EFPIA response to Dutch customs' Rx drug grab

The European Federation of Pharmaceutical Industries and Associations has called on its members to "re-examine their procedures to ensure  that any inappropriate interceptions are resolved as a matter of  urgency," in response to recent seizures of generic medicines in the  Netherlands (Marketletters passim). The EFPIA's statement followed the  confiscation a 500kg shipment of losartan potassium, the active  ingredient in US drug major Merck & Co's antihypertensive Cozaar,  which was in transit from India to Brazil.

According to some media reports, the issue may have contributed to  the World Health Organization's failure to adopt an International  Medical Products Anti-Counterfeiting Taskforce (IMPACT) proposal to  strengthen the definition of fake medicines (Marketletters passim).  Both Brazil and India argued that the customs actions violated the  World Trade Organization's agreement on Trade-Related Aspects of  Intellectual Property Rights (TRIPs). The case also provided  substance to Indian firms' claims that the new counterfeit definition  could hamper legitimate generic products.

At a meeting of the WTO's TRIPs Council, UNITAID, which purchases  medicines for HIV/AIDS sufferers in developing countries, reported the  interception by Dutch customs officers of a shipment of abacavir  sulfate, the active ingredient of UK drug major GlaxoSmithKline's  Ziagen. The 49kg-shipment of the second-line antiretroviral agent did  not violate IPRs or contain fakes, UNITAID said. This case assumed  embarrassing proportions when it emerged that GSK had not objected to  the UNITAID purchase, and several European Union governments, including  France and the UK, had contributed to the shipment's costs. However, the  seizure rules are understood to be that goods not considered to be  counterfeit should not be seized for alleged IPR violations without the  request of the patent-owning firm.