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Implementation of the WTO General Council Decision on Paragraph 6 of the DOHA Declaration on the Trips Agreement and Public Health - Health Economics and Drugs Series No. 016
(2004; 49 pages)

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Abstract

Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, adopted at the Fourth World Trade Organization (WTO) Ministerial Conference (9-14 November 2001), instructed the WTO Council for TRIPS (Trade-Related Aspects of Intellectual Property Rights) to address how WTO Members lacking or with insufficient manufacturing capacities in pharmaceuticals can make effective use of compulsory licensing. Many developing countries and the least developed countries (LDCs) cannot produce either active ingredients or formulations, due to lack of technology, equipment, human resources or economic viability of domestic production. While these countries may issue compulsory licences to import generic versions of patent-protected medicines, TRIPS rules impose constraints on the ability of countries to authorize exports of such products. Paragraph 6 promised a solution to the export problem caused by these constraints. Currently, some developing country Members of WTO do not yet provide patent protection for pharmaceutical products. Some companies in these countries produce generic versions of pharmaceuticals at prices significantly lower than those offered by brand name companies. Those products may legally be exported freely to other countries, provided that a) they are not covered by patents in the importing country; or b) if the product is patent protected in the importing country, that a compulsory licence is granted there. The problem is that, as product patents for pharmaceuticals become enforceable in accordance with the TRIPS Agreement, countries with industrial and export capacity will face legal obstacles to produce and export cheap generic copies of patented medicines... This paper examines the ways in which the Decision can be implemented in prospective importing and exporting countries. It is addressed to policy-makers and to potential suppliers and purchasers of pharmaceutical products...

Table of Contents

Implementation of the WTO General Council Decision on Paragraph 6 of the DOHA Declaration on the Trips Agreement and Public Health - Health Economics and Drugs Series No. 016

Carlos M. Correa
University of Buenos Aires
April 2004

Essential Drugs and Medicines Policy

This document was produced by the
Drug Action Programme
of the Department of Essential Drugs and Medicines Policy
Ordering code: WHO/EDM/PAR/2004.4

This document is available on the Internet at:
http://www.who.int/medicines/

Copies may be requested from:
World Health Organization
Department of Essential Drugs and Medicines Policy
CH-1211 Geneva 27, Switzerland
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The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.

The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.

The World Health Organization does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use.

	Acknowledgements
	Introduction
	Circumstances in which the Decision may be used
	Compulsory licence in the importing country
	Compulsory licence in the exporting country
	Anti-diversion measures
	Suspension of the system
	Conclusions
	Annex 1: WTO Decision of 30 August 2003 (WT/L/540)
	Annex 2: Summary of context and steps required to use the system

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Implementation of the WTO General Council Decision on Paragraph 6 of the DOHA Declaration on the Trips Agreement and Public Health - Health Economics and Drugs Series No. 016

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