EU hoping for solution after FTA talks stalled over drug ban

NEW DELHI: The European Union today defended its decision to ban around 700 generic drugs clinically tested by GVK Biosciences which had prompted India to defer the talks with the 28-nation bloc on the proposed free trade agreement.

The EU, however, said it remained committed to continue working towards conclusion of the FTA and hoped that a solution will be found to the "current deferral" of talks.

"The decision concerning a ban on 700 generic drugs was based on scientific and not trade considerations and in accordance with the advice of the scientific Committee of the EMA ( European Medicines Agency)," said Cesare Onestini, acting Head of Delegation of the European Union to India.

On banning of the drugs, Onestini said the relevant Scientific Committee noted that there was no evidence of harm or lack of effectiveness in the medicine.

"However, this does not address the issue of inaccurate data provided. Data integrity is an indispensable element in the EU marketing authorisation system.

"Similar necessary suspensions occurred in the past in different countries. Such procedures do not question the reputation of the company nor the countries concerned, nor of generic medicinal products. They are an integral part of a rigorous scientific assessment process," Onestini said.

After a gap of about two years, chief negotiators of India and the EU were scheduled to resume talks here on August 28 on the FTA officially dubbed as Broadbased Investment and Trade Agreement (BTIA). India on Tuesday deferred the talks following EU's decision to ban the drugs.

The trade talks, which were launched in June 2007, remain stuck as both sides are not satisfied with each other's offers.

"The EU remains committed to continue working towards conclusion of an agreement between India and the EU that will be acceptable to both sides. For this reasons, the EU hopes that a solution will be found to the current deferral," Onestini said.

The EU official said the purpose of the meeting at Chief Negotiators level was to explore the possibility of resuming the FTA talks, and was not meant to constitute in anyway a "full-fledged" negotiation round.