Update on Pharmaceutical Manufacturing Plan for Africa Dr. Djoudalbaye Benjamin Senior Health Officer African Union Commission 1 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: Born out of the recognition by African Heads of state of the tremendous challenges facing African healthcare systems; Original Initial decision to develop a PMPA – Abuja 2005; Plan endorsed by Heads of State – Accra 2007; Series of technical dialogues undertaken; workshops and political 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 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, accessible incentives. easily understood, and 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 11 11 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 Disease burden • 25% of the global disease burden • >50% of the global deaths of children under five • High infectious disease burden • Growing NCD Infrastructure • Software –HR ~ 3% of the world’s deployed– inequitably distributed, Migration • Hard ware – clinics, hospitals, labs, inadequate, Supply chain •1% of global healthcare expenditure Funding • Limited National budgets (by 2010 only 6 countries had met Abuja’s 15%) •Donor dependence 13 14 15 “No Indian company can make an API that meets our specifications” Global R&D company in letter to an Indian Pharma company in 1984 Holistic & pragmatic Current model unsustainable. of Stand-alone solutions is Urgent need to coordinate and align the activities of various organizations Cognisant of country-specific challenges Highly heterogeneous contexts development of the pharmaceutical & stages of Legal-regulatory frameworks and institutional capacities; North Africa and Sub-Saharan Africa. 17 National Medicines Regulatory Authorities e.g. oversight of clinical trials and GLP Inputs e.g. dossier review, plant inspection, GMP certification & monitoring Local Manufacturing Trade Associations* Business partners -access to formulations and know how -Supply agreements -etc e.g. Pharmacovigilance and adverse events reporting system e.g. oversight and enforcement of GDP and GWP Distribution Market National Markets Public procurement Private market NGO procurement Distribution -array of public & private systems Material inputs (e.g. API, excipients) Utilities Other supporting industries e.g. Maintenance and repair of equipment Clinical research for BA/BE Sub-regional exports • Public procurement • Private market • NGO procurement Manufacturers Formulation development Final formulation Packaging Distribution -range of mechanisms including national systems and donor operated supply chains National Standards Board e.g. calibration of equipment e.g. Tariffs on Inputs, FDI incentives e.g. Incentives to support industry Donor funded market for pandemics (both national and export), e.g. • Global Fund • PEPFAR • PMI e.g. dossier review, plant inspection and GMP certification and monitoring External Players Products from other countries particularly India as well as intra African Trade Other NMRAs Other MoF Other MoH International regulatory bodies e.g. - WHO prequalification prorgamme - Stringent regulatory authorities (e.g. FDA) Prequalified products from other countries largely from India e.g. content of EML, national drug policy, export incentives, inclusion of TRIPS flexibilities in national legislation e.g. procurement policies and functions of the CMS Various National Ministries including Health, Finance, Industry, Trade * - Note trade associations can perform a range of functions on behalf of their members to influence the business environment, such as dissemination of best practice, partnership brokering, lobbying Key: = Material flows = supply of services/access to knowledge = influence, including through regulatory oversight, policy, lobbying etc. 18 African Pharma Value Chain 19 Key PMPA Success Factors 20 Proposed package of solutions 21 Implementation at the country level (RECs & continental). interconnectedness of key dimensions and requirements of the manufacturing system No 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 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 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.