PHM-Exch> MSF Letter to Indian PM Dr. Manmohan Singh

[Claudio Schuftan]

-From: Meghana Bahar meghana at haiap.org


Dear Prime Minister,

We write to you on behalf of Médecins Sans Frontières (MSF), an
international medical humanitarian organisation that provides emergency
medical assistance to populations in distress in more than 80 countries. MSF
has been providing antiretroviral therapy to people living with HIV/AIDS
since 2000.

We understand that both informal and formal negotiations between India and
the European Union towards the signing of a Free Trade Agreement (FTA) are
about to conclude. MSF would like to draw your attention to the harmful
effects of proposals likely to be contained in the FTA.

India has played a pivotal role in supplying affordable generic versions of
drugs used throughout the developing world. MSF for example sources over 80%
of its antiretroviral medicines used in its AIDS projects around the world
from India. The availability of fixed-dose combination therapy (or
three-in-one pills) has revolutionised AIDS treatment, a fact we have
witnessed first hand in our own programmes. Providing this form of treatment
adapted to resource-poor settings in developing countries has only been
possible because there were no patent constraints in India on putting these
medicines together in one tablet. People living with HIV thus rely on India
not only for affordable medicines but also for the best standard of
treatment like fixed dose combinations, some of which are only available
from Indian companies. Currently 92% of people living with HIV on treatment
in low- and middle-income countries use generic antiretrovirals manufactured
in India.

In the current economic scenario, with fewer funds available for AIDS
programmes around the world, millions of lives will depend on India being
able to continue supplying generic medicines.

In 2005, in order to comply with the TRIPS Agreement, India was obliged to
grant patents on medicines, and some newer antiretrovirals to treat HIV are
already patented in India, essentially blocking their generic production.

We are concerned that the EU-India FTA may contain provisions that further
restrict access to medicines in India and the rest of the developing world.
Such provisions will have drastic consequences with regard to access to
medicines: they will strengthen and extend the monopoly rights of
multinational pharmaceutical manufacturers at the expense of patients in
India and beyond. More specifically, these provisions all seek to limit, and
in some cases completely block, what remains of generic competition. Generic
competition has proven to be key in lowering the prices of medicines,
thereby improving access to medicines.

We would like specifically to call your attention to the following concerns
in FTAs negotiated by the European Union:

* Data Exclusivity: Data exclusivity provisions being pushed by the EU in
FTA negotiations will delay, and could even prevent, the registration of
generic versions of medicines - even when there is no patent on a medicine.
Further, data exclusivity could effectively block compulsory licenses.
* Patent term extensions: The EU is seeking to “compensate” drug companies
for the time a national drug regulatory authority takes to examine an
application for registration, or a patent office takes to examine a patent
application. The life of the patent would be extended beyond 20 years,
extending the patent holder’s monopoly position and preventing generic
competition.
* Enforcement and border measures: Border measures that seek to detain
imports or exports of good suspected of infringing intellectual property
rights are of great concern to other developing countries as well as
international agencies like MSF that procure their medicines from India. In
2008, Indian generic medicines, including crucial AIDS drugs, transiting
through the EU en route to Africa and Latin America were seized by the
European Union. The EU is now seeking to export the provisions of its
customs regulations that allow such seizures to developing countries. Any
FTA that contains provisions on border measures will in effect legitimise
the actions of the EU in seizing Indian medicines.

None of these restrictive provisions are required under the World Trade
Organization (WTO) Agreement on Trade-related Aspects of Intellectual
Property Rights (TRIPS), and this is reaffirmed by the November 2001 Doha
Declaration on TRIPS and Public Health. Rather, these proposals are part of
a deliberate strategy by the EU to increase the standards of intellectual
property protection above the WTO requirements, directly undermining the
Doha Declaration, and to ensure that EU intellectual property standards
become a global norm.

For people living in India and all the developing world, these provisions
could seriously undermine access to life-saving medicines by further
limiting generic competition. We therefore urge you to reject any
intellectual property proposals that go beyond the requirements of the TRIPS
Agreement.

Executive Director
Médecins Sans Frontières Campaign for Access to Essential Medicines
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