a patent
monopoly to increase access to the medicine. However the generic manufacturer
will not he able to make use of the license to manufacture and sell the medicine if it
is unable to obtain marketing approval without first generating test data;
> Unpatentable or Off-patent drugs will get protection without any beneficial
contribution to the society.
Effective competition in the market would be prevented resulting in higher prices
for the drugs.
> Theoretically it does not legally prevent generic manufacturers from generating
their own test data for marketing approval. However in reality the financial
resources and the time neededfor conducting clinical trials for generating test data
already available with the Drug Controller creates a market barrier that is difficult
for generic manufacturers to overcome;
TRIPs Does Not Require Data Exclusivity.
The move to amend the DC A to provide data exclusivity is apparently linked to India’s
obligations under Article 39.3 of the TRIPS Agreement. Article 39.3, however, only
requires countries to protect undisclosed test or other data relating to new chemical
entities against unfair commercial use. In fact, “data exclusivity” was specifically
excluded from the language of Article 39.3 during the TRIPS negotiations.
Under the current drug registration process, a generic company does not have access to
and never uses the originator’s data. Thus, there is no unfair commercial use by the
generic companies. On the other hand the regulatory authorities may rely on such data,
but since the regulating authority is not a commercial organization, this is not
‘commercial use’ as per TRIPS.
In the context of Article 39 of TRIPS, the phrase ‘commercial use’ is used in relation to
unfair trade practices, which cannot cover the work of a government body entrusted with
the task of protecting the public. Thus, it is entirely consistent with the language of Art.
39.3 to simply require that data submitted for drug approval is protected from ‘unfair
commercial use’ by the office of the Drug Controller while allowing the Drug Controller
to rely on this data to approve subsequent generic applications. Indeed, the World Health
Organisation concludes that TRIPS does not require data exclusivity, and states that
“from the perspective of public health and access to medicines, it is preferable not to
grant data exclusivity.”
The impact of Data Exclusivity on Access to Medicines
With the passage of the Patents (Amendment) Act, 2005, Parliament attempted to find a
delicate balance between the need to comply with India’s international obligations and
the need to ensure that monopolies are not granted at the cost of public health. The
introduction of a data exclusivity provision would upset this delicate balance in favour of
the multinational pharmaceutical industry and at the cost of the people of India. Special
provisions that Parliament introduced to ensure that frivolous patents are not granted, as
well as provisions designed to ensure the ready availability of essential medicines in the
event of public health crises could be weakened or made ineffective with the introduction
of a data exclusivity provision.
Unpatented medicines / Patent expired medicines
More importantly a data exclusivity provision will prevent competitors from registering
generic versions of medicines even when there is no patent covering a drug. India’s
Patents Act contains some unique provisions that were introduced in order to prevent the
patenting of frivolous improvements to already-existing drugs that only serve to extend
the patent holder’s market dominance. Because of such provisions, it is likely that many
drugs that have been granted patents in other countries will not be patent protected in
India, and for good reason. However, with a data exclusivity provision, a drug
manufacturer would nevertheless have an opportunity to enjoy a period of monopoly over
a drug that has been denied a patent. This is not only contrary to Parliament’s intent in
enacting special protections within the Patents (Amendment) Act, but completely against
the liberalization policy India adopted since 1992 by preventing effective competition
and price reduction. This would seriously affect the accessibility and affordability of
medicines.
Compulsory license
Data exclusivity could prevent registration of medicines produced under a compulsory
license if any compulsory license is issued in public interest. Even if companies are given
compulsory licenses to produce medicines when a serious health crisis occurs they could
be prevented from relying on the data for registration and delay the entry into the market.
This would make the compulsory license provisions useless and there would not be any
mechanism to combat such situations.
Preventing competition
If a data exclusivity provision is enacted, then generic competitors have only two options.
Either to wait till the data exclusivity period is over and then rely on the data of the
originator and get marketing approval for their generic drug or to produce the relevant
data by conducting their own clinical trials and then get registration. Given the costs and
time required for clinical trials most companies may prefer the first option which would
delay the entry of competitors in the market thereby maintaining higher prices for a
longer time.
Higher costs for drugs
If at all a generic company decides to conduct its own clinical trials and produce the data
to enter the market earlier the consequent prices of the dugs will be higher and affect the
accessibility and affordability of the drugs for the poor classes in India.
Ethical issues
Data exclusivity also brings to light many ethical issues which for a country like India
has very serious consequences. Prevention of relying on the originator’s data would
compel competitors to conduct their own clinical trials. This is clearly duplication of
clinical trials solely for commercial purposes, i.e. ostensibly for protecting the investment
of a company in originating data for drug registration. This kind of protection is ethically
unjustifiable. Data exclusivity is not intended to be an incentive for data generation
because data generation is not a creative activity, which is presumed to be generated only
through incentives. It is a mandatory requirement to ensure the safety and efficacy of the
drugs to protect the public interest. Moreover additional clinical trials would increase the
price of the concerned drugs. It would make the drugs inaccessible and unaffordable to
majority of the people in India. Furthermore when a drug already has been proven to be
safe and effective, it is not justifiable to test the drugs again on humans simply to
reproduce data to prevent relying the originator’s data.
India is a signatory to the Doha Declaration on the TRIPS Agreement and Public Health,
which states, in part, "we affirm that the [TRIPS] Agreement can and should be
interpreted and implemented in a manner supportive of WTO members’ right to
protect public health and, in particular, to promote access to medicines for all. ’
This principle was recently reaffirmed and reiterated at the UNGASS review meeting in
May 2006, in part through the active participation of the Indian delegation. This is in
keeping with the guarantee of the right to life and health under Article 21 of the
Constitution of India. The introduction of a data exclusivity provision is both unnecessary
under TRIPS and harmful to public health, and would be nothing less than a betrayal of
the solemn promise of Doha.
