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African Medicines Regulatory Harmonisation


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Presentation by NEPAD Agency on the African Medicines Regulatory Harmonisation made at the Euro-Africa Health Investment Conference, March 26 - 27, 2013, London, United Kingdom.

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African Medicines Regulatory Harmonisation

  1. 1. African Medicines Regulatory Harmonisation (AMRH) Initiative: Presentation by Margareth Ndomondo-Sigonda Pharmaceutical Coordinator NEPAD Agency 26 March, 2013 1
  2. 2. Presentation Outline 1. 2. 3. 4. Background AMRH Vision, Mission, SD & Partners AMRH achievements Pharma Industry participation • • • Perceptions by local manufacturers Opportunities for local manufacturers Market Viability 5. Conclusion & Way Forward 2
  3. 3. 1. AMRH Initiative Background 3
  4. 4. New Partnership for Africa’s Development (NEPAD) • 2001: A Programme of the African Union (AU) adopted in Lusaka, Zambia • February 2010: Integration of NEPAD under the AU structures • Re-newed mandate as a technical body of the African Union to: • Facilitate and coordinate the implementation of the continental and regional programmes and projects; • Mobilize resources and partners in support of the implementation of Africa’s priority programmes and projects; • Conduct and coordinate research and knowledge management; • Coordinate the implementation of programmes and projects, & • Advocate on the AU and NEPAD vision, mission and core principles/values
  5. 5. Est.: OAU – May 1963 AU – July 2002 Tel: +251-11 551 77 00 Fax: +251-11 551 78 44 Website: Head Office Address: P.O. Box 3243, Roosevelt Street (Old Airport Area), W21K19, Addis Ababa, Ethiopia Algeria Libya Benin Madagascar Botswana Created by: Mrs. Andriëtte Ferreira – NEPAD Secretariat, 1258 Lever Road, Headway Hill, Midrand, Johannesburg, South Africa, Email: Information source: Angola Malawi Burkina Faso Mali Burundi Mauritania Cameroon Mauritius Cape Verde Mozambique C/African Rep. Namibia Chad Niger Comoros Nigeria DRC Rwanda Congo Sharawi Arab DR Côte d’Ivoire São Tomé & Prínc. Djibouti Senegal Egypt Seychelles Equatorial Guinea Sierra Leone Eritrea Ethiopia Gabon Gambia Ghana Guinea Guinea-Bissau Kenya Lesotho Liberia Somalia South Africa Sudan Swaziland Tanzania Togo Tunisia Uganda Zambia
  6. 6. African Union • 54 member states of the African Union – fifty two republics, and two kingdoms – South Sudan is the newest member state, joining on 2011 July 27 • Total population: ~ 1 billion • 8 Regional Economic Communities: – Arab Maghreb Union (UMA), Common Market for Eastern and Southern Africa (COMESA), Community of Sahel Saharan States (CENSAD), East African Community (EAC), Economic Community of Central African States (ECCAS), Economic Community of West African States (ECOWAS), Intergovernmental Authority on Development (IGAD) and Southern Africa development Community (SADC) 12/25/2013 6
  7. 7. PMPA-AMRH Genesis African Union Assembly Decision 55 of 2005 - Abuja Summit:  African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the NEPAD Framework  Aim: to contribute to a sustainable supply of quality essential medicines to improve public health and promote industrial and economic development on the continent  Critical elements for successful implementation of PMPA :  Legislative framework: Sound regulatory systems e.g. GMP, GDP, GCP e.t.c.  Full use of TRIPS and related flexibilities  Appraisal of technical feasibility and financial viability  A market size to ensure sustainability  Technology transfer  Human resource  Duties and taxes 7
  8. 8. 2. AMRH Vision, Mission, Strategic Directions & Partners 12/25/2013 8
  9. 9. AMRH VISION & MISSION VISION: African people have access to essential medical products and technologies MISSION: Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa 12/25/2013 9
  10. 10. AMRH Strategic Directions • Policy and Regulatory Reforms – Increased use of harmonized policies and regulatory frameworks by member states • Regulatory capacity Development – Increased human and institutional capacity for regulation of medical products and technologies – Use of existing structures & institutions to ensure sustainability • Knowledge Management – Knowledge assets on medicines regulation at country, regional and continental levels created • Enabling environment for AMRH – Governance & coordination – Partnership Platform Accountability Framework – M&E and impact assessment framework 12/25/2013 10
  11. 11. Consortium of key partners established to accelerate and ensure African Medicines Regulatory Harmonization (AMRH) Consortium Partners NMRA Representatives Other Stakeholders COHRED 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 Global Medicines Regulatory Harmonization - Multi-Donor Trust Fund established under the World Bank 11
  12. 12. AMRH Partners….  Political/Technical/Operat  AMRH Partners Roles ional • • • • • 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) • Mobilising political support, and financial and technical resources for AMRH programme • Promoting and facilitating inter-REC communication, coordination, technic al consistency and shared learning • Building a continental initiative, assisting in priority setting and plans for regulatory harmonization 12
