Minister: India Anticipates European Fix To Law Delaying Generics Shipments

Europe has promised at the “highest levels” to fix laws that caused generic medicine seizures in the Netherlands, the Indian Minister of Commerce and Industry said today. The minister is in Geneva for meetings on the ongoing Doha Round trade liberalisation talks at the World Trade Organization.

“The actions that were taken were not only TRIPS plus but TRIPS illegal,” Minister Anand Sharma told journalists at the WTO, referring to the 1994 WTO Trade-Related Aspects of Intellectual Property Rights agreement, as well as to delays in generic drug shipments in 2008 (IPW, WHO, 5 June 2009)

Indian “generics have brought about a paradigm shift in changing the global discourse about access to lifesaving medicines at affordable prices,” he said. Before Indian-made generics, the price of treatment for one patient for one year of antiretroviral medicines (used for HIV/AIDS patients) was US $12,000. In one stroke, this fee was knocked down to $1100 and now is at $400, he said.

“Generics assured the availability of these medicines” for poor people in poor countries, Sharma said. And these medicines are “genuine, not counterfeit, so any move to confuse between the two is unacceptable [and] would be deceitful.”

“India is fully TRIPS compliant,” he said, and was provoked to move to the WTO consultative mechanism along with Brazil in response to the seizures. India has had meetings with the Directorate-General for Trade at the European Commission, and EU Trade Commissioner Karel De Gucht and his predecessor Catherine Ashton, he said.

Some were expecting India to call for formation of a panel in the dispute case after several months of consultations, but that was not forthcoming today.

India has received “clear assurance, categorical assurance given by the EU trade commissioner, that the notification under which actions were taken, a, was misinterpreted and b, will be amended to plug all loopholes.”

“[We] have every reason to believe that assurances given at the highest level will be implemented and once implemented will be resolved,” he said.

Regarding ongoing negotiations for an EU-India free trade agreement, which many public health advocates have said contains provisions potentially threatening to public health (IPW, Public Health, 27 April 2010), Sharma said, “what is being discussed in the IPR chapter is within the ambit of India’s” domestic laws.

“Nothing will ever be discussed in the bilateral agreements or regional trade and investment agreements which jeopardises” public health nor which is in conflict with India’s commitments in multilateral agreements or in domestic legislation, said the trade minister. It is unclear if India’s health ministry would take the same view.

India’s trade ministry also recently released a draft discussion paper on compulsory licensing (available here [doc]). On this paper, Sharma said in India, the pharmaceutical industry had assured the availability of medicines at affordable prices, not only domestically but throughout the developing world. Many countries have invoked compulsory licences, a provision which is in the TRIPS agreement. If such licences are required, India will invoke them, but the purpose with the paper was to stimulate discussion and feedback.

On several TRIPS issues up for discussion under the ongoing Doha Round of negotiations, India is working with other developing countries in particular on an issue of linking the UN Convention on Biological Diversity to TRIPS. The other connected issues involve geographical indications, or product names associated with a particular place and characteristics, said D. K. Mittal, the lead WTO negotiator for India. But he said ultimately it is the WTO Director General Pascal Lamy, leading the process.

On wider Doha Round issues, Sharma said there is clear interest from all countries in reaching an early conclusion, in fact that it was “imperative for the world to do so.”

The Doha Round began in 2001 and has consistently blown through deadlines for its completion. The closest countries came to reaching an agreement was in the midst of the 2008 financial and food crises, when talks eventually broke down at the last minute due to disagreements between India and the United States about a Special Safeguard Mechanism for agricultural products, though some commentators at the time thought this was a red herring and there were other difficult parts of the disagreement (IPW, WTO, 29 July 2008). The SSM measures are still considered important, Sharma said, adding that in “final round of the closing lap we do expect that there would be a spirit of accommodation some more adjustments to bring about ambitious and balanced outcome.”

Lamy yesterday called on WTO members to move Doha negotiations into “higher gear.”