Considering India’s international obligations and India’s internal needs, a data exclusivity
provision is not required in any way. The need of the time is to have a clear policy that
facilitates access and affordability of drugs thereby fulfilling the right to health of the
people of India. We hope these issues will be taken up strongly and will be given serious
consideration in any changes intended to be made now or in the future in the policies or
in the legislations.
Regards,
For the Affordable Medicines and Treatment Campaign
cc:
B.P Sharma
Joint Secretary
Dept, of Health
Ministry of Health and Family Welfare
New Delhi
Fax: 23061723
Mr. Prasanna Hota
Secretary
Dept, of Health & Family Welfare
Ministry of Health and Family Welfare
Government of India
Nirman Bhawan, New Delhi 110011
Tel: 23061863/23063221
Fax: 23061252
Mr. Gurdial Singh Sandhu
Joint Secretary (Pharmaceuticals Industry) & Chief
Vigilance
Officer, Department of Chemicals & Petrochemicals
Room No.340-B A wing, Shastri Bhawan,
Dr. Rajendra Prasad Road,
New Delhi 110 001
Phone: 23385131,
Fax: 23387222
Mrs. Satwant Reddy
Secretary
Department of Chemicals & Petrochemicals
Ministry of Chemicals and Fertilizers
Room 501 'A' Wing, Shashtri Bhawan
New Delhi 110 001
Ph: 23382467, Fax: 23387892
Sri Kamal Nath
Honourable Minster of Commerce & Industry
Room No. 45, Udyog Bhavan
New Delhi
Tel: 23061008, Fax: 23012947
Sri Ramvilas Paswan
Honourable Minister of Chemicals and Fertilizers
Shastri Bhawan, Dr. Rajendra Prasad Road
New Delhi 110 001
Tel: 23386519, Fax: 23384020
Dr Anbumani Ramadoss
Honourable Minster of Health and Family Welfare
Nirman Bhavan, Maulana Azad Road
New Delhi 110011
Tel: 23061751, Fax: 23062358
Mrs. Sonia Gandhi
President
Indian National Congress Party
PM urged not to introduce data exclusivity
Repealing clinical trials will force drug companies to perform unethical studies
NEW DELHI: The Washington-based non-profit agency, Global AIDS Alliance, has urged Prime
Minister Manmohan Singh to ensure that amendments are not made to the Indian Drugs and
Cosmetics Act to introduce data exclusivity provisions as this will seriously affect India's ability
to provide generic drugs to millions of people in developing countries.
In a letter sent to Dr. Singh, the Alliance has expressed concern that such amendments will have
adverse effects on the global availability of affordable essential medicines meant to treat
HIV/AIDS, hypertension, diabetes, asthma and many other diseases. "Without Indian generic
drugs, millions of people in developing countries will die as a result of lack of access to
affordable medicines," it says.
I he bioad based alliance, which has Bishop Desmond 1 utu on its board of directors, argues that
data exclusivity provisions, if added to the Drugs and Cosmetic Act. will prevent generic
companies from using data on existing drugs to gain regulatory approval for generic versions. It
maintains that generic companies will be forced to repeat time-consuming and expensive studies
to receive regulatory approval.
Essential medications will be prohibitively expensive without the competition from generic
companies and generic drugs will take years to bring to market under data exclusivity laws, it has
stressed.
The Alliance has stated in the letter that repeating clinical trials will force drug companies to
perform unethical studies that withhold medicines known to be effective from the control group.
"The people of India and the developing world will be denied access to the newest treatments
available to those who can afford brand name drugs," it has said.
In addition, it has pointed out that the TRIPS agreement does not require India to implement data
exclusivity provisions. Article 39.3 simply requires that members protect "undisclosed test or
other data... against unfair commercial use."
It notes that World Health Organization's Commission on Intellectual Property Rights,
Innovation, and Public Health recently reinforced the view that TRIPS does not require data
exclusivity.
Underlining the need to avoid amending the Drugs and Cosmetics Act. the alliance says the
Commerce Ministry of Commerce has already publicly stated its opposition to the
implementation of data exclusivity provisions.
"We hope that the Ministry of Health and Family Welfare and the Ministry of Chemicals and
Fertilizers will follow suit and oppose a data exclusivity amendment to the Drug and Cosmetic
Act," it says.
http://www.hindu.com/2006/06/25/stories/20060625022 1 1300.htm
I
Pesticide MNCs seek 5-10 year data exclusivity’
Harish Damodaran New Delhi , March 7
MULTINATIONAL crop protection chemical majors are lobbying hard for a 5-10 year period protection or
exclusivity on the test data relating to new pesticide molecules, which they are now obliged to submit to
the Government to obtain authorisation for marketing in the country.
The demand
aimed at tackling unfair' competition from domestic me-too' generic agro-chemical
manufacturers — is broadly in line with what their counterparts in the drugs/pharma industry have been
seeking.
€ unently, Section 9 (3) of the Insecticides Act, 1968 mandates any manufacturer or importer wanting to
intioduce a new pesticide to obtain approval from a Registration Committee under the Agriculture
Ministry. The registrant, in turn, has to furnish detailed information (typically running to 20,000 or more
pages) pertaining to the chemistry, toxicology, bio-efficacy and maximum residue limits (MRL) of the
proposed molecule, which also covers the data generated during field trials here.
The Committee, "after satisfy ing itself that the insecticide conforms to the claims made by the importer or
by the manufacturer", then issues a registration certificate.
As of now, there are 184 pesticides registered for use in the country, the bulk of which are proprietary
molecules of multinationals, for which they were also the original Section 9 (3) registrants here. These
include the more recent, new generation' molecules touted to be relatively environment-friendly, by virtue
of requiring lesser number of sprays for producing the same impact.
