TRIPS flexibilities help change policy and practice to increase access to medicines: evidence from 2001 to 2024

Millions of people lack access to safe and effective pharmaceuticals because they are unaffordable or unavailable, particularly in 'developing' and 'least-developed' countries (DCs, LDCs), and increasingly in high-income countries (HICs). Management of intellectual property (IP) related to new medicines has a significant impact on access to safe, affordable and effective medicines. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides the international legal framework for IP protection and mandates 20-year patents in all technological fields, including pharmaceuticals. TRIPS contains flexibilities, such as compulsory licensing (CL) and transition provisions for LDCs, which governments can use to facilitate access to health technologies. The use of these flexibilities is underreported in the literature, and a thorough analysis has not been undertaken since the COVID-19 pandemic.

A scoping review of three medical and legal databases and temporal analysis of all known instances of use or potential use of CLs and the LDC pharmaceutical transition measure between 2001-2024.

61% of the 149 CL instances were executed. The relative rates of CL use between countries have shifted: HICs represent over half of CL instances in the last decade. CLs are increasingly considered for chronic, non-communicable and rare diseases. The threat of CL use continues to provide impetus for price negotiations, voluntary licences or other measures to improve access. Almost all eligible countries have invoked the right to use the LDC transition measure.

TRIPS flexibilities have been used to facilitate access to medicines (including vaccines) over the quarter-century since the adoption of the World Trade Organization's Doha Declaration on TRIPS and Public Health. The flexibilities play a vital role in ensuring that new medicines are affordable and are likely to continue to be in a future where geopolitical forces have drastically altered the financing structures of medicines provision in DCs and LDCs.