New Delhi: European commissioner for health and consumer policy Antonio Borg on Friday said the proposed trade agreement with India won’t impose data exclusivity, patent extensions or linkages, in a bid to deflect criticism over the purported stance of the European Union.
Patient groups and other organizations have protested against the planned free trade agreement (FTA) between India and the EU on the grounds that it will lead to stricter patent laws, delaying the entry of generic drugs into the market and raising prices.
Borg refused to comment on the specifics of the proposals on intellectual property rights.
“The relevance of Indian generic drug industry to the developing world is known to us,” he said. “The negotiations do not demand anything that goes beyond the TRIPS (trade-related aspects of intellectual property rights) agreement.”
Borg met officials in the health ministry and the Pharmexcil (Pharmaceutical Export Promotion Council of India). “Representatives of the industry maintain very few injunctions are granted when patent infringements happen. FTA is trying to get the right balance which will satisfy generic manufacturers and the innovator firm,” said Borg.
Opponents said the agreement could block the export of generic medicines as it may introduce intellectual property enforcement provisions beyond the TRIPS agreement.
“The inclusion of these enforcement provisions will undermine the Indian judicial system and deprive people of access to medicines,” said Anand Grover, director of Lawyers Collective, a non-governmental organization supporting patient groups. “Such provisions threaten to subvert the fundamental tenets of the constitution of India. Further, demands for patent extensions, patent linkages and data exclusivity will delay the entry of generics in the market, thereby affecting millions of patients.”
The latest round of FTA talks are taking place days after the Indian Supreme Court dismissed Swiss drug maker Novartis AG’s patent claim on blockbuster anti-cancer drug Glivec.
On 14 April, commerce and industries minister Anand Sharma will meet EU trade commissioner Karl De Gucht in Brussels for what is supposed to be a final round of negotiations.
“Having failed to get their way in the Novartis case, we can expect EU to push industry demands for changes in the Indian law to curb the Indian judiciary,” said Y.K. Sapru, member of the Cancer Patients Aid Association, a petitioner in the Glivec case.
India is a major supplier of generic medicines to many low- and middle-income countries. Generic medicine consignments by Indian firms have been seized in the past in transit at European ports several times on grounds of alleged patent infringement.
In 2008, there were 17 cases of medicine seizures in the Netherlands alone, according to a response from Dutch authorities to Health Action International, a non-profit organization, under a freedom of information request.
Of these, 16 were shipments from India and one from China. India launched a trade dispute against the EU and the Netherlands in May 2010 over the seizure of generic medicines in transit. It later withdrew this after the EU directed customs authorities not to seize any such consignments.