Wbile the original registrant has to provide detailed test data to the authorities, there is no such stringent
binding, however, on subsequent me-too' registrants desiring to import or manufacture the same pesticide
under Section 9 (4) of the Act. Section 9 (4) registrants seeking to manufacture formulations of the already
registered molecules do not have to submit any data.
Even with regard to the technical material, the me-too' applicant has to only demonstrate the similarity of
the molecular structure of his pesticide with the original molecule. "In addition, he has to submit minimal
bio-efticacy and toxicological data, which runs to a few hundred pages, at the most", claimed an official of
a leading agro-chemical MNC affiliate.
As a result, for almost every molecule originally registered by an MNC here, there are several me-too'
manufactuieis today. Take Imidacloprid, an insecticide for seed treatment and foliar application, registered
in 1999 by Bayer India.
This molecule is now produced by a host of domestic companies, including Rallis India Ltd, Nagarjuna
Agrichem Ltd, Sudarshan Chemical Industries. Excel Industries. Jaysynth Dyechem Ltd. Bhagirdha
C hemicals and Bhaskar Agro Chemicals Ltd, who have all been granted registration for technical
indigenous manufacture under Section 9 (4).
The same is true for Sulfosulfuron, a wheat herbicide that Monsanto launched in the 1998-99 rabi season
under the Leader' brand. Today, the list of me-too' manufacturers of this molecule include United
Phosphorous. Nagarjuna, Gharda Chemicals and Atul Ltd. Atul has similarly received the nod to
indigenously manufacture Metsulfuron methyl, for which E.I. Dupont India was the original Section 9 (3)
registrant.
Acetamiprid — an insecticide sprayed against sucking pests in cotton and originally registered by DeNocil, a Dow Chemicals subsidiary — is now also manufactured by Rallis and Gharda Chemicals.
2
The MNCs contend that the absence of protection for the voluminous test data that they are statutorily
obliged to submit to the registration authorities for their pesticides "allows other companies to access this
information and come out with the same or similar molecules".
Moreover, since the me-too' registrants do not have to incur the costs involved in developing the molecule
and generating the detailed field trial data, they are able to reverse engineer and market the same pesticide
at much lower prices.
'
"What we want is a 5-10 year period of data exclusivity during which the Government respects the
confidentiality of the test data furnished by any agro-chemical company for a particular molecule.
Over this period, applicable from the day of according registration, this data cannot be referred to bv
another company. Besides, we are seeking a minimum time gap for granting me-too registration for any
pesticide, subsequent to its original registration under Section 9 (3). This interval will help us recover the
cost of R&D and data generation", the official added.
What the WTO agreement says
Article 39.3 of the World Trade Organisation's (WTO) Agreement on Trade Related Aspects of Intellectual
Property Rights (TRIPS), to which India is a signatory, provides that "members, when requiring as a
condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilise
new chemical entities, the submission of undisclosed test or other data, the origination of which involves a
considerable effort, shall protect such data against unfair commercial use".
In addition, members shall protect such data against disclosure, except where necessary to protect the
public or unless steps are taken to ensure that the data are protected against unfair commercial use".
While member-countries are obliged to provide data exclusivity to protect against "unfair commercial use"
the Article does not, however, explicitly stipulate any specific period for such exclusivity to ensure that
"undisclosed test data" is not misappropriated. This is unlike the 20-year protection period given in respect
ot product patents from the date of filing and to extend to all products, for which patents were filed after
2005ary 1995 The C0Unt,y is also recJuired t0 f°rnia,|y institute a product patent regime from January I,
If the Government were to accept the demand for granting a 5-10 year period of data exclusivity, over and
above the mandatory 20-year protection on patents, it would mean going beyond even TRIPS and inviting
allegations of "sell-off to the global pharma and agro-chemical lobby". It is precisely for this reason that the
C ommerce Ministry, which, only last year, said to be favourably inclined to a 3-5 year data exclusivity
period, has suddenly developed cold feet and passed on the buck to the administrative ministries concerned
Agriculture and the Department of Chemicals l& Petrochemicals.
Opponents of data exclusivity say that the granting of product patents provides sufficient protection against
me-too generic producers, who will, from next year onwards, not be able to manufacture any drug or
pesticide that has been patented after January 1, 1995.
It is a different matter though that most of the new generation' pesticides introduced by multinationals in
die country in the last 4-5 years pertain to molecules that were patented prior to 1995. The gap between the
fi mg of patent for a product and for its actual introduction in the marketplace is usually in the region of 810 years. Providing data exclusivity would, in a sense, extend protection to any newly introduced pesticide
irrespective of whether or not it enjoys patent rights.
http://wwwjhehindubusinessline.com/2004/03/08/stories/2004030800560700.htm
3
PATENTS & DATA EXCLUSIVITY
Wednesday, September 10, 2003 08:00 1ST
P A Francis
After successfully managing the WTO agreement on TRIPs and Public Health in its
favour, the US and its powerful drug multinationals are actively pursuing for a data
exclusivity provision for drugs in the Indian regulatory system. A handful of top Indian
drug companies are also backing this US move, of late. The goal is to convince or force
the Indian government to incorporate data exclusivity condition at least into the new
patent law of the country expected in place by 2005, if not early. In the US, data
exclusivity is given for five years whereas in Europe it is anything between 6 to 10 years.
