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African Medicines Regulatory Harmonization (AMRH) Contribution to PMPA

Parliamentary Roundtable 25-26 March 2014. African Medicines Regulatory Harmonization (AMRH) Contribution to PMPA. Presentation Outline. PMPA-AMRH Background Vision & Objectives of the AMRH Initiative Achievements Challenges and Lessons Learnt Role of Parliamentarians

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African Medicines Regulatory Harmonization (AMRH) Contribution to PMPA

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  1. Parliamentary Roundtable 25-26 March 2014 African Medicines Regulatory Harmonization (AMRH) Contribution to PMPA

  2. Presentation Outline PMPA-AMRH Background Vision & Objectives of the AMRH Initiative Achievements Challenges and Lessons Learnt Role of Parliamentarians outcomes coming from the projects Challenges and lessons learnt that can

  3. PMPA-AMRH Background

  4. AU Policy & Frameworks • AU Decision 55 January 2005: Development of Pharmaceutical Manufacturing Plan for Africa (PMPA) under the NEPAD Framework • July 2012 : AU Roadmap on Shared responsibility and Global Solidarity on HIV/AIDS, TB and malaria Response • Policy option: Access to quality, safe and efficacious medicines for treatment of diseases affecting the African population

  5. PMPA-AMRH …. • Medicines regulatory environment • Inadequate medicines legislations (absent or weak legal and regulatory frameworks) • Lack of/limited regulatory capacity to approve medicines in a timely manner and ensuring acceptable quality, safety and efficacy standards • Manufacturers confronted with different regulatory requirements, frequent delays, and little process transparency Critical Success Factors for PMPA Full use of Trade Related Intellectual Property Rights (TRIPS) & related flexibilities Appraisal of technical feasibility and financial viability A market size to ensure sustainability Technology transfer Human resource Legislative framework: Sound regulatory systems e.g. GMP, GDP, GCP e.t.c. Duties and taxes • Limited access to good quality, safe and efficacious essential medicines to majority of African population

  6. COHRED Consortium of key partners established to spearhead the African Medicines Regulatory Harmonization (AMRH) Consortium Partners NMRA Representatives Other Stakeholders Consortium and major stakeholders convened in February and November 2009 Regional Economic Communities and Organizations (RECs) Unanimous consensus emerged: now is the right time to push for regulatory harmonization in Africa

  7. AMRH Partners…. • AMRH Partners Roles • Mobilising political support, and financial and technical resources for AMRH programme • Promoting and facilitating inter-REC communication, coordination, technical consistency and shared learning • Building a continental initiative, assisting in priority setting and plans for regulatory harmonization Political/Technical/Operational New Partnership for Africa’s Development (NEPAD Agency) African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) The World Bank Donors & NGOs Bill & Melinda Gates Foundation UK Department for International Development (DFID) Clinton Health Access Initiative (CHAI)

  8. Vision & Objectives of the AMRH Initiative

  9. AMRH… • Overall Objective • To improve public health by increasing access to quality, safe and efficacious essential medicines for the treatment of priority diseases • Contribute to socio-economic development agenda for Africa • Specific Objective • To reduce the time taken to register priority medicines

  10. AMRH Approach • Approach: • Building on the existing regional efforts, political mandates and plan • Registration as pathfinder to a broader harmonization of other regulatory functions and products • Situation analysis of regulatory systems in Africa

  11. AMRH Vision • ~ 54 National Medicines Regulatory Authorities (NMRAs) governing medicines regulation across Africa • Regulators' capacity highly variable, some with almost no capacity at all • Different requirements and formats, lack of clear guidelines • Minimal transparency, No clear timelines • Reference evaluations1 underleveraged Today • Between 5-7 regional economic communities (RECs) covering the entire African continent1 • Stronger, institutionalized regulatory capacity & systems strengthening programmes • Single set of requirements, Clear guidelines, Fewer dossiers to prepare (one per REC) • Transparent regulatory processes with clear timelines • Resource pooling and information sharing • Faster registration Streamlined (harmonized) future Earlier approval of more medicines & vaccines 1. WHO prequalification, Article 58 positive opinions, stringent regulatory approval, certificate of pharmaceutical product (CPP) 11

