Pharmaceutical Production and Related Technology Transfer

1 Pharmaceutical Production and Related Technology TransferIntellectual Property and TradeFinancingTechnology TransferImproving AccessR&D, InnovationMonitoring and ReportingPharmaceutical Production and Related Technology TransferPrepared for the WHO Department of Public Health, Innovation and Intellectual Property by Suerie Moon (Kennedy School of Government and School of Public Health, Harvar d University).This report forms part of the project entitled: Improving access to medicines in developing countries through Technology tr ansfer Related to medical products and local Production .

2 It is implemented by the Department of Public Health Innovation and Intellectual Property of the World Health Organization (WHO/PHI) in partnership with the United Nations Confer ence on Trade and Development (UNCTAD) and the International Centr e for Trade and Sustainable Development (ICTSD) with funding fr om the European Union (EU). The over all objective of the project is to increase access especially for the poor in developing and least developed countries to medicines, vaccines and reports associated with this project ar e available for fr ee download fr om the following website: publication has been produced with the assistance of the European Union.

3 The contents of this publication ar e the sole responsibility of the World Health Organization and can in no way be taken to reflect the views of the European and design by In s Communication Librar y Cataloguing-in-Publication DataPharmaceutical Production and Related Technology Transfer : landscape drugs. preparations. tr ansfer . , Pharmaceutical . compounding. countries. Health 978 92 4 150235 1 (NLM classification: QV 704)All rights reserved. Publications of the World Health Organization ar e available on the WHO web site ( ) or can be purchased fr om WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.)

4 : +41 22 791 3264; fax: +41 22 791 4857; e-mail: for permission to reproduce or tr anslate WHO publications whether for sale or for noncommercial distribution should be addressed to WHO Press through the WHO web site (h ).The designations employed and the presenta tion 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 countr y, territory, city or ar ea or of its authorities, or concerning the delimitation of its fr ontiers or boundaries.

5 Dotted lines on maps represent approximate border lines for which there may not yet be full mention of specific companies or of certain manufacturers products does not imply that they ar e endorsed or recommended by the World Health Organization in pref er ence to others of a similar nature that ar e not mentioned. Errors and omissions excepted, the names of proprietary products ar e distinguished by initial capital reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication.

6 However , the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the in terpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising fr om its in FrancePhoto: WHO World Health Organization 2011iiiiiContentsAbbreviations ivAcknowledgments viExecutive summary 11.

7 Introduction 132. Methods 203. Overview of local Production of drugs in low- and middle-income countries 234.

8 Findings on initiatives for local Production and Technology Transfer 265. Discussion and key issues 416. Recommendations and conclusions 52 References 57 Annex I: Technology Transfer projects for local Production 65 Annex II: Technology Transfer projects for local Production 73 Annex III.

9 Voluntary licences for drugs (with and without Technology Transfer ) 75 Annex IV: Interviewed individuals 78 Annex V: Interview protocol 79ivAbbreviationsAIDS acquired immunodeficiency syndromeAPI active Pharmaceutical ingredientARV antiretroviralAusAID Australian Government Overseas Aid ProgramBMZ German Federal Ministry for Economic Cooperation and DevelopmentBuZa Ministerie van Buitenlandse Zaken (The Netherlands International Cooperation Agency)

10 CGMP current good manufacturing practiceCIDA Canadian International Development AgencyDanida Danish International Development AgencyDEG Deutsche Investitions- und EntwicklungsgesellschaftDFID United Kingdom Department for International DevelopmentDNDi Drugs for Neglected Diseases initiativeEAC East African CommunityECOWAS Economic Community of West African StatesEMEA European Medicines AgencyEU European UnionFDC fixed-dose combinationFIOCRUZ Oswaldo Cruz FoundationGFATM Global Fund to Fight AIDS, TB and MalariaG-FINDER Global Funding of Innovation for Neglected DiseasesGCP good clinical practiceGLP good laboratory practiceGMP good manufacturing practicesGNI gross national incomeGSK GlaxoSmithKlineGSPA-PHI Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property GIZ Gesellschaft f r Internationale Zusammenarbeit (Germany)