The European Union (EU) has come under renewed pressure not to push for strong enforcement provisions in its proposed Free Trade Agreement (FTA) with India which, critics claim, would "shut down the pharmacy of the developing world."
As EU and Indian negotiators resumed talks at an FTA summit in New Delhi on February 10, critics including nongovernmental organisations (NGOs), patient representatives and industry groups condemned the tough enforcement provisions which they say the EU is seeking.
These provisions include:
- data exclusivity requirements which will delay the registration of generics and block their production, even if a patent is not granted or has expired. "While the EU has stated that they are no longer officially demanding data exclusivity, behind closed doors, the EU continues to pressure India to change its laws," said the NGO Medecins San Frontieres (MSF);
- investment rules which would allow multinational drugmakers to sue the Indian government when it regulates health in the public interest. Critics note that these disputes would be handled by secret settlement panels rather than in domestic courts; and
- intellectual property (IP) enforcement measures designed to prevent legitimate Indian-made drugs from reaching patients in other developing countries.
EU negotiators say they are proposing a clause in the FTA which would it ensure that it contains nothing to "limit India's freedom to produce and export life-saving medicines," and they have reportedly dropped demands relating to patent extensions and data confidentiality, but protesters warn of the impact which the proposed new provisions would have for access to affordable medicines around the world.
"We have watched too many people die in places where we work because the medicines they need are too expensive. We cannot allow this trade deal to shut down the pharmacy of the developing world," said MSF's international president, Unni Karunakara.
"What the EU is trying to do with this trade agreement is effectively slowly poison the production of affordable generic medicines in India, which has helped keep so many people alive," added Piero Gandini, head of mission for MSF in India. Moreover, the provision "could target us as treatment providers, simply for buying generic medicines from India to treat patients in our programmes," he warned.
Nonkosi Khuamalo, chair of South Africa's HIV/AIDS group Treatment Action Campaign (TAC) said that since TAC was set up in 1998, the price of life-saving antiretroval medicines (ARV) has dropped by nearly 99%, primarily because of market competition among generic producers in India.
The EU's "experiment" in increasing the enforcement of IP through seizures by European customs of generic Indian-made HIV medicines, made on allegations of IP violation, had had "the very real consequences” of "stock-outs of medicines in clinics in poor countries and the interruption of life-saving treatment. The EU is now trying to legitimise these measures through trade agreements," she said.
Ms Khuamalo also noted that the FTA is being negotiated in secret and that the EU has threatened to back out of the talks if the deal is not signed this month. "Our lives hang in the balance as the two sides make trade-offs to come to an agreement," she said.
Rohit Malpani, policy adviser at Oxfam, warned that if the EU succeeds in imposing strict IP rules on the Indian government, "the massive hike in medicine prices could undermine European leadership to provide international aid for global health. Worryingly, it could also debilitate donor programmes that provide access to treatment around the world," he added.
Analysts quoted by the Economic Times of India say the harm that these provisions would do for medicines access among the world's poorest would unlikely be reflected in the fortunes of India's drugmakers, which could gain increased access to EU markets.
"The industry will be OK - they can produce anything," the newspaper quotes analyst Bino Pathiparampil of IIFL Capital as stating.