Revisiting public health emergency in international law: a precautionary approach

Abstract

This work develops a means to encourage states to take advantage of the flexibilities of compulsory licensing in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) which promotes access to medicines in a public health emergency. In pursuing this solution, the precautionary approach (PA) and the structure of risk analysis have been adopted as a means to build a workable reading of TRIPS and to help states embody the flexibilities of intellectual property (IP). This work argues for a PA reading of TRIPS and that states have the precautionary entitlements to determine an appropriate level of health protection from the perspective of “State responsibility” in international law. A philosophical review is conducted followed by the examination of existing international legal instruments including the WTO Agreement on the Application of Sanitary and Phytosanitary Measures, the WHO International Health Regulations, the Codex Alimentarius, and the Cartagena Protocol on Biosafety. The PA has been found to have a pervasive influence on risk regulation in international law, yet the application is fraught with fragmentations in different legal regimes. In order to reach a harmonious interpretation and application of the PA in the WTO, the legal status of PAs of different WTO instruments have been analysed. Further, a comparative study on PAs in terms of legal status in the exemptions of the WTO and TRIPS obligations has been proposed. The political and moral basis for compulsory licencing in a public health emergency has been bolstered through the interpretation and the creation of legal status of the PA in WTO/TRIPS law.