Domesticating the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities to access essential medicines: Any lessons for the SADC from Botswana?

Authors Lonias Ndlovu

ISSN: 2522-3062
Affiliations: Associate Professor, Department of Mercantile Law, University of Venda, Thohoyandou, South Africa
Source: Comparative and International Law Journal of Southern Africa, The, Volume 50 Issue 3, p. 347 – 371


The Southern African Development Community (SADC) has a high disease burden. This is largely attributed to HIV/AIDS, tuberculosis, malaria, and, most recently, life-style diseases, such as cancer and heart disease. In order for the disease burden to be reduced, access to medicines, which are usually expensive and protected by patent rights, must be improved. Access to medicines, a concept with no clear definition, is generally considered to include various dimensions, such as accessibility, affordability, acceptability and availability. In developed nations, over 70 per cent of drugs are publicly funded or reimbursed. However, in Africa, 50 to 90 per cent of pharmaceutical expenditure is funded out of pocket. This impedes access to medicines, because, in the absence of price regulations, drug prices create affordability barriers. One of the most frequently touted solutions to access to medicines is the continuing call to reform intellectual-property (IP) laws, especially patent laws, to reduce the effect of monopolistic prices charged by large pharmaceutical companies. It has been suggested that, in order for this law-reform project to yield positive results, it must be conducted in compliance with the tenets of the World Trade Organisation’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement by taking advantage of flexibilities, which include parallel imports, competition law, compulsory licensing, pre- and post-grant patent opposition and research exceptions. Botswana, a WTO member, has set the trend for other SADC members by courageously initiating patent-law reform in order to improve access to medicines through promulgating the Industrial Property Act of 2010. The Act incorporates most of the TRIPS Agreement flexibilities and Botswana’s experience may, therefore, offer a useful example for other SADC members. This article provides a critical appraisal of Botswana’s recent IP law-reform project directly relevant to access to medicines and identifies thematic lessons from which other SADC members may benefit.