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

Definition TRIPS Agreement TRIPS and Public Health About the PMPA Background & key milestones Philosophy Objectives Vision Conclusion

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.

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."

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

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

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

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). 8

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. 9

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 10

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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 12

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 13

14 African Pharma expected to grow dramatically in the next decade

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

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. 17

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19 African Pharma Value Chain

20 Key PMPA Success Factors

21 Proposed package of solutions

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 22

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 23

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. 24