Update on Pharmaceutical Manufacturing Plan for Africa Dr Djoudalbaye Benjamin Senior Health Officer African Union Commission Presentation outline Definition TRIPS Agreement TRIPS and Public Health ID: 753172
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TRIPS and Public Health: Implications for the Pharmaceutical Sector in Africa
Update on Pharmaceutical Manufacturing Plan for AfricaDr. Djoudalbaye BenjaminSenior Health Officer African Union CommissionSlide2
Presentation outlineDefinitionTRIPS AgreementTRIPS and Public HealthAbout the PMPABackground & key milestones
PhilosophyObjectivesVisionConclusion Slide3
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.Slide4
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."
TRIPS AGREEMENTSlide5
Background & Key Milestones
PMPA: Born 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.Slide6
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. 6Slide7
Core objectivesSupport local pharmaceutical manufacturing:
Increased access to affordable quality medicines;Sustainable supply of essential medicines;
Improved public health outcomes;Industrial and economic development. 7Slide8
Imperative for success 1/2
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). 8Slide9
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.
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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 panacea10Slide11
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Strategic Context; Africa’
s Healthcare Challenges11Slide12
Strategic ContextAfrica = 54 countries, >1 billion people (about 14% of the global population)
Highly heterogeneous contextEconomic developmentDisease contextsStatus of pharma
industry & quality systemsMultiple RECs and Trade blocs12Slide13
Significant challenges impacting on health outcomes
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African Pharma expected to grow dramatically in the next decadeSlide15
The PMPA Business Plan Adopted approach
MethodologyBP outline15Slide16
“No
Indian company can make an API that meets our specifications”Global R&D company in letter to an Indian Pharma
company in 198416Slide17
Adopted ApproachHolistic & pragmatic
Current model of Stand-alone solutions is unsustainable. Urgent need to coordinate and align the activities of various organizations
Cognisant of country-specific challengesHighly heterogeneous contexts & stages of development of the pharmaceuticalLegal-regulatory frameworks and institutional capacities; North Africa and Sub-Saharan Africa. 17Slide18
Pharmaceutical ‘System’
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African Pharma Value ChainSlide20
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Key PMPA Success FactorsSlide21
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Proposed package of solutions Slide22
Implementation- key principlesImplementation at the country level (RECs & continental).
interconnectedness of key dimensions and requirements of the manufacturing systemNo organization has the breadth of expertise to deliver the full package of solutionVertical stand-alone solutions not enough – need a systemic approachPartnership & Collaboration – alignment and coordination of various interventions critical --- but need for a central depository of expertise, knowledge, skills for deployment where required
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Systemic Orientation of solutions package
Development of Human CapitalDevelopment of a GMP road map
Legislative and policy advice tools for developing - Incentives, regulatory structure etcTechnical assistance to Regulators PMPA Business linkages platform Product development (FDC’s paediatric, new FF, delivery platforms)Strengthening trade associationsAssistance with developing market data collection capabilities
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ConclusionThe 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.
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I thank you for your attention