The Free Trade Agreement between India and European Union and its Implications to Access to HIV/AIDS Medicines

Abstract: This thesis examines how the Free Trade Agreement (FTA) that India is currently negotiating with the European Union (IndEUFTA) may impede the production of Indian generic version of HIV/AIDS medicines and thereby hinder access to HIV/AIDS medicines. The reason for discussing specifically HIV medicines in the context of Indian generic manufacture is important in two ways. First, considering the disasters that HIV pandemic brought while at the same time there are huge cuts in the budget of the major international donors providing access to HIV treatments. Second, Indian generic companies have been contributing their immense role in facilitating access to particularly HIV medicines. The aim is also to show that access to medicines, though subject to some debate, can be claimed as a human right under the umbrella of the right to health and that the IndEUFTA may infringe this right. The thesis starts with the discussion of approaching access to medicines as a human right under the auspices of the right to health. Then the thesis offers the reader the important role and contribution Indian generic manufacturers have been providing in relation to access to HIV/AIDS medicines by offering low cost good quality generic version of antiretroviral drugs (ARVs). This will help the reader to realize the seriousness of the problem at stake if the Indian generic companies are hindered. Indian pharmaceutical industry has been able to accomplish its advanced generic institutions mainly because from 1970 to 2005 India did not grant patent protection for medicines. This is further explained in detail by looking at the history of Indian pharmaceutical industry. However, in 2005 India started complying with the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and thus was obliged to introduce patent protection for medicines. The introduction of patent rights over pharmaceuticals blocked the production of generics in general and generic version of ARVs in particular to certain extent. The thesis explains how India managed to avoid total obstruction of its generic production by using so called “TRIPS flexibilities”. More importantly for the purpose of this study, the IndEUFTA that India has been negotiating with the EU may bring further hurdle for already constrained Indian generic industry since it contains some provisions which seek even more stringent protection of intellectual property rights (IPRs) than TRIPS. This thesis analyzes strict provisions contained in the IndEUFTA that have been subject to the most of the debates and that may have far reaching impact. Those provisions include data exclusivity, extensions of patent protection term, stringent enforcement of IPRs, and broad scope of investment protection. The thesis also looks at the experience of other developing countries that entered into FTAs with similar provisions in order to see the impact that those developing countries had on their pharmaceutical industry, particularly in relation to prices of and access to medicines. This will enable to see the real possible effects that the pharmaceutical industry of India may have if such provisions are included in the IndEUFTA. For this purpose, the FTAs that Jordan, Colombia, Peru and Thailand each concluded with the United States of America (U.S.) are discussed. The IndEUFTA is still under negotiation and there is no clear cut answer as to whether stringent provisions discussed in this thesis will be included in the agreement. However, even assuming that India may not agree for any conditions of the IndEUFTA that may affect its generic production, this study does not lose its value since there are some other even stronger proponents of stricter patent laws, for example like the U.S., that are intending to have an FTA with India. In this sense, this study remains to be helpful so as to aware about the possible implications to access to medicines from FTAs that seek for more rigorous patent protection that India may encounter in the future.