MSF Letter to Indian PM Dr. Manmohan Singh
"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."
Dr. Manmohan Singh
Hon’ble Prime Minister of India
Government of India
Room No.148 B
New Delhi, India-110 001
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. Sincerely,
Dr. Tido von Schoen-Angerer
Médecins Sans Frontières Campaign for Access to Essential Medicines
Head of Mission - India,
Médecins Sans Frontières Holland
Head of Mission – India,
Médecins Sans Frontières Belgium
cc Honourable Anand Sharma, Minister of Commerce and Industry
cc Honourable Ghulam Nabi Azad, Minister of Health and Family Welfare