(2004; 110 pages)
V.1 Summary of Recommendations
Many of the issues that need to be addressed through regional frameworks such as developing technical expertise on intellectual property and development matters including public health, coordination of drug registration, research and manufacturing issues, however, raise important political and other practical issues that will have to be dealt with and, in some cases, hard decisions need to be made. There are also issues about sharing of benefits and participation by the private sector and civil society in regional initiatives that will have to be addressed. That said, the following is a summary of recommendations, which emerge in this study, which can help developing countries further explore the role of regional approaches to overcoming the constraints that they face in implementing the TRIPS flexibilities effectively at the national level for public health purposes.
1. RECs and other similar regional bodies should establish regional 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. As far as possible, however, developing countries should avoid a harmonization approach or using regional patent or industrial property organizations with no broad economic and development mandates as a basis for regional cooperation on the use of TRIPS flexibilities in general and for public health in particular.
2. There are a number of steps that can be taken in the regional context to facilitate the enhancement of the pharmaceutical research and manufacturing capacities of developing countries as well as facilitating the implementation of paragraph 6(i) of the WTO 30 August 2003 Decision. These include:
• Undertaking further research with respect to the factors necessary for pharmaceutical production in a disaggregated way, that is, the factors relevant for different types of pharmaceutical production. A research agenda on the lines of the Kaplan et al. paper or another method of identifying gaps could form the basis for further work in this regard.
• Undertaking a review of the AICO and other similar industrial schemes to determine their viability for pharmaceutical production and further research on how such schemes could be improved to include a stronger research focus.
• Developing, with respect to the 30 August 2003 Decision, a system for the issue of regional compulsory licences where there are regional patents, such as in OAPI countries, and 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 country where there are no regional patents.
3. Regional coordination on regulatory issues will offer significant benefits to developing countries and help them overcome current constraints in this area. Existing South-South RECs in Africa, Asia, Latin America and the Caribbean offer ready institutional frameworks for this purpose which should 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. Existing regional efforts on these issues should be studied and lessons on good and bad practices shared.
4. Regional cooperation in pharmaceutical management and procurement offers undoubted benefits for developing countries. Depending on the level of existing cooperation in health matters, countries should put in place mechanisms to facilitate the implementation of any of the four models of cooperation identified in this study. 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. The criteria developed by MSH to assess the feasibility of pooled procurement and the ‘lessons learned’ report, could be a starting point for various RECs and other organizations to assess which model best suits the circumstances of their members.
5. Developing countries should 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 creating regional ACTRIPS. The need for enhanced civil society participation in regional and RECs processes is already recognized. For example, the EAC Treaty specifically recognizes that one of the reasons that the earlier integration process in East Africa failed was the lack of participation by civil society organizations in its processes and engagement in the political process. For their part, a large number of civil society groups perceive integration as a process that articulates and promotes development, with an integrated approach encompassing political and social aspects.
6. Competition enforcement is critical in ensuring a competitive pharmaceutical industry both in terms of lowering prices and ensuring availability of essential medical products. Because of lack of expertise and the necessary economic and political clout in individual developing countries, they should utilize RECs to enforce competition rules. There are particularly important benefits realizable in terms of undertaking joint investigations and information exchange. Existing RECs already have an institutional framework that can be adapted to establish mechanisms for regional competition enforcement.