The technological transformation of the 20th Century has had the effect of advancing the frontiers of science in many technological fields. In the medical and pharmaceutical field, in particular, major technological breakthroughs have been witnessed including the mapping of the human genome, antiretroviral (ARV) therapy for the treatment of HIV/AIDS and second line treatments for tuberculosis and malaria. These dramatic developments have provided increasing hope for the realization of the right to health in the developing world.1 For the people in these regions, however, the reality on the ground is the stark opposite; treatable and preventable diseases continue to kill millions each year.2 Today, despite significant scientific and technological developments, there continue to exist unacceptable inequalities in the health status of people between developed and developing countries as well as within developing countries. It is in this context that efforts have been under way over the last several years to make medical technology work better for developing countries and for poor people.
1 The right to health is today solidly embedded in international, regional and national human rights instruments. At the international level, the starting point is article 25 of the Universal Declaration of Human Rights (UDHR) (General Assembly resolution 217 A (III) of 10 December 1948). It provides inter alia that:
[25(1)] "Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social ser vices, and the right to security in the event of unemployment, sick ness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.
The provisions of this article are further defined and given legal standing in international law by article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). At the regional level, article 11 of the European Social Charter and article 16 of the African Charter on Human and Peoples’ Rights, for example, contain the right to health along the lines of the ICESCR.
2 According to the latest UNAIDS Report, 3 million people died of HIV/AIDS in 2003, a majority of them in the developing world. See UNAIDS (2003).
A major component of these efforts has focused on the impact of the expansion of patent protection to pharmaceutical products and processes under the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).3 The initial challenge related to the scope and interpretation of the policy flexibilities embodied in the Agreement that could be used to improve availability and access to essential patented medicines. This challenge was resolved by the Doha Declaration on the TRIPS Agreement and Public Health (the Doha Declaration) which affirmed that public health considerations can and should condition the extent to which patents on pharmaceuticals are enforced and that flexibilities in the TRIPS Agreement should be used to this end.4
3 The TRIPS Agreement was adopted as part of the Final Act of the Uruguay Round of Multilateral Trade Negotiations in Marrakech, Morocco on 15 April 1994. For the full text of the Agreement see WTO (1999) pp. 321-353.
4 The Declaration was adopted at the Fourth Session of the WTO Ministerial Conference in Doha, Qatar on 14 November 2001. See WTO document WT/MIN(01)/DEC/W/2.
However, at the time of adopting the Doha Declaration, the WTO membership also recognized that for many of them, it remains difficult to make effective use of these flexibilities as a public health policy tool. For example, paragraph six of the Declaration recognized that while developing countries have the right to issue compulsory licences, they nevertheless faced difficulties in making effective use of this policy tool due to lack of or insufficient manufacturing capacity.5 This is, however, just one of the constraints that developing countries face at the national level in their efforts to use TRIPS flexibilities. Other constraints include: lack of technical expertise effectively to implement the TRIPS flexibilities; insufficient technical and infrastructural capacities for medicines regulations; bilateral and other pressures not to use the TRIPS flexibilities for public health purposes; difficulties in regulating anti-competitive practices and abuse of patent rights; and difficulties in accessing pricing and patent status information. Consequently, after Doha, the challenge is to ensure that the policy flexibilities embodied in the TRIPS Agreement are used effectively by developing countries to protect and promote public health. A number of the constraints that individual developing countries face in utilizing the TRIPS flexibilities can be addressed by adopting complementary policy and legal measures at the regional level. A regional approach will enable similarly situated countries (countries trying to use TRIPS flexibilities for public health protection and promotion) to address their constraints jointly by drawing on each others’ expertise and experience and by pooling and sharing resources and information.
5 Para. 6 provides inter alia that:
"We recognize that WTO Members with insufficient or no manufac turing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement."