Dispute over EU generic drug seizures nears resolution

Customs signThe long-running dispute between India and the EU over confiscation of generic medicines in transit took another step closer to being resolved last week.

Under the terms of a written (but as yet unpublished) agreement between the two parties, EU customs officials will no longer be entitled to intercept and seize shipments of generic pharmaceuticals in transit through the EU simply on the grounds of an existing EU patent, according to India's government.

Seizures would be permitted in cases where "there is adequate evidence that satisfies the customs authorities that there is a substantial likelihood of diversion of such medicines on to the EU market," it said in a press release.

India filed a complaint against the EU with the World Trade Organisation last year in the wake of several seizures by EU customs of generic drug shipments en route from India to markets such as Latin America.

Although the products were legitimately-made medicines and could legally be marketed in their destinations, they were intercepted on the grounds that they violated EU intellectual property rights.

The problem lay in the interpretation of EU Regulation 1383/2003. Customs in the Netherlands and France, for example, on occasion took the position that if such a generic medicine touched ground in the EU, it was considered subject to local customs procedures and IPR laws.

The seizure incidents fanned the flames of a debate about the conflation of legitimate generics with counterfeit medicines on IPR grounds, which continues to cause controversy around the world.

Some non-governmental organisations such as Oxfam and Health Action International have argued that the EU is complicit in a "global offensive to increase enforcement of intellectual property under the banner of combating counterfeiting," and was inhibiting access to medicines for people in the developing world.

The EU has said it will amend EU Regulation 1383/2003 to take into account India's concerns over generic medicine seizures, although amendment to the existing regulations would have to be approved by both the European Parliament and Council.

"India would watch with interest EU’s further steps in implementing its commitments," says the government press release.

"India's options to revive the dispute remain intact in case the EU does not abide by the core principles agreed to in the understanding."


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