Printed in Austria V1-November 2012 PHARMACEUTICAL M ANUFACTURING PLAN FOR A FRICA - Business Plan PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA Business Plan African Union Commission P.O. Box 3243, Roosvelt Street (Old Airport Area), W21K19 Addis Ababa, Ethiopia Internet: www.au.int This document has been produced without formal United Nations editing. The designations employed and the presentation of the material in this document do not imply the expression of any opinion whatsoever on the part of the Secretariat of the United Nations Industrial Development Organization (UNIDO) concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries, or its economic system or degree of development. Designations such as “developed”, “industrialized” and “developing” are intended for statistical convenience and do not necessarily express a judgment about the stage reached by a particular country or area in the development process. Mention of firm names or commercial products does not constitute an endorsement by UNIDO. The opinions, statistical data and estimates contained in signed articles are the responsibility of the author(s) and should not necessarily be considered as reflecting the views or bearing the endorsement of UNIDO. Although great care has been taken to maintain the accuracy of information herein, neither UNIDO nor its Member States assume any responsibility for consequences which may arise from the use of the material. Cover photographs Left image Shutterstock, Inc. Middle image Shutterstock, Inc. Right image Shutterstock, Inc. PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA Business Plan Addis Ababa, 2012 ACKNOWLEDGEMENT This Business Plan was developed by a partnership of the African Union Commission (AUC) and the United Nations Industrial Development Organization (UNIDO) to accel- erate the implementation of the Pharmaceutical Manufacturing Plan for Africa (PMPA), with funding from the German government. The Commission therefore extends special appreciation to UNIDO for the resourceful collaboration through which this Business Plan has been developed. The Commission greatly appreciates all member states constituting the Technical Com- mittee of the Pharmaceutical Manufacturing Plan for Africa from North Africa (Egypt and Libya), West Africa (Ghana, Nigeria and Senegal), Central Africa (Burundi, Cameroon and Gabon), East Africa (Kenya and Ethiopia) and Southern Africa (South Africa and Angola) for their support to the process. The Commission further wishes to recognize the effort of other members of the Technical Committee such as NEPAD Planning and Coordinating Agency, WHO, UNAIDS, Region- al Economic Communities, Southern African Generic Manufacturers Association, Fed- eration of African Pharmaceutical Manufacturers Associations, COHRED, EDCTP, and ANDI, who since joining the Technical Committee, have supported the implementation of its broadened mandate. The Commission thanks all the organizations including members of the consortium of the AMRH Programme that are supporting Africa’s development agenda through implement- ing programmes geared towards promoting access to quality affordable medicines. The Commission acknowledges the efforts of the authors of the Business Plan, a team com- posed of Dr. Skhumbuzo Ngozwana & Mr. Alastair West from UNIDO and Dr. Ademola Olajide & Dr. Janet Byaruhanga from the Health, Nutrition and Population Division of the AUC Department of Social Affairs. FOREWORD During the last decade promoting sustainable access to quality and affordable medicines and integrating local production as part of the overall health systems strengthening package has been of significant concern to African leaders. A viable pharmaceutical industry in Africa shall not only impact on the African health sys- tem and its capacity to respond to the health needs of the people but also will contribute to the overall socioeconomic development of the continent. For this reason, African governments have committed to enhancing the attainment of one of the set targets of the 8th Millennium Development Goal, to increase the proportion of the population with access to affordable essential drugs on a sustainable basis. The African Union Commission has been at the forefront in galvanizing the necessary po- litical will and providing the leadership to the broad range of processes required for promot- ing a sustainable local pharmaceutical industry. The Commission has made significant efforts towards ensuring delivery on set objectives of Africa’s highest decision making body (The Assembly of Heads of State and Government) as they relate to the implementation of a Pharmaceutical Manufacturing Plan for Africa (PMPA). These range from conducting studies to establish Africa’s local pharma production capacity, building strategic partnerships required for the development of a concrete action plan, to engaging governments in the development of the Business Plan for the operation- alization of the PMPA. This Business Plan is a product of multi-stakeholder efforts all geared towards providing a package of solutions to address the various challenges confronting the African pharma sec- tor in general. It is not an end in itself but rather a means through which governments either through their national systems or regional economic communities will engage with relevant partners to implement specific activities according to their unique needs/priorities. The road ahead remains long and challenging but the desired objectives remain compelling and non-negotiable. Consequently I invite all stakeholders from member state governments to Regional Economic Communities; from the Private for Profit Sector to Donors and De- velopment partners to strategically engage and collaborate, creating the unity of purpose and necessary synergies to realize the noble objectives of this Business Plan. Bience P. Gawanas Commissioner for Social Affairs iii iv CONTENTS ACKNOWLEDGEMENT ........................................................................................................... ii FOREWORD .......................................................................................................................... iii List of Abbreviations .......................................................................................................... vii List of Figures ....................................................................................................................... x List of Tables ....................................................................................................................... xi EXECUTIVE SUMMARY ..........................................................................................................1 SWOT ANALYSIS ...................................................................................................................6 1. Introduction and Background ..........................................................................................11 1.1 THE STRATEGIC CONTEXT OF AFRICA’S HEALTHCARE CHALLENGES ................................ 12 1.2 THE PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA ........................................... 18 1.3 BUSINESS PLAN ................................................................................................................20 1.4 SUMMARY OF CHAPTER 1 .................................................................................................22 2. Overview of Pharmaceutical Manufacturing in Africa .................................................... 25 2.1 INTRODUCTION: THE PHARMACEUTICAL MANUFACTURING SYSTEM ................................25 2.2 THE CURRENT STATUS OF THE PHARMACEUTICAL INDUSTRY AND OTHER STAKEHOLDERS ...................................................................................................29 2.3 CHALLENGES AND OPPORTUNITIES FOR LOCAL PRODUCTION ........................................47 2.4 SUMMARY OF CHAPTER 2 ................................................................................................54 3. Solutions .........................................................................................................................57 3.1 THE GENERIC SOLUTIONS PACKAGE .................................................................................58 3.2 OTHER ACTIVITIES ...........................................................................................................77 3.3 SUMMARY OF CHAPTER 3 ................................................................................................82 4. Implementation Plan ..................................................................................................... 85 4.1 PHASED APPROACH TO IMPLEMENTATION ......................................................................86 4.2 STAKEHOLDER ENGAGEMENT .......................................................................................... 91 4.3 PROPOSED STRUCTURE FOR DELIVERING THE PMPA ....................................................93 4.4 RESOURCE REQUIREMENTS ............................................................................................95 4.5 MONITORING AND EVALUATION .......................................................................................99 4.6 RISK MANAGEMENT.........................................................................................................101 4.7 SUMMARY OF CHAPTER 4 .............................................................................................. 102