NEPAD Planning and Coordinating Agency Universal Health Coverage: Considerations in designing Medicines Benefits Policies and Programmes, September 28-29, 2014, Cape Town, South Africa Multiple-Stakeholder Partnerships for Medicines Benefits in Moving Towards UHC NEPAD Planning and Coordinating Agency

Presentation Outline Progress in the Implementation of Abuja Declaration The African Medicines Regulatory harmonization Initiative Background, Vision & Progress Proposed Model for implementation of Medicines Benefits Programs

Abuja Declaration 2001 Significant progress has been made on the Abuja commitments, although that progress remains partial and uneven Since the Abuja Declaration, national governments have taken ownership of Africa’s health challenges. They have established dedicated offices, coordination mechanisms and national strategic plans for all major diseases—especially AIDS The AU Commission developed both strategic plans for HIV from 2005–2007 and the AIDS Watch Africa strategic framework to better harmonize the continent’s intensified efforts to respond to the AIDS epidemic. Health funding has risen in Africa since 2001, but it still has not reached the level that the Abuja Declaration promised. From 2001 to 2011, health budgets in AU Member States increased from 9% to 11% of public expenditures. Six AU Member States (Liberia, Madagascar, Malawi, Rwanda, Togo and Zambia) have achieved the Abuja target of allocating 15% of public expenditure to health, and a number of other countries (e.g. Djibouti, Ethiopia, Lesotho and Swaziland) are within reach of the 15% target. Still, the vast majority of African nations have not met this essential commitment In 2012, AU Member States built on this progress by adopting a historic Roadmap on Shared Responsibility and Global Solidarity for AIDS, TB and Malaria Response in Africa. Under this roadmap, the Member States pledged concerted action to strengthen and diversify health funding, strengthen health leadership and governance, and enhance access to affordable and quality-assured medicines. Affordable and quality-assured medicines are much more accessible today. This is especially true for AIDS—millions of people have received HIV treatment in the last decade. This is, in part, thanks to a combination of sharp price reductions, national leadership and international solidarity. TB and Malaria medicines are also much more widely available today.

Background AU-PMPA AU-Roadmap on Shared Responsibility & Global Solidarity for ATM response in Africa Creating an Enabling Regulatory Environment Pharmaceutical sector development (Optimizing the African Market for new medical products and technologies) Increased access to medical products and technologies 2005-2007: AU Pharmaceutical Manufacturing Plan for Africa (PMPA) In 2005, the African Heads of States approved the pharmaceutical manufacturing plan for Africa (PMPA) as a framework to facilitate local production of essential medical products and technologies in the continent. Harmonization of regulatory requirements was considered key in facilitating trade among countries, expanding the markets and improving patients’ access to the needed medical products and technologies. To complement these efforts, the Roadmap on Shared Responsibility & Global Solidarity for AIDS, TB and Malaria was endorsed by the AU Summit in July 2012 which among other things emphasises the importance of AMRH initiative as a foundation for strengthening national regulatory systems and establishing regional and continental medicines regulatory agencies. All these frameworks and initiatives are key in improving access to medical products and technologies.

The African Medicines Regulatory Harmonization Initiative The African Medicine Regulatory Harmonization (AMRH) initiative aims to accelerate the access to products by improving the fragmented system of product registration in Africa Main focus Develop common requirements / guidelines / format Work sharing among countries Streamlined regional decision making at the regional level Current Partners RECs, NEPAD, WHO, World Bank, BMGF, DfID Other AU Organs involved: AUC, PAP Initial stakeholder engagement (NEPAD) Regional proposals developed Multi-donor trust- fund established EAC harmonization launched Focus on WAHO/UEMOA and SADC Region projects consolidation 2009 2010/ 2011 2011 2012 2013/ 2014 The key AMRH partners include the regional economic communities (RECs), NEPAD Agency, World health Organization, World Bank, Bill and Melinda gates Founation, UK Department for Internationl Development (DFID)

Vision for AMRH Programme IGAD / AMU / CEN-SAD African Medicines Agency WAHO / UEMOA EAC Vision: East African Community Medicines and Food Safety Commission MRH Project launched March 2012 ECCAS/ OCEAC The African Medicines Regulatory Harmonization (AMRH) Programme provides a foundation for establishment of regional medicines agencies such as the East African Community Medicines and Food Safety Commission (as an offshoot of the MRH project) and in the long run the African Medicines Agency (AMA) SADC/COMESA 55 countries 5regions 1 continent

Roughly 85% of Sub-Saharan Africa covered with medicines registration harmonization (MRH) Projects at different levels WAHO/UEMOA EAC ECCAS/OCEAC REC progress CEN-SAD/UMA/COMESA REC Status Comments EAC OCEAC/ECCAS WAHO/UEMOA SADC North/Northeast Africa Implementation In progress Ongoing discussions Launched 2012 Launch of Steering Committees Expected 2014 IGAD Completed or in-process RECs Countries covered Total members* % pop covered EAC & OCEAC EAC, OCEAC, ECOWAS EAC, OCEAC, ECOWAS, SADC 12 (20%) 26 (46%) 41 (74%) 11 26 41 17% 45% 72% While EAC has made progress in the establishment and operationalization of the Steering Committee and Expert Working Groups, development of harmonized guidelines for registration, GMP inspection, quality management system and information management system, West African (ECOWAS/UEMOA) and Southern African (SADC) regions are to launch their MRH Project Steering Committees before end of 2014. The AMRH scope is now being expanded to cover pharmacovigilance and post market surveillance, clinical trials oversight. A Model Law on medicines Regulation and Harmonization is undergoing stakeholders consultation with a view to be endorsed by AU Head of States in 2016, already 5 countries have committed to adopt the provisions on the Model law. SADC We are pushing forward those RECs that are ready while continuing to work with the remaining regions Governance structures, harmonized guidelines, joint assessments and inspections, regional and continental policies and legal frameworks, RCOREs 11/11/2018 7

Proposed Model for implementation of Medicines Benefits Programs What can be done: Establish a partnership framework for medicines benefit programmes at national, regional, continental and international levels with clear roles and responsibilities Finalize the countries mapping exercise on the status of implementation of health insurance schemes including medicine benefits programs Agree on standard tools to be employed based on countries needs Develop strategies for countries uptake and advocacy (including governance structures) Monitor countries progress in the implementation of the program

Medicines Benefit Program Partners Roles Mobilising political support, and financial and technical resources needed for the program Promote and facilitate inter-REC communication, coordination, technical consistency and shared learning Build a continental initiative, assisting countries and regions in priority setting and plans

Thank You