An Enabling Business Environment and A Strategy and Collaborative Approach for Sustainable Quality Local Production Africa Pharma Conference 4-5 June 2019, Johannesburg, South Africa Jicui DONG (PhD, MS, MBA) Programme Manager (Local Production & Access to Health Commodities) Regulatory Systems Strengthening Regulation of Medicines and Other Health Technologies Access to Medicines, Vaccines and Pharmaceuticals

Local production in the public health context “The term ‘Local Production’ can be defined in various ways. For the purposes of this statement, ‘local’ refers to the geographical location, i.e. occurring in the country or region, and ‘production’ – in regard to pharmaceuticals for example – refers to all activities along the pharmaceutical manufacturing value chain. Within the context of the public health agenda, promoting local production requires a holistic approach that considers policy coherence, regulatory systems strengthening, access to finance for sustainable production, a careful assessment of the business case, development of skilled human resources, access to technology for production and needs-based innovation, creation of investment incentives and other factors, to enable manufacturers to comply with international quality standards, be competitive and engage in sustainable manufacturing.” – Extracted from the “Interagency Statement on Promoting Local Production of Medicines and Other Health Technologies”

Sustainable Quality Local Production Promoting sustainable quality local production is a cross-cutting endeavour and needs government commitment and policy coherence Different sectors need to work in concert to enable the business environment HEALTH TRADE INDUSTRY Sustainable Quality Local Production … FINANCE LABOUR EDUCATION

Other key elements for sustainable quality local production Regulatory system Skilled workforce (HR) Capital and Financing Materials & equip (e.g. API, spare parts) Infrastructure (e.g. power, water) Markets (e.g. economies of scale) Market intelligence Foreign direct investment …

Quality assured products are key to achieve public health and economic benefits PUBLIC HEALTH PERSPECTIVE BUSINESS PERSPECTIVE Lack of quality assurance puts health at risk Ineffective treatments Drug resistance (e.g. AMR) Adverse events Lack of quality assurance puts business viability and sustainability at risk No access to national and international procurement tenders Financial loss due to product recall Less attractive to partners and investors Loss in confidence and trust

NRA and Industry have a concurrent role to ensure quality NATIONAL REGULATORY AUTHORITY (NRA) MEDICAL PRODUCT INDUSTRY Efficient and transparent regulatory system Regional and international quality assurance standards Regulatory convergence and harmonization Strong partnership with the medical product industