Should access to medicines and TRIPS flexibilities be limited to specific diseases

I. DISEASE-BASED LIMITATIONS IN GLOBAL PATENT LAW The health needs of most of the world's population are not well served by patent-based pharmaceutical markets. The poor in low- and medium-income countries (LMICs) lack the financial resources to sustain the attention of global commercial drug companies. After an extensive consultation process, in 2006, the World Health Organization's Commission on Innovation, Intellectual Property and Public Health issued its Report (the WHO CIPIH Report), finding this concern to be significant: In the context of our work one of the important points is that, where the market has very limited purchasing power, as is the case for diseases affecting millions of poor people in developing countries, patents are not a relevant factor or effective in stimulating R&D and bringing new products to market.1 On this issue, the WHO CIPIH Report was preceded by the Access to Medicines movement, an informal coalition of civil society organizations such as Medecins Sans Frontieres, Treatment Action Campaign, Health GAP, Oxfam, and Knowledge Ecology International (formerly the Consumer Project on Technology). These groups and many others identified patents on pharmaceuticals as an inappropriate barrier to access in developing countries.2 They devoted particular attention to the World Trade Organization TRIPS Agreement, which is the minimum global legal standard for pharmaceutical patents.3 In response to challenges about the need for innovation, some have reframed the movement as "Access + Innovation." This article follows in the Access + Innovation genre, attempting to simultaneously address both equitable access and optimal innovation.4 Global patent-based pharmaceutical companies and the United States Trade Representative (USTR) have not been particularly supportive of the Access + Innovation agenda.5 Many attempts have been resisted, even to the point of suing South Africa for its use of unlicensed AIDS drugs in the face of an epidemic.6 In response to sustained global pressure, the companies eventually conceded the case in South Africa, and the WTO members unanimously adopted the Doha Declaration in November 2001. However, several attempts have been made to limit access initiatives and TRIPS flexibilities to particular diseases, namely AIDS, tuberculosis and malaria, or more generally to infectious public health emergencies.7 The primary concern appears to be profit-driven: companies are concerned that any flexibilities for LMICs could lead to price erosion in highincome markets, through physical or virtual arbitrage,8 demands for expanded access, compulsory licensing, or other TRIPS flexibilities.9 These concerns are especially acute for blockbuster drugs treating major chronic diseases. Nothing in the TRIPS Agreement limits compulsory licenses or other flexibilities to a narrow category of diseases. In the Doha Declaration itself, the U.S. requested an explicit limitation to particular diseases, and was the last country to assent to the unanimous resolution.10 The ultimate compromise language states: We recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.11 At first blush, this appears to be a disease-specific limitation, but the Doha Declaration merely uses the Big 3 to illustrate examples of "national emergency or other circumstances of extreme urgency."12 The Doha Declaration clearly supports WTO Members' rights to utilize TRIPS flexibilities - including compulsory licensure and parallel trade - to "protect public health" without regard to the type of disease:13 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. …