The pharmacy of the developing world : India, patent law and access to essential medicines

Abstract

In a critical evaluation of the influence of the TRIPS Agreement 1994 on India's patent regime, this thesis considers whether India can retain its pre-eminent role as the pharmacy of the developing world. Using Amartya Sen's conception of justice, development as freedom and capability approaches as thematic foundation, I have problematised key domestic and international developments in the area of patent law and access to essential medicines. With the help of original case studies, this work provides an in-depth and thorough analysis of major controversies which are currently dominating the global discourse about patents and access to medicines. The patent saga in India highlights the problem of evergreening in patent law; the tensions between the right to health and the right to property; and the role of international law. The next case study -the Pfizer, Natco controversy - highlights the limitations and shortcomings of the World Trade Organization's rules on compulsory licensing for exports. The Indian experience shows that implementation of the Waiver Decision 2003 is extremely cumbersome and India's domestic regulations have also failed to address this problem. The third case study of this thesis deals with the detention of generic drugs in transit and border enforcement measures, and shows that barriers to access to essential medicine are sometimes operating beyond the limits of patent laws and domestic regulations. In addition to calling for a modernisation of Indian patent law, this thesis also considers new models of medical innovation in the Indian context. It maintains that the ongoing debate in India about the regulation of publicly funded research should be fully informed about the consequences of excessive patenting. India should consider adopting open source drug discovery models by facilitating and participating in patent pools. Two alternatives models of medical innovation - the Health Impact Fund and Prizes - are discussed in the Indian context to show how India can maintain its pre-eminence the pharmaceutical manufacturing sector. This study concludes that a number of multilateral and bilateral initiatives mandating TRIPS-Plus standards have the potential to further compromise India's access to a medicines regime. It is argued that the Indian government should resist entering into any TRIPS-Plus trade agreement, which could limit its ability to manufacture cheap and affordable generic drugs. The World Trade Organization should reconsider the mandate of the Doha Declaration on TRIPS and Public Health 2001 in the light of domestic experiences to provide a readily available and easy to implement export mechanism. The World Health Organization should take a leadership role in promoting and implementing alternative models of medical innovation. The thesis also recommends that the World Intellectual Property Organization needs to substantively implement its Development Agenda in order to promote access to medicines. Show more