1. Introduction
The Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) is a 12-party plurilateral trade agreement to which Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, Peru, New Zealand, Singapore, Vietnam and the United Kingdom (UK) are signatories. It incorporates most of the provisions of a previously negotiated agreement, the Trans-Pacific Partnership Agreement (TPP), which initially included the United States (US). President Trump withdrew the US in 2017, rendering the Agreement defunct (Office of the United States Trade Representative, 2017, 30 January). In 2018, the remaining 11 Parties signed a new agreement, the CPTPP, which incorporates, by reference, most of the TPP’s provisions (Australian Government Department of Foreign Affairs and Trade, 2018). The UK acceded in December 2024 and an accession process for Costa Rica commenced in November 2024. The aim of the Parties has always been for it to expand to include other countries (New Zealand Government, 2017), making it highly likely that more countries will join.
The original TPP text included an intellectual Property (IP) chapter with multiple ‘TRIPS-plus’ provisions that provide a greater level of IP protection than that required by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) adopted by Member States of the World Trade Organization (WTO) in 1995. These provisions present obstacles for countries in ensuring access to affordable medicines for their populations (United Nations Secretary General’s High Level Panel on Access to Medicines, 2016), and meeting the Sustainable Development Goals, particularly Goal 3, Target 3.8, which includes access to ‘safe, effective, quality and affordable essential medicines and vaccines for all’ (United Nations, n.d.). The real-world implications of lack of access to medicines for people’s lives are illustrated by the devastating effects of the HIV epidemic in Africa during the 1990s, where less than one in a thousand people living with HIV were able to access treatment due to the high prices for patent-protected drugs (‘t Hoen et al., Reference ‘t Hoen, Berger, Calmy and Moon2011). More recently, inequitable access to COVID-19 vaccines in 2021 was estimated to have resulted in 1.3 million unnecessary deaths in low and middle-income countries (LMICs) (Moore et al., 2022).
In 2009, the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health warned LMICs against adopting TRIPS-Plus provisions in their national laws and high-income countries (HICs) against including them in trade agreements (United Nations Human Rights Council, 2009). The United Nations High Level Panel on Access to Medicines (2016, p. 9) made similar recommendations, stating that ‘governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfil the right to health’. This advice was reiterated in the UN Human Rights Council (2025) report on access to medicines, vaccines and other health products.
Historically, the US has sought to extend IP protection through trade negotiations (Lopert and Gleeson, Reference Lopert and Gleeson2013). During TPP negotiations, US proposals for the IP chapter were strongly criticised by health and humanitarian organisations for forcing inappropriately high levels of IP protection on LMICs (Lopert and Gleeson, Reference Lopert and Gleeson2013). Although the original US proposals were mitigated, Médecins Sans Frontières (2015) stated that ‘…the TPP will still go down in history as the worst trade agreement for access to medicines in developing countries…’. A comparative analysis of the effect the TPP’s IP provisions would have had on the patent laws and regulatory regimes of the TPP Parties, had it entered into force, found that the implementation burden would be borne by the LMIC Parties (Gleeson et al., Reference Gleeson, Lexchin, Lopert and Kilic2018).
Following the US withdrawal, the CPTPP Parties agreed to suspend some provisions that were primarily sought by the US (McBride et al., Reference McBride, Chatzky and Siripurapu2021). These suspended provisions could be reinstated if the CPTPP Parties agree in future (McBride et al., Reference McBride, Chatzky and Siripurapu2021). Given divergent domestic preferences among the CPTPP Parties for different levels of IP protection, with HICs such as Japan, Canada, Australia favouring stronger IP laws than LMIC Parties (and now joined by the UK), the strength of consensus on keeping these provisions suspended is unclear.
The CPTPP is currently undergoing a General Review provided for in Article 27.2.1(b) of the Agreement. The General Review’s purpose is to examine the operation of the Agreement with a view to updating and enhancing it to ensure that it remains relevant to issues and challenges confronting the Parties (Government of Canada, 2025). Here we focus on the implications of the CPTPP on access to medicines considering its IP provisions, both those that are currently suspended and those that are still active.
The paper aims to make a case for removing TRIPS-Plus IP provisions from the CPTPP, based on evidence of their potential effects on access to medicines, experiences from the COVID-19 pandemic, and changes in the political environment since the CPTPP was negotiated, all of which suggest that the global IP regime needs realignment. We begin by examining the TRIPS-Plus provisions related to pharmaceuticals in the CPTPP, including both suspended and retained provisions. We then review the empirical evidence of the impact of TRIPS-Plus provisions on access to medicines and examine changes in the global political and economic environment. We finish by making recommendations for actions that should be taken as a result of the review.
