Abstract
In 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 flu pandemic led to calls for Roche to relax patent restrictions on oseltamivir, a drug with potential efficacy against bird influenza [1,2]. In the context of the fall 2001 anthrax attacks, the US government faced pressure to break Bayer's patent on ciprofloxacin 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 intensified 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 first examine developments in IP law in the wake of WTO's Doha Declaration, which affirmed the priority of public health over the protection of patents. We look specifically 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.
Highlights
In recent years, globalization has forced a deeper appreciation of the relationship between intellectual property (IP) law and global health
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
For all the wrangling over the specific provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and the self-proclaimed interest by multinational pharmaceutical companies and the US government in promoting global health, we argue that little has changed to suggest that WTO rules improve global public health
Summary
How Do Intellectual Property Law and International Trade Agreements Affect Access to Antiretroviral Therapy?. On August 30, 2003, the TRIPS council issued the “Decision on Implementation of Paragraph 6 of the Doha Declaration,” stating that countries without manufacturing capacities—a definition that still remains unclear—could declare compulsory licenses and on that basis alone legally import generic medications This decision was only a temporary waiver until a permanent amendment could be agreed upon. The US and the Pharmaceutical Research and Manufacturers of America (PhRMA) touted the amendment as “part of the wider national and international action, including many activities taken by PhRMA companies, to address the gravity of the public health problems afflicting many developing and leastdeveloped countries” [11] Do these acts of apparent generosity translate into tangible advances in access to essential medicines in low- and middleincome countries?
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