News has been trickling in of different shipments of medicines from India being seized at ports of the European Union (EU). These consignments were en route to Latin America. It was not till mid-January when news broke of a shipment from Dr Reddy’s Laboratories bound for Brazil being impounded in Amsterdam that raised concerns. At the recent WTO TRIPS meeting, India and Brazil, along with other developing countries strongly criticized the EU for its attitude towards generic medicines in transit between developing countries. On 3 March 2009, India delivered an intervention at the WTO Council for TRIPS meeting on the issue of the public health dimension of the TRIPS Agreement in the context of the Dutch seizures.

As per an expert, EU is using Council Regulation (EC) No. 1383/2003 to impound drugs that are suspected of violating patents registered in member-countries even if these are simply in transit. The regulations permit customs to hold these goods while informing the patent holder of the seizure. The patent holder then applies to a civil court to initiate legal proceedings in order to prove that infringement has taken place. Dr Reddy’s impounded consignment, according to a news report, consisted of 500 kg of Losartan potassium valued at $55,000 that was bound for Brazil. EU which apart from Regulation on trans-shipments is also planning to amend another directive (2001/83/EC) that seeks to prevent the entry of “medicinal products which are falsified in relation to their identity, history or source” into the legal supply chain through a change in the definition of such products. The new definition seems to be based on the proposal accepted at a 2007 meeting of the WHO agency IMPACT (International Medical Products Anti-Counterfeiting Taskforce). However, the concern emanating from the EU measures and the WHO-sponsored agency IMPACT seems to have taken a back seat when WHO shelved a hotly-contested resolution to redefine counterfeit medicines. Experts point out that an adherence to re-defining counterfeit medicines would have put at risk exports of even quality generics from India because these could be termed counterfeit under the new definitions that were proposed on “false representation of identity, history or source”.

Ancillary to the dimension of public health and counterfeiting, costs seem to be another worry for the Indian generics as most of them use European ports to trans-ship pharmaceutical products to markets where the patent is not recognized or is off patent.