2. TRIPS-plus provisions relevant to pharmaceuticals in the CPTPP
This section examines the CPTPP’s key TRIPS-Plus provisions relevant to pharmaceuticals, including provisions that are currently suspended, along with a ‘patent linkage’ provision retained from the TPP text.
2.1. TPP article 18.37: patentable subject matter
Under one of the suspended paragraphs in this clause (para 2), patents were 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. Known as secondary patents, these are additional to the patent on the original active ingredient, and can extend monopolies for many years.
2.2. TPP article 18.46: patent term adjustment for unreasonable granting authority delays
This clause (suspended in its entirety from the CPTPP), if restored, would allow adjustment to a patent’s term of protection to compensate the owner if there are unreasonable delays in issuing a patent. An unreasonable delay was defined as ‘a delay in the issuance of a patent of more than five years from the date of filing of the application in the territory of the Party, or three years after a request for examination of the application has been made, whichever is later’ (Article 18.46 para 4). The effect of a patent term extension would be to delay the introduction of less costly generics.
2.3. TPP article 18.48: patent term adjustment for unreasonable curtailment
Article 18.48 of the TPP, also suspended in the CPTPP, requires adjustment of a pharmaceutical patent’s term of protection to compensate the patent-owner for unreasonable delay in the marketing approval process.
2.4. TPP article 18.50: protection of undisclosed or other data
Suspended TPP Article 18:50 provided five years of exclusivity for small-molecule drugs for the data generated from premarket clinical trials that are submitted to regulatory authorities to get approval to market new drugs. Until a data protection period ends, generics cannot be approved even if relevant patents have expired. Unlike patents, data protection is granted automatically and cannot be challenged in the courts (World Health Organization et al., 2012). The TPP also required Parties to provide either three years of additional exclusivity for new clinical information submitted for previously approved products, or five years for new combination products that include a chemical entity not previously approved.
2.5. TPP article 18.51: biologics
This article, also suspended in the CPTPP, granted eight years of effective market protection for biologics, to be provided via at least eight years of data exclusivity or at least five years of data exclusivity along with other measures to ‘deliver a comparable outcome in the market’, likely three additional years of market exclusivity. Market exclusivity means that although data generated by the original trials can be used to approve generics, the product cannot be sold until the market exclusivity expires. In LMICs that are CPTPP Parties, like Peru and Vietnam, the increased spending is very likely to seriously affect access to medicines (Gleeson et al., Reference Gleeson, Lexchin, Lopert and Kilic2018).
2.6. CPTPP article 18.53: measures relating to the marketing of certain pharmaceutical products (patent linkage)
In addition to the suspended provisions, the CPTPP includes a patent linkage provision (Article 18.53) retained from the TPP. Patent linkage involves a conditional relationship between granting marketing approval for a generic medicine and the patent status of the originator medicine (Baker, Reference Baker2008). Patent linkage provisions, thereby, change patents from private rights, where enforcement is the patent-holder’s responsibility, to public rights, where publicly-financed national authorities must enforce patents (Son et al., Reference Son, Lopert, Gleeson and Lee2018).
The CPTPP allows for two different ways in which the patent linkage obligation can be implemented. The first, described in Art. 18.53 para 1, involves adopting a system that allows for a patent-holder to be notified when a third party requests marketing approval for a patented product, provides time and opportunity for the patent-holder to seek remedies, and requires provision of a judicial or administrative process for resolving disputes. The second option (Art 18.53 para 2) requires direct coordination between the marketing approval authority and the patent office, and an automatic veto of marketing approval if a patent is allegedly being infringed. An analysis of Canada’s system, based on the first option, concluded that ‘Patentees have strong incentives to litigate even weak or clearly not infringed patents, and potential generic entrants have weak incentives to litigate even when they expect to win’ (Hollis, Reference Hollis2025).
3. Evidence of the impact of TRIPS-Plus provisions on access to medicines
Since the CPTPP was finalised, two systematic reviews concluded that TRIPS-Plus provisions like those in the TPP negatively impact access to medicines. These reviews cover, respectively, the empirical evidence on IP provisions in trade agreements and their impacts on LMICs (Islam et al., Reference Islam, Kaplan, Trachtenberg, Thrasher, Gallagher and Wirtz2019) and IP protections adopted for any reason and their impacts on medicine cost, price or access – a more comprehensive survey of the relevant evidence (Tenni et al., Reference Tenni, Moir, Townsend, Kilic, Farrell, Keegel and Gleeson2022).
