Introduction

Recent years have seen a rapid increase in scientific and technological advances in the areas of molecular biology, genetics and bioengineering. Such scientific and biomedical developments have taken advantage of the fundamental freedoms protected by the human rights and other instruments, in particular, the freedom to engage in research and commerce. Because commercial genetic engineering and globalised trade are mutually supportive, a mechanism has been established by transnational corporations engaged in the biotechnology-pharmaceutical ‘life science’ industry, in partnership with supportive governments, to effectively open the market for systems for the production and supply of biomedicines throughout the developed countries, through the regime of the World Trade Organization (WTO).

This regime is based on the General Agreement on Trade in Services (GATS) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) annexed to the Marrakesh Agreement Establishing the World Trade Organization, which entered into force on 1 January 1995. It is also important to note the effect of the Doha Declaration on the TRIPS Agreement and Public Health of 14 November 2001 and of other relevant soft law instruments adopted by the specialised agencies of the United Nations system, in particular the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO), without prejudice to the most important instrument of the United Nations in this field: the Convention on Biological Diversity of 5 June 1992.