The potential impact of the comprehensive and progressive agreement for Trans-pacific partnership on Thailand’s hepatitis C treatment program

Tenni et al. Globalization and Health (2024) 20:46 https://doi.org/10.1186/s12992-024-01053-9 Globalization and Health Open Access RESEARCH The potential impact of the comprehensive and progressive agreement for Transpacific partnership on Thailand’s hepatitis C treatment program Brigitte Tenni1,2* , Joel Lexchin3 , Chutima Akaleephan4, Chalermsak Kittitrakul5 and Deborah Gleeson1 Abstract Background Thailand has expressed interest in joining the Comprehensive and Progressive Agreement for TransPacific Partnership (CPTPP), a twelve-country plurilateral trade agreement whose original incarnation included the United States of America (USA). When the USA withdrew from this agreement, key intellectual property clauses relevant to pharmaceuticals were suspended. These could be reinstated should the CPTPP Parties decide to do so. Methods This study uses two scenarios to cost the impact the CPTPP would have had on Thailand’s 2020 hepatitis C treatment regime if Thailand joined the CPTPP and suspended clauses were reinstated. Results Joining the CPTPP could have increased the cost more than tenfold if suspended CPTPP clauses were reinstated and Thailand was not willing or able to issue compulsory licenses. Based on the 2020 budget, the price for this possible scenario could have reduced hepatitis C treatment coverage by 90%. Conclusions Acceding to trade agreements such as the CPTPP that require increasing intellectual property protection, could compromise Thailand’s hepatitis C program and other national treatment programs reliant on affordable generic medicines. The CPTPP could also prevent Thailand from relying on its own pharmaceutical capabilities to manufacture medicines needed to sustain its treatment programs. Keywords Intellectual property, Patents, Generic medicines, Compulsory licencing, TRIPS flexibilities, Trade agreements, TRIPS-plus, Hepatitis C, Direct-acting antivirals *Correspondence: Brigitte Tenni 1 School of Psychology and Public Health, La Trobe University, Melbourne, Australia 2 Nossal Institute for Global Health, University of Melbourne, Melbourne, Australia 3 School of Health Policy and Management, York University, Toronto, Canada 4 International Health Policy Programme, Ministry of Public Health, Bangkok, Thailand 5 AIDS Access Foundation Bangkok, Bangkok, Thailand © The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Tenni et al. Globalization and Health (2024) 20:46 Introduction and background Thailand has repeatedly expressed interest in joining the Comprehensive and Progressive Agreement for TransPacific Partnership (CPTPP) [1], a plurilateral trade agreement between Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, Peru, New Zealand, Singapore, Vietnam and the United Kingdom (UK). This research aims to measure the potential impact that accession to this agreement could have had on access to medicines in Thailand in 2020, specifically the impact of its suspended intellectual property (IP) provisions on access to direct acting antivirals (DAA) used to treat hepatitis C. As a Member of the World Trade Organization (WTO), Thailand must comply with its Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and provide minimum standards of IP protection, including making patents available for least 20 years from the time the application is filed, for pharmaceutical products or processes that meet standard criteria for patentability, novelty, inventive step and industrial applicability [2]. While these provisions impose obligations to make patents available for pharmaceuticals, TRIPS also contains “flexibilities” or provisions that can be used by Table 1 Suspended TRIPS-plus IP articles of the CPTPP Suspended article Article 18.37 (Patentable Subject Matter) (i) paragraph 2: all of this paragraph; (ii) paragraph 4: the last sentence; Article 18.46 (Patent Term Adjustment for Unreasonable Granting Authority Delays): all of this Article including footnotes 36 through 39; Article 18.48 (Patent Term Adjustment for Unreasonable Curtailment): all of this Article including footnotes 45 through 48; Article 18.50 (Protection of Undisclosed Test or Other Data): all of this Article including footnotes 50 through 57; Article 18.51 (Biologics): all of this Article including footnotes 58 through 60; Explanation Patents to be made available for at least one of: new uses of a known product, new methods of using a known product or new processes of using a known product. Patents must be available for inventions derived from plants. Adjust, upon request, a patent’s term of protection to compensate the patent owner if there are unreasonable delays in a patent office’s issuance of a patent. Adjust a pharmaceutical patent’s term of protection to compensate the patent owner for unreasonable curtailment of the effective term of a patent as a result of the marketing approval process for a pharmaceutical product. A period of at least 5 years during which a regulator cannot provide marketing approval for a generic version that relies on the original clinical trial data submitted to the regulatory agency to prove safety and efficacy of a new medicine. At least eight years of effective market protection for biologics, provided via at least 8 years of data exclusivity or at least 5 years of data exclusivity and other measures to ‘deliver a comparable outcome in the market’. Adapted from Comprehensive and Progressive Agreement for Trans-Pacific Partnership text. See https://www.dfat.gov.au/sites/default/files/tpp-11-treatytext.pdf Page 2 of 12 Member States to mitigate the impact of patents, such as excessively high medicine prices, in the interests of public health. Together with Ecuador, Thailand has made the most frequent use of compulsory licencing of any country [3]. Compulsory licenses are an important example of TRIPS flexibilities [4]. A compulsory licence is an authorisation granted by a government that allows (...truncated)