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Cheap drug loss fear on EU pact

New Delhi, April 10: A proposed free trade agreement (FTA) between India and the European Union might pose a new threat to affordable medicines from India by imposing rules that discourage generic medicines, lawyers and patients’ groups said today.

The lawyers, who said they have access to leaked portions of the proposed FTA text now under negotiation, said the EU is demanding an enforcement of intellectual property measures that go beyond what India is required to implement under a global trade agreement.

Commerce minister Anand Sharma is expected to visit Brussels on April 14 and 15 for ministerial-level talks to finalise the FTA which is being projected to bolster trade between India and the EU. India hopes the FTA will expand the EU market for Indian gems, leather, and textiles.

But the EU is demanding that its companies can ask for freezing of bank accounts and seizure of properties of generic medicine manufacturers on mere allegations of infringement of patents, said Anand Grover, a senior advocate with the Lawyers Collective, an organisation campaigning for affordable medicines and patients’ rights.

“We fear India is also under pressure to accept changes in patent laws to introduce a concept called data exclusivity which would curb the ability of generic manufacturers to produce affordable medicines,” Grover said.

Under data exclusivity rules, generic companies would not be able to rely on clinical research data submitted by the original manufacturer of a drug to seek regulatory approval of a generic version of a medicine.

Representatives of multinational drug companies have often accused Indian generic drug manufacturers of “piggybacking” on their clinical research data. Generic companies save costs by simply carrying out relatively less costly bioequivalence studies to establish that generic versions are equivalent to the original compounds.

“We won the case against Novartis (last week), but the India-EU FTA may threaten the supply of other generic drugs,” said Yogendra Sapru, director of the Cancer Patients Aid Association, a non-government organisation in Mumbai. The CPAA had opposed the patent application by Swiss company Novartis on its anti-cancer drug called Glivec.

The Supreme Court had last week ruled that Glivec did not deserve a patent as, under Indian patent law, it was only a new form of a known molecule without any significant improvements in efficacy.

Several hundreds of people infected by the human immunodeficiency virus (HIV) staged demonstrations in Delhi calling on the government to reject EU demands in the FTA that they said could hurt the supply of generic medicines.

An Indian traders’ body also expressed its fears that the impact of the India-EU FTA will extend beyond generic medicines to agriculture and India’s food processing industry.

“We fear certain provisions in this FTA will open up the Indian market to agricultural produce from Europe — this will hurt Indian farmers and the domestic food processing industry,” said Praveen Khandelwal, secretary-general of the Confederation of All India Traders.

“The FTA now under negotiation is particularly likely to severely harm the Indian dairy industry,” Khandelwal said. “There are fears that it will allow the EU to dump subsidised farm and milk products into India.”