The research-based US and European pharma companies feel that India should
guarantee to a period in which test and clinical data of a new drug filed with regulatory
authorities should not be referred to by any other company for obtaining marketing
authorization to launch a similar product. Currently, when manufacturers of generics
apply for approval of their drug, they claim bioequivalence to the originator's product
without conducting clinical trials by themselves. They just make a reference to the
originators submitted data for approval. Regulatory authorities then rely on such data for
determining the safety and efficacy of the drug before marketing approval is granted to
subsequent applicants. Such a position is justified considering the social and economic
i0StRS/^°,V.ed 'n the rePetitive animal and human trials in developing countries. What
the MNCs fear is that the generic companies, which usually wait to launch a copycat
product soon after the drug goes off patent, may capture their market by using the
inZtnt?irS c,inical data- 11 is Poss*ble that entry of generics would take away a good part
of the drug s market because of the lower prices. But on the other hand, data exclusivity
will provide a free hand to the originator company to continue with its monopoly pricing
for an undesirably longer period. For instance, if five-year data exclusivity is granted in
any country, the original inventor could get a market exclusivity for 23 years if the
product is introduced in that country in the 18th year of the patent life. Therefore, it is
important that if at all India decides to allow data exclusivity provision, that should run
concurrently with the expiry of patent. The stand of the US based Pharmaceutical
Research and Manufacturers of America that protecting confidentiality of clinical data
submitted to the regulators is a an obligation under the Article 39.3 of the TRIPs
agreement does not seem to be based on a correct understanding of the provision.
http://www,pharmabiz,com/article/detnews.asp?articleid=17925§ionid=47
4
Data Exclusivity
ta Exclusivity and Macket
|
>
Data Exclusivity guarantees additional market protection for originator pharmaceuticals by
preventing health authorities from accepting applications for generic medicines during the
period of exclusivity...
What is data exclusivity?
Data exclusivity guarantees additional market protection for originator pharmaceuticals by
preventing health authorities from accepting applications for generic medicines during the
period of exclusivity.
The effective period of market exclusivity gained by the originator company is the period of
data exclusivity (currently 6 or 10 years) plus the time it takes to register and market the generic
medicine — a further I to 3 years.
Data Exclusivity was introduced in 1987
1987 to
to compensate
compensate for
for insufficient
insufficient product
product patent
patent
protection in some countries. However, strong product patents are now available in all 25 EU
Member States. The rules on data exclusivity have been changed in the new EU pharmaceutical
laws adopted in 2004.
►Generics do not use originator data
Data exclusivity prevents regulatory authorities from assessing the safety and efficacy profile of
a generic application for a period of time beginning from the first marketing approval of the
oiiginatoi pioduct. Generics applications do not use data from the originator registration file.
They are approved on their own merits, using their own development data, under the same EU
requirements as the originators. The originator's data is never released to third parties by the
medicines authoiities. It therefore is not and cannot be used by generics producers.
However, since generics contain well-known, safe and effective quality substances, unnecessary
animal testing and clinical trials on humans performed by the originators are not repeated.
Instead, regulatory authorities evaluate the generic application against the originator
documentation on file — but only after the period of data exclusivity has expired. This
assessment is caiiied out internally by the authorities. In no instance is the originator’s research
data ieleased oi disclosed to the generics producer or anyone. The generics manufacturer never
sees the originator data.
►Data Exclusivity is not Data Protection
Data exclusivity has nothing to do with protecting research data. Long after the data exclusivity
period has expired, the originator documentation remains protected by copyright laws and other
legal provisions. Data exclusivity merely extends the originator company's market monopoly
over a product by not allowing the authorities to process an application for marketing
authorisation.
► Current legal framework
Under Directive 2001/8j/EC, EU data exclusivity laws guarantee market protection for
oiiginatoi medicines foi either 6 or 10 years. Data exclusivity extends for six-years after
European marketing authorisation is granted in Austria. Denmark. Finland, Greece, Ireland,
loitugal, Spain, Noiway and Iceland and is the period adopted by the 10 new Member States
during their negotiations for EU accession. Ten-year periods of exclusivity are operated in
Belgium, Germany, France, Italy, Luxembourg, the Netherlands, Sweden and the UK. A tenyear period is also granted to an originator gaining marketing approval through the Centralised
Procedure.
5
......... ............. .
The New EU Pharmaceutical Legislation adopted in 2004 has created a harmonised EU eightyear data exclusivity provision with an additional two-year market exclusivity provision This
jeai
effective 10-year market exclusivity can be extended by an additional one year maximum if.
cui mg the fust eight years of those ten years, the marketing authorisation holder obtains an
authoi's a 'on for one or more new therapeutic indications which, during the scientific evaluation
ex Sti ° le" aUthof'satlon’ ay held to bring a significant clinical benefit in comparison with
xisting therapies. This so called 8+2+1 formula applies to new chemical entities (NCE)s in all
dem™/'63
JV Meinber States <unless ^tain new Member States are awarded
e ogations, which they can request following publication of the new law).
In practical terms, this means that a generic application for marketing authorisation can be
ubmitted aftei Year 8, but that the product cannot be marketed until after Year 10 — or I I (see
chart below).
v
How the new
Data Exclusivity,
i'/Zi'c/a the uppiiutitiOM nJ u
f MedlCUli:
Data Exclusivity
Market Exclusivity
2 years
Authorisation
r Market mg Auu
W,l5H
l: of Reference Pt oducl
Generics ' Application
Assessment - ?t1A granted
MRP. Pacing S Resmb
Pr^psirw to L»;nch
Generics |.
Launch
no nes*, patent
s
I£
Extra Market Excl
if new indcabcn
is registered tn
first 8 years
8^2 (^1) Data Exclusivity Formula
for ail Marketing Authorisation Procedures
he icvised legislation also provides a one-year data exclusivity provision for products
switching from prescription-only” to “over the counter” (OTC) status, on the basis of new prechnical or clinical data. The law also grants one-year data exclusivity for any new indication for
a product which can demonstrate well-established use. This latter provision is non-cumulative
le, it covers only the use of the new indication, and can only be used once.
