by Robert Weissman
Misleading statements by the brand-name pharmaceutical industry and its allies continue to confuse numerous members of the media about countries’ authority to undertake compulsory licensing.
Here are some quick clarifications:
1. COMPULSORY LICENSES ARE *NOT* LIMITED TO EMERGENCY SITUATIONS
Under the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights, countries are free to issue compulsory licenses on whatever grounds they choose (TRIPS Article 31).
To remedy confusion about this point, the member countries of the WTO adopted the Doha Declaration on the TRIPS Agreement and Public Health. It specifically states,
Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted (Paragraph 5(b)).
There is no requirement to have declared an emergency to issue a compulsory license. TRIPS says only that certain otherwise required procedures can be bypassed in emergencies.
2. COMPULSORY LICENSING IS NOT A RIGHT LIMITED TO THE LEAST DEVELOPED COUNTRIES
Both the TRIPS Agreement and the Doha Declaration make this clear.
Rich countries routinely use compulsory licensing in a variety of contexts. The United States is likely the most frequent user of compulsory licensing.
3. THAILAND IS NOT REQUIRED UNDER TRIPS TO NEGOTIATE WITH PATENT HOLDERS BEFORE ISSUING COMPULSORY LICENSES
The Thai compulsory licenses are issued for “government use” — for use by the Ministry of Health.
Under TRIPS, compulsory licenses issued for government use do not require prior negotiation with the patent holder (The prior negotiation obligation may be waived “in cases of public non-commercial use,” Article 31(b)).
The United States, among other nations, makes use of this flexibility and does not require prior negotiations in cases of government use.
4. THAILAND IS ACTING LEGALLY UNDER ITS NATIONAL LAWS
Thai law permits compulsory licensing, and includes the TRIPS flexibility of waiving requirements for prior negotiation with patent holders in case goverment use.
For a brief legal analysis, see Washington College of Law’s Sean Flynn’s analysis.
Journalists should be aware of these facts before suggesting that Thailand’s actions are not legal, or quoting drug company representatives or industry allies making such representations.