Trends in compulsory licensing of pharmaceuticals since the Doha Declaration: a database analysis

Area of Science:

• Global Health Governance
• Intellectual Property Rights
• Pharmaceutical Policy

Background:

• The 2001 Doha Declaration aimed to facilitate compulsory licensing (CLs) for pharmaceuticals.
• Skepticism existed regarding the actual utilization of CLs due to political and economic factors.
• Systematic assessment of the Doha Declaration's impact has been limited.

Purpose of the Study:

• To systematically assess the impact of the Doha Declaration on compulsory licensing activity.
• To analyze trends and characteristics of compulsory licensing episodes globally.
• To evaluate the factors influencing the use of compulsory licenses.

Main Methods:

• Compiled a global database of compulsory licensing episodes from 1995 onwards.
• Verified government participation in 24 compulsory licensing cases across 17 nations.
• Coded episodes by outcome, national income, and disease group over distinct periods.

Main Results:

• Compulsory licensing activity peaked between 2003-2005, predominantly involving HIV/AIDS drugs in upper-middle-income countries (UMICs).
• No compulsory licenses were recorded in least-developed or low-income countries.
• Despite incentives, UMICs faced significant pressures limiting compulsory license use.

Conclusions:

• While compulsory licensing occurred more than expected, activity has significantly declined since 2006.
• Continued compulsory licensing is unlikely due to persistent countervailing pressures.
• Further systematic evaluation of global health governance is necessary.