European Generic Drug Seizures Take Centre Stage at TRIPS Council Meeting

10 June 2009

German custom officials seized a shipment of generic drug Amoxicillin that was passing through Frankfurt, Germany en route to the Republic of Vanuatu last month, adding fuel to an ongoing debate over whether European patent rules are inhibiting access to medicines in developing countries.

The antibiotics, worth approximately €28,000, were held for four weeks before the authorities released the medicines to Vanuatu. The release came after the British drug manufacturer GlaxoSmithKline, the former patent holder for the Amoxil brand of Amoxicillin, confirmed that there was no trademark violation.

The incident has intensified recent debate over the EU Regulation on Border Measures, which allows customs officials to intercept goods suspected of infringing certain intellectual property rights. The issue was raised again at an 8 June meeting of the WTO's TRIPS Council, the committee that deals with trade-related aspects of intellectual property rights. Brazil and India, supported by several other developing countries including China, Cuba and South Africa, complained that the EU was confusing legitimate generics with counterfeits and undermining poorer countries' ability to acquire cheaper medicines. The countries called the action by the EU customs officials a violation of the provisions of the General Agreement on Tariffs and Trade (GATT) and argued that the action amounted to ‘extra-territoriality'- a country imposing its own law on others.

In response, the EU maintained that it has no intention to obstruct trade in genuine generics. The European representative said that the German customs officials were checking for counterfeits, which it called a fast-growing and dangerous problem that can harm public health in developing countries. It said the action was taken under regulations that set short time limits on seizures and allow consignment owners legal redress for false complaints.

The US also weighed in, adding that brand names can ensure quality, whereas fakes mislead consumers and can endanger public health. The US said that the public and private sectors will need to cooperate to deal with counterfeit trade.

Several global health care interest groups have also expressed their concern over the development. In a joint statement, Health Action International (HAI), Oxfam International, BUKO-pharma, Medico International, and the Third World Network, called the seizure "the latest in the list of cases that demonstrate that EU regulations are actively hampering timely access to medicines to developing countries."

"There is no valid reason for detaining these medicines especially since the name Amoxicillin is an international non-proprietary name," the groups added, referring to a designation set out by the World Health Organisation.

The group of NGOs has urged the European Commission to take immediate action to ensure that its regulations and laws do not deny developing countries timely access to essential medicines.

The Amoxicillin incident follows a controversial case that came earlier this year when Dutch customs authorities detained a shipment of the drug ‘losartan' in transit from India to Brazil. The incident sparked controversy at the World Health Organisation's Executive Board meeting in  January and elicited a strong reaction from Brazil and India on the issue (see Bridges Weekly

Public health advocates and NGOs warn that such seizures may evolve into a further impediment to public health by creating yet another barrier to the delivery of quality, affordable generic drugs to developing countries.

ICTSD reporting; "Row over generic drugs intensifies after seizure in Germany," THE ECONOMIC TIMES, 8 June 2009.

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