Indian dispute on generic drug access heats up

[NEW DELHI] A leading health pressure group is locked in dispute with the Indian government over whether a proposed free-trade agreement with the European Union (EU) will reduce access to cheap anti-HIV drugs in the developing world.

International medical charity Médecins Sans Frontières (MSF) said the agreement, in negotiation since 2007 and expected to be concluded later this year, could limit India's production of generic drugs based on drugs developed and patented in Europe. According to MSF, this would dry up the supply of more affordable generic drugs across the developing world.

But such warnings have been rejected by the Indian minister of commerce and industry Anand Sharma, who told Reuters yesterday (22 March): "We will not allow any injury to be caused to the Indian generics industry."

India has faced challenges to its prolific generics industry ever since it signed up to the World Trade Organisation's Trade Related Intellectual Property Rights (TRIPS) agreement in 2005, which meant that drugs themselves — and not just the processes for making those drugs — were potentially patentable in India.

Until now, the risks have been minimised because of public health safeguards built into the law (see Victory for generics in Indian patent case).

But in a letter to Indian prime minister Manmohan Singh, Tido von Schoen-Angerer, executive director of MSF's Campaign for Access to Essential Medicines, said: "We are concerned that the EU–India FTA [Free Trade Agreement] may contain provisions that further restrict access to medicines in India and the rest of the developing world".

MSF is particularly concerned about clauses on 'data exclusivity' which would block access to drug companies' existing data for those seeking to make generic drug versions. It also highlights the plan to extend the drug patent life beyond the current 20 year period.

Another concern is that the government will no longer be able to waive drug patent rules during national health emergencies (see Brazil breaks patent on HIV/AIDS drug), as it is currently permitted to do under TRIPS.

Some 80 per cent of the anti-HIV drugs used by MSF in more than 30 countries come from Indian generics companies.

MSF India, along with Indian networks of HIV infected people and civil society organisations, held a rally in New Delhi earlier this month (12 March) protesting against the government's failure to make public the negotiating text of the agreement.  

Supporters of the agreement believe it could help Indian drug companies move on from the "retro-engineering" of existing drugs to more innovative development of new drugs. The move could also open up a vast trading market in Europe for India.