The Trans Pacific Partnership Agreement and Pharmaceutical Regulation in Canada and Australia

Lexchin J and Gleeson D. (2016) The Trans Pacific Partnership Agreement and Pharmaceutical Regulation in Canada and Australia. International Journal of Health Services, 46(4):597-613. doi: 10.1177/0020731416662612

30 Pages Posted: 25 Oct 2016

Date Written: 2016

Abstract

The Trans Pacific Partnership Agreement (TPP) is a large regional trade agreement involving twelve countries. It was signed in principle in February 2016 but has not yet been ratified in any of the participating countries. The TPP provisions place a range of constraints on how governments regulate the pharmaceutical sector and set prices for medicines. This paper presents a prospective policy analysis of the possible effects of the TPP on these two points in Canada and Australia. Five chapters of relevance to pharmaceutical policy are analyzed: chapters on Technical Barriers to Trade (Chapter 8), Intellectual Property (Chapter 18), Investment (Chapter 9), Dispute Resolution (Chapter 28), and an annex of the chapter on Transparency and Anti-Corruption (Chapter 26, Annex 26-A). The paper concludes that the TPP could have profound effects on the criteria these countries use to decide on drug safety and effectiveness, how new drugs are approved (or not) for marketing, post-market surveillance and inspection, the listing of drugs on public formularies, and how individual drugs are priced in future. Furthermore, the TPP, if ratified and enforced, will reduce future policy flexibility to address the increasing challenge of rising drug prices.

Keywords: international trade agreements, pharmaceutical regulation, intellectual property, access to medicines, Trans Pacific Partnership Agreement

Suggested Citation

Lexchin, Joel and Gleeson, Deborah, The Trans Pacific Partnership Agreement and Pharmaceutical Regulation in Canada and Australia (2016). Lexchin J and Gleeson D. (2016) The Trans Pacific Partnership Agreement and Pharmaceutical Regulation in Canada and Australia. International Journal of Health Services, 46(4):597-613. doi: 10.1177/0020731416662612. Available at SSRN: https://ssrn.com/abstract=2858703 or http://dx.doi.org/10.2139/ssrn.2858703

Joel Lexchin (Contact Author)

York University ( email )

4700 Keele Street
Toronto, Ontario M3J 1P3
Canada
+416-736-2100 x 22119 (Phone)
+416-736-5227 (Fax)

Deborah Gleeson

La Trobe University ( email )

School of Psychology and Public Health
Victoria, 3068
Australia
+61 3 9479 3262 (Phone)

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