Addressing legal and political barriers to global pharmaceutical access: Options for remedying the impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the imposition of TRIPS-plus standards JILLIAN CLARE COHEN-KOHLER* Assistant Professor, Leslie Dan Faculty of Pharmacy, University of Toronto, Canada LISA FORMAN Post-Doctoral Fellow, Canadian Institutes of Health Research & Comparative Program in Health and Society, Munk Centre for International Studies, Toronto, Canada NATHANIEL LIPKUS Gilbert’s LLP, Toronto, Canada Abstract: Despite myriad programs aimed at increasing access to essential medicines in the developing world, the global drug gap persists. This paper focuses on the major legal and political constraints preventing implementation of coordinated global policy solutions – particularly, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and bilateral and regional free trade agreements. We argue that several policy and research routes should be taken to mitigate the restrictive impact of TRIPS and TRIPS-plus rules, including greater use of TRIPS flexibilities, advancement of human rights, and an ethical framework for essential medicines distribution, and a broader campaign that debates the legitimacy of TRIPS and TRIPS-plus standards themselves. Pharmaceuticals are indispensable to health systems; they can complement other types of health care services to reduce morbidity and mortality rates and enhance quality of life. As pharmaceuticals have curative and therapeutic quali- ties, they are not ordinary commodities. Access to pharmaceuticals is often a life and death issue, illustrated most dramatically in sub-Saharan Africa where 77% of people infected with HIV lack access to essential AIDS medicines (UNAIDS and World Health Organisation [WHO], 2006) and where a lack of access to other essential medicines is endemic. Given its broader public health and devel- opmental implications, access to essential medicines has become a central topic at the international policy-making level, not simply as a moral issue, but as a *Corresponding author: Jillian Clare Cohen-Kohler, Assistant Professor, Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S 3M2, Canada. Email: jillian.kohler@ utoronto.ca 229 Health Economics, Policy and Law (2008), 3: 229–256 ª Cambridge University Press 2008 doi:10.1017/S1744133108004477