  12. AMRH contribution to public health and socio-economic development goals Prevention and treatment of infections diseases (overall) Enhanced access to new health technologies Broad economic development in the region Short term Increased access to generics treating many important diseases ü Intermediate term Broader, more rapid access to vaccines and other therapies More efficient launches for vaccines and other PDP products Foundation for African pharma industry (PMPA) • Benefit to Regional Economic & Trade Treaties • Increased market access ü ü ü Long term Extension to all regulatory functions Greater impact of new life-saving technologies Healthier, more productive workforce ü ü ü 12

  13. AMRH creates a platform on which to build African regulatory capacity Future Focus Registration platform • Common requirements / guidelines • Common dossier • Common assessments / inspections • Streamlined decision processes • Strengthened capacity and infrastructure • Work sharing / pooling of resources Accelerated registration... ...initially for generics ...extending to all product types with time Initial focus Regional regulatory platform • Organization and infrastructure • Political commitment • Common processes and frameworks • Trust and relationships • Momentum Capacity building across all regulatory functions: Clinical trials regulation Adverse event surveillance Market control etc... Future: broaden regulatory functions 13

  14. AMRH Achievements

  15. GMRH Multi-Donor Trust Fund 15 • The World Bank administration of a Global Medicines Regulatory Harmonization Multi-Donor Trust Fund (GMRH-MDTF) • Initial funds to cover EAC Medicines Registration Harmonization Project and AMRH Partners • Bill & Melinda Gates Foundation provided initial start-up grant while other interested donors are engaged • DFID • Strategically mobilize additional resources to cover other RECs

  16. AMRH in RECSs 16 • EAC MRH Project Launched in March 2012 • Regional harmonized regulatory standards and procedures for medicines registration and inspection of manufacturing sites agreed • Harmonized quality management systems to increase efficiency and transparency in regulatory services • Harmonized Information Management System (IMS) with a view to assist countries to share regulatory information through national & regional platform 2. Plans to launch the AMRH in West Africa & Southern African region in 2014 3. Ongoing discussions with central Africa & Northern African RECs

  17. WAHO/UEMOA EAC OCEAC Roughly 85% of Sub-Saharan Africa with MRH projects at various levels REC progress • Status • Comments • REC • EAC • West Africa WAHO/UEMOA • ECCAS/OCEAC • SADC • North/NortheastAfrica • Project launched 30th March 2012 • MRH Project Proposal finalized 2011 • MRH implementation framework agreed by end 2012 • Under consultation • Partners consultation • Under consultation SADC We are pushing forward those RECs that are ready while continuing to work with the remaining regions Source: BCG analysis 17

  18. AMRH STRATEGIC DIRECTIONS2011-2015 • Policies and Regulatory Reforms • Regulatory Capacity Development • Knowledge Generation & Leveraging • Governance, Management & Partnerships

  19. REGULATORY CAPACITY DEVELOPMENT

  20. KNOWLEDGE GENERATION & LEVERAGING

  21. POLICY & REGULATORY REFORMS

  22. AMRH GOVERNANCE, MANAGEMENT & PARTNERSHIPS

  23. GOVERNANCE, MANAGEMENT & PARTNERSHIPS…

  24. Challenges and Lessons Learnt

  25. Challenges & Lessons… • Process is slow requires extensive consultation • Country and RECs priorities vary • Linguistic divide amongst countries and regions • Various development partners engaged in regulatory initiatives across the continent • duplication of resources • confusion on member states

  26. Role of Parliamentarians…

  27. Role of Parliamentarians • Advocate for strengthening medicines regulation and harmonization in Africa through: • Supporting the RECs Medicines Regulatory schemes • Supporting the Model Law on Medicines Regulation and Harmonization in Africa • Supporting harmonization of regulatory capacity development through the adopted strategy for institutionalization of training programmes using the existing institutions and structures on the continent

  28. Role of Parliamentarians… 4. Promote good governance in medicines regulation through the establishment of Partnership Platforms and Accountability Frameworks • coordination of partners, monitoring, evaluation and assessment of impacts 5. AMRH provides a foundation for establishment of strong national medicines agencies which will be supported by regional medicines agencies through the existing RECs structures. 6. The ultimate goal is to establish the African Medicines Regulatory Agency

  29. Thank You! Merci! Obrigado! Ahsanteni Sana!

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