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Local Production of Pharmaceuticals and Related Technology Transfer in Developing Countries a Series of Case Studies by the UNCTAD Secretariat

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Local Production of Pharmaceuticals and Related Technology Transfer in Developing Countries a Series of Case Studies by the UNCTAD Secretariat Monitoring and Intellectual R&D, Technology Improving Access Financing Property and Trade Innovation Transfer Reporting A series of case studies by the UNCTAD Secretariat UNCTAD the by studies case of A series Developing Countries Developing Local Production of Pharmaceuticals in Transfer and Related Technology Local Production of Pharmaceuticals and Related Technology Transfer in Developing Countries A series of case studies by the UNCTAD Secretariat New York and Geneva, 2011 UNCTAD/DIAE/PCB/2011/ Local Production of Pharmaceuticals and Related Technology Transfer in Developing Countries: A Series of Case Studies by the UNCTAD Secretariat 1.Essential drugs. 2.Pharmaceutical preparations. 3.Technology transfer. 4.Technology, Pharmaceutical. 5.Drug compounding. 6.Developing countries. ISBN-13: 978-92-1-112838-3 eISBN: 978-92-1-055150-2 Sales #: E.11.II.D.18 Copyright © United Nations, 2011. All rights reserved worldwide. This report forms part of the project entitled: Improving access to medicines in developing countries through technology transfer related to medical products and local production. 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 Conference on Trade and Development (UNCTAD) and the International Centre for Trade and Sustainable Development (ICTSD) with funding from the European Union (EU). The overall objective of the project is to increase access – especially for the poor in developing and least developed countries – to medicines, vaccines and diagnostics. UNCTAD has granted to the World Health Organization (WHO) and the International Centre for Trade and Sustainable Development (ICTSD) worldwide, non-exclusive, royalty-free, perpetual licenses. This material is available for free at http://www.unctad.org/ddip and http://www.who.int/phi/en/ 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 United Nations (UNCTAD or WHO) 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 United Nations (UNCTAD or WHO) 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. All reasonable precautions have been taken by UNCTAD to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall UNCTAD be liable for damages arising from its use. Editing and design by Inís Communication – www.iniscommunication.com Photo: WHO Printed in France and the United States This publication has been produced with the assistance of the European Union. The contents of this publication are the sole responsibility of UNCTAD and can in no way be taken to reflect the views of the European Union. Contents Abbreviations . iv. Acknowledgements . 1. Note. 2 Preface . 3. Overview: . .5 . Case study 1 Argentina . 17. Case study 2 Bangladesh . .57 . Case study 3 Colombia . 89. Case study 4 Ethiopia . .137 . Case study 5 Indonesia . .169 . Case study 6 Jordan . 193. Case study 7 Thailand . .225 . Case study 8 Uganda . .261 . Annex: Field questionnaire . 295. Index . 309. iii Abbreviations AIDS acquired immunodeficiency syndrome AIM Alternative Investment Market API active pharmaceutical ingredient ARV antiretroviral ASEAN Association of South-East Asian Nations cGMP current good manufacturing practices CIF cost, insurance and freight COMESA Common Market for Eastern and Southern Africa CRO contract research organization DFID [UK] Department for International Development DSU Dispute Settlement Understanding EAC East African Community EMEA European Medicines Agency EU European Union FDA Food and Drug Administration FDI foreign direct investment FTA free trade agreement GCC Gulf Cooperation Council GDP gross domestic product GIZ Gesellschaft für Internationale Zusammenarbeit GMP good manufacturing practices GSPA-PHI Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property HDI Human Development Index HIV human immunodeficiency virus ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICSID International Centre for Settlement of Investment Disputes ICT information and communication technologies iv IFC International Finance Corporation ICTSD International Centre for Trade and Sustainable Development IFPMA International Federation of Pharmaceutical Manufacturers Association