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Pharma cos, public health groups want patent issue out of FTA talk with EU

Financial Express, India

Pharma cos, public health groups want patent issue out of FTA talk with EU

By Soma Das

27 April 2010

New Delhi/Indian pharmaceutical firms and the network of public health groups have separately urged the government to keep patent-related issues out of the ongoing talks for the proposed India-EU free trade agreement.

The Indian Drug Manufacturers’ Association, the industry body which represents the interest of domestic drug companies, has written to the ministry of commerce, the ministry of health and the department of pharmaceuticals that the entire chapter dealing with intellectual property rights should be excluded from the FTA negotiation. Public health groups, including Lawyers Collective HIV/AIDS and Delhi Network of Positive People, recently met commerce ministry officials and appealed for public consultation on the proposed India-EU FTA.

Both Indian drug firms and civil society organisations have pleaded with the government to not yield to EU’s demands on IPRs, especially for what they called a trade-related aspect of intellectual property rights (TRIPS) and issues, fearing that such a move would push up the prices of drugs in the Indian market.

“The Indian side wants to limit the exercise to TRIPS while the EU wants to go beyond TRIPS. This is totally unacceptable because anything more than TRIPS is not in our interest. We oppose it,” said IDMA executive director, Gajanan Wakankar in the letter. He added that the government should steer clear of promising anything on the issue of ‘data exclusivity’ and ‘patent linkage’ and stick to India’s current position.

Data exclusivity guarantees additional market protection for innovator pharmaceutical companies by preventing health authorities from accepting and evaluating applications for generic medicines during a specified period of granted exclusivity, which varies from one country to another. Patent linkage implies that marketing approval to the generic version of a drug would not be given till the patent granted to the innovator expires or is proved to be invalid.

Public and health groups fear both these provisions can drive up costs of essential medicines in a market. Prathibha S, Lawyers Collective HIV/AIDS Unit, India, said, “These FTAs push TRIPS-plus provisions like data exclusivity, patent linkages, and patent-term extensions and also restrict TRIPS flexibilities. They infringe upon national sovereignty by effectively legislating India public health policy from abroad without taking into account India’s obligations under its Constitution and international human rights instruments “. The civil society groups want the government to be more transparent about the stance that India is adopting and want to have a say in the process leading upto signing of FTAs as they argue that the agreement would have significant repercussions on many aspects of public health like the cost of drugs.

The IDMA is also fiercely opposing another EU demand which could make it mandatory for generic drugmakers to undertake the entire course of clinical trials individually to prove the safety and efficacy of their version of drug. This step would escalate the costs of getting marketing approval significantly for the generic players, pushing up the prices at which they market their drugs. IDMA argues that while talking about the patent laws, EU keeps referring to the ‘Patent Law Treaty’, which India has not ratified. Instead, we are restricting ourselves to the Patent Cooperation Treaty, the letter added.