Importance of the intellectual property system in attempting compulsory licensing of pharmaceuticals: a cross-sectional analysis

Abstract

Background Recently, interest in compulsory licensing of pharmaceuticals has been growing regardless of a country’s income- level. We aim to investigate the use of compulsory licensing as a legitimate part of the patent system and tool for the government to utilize by demonstrating that countries with a mature patent system were more likely to utilize compulsory licensing of pharmaceuticals. Methods We used a multivariate logistic model to regress attempts to issue compulsory licensing on the characteristics of the intellectual property system, controlling for macro context variables and other explanatory variables at a country level. Results A total 139 countries, selected from members of the World Trade Organization, were divided into a CL-attempted group ( N = 24) and a non-CL-attempted group ( N = 115). An attempt to issue compulsory licensing was associated with population (+) and a dummy variable for other regions, including Europe and North America (−). After controlling for macro context variables, mature intellectual property system was positively associated with attempting compulsory licensing. Conclusions Our study provided evidence of an association between attempting compulsory licensing and matured patent systems. This finding contradicts our current understanding of compulsory licensing, such as compulsory licensing as a measure to usurp traditional patent systems and sometimes diametrically opposed to the patent system. The findings also suggest a new role of compulsory licensing in current patent systems: compulsory licensing could be a potential alternative or complement to achieve access to medicines in health systems through manufacturing and exporting patented pharmaceuticals.

Compulsory Licensing of Pharmaceuticals in High‐Income Countries: A Comparative Analysis

“…Since our study question necessitated a narrow focus on high‐income countries, we cannot generalize on the motivations for and outcomes of compulsory licensing actions in low‐ and middle‐income countries. However, it is in these countries where compulsory licensing has had the greatest impact on public health, in particular through increased access to antiretroviral therapy for HIV/AIDS 17‐20 …”

A Covid Competition Dilemma: Legal and Ethical Challenges Regarding the Covid-19 Vaccine Policies during and after the Crisis

“…It appears that ensuring collective benefits, even if it harms certain individuals, is morally justifiable . Even in non-pandemic contexts, the theory of essential facilities 3 and compulsory pharmaceutical licensing has justified the coercion of producers for the benefit of society (Son, 2019;Lo Bianco, 2020, pp . 2-4) .…”

Ideas-Driven Endogenous Growth and Standard-Essential Patents

“…The IP holder loses full protection of the IP and the associated monopoly mark-up. These measures have been profound in the context of public healthcare systems to ensure continuous availability of essential drugs (Son [2019]). Compulsory licensing is an extreme example of "fair and reasonable" pricing, which entails very little negotiation with the IP holder once implemented.…”

“…One of the oldest policy have been compulsory licensing, in which the patent holder is obliged by the government to release the intellectual property to the end-users at some mandated price. More recently, under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) governments can authorize various forms of compulsory licensing for its own purposes (Son [2019]).…”

“…Unlike compulsory licensing, which is a "stick-measure" and has been documented to be often limited and sporadic (Son [2019]), the "carrot-measure" of FRAND pricing seem to be more promising in speeding up further development of the IP due to simplifying the "basics" of standard usage as an interface for everybody to use. Our model suggests it is important to complement mark-up regulation with promoting further innovation when addressing patent abuse.…”