TRIPS and Essential Medicines: Must One Size Fit All? Making the WTO Responsive to the Global Health Crisis
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The establishment of the World Trade Organization (‘WTO’) marked an important new chapter in the administration of patent law, especially regarding inventions in the medical arena. Although intellectual property protection has long been governed by international norms, the principal international instrument on patents—the Paris Convention for the Protection of Industrial Property—largely focused on procedural issues. It required each state to accord national treatment to the citizens of other signatories, but it left most details on the scope and the substance of patent rights to the domestic law of each of its members. While many countries provided plenary protection to pharmaceutical products in order to stimulate their discovery, others took the position that medicines were too important to their citizens’ welfare to privatize. In 1994, that regime was significantly modified. Intellectual property, now conceptualized as a trade issue, became the subject of a new international instrument, the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’ or ‘TRIPS’). Under the WTO framework, adherence to TRIPS is not only required of every WTO member, it is also enforceable through the WTO’s elaborate Understanding on Dispute Settlement (‘DSU’), an essentially adjudicative mechanism, administered by the Dispute Settlement Board (‘DSB’), complete with an Appellate Body to entertain appeals from Panel decisions and sanctions for non-compliance. Because TRIPS imposes substantive patent law standards, including a requirement that protection be accorded ‘in all fields of technology’, it is no longer possible for a WTO member to exclude medicines from the purview of protection. While the WTO is certainly a boon to any country seeking large foreign markets for its products, observers have been extremely concerned about TRIPS’ ‘one size fits all’ aspect, which ignores the heterogeneity of the world’s population and especially the problems that confront developing nations. Because these countries generally do not innovate at world levels, patents have highly adverse distributive consequences for them. Specifically, while the patents mandated by TRIPS may enhance incentives to engage in medical research, they shift wealth from developing nations to the developed economies that are the source of most pharmacological advances. In effect, patents act as a tax, putting treatment beyond the reach of all but the richest of the world’s populace. The key question, however, is whether the TRIPS Agreement is necessarily a one size fits all system. As a formal matter, the Agreement is a minimum standards regime, which (in theory) gives members freedom to tailor their laws to their individual circumstances. Furthermore, TRIPS’ statement of Principles and Objectives acknowledges the importance of balancing interests, promoting social welfare and protecting public health. While it is true that to date, outcomes in the DSB have tended to straitjacket member states and create fodder for the ‘one size fits all’ critique, adjudicators currently lack judicially manageable standards for converting the aspirations articulated in TRIPS’ Principles and Objectives provisions into concrete legislative safeguards for public interest concerns. But there are reasons to believe that the situation is susceptible to change. Emerging economies, such as India, South Africa and Brazil, are becoming far more sophisticated about their intellectual property needs. In the latest series of trade negotiations (the Doha Round), a coalition among these countries, less-developed economies, and an increasingly proactive set of non-governmental organizations (‘NGOs’), provoked the adoption of the Doha Declaration, which made a significant change to the TRIPS Agreement as it pertains to healthcare. And more can be expected. Countries in the developed world are now confronting novel technologies, such as synthetic biology, genomics and bioinformatics. As they cope with the problem of applying a legal regime developed during the Industrial Age to the advances of the Knowledge Economy, they too are beginning to feel TRIPS’ pinch. 16 As important, observers have become concerned about the legitimacy of WTO law-making more generally. With new approaches for making the WTO accountable, transparent and democratic, it should become easier to correct the shortcomings in the TRIPS Agreement. Section 2 of this chapter describes the requirements the TRIPS Agreement imposes regarding patent protection. Using an example drawn from India’s new patent law, it demonstrates the Agreement’s capacity to accommodate diverse interests as well as the weaknesses in the current regime. Section 3 takes up the question of how to make that international system more responsive to the healthcare needs of the global community. It suggests that the TRIPS Council, which was created to administer the TRIPS Agreement, could better utilize the expertise of the World Intellectual Property Organization (‘WIPO’), the World Health Organization (‘WHO’) and other institutions that deal with issues of intellectual property, development, health and human rights. Even if fully effectuated, the suggestions in section will not completely alleviate the global health crisis. TRIPS can certainly be altered to improve access to existing medicines. However, patent law relies in a fundamental way on the market to fuel innovation. Thus, it cannot create incentives to meet the needs of populations too poor to provide the level of profits that technological entrepreneurs seek. For neglected diseases, like malaria and dengue fever, it is necessary to devise an entirely new incentive structure, such as the one advanced by Thomas Pogge in this volume. This chapter also comments on the compatibility of some of these proposals with TRIPS.
Source Publication
Incentives for Global Public Health: Patent Law and Access to Essential Medicines
Source Editors/Authors
Thomas Pogge, Matthew Rimmer, Kim Rubenstein
Publication Date
2010
Recommended Citation
Dreyfuss, Rochelle C., "TRIPS and Essential Medicines: Must One Size Fit All? Making the WTO Responsive to the Global Health Crisis" (2010). Faculty Chapters. 1186.
https://gretchen.law.nyu.edu/fac-chapt/1186
