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Compulsory Licensing of Pharmaceuticals in High-Income Countries: A Comparative Analysis.
Lindor Qunaj1, Anna Kaltenboeck2, Peter B Bach2
1Montefiore Medical Center, Albert Einstein College of Medicine.
The Milbank Quarterly
|March 8, 2022
Summary
Compulsory licensing is rarely used by high-income countries to lower prescription drug prices. This practice is unlikely to explain price differences between the US and other developed nations.
Area of Science:
- Health policy research
- Pharmaceutical economics
- Intellectual property law
Background:
- Compulsory licensing allows generic drug production before patent expiry.
- Historically used for essential medicines and public health crises.
- Its role in high-income countries' drug pricing is debated.
Purpose of the Study:
- To investigate the frequency and impact of compulsory licensing on drug prices in high-income countries outside the US.
- To determine if compulsory licensing explains drug price discrepancies.
Main Methods:
- Compiled a database of compulsory licensing episodes in the US and 17 comparator nations (2001-2021).
- Analyzed motivations and outcomes, including price discounts.
- Utilized reports from pharmaceutical intellectual property organizations, legal proceedings, and PubMed literature reviews.
Main Results:
- Identified 45 compulsory licensing episodes (24 US, 21 outside).
- Only 24% of non-US petitions were motivated by high prices.
- Few instances led to price discounts; none for new, high-cost drugs.
Conclusions:
- Compulsory licensing is not a frequent tool for price control in high-income countries.
- Its threat or implementation does not significantly impact drug prices.
- Unlikely to be a factor in US-other developed nation drug price disparities.
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