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Patients rally against trade pact with EU

New Delhi, March 2: Patients battling cancer, infections and mental illness joined a rally here today beseeching the government to reject a trade pact with the European Union that they fear will threaten the availability of inexpensive generic medicines in India.

An estimated 2,000 people, many among them infected with HIV, walked along Delhi’s Parliament Street on a day when Indian and EU officials were negotiating a free trade agreement in Brussels.

Health activists and lawyers familiar with leaked sections of the text under negotiation have said the EU has built pressure on India to accept intellectual property protection that goes beyond what global trade rules require. They say a provision called “data exclusivity” would block inexpensive generic medicines from the market, even for drugs that no longer have patents on them.

“Accepting data exclusivity would be a colossal mistake — it will severely hurt patients in India and in other developing countries that rely on India for inexpensive generic drugs,” said Anand Grover, the UN Special Rapporteur on the Right to Health.

Grover said India’s three ministries involved with medicines — the health ministry, the chemicals ministry and the commerce ministry — have all indicated to health groups that they are opposed to data exclusivity. “They appear to agree that data exclusivity is not good for our country — but the Prime Minister’s Office has written to them (the ministries) to look at this issue again,” Grover said.

A group of non-government health organisations had last year released documents that suggested that multinational drug companies had used the Prime Minister’s Office to try to influence government policies, including India’s stand on data exclusivity.

“I think people haven’t really understood the massive impact that data exclusivity will have on health care,” said Navneet Tewatia, a pharmaceutical industry affairs specialist involved in guiding Indian parliamentarians on HIV issues.

“This is likely to affect all therapy areas — from HIV to cancer to vaccines,” he said.

Current Indian drug laws require generic companies only to establish bioequivalence of the molecules they plan to market. Data exclusivity will protect clinical trials data generated by the innovator companies and force generic manufacturers to repeat the clinical trials.

“This would virtually mean no more inexpensive generics of new medicines,” said Leena Menghaney, a lawyer with Medecins Sans Frontieres, an organisation that relies on India’s generics to supply anti-HIV and anti-TB drugs to Asian and African countries.

Health activists also warn that the free trade agreement contains elements that will allow the EU to stifle any change in Indian government policy that it fears will hurt investments. “This is already happening elsewhere,” said Grover, a human rights lawyer.

A multinational tobacco company has used a trade agreement signed by Uruguay to sue the Uruguay government for its decision to introduce larger and more graphic health warnings on its tobacco packets, said Y.K. Sapru with the Cancer Patients Aid Association.

“India’s own control tobacco control efforts may also be at risk through such a free trade agreement,” Sapru said.

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