Free Trade of Pharmaceutical Products: The Limits of Intellectual Property Enforcement at the Border


by Xavier Seuba

Programme on IPRs and Sustainable Development Series • Issue Paper 27

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Issue Paper 27: Free Trade of Pharmaceutical Products 1.94 MB

The ICTSD Programme on IPRs and Sustainable Development is pleased to announce the availability of Issue Paper No.27, entitled “Free Trade of Pharmaceutical Products: The Limits of Intellectual Property Enforcement at the Border” by Xavier Seuba, Senior Lecturer in Public International Law, at the Universitat Pompeu Fabra, Barcelona.

The detentions of generic medicines in transit as a result of the implementation by certain countries of border measures, which go beyond the minimum standards set by the TRIPS Agreement, have attracted international attention. At the same time, such measures are often considered, by these countries, as instrumental in the fight against the circulation of “counterfeit” medicines. Clearly, the border measures in question raise complex legal and technical issues under the rules of the World Trade Organization (WTO).

In order to achieve a better understanding of the issues at stake, ICTSD released, last summer, a working paper, by the same author, entitled: Border Measures Concerning Goods Allegedly Infringing Intellectual Property Rights: the Seizures of Generic Medicines in Transit..

In the months that followed, the working paper received numerous comments and was presented at a number of seminars and meetings. The challenges posed to the free trade of generic medicines by TRIPS-plus border measures and strengthened IPRs enforcement emerged as the most important reflection resulting from the months of dialogue between issuing the working paper and the present publication. It is also the reason why the author has changed the title to a more appropriate one that fully reflects this new emphasis: Free Trade of Pharmaceutical Products: the Limits of Intellectual Property Enforcement at the Border.

Against this background, the paper shows how detentions of generic medicines in transit have revived long standing tensions between the principles of free trade and those of intellectual property.

In this context, the paper provides an in depth analysis of the complex legal issues raised by the EC custom border regulations and their relationship with the General Agreement on Tariffs and Trade (GATT), the TRIPS Agreement and subsequent WTO instruments, particularly the Doha Declaration on TRIPS and Public Health (2001) and the General Council Decision of 30th August 2003.

The author highlights that the power granted to WTO members to set higher standards of enforcement than those stipulated by Articles 51 and 52 of the TRIPS Agreement has to be consistent with other TRIPS provisions and balanced with the key legal principle of territoriality of IPRs. The principle of free trade in the GATT Agreement and the aim of the TRIPS Agreement to reduce any “distortion and impediments to international trade” should also be respected.

Finally, the author points to the risks that similar detentions occur in developing countries in the future as a result of the implementation of the EU border measures scheme in these countries through the free trade agreements that the EU concludes with them.

For further information, please contact Ahmed Abdel Latif at [email protected]

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