DNA | Wednesday, July 15, 2009
India talks FTA with Switzerland
Priyanka Golikeri / DNA
Mumbai: Instead of stopping the West and multinational drugmakers in their efforts to block India’s low-cost generic drugs exports, the government is helping their cause by aggressively pursuing free trade agreements (FTAs) with developed economies — agreements that could further hamper the world’s access to such drugs.
While negotiating FTAs, countries make some demands and agree to some. After the European Union (EU) and Japan, India is seeking an FTA with the European Free Trade Association (EFTA), which has countries like Switzerland, Norway, Iceland and Lichtenstein as members.
Industry watchers following the FTAs say if India agrees to calls for ’data exclusivity’ for a period of five years, the cost of bringing low-cost drugs to the market could increase. Usually, for registering low-cost generics, the Drugs Controller General of India (DCGI) refers to the clinical trials data of the innovator company.
If data exclusivity is granted, local drugmakers would have to conduct all the trials required to bring a medicine to the market.
Multinationals such as Novartis, Wyeth, etc, have been demanding this provision for a long time (DNA reported this in June). Japan and the EU have also pressed for this provision.
Another EFTA demand is an extension of the monopoly granted by a patent by five more years (in addition to the current 20) to compensate for the time taken to get marketing approval for the product.
According to intellectual property rights (IPR) experts, these demands not only delay the entry of low-cost generics, but also go beyond the mandate of the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which India is party to.
A few months ago, Norway withdrew from negotiations on IPR between EFTA and India, saying it won’t participate in any demands that require stronger patent protection than that in TRIPS. "Now with Norway out, Switzerland gets to dominate the proceedings, as others like Iceland are too small. The Swiss would definitely work to ensure continued dominance of their companies like Roche, Novartis, etc," said an IP expert from Third World Network, a non-profit international network of organisations and individuals involved in development issues.
A legal expert who has interacted with bureaucrats negotiating the FTAs said, "There is no transparency in this whole process. India is pursuing FTAs without realising the implications." He said different bureaucrats are taking different stances while negotiating the agreements with Japan, EU and EFTA. "Parliament is not aware of any of these FTAs. No efforts are being made by the government to share any kind of information with Parliament or the public. Some of the negotiators who are negotiating the FTAs are not at all interested in hearing views expressed by public health groups," said the expert.
He added, "We don’t have a clear negotiating strategy and our negotiators and bureaucrats fail to understand the subtle manner in which IPR provisions are inserted into the FTAs. So there are huge chances that India may give in to the demands in any of the FTAs."