New Delhi – India should resist pressure from the European Union to accept, as part of a free trade agreement, harmful provisions that will have a major negative impact on access to affordable medicines, the international medical humanitarian organisation Médecins Sans Frontières (MSF) said today.  

As discussions on the sensitive intellectual property chapter in the free trade agreement resume, reports now indicate the Indian Prime Minister’s Office (PMO) may be ready to concede to European demands, imposing severe limitations on the ability of Indian generic manufacturers to produce affordable medicines.

“We urge the Indian Prime Minister to stand strong against Europe and defend India’s role as pharmacy of the developing world,” said Dr. Unni Karunakara, MSF International President.  

MSF relies on affordable medicines produced in India to treat more than 160,000 people living with HIV/AIDS across the developing world.  India is also the source of 80% of the AIDS medicines purchased by donors like the Global Fund. But in a leaked draft of the trade deal, the Europeans are pushing several provisions that would limit competition from generic manufacturers.

“The Indian negotiating position has been committed to systematically opposing Europe’s attempts to impose greater restrictions on generic medicines production than required under international trade rules,” said Leena Menghaney, of MSF’s Campaign for Access to Essential Medicines. “But latest reports now suggest the Prime Minister is ready to reconsider in order to conclude the agreement fast.  We appeal to the Indian Prime Minister to resist the EU’s demands.”

Generic medicines from India have played a critical role in scaling up AIDS treatment across the developing world because until 2005, the country did not grant patents on medicines.  This allowed manufacturers to produce more affordable drugs, pushing their price down by more than 99% over the past decade.  But World Trade Organization rules obligated India to start granting medicines patents in 2005.  This is having a negative impact on access to affordable versions of the newer generation of HIV/AIDS drugs, some of which have already been patented in India.  

Now the policies the EU are pushing would restrict the production of affordable medicines even further.   In particular the EU is seeking to impose ‘data exclusivity’ which would act like a patent and block the marketing of generic medicines for up to ten years.  Alarmingly, data exclusivity would apply even for products that didn’t deserve a patent in the first place under India’s law. Acting as a way to secure monopolies through the backdoor, it would block the development of new fixed-dose combinations, where several medicines are combined into one pill, even though these cannot be patented in India.

“The European Trade Commissioner has confirmed to us that he continues to ask India for data exclusivity,” said Dr. Karunakara. “We ask India to reject data exclusivity and any other aspect of the European trade agenda that exceeds what is required under international trade rules and threatens the lifeline of affordable medicines for the developing world.”