The WTO "Paragraph 6 System"
Beatrice Stirner, University of Neuchâtel
With the World Trade Organization’s (WTO) General Council Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (the Decision) in 2003 a new flexibility has been created to regulate the conditions under which WTO members may issue compulsory licenses to produce and export generic versions of patented drugs to countries without or with insufficient pharmaceutical manufacturing capacities. This flexibility has been introduced into the national laws of more than 60 countries. Since its adoption, the system’s procedure has been used only one time effectively, while in a second case the compulsory license was not granted. Non-governmental organizations argue that the reason for this slow start is the regime’s complexity, while some developing countries’ governments suggest that the solution is ineffective. Other WTO members refer to the existence of more relevant measures to increase access to medicines in developing countries, with compulsory licenses being only one of them. Based on the analysis of the two known cases involving, on the one hand, the Canadian generic pharmaceutical manufacturer Apotex Inc. and Rwanda, and on the other hand, the Indian generic producer Natco and Nepal, the lecture intends to answer the questions on the effectiveness and operability of the Decision’s system with respect to its humanitarian purpose, as well as the pertinence for countries to implement, update or amend the compulsory license regime. The lecture will also include the results of a series of interviews performed with relevant stakeholders. While well intended, the Decision’s compulsory license regime appears to be maladapted to the international and national medicine procurement environment and displays weaknesses that make its use unattractive for key stakeholders, such as developing countries and generic pharmaceutical manufacturers.