The Use of TRIPS Flexibilities to Improve Sustainable Access to Essential Medicines in the Global South: Which Flexibilities suit Vietnam?

  • Huong Thanh Nguyen

Student thesis: Doctoral Thesis


This dissertation explores how to improve sustainable access to essential medicines in Vietnam by using the ‘flexibilities’ available under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
The dissertation provides justification for, and strategies to implement, steps to use TRIPS flexibilities in order to achieve public health goals. It evaluates whether Vietnam can use those flexibilities. This is significant to Global South countries including Vietnam because the TRIPS Agreement establishes minimum standards for pharmaceutical intellectual property (IP) protection that primarily benefit corporate interests in the Global North, resulting in a lack of access to
essential pharmaceuticals in the Global South. Pharmaceutical firms’ use of patent law for ‘disproportionate’ profit-seeking, leading to much of the population in the Global South lacking access to life-saving medicines, has been widely criticised. Implementing TRIPS flexibilities is important in resolving this challenge.
The dissertation is the first significant study of Vietnam’s engagement with TRIPS flexibilities related to pharmaceuticals. It examines the Vietnamese and worldwide IP systems through the prism of human rights. In principle, Vietnam can use TRIPS flexibilities and, from a human rights perspective, in
accordance with the Doha Declaration on TRIPS and public health, the country should do so to ensure public access to essential pharmaceuticals. In practice, many obstacles prevent it from doing so. The dissertation explains the reasons for this, which include: (1) lack of domestic manufacturing capacity; (2) inadequate capacity within government, particularly the patent office;
(3) concern about potential economic pressure from the United States; and (4) being restricted by Free Trade Agreements (FTAs) that conflict with the Doha Declaration. Thus, even though someflexibilities are recognised in national law, Vietnam has never used them effectively for public health purposes. This failure is critical for evaluating the flexibilities under TRIPS, but little in the
literature considers the feasibility of such flexibilities and the strategy for using them to promote medicines access in Global South countries such as Vietnam.

The dissertation brings together research on regulatory theory and the political power dynamics affecting the IP system. By recognising that IP law is also a matter of political power, it draws on the work of Peter Drahos, John Braithwaite, Carlos M Correa, Susan K Sell, Ken Shadlen, Ellen 'tHoen, and others. Western nations’ pressure to strengthen IP rights by adopting new IP rules
called ‘TRIPS-plus’ in FTAs makes it far more challenging for Global South countries (such as Vietnam) to address the problem of medicines access.
Vietnam’s case demonstrates that the Doha Declaration has been ineffective in resolving conflicts between human rights and patent law. This failure could be remedied by establishing partnerships among the Global South's weaker countries; and resisting the use of FTAs to weaken Doha in order to safeguard ‘the right to health’. To do this, the Vietnamese government’s political willpower is critical.
The dissertation features specific recommendations about developing policy and technical expertise in Vietnam, legislative reform, and cooperation development. It achieves this by exploring how other Global South countries – such as India, Thailand, and Indonesia – use TRIPS flexibilities, as a reference for Vietnam.
Date of Award2023
Original languageEnglish
SupervisorSascha-Dominik Dov Bachmann (Supervisor), Alison Mclennan (Supervisor), Bruce Baer Arnold (Supervisor) & Wendy Bonython (Supervisor)

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