[Ip-health] Indian Civil Society Statement on IGWG

[Sarah Rimmington]

INDIAN CIVIL SOCIETY STATEMENT ON THE INTERGOVERNMENTAL WORKING GROUP ON
PUBLIC HEALTH, INNOVATION AND INTELLECTUAL PROPERTY
22 April 2008

The Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property (IGWG) is scheduled to have its next round of
discussions from April 28th in Geneva. While this is supposed to be the
final round of discussions, it is unclear if this meeting can conclude
all discussions in this session.

Background: The IPR based R&D model is not working
The IGWG has been set up specifically to address the inability of the
present intellectual property rights (IPR) based system, governed by the
TRIPS agreement to address the real health needs of an overwhelming
number of people in the world. In 1995 the TRIPS agreement introduced a
uniform, global and higher level of patent protection. The promise that
this would lead to higher levels of innovation remains a mirage.
Globally, the number of New Chemical Entities (NCEs) has decreased over
the past decade; of those approved for marketing, less than 3%
constitute a significant advance over prevailing therapies. The vast
majority of new products address the needs of wealthy populations in the
global North, while the disease burden is largely in the global South.
While the industry researches drugs for lifestyle conditions of the
affluent =96 obesity, erectile dysfunction, baldness, etc. =96 conditions
such as Tuberculosis, Kala Azar, Sleeping Sickness, have to make do with
decade old therapies. The last drug developed specifically for
Tuberculosis, was introduced some three decades back.

Clearly the IPR based model for innovation is just not working. Strong
IPR protection is encouraging protectionism and harming the way science
is done. Many more patents are taken out to stop others from working
rather than to protect one=92s own research. This is premised on very high
costs of development, that are sought to be recovered through high
monopoly pricing of products, closing the door for research required by
the global poor who do not have pockets deep enough to afford the high
prices.

The importance of the IGWG negotiations for India: alternatives to IPR
based R&D funding
The IGWG negotiations are of vital importance for India, as well as for
developing countries. This is the first time that a global forum is
engaged in discussing ways to channelise R&D into areas of concern for
developing countries and ways to make new health products =96 medicines,
vaccines, diagnostics =96 available at affordable prices. The discussions
are important for India for several reasons.

First, India has the world=92s highest incidence of diseases such as T.B.,
Kala Azar, Malaria and Leprosy, and the third highest incidence of
HIV/AIDS in the globe. New remedies for some of these diseases are
desperately needed. Moreover, after the amendment of India=92s patent law,
a vast majority of Indians will be denied access to patented medicines
because of unaffordable monopoly prices.

Second, the outcome of the discussions can also leverage India=92s
position as a global leader in research on health related products.
While India has the best-developed capacity for research in the
pharmaceutical sector in the developing world, the IPR based system
prevents India from emerging as a global leader.

However, if some of the proposals under discussion in the IGWG are
agreed upon, India can draw immense benefits from an alternate system of
R&D that is not premised on IPR but on an open source model of R&D. This
is an area of particular interest for India given that the Council for
Scientific and Industrial Research in India has already initiated an
open source drug discovery programme.

Caution: TRIPS plus provisions ahead!
The discussions of the IGWG, however, need to be pursued with caution
because the US, Switzerland and EU have counter proposals on the table
that, in fact, seek to further strengthen the TRIPS agreement by
proposing several =93TRIPS plus=94 measures, such as strong adherence to
data exclusivity, and harmonization of standards that would benefit
developed countries. They are also obstructing moves that would give WHO
a greater role in IPR related issues, when public health is affected. It
is important that Indian negotiators do not negotiate away our national
concerns, which have been discussed and agreed upon by the Indian
Parliament.

Government of India position unclear: need for public accountability
It is a matter of concern that the Indian Government has not discussed
what positions it has been taking and shall be taking at the IGWG
discussions, in any public forum in the country. The matter has not been
discussed in the Indian Parliament, and neither has any explicit
position been shared with other political parties or with civil society.
The Government has had a few rounds of consultations in the country, but
at no point has the Government made public its position. This secrecy is
confounding and leads unnecessarily to suspicions regarding the real
intent of the Government in these negotiations. Much of our reading of
India=92s role in the negotiations is based on hearsay, in the absence of
an explicit position. We understand that in global negotiations
countries need to retain some flexibility, but that does not mean that
absolutely nothing will be made public on at least the bare
non-negotiables in public interest.

