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Sunday, August 14, 2011

Guest Blogger J. Janewa OseiTutu: Public Health and Intellectual Property - Seizure of Generic Drugs in Transit

Jan OseiTutu In May 2010, Brazil and India filed complaints against the European Union (“EU”) and the Netherlands at the World Trade Organization (“WTO”) over the confiscation of generic drugs in transit. A settlement of the dispute between India and the EU was announced at the end of July 2011. 

The EU border seizures were part of its intellectual property enforcement program. The drugs in question were not patent protected in either the point of origin or the final destination. Brazil and India cited a number of provisions under the WTO Agreement on Trade-Related Intellectual Property Rights (“TRIPS”) and the General Agreement on Tariffs and Trade (“GATT”) in support of their complaints. In its WTO request for consultations, pursuant to the WTO Understanding on Rules and Procedures Governing the Settlement of Disputes (“DSU”), Brazil complained about the confiscation by Dutch authorities of a shipment of a generic drugs from India that were destined for Brazil. The shipment was seized in Amsterdam and returned to India. Brazil complained that many similar shipments had been seized while in transit through the Netherlands and alleged inconsistency with TRIPS and GATT. Similarly, India complained about the Dutch seizures of generic drugs originating from India and destined for developing countries like Nigeria and Peru.  

Brazil and India relied on different provisions of TRIPS in making their complaints. In its complaint, Brazil (unlike India) did not identify specific developing country issues or the relationship between intellectual property and public health as part of the basis for its complaint. I will focus on the Indian complaint, which has been settled, because it raises important arguments about the appropriate balance in TRIPS, the concerns of developing countries, and the need to interpret TRIPS provisions in light of the 2001 Doha Declaration on the TRIPS Agreement and Public Health (“Doha Declaration on Public Health”).

In paragraph 5 of its complaint, India argued that the regulations leading to the seizures of the generic drugs had a “serious adverse impact” on the ability of developing countries to protect public health and to ensure that their citizens would have access to the medicines they need. As part of its complaint, India cited article 7 of TRIPS, which identifies, as an objective of intellectual property protection, the promotion of innovation “in a manner conducive to social and economic welfare” and to a balance of rights and obligations. Article 8 of TRIPS, which was also cited, sets out the principles of the agreement, and provides that WTO member states may take measures to protect public health. In addition, India referred to article 12 (1) of the International Convention on Economic, Social and Cultural Rights, which recognizes that everyone has a right to the highest attainable level of physical and mental health.

Various commentators have argued for the need to interpret TRIPS in light of its principles and objectives as set out in articles 7 and 8 of the agreement. It would have been interesting to see how a WTO dispute resolution panel would approach the health and development issues raised in India’s complaint. A WTO panel last had the opportunity to address the balance between intellectual property rights and public health in the Canada-Pharmaceuticals dispute, which was decided in 2000. That case was analyzed and decided primarily based on the rights and interests of the patent holder. Arguably, however, if TRIPS is interpreted in light of its principles and objectives, and in light of the Doha Declaration on Public Health, a WTO panel hearing such a case today would need to take into account the balance between public health, access to medicines and the private rights of the patentee. I discuss this further in my forthcoming piece, Value Divergence in Global Intellectual Property Law, 87 Ind. L. J. (2012)

 Despite its efforts to examine the relationship between TRIPS and public health, it is not clear that a trade organization, like the WTO, would be prepared to take the lead in this regard, nor that it is the appropriate forum. Yet, in the current environment, where the trend is to increase intellectual property protection and enforcement through bilateral trade agreements, and agreements like the Anti-Counterfeiting Trade Agreement or the Trans-Pacific Partnership Agreement, a WTO panel decision favoring public health could serve as a helpful signal for developing countries, health organizations, and their advocates, that TRIPS does indeed recognize the need for balance.

- J. Janewa OseiTutu

http://lawprofessors.typepad.com/healthlawprof_blog/2011/08/in-may-2010-brazil-and-india-filed-complaints-against-the-european-union-eu-and-the-netherlands-at-the-world-trade-o.html

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