WHO guide on compulsory licensing and government use: Forthcoming?

On 23 October 2006, the WHO, as an intergovernmental organization with observer status at the WTO TRIPS Council, presented a seven page report on its technical cooperation activities with respect to “Trade, Intellectual Property Rights and Access to Medicines”.

The full document IP/C/W/478/Add.4 can be found on the WTO document database:

Under “Policy and technical guidance”, the WHO indicated that a forthcoming publication entitled Guide for the Application and Granting of Compulsory Licences and Authorization of Government Use of Pharmaceutical Patents would be released. This guide is a joint activity between WHO, UNICEF and UNAIDS. The mandate of WHA 60.30 requested the WHO Director-General to provide technical and policy support to countries using the flexibilities of the TRIPS Agreement and other international agreements and to “implement the Doha Ministerial Declaration”. Ten months after WHO’s bold announcement at WTO, we are still awaiting with baited breath, the release of this compulsory licensing guide. As recent experience in Thailand and Brazil has shown, there has been a dearth of political and practical support from WHO in helping countries implement the Doha Declaration which reaffirms WTO Members’ “right to protect public health and in particular, to promote access to medicines for all.” This must change.

The description of the guide furnished by WHO to the WTO TRIPS Council is extracted below.

A. Policy and technical guidance

14. WHO is also in the process of publishing the Guide for the Application and Granting of Compulsory Licences and Authorization of Government Use of Pharmaceutical Patents. The concept of the Guide had been agreed upon at an inter-agency technical workshop organized by WHO and UNICEF, with the support of UNAIDS in August 2005. Participants included representatives from UN agencies and international organizations such as the Global Fund for the Fight against AIDS, Tuberculosis and Malaria (GFATM), UNAIDS, UNDP, UNICEF and WHO. This Guide focuses on the grant of compulsory licences and government use authorization, in the context of the purchase and import of patent-protected pharmaceutical products. It provides general recommendations to governments, procurement agencies and nongovernmental organizations on the modalities for the application of compulsory licences and government use authorization. It also addresses the special situation of least developed countries, as provided for in Paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health, which allows least developed countries a transition period until 2016 during which they need not provide for, nor enforce, patent rights and exclusive marketing rights in relation to pharmaceutical products.