Flexibilities under Trips: Implementation Gaps between Theory and Practice

Abstract

Agreement on Trade Related Aspects of Intellectual Property (hereinafter TRIPS) aimed at fostering innovation and developing a system based on innovation-oriented national economies. TRIPS could have enabled all member states to achieve economic development had the enforcement mechanisms been properly implemented. But owing to varying level of development of the member states, the system lacked balance and its implementation was open to abuse.1 When TRIPS Agreement was concluded, the problems faced by the third world countries, especially due to outbreak of epidemics and pandemics, were not foreseen and public health concern was not given due importance. Instead of having mechanisms in favor of access to essential medicines in its main provisions, the TRIPS included them as exceptions. Compulsory licensing2 and parallel importation3 are two such flexibilities provided to the lowincome countries.4 TRIPS Agreement –one of the most comprehensive treaties on intellectual property rightsintroduced a strict legal regime for the protection of IPRs. Prior to TRIPS, pharmaceuticals were excluded from patent protection in domestic laws of about fifty countries. Even many of the present world’s developed countries excluded pharmaceutical products from patent protection prior to TRIPS.5 TRIPS Agreement provided protection to patents6 in all fields of technology, including pharmaceuticals, for a period of twenty-years.7 Higher price of drugs due to monopoly provided to the patent holders became a common concern of developing countries considering stronger IPRs protection.8 Compulsory licensing safeguard initially provided under TRIPS had no practical significance for least developed countries (hereinafter LDCs) which lacked manufacturing capacity of their own because the pharmaceutical products manufactured under compulsory license could only be used for domestic use. With the outbreak of epidemics and pandemics like HIV/AIDS in Africa, the outcry by NGOs and human rights activists succeeded to draw attention of the world community towards practical problems faced by the LDCs (lacking manufacturing capacity) despite the flexibilities provided in the TRIPS. Changes were made in the existing system under Doha Declaration 20019, and WTO10 Waiver Decision 200311 to address problems of the LDCs by allowing export of generics produced under compulsory licensing to these countries. Whether the changes were substantial or cosmetic and to what extent the third world countries have been able to use these flexibilities and mechanisms is a debatable issue. Purpose of this work is to explore the practical implications faced by the poorer countries in availing the legitimate flexibilities provided under TRIPS and to discuss the implementation gaps between theory and practice of compulsory licensing.