India should take the lead in the creation of an alternative R&D system
that de-links prices of medicines from R&D costs
It is surprising that India does not seem to have taken the lead in the
process since its inception. The initial proposal for the Working Group
was moved by Kenya and Brazil in 2006. Since then, a large number of
developing countries have made written submissions, but there have been
few issues on which our government has taken the lead. There have been
occasions in the negotiations when the Indian position has been contrary
to the position of many developing countries =96 such as its insistence
that the scope of diseases under discussion be restricted. It is
understood that India has, in the negotiations, been keen to follow up
the proposal of a global fund that would support R&D in needed areas.
While in itself a welcome idea, the precise manner in which such a fund
will be governed and utilized is of prime importance; the proposed fund
should not end up providing the already dominant pharmaceutical industry
with still more money.

India has lead by example in placing health concerns over commercial
interests in the changes to its patent law. It is thus uniquely placed
to ensure that the IGWG negotiations firm up proposals that mandate such
public health oriented implementation of IPR in developing countries
including restrictions on patentability. The Ministry of Health and
Family Welfare has stood firm on its stand against the introduction of
data exclusivity recognizing the detrimental impact of yet another
monopoly on the health and welfare of patients. The Ministry is now in a
position to have its stand validated at an international platform.

Finally, there is no necessity for India to agree to the conclusion of
the negotiations in this round itself. The negotiations have
implications on research and development, drug regulation, clinical
trials, pricing, competition, generic manufacture, patents, the
application and interpretation of WTO rules and so on. Further it is
likely that in the coming months, changes of administrations in some
developed countries will likely see a change in the attitudes and
approaches of these countries to the IGWG discussions. It would be
prudent not to negotiate in haste, especially on issues that are
contentious and on which a national consensus is needed. We trust that
the Indian negotiating team shall keep this in mind while negotiating
our concerns in Geneva.

In the above background some of the issues and the positions that we
believe India needs be explicit in pursuing in the negotiations are:

=95 Health is a fundamental human right: The single guiding principle in
the negotiations by the Indian delegation must be the universal and
constitutional right to health of all persons.

=95 =93Alternative=94 R&D model the need of the hour: India=92s own experie=
nce
as well as that documented from around the developing world shows that
the existing system does not work. This must be fully and accurately
represented in the negotiations which must stand strong on supporting an
alternative model for R&D that de-links prices from R&D costs.

=95 Caution on limitation of scope of diseases: While the intention of
focusing attention on certain diseases is well meaning it in effect
freezes the document, requiring re-negotiations and justifications by
developing countries at later stages when public health needs may change.

=95 No TRIPS-plus provisions: The negotiations must reject any and all
TRIPS-plus references including the numerous references to data
exclusivity/data protection in the strategy document.

=95 R&D Fund to be based on open source, transfer of technology,
alternative R&D models: While a global R&D fund is welcome, it should
not plough even more money back into big pharmaceutical companies. It
must work on non proprietary, non IPR based principles and in developing
countries.

=95 Clear mandate to WHO to look at innovation and access: The WHO=92s
mandate to look at issues of innovation, public health and IPR must be
clear and unhindered by conditions to collaborate with the WTO and/or WIPO.

=95 No harmonization of systems: Proposals to harmonise drug regulatory
and patent systems should be rejected as they are likely to import IPR
based regulation from developed countries. Harmonised standards for
traditional knowledge that will have a detrimental impact on small
practitioners and manufacturers must also be rejected.

=95 Promotion of competition and access to generic medicines: Proposals
that suggest the promotion of generic competition after =93patent expiry=94
go against the spirit of compulsory licensing which is essential for
increasing access to essential drugs.

=95 Public access, accountability and transparency: In the finalization of
the strategy document and in its implementation, the involvement and
representation of genuine public interest and health groups must be assured=
.

National Working Group on Patent Laws, Peoples Health Movement =96 India,
All India Peoples Science Network, Knowledge Commons, All India Drug
Action Network, Delhi Network of Positive People, Initiative for Health
Equity and Society, Drug Action Forum =96 Karnataka, Lawyers Collective
HIV/AIDS Unit and Center for Trade and Development.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/