How Do Intellectual Property Law and International Trade Agreements Affect Access to Antiretroviral Therapy?

I n recent years, globalization has forced a deeper appreciation of the relationship between intellectual property (IP) law and global health. The threat of an emergent avian bird fl u pandemic led to calls for Roche to relax patent restrictions on oseltamivir, a drug with potential effi cacy against bird infl uenza [1,2]. In the context of the fall 2001 anthrax attacks, the US government faced pressure to break Bayer's patent on ciprofl oxacin in order to increase availability of the drug [3]. Such situations have generated intense debate over the value of patent protection amidst health crises. Nowhere have these debates been more intense than around the issue of global access to HIV treatment. Multinational pharmaceutical companies, World Trade Organization (WTO) members, US and European Union trade representatives, and health-care activists have clashed over provision of antiretroviral therapy (ART) to people living with AIDS in developing countries. The debate centers upon the value and role of patents obtained for HIV-related pharmaceutical products, drug-manufacturing techniques, and forms of drug delivery. These arguments have recently intensifi ed amidst an increased US pursuit of bilateral, regional, and multilateral trade agreements—which include strong IP provisions—with low-and middle-income countries throughout the world. In this paper, we examine the key areas of concern regarding access to ART related to US-negotiated bilateral, regional, and multilateral trade agreements. We fi rst examine developments in IP law in the wake of WTO's Doha Declaration, which affi rmed the priority of public health over the protection of patents. We look specifi cally at those developments with particular salience for health-related issues and link this history with the current context of access to antiretrovirals (ARVs) worldwide. Next we map out the key claims about, and questions surrounding, the role of patent law, followed by a critical look at the impact of trade agreements on IP law and their potential threat to global health. Finally, we suggest policy and advocacy strategies to ensure and promote access to ART in the era of US-led attempts to strengthen global IP law through the vehicle of " free " trade agreements. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, completed in 1994, revolutionized global patent law by requiring the standardization of IP law among all WTO members by January 1, 2005. Immediately, concern arose that the TRIPS agreement would constrain the protection of public health in low-and middle-income countries. In response, WTO delegates …