  13. 13. 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 – Registration as pathfinder to a broader harmonization of other regulatory functions and products 13
  14. 14. AMRH Approach… Building on the existing regional efforts, political mandates and plan 14
  15. 15. AMRH …  ~ 54 National Medicines Regulatory Authorities (NMRAs) governing medicines regulation across Africa Today  Lack/inadequate medicines policies and laws  Regulators' capacity highly variable: Financial, HR, Institutional  Different requirements and formats, lack of clear guidelines  Minimal transparency, No clear timelines  Reference evaluations1 underleveraged  Between 5-7 regional economic communities (RECs) covering the entire African continent1 Streamlined (harmonized) future  Harmonized medicines policies and Laws  Stronger, institutionalized regulatory capacity & systems strengthening programmes Earlier approval of more medicines & vaccines  Single set of requirements, Clear guidelines, Fewer dossiers to prepare  Transparent regulatory processes with clear timelines  Resource pooling and information sharing 1. WHO prequalification, Article 58 positive opinions, stringent regulatory approval, certificate of pharmaceutical product (CPP) 15 15
  16. 16. Critical Milestones 1. Harmonised requirements and standards Fully Harmonised Not Harmonised Member States Operating independently Member States Collaborate on selected topics Harmonised standards and broad collaboration Centralized Procedure • each country has its own technical requirements and format for registration applications Regional harmonised guidelines & procedures: • Guidelines for registration of medicines • Procedures for evaluation of medicines • GMP guidelines & Inspection procedures • Centralized registration on behalf of participating member states • • • Joint evaluations and inspections Sharing assessment and inspection reports Quality Management Systems Information Management Systems Regional Medicines Agencies e.g. EACMFSA National sovereignty is respected: Medicines registration decisions remaining firmly that of sovereign nations Robust & transparent regulatory processes 16
  17. 17. Critical Milestones 2. Regulatory capacity development Ad-hoc training programmes Working Member States independ Collaborate on ently training programmes Existing training program mes for NMRA staff based on donor funding Institutionalised training programmes Harmonised training standards and broad collaboration • Evaluation & registration of medicines • GMP Inspections • Quality Management Systems • Management Information Systems • Utilise Existing Regional structures & expertise: NMRAs & Academic institutions • Harmonised training curriculum • Certification • Evaluation of training programmes • Potential partners: Short Term: • Twinning/Exchange programmes among NMRAs within & outside the continent • Regional Centres of Regulatory Excellence (RCORE) Long-Term: • Engagement of academic institutions to offer post graduate courses in Regulatory Science WHO, US-FDA, PQM, AfDB, EDCTP, ANDi, PDPs, SIAPS Increased regulatory workforce in Africa 17
  18. 18. Critical Milestones 3. Policy and Regulatory Reforms Inadequate policies & laws Harmonised policies & Laws Current status Country level • Lack/Weak medicines laws • Medicines regulated within territories • Varying comprehensivenes s of laws • No sanctions on non compliance to regional treaties • Adoption • Binding • At least 5 regions have and regional adopted regionally domesticati legal harmonized policies and on of model instruments legislative frameworks law on • At least 20 countries medicines implementing the regionally regulation harmonized policies and legislative frameworks • Mutual • At least 2 regional medicines recognition agencies established agreements • Regional level Continental level Increased adoption of regionally agreed standards • Mutual recognition of regulatory decisions 18
  19. 19. 3. AMRH Achievements 19
  20. 20. 1. GMRH Multi-Donor Trust Fund • 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 • US$ 12.5 million • Bill & Melinda Gates Foundation provided initial start-up grant while other interested donors are engaged • Strategically mobilize resources to cover other RECs • Sustainable domestic financing options 20 20
  21. 21. 2. CONTINENTAL PROGRESS • AMRH Advisory Committee established – NEPAD Agency Secretariat: Coordination and Political advocacy – Provides strategic and policy advise on AMRH programme implementation – Composed of representatives from RECs, NMRAs, AUC, PAP, NEPAD, WHO, World Bank, industry associations, civil society • Technical Working Groups – Regulatory Capacity Development – Medicines Policies & Regulatory Reforms • Draft Model Law for Medicines Regulation Harmonization in Africa developed – Stakeholders consultations planned for 2013 12/25/2013 21
  22. 22. CONTINENTAL PROGRESS… Related Continental Frameworks • July 2012: 19th AU Assembly decision on Roadmap for Shared Responsibility and Global solidarity for the AIDS, TB and Malaria response in Africa – Emphasis - accelerate and strengthen regional medicines regulatory harmonization initiatives – Establishment of regional medicines agencies – Foundation for a single African Regulatory Agency – Lead Partners: AUC, UNAIDS & NEPAD Agency 22