Because ol the adamant opposition to this overall increase in data exclusivity from the current
six-year countries
especially from the Accession countries, who had not agreed to this law in
their accession agreements, were not yet entitled to vote on it during the legislative process, and
who felt it would have a significant effect on their government medicines bill — an additional
clause was inserted at the last minute making the law prospective. As a result, the new periods
of data exclusivity will only take effect for reference products applying for marketing
authoiisation after the new law is fully in effect (around November 2005). Therefore, the first
generics applications under the 8+2+1-year data exclusivity period will not occur until late
http://www.egagenerics.com/gen-dataex.htni
6
Centre mulls law change: Firm should test before selling drug
Toufiq Rashid
NEW DEL,! 11. JUNE 21: As A follow-up to the TRIPS agreement on intellectual property rights,
the Centre is now thinking of amending the Drug and Cosmetics Act to make it mandatory for
generic companies in India to conduct their own clinical trials before marketing a drug.
The amendment will also provide data exclusivity to the original producer of the drug for about
five years, meaning it will take that much time for cheaper versions of the drug to hit the market.
The various ministries concerned — Health. Commerce, Chemicals and Fertilisers, Science and
J echnology — however, differ on the need for the amendment. The PMO has called a meeting of
the ministries and the Centre for Scientific and Industrial Research on July 12, 2006.
According to the existing law, a pharmaceutical company provides test data for safety and
efficacy to the drug regulatory authority to get first-time approval or registration for a new
medicine before marketing it. For drugs already registered in other countries, the Drug Controller
in India relies on the data already submitted to their counterparts for approval in other countries
such as the US, UK or Europe.
1 he generic manufacturers in India only need to provide a ‘bio-equivalence certificate’ to prove
that the drug produced by them is equivalent to the original. The amendment in the existing law
would mean that generic manufacturers have to conduct their own tests before seeking approval
for marketting the drugs in India. The data exclusivity is not likely to be restricted to patented
drugs but new use or innovation of old drugs as well.
The Ministry of Health is opposing the amendment as it believes the cost of treatment will go up.
“We are not against innovation or foreign investment but have to find some middle path and not
go for extremes,” said Secretary (Health) PK Hota.
Generic drug manufacturers have already made representations to the expert group against an
amendment. “Various submissions have been made to the expert group that India need not go
beyond what is in the TRIPS agreement. Our immediate obligation is to complete the TRIPS
agreement so that data is protected against unfair commercial use and not made available to
competitors.” said DG Shah, secretary-general of the Indian Pharmaceutical Alliance. “This
provision will create monopolies in the market which will lead to increase in the prices of the
medicines as generic companies cannot cover the cost of clinical research. Even if they do, the
research will take years and the generic versions will come late into the markets.”
Those in favour of the amendment say it will help rid Indian companies remove of the copycat
tag. “Indian companies are feeling unsafe to submit clinical data as it is passed to rivals in the
market. So we need to feel safe to do drug trials in the country. Besides, it will encourage
multinationals to do research in diseases affecting the country, which has not been happening in
the past.’ said Harinder Sikka, president of corporate relations at Nicholas Piramal.
toufiq. rashidf^xpressindia. com
http://www.indianexpress.coin/story/7172.litml
7
Elusive data exclusivity norms
India should learn from the competition
BJP leader Murli Manohar Joshi’s letter to the Prime Minister cautioning against allowing for
Sht' UPR r y °nCe agai" brings t0 the fbre the reluctance to concede on intellectual property
rights (IPR) issues, even after other countries have taken a clear stand long before Data
exclusivny provfs'ons of the Trade Related Intellectual Property (TRIPS) agreement requires
WTO membei-states to protect clinical data filed for securing marketing approval or for
registiation. It means that the clinical data filed by patent holders should not be used for ensuing
applications on similar products. This is because clinical tests for generating data are very
xpens.ve-as much as $500 million or even more-and it would be only Air to the orSnal
Xd oOnimeCOmPeting Pr°dUCtS 3,6 '101 a"°Wed l° benefi‘ frOm the data’ at least for a
^pP0rJents °Jexclusivity provisions argue the TRIPS provisions speak only about the
piotection of test data against unfair use and nothing on data exclusivity. It is also pointed out that
da a exclus.v.ty m.ght restrict access to drugs, especially generics, which helps keep down mices
Othc argmuen s focus on unwarranted extension of patent rights and obstacles to compulsory '
f WHO g’ Wh'C? 16 PS P°Or COuntries t0 avert emergencies. The World Health Organisation '
onn. °).SUPI? t0J116 \leWS that IPRs and dl ug regu|ations are separate issues, also buttress the
bZ and" SouihAfrT T°St
de^lop.ed C0Untries and most developing ones, including China,
Biazil and South Africa, to name a few. have ruled in favour of data exclusivity. The extent of
ZA |nA0'im y jCr°SS nat'°nS IS ma'nly ab°Ut the peri0d of exclusivity: it is seven years in the
Ui ted States and six years m China. The EU allows member-countries a six or 10-year period
I O-year period.
c pending on pi oduct characteristics. Even Israel, one of the most important producers of generic
ledicmes. gave in to demands for data exclusivity around last year.
h
'h have little choice, as the potential losses from not having data exclusivity are much
h'ghei- How will it be in India’s interest if the absence of these norms discourages companies
horn m roducmg new products? Strong IPRs remain a keystone to accelerated growth of the
buoyant Indian pharmaceutical industry. And it certainly would not be in India’s interest if the
R&D majois take flight and decide to pull out their investments. So. it is time we took the call
and sent the light signals. Any further delay will only benefit the competition.
