Dutch Government Detains Generic Drugs in Transit

Recently the Dutch Government detained a shipment of the generic antiretroviral abacavir (ZIAGEN), which was en-route to Nigeria from India, on the grounds that the shipment breached the intellectual property rights of the branded manufacturer GlaxoSmithKline (GSK). The shipment was detained even though GSK did not have any plans to challenge the legality of the shipment and it did not believe that its patents on abacavir had been infringed. This followed a similar detainment several months ago by the Dutch Government of a shipment of the generic blood pressure medication losartam (COZAAR), which was in transit from India to Brazil. These detainments have raised questions about the conflict between European Union (EU) legislation and World Trade Organization (WTO) rules. The drugs in question were detained under EC Regulation No. 1383/2003 (EC Regulation), which allows European Member States to detain counterfeit goods, pirated goods and generally any goods infringing an intellectual property right, which are in transit through their Member State. A number of stakeholders, including countries to which the drugs were destined, such as Brazil, NGOs including Oxfam International and Médecins Sans Frontières, and the World Health Organization have argued that the EC Regulation goes beyond the obligations required under the WTO's Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). The TRIPS Agreement provides that it should be interpreted and implemented in a manner supportive of a WTO Member's right to protect public health and promote access to medicines for all. Accordingly, the stakeholders argue that public health and the access to medicines are fundamental principles of the TRIPS Agreement and that while Articles 41 and 51 of the TRIPS Agreement neither mandate nor forbid the seizure of counterfeit or pirated goods in transit, the detention of the generic medicines violated the spirit of the Agreement. In opposition, the European Commission (EC) supported the Dutch Government's actions at the WTO General Council, arguing that the detainments were made in accordance with EU legislation and the TRIPS Agreement. The opposing opinions of the stakeholders and EC rest largely on the classification of the drugs as either approved generics or as counterfeit medicines. For relevant EC Regulation, see: http://tinyurl.com/cscxtx For the TRIPS Agreement, see: http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm For commentary on the detainments, visit: http://tinyurl.com/cbqrw5; and http://tinyurl.com/c7hw2b Summary by: Michael Migus