Islam et al. (Reference Islam, Kaplan, Trachtenberg, Thrasher, Gallagher and Wirtz2019) concluded that ‘changes in IP policy due to the implementation of trade agreements are associated with changes in price, medicines expenditure and sales, consumer welfare, and ultimately the affordability, of medicines’. While ex-ante studies showed stronger effects than ex-post studies, Islam et al. (Reference Islam, Kaplan, Trachtenberg, Thrasher, Gallagher and Wirtz2019) found strong evidence from both study types that TRIPS-plus data protection would increase medicine prices and costs and reduce access. The second review (Tenni et al., Reference Tenni, Moir, Townsend, Kilic, Farrell, Keegel and Gleeson2022) also concluded that ‘stronger pharmaceutical monopolies created by TRIPS-plus intellectual property rules are generally associated with increased drug prices, delayed availability and increased costs to consumers and governments’.
In addition, there were impacts of secondary patenting, patent term extensions and data exclusivity from other studies. Five studies found that secondary patents in HICs delayed generic entry (Amin and Kesselheim, Reference Amin and Kesselheim2012; Beall et al., Reference Beall, Nickerson, Kaplan and Attaran2016; Kapczynski et al., Reference Kapczynski, Park and Sampat2012; Yin, Reference Yin2023), increased costs (Moir, Reference Moir2016) and resulted in social welfare losses (Kapczynski et al., Reference Kapczynski, Park and Sampat2012). A study examining the impacts of restricting secondary patenting in Argentina, India and Brazil (Sampat and Shadlen, Reference Sampat and Shadlen2017) found little measurable effect, however, as other aspects of patent systems were found to affect patent application outcomes in these countries (Sampat and Shadlen, Reference Sampat and Shadlen2017).
Five studies of patent term extensions introduced unilaterally in three countries (the US, Canada and Australia) found they led to higher health expenditure (DiMatteo and Grootendorst, Reference DiMatteo and Grootendorst2002; Harris et al., Reference Harris, Nicol and Gruen2013; Kesselheim et al., Reference Kesselheim, Fischer and Avorn2006; Nelson et al., Reference Nelson, McAdam-Marx, Evans, Ward, Campbell, Brixner and Lafleur2011; Office of the Parliamentary Budget Officer, 2018), increased prices (Kesselheim and Solomon, Reference Kesselheim A and Solomon D2010; Sampat and Shadlen, Reference Sampat and Shadlen2017), and slower availability of affordable generic drugs (DiMatteo and Grootendorst, Reference DiMatteo and Grootendorst2002). Three retrospective studies measuring the impact of data exclusivity introduced unilaterally in the US found that it raised the prices of specific drugs (DiMatteo and Grootendorst, Reference DiMatteo and Grootendorst2002) and increased public drug coverage programme costs (Moir, Reference Moir2016; Sampat and Shadlen, Reference Sampat and Shadlen2017).
A recent study (Tenni et al., Reference Tenni, Lexchin, Akaleephan, Kittitrakul and Gleeson2024) costed the impact the CPTPP would have had on Thailand’s 2020 hepatitis C treatment programme if Thailand joined the CPTPP and the suspended clauses were reinstated. It found that costs could have increased more than tenfold if Thailand was not willing or able to issue compulsory licenses. Although the CPTPP IP chapter does not place additional restrictions on compulsory licensing beyond those in TRIPS, it is possible that its investment chapter may, as IP rights are recognised as covered instruments (Baker, Reference Baker2016). Based on the programme’s 2020 budget, the price for this scenario could have reduced hepatitis C treatment coverage by 90% (Tenni et al., Reference Tenni, Lexchin, Akaleephan, Kittitrakul and Gleeson2024).
While there are few empirical studies measuring the impacts of patent linkage, the literature suggests that it maintains the high prices of originator medicines (Correa, Reference Correa2006; Lopert and Gleeson, Reference Lopert and Gleeson2013; Sell, Reference Sell2007) by delaying the market entry of more affordable generics. A health impact assessment found that implementing patent linkage could negatively impact Thailand’s domestic pharmaceutical industry by slowing the market entry of locally-produced generic medicines, making Thailand reliant on more expensive imported drugs (Sakulbumrungsilp et al., Reference Sakulbumrungsilp, Kessomboon, Techakhunwut, Kanchanaphiboon and Vanichayakon2020). Patent linkage provisions have mostly been implemented by HICs as a requirement of bilateral US trade agreements, including Canada, Australia, and South Korea which introduced forms of patent linkage in 1993, 2005, and 2015, respectively (Son et al., Reference Son, Lopert, Gleeson and Lee2018). Son et al. (Reference Son, Lopert, Gleeson and Lee2018) suggest that the negative impacts of patent linkage on access to generic medicines can be mitigated to some extent by exploring ambiguities in the text of these bilateral US agreements and adopting a discretionary approach to patent linkage implementation. However, ideally nations, particularly LMICs, would avoid binding commitments to implementing patent linkage systems, even where there is some flexibility regarding the type of system.
