Optimizing the global pharmaceutical value chain for improved health and development

 Background and milestones  5 principles underpinning the AU model for promoting and developing Africa’s pharmaceutical manufacturing industry  Overview of the pharmaceutical manufacturing system situation in Africa  Key achievements, challenges and opportunities  Recommendations on way forward

PMPA: Borne 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  Endorsement of Business plan – 2012 Medicines regulatory systems strengthening: borne out of need to ensure quality, safety, and efficacy of products  AMRH Programme developed  AU model law on medical product regulations-2013  Endorsement of the concept and milestones for establishment of AMA- 2015

1. Quality and affordability of medical products is essential for promoting public health and for viability and sustainability of the local industry ; 2. Expansion of the local industry will trigger strengthening of regulatory systems to promote safety, efficacy and curtail counterfeit products; 3. Competitiveness driven by enhancing skills, innovation & technology base will bring the industry closer to the consumer market;

4. Self reliance will emanate from optimizing the global pharmaceutical value chains as opposed to dependence on imported finished products; 5. Development and enforcement of coherent policies across supporting sectors will create enabling environment for sustainability of robust healthcare delivery systems.

Drug Policy exist but incoherence with other policies that impact success Efforts policy coherence challenge being tackled ( dialogue across ministries ) Policy & legislation Academic and research institutions exist can be upgraded Skills mismatch Efforts: access to technology know how and (international cooperation) Establishment of COEs (ANDI) Skills mismatch being tackled Skills and HR Few NMRAs carry out full range of regulatory functions Regulatory Requirements vary across countries affecting access- Efforts: harmonization at regional level in process RCOREs to increase capacity Regulatory capacity Small, fragmented small share of global Mainly SMEs, access to international markets increasing SA and NA Efforts CFTA, BIAT, SMEs Market size and actors imported machinery, equipment, packaging materials, APIs. Local contribution -sugars, starch High cost of production API production in some countries FDI, joint ventures Efforts: Raw materials: CAADP, Traditional medicine Production inputs More products on EML list than are produced Efforts: roadmap to support countries to achieve international standards for GMP to increase Potential to expand product portfolio for pandemics Product portfolio Very few co. meet international GMP, or WHO preq. Northern and SA some meet GMP and WHO preq Efforts: PMPA BP, AIDA,AMRH,AMA, Quality of production Logistics, transport, ICT, Utilities High cost, unreliable Efforts – PIDA, Support industry and infrastructure

 Maintaining sector on continental and global agenda while leveraging support through international multilateral and bilateral cooperation China, EU, USA, India..;  Creating strategic partnerships, collaboration with local and global public and private sector actors;  Facilitating country and regional level adoption/adaption /implementation of continentally agreed policy, legislative and regulatory frameworks/strategies/initiatives e.g AU Roadmap on SRGS, AMRH, AMA, AU model law on medical product regulation;

 Supporting enhancement of national and regional institutional manufacturing and regulatory capacities and capabilities(sector strategies for some MS and RECs e.g. EAC, ECOWAS, SADC;  Anchor/leverage other continental socio economic development efforts (industry(AIDA), trade(CFTA), infrastructure(PIDA), agriculture(CAADP), Science and Technology and Innovation(STISA), CAP etc.)”.

International bilateral, multilateral, cooperation Strategic partnerships/Collaboration Institutional Capacity enhancing Conducive Policy, legislative environment Africa- EU, Africa-USA, Africa- China, Africa-India.. Advocacy, coordination & resource mobilization AMRH Consortium, PMPA consortium, FAPMA, Africa-china roundtables RCOREs, ANDI CoEs,GMP Roadmap AMA, AU Model Law on medical product regulations, AMRH

10 Challenges: Pharma Value Chain

25% of the global disease burden High infectious disease burden Growing non communicable disease Disease burden Software – Shortage of HR ~ 3% of the world’s healthcare workers deployed in Africa – inequitably distributed Hard – clinics, hospitals, labs, inadequate Supply chain Infrastructure 1 % of global healthcare expenditure Limited National budgets (<10 countries have met Abuja’s target of 15% allocation) Dependence external aid Funding 11

Economic 1.3 billion population by 2020 Combined GDP of2.9trn Healthcare expenditure of 200billion Pharma market of USD 23billion Household income >20USD Investments in healthcare reforms Public health Patent expiries and TRIPS flexibilities Changing disease patterns towards chronic Towards universal health coverage Support industry Infrastructure boom- transport, communication, energy Education –innovation, R&D, skills matching market requirement Agriculture – Raw materials Diversification -shift commodity driven to optimization of global value chains

 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  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. 13

Support and facilitate:  Increased dialogue at national, regional, continental and international fora to maintain awareness and recognition by policy and decision makers of the potential contribution of the pharma sector to both industrial agenda and the healthcare system of the continent;  Implementation of continental strategies that define Africa's trajectory for promoting and developing the sector that have been elaborated and endorsed by high level policy makers and attracted the interest of a broad range of stakeholders from both public and private sectors and stimulated action at national and regional level;

Support and facilitate:  strategic partnerships and platforms for international cooperation fostered by AU leadership to leverage support for growth of the local manufacturing industry across the its value chain;  Continental level efforts to promote the creation of enabling policy and legislative environment for the growth of the sector to sustain action at national and regional level and trigger investments/support from public and private sector, local and international actors

Agree to support and adopt the following as key instruments and mechanisms for sustaining national and regional level achievements in promoting and developing the pharmaceutical sector for improved health and development : ◦ PMPA business plan ◦ AU model law on medical product regulations ◦ Task team to facilitate the establishment African Medicines Agency and take note its progress report ◦ Biennial African regulators forum

THANK YOU FOR YOUR KIND ATTENTION !