Global Intellectual Property Protection for Innovative Pharmaceuticals: Challenges for Bioethics and Health Law

Abstract

Multilateral and bilateral trade agreements have become important vehicles by which US multinational corporations, through close collaboration with government officials, are striving, amongst other objectives, for increasingly stringent global intellectual property protection (GIPP), particularly over what they term “innovative” pharmaceuticals.

This chapter explores the evolution and structural dynamics of GIPP. It particularly considers the hypothesis that GIPP represents a corporate-driven ideology whose legitimacy in a democratic polity is undermined by its uncertain foundation in public health research and inadequate integration with norms of bioethics and health law, including international human rights.

This detailed analysis begins with consideration of the domestic evolution of GIPP from within the US patent system. This may reveal how many of its important structural features had their roots in a domestic profit-making ideology. The chapter then examines the critical initial globalization role of the US Trade Act 1974, particularly section 301. This permitted US industry to request an investigation by the US International Trade Commission of foreign nations whose practices allegedly caused it material injury. The Agreement on Trade Related Intellectual Property Rights (TRIPS) is analyzed as a mature component of GIPP by which increased intellectual property rights [intellectual monopoly privileges] in particular over pharmaceuticals, were linked with strong trade sanctions. The sophisticated contribution to GIPP made by the Medicare Prescription Drug Improvement and Modernization Act 2003 (US) is then evaluated, particularly its prohibition of Federal Government medicine price setting and its requirement for a study of pharmaceutical price controls in other developed countries. In each case the extent to which GIPP attempted or failed to integrate its corporate-designed principles with basic norms of bioethics, public health law and international human rights is discussed.

Keywords: TRIPS, intellectual monopoly privileges, intellectual property rights, patents, global pharmaceutical regulation, essential medicines

JEL Classification: O34, O31, M37, M14, L65, K31, H41, I18, D46