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.

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Bibliographic Details
Main Authors: Abbott, Frederick M., Van Puymbroeck, Rudolf V.
Language:English
en_US
Published: Washington, DC : World Bank 2005
Subjects:ANTI-COMPETITIVE PRACTICES, CANCER, COMMERCIAL POLICY, COMMERCIAL USE, COMPONENT MATERIALS, COMPULSORY LICENSES, COMPULSORY LICENSING, DEVELOPED COUNTRIES, DOMESTIC LAW, DOMESTIC LEGISLATION, DOMESTIC MARKET, DOMESTIC SUPPLY, ECONOMIC VALUE, ECONOMIES OF SCALE, EFFECTIVE USE, EXERCISES, EXPORTING COUNTRIES, EXPORTING COUNTRY, FINISHED PRODUCTS, IMPORTING COUNTRIES, IMPORTING COUNTRY, INCOME, INCOME COUNTRIES, INTELLECTUAL PROPERTY, INTELLECTUAL PROPERTY RIGHTS, INTERNATIONAL COMMUNITY, INTERNATIONAL ORGANIZATIONS, INTERNATIONAL TRADE, INTRA-REGIONAL TRADE, LEGAL FRAMEWORK, LEGAL ISSUES, LEGAL REQUIREMENT, LEGAL RULES, LEGAL SIGNIFICANCE, LEGAL STATUS, LOCAL PRODUCTION, MALARIA, MEDIA, MEDICINES, MEMBER COUNTRIES, MEMBER COUNTRY, MEMBER STATES, MULTILATERAL NEGOTIATIONS, NATIONAL COURT, NATIONAL LAW, NATIONAL LEGISLATION, PARTNERSHIP, PATENT PROTECTION, PATENTED PROCESS, PATENTS, PATIENTS, PRODUCT PATENT, PUBLIC HEALTH, PUBLIC NON-COMMERCIAL USE, REGIONAL TRADE, REGIONAL TRADE AGREEMENT, REGIONAL TRADE ARRANGEMENTS, REGULATORY FRAMEWORK, SUBSIDIARY RIGHTS, TAXATION, TECHNICAL ASSISTANCE, TECHNOLOGY TRANSFER, TRADE DIVERSION, TRADE POLICIES, TRADE REGIME, TRIPS AGREEMENT, TRIPS] AGREEMENT, WORLD TRADE, WORLD TRADE ORGANIZATION, WTO, WTO AGREEMENT, WTO MEMBERS,
Online Access:http://documents.worldbank.org/curated/en/2005/07/6258659/compulsory-licensing-public-health-guide-model-documents-implementation-doha-declaration-paragraph-6-decision
https://hdl.handle.net/10986/7269
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Summary: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.