Public law challenges to the regulation of pharmaceutical patents in the US bilateral free trade agreements

Introduction The international trade law regime has been flourishing with its institutionalization and judicialization under the auspices of the World Trade Organization (‘WTO’). While some people applaud the development towards constitutionalization, the intergovernmental nature of the legal regime, especially at the law-making phase, has remained at the penumbra. Illustrative is the barrier against access to essential medicines caused by pharmaceutical patent protection under the WTO regime. Pressures have been mounting to alleviate the problem in multinational forums, and yet the initiative by the US to set a higher level of intellectual property protection over pharmaceutical products through bilateral trade agreements has impeded change. This chapter examines the issue of access to essential medicine within the framework of public international law as one of the challenges posed to its legitimacy with particular focus on the US bilateral free trade agreements. As examined in the next section, the conclusion of such bilateral trade agreements represents an attempt to erode flexibilities permitted for developing countries under the WTO regime within the conventional international law framework. However, this conventional wisdom has been called into question. Section 3 will examine three challenges to international law as it applies to the US bilateral free trade agreements: democratic deficit; normative fragmentation; and regulatory failure. Section 4 will explore how public law values can help international trade regulation to overcome the limits of the traditional international law framework stemming from the private nature of treaty law.