25 June 2024

TRIPS

Factors influencing the prioritisation of access to medicines in trade-related intellectual property policymaking in Thailand' by Brigitte Tenni, Joel Lexchin, Chutima Akaleephan, Chalermsak Kittitrakul, Belinda Townsend, Deborah Gleeson in (2024) Journal of World Intellectual Property comments 

International trade is often viewed as an essential component of economic growth, however trade agreements come with risks to public health, including to access to medicines. Thailand, like many other low and middle-income countries (LMICs), faces ongoing trade-related challenges that threaten access to an affordable and sustainable supply of medicines. These challenges include external trade pressures to modify policies and laws that govern intellectual property (IP) and bilateral and regional trade agreements through which high-income countries like the United States (US) seek to increase patent protection for pharmaceutical products and processes. 

Access to an affordable and sustainable supply of medicines is an important policy objective for Thailand given its commitment to universal health coverage (UHC) and reliance on locally produced and imported generic medicines. In 2002, Thailand became one of the first middle-income countries to implement UHC which covers 47 million people or 72% of the population. IP barriers have been a consistent challenge to Thailand's ability to ensure access to affordable medicines within its UHC scheme. 

Thailand has a rich history of balancing trade pressures and public health priorities and has been lauded for achieving a degree of policy coherence between trade and health. This balance has been attributed to instances of bold political leadership and skilled advocacy by a well-networked and informed civil society. Trade and health officials have often come together to address divergent interests and positions. A broad range of stakeholders that includes academics, lawyers, pharmacists, patient interest and consumer groups and access to medicines activists, has closely followed these developments and has created broad-based coalitions and sustainable advocacy to preserve Thailand's policies that maximise access to affordable generic medicines. Thailand, therefore, provides an interesting case study of the relationship between trade-related IP and access to medicines as many LMICs look to Thailand for lessons of how to navigate and balance public health imperatives and IP obligations. 

Thailand's IP laws and policies, including its patent laws, are shaped by its membership of the World Trade Organization (WTO). Thailand has been a WTO member since its inception in January 1995 and a member of General Agreement on Trade and Tariffs since 20 November 1982. As a condition of WTO membership, Thailand must abide by the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) which came into effect on 1 January 1995 and remains the most comprehensive multilateral agreement on IP. TRIPS binds WTO Members to minimum standards of IP protection and obliges Member States to make patents available for pharmaceutical products or processes that meet the standard criteria for patentability, novelty, inventive step and industrial applicability. TRIPS also contains ‘flexibilities’, designed to mitigate the negative impacts of patents, such as high medicines prices caused by pharmaceutical company monopolies. Compulsory licensing (CL) is one such example of a TRIPS flexibility. CL refers to the process through which a government allows the production of a patented product or the use of a patented process without the consent of the patent owner. The patent holder must be paid a royalty based on a percentage of sales by the licensee. 

Thailand has also experienced ongoing pressures to extend IP protection through its participation in trade agreements with provisions that exceed the requirements of TRIPS (often referred to as ‘TRIPS-plus’ provisions). TRIPS-plus provisions, such as obligations to extend patent terms beyond 20 years, lower thresholds for granting patents or restrict the grounds for granting compulsory licences, can lead to longer monopoly periods for new medicines and delays to the market entry of affordable generics. Thailand has not yet signed a trade agreement with these patent-related TRIPS-plus provisions, yet it has experienced ongoing pressures to do so. 

Indeed, Thailand provides an interesting puzzle. It introduced patent IP protection in the early 1990s before it was required to through TRIPS, is one of the few countries that has initiated CL for local production of generic medicines, and has actively opposed TRIPS-plus measures in trade negotiations, yet has repeatedly expressed interest in joining the Comprehensive and Progressive Agreement on Trans-Pacific Partnership (CPTPP), which includes TRIPS-plus measures (although some of these are currently suspended). 

Why and how governments prioritise access to medicines in their trade policymaking has not received much attention to date in the scholarly literature on trade and health. One study of how health issues fared on the Australian government's agenda during its participation in the Trans-Pacific Partnership negotiations identified 16 factors including the strength of exporter interests; extent of political will of Trade and Health Ministers; framing of health issues; support within the major political parties; the strength of available evidence; and the presence of existing domestic legislation and international treaties, among others. Similarly, a study of why TRIPS-plus measures dropped off the negotiating agenda of the Regional Comprehensive Economic Partnership Agreement (RCEP) negotiations (to which Thailand was party) identified the importance of the technical capacity of strong civil society actors and LMIC negotiators; supportive public health norms; processes that allowed for public scrutiny and public health views; the use of evidence; and country specific support for public health issues. 

A recent narrative review of public health advocacy strategies to influence trade policy identified a range of factors as important for advancing health issues on trade policy agendas, including favourable international media attention and mainstream media coverage, leadership by Ministers of Trade and Health; public support; and political party support. Very few studies identified by the narrative review included Thailand or other nations in Southeast Asia. Two studies explored the feasibility of implementing a human rights-based impact assessment tool to measure the impact of TRIPS-plus trade agreements in Thailand. A study of the access to medicines movement in Thailand traces its links to AIDS activism and identified access to knowledge as a key component of the movement's success. Another study from Thailand explored the capacity building of health actors to engage in global health diplomacy including trade negotiations. This study found that an increase in the capacity of health actors to engage with trade negotiators and a greater understanding of the effects of trade on health led to greater attention to health within trade negotiations. In terms of compulsory licencing, a study analysed the policy processes that led to the granting and implementation of Thailand's compulsory licences and found that the effective confluence of knowledge and evidence, civil society movements, public support and leadership of policy makers and politicians helped overcome the seemingly insurmountable obstacles to issuing the CLs in Thailand. Similarly, Rosenberg found that established relationships between individuals, collective advocacy and structural elements in Thailand created an enabling environment for Thailand to prioritise health over IP rights. 

The current study aims to elucidate the factors that have influenced prioritisation of access to medicines in trade-related IP policy making in Thailand by focusing on three policy case studies: (1) Thailand's patent law and its amendments; (2) its issuance of compulsory licences; and (3) its decision-making about TRIPS-plus trade agreements including potential membership of the CPTPP. These case studies were chosen because they reflect distinct episodes in Thailand's IP policymaking. The findings can provide an evidence base for future trade-related IP decision making for Thailand and other countries that seek to overcome trade-related IP barriers to access to an affordable supply of medicines.