A trade pact set to be finalised between India and four European countries will restrict the capacity of Indian drug makers to produce generic versions of new medicines, an international medical humanitarian agency has written to the Prime Minister’s Office.

Medecins Sans Frontieres (MSF), the agency that relies heavily on Indian medicines, has expressed concern that proposed rules in the trade pact would prevent Indian drug regulatory authorities from relying on data generated by foreign companies while approving generic versions of medicine.

A leaked draft of the European Free Trade Association (EFTA)-India Free Trade Agreement (FTA) contains text that seeks to protect data against any “unfair commercial use” and prevent others from using the data for “at least six years".

The EFTA member states are Iceland, Liechtenstein, Norway, and Switzerland. Patients’ rights groups in India believe Switzerland — the home of pharmaceutical firm Novartis — has been pushing the hardest for the trade rules invoking what is widely known as "data exclusivity".

Indian drug regulators while evaluating applications from local drug makers for generic versions of medicines often rely on approval decisions and data cited by other regulators such as the US Food and Drug Administration or the European Medicines Agency. The World Health Organisation's South East Asia Regional Office had said in a March 2006 briefing document that the use of data by drug regulators is not commercial use.

Foreign drug makers have argued that data exclusivity recognises the investments they have made to generate the data. But data exclusivity clauses in the FTA would compel Indian companies to repeat clinical studies on generic versions of medicines already approved by foreign regulatory authorities.

“Such an exercise would be needlessly repetitive, expensive, and ethically questionable,” said Leena Menghaney, a public health lawyer and intellectual property advisor to MSF. "When a medicine has already been proven to be safe and effective and has already been approved in another country, why would ethical committees in India agree to clinical trials on it?"

In its letter to the PMO, MSF has said data exclusivity will delay generic versions of new medicines or new formulations for a set period of years even when there is no patent on the medicine and when it meets quality standards prescribed by India’s drug regulatory authorities.

The data exclusivity provisions will have “drastic consequences” on access to medicines,” MSF has said. “They will strengthen and extend the monopoly rights of multinational pharmaceutical corporations at the expense of patients in India and beyond,” Menghaney said.

MSF provides medical assistance to populations in some 80 countries. Indian-made generic versions account for 90 per cent of anti-HIV drugs, 50 per cent of medicines against the hepatitis-C virus, 36 per cent of anti-tuberculosis drugs and 30 per cent of vaccines MSF uses worldwide.

“Pressure on India to accept data exclusivity in FTAs has been long-standing,” said Menghaney. “But India had for years successfully resisted this, refusing to include such provisions. But we now fear this might change with the EFTA-India FTA.”

India has in the past resisted proposals to include data exclusivity clauses during FTA negotiations with the European Union and Asia-Pacific countries.