[Ip-health] Clarifications on Thai Compulsory Licensing

[robert weissman]

Clarifications on Thai Compulsory Licensing
Robert Weissman
Essential Action
January 31, 2007

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.

For an overview of compulsory licenses issued in the last five years,
see a memo from James Love of Knowledge Ecology International at:

http://lists.essential.org/pipermail/ip-health/2007-January/010435.html

and the broader overview of licenses here:

http://www.cptech.org/ip/health/cl/recent-examples.html

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 at:

http://lists.essential.org/pipermail/ip-health/2006-December/010326.html

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.