India-EU FTA won't hit generic drugs industry: EU envoy

EU had demanded an amendment to the Indian patent law, in the wake of a patent being rejected to Novartis, for its cancer drug, Glivec

The much-hyped bilateral trade and investment agreement (BTIA) between India and the European Union (EU) would not impact the Indian generic drugs industry or lead to a change in the country's patent law, João Cravinho, EU ambassador to India, said on Friday.

"Our position is very clear. We do not want any change to any Indian legislation," Cravinho told Business Standard on the sidelines of a meeting here. He was referring to speculation that the EU had demanded an amendment to the Indian patent law, in the wake of a patent being rejected to Swiss pharmaceutical major Novartis, for its cancer drug, Glivec.

Cravinho said under the India-EU trade deal negotiations, EU hadn't demanded "anything more than what is there in TRIPS (trade-related intellectual property rights), neither have we asked for data exclusivity or patent linkages".

"Because the issue (of pharmaceuticals) is somewhat political, it can reach a high level of mobilisation and there are people who are anti-free trade anyway. So, it can be a vehicle for mobilising their views. Pharmaceuticals are not a significant area of difficulty in the negotiations. Seriously, the generics industry in India is not worried," Cravinho said.

He added the EU "does not stand by" the documents reportedly leaked by civil society groups in that region. According to these documents, India had buckled under pressure from EU to change its intellectual property right (IPR) laws, and this would affect accessibility and affordability of medicines.

Apparently, EU has demanded an exclusive chapter on data exclusivity. By gaining exclusive rights over data, innovator companies can prevent their competitors from securing marketing licences for low-cost versions during the tenure of this exclusivity. In the case of pharmaceuticals, data exclusivity refers to the data generated by drug companies through expensive global clinical trials to prove the efficacy and safety of new medicines.

EU commissioner for health and consumer policy Tonio Borg, currently in India, said under the negotiations, EU hadn't demanded anything, as far as issuing injunctions for patent infringement was concerned. He was referring to the fact that a few Indian drug makers were facing lawsuits by global pharmaceutical companies for breach of patents. According to norms, Indian courts abstain from issuing injunctions during hearings for cases concerning patents, in case it results in stopping the supply of generic drugs to the market.

Since the alleged text on negotiations between India and EU was leaked, Indian civil society groups and health activists have been up in arms against India-EU trade pacts.

They believe EU's demand for stronger implementation of IPR norms might affect the country's generic drugs industry, which exports 67 per cent of its produce to poor and developing countries.

Currently, India supplies low-cost versions of expensive medicines manufactured by major pharmaceutical companies, a practice that has earned it the reputation of 'pharmacy to the developing world'. Any change in IPR laws would prove to be a death knell for Indian generics manufacturers.

On April 15, Anand Sharma, minister of commerce & industry and textiles, would meet EU trade commissioner Karel de Gucht and EU commissioner for agriculture and rural development Dacian Ciolo to discuss the BTIA, talks for which started in 2007.