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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) View the PDF document
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
View the documentAcknowledgements
View the documentIntroduction
View the documentCircumstances in which the Decision may be used
View the documentCompulsory licence in the importing country
View the documentCompulsory licence in the exporting country
View the documentAnti-diversion measures
View the documentSuspension of the system
View the documentConclusions
View the documentAnnex 1: WTO Decision of 30 August 2003 (WT/L/540)
View the documentAnnex 2: Summary of context and steps required to use the system

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

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