The substantial gains in life expectancy and unparalleled medical advances of the 20th century, as noted above, have left most of the world’s population behind in important ways.6 In all the developing regions - Africa, Asia, the Caribbean and Latin America - the disease burden remains high. Africa, where millions still die from preventable and treatable diseases, is a particularly telling case. In working to address this heavy disease burden, the countries of the South face new challenges. One important challenge relates to the high costs of essential medicines and related products due to the mandatory requirement under the WTO TRIPS Agreement for patent protection for medicines and for the processes of manufacturing medicines. Before 1994, when the TRIPS Agreement was adopted as part of the Final Act of the Uruguay Round of Multilateral Trade Negotiations, the various countries approached the patenting of pharmaceutical products differently. A large number of countries did not grant patents for medicines so as to keep the cost low and affordable and to ensure their ready availability to their populations at all times.
6 Médecins Sans Frontieres (MSF) Drugs for Neglected Diseases Working Group and Campaign for Access to Essential Medicines (2001), p. 8.
After TRIPS, problems arose in large measure due to the prohibitive cost of patented ARV medicines as well as for medicines used in the treatment of opportunistic infections. The high prices for these medicines seriously compromised the ability of governments, communities and other players in the health sector in developing countries effectively to manage the HIV/AIDS epidemic. The cost disparity guaranteed, virtually, that most of the sick in these countries would have little or no access to the best available treatments. It is important to remember, however, that the problems of cost go beyond HIV/AIDS and other politically visible diseases such as malaria and tuberculosis.
The international debate on the implications of the TRIPS Agreement for access to essential medicines came into the international media limelight in 1997 with the attempts by the United States Government to force the revision of the South Africa’s Medicines and Related Substances Amendment Act and the subsequent filing of a legal challenge against that law by the South African Pharmaceutical Manufacturers Association.7,8 Thereafter, particularly in the period leading up to the Fourth Session of the WTO Ministerial Conference in Doha, developing countries were pitted in a bitter debate against developed countries over the interpretation and scope of TRIPS flexibilities and how these could be utilized to address the public health needs in developing countries.
7 Act No. 90 of 1997. Among other things, the law provided for parallel importation and generic substitution.
8 For further discussion on this case and the debates in the WTO, see t’Hoen (2002) and also Sell (2002).
The Doha Declaration, adopted at the Conference, represents a final agreement between the two groups of countries, that public health considerations condition the extent to which rules on patent protection are implemented. The Trade Ministers of the then 142 Members of the WTO expressed their agreement in the following words:
"We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and in particular, to promote access to medicines for all."9
9Supra note 4.
The Doha Declaration marked a significant achievement for developing countries. It testifies to the need for cooperation among the countries of the South in finding solutions to alleviate the disease burden. It is indisputable that today, the debilitating social, economic, cultural and political consequences of diseases, particularly HIV/AIDS, pose the greatest challenge to sustainable development in the developing world. The gains made in economic development through regional integration and cooperation are being reversed. Access to essential medicines and therapies is therefore an integral part of the socio-economic and other responses needed to manage the enormous disease burden in the South and to improve the living standards of people.