The European Commission clarified today that no breakthrough in the ongoing dispute between India and the European Union (EU) regarding generic drug seizures had been reached. In response to queries from Business Standard, John Clancy, the EC’s spokesperson on trade, said he was unable to confirm Indian media reports that the matter had been resolved.
“We can confirm that the European Commission is engaged in consultations with India and that talks are constructive, with both sides agreeing that an amicable solution to this dispute would be preferable,” he said.
In May, India along with Brazil took the matter to the World Trade Organization (WTO), where they were asked to establish consultations with EU as a precursor to setting up a Dispute Settlement Panel. Since then, two rounds of official talks have taken place in Geneva, where WTO is based.
The point of contention has to do with the 20-odd cases of seizures of Indian-made generic drugs in transit at European ports in 2008 and 2009. In 2008, 16 seizures were reported in the Netherlands alone.
India and public health NGOs have claimed these seizures were not only illegal since they contravened WTO norms, but were also damaging to developing countries by denying or delaying them access to life-saving medicines.
But EU cites domestic customs laws that allow goods in transit to be stopped if they are suspected of being either illegal or substandard, as justification. The generic drugs in question were off patent in both India and the countries to which they were destined. However, in some cases the seized drugs were patent-protected in EU.
India maintains that European countries are creating trade barriers against Indian drug companies to protect the interests of their firms.
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At issue in the ongoing talks is the question of whether customs officials have the competence to judge intellectual property rights’ infringements. The EU directive in the spotlight is a Customs Regulation 1383, which lays out the details of the condition under which European customs can legitimately stop goods in transit.
According to sources, the main focus of the discussion at present is under what conditions Regulation 1383 can and should be activated. India has asked for a clause in the regulation to be amended.
Although the regulation is currently in the process of being revised by the European Commission, this is an internal EU move that is taking place in parallel to consultations with India. Moreover, it is not clear whether the proposed revision will address India’s concerns.
There has thus been no “acceptance” of the Indian position on the matter as suggested by Indian Commerce Minister Anand Sharma last week and widely reported in the media.
The EU trade spokesperson, in fact, insisted that the “EU legislation on border enforcement of intellectual property by customs poses no obstacle to generics in transit through EU.”
He added that during the ongoing consultations “EU listened to India’s concerns and in light of those provided clarification of the EU legal framework for border enforcement.” No further details were forthcoming.