Among the many trade conflicts that divide the postindustrial economies of Europe, the United States, Japan, and the Commonwealth from the less information-driven economies of the rest of the world, one of the most consequential is the debate over how to balance access to medicines with the intellectual property protection demanded by their developers. Among the many facets of this debate is the question of whether pharmaceuticals, vaccines, biologics, and other therapeutic or preventative health consumables (to which this article will refer collectively as “drugs”) should be patentable in developing countries. This debate was partly resolved by the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement), which allows signatories to exclude from patentability “diagnostic, therapeutic and surgical methods for the treatment of humans or animals” yet requires the patenting of pharmaceuticals after a transition period. Nonetheless, disagreement about access to medicines has plagued subsequent negotiations. The economically developed states, led by the United States, have demanded that WTO members cease liberal compulsory licensing practices and adopt patent protection regimes equivalent in most significant respects to those of the United States and Europe. Developing countries have requited these demands with insistence on better access to affordable drugs and medical technology originating in the economically developed states. The debate over patentability and compulsory licensing hinges partly on disagreement over whether patent protection in developing countries is a necessary incentive for optimal drug development and distribution. It is generally contended that the TRIPs Agreement has a significant effect in either promoting or retarding innovation necessary for pharmaceutical companies to invent and register drugs that prevent or treat diseases prevalent in developing countries. The WTO General Council has temporarily quieted this debate with its September 2, 2003, decision on paragraph 6 of the Doha Declaration, which sanctions compulsory licensing by the least-developed countries pursuant to notification requirements and other limitations. The Doha Round negotiations have not yet resolved, however, a second, equally contentious debate that focuses on whether similar incentives are needed to stimulate drug developers to seek marketing approval in developing countries.
Harvard International Law Journal
The oldest and most-cited student-edited journal of international law, the Harvard International Law Journal covers a wide variety of topics in public and private international law.