4. Changes in the global political and economic environment
The negotiation of the TPP occurred at a time in history when the US was pursuing increasingly strong TRIPS-Plus trade rules – a trajectory that continued with the negotiation of the United States-Mexico-Canada Agreement (USMCA), signed in 2018. The USMCA’s final text included similar TRIPS-Plus provisions to the TPP, and an even longer period of market exclusivity for biologics (Labonté et al., Reference Labonté, Crosbie, Gleeson and McNamara2019). However, the Democrat-controlled Congress subsequently forced a renegotiation of the USMCA, completely removing its provisions for secondary patents and market exclusivity for biologics, and mitigating its patent term extension and data exclusivity provisions (Labonté et al., Reference Labonté, Gleeson and McNamara2020).
The position that the Republican-controlled Congress will take on IP provisions in trade agreements is unknown. However, given President Trump’s antipathy to regional and multilateral trade agreements, irrespective of his obligation to renegotiate the USMCA, it seems highly unlikely that the US will seek to return to the CPTPP. Therefore, whether the US remains committed to high IP standards is unlikely to affect the CPTPP. Moreover, reinstating the suspended provisions in the CPTPP would be counter-productive for Canada and Mexico, for whom it would mean sacrificing the higher degree of policy flexibility in the amended USMCA.
Since the TPP was negotiated, the legitimacy of strong IP protections for pharmaceuticals has been challenged significantly at the global level, making TRIPS-Plus provisions like those in the TPP even less palatable. Stark inequalities in access to COVID-19 vaccines, treatments and tests illuminated the barriers IP poses for access to medicines and led to efforts by LMICs to negotiate a waiver of TRIPS for COVID-19 health products and technologies (Gleeson et al., Reference Gleeson, Townsend, Tenni and Phillips2023). While this effort faced strong opposition by HICs with sizeable research-based pharmaceutical sectors, and the ultimate result of 20 months of negotiations was a very limited waiver to certain requirements related to patents, it raised debate over the limitations of using the compulsory licensing provisions in TRIPS (Yu, Reference Yu2022).
More recently, the second Trump presidency has wrought profound changes to the global trade regime, threatening the collapse of the multilateral rules-based trading system. In a chaotic fashion, the Trump administration has introduced a variety of steep tariffs on its trading partners, and threatened more, including 200% tariffs on pharmaceuticals (Constantino, Reference Constantino2025, July 8). In this tumultuous environment, governments, particularly those in LMICs, will need to preserve maximum policy space to ensure they can deliver affordable medicines for their populations. As multilateral organisations like the WTO flounder, nations are increasingly likely to turn to broad-based agreements like the CPTPP to fill the gap and provide some certainty and predictability. Going forward, it will therefore be important for the CPTPP to set an appropriate standard of IP protection that does not curtail access to affordable medicines.
The turbulent geopolitical context does create some potential challenges to the removal of the CPTPP’s TRIPS-Plus provisions, however. For example, the four highest-income Parties (Japan, Canada, Australia and the UK) are likely to continue to perceive strong IP protection as vital to safeguarding pharmaceutical innovation – consistent with HIC positioning in the TRIPS Waiver negotiations (Yu, Reference Yu2022). Parties seeking reform of the IP provisions may also need to navigate debates about the standard-setting and strategic role of the CPTPP vis-à-vis the competing regional trade bloc, the Regional Comprehensive Economic Partnership – which has fewer TRIPS-Plus provisions. In this context, it will be important for states seeking to reform the CPTPP’s IP chapter to engage deeply with the research evidence and make a strong case for winding back TRIPS-Plus protections based on evidence of their economic and health costs.
5. Conclusions and recommendations
Based on our review of the evidence of the effects of TRIPS-Plus obligations on access to medicines, the suspended provisions relevant to pharmaceuticals from Chapter 18 of the CPTPP should be completely removed during the review of the CPTPP. The patent linkage provision of the CPTPP should also be removed or suspended, particularly considering the potential negative consequences for LMICs that may join in future. While states seeking reform will need to navigate geopolitical complexities, adopting these recommendations would preserve policy flexibility for current and future CPTPP Parties to adjust domestic IP laws to protect access to affordable medicines. It will also signal other IP negotiations or review processes to avoid such provisions.
Financial support
No funding was received for this work.
Competing interests
The authors have no competing interests to declare.
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