Compulsory Licensing For Public Health: A Guide And Model Documents For Implementation Of The Doha Declaration Paragraph 6 Decision (world Bank Working Papers)

This work addresses the complexity of the WTO's August 30, 2003 decision on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. It provides an explanation of the decision and model legal texts for the required notifications to the WTO and for the amendments of their patent law that most developing countries will need to pass in order to incorporate the decision in their domestic legal framework. 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 This overview of health financing tools, policies and trends--with a particular focus on challenges facing developing countries--provides the basis for effective policy-making. Analyzing the current global environment, the book discusses health financing goals in the context of both the underlying health, demographic, social, economic, political and demographic analytics as well as the institutional realities faced by developing countries, and assesses policy options in the context of global evidence, the international aid architecture, cross-sectoral interactions, and countries' macroeconomic frameworks and overall development plans