TRIPS, Public Health Systems and Free Access
Edited by Benjamin Coriat
Chapter 7: Compulsory Licensing in the Real World: The Case of ARV Drugs in Brazil
7. Compulsory licensing in the real world: the case of ARV drugs in Brazil Cristina de Albuquerque Possas INTRODUCTION In the contemporary world, new advances in molecular biology and genetic engineering resulting from the new biotechnology revolution are reshaping science and technology into new paradigms, creating a broad range of processes and products with fantastic potential in diverse areas of human activity. The impact of these changes on the pharmaceutical industry has been extraordinary. New recombinant vaccines and drugs are emerging as important innovations for the prevention and treatment of several infectious and chronic degenerative diseases. These new technological developments are challenging both developed and developing countries to implement new ethical and regulatory procedures, related to biosafety and intellectual property rights (IPR), raising crucial and controversial issues. The interesting aspect in the emergence of these relatively recent regulatory procedures is that in most cases they have extended their scope far beyond the need to protect innovators, raising ethical and moral concerns about the protection of the life and health of consumers and volunteers for clinical trials. In fact, they have become increasingly subordinated to monopolistic market strategies and are used by ﬁrms in the developed world as important economic barriers to access by the developing world to favourable international trade conditions, thus broadening the gap between north and south. Following this regulatory tendency, an international system for patenting life and life-saving products emerged after the Uruguay Round in 1984 and the creation of the World Trade Organization (WTO). In the...
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