Debate on EU-India FTA deal relating to pharma continues ahead of conclusion

The proposed free trade agreement between the European Union and India has caused considerable debate and objections for the latter’s drugmakers as well as AIDS activists and non-governmental organizations, with the likes of Medecins Sans Frontieres (MSF) mounting a campaign under the banner “Europe – Hands off our Medicines” and marches (The Pharma Letters passim).

Much of the opposition focused on an EU request for a “data exclusivity” clause which opponents claim would prevent India from producing cheap generics. A conclusion to the talks is expected this spring.

Currently, generic drugmakers just have to demonstrate their medicines are equivalent to the original drug to be approved. Under new rules, they would have to conduct clinical trials, which cost millions of dollars, to duplicate the data produced by the original company. Activists are also worried about attempts to extend patent protection to beyond 20 years and measures to seize generic medicines as they cross borders.