TRIPS and Public Health: Implications for the Pharmaceutical Sector in Africa

1. TRIPS and Public Health: Implications for the Pharmaceutical Sector in Africa Update on Pharmaceutical Manufacturing Plan for Africa

2. Presentation outline • Definition • TRIPS Agreement • TRIPS and Public Health • About the PMPA • Background & key milestones • Philosophy • Objectives • Vision • Conclusion

3. Definition • The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement administered by the World Trade Organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) regulation as applied to nationals of other WTO Members. It was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994.

4. TRIPS AGREEMENT • The TRIPS agreement introduced intellectual property law into the international trading system for the first time and remains the most comprehensive international agreement on intellectual property to date. • In 2001, developing countries, concerned that developed countries were insisting on an overly narrow reading of TRIPS, initiated a round of talks that resulted in the Doha Declaration. The Doha declaration is a WTO statement that clarifies the scope of TRIPS, stating for example that TRIPS can and should be interpreted in light of the goal "to promote access to medicines for all."

5. Background & Key Milestones • 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

6. Philosophy • 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 6

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

8. Imperative for success1/2 • 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).

9. Imperative for success 2/2 • Strong independent and predictable NMRA’s; • 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.

10. The key considerations • 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

11. Strategic Context; Africa’s Healthcare Challenges 11

12. Strategic Context • 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

13. Significant challenges impacting on health outcomes 13

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

15. The PMPA Business Plan Adopted approachMethodologyBP outline

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

17. Adopted Approach • 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.

18. Pharmaceutical ‘System’

19. African Pharma Value Chain

20. Key PMPA Success Factors

21. Proposed package of solutions

22. Implementation- key principles • 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

23. Systemic Orientation of solutions package • 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 (FDC’s paediatric, new FF, delivery platforms) • Strengthening trade associations • Assistance with developing market data collection capabilities

24. Conclusion • 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.