(2004; 110 pages)
I.1 The Rationale for and Scope of the Study
The effective use of the TRIPS flexibilities such as compulsory licensing as a public health policy tool, presupposes the existence of certain conditions such as the existence of local research and pharmaceutical manufacturing capacities and the existence of adequate regulatory measures for use of medicines as well as for quality control. While efforts are being made to establish these conditions at the national level, many developing countries find it difficult to do this on their own. It is in this context that South-South frameworks such as regional economic communities (RECs), offer strategic opportunities for countries to cooperate and make maximum use of the TRIPS flexibilities.
These frameworks, if strategically utilized, will help developing countries devise ways by which national constraints in the use of TRIPS flexibilities can be overcome. This study is aimed at providing the conceptual as well strategic basis for further thinking and decision-making on how to effectively use TRIPS flexibilities for public health purposes through regional mechanisms and cooperation. The study should therefore be seen as a first step and not as the A to Z of regional approaches to the use of TRIPS flexibilities. The study raises critical issues with a regional dimension that need to be further explored through empirical research and discussions. It is noteworthy, however, that a number of the regional approaches considered in this study, such as regional pooled procurement, are already being implemented in the South, albeit not in the context of TRIPS flexibilities.
Policies that are likely to benefit significantly from a regional approach to implementing TRIPS flexibilities include those related to production of pharmaceuticals, regulatory approval of medicines, market surveillance and maintenance of quality standards, border control measures, import rules and competition issues, among others. An additional issue that deserves consideration is the question of research and development and the supply of medicines for neglected diseases. A collective regional approach to the issue of patents and public health has several advantages. First, it creates better policy conditions for addressing the challenges of implementing TRIPS flexibilities, which can be daunting for each individual country. Second, a common approach to improve access to essential medicines will enhance the efforts by developing countries to pursue common negotiating positions at the WTO and in other multilateral negotiations, such as those on a substantive patent law treaty at the World Intellectual Property Organization (WIPO), by providing a solid basis for technical discourse as well as political coordination. In addition, this approach coincides with the objective of enhancing South-South cooperation in dealing with matters of public health and development.