Factors affecting the use of compulsory licensing to increase access to medicines: An exploratory econometric analysis for 193 countries

Background: The findings from previous studies on the relationship between a country's use of compulsory licensing and its national characteristics have been inconsistent and contradictory.

Purpose: To explore what national-level factors are associated with a county's decision to implement compulsory licenses.

Methods: Binary and ordered logistic regression models were used to estimate the likelihood that a country would use any compulsory licenses for increasing access to medicines. Key predictor variables included country-level socioeconomic and demographic characteristics, disease burden, WTO membership, patent activities, and size of export.

Results: The analysis using binary logistic models showed that: (1) an increase of 100 annual patent filings was significantly associated with a 1.32% decrease in the odds of a country issuing a compulsory license and a 0.15% decrease when threat of compulsory licensing was additionally included; (2) an increase of $1 billion in merchandise export showed a 2.09% and a 1.51% increase in each odds, respectively; and (3) an increase of 100 age-standardized DALYs of HIV/AIDS showed a 1.37% and 1.49% increase in each odds. However, the findings from ordered logistic regression models showed that the association between the number of patent filings and the issuance of a compulsory license was not statistically significant.

Conclusions: Countries with a greater size of export or greater burden of HIV/AIDS are more likely to issue compulsory license, while countries with higher patent activities are less likely to do so. However, findings from this analysis are sensitive to model specification and further study is warranted.