1. 1 The Parliamentary Roundtable Update on Pharmaceutical Manufacturing Plan for Africa Presented By Dr. Marie Goretti HARAKEYE Department of Social Affairs

2. Background & key milestones Philosophy Objectives Imperative for success Key Considerations Strategic Context; Africas Healthcare Challenges The PMPA Business Plan ;Adopted approach Methodology and BP outline Conclusion

3. PMPA: Borne out of the recognition by African Heads of state of the tremendous challenges facing African healthcare systems Original decision to develop a PMPA – Abuja 2005 Initial Plan endorsed by Heads of State – Accra 2007 Series of technical workshops and political dialogues undertaken Development and adoption of Business plan – 2012

4. Access to quality healthcare is a fundamental Human Right The promotion of industrial development and the safeguarding and protection of public health are not mutually exclusive priorities The production of quality medicines and the development of an international GMP compliant industry in Africa are possible, desirable and eminently doable 4

5. Support local pharmaceutical manufacturing: Increased access to affordable quality medicines; Sustainable supply of essential medicines; Improved public health outcomes; Industrial and economic development. 5

6. Political support & Policy coherence; Recognizes the on-going human tragedy on our continent resulting from limited access to medicines & the dire need for lasting solutions; Demands courage, foresight and the willingness to take tough decisions (govt. catalytic role); African R&D and blockbuster drugs (Diaspora skills). 6

7. Strong independent and predictable NMRAs; Human Capital development; Increased and enhanced competition; Reduced demand uncertainty and accurate forecasting; Investment and access to affordable finance; Provision of time-limited, easily understood, and accessible incentives. 7

8. Recognition of on-going efforts (REC / country level); Recognition that there are Organizations already engaged in various activities including regulatory harmonization, skills development, technology transfer and so forth – Augment not Supplant; Coordination and integration of these various initiatives will be critical – avoid duplication & wasted effort; PMPA not panacea 8

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10. Africa = 54 countries, >1 billion people (about 14% of the global population) Highly heterogeneous context Economic development Disease contexts Status of pharma industry & quality systems Multiple RECs and Trade blocs 10

11. 25% of the global disease burden >50% of the global deaths of children under five High infectious disease burden Growing NCD Disease burden Software –HR ~ 3% of the worlds deployed– inequitably distributed, Migration Hard ware – clinics, hospitals, labs, inadequate, Supply chain Infrastructure 1 % of global healthcare expenditure Limited National budgets (by 2010 only 6 countries had met Abujas 15%) Donor dependence Funding 11

12. 12 African Pharma expected to grow dramatically in the next decade

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14. No Indian company can make an API that meets our specifications Global R&D company in letter to an Indian Pharma company in 1984 14

15. Holistic & pragmatic Current model of Stand-alone solutions is unsustainable. Urgent need to coordinate and align the activities of various organizations Cognisant of country-specific challenges Highly heterogeneous contexts & stages of development of the pharmaceutical Legal-regulatory frameworks and institutional capacities; North Africa and Sub-Saharan Africa. 15

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17. 17 African Pharma Value Chain

18. 18 Key PMPA Success Factors

19. 19 Proposed package of solutions

20. Implementation at the country level (RECs & continental). interconnectedness of key dimensions and requirements of the manufacturing system No one organization has the breadth of expertise to deliver the full package of solution Vertical stand-alone solutions not enough – need a systemic approach Partnership & Collaboration – alignment and coordination of various interventions critical --- but need for a central depository of expertise, knowledge, skills for deployment where required 20

21. Development of Human Capital Development of a GMP road map Legislative and policy advice tools for developing - Incentives, regulatory structure etc Technical assistance to Regulators PMPA Business linkages platform Product development (FDCs paediatric, new FF, delivery platforms) Strengthening trade associations Assistance with developing market data collection capabilities 21

22. The production of quality medicines and the development of an internationally GMP compliant industry in Africa is not only possible, but necessary (desirable) and eminently doable. Local production has huge potential to not only contribute to improved healthcare provision, but also to stimulate economic growth, self reliance and develop skills and increase the knowledge base. 22

23. THANK YOU