Abstract
BackgroundTrade and investment agreements negotiated after the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy. Despite the large body of literature on intellectual property and access to affordable medicines, the ways in which other provisions in trade agreements can affect pharmaceutical policy and, in turn, access to medicines have been little studied. There is a need for an analytical framework covering the full range of provisions, pathways, and potential impacts, on which to base future health and human rights impact assessment and research. A framework exploring the ways in which trade and investment agreements may affect pharmaceutical policy was developed, based on an analysis of four recently negotiated regional trade agreements. First a set of core pharmaceutical policy objectives based on international consensus was identified. A systematic comparative analysis of the publicly available legal texts of the four agreements was undertaken, and the potential impacts of the provisions in these agreements on the core pharmaceutical policy objectives were traced through an analysis of possible pathways.ResultsAn analytical framework is presented, linking ten types of provisions in the four trade agreements to potential impacts on four core pharmaceutical policy objectives (access and affordability; safety, efficacy, and quality; rational use of medicines; and local production capacity and health security) via various pathways.ConclusionsThe analytical framework highlights provisions in trade and investment agreements that need to be examined, pathways that should be explored, and potential impacts that should be taken into consideration with respect to pharmaceutical policy. This may serve as a useful checklist or template for health and human rights impact assessments and research on the implications of trade agreements for pharmaceuticals.
Highlights
Trade and investment agreements negotiated after the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy
US trade agreements with Australia and Korea have included provisions applying to national pharmaceutical coverage programs and regulation of pharmaceutical marketing [3], and similar rules subsequently appeared in the Trans-Pacific Partnership Agreement (TPP) [12] and the United States-MexicoCanada Agreement (USMCA) [13]
This paper aims to help fill this gap by identifying the provisions in recently negotiated regional trade and investment agreements that are relevant to pharmaceutical policy and practice, tracing the pathways through which they can affect pharmaceutical policy objectives, and developing a framework for analyzing the impact of trade and investment agreements on pharmaceutical policy and access to medicines
Summary
Trade and investment agreements negotiated after the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy. The 1995 World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement) set minimum global standards for intellectual property rights that included committing members to providing patent terms of at least 20 years for pharmaceuticals (initiated from the date of filing) [1, 2].1 Since this time, subsequent bilateral and regional trade agreements, those negotiated by the USA and the EU (where most of the global researchbased pharmaceutical industry is headquartered), have progressively expanded and extended intellectual property (IP) protection beyond the requirements of TRIPS through a multitude of additional provisions: the “TRIPSPlus” protections [1,2,3]. Many provisions commonly included in trade agreements can impinge on access to safe, effective, quality and affordable medicines, potentially undermining the achievement of universal health coverage and the SDGs
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