Free Trade Agreements and Access to Medicines : Need for Regulation

Abstract

ABSTRACT

AIMS AND OBJECTIVES 1. To understand the nature of the Intellectual Property provisions of the various Free Trade Agreements; 2. To understand the impacts of such IP provisions under the FTAs on the access to medicines in developing countries; 3. To understand the role of the absence of the MFN exemption under TRIPS agreement in giving the TRIPS plus provisions of the FTAs a global face; 4. To identify the boundaries of TRIPS plus. STATEMENT OF PROBLEM TRIPS Agreement was entered into by WTO members as a means to create a unified Intellectual Property regime across the world. The provisions of TRIPS act as a minimum standard which has to be followed by the member countries. TRIPS provisions had forced the developing and least developed countries to create and follow an IP regime which was not suitable for their technology and needs. One of the severe impacts of following such a regime was on the public health sector. Before TRIPS came into being, a large number of countries had refused to grant patents for pharmaceutical products and even if the same was granted the countries provided for a flexible compulsory licensing procedure, enabling the growth of generic drug industries, thus allowing the manufacture of essential drugs at a cheaper cost. This flexibility was taken away by the TRIPS agreement which hampered the capability of the developing and least developed countries to provide for an effective public healthcare system. This disparity led to the Doha Declaration and WTO Para.6 decision in 2003, allowing more flexible provisions regarding compulsory licensing and thereby to some extends resolving the issues. While these measures were being adopted which were lauded by organs of UN and WHO, the developed countries went on with TRIPS plus provisions in their countries. Recent years have shown the world a new trend amongst the developed countries, wherein

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they, through the Free Trade Agreements (FTAs) with the developing countries, impose TRIPS Plus Intellectual Property Standards. The Regional Trade Agreements (RT As) and Bilateral Trade Agreements envisaged under GAIT Agreement, had been negotiated mainly for favourable tariff rates and lower customs barriers in the initial stage acting as an exception for the MFN Rule. But recently as mentioned earlier these Agreements are including within them Intellectual Property chapters involving TRIPS Plus provisions. Unlike the GATT and GATS Agreements, TRIPS Agreement does not include any provisions which exempt the application of MFN principle for the Intellectual Property provisions in FTAs. Thus the inclusion of IP chapters in these FTAs results in an increase of the Intellectual Property standards prevailing around the globe. This practice is defeating all the efforts taken by the developing countries including India in Doha to ensure access to medicines for the people of the developing countries and least developed countries (LDGs) and is nullifying the fJexibilities under Doha Declaration. If such a policy is allowed to be fOllowed, the flexibilities and the safeguards under TRIPS will remain as a mere scarecrow and in near future itself the TRIPS will lose its significance. RESEARCH QUESTIONS i. How did the Doha Declaration on Access to Medicines help to overcome the short comings of TRIPS Agreement? ii. What is the nature of the Intellectual Property provisions under the Free Trade Agreements? iii. What are the impacts of the Intellectual Property provisions under the FTAs on effective access to medicines in the· developing countries and LDGs? iv. How do the measures like Data Exclusivity and prohibitions of parallel importation defeat the flexibilities provided under the Doha Declaration and WTO Para.6 Decision of 2003? v. Whether the Articles 7 and 8 of TRIPS Agreement which calls for ensuring social and economic welfare and protection of Public

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Health and the provisions of Doha Declaration on TRIPS and Public Health and the WTO Para.6 decisions are to be considered merely as minimum standards to be followed, which could be overcome through TRIPS Plus IP chapters of FTAs? vi. How can the FTAs be regulated so as to prevent them from neutralising the flexibilities provided under Doha Declaration? vii. Will the inclusion of a FTA related MFN exemption clause in the TRIPS Agreement be able to resolve this issue? HYPOTHESIS The Intellectual Property law provisions under the FTAs are advocating TRIPS plus provisions undermining the f1exibilities under Doha Declaration and thus fracturing the measures taken by the Developing countries and the LDCs to ensure effective access to medicines for their citizens. The provisions under GATT, 1949 related to FTAs, especially, Article XXIV should be amended so as to ensure the compatibility of the FTAs with other agreements under WTO especially TRIPS. Further an MFN exemption provision in a similar fashion as of the GATT and GATS should be incorporated under the TRIPS Agreement. RESEARCH METHODOLOGY The researcher will be adopting analytical and doctrinal methods of research in the course of his research. CHAPTERISATION 1. Introduction 2. Journey from Trips to·Doha 3. Intellectual Property Chapters of the Free Trade Agreements 4. Impacts of the Ip Chapters of FTA's on Public Health: Actual and Potential 5. FTAs' Knitting a Web of Higher Intellectual Property Standards Globally? 6. Fencing the TRIPS Plus 7. Conclusion