SEIZURE OF GENERIC PHARMACEUTICALS IN LOSARTAN CASE: THE CONFORMITY OF EC REGULATION 1383 WITH THE INTERNATIONAL STANDARDS OF IP PROTECTION

Abstract

One of the most heated debates in the IP field has started on 2008, when the Dutch custom authorities seized a big number of containers of in transit generic pharmaceuticals originated from India and having Brazil as their final destination. The legal basis of this particular seizure was the application of the EC Regulation 1383/2003 concerning the Border measures and Freedom of Transit in EU countries. From the first reactions of the two countries involved in the incident, namely Brazil and India as well as from other developing countries, it is possible for someone to understand the main concern related to the application of EC Regulation 1383 to the trade of generics in transit. In the International IP Protection, the emergence of a strong lobby of developing countries at the World Trade Organization (hereinafter WTO) has made it harder for the developed countries, such as the members of European Union to achieve a very high standard of IP protection by introducing strong and effective trade and IP policies in the WTO. Thus, these countries have used their independence to select appropriate measures for the implementation of IP protection so as to introduce measures of absolute and high standard protection in regional and multilateral Agreements, such as the EU law. As a result, this high standard protectionism in the regional level has several consequences on the flexibilities and policy space left under the TRIPS Agreement by making meaningless the use of these flexibilities by developing countries in important policy sectors such as Public Health and the Access to Knowledge.