(2004; 110 pages)
Despite the significant scientific and technological developments of the 20th century, there continue to exist unacceptable inequalities in the health status of people as between developed and developing countries as well as within developing countries. It is in this context that efforts have been underway over the last several years to make medical technology work better for developing countries and for poor people. A major component of these efforts has focused on the impact of the expansion of patent protection to pharmaceutical products and processes under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The initial challenge related to the scope and interpretation of the policy flexibilities embodied in the Agreement that could be used to improve availability and access to essential patented medicines. This challenge was resolved by the Doha Declaration on the TRIPS Agreement and Public Health (the Doha Declaration), which affirmed that public health considerations can and should condition the extent to which patents on pharmaceuticals are enforced and that flexibilities in the TRIPS Agreement should be used to this end.
However, while developing countries have the right to exercise the flexibilities under the TRIPS Agreement, in reality it remains difficult for many of them to make effective use of these flexibilities as a public health policy tool. For example, paragraph six of the Doha Declaration on TRIPS and public health recognized that while developing countries can issue compulsory licences; they nevertheless faced difficulties in making effective use of this policy tool due to lack of or insufficient manufacturing capacity. This is, however, just one of the constraints that developing countries face at the national level in their efforts to use TRIPS flexibilities. Other constraints include: lack of technical expertise effectively to implement the TRIPS flexibilities; insufficient technical and infrastructural capacities for medicines regulations; bilateral and other pressures not to use the TRIPS flexibilities for public health purposes and/or to adopt TRIPS-plus standards; difficulties in regulating anti-competitive practices and abuse of intellectual property rights; and difficulties in accessing pricing and patent status information. Many of these constraints can be addressed by adopting complimentary policy and legal measures at the regional level.
A regional approach to the use of TRIPS flexibilities will enable similarly situated countries to address their constraints jointly by drawing on each others’ expertise and experience and by pooling and sharing resources and information. This approach 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 at the World Intellectual Property Organization (WIPO). In addition, a regional approach coincides with the objective of enhancing South-South cooperation on health and development.
Consequently, if strategically utilized, regional South-South frameworks will significantly help developing countries devise ways by which national constraints in the use of TRIPS flexibilities can be overcome. This study provides the conceptual as well as a strategic basis for further thinking and decision-making on how effectively to use TRIPS flexibilities for public health purposes through regional South-South mechanisms and cooperation. The study should, however, not be seen as the A to Z of regional approaches to the use of TRIPS flexibilities, but rather as a first step. Critical issues with a regional dimension that need to be further explored through empirical research and discussions are identified and explored. In this regard the study recommends, among other things, that:
• Regional economic communities (RECs) and other similar regional bodies should establish regional Advisory Councils on Trade-Related Innovation Policies (ACTRIPS) or functionally equivalent mechanisms as a central feature of an institutionalized approach to regional research and innovation including essential health research and, in particular, as a focal point for training, research, information exchange and political coordination in the use of TRIPS flexibilities for public health promotion and protection;
• Serious consideration be given to the viability of developing regional pharmaceutical research and manufacturing capacities and that further research be undertaken with respect to the factors necessary for pharmaceutical production in a disaggregated way, that is, the factors relevant for different types of pharmaceutical production be studied. With respect to the WTO’s 30 August 2003 Decision, that consideration be given to developing a system for the issue of regional compulsory licences where there are regional patents such as in the African Intellectual Property Organization (OAPI) countries and also developing a system of mutual recognition where REC members can issue their own compulsory licences based on the issuance of a licence in another REC member, where regional patents do not exist;
• Existing South-South RECs in Africa, Asia, Latin America and the Caribbean be utilized to address among other things, challenges in drug registration and post-marketing surveillance, development of essential medicines lists, development of medicines policies, and rules on pharmaceutical advertising and labelling;
• Depending on the level of existing cooperation in health matters in each region, mechanisms be put in place to facilitate the implementation of suitable models of cooperation in pharmaceutical management and procurement. Whenever feasible, developing countries should seek to put in place regional procurement systems where they would jointly conduct tendering through an entity acting on their behalf and a central purchasing agency managing the purchases on behalf of all the member countries;
• Developing countries use their regional institutions and frameworks in resisting pressures to forgo the use of TRIPS flexibilities for public health as well as TRIPS-plus pressures. In this connection, the establishment of regional NGO and community-based organization (CBO) networks should be facilitated through RECs and other institutions. This effort should be linked to the creation of regional ACTRIPS; and,
• In recognizing that competition enforcement is critical in ensuring a competitive pharmaceutical industry, both in terms of lowering prices and ensuring availability of essential medical products, and the fact that developing countries lack expertise and the necessary economic and political clout, they should utilize RECs to enforce competition rules. There are particularly important benefits to be gained from undertaking joint investigations and information exchange.