Pharmaceutical Compulsory Licensing in High-Income Countries: Motivations & Outcomes
Author(s)
ABSTRACT WITHDRAWN
OBJECTIVES: The patent flexibilities codified by the World Trade Organization’s Doha Declaration in 2001 were designed to improve access to medicines essential to public health in developing countries. More recently however, pharmaceutical trade groups and media outlets in the United States have pointed to compulsory licensing as a possible explanation for the comparatively high prices the U.S. pays for drugs relative to other high-income countries. Our study sought to test the credibility of this argument. METHODS: We conducted a systematic review of the scientific literature, U.S. legal proceedings, and other publicly available databases to identify episodes of compulsory licensing across a basket of 18 developed countries. For each episode, we identified the group petitioning for the license, the motivation for doing so, the pharmaceutical product involved, and the final outcome (i.e., whether or not a license was granted or a price discount secured). RESULTS: Our search yielded 41 instances of compulsory licensing either being issued or threatened in the 20 years following the Doha Declaration, with the majority (54%) occurring in the U.S. The high price of pharmaceuticals motivated a minority of petitions for compulsory licensing (26% of all cases outside the U.S). Overall, 13 licenses were granted in the geography examined, with a smaller number (n=6) of these occurring outside the U.S. Only three instances were associated with a publicly confirmed price discount. CONCLUSIONS: Given that compulsory licensing appears to be infrequently employed in high-income countries outside the U.S., rarely results in reduced drug prices, and is similarly common in the U.S. itself, this patent flexibility is unlikely to contribute to differences in drug prices between the studied countries.
Conference/Value in Health Info
2021-11, ISPOR Europe 2021, Copenhagen, Denmark
Value in Health, Volume 24, Issue 12, S2 (December 2021)
Code
POSC214
Topic
Health Policy & Regulatory, Organizational Practices
Topic Subcategory
Industry, Pricing Policy & Schemes, Public Spending & National Health Expenditures, Reimbursement & Access Policy
Disease
Drugs, Generics