TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines

Abstract

Governed through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1995, the current medical R&D system requires significant trade-offs between innovation and high monopoly prices for patented drugs that restrict patient access to medicines. Since its implementation, few amendments have been made to the original TRIPS agreement to allow low- and middle-income countries (LMICs) to facilitate access by generic manufacturers through flexible provisions, such as compulsory licensing and parallel import. Although a useful policy tool in theory, the routine use of TRIPS flexibilities in LMICs in the procurement of new essential medicines (EMs) is regarded as a ‘last resort’ due to strong political response in high-income countries (HICs) and new trade agreements’ restrictions. In this context, access-oriented biomedical Public-Private Partnerships (PPPs) have emerged. More recently, leading multilateral health organizations have recommended different types of intellectual property (IP) interventions, voluntary biomedical patent pools, as strategies to reduce prices and increase the diffusion of novel EMs in LMICs. Nevertheless, the recent Ebola and COVID-19 outbreaks highlight growing concerns regarding the use of TRIPS flexibilities and the limited success of voluntary mechanisms in promoting access to medicines in the Global South amidst health crises. This review aims at describing the state-of-the-art empirical research on IP-related options and voluntary mechanisms applied by emerging PPPs to guarantee timely and affordable access to EM in LMICs and reflect on both models as access paradigms. Some suggestions are put forward for future research paths on the basis of these analyses and in response to contemporary debates on waiving key IP rights on COVID-19 therapies, diagnostics, and vaccines.

Cambodia's Imminent Graduation from Least Developed Country Status: What Will be the Impact of the TRIPS Agreement on Access to HIV and Hepatitis C Medicines in Cambodia?

“…It has been argued that IP barriers, such as the introduction of patent protection, can be addressed by remedial policies like voluntary licensing. 66 A voluntary license (VL) is an authorization given by a patent holder to a generic company, allowing it to produce a generic version of a patented pharmaceutical product. 67 VLs have been touted as a way to address the barriers that patents pose such as high prices and can substantially improve access to affordable generic medicines 68 ; however, current VL agreements would not provide sufficient access to the suite of medicines needed for Cambodia's HIV and hepatitis C treatment programs to alleviate the effects of Scenario 2 for each program.…”

The potential impact of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership on Thailand’s hepatitis C treatment program

“…Some commentators argue that potential patent barriers, like those created by membership of TRIPS-plus agreements such as the CPTPP, can be addressed by introducing remedial policies like voluntary licencing [ 44 ]. A voluntary licence is an authorisation given by a patent holder to a generic company, allowing it to produce a generic version of a patented pharmaceutical product [ 45 ].…”

Vaccine technology transfer in a global health crisis: Actors, capabilities, and institutions

“…technology transfer from the originator to partners. In contrast, then, to what was witnessed with AIDS, where generic producers (public and private) could make abundant and affordable treatments available ( Waning et al, 2010 ; Cassier and Correa, 2003 ), efforts to expand global supply of vaccines during the COVID-19 pandemic have depended on originator firms transferring technology and know-how to manufacturing partners ( Bown and Bollyky, 2022 , Fu et al, 2022 , Maxmen, 2021 , Krishtel and Hassan, 2021 , McMahon, 2021 , Mermelstein and Stevens, 2022 , Schultz, 2021 , Yamey et al, 2022 , Santiago, 2020 , O’Sullivan et al, 2020 , World Health Organization, 2021b , Barnes-Weise et al, 2022 ).…”

“…In building manufacturing networks to respond to unprecedented demands for vaccines, developers have transferred technology to partners around the globe. While the extent of technology transfer partnerships between COVID-19 vaccine developers in the Global North and local pharmaceutical companies in the Global South has been the subject of considerable debate, lauded by some for its extent and criticized by others for its limits ( Maxmen, 2021 , Cheng and Hinnant, 2021 , McMahon, 2021 , Schultz, 2021 , Yamey et al, 2022 , Jensen et al, 2022 ), the reliance on this approach to scaling-up production is unquestionably a defining feature of the pandemic ( Bown and Bollyky, 2022 , Fu et al, 2022 , Maxmen, 2021 , Krishtel and Hassan, 2021 , McMahon, 2021 , Mermelstein and Stevens, 2022 , Schultz, 2021 , Yamey et al, 2022 , Santiago, 2020 , O’Sullivan et al, 2020 , World Health Organization, 2021b ).…”