  23. 23. 3. REGIONAL PROGRESS East African Community • Launch & subsequent implementation of EAC Medicines Registration Harmonization (MRH) Project since March 2012 • 5 EAC Partner States (6 NMRAs) participating in the AMRH Initiative: Burundi, Kenya, Rwanda, Tanzania, Uganda • MRH Project Steering Committee Established • Technical Working Groups (TWG) established to develop registration and GMP guidelines and procedures in line with internationally acceptable standards • Partner States NMRAs taking lead • • • • Tanzania: TWG on medicines evaluation & registration Uganda: TWG on good manufacturing inspection Kenya: TWG on quality management systems Rwanda: TWG on Information Management System (IMS) 23 23
  24. 24. REGIONAL PROGRESS… West African region: • 15 participating member states • 2011: Development of MRH Project framework in consultation with industry • August – Nov 2012: – WAHO, UEMOA, WHO & NEPAD Agency High Level consultation meetings – Experts consultation meetings – WAHO engagement of 7 countries (5 Anglophone & 2 Lusophone) – UEMOA engagement of 8 Francophone countries • 2013: WAHO/UEMOA Regional coordination framework, plan of action and Memorandum of Understanding 24
  25. 25. REGIONAL PROGRESS… Central African region • 10 participating member states • 2009-11: Situation analysis and development of a project framework for OCEAC/ECCAS • 2012: Consultation with OCEAC and ECCAS • 2013: Consultation on OCEAC/ECCAS Regional coordination framework, plan of action and memorandum of understanding 25
  26. 26. 4. PHARMA INDUSTRY PARTICIPATION • 2010-2012: NEPAD commissioned situation analysis of medicines regulation & harmonization across African RECs and countries – National & regional policy & legislative frameworks – NMRAs assessment • 3 categories based on agreed criteria; i) Existing NMRA; ii) Existing legal framework; iii) performance of full regulatory functions (registration, GMP); iv) Existing Management Information System; v) Available HR – Industry perception on AMRH • Consultation through National & regional industry associations • General agreement • EAC, SADC, ECOWAS consultation meetings – Development of regional MRH Frameworks 26
  27. 27. AMRH Coverage Roughly 85% of Sub-Saharan Africa REC Status/Progress Countries covered Population (Mill) Pharma market (US$ Bill p.a.) EAC ECCAS/OCEAC ECOWAS-WAHO/UEMOA SADC UMA/CENSADC/COMESA/IGAD 5 10 15 15 9 133.1 120 ~300 267.58 N/A N/A N/A 3.5 (2010) 3 (2006) N/A Total: 54 • We are pushing forward with RECs that are willing Industry participation in stakeholders consultation is key National & regional industry association a good platform for engagement RECs • • Source: BCG analysis EAC ECCAS/ OCEAC SADC 27 27
  28. 28. AMRH contribution to Pharma Industry Development dev Prevention and treatment of infections diseases (overall) Short term Intermediate term Long term   Enhanced access to new health technologies Broad economic development in the region Increased access to generics treating many important diseases Broader, more rapid access to vaccines and other therapies   Extension to all regulatory functions    More efficient launches for vaccines and other PDP products Greater impact of new lifesaving technologies Foundation for African pharma industry (PMPA) • Benefit to Regional Economic & Trade Treaties • Increased market access Healthier, more productive workforce 28 28
  29. 29. 5. WAY FORWARD • Regional Stakeholders consultation – EAC harmonised guidelines & procedures – AMRH Model Law • Institutionalization of the regulatory training programmes in the continent – Establishment of Regional centres of regulatory Excellence (RCOREs) – Training for regulators & industry – Key for sustainability • Expanding the scope for harmonization to clinical trials oversight and safety monitoring • Governance and effective coordination regionally & continentally – Establishment of Partnership Platform Accountability Framework – Impact assessment of policy & regulatory reforms in Africa 29
  30. 30. WAY FORWARD… • 1st Scientific conference for medicines regulation in Africa – Theme: “Building Partnerships for Sustainable Capacity Development in Medicines Regulation in Africa” – Target group: African regulatory authorities, researchers, academic institutions and industry • Necessity of working together to address socio-economic issues affecting the African populace – Call for Abstracts • Read: AMRH-PMPA Policy Brief • Visit: 30
  31. 31. CONCLUSION • AMRH is a strategic initiative for pharmaceutical sector development in Africa • Strong political constituency and partnerships built – AU organs (AUC, NEPAD Agency, PAP), RECs, NMRAs, pharmaceutical industry & Civil Society – Donors, development partners & international agencies • Cooperation, collaboration and commitment by all stakeholders is key for success – Need practical alignments & engagement between African NMRAs, industry, academia and researchers • EAC MRH Project provides a Model for replication to other RECs 12/25/2013 31
  32. 32. Thank You! Merci! Obrigado! Ahsanteni Sana! 32