Analyzing the impact of trade and investment agreements on pharmaceutical policy: provisions, pathways and potential impacts

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.

Understanding the trends in international agreements on pricing and reimbursement for newly marketed medicines and their implications for access to medicines: a computational text analysis

“…We formulated the framework to understand international agreements from the perspective of the pricing and reimbursement process for newly marketed medicines. In particular, we undertook a purposive review of the literature on the impacts of international agreements on the pricing and reimbursement schemes in member countries [ 25 – 29 ] and the pricing and reimbursement process of newly marketed medicines in various countries [ 38 – 42 ]. Based on the framework, we applied two distinct approaches to understand international agreements: the law-as-code approach and the law-as-data approach.…”

“…Little of the literature has discussed the impact of international agreements on pricing and reimbursement processes within member countries. Researchers have meaningfully analyzed the TPP and the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) and suggested their implications on access to medicines from the perspectives of pricing and reimbursement policies [ 25 – 29 ]. However, the literature has been interested in the “overall” characteristics of “the TPP or the CPTPP” .…”

USMCA 2.0: a few improvements but far from a ‘healthy’ trade treaty

“…Many other chapters in the USMCA have implications for access to medicines and other aspects of pharmaceutical policy, such as pricing and reimbursement, the assessment of safety and efficacy, and the ability of countries to support a viable generic medicines industry [4]. These parts of the text remain unaltered by the amendments, representing a lost opportunity for wider reforms to the US trade negotiating template.…”

Analyzing Business Model, Narrative and Numbers of GSK (Glaxosmithkline)

“…In 2014, GSK announced restructuring of R&D efforts thus eliminating 900 US employees, mostly laid off and staff reallocation would take place within the firm's Research Triangle Park in North Carolina (Vence, 2014). Also, it is country specific to keep the balance of importing pharmaceuticals and local production, as sometimes importation may be more effective financially (Gleeson et al 2019). In the creation of public policies, it is very important that shortterm policy is coherent with long-term policy (Cergic, 2019).…”