The Use of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (2001): A Review of Implementation Experiences in the Developing Countries

Abstract

Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (2001) recognized the difficulty of some WTO member states in using the compulsory licensing flexibility allowed in the TRIPS Agreement due to their lack of local pharmaceutical manufacturing capacities. However, there has been almost no implementation by countries of the subsequent WTO General Council decision of 30th August, 2003 which was designed to resolve this Paragraph 6 issue. This is due to the existence of various impediments – generally in the form of external and internal barriers. A comparative analysis is undertaken of the implementation of the Council Decision in two countries with varying levels of development and with different obligations with regards to enforcement of the TRIPS Agreement. It is shown that external barriers such as proliferation of bilateral agreements have more impeding effect on developing countries such as South Africa which are already part of the full TRIPS compliance regime. Conversely, internal barriers such as institutional and structural drawbacks have more of an impact in Least Developing Countries (LDCs) such as Bangladesh which have been given a transition period for TRIPS compliance and are not yet fully susceptible to external pressures of the international trade regime. The increased preference of countries to use alternative innovative mechanisms such as the Medicines Patent Pool to improve access to medicine outside the framework of the global IP/Trade regime reiterates the unworkability of the Council Decision in promoting access to medicines.