INN international nonproprietary name IPRC International Pharmaceutical Research Centre KfW Kreditanstalt für Wiederaufbau LDC least developed country LIBOR London interbank offered rate MDG Millennium Development Goal MENA Middle East/North Africa MHRA United Kingdom Medicines and Healthcare Products Regulatory Agency NCE new chemical entity NDDS new drug delivery system NGO nongovernmental organization NIH United States National Institutes of Health OECD Organisation for Economic Co-operation and Development OTC over-the-counter PAHO Pan American Health Organization PCT Patent Cooperation Treaty PIC/S Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme PPP purchasing power parity R&D research and development SCI Science Citation Index STA scientific and technological activities TB tuberculosis TRIPS Agreement on Trade-Related Aspects of Intellectual Property Rights UN United Nations v UNCTAD United Nations Conference on Trade and Development UNICEF United Nations Children’s Fund UNIDO United Nations Industrial Development Organization USAID United States Agency for International Development USPTO United States Patent and Trademark Office VAT value-added tax WHO World Health Organization WIPO World Intellectual Property Organization WTO World Trade Organization vi Acknowledgements This series of case studies was prepared by UNCTAD’s Intellectual Property (IP) Unit, under the supervision of Kiyoshi Adachi, Chief, IP Unit, in the Investment Capacity-Building Branch of the Division on Investment and Enterprise, under a joint project with the World Health Organization (WHO) and the International Centre for Trade and Sustainable Development (ICTSD). This project has been funded by the European Union (EU). UNCTAD, WHO and ICTSD gratefully acknowledge the following contributions to this series: • An overview of eight country case studies: Padmashree Gehl Sampath, formerly Technical Officer at the Public Health, Innovation and Intellectual Property department, WHO, and now Economic Affairs Officer, Science, Technology and Innovation Branch, Division on Technology and Logistics, UNCTAD, Switzerland; • The Local Production of Pharmaceuticals and Related Technology Transfer: Argentina: Luis Mariano Genovesi, Professor of Law at Universidad de Buenos Aires, Argentina; • The Local Production of Pharmaceuticals and Related Technology Transfer: Bangladesh: Padmashree Gehl Sampath, UNCTAD, Ermias Biadgleng and Christoph Spennemann, Legal Experts, IP Unit, UNCTAD; • The Local Production of Pharmaceuticals and Related Technology Transfer: Colombia: Luis Mariano Genovesi, Universidad de Buenos Aires, with the assistance of Maximiliano Chab, Regionalism Programme Officer, ICTSD, Switzerland; • The Local Production of Pharmaceuticals and Related Technology Transfer: Ethiopia: Ermias Biadgleng, UNCTAD, Onno Schellekens, then Managing Director, PharmAccess Foundation, and now Managing Director, Investment Fund for Health in Africa (IFHA), The Netherlands, and Arie de Groot, Couloir Partners, Switzerland, and Consultant to PharmAccess Foundation; • The Local Production of Pharmaceuticals and Related Technology Transfer: Indonesia: Kiyoshi Adachi, UNCTAD, and Brian Tempest, Partner, Hale & Tempest; • The Local Production of Pharmaceuticals and Related Technology Transfer: Jordan: Ermias Biadgleng, UNCTAD, and Brian Tempest, Hale & Tempest; • The Local Production of Pharmaceuticals and Related Technology Transfer: Uganda: Padmashree Gehl Sampath, UNCTAD, and Christoph Spennemann, UNCTAD; • The Local Production of Pharmaceuticals and Related Technology Transfer: Thailand: Cecilia Mei-Yun Oh, independent consultant, Bangkok, Thailand. The organizations express gratitude for the support given by local agencies, especially WHO country offices (Jordan and Bangladesh), the Pharmaceutical Producers Association (Jordan), the Gesellschaft für Internationale Zusammenarbeit (GIZ) (Bangladesh and Ethiopia) and Kreditanstalt für Wiederaufbau (KfW) (Bangladesh) for their support during field missions. The organizations wish to thank all stakeholders who participated at a peer review workshop on 22–23 November 2010 in Geneva as well as at regional dialogues on 11–12 December 2009 in Cape Town, South Africa, 18–19 March 2010 in Buenos Aires, Argentina, and 29–30 April 2010 in Kuala Lumpur, Malaysia for their comments and suggestions. 1 Note UNCTAD serves as the lead entity within the United Nations Secretariat
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