Regional Mechanism under TRIPS Amendment-Exploring a Pooled Pharmaceutical Access Model for Low-Income Countries

《與貿易有關的知識產權協定》修正案下的區域機制:關於低收入國家藥品獲取聯合模式的研究

Student thesis: Doctoral Thesis

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Award date12 Aug 2021

Abstract

Since the creation of the World Trade Organization (WTO) and the entry into force of its Agreement on Trade-related Aspects of Intellectual Property (TRIPS), the relationship between patent protection, trade and access to medicines has been controversial. TRIPS agreement has taken a prominent place in international discourse. The agreement has been characterized by heated debates on how to achieve a balance between rights and obligations within intellectual property system and in particular, a balance between pharmaceutical patent protection and access to medicines. Although the existing literature on TRIPS and access to medicines is abundant, this thesis brings a distinctive contribution by lucidly and pedagogically appraising the regional mechanism under TRIPS amendment using the East African Community (EAC) as a case study. The EAC adopted the East African Community Regional Pharmaceutical Manufacturing Plan of Action (EACRPMPoA) to serve as a roadmap in its bid to utilize TRIPS flexibilities in building regional pharmaceutical manufacturing capacity and improving access to medicines. The dissertation acknowledges that the challenge of access to essential medicines in low-income countries is a complex one in which intellectual property law and TRIPS flexibilities are just components. The challenge entails several non-TRIPS related factors such as pharmaceutical market intelligence, competition law, global coordination, domestic research and manufacturing capabilities, technical and infrastructural capacities for medicines regulation, efficient pharmaceutical management, procurement systems etc. Therefore, the primary thesis of this dissertation is that strategies focused on regionally coordinated attempts to address the intellectual property impediments to access to essential medicines would be able to create an organizational infrastructure capable of dealing effectively with both TRIPS and non-TRIPS challenges. At the very least, it is worth considering how to leverage solutions to the legal problems in ways that simplify the related issues.

Building on the philosophy of balance of rights and obligation and the mediation between utilitarianism and egalitarianism within TRIPS framework, the thesis argues for a pro-development interpretation of TRIPS and the revitalization of its object and purpose as captured in its articles 7 and 8. Beyond foreign aid and drug donations to low-income countries, the thesis argues for the need to hold developed countries more accountable in fulfilling their obligation under articles 66.2 and 67 of TRIPS agreement.