The European Commission has agreed to amend its customs regulations so that Indian-made generic drugs bound for Third World countries will no longer be seized while they are in transit through European countries.

The agreement was reached during the India/European Union (EU) Free Trade Agreement (FTA) summit in Brussels last Friday (December 10). According to an official statement, EU Trade Commissioner Karel De Gucht said “categorically” that the EU customs rules, set out in EC Regulation 1383, will be amended “to take care of India’s concerns related to seizures,” and that no further confiscations will take place while the regulation is being amended.

Generic transports in transit “will no longer be checked, except for counterfeiting,” said Commissioner de Gucht.

As a result, India has suspended - but not withdrawn - the complaint against the EU which it lodged, together with Brazil, at the World Trade Organisation (WTO) over the seizures in 2009. Brazil has neither suspended nor withdrawn its complaint.

However, critics claim that this undertaking is of minor relevance, as measures which represent the real threat to the Indian drug industry’s competitiveness, including data exclusivity, are still being discussed by trade negotiators.

“We know that behind the scenes, Germany, the UK and France are the ones doing the bidding for their pharmaceutical industries to try to stamp out the competition from India,” said Michelle Childs, policy director at international aid agency Medecins Sans Frontieres (MSF)’s Campaign for Access to Essential Medicines, speaking as the trade talks began.  

“The EU is trying to give their pharmaceutical companies a backdoor route to monopoly status, when they can’t get a patent through the front door,” said Ms Childs. “Vague reassurances that the EC is not seeking to harm the production of affordable medicines are not enough, as the devil is very much in the details.  At this point, we want a clear statement from the EC that data exclusivity and other damaging provisions are out of the free trade agreement text,” she added.

However, in a joint statement issued after the summit, India’s Commerce Minister Anand Sharma and Commissioner De Gucht dismissed claims that the FTA would endanger India’s role as “pharmacy to the world.”

“Nothing could be further from the truth,” they said.

“We agree that nothing should prevent the poorest people from accessing life-saving medicines. This remains a core principle and will be reflected explicitly in the trade agreement. The agreement will in no way limit India’s scope for developing and exporting life-saving medicines. Specifically, it will not stop India from using its flexibilities under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), in particular the possibility of manufacturing generic medicines under compulsory licence for export to other developing countries facing public health problems,” said the officials.

The FTA, which is now expected to be finalized next spring, will be the largest and most significant deal ever concluded by either the EU or India, they added.