Compulsory licensing in middle‐income countries: A comparative content analysis

Abstract

Many countries all over the world have become more interested in the compulsory‐license policy tool since the COVID‐19 pandemic. The World Trade Organization's Agreement on Trade‐Related Aspects of Intellectual Property Rights allows Member States to adopt legislation that enables them to issue compulsory licenses for matters in the public interest and beyond. Compulsory licensing has been shown to decrease the prices of essential medicines and increase access to treatment for the target population. It is especially important for middle‐income countries that are commonly excluded from voluntary licenses. Using a quantitative scoring system, this study explores the extent to which 15 selected middle‐income countries have adopted TRIPS flexibilities into their compulsory licensing legislation, comparing their national laws with practices deemed by experts to maximize the effectiveness and useability of such laws. Findings demonstrate that all the study countries fall far short of what is allowable in terms of adopting TRIPS flexibilities relevant to compulsory licensing and should make legislative changes to increase the possibility of issuing effective compulsory and government use licenses. However, changing national laws is only one step toward effective use of compulsory and government use licenses to increase access to medicines.