Compulsory licensing and the AIDS epidemic in South Africa

One cannot look at the high prevalence and persistent, dramatic spread of HIV in developing countries, especially those in Sub-Saharan Africa, without also examining economic and public health systems. Recent developments in South Africa have highlighted an emerging controversy surrounding the issue of access to essential medicines and drug pricing. Sparked by a South African amendment, Article 15(C) of the Medicines and Related Substances Act 101, passed in 1997, that would allow the South African Minister of Health to provide less expensive generic forms of essential medicines, including anti-HIV therapies, to South Africa, law- and policymakers as well as activists have been taking sides in a complicated debate that mixes important health issues with international trade law, patent protection, economic incentives, and United States domestic law. Threatened by what could be a weakening of patent protection, pharmaceutical firms in the United States, South Africa, and Europe have generally opposed the efforts of the South African government to allow production of such generic products, claiming that the 1997 amendment violates international trade law, particularly the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. AIDS activists and consumer advocates generally support the efforts of the South African government, claiming that international law is flexible in cases of national emergency. Lobbied by the pharmaceutical industry, United States government officials have proposed bilateral trade sanctions in an effort to pressure South Africa to repeal the 1997 amendment. These issues are reviewed in this report. Relevant provisions of Article 15(C) and the TRIPS Agreement are available on the Internet or from the American Foundation for AIDS Research (amfAR).