Compulsory licensing for public health : a guide and model documents for implementation of the Doha Declaration paragraph 6 decision

The Doha Declaration on the TRIPS Agreement and Public Health recognized that developing countries with insufficient, or no manufacturing capacity in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. The World Health Organization's (WTO) decision of August 30, 2003 set up a system intended to overcome these difficulties. The present work is a guide to the implementation of that system. The first part gives the reader an understanding of the issues involved; the second part provides model documents for use by governments. Four model instruments of notification are included: three for notification of the WTO as required by the Decision, and one for notification of the patent or right holder pursuant to Article 31 of the TRIPS Agreement. Because most countries will have to amend their legislation (typically their patent law) to implement the system, model amendment provisions have been provided both for exporting countries, and for importing countries. All model documents contain their own detailed commentary.