Posted online: Friday, June 23, 2006 at 0000 hours 1ST
http.//www.financialexpress.com/fe_full_story.php?content_id=l31450
8
Joshi cautions govt on data exclusivity
SEBASTIAN PT
Posted online; S
2006 a
NEW DELHI, JUNE 16: Stating that certain ministries were on the verge of conceding to MNCs’
demand of data exclusivity, B.IP leader Murli Manohar Joshi on Friday cautioned Prime Minister
Manmohan Singh on ministries pushing for TRIPS-plus' measures for legislation. In a letter to the Prime
Minister on Friday, Dr Joshi said the demand for data exclusivity had been raised at a bilateral level with
the Indian government by MNCs and the US government.
It is understood that the ministries concerned have been deliberating on this issue for the last two to three
years and now the government is on the verge of conceding to the bilateral demand of data exclusivity,
instead of implementing data protection as stipulated in the Trade Related Intellectual Property Rights
(TRIPS agreement)," he said.
He said that conceding to the demand for data exclusivity would have serious implications for the role of
domestic enterprises in the fields of pharmaceutical and agro-chemical products. Besides, even if the
domestic firms have been granted compulsory licence to use the patented subject matter they would be
prevented from taking marketing approval during the period the data exclusivity is in operation.
1 bus, the compulsory licence provision, a TRIPS-compliant provision available with national governments
to sidestep patents in the event of a national emergency, would be rendered unimplementable, he said. This
would give the patent holder an unfair advantage, he argued.
...... ' ... ' ' .. ......
.. '
.. ' :
Attaching a copy of World Health Organisation (WHO) document, the
Protection Matters
former minister said that even the WHO has recommended that the
_ ______ ___ _______________
developing countries would be well advised to keep the two systems
• Data exclusivity will have
of IPR and drug regulation separate, and to reject any and all efforts to serious implications in the areas of
make connections between them.
pharmaceuticals and agro
chemical products
• Even the WHO document stated
that TRIPS required data
protection, but not data exclusivity - and national laws do not need to
protection
be more stringent or more restrictive than TRIPS. In fact, the
• National laws do not need to be
commerce ministry, which was represented in a high-level committee
more
stringent or more restrictive
which deliberated on the issue, had clearly stated that data exclusivity
than
TRIPS
is no TRIPS obligation. Data protection merely mandates the
___________
The WHO document further stated that TRIPS requires data
regulators concerned to not publish the invention-related data submitted before them for regulatory
approval. Data exclusivity, on the other hand, prevents them from even using such data for subsequent
applications. In the pharma industry, for instance, this would result in unnecessary burden on the second
and subsequent applicants in terms of regulatory procedures such as clinical trials.
Dr Joshi, who is also the chairman of the parliamentary standing committee on commerce, said that the data
exclusivity issue and its implications were also brought before the panel in a meeting held recently. “In my
opinion, the views of the WHO deserve an indepth consideration,” he insisted. He pointed out that the
Uruguay round of GATT negotiations had rejected the demand by the US and other developed countries for
data protection/ exclusivity. “Only specific provisions was incorporated in Section 7 of the TRIPS pact for
protection of undisclosed information,” he said.
http://www.financialexpress.com/fe full story.php?content id-130840
9
Erroneous exclusivity
AMIT SEN GUPTA
Posted online: Friday, June 23, 2006 at 0000 hours 1ST
The government had recently set up an inter-ministerial group to opine on the issue of data
exclusivity (DE) and it is understood the PMO has convened a meeting in July to arrive at a final
position.
DE refers to a practice whereby, for a fixed period (usually five years), drug regulatory
authorities do not allow the data filed by the originator company to get marketing approval to be
used to register a generic version of the same medicine. Many assume that if national laws allow
for patent protection, they also need to allow for DE. Incorrect on several grounds. Patents and
DE are entirely different concepts. In fact, enforcement of DE can have the biggest impact in
situations when patents cannot or are not being enforced. Second, the TRIPS Agreement does not
mention DE, but ’Data Protection.' Prominent intellectual property experts have said if regulatory
agencies do not share the data with other companies or make it public, the requirements under
TRIPS are met. This does not prevent regulatory agencies from registering generic drugs if the
innovator firm’s drug has already been approved. Thus, in India's case, very little needs to be
done—possibly a small insertion in the Drugs and Cosmetics Act, clarifying that test data from an
innovator company will not be made public or shared with its competitors for a fixed period.
Under the guise of DE, drug regulatory authorities are being asked to reject the application for
marketing of a drug by a local company if it doesn't submit fresh data from its own clinical trials.
If the same agency has approved a drug based on clinical data provided by one company, there is
no logical reason why the same drug should be refused marketing approval if another company
produces it, as the issues of safety and efficacy have already been taken care of when the
originator company’s drug got approval.
For India, the principal instrument to curb the monopoly of MNCs is the use of a compulsory
licence. But if India allows for DE, such a licence would be useless, as the DGCI would then
insist Indian firms conduct fresh clinical trials before getting marketing approval. Such trials are
expensive and would add to the cost of the drug, and being time-consuming, delay its
introduction. If we know a drug is useful and safe, to conduct trials again on humans is unethical.
There are clear reasons why India need not allow for DE. It is not required under TRIPS. It is
unfortunate the government should seriously consider amending domestic laws under foreign
commercial pressure. To allow for DE, the Drugs and Cosmetics Act has to be amended.
Parliament should reject it.
The writer is general secretary, All India Peoples Science Network, Delhi
10
'Life-saving drugs to be out of reach of India'
REUTERS
Posted online: Friday;
006 at 1210 hours IS
NEW DELHI, JUNE 23: Plans to change India's drug approval system would price life-saving drugs out
ThmX0 m
°nS °f P°Or Pe°Ple
PreVent'nS gener'C VerSi°nS be'ng made’ camPa'gners said on
New Delhi, under pressure from the United States and global drug giants, is considering a law that could
effectively grant a monopoly to the developer of a
new drug for several years even without a patent.
