The proposed India/European Union (EU) Free Trade Agreement (FTA) will make clear that “there should be no limit on India’s capacity to produce and export life-saving medicines,” an EU official has said.

In addition, an internal EU customs regulation will be changed to ensure there are no further seizures by EU customs of Indian-made drugs bound for Africa and Latin America while they are in transit through Europe, according to Daniele Smadja, Ambassador of the EU Delegation to India.

“We are in the process and contemplating some clarification of our internal European legislation to make sure customs have clear instructions and that no such problems take place,” said Ambassador Smadja, speaking in Brussels during the latest round of negotiations for the FTA. Both sides hope to have the agreement completed by the end of the year.

“We are committed that what had happened a year and a half ago doesn't happen again,” the EU official added, referring to the 18 seizures of Indian-made medicines at EU ports, which were reportedly made based on claims by manufacturers that the drugs contravened their EU patents. However, the products’ Indian manufacturers have always pointed out that the drugs are not patented, either in India or the importing markets.

The first such seizure was made by Dutch customs, of a shipment bound for Brazil, but last month Marten van den Berg, Deputy Director General for Foreign Economic Relations in the Dutch Ministry of Economic Affairs, assured India that no such events would occur again once amended EU regulations were in place.

India’s Minister of Commerce and Industry, Anand Sharma’s initial response last week to Ambassador Smadja’s assurances was to state that Indian officials would examine the EU’s proposed amendment to its customs regulations to assess whether it was “adequate to address the issues raised.” However, a Ministry spokesman subsequently said this week that the amendment was “minimal” and would not address the problem, and that India would now go ahead with lodging a formal complaint against the EU with the World Trade Organisation (WTO).

India has already brought the issue to the WTO dispute settlement forum for consideration but it has also been readying plans to bring a formal complaint against the EU at WO headquarters in Geneva, which it was planning to file jointly with Brazil. However, the Ministry spokesman said this week that, due to the clearance procedures in Brazil, a joint filing could take too long and India may well now start the procedure alone.

Meantime, ahead of the latest round of FTA negotiations, which were held in secret, international aid agencies and others had complained about the text of the present draft, which had been leaked. Its provisions reportedly retained controversial provisions included in an earlier text which would extend patent protection for up to five years, introduce data exclusivity and enforce intellectual property rights and “border protection” measures, all of which would jeopardize India’s position as the leading supplier of generic drugs to world markets.

The European Parliament working group on Innovation, Access to Medicines and Poverty-Related Diseases warned that implementing these provisions would reverse the advances made on access to medicines, while Michelle Childs of aid agency Médecins Sans Frontières (MSF) said "millions of lives” were at stake because India is the source of 80% of drugs used by MSF in its aid work.

Ambassador Smadja responded that the text had been simply a starting point for negotiations, while EU Trade Commissioner Karel De Gucht stated that “the European Commission is going to take care that there are no hindrances for access to essential medicines for people from a developing country,” he said.