Business Plan PHARMACEUTICAL MANUFACTURING PLAN …

1 PHARMACEUTICAL MANUFACTURING plan FOR AFRICAB usiness PlanAfrican Union Commission Box 3243, Roosvelt Street (Old Airport Area), W21K19 Addis Ababa, EthiopiaInternet: Printed in AustriaV1-November 2012 PHARMACEUTICAL MANUFACTURING plan FOR AFRICA - Business PlanThis document has been produced without formal United Nations editing. The designations employed and thepresentation of the material in this document do not imply the expression of any opinion whatsoever on the partof the Secretariat of the United Nations Industrial Development Organization (UNIDO) concerning the legal statusof any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers orboundaries, or its economic system or degree of development.

2 Designations such as developed , industrialized and developing are intended for statistical convenience and do not necessarily express a judgment about thestage reached by a particular country or area in the development process. Mention of firm names or commercialproducts does not constitute an endorsement by UNIDO. The opinions, statistical data and estimates containedin signed articles are the responsibility of the author(s) and should not necessarily be considered as reflecting theviews or bearing the endorsement of UNIDO. Although great care has been taken to maintain the accuracy ofinformation herein, neither UNIDO nor its Member States assume any responsibility for consequences which mayarise from the use of the photographsLeft image Shutterstock, image Shutterstock, image Shutterstock, MANUFACTURING plan FOR AFRICAB usiness plan Addis Ababa, 2012 ACKNOWLEDGEMENTThis 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.

3 The Commission therefore extends special appreciation to UNIDO for the resourceful collaboration through which this Business plan has been 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 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.

4 Have supported the implementation of its broadened 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 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. iiiFOREWORDD uring 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 signi!

5 Cant 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 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 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.

6 The Commission has made signi!cant 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 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.

7 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 speci!c activities according to their unique 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 Pro!t 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 P. GawanasCommissioner for Social Affairsiv vCONTENTSACKNOWLEDGEMENT.

8 IiFOREWORD ..iiiList of Abbreviations ..viiList of Figures ..xList of Tables ..xiEXECUTIVE SUMMARY ..1 SWOT ANALYSIS ..61. Introduction and Background .. THE STRATEGIC CONTEXT OF AFRICA S HEALTHCARE CHALLENGES .. THE PHARMACEUTICAL MANUFACTURING plan FOR AFRICA .. Business plan .. SUMMARY OF CHAPTER 1 ..222. Overview of PHARMACEUTICAL MANUFACTURING in Africa .. INTRODUCTION: THE PHARMACEUTICAL MANUFACTURING SYSTEM .. THE CURRENT STATUS OF THE PHARMACEUTICAL INDUSTRY AND OTHER STAKEHOLDERS .. CHALLENGES AND OPPORTUNITIES FOR LOCAL PRODUCTION .. SUMMARY OF CHAPTER 2 ..543. Solutions .. THE GENERIC SOLUTIONS PACKAGE .. OTHER ACTIVITIES .. SUMMARY OF CHAPTER 3 ..824. Implementation plan .. PHASED APPROACH TO IMPLEMENTATION.

9 STAKEHOLDER ENGAGEMENT .. PROPOSED STRUCTURE FOR DELIVERING THE PMPA .. RESOURCE REQUIREMENTS .. MONITORING AND EVALUATION .. RISK SUMMARY OF CHAPTER 4 ..102viviiLIST OF ABBREVIATIONS AA artesunate/amodiaquineACT Artemisinin-based Combination TherapyAfDB African Development BankAL artemether/lumefantrineALMA African Leaders Malaria AllianceAMFm Affordable Medicines Facility for malariaAMRH African Medicines Regulatory Harmonization ANDA Abbreviated New Drug ApplicationANDI African Network for Drugs and Diagnostics InnovationAPI Active PHARMACEUTICAL IngredientARIPO Africa Regional Intellectual Property OrganizationARV antiretroviral drugBA/BE Bioavailability/BioequivalenceAU African UnionAUC African Union CommissionBRIC Brazil, Russia.

10 India and ChinaCCATP Collaborating Centre for Advocacy and Training in Pharmacovigilance CHAI Clinton Health Access InitiativeCL Compulsory LicenceCMS Central Medical StoreCOHRED Council on Health Research for DevelopmentCSIR Council for Scienti!c and Industrial Research (RSA)CTD Common Technical DocumentDE Data ExclusivityDFI Development Finance InstitutionDFID Department for International Development (UK)DNDi Drugs for Neglected Diseases InitiativeDRC Democratic Republic of CongoEAC East African CommunityECCAS Economic Community of Central African States ECOWAS Economic Community of West African States EDL Essential Drugs ListEGA European Generic Medicines AssociationEIU Economist Intelligence UnitEMA European Medicines AgencyEML Essential Medicines ListFDA Food and Drug Administration ( )