Govt may move WTO on EU drug seizures

The government plans to file a complaint to the World Trade Organisation (WTO) against seizures of its legitimate low-cost generic drugs by the European Union (EU), according to people in the know.

About 17 consignments of legitimate generics worth crores of rupees from India, which were bound for markets in South America such as Venezuela, Brazil and Peru, were seized at ports in the Netherlands and Germany in late 2008 and early this year, on charges of patent infringement.

The generics were not meant for the EU markets, and were seized as their innovators held patents in EU countries. The consignments were from drug makers such as Dr Reddy’s Laboratories, Cipla, Aurobindo Pharma and Ind-Swift Laboratories.

This not only affected India’s generic exports (drug exports from India between April 2008 and January 2009 totalled Rs 31,608 crore, according to the commerce ministry), but also denied patients in South America access to cheaper medicines.

Experts say India could argue specifically on Article 7 and 8 of the trade related aspects of intellectual property rights (TRIPS) agreement of the WTO.  Article 7 says the enforcement of intellectual property rights should be done “in a manner conducive to social and economic welfare.”

Article 8, on the other hand, gives members permission to adopt measures to protect public health and nutrition, and other public interest goals. However, legal activists feel the free trade agreement (FTA), which India is negotiating with the EU, might force it to water down any complaint.

“India has been talking for sometime on approaching the WTO, but no concrete steps have yet been charted out. Our government is pursuing the FTA aggressively and so may not want to upset the EU by approaching the WTO,” said a New Delhi-based legal activist working in the area of access to medicines.

According to a Kolkata-based intellectual property expert, the government should insist in the FTA that legitimate transit drugs should not be detained or seized as per certain provisions of TRIPS.

“Unfortunately, the FTA negotiations at present seem one-sided, with India not asserting itself on the seizures and rather getting coaxed into accepting two provisions of patent extensions and data exclusivity that the EU is pressing and which can severely impact access to cheap medicines,” said another IP professional who has been closely interacting with some FTA negotiators from India.

According to him, the drug seizure episodes could proliferate to countries like Japan and the US unless India makes the right moves at the right time. “In the last two to three months, we haven’t officially heard about any seizures of Indian consignments. But there is not guarantee about the future and India should not relent if the seizures stop for a few months.”