This will seriously affect accessibility to essential drugs for people in developing countries,” said Leena
Menghaney of Swiss-based Medecins Sans Frontieres, which has been campaigning for better access to
healthcare.
The law would particularly affect people with HIV who had developed immunity to first-line anti-retroviral
diugs and were waiting for second-line drugs to become affordable, she added.
Making generic copies of a new, unpatented drug is a hugely lucrative business in India.
Once a new drug is approved for sale, other drug companies only need to point to the clinical safety data
a ready filed with India’s drug controller by the drug’s original developer, and prove that their generic drug
is identical to the original.
But innovating drug companies - which invest millions of dollars collecting the necessary data they need
tor marketing approval through clinical trials - say this is unfair.
This system allows them to recover little of their investment and reduces the incentive to research and
develop new drugs, they say.
India, as a member of the World Trade Organisation, should give them exclusive rights to reap the benefit
of their data for several years under the Trade-related aspects of Intellectual Property Rights (TRIPS)
In bilateral talks with New Delhi, Washington is also urging India to adopt the change.
But otheis. including the World Health Organisation, say data exclusivity goes beyond what TRIPS
requires and should not be introduced at the expense of public health.
They say generic drug companies are unlikely to invest in conducting their own trials and would have to
wait for the data exclusivity period to end before making their cheaper versions.
Indian officials said the government was considering a safeguard in the new law that would allow it to
overnde data exclusivity in the interest of Indian public health. The possibility of generic drug-makers
paying royalties to use other companies' data was also being looked at. "We are still trying to evolve some
kind of consensus," Gurdyal Sandhu, a top official in the Ministry of Chemicals and Fertilisers told
Reuters.
btiKZ/www.financialexpress.com/latest full story.php?content id^131553
I I
India law could hit access to vital drugs - activists
Plans to change India's drug approval system would price life-saving drugs out of the reach of
millions of poor people by preventing generic versions being made, according to campaigners on
Thursday, reports Reuters.
New Delhi, under pressure from the United States and global drug giants, is considering a law
that could effectively grant a monopoly to the developer of a new drug for several years even
without a patent. "This will seriously affect accessibility to essential drugs for people in
developing countries," said Leena Menghaney of Swiss-based Medecins Sans Frontieres, which
has been campaigning for better access to healthcare.
The law would particularly affect people with HIV who had developed immunity to first-line
anti-retroviral drugs and were waiting for second-line drugs to become affordable, she added.
Making generic copies of a new, unpatented drug is a hugely lucrative business in India.
Once a new drug is approved for sale, other drug companies only need to point to the clinical
safety data already filed with India's drug controller by the drug's original developer, and prove
that their generic drug is identical to the original. But innovating drug companies, which invest
millions of dollars collecting the necessary data they need for marketing approval through clinical
trials say this is unfair.
This system allows them to recover little of their investment and reduces the incentive to research
and develop new drugs, they say. India, as a member of the World 1 rade Organisation, should
give them exclusive rights to reap the benefit of their data for several years under the Traderelated aspects of Intellectual Property Rights, TRIPS, treaty.
In bilateral talks with New Delhi, Washington is also urging India to adopt the change. But
others, including the World Health Organisation, say data exclusivity goes beyond what I RIPS
requires and should not be introduced at the expense of public health.
They say generic drug companies are unlikely to invest in conducting their own trials and would
have to wait for the data exclusivity period to end before making their cheaper versions. Indian
officials said the government was considering a safeguard in the new law that would allow it to
override data exclusivity in the interest of Indian public health.
The possibility of generic drug-makers paying royalties to use other companies' data was also
being looked at. "We are still trying to evolve some kind of consensus," Gurdyal Sandhu, a top
official in the Ministry of Chemicals and Fertilisers, told Reuters.
http://news.moneycontrol.com/india/news/topindianews/indialawcouldhitaccesstovitaldrugsactivists/results
viewsipomfinsurancetaxniiinterviewsceocoinmentspressreleases/market/stocks/ailicle/l 9146/999999
12
& Member of Parliament
10, Janpath
New Delhi 110 001
Tel: 23014161,23012656
N
(5r ^awi^cCKo \a[plaice .
,
C^cTK.
)
^/y 0 7~V-i
fr
k-> Rjq-tO
oj.
^ocobtau^a. S.
3,
CJbsH
A^Ucx^Ai^ kt&wafonzxt
cA^aYo
33^^^
ZAc'j-yvSoc^c^
A^uynz/^Rtj c<
f)y^Li wo y/Mg,
> /jQt'tAoL''3^^
Itovwx
C
'Ttw^ ^La32
|uS. AA^VVac/^-'—^/y
( pz.^ K K)
2
I
\J^S
I 0 |?h^WhM< -
K<-
II-
M ' ^kVU-Ajx^-jCy
;
p> K cJ&j)cbi& "pkwji
’J.
P-v
ii ( l/W
K-A P
t"n y]
t'Y'-'Awft
P£Nmic4
I fl Mfr
P^YWt/.
^^Au^oLcj a (W'^sv't
AiW^/a
ll
cpA^s^V-^
^X^cka
^vtolyu^
■to’ fjA
A>'\^(
V
Ref:
July 25, 2006
Shri. Sathya Murthy
The City Editor
The Hindu
Bangalore
Fax:22864052
SUB: CIVIL SOCIETY GROUPS IN KARNATAKA DENOUNCE DATA
EXCLUSIVITY - DEMAND ITS IMMEDATE REJECTION
Dear Shri. Sathya Murthy,
The civil society in Karnataka, including health groups, lawyers’ groups, and civil society
organizations working on HIV/ AIDS and other health and development issues (list of persons
and organisations attached) have strongly protested against the inclusion of ‘data exclusivity’ by
amending the Drug and Cosmetics Act. They have warned of the disastrous consequences that
such a move will have on the cost of generic drugs and the costs of health care which will greatly
impact people’s access to medicines.
A letter to this effect was sent to the PM and other ministries (including Chemicals & Fertilizers,
and Health & Family Welfare). We request you to cover it in your esteemed publication. The
letter to the PM along with the list of organisations / networks who have called for the rejection of
data exclusivity is enclosed.
Thank you.
Sincerely,
Naveen Thomas
Health Policy Fellow
Community Health Cell
Ref: CHC/
/2006/
August 8, 2006
To
Shri Ram Chander
Under Secretary to the Govt, of India
Ministry of Chemicals and Fertilizers
Department of Chemicals and Petrochemicals
Shastri Bhawan, Dr. Rajendra Prasad Road
New Delhi 110 001
Ph:011-23384086
Dear Shri Ram Chander,
Sub: More information regarding the impact of data exclusivity on people's health
Ref: Your letter dated 28 July 2006
Thank you for your response to our letter expressing concern about data exclusivity and its impact on
people's health. I am enclosing the relevant sections of the The Repoit of the Commission on
Intellectual Property Rights, Innovation and Public Health (C1PRIPH) for your reference. The whole
report can be downloaded from the following link:
http://www.who.int/intellectualproperty/en/
Alternatively, you could write to World Health Organization, Regional Office for South-East Asia,
World Health House, Indraprastha Estate, Mahatma Gandhi Marg, New Delhi 110 002, Ph: 23370804,
23370809-11, Fax: 23370197, 23379395, 23379507 for a copy.
For additional information, I am enclosing Medecins Sans Frontieres (MSF)'s briefing note on data
exclusivity. As you know, MSF is a Nobel Peace Prize winner and is well known for its work on
access to medicines. I am also enclosing a recent WHO briefing note on data exclusivity for your
reference. All the information and evidence points out that data exclusivity can have an immense
impact on people's access to medicines and health care. So, please stop any attempts at bringing 'data
exclusivity' into our legislation.
In case you need more information, please contact us.
Thank you.
Sincerely,
Naveen I. Thomas
Health Policy Fellow
Encl:
1) The Report ofCIPRIPH
2) MSF)'s briefing note on data exclusivity
3) WHO briefing note on data exclusivity
Page 1 of I
Main Identity
From:
To:
Cc:
Sent:
Subject:
"Mira Shiva" <mirashiva@yahoo.com >
"Dr.B.Ekbal" <ekbalb@gmail.com>
"Naveen" <navthom@gmail.com>; "Abhay Shukla" <abhayseema@vsnl.com>
Tuesday, July 04, 2006 12:02 AM
Re: [pha-ncc] Re: DATA EXCLUSIVITY DRUG POLICY
Dear NA VEEN ,
I IIAD NOT RECEIVED THE ORIGINAL DRAFT . ARE YOU SURE THIS IS THE FINAL ()NE
FROM YOUR SIDE BECAUSE THE F’EEIDBACK RELATED TO GENERICS , DR MASI III,KAR
DRUGS & COSMETICS ACT HAS NOT BEEN INCORPORATED
Cl IANGE THE HEADING IT SHOULD BE " REJECTION OF DATA EXCLUSIVITY A I RIPS
PLUS MEASURE HAVING NEGA TIVE PUBLIC HEALTH IMPLICATIONS;-"
I made the changes on the draft but I am not able to send it.
I am therefor retyping it.
No 4 should be no lelearly stating that 39.3 of TRIPS deals with DATA PROTECTION &DATA
EXCLUSIVITY is TRIPS PLUS.
Pg 2 last para Pg 3TRIPS PLUS PARA PLEASE DELETE MENTION OF VICE CHAIRPERSON
DR MASHELKAR Reasons already given.
Pg 3 UNethical Practice line 2 instead of generic change it to GENERIC EQUIVALENT
DENIAL OF REASONABLE PRICED GENERIC EQUALENT( THESE COULD BE NON
(iRIGINAL BRAND DRUGS ), TO NUMEROUS OTHER PEOPLE who cannot afford costly drill’s.
ORIGINAL for which MARKETING Lil 'ENSE is given .MANY OF THESE DRUGS BEING I IIOSF
Wl IOSE PATENT PROTECTION PERK)D I IAS EXPIRED.
US ING DRUG CONTROL INFRASTUCTURE TO DO POLICING FOR PHARMACEU I K’AI.
COMPANIES FOR DATA EXCLUSIVII YT1[ROUGH AMENDMENT OF THE DRUGS &
COSMETICS ACT IS UNETHICAL WHEN THE DRUG REGULATION NEEDS
S LENGTHENING , AS THE ISSUE OF QUALITY , ENSURING GMP , GLP,ADVERSE DRUG
RF.AC'I ION MONITORING need to be addressed moreeffectively.
pg 3111 iALTH CARE COSTS
I st line In a country where ADD THE STATE HAS FAILED TO PROVIDE HEALTH CARE
SERVICES TO ITS MILL1ONS,& Wl IFIRE MEDICAL INDEBTEDNESS IS EMERGING AS A
MAJOR CONCERN .
Pg 4OPPOSITION FROM WITHIN
1st LINE CHANGE IT TO
CONCERN BY IPR & PUBLIC HEAL I11 EXPERTS INCLUDING MINISTERY OF' IIEAL 111
NAVEEN ARE YOU SURE THIS WAS THE FINAL VERSION .
Il is too long . 11 COULD BE MORE Pl INCI IY . WE MAY NEED TO LOOK AT IT ONCE: Ml )RF
BEFORE SENDING IT
REGARDS
MIRA SHIVA
7/4/2006
Position: 1796 (2 views)