DIRECTIONS IN DEVELOPMENT Human Development Improving Access to HIV/AIDS Medicines in Africa Trade-Related Aspects of Intellectual Property Rights Flexibilities Patrick L. Osewe, Yvonne K. Nkrumah, and Emmanuel K. Sackey Improving Access to HIV/AIDS Medicines in Africa [...]... industries consistent with international law.”6 Also, during the Special Session, the United States withdrew its WTO case against Brazil’s use of compulsory license.7 Before the Special Session, in April 2001, the African Group of the WTO had brought up the need to include the issue of access to medicines in 4 Improving Access to HIV/AIDS Medicines in Africa the TRIPS Council agenda The HIV/AIDS pandemic was... and interpreted in the context of the Declaration and the Decision The prevailing SSA intellectual property rights (IPRs) regime is examined in relation to these permissibility criteria to ascertain if and how countries are utilizing the TRIPS flexibilities to improve their access to HIV/AIDS medicines Bearing in mind the close linkage between the legal instruments of international and regional institutions... resource persons in government institutions, the private sector, and civil society groups, especially NGOs at the 6 Improving Access to HIV/AIDS Medicines in Africa national level Information was gathered from officials of the regional patent institutions, OAPI and ARIPO, along with official documents of these institutions International organizations involved in HIV/AIDS work in SSA also provided input The... overriding challenge for these countries is to interpret and implement the obligations, rights, and flexibilities under the TRIPS Agreement in ways that 1 2 Improving Access to HIV/AIDS Medicines in Africa are internationally acceptable, yet still protect public health by ensuring access to high-quality, affordable medicines Pharmaceutical products are a major means by which the health care services industry... rights on the patent holder, including exclusive marketing rights for the entire patent 9 10 Improving Access to HIV/AIDS Medicines in Africa duration (subject to the provisions of article 30) Article 33 provides that the minimum period of patent protection from the filing date shall be 20 years Another obligation that has a direct impact on access to medicines is the requirement in article 39.3 that member... OAPI region, and the pharmaceutical industry there remains in its infancy A common gap in the legislation of countries in the region is the lack of a clear provision for determining the level of “adequate remuneration” to be paid upon the issuance of a compulsory license Moreover, there 18 Improving Access to HIV/AIDS Medicines in Africa are no specific provisions in the laws of the region’s countries... Complicating factors include poverty and inadequate funding, a lack of appropriate chemical industry capacity, poor social and medical infrastructure and amenities, inadequate legislation, and the existence of patents on ARVs Although patent protection is by no means the only barrier to access, patents play a significant or even a determinant role in limiting access to affordable HIV/AIDS medicines because... to create a legal framework within which to increase the availability of lower-cost medicines in the country It was, Introduction 3 however, opposed by the Pharmaceutical Manufacturers’ Association of South Africa Together with 39 transnational pharmaceutical industries, the association filed a lawsuit against the government of South Africa in the High Court in Pretoria, alleging that the changes in. .. can be seen as the balancing criteria that developing countries were able to achieve to address their specific concerns over patent protection and access to medicines during related negotiations within the WTO However, any analysis of the usefulness of the flexibilities in protecting public health must take into account the ability of developing-country member states of the WTO to implement them This... critically examines each of the flexibilities listed in table 2.1 and evaluates its implementation within SSA to enhance access to HIV/AIDS medicines in the region The two regional patent systems, ARIPO and OAPI, play pivotal roles in determining how their member states deal with IP issues, including utilization of the TRIPS flexibilities ARIPO’s members include 16 mainly anglophone African states, . Emmanuel K. Sackey Improving Access to HIV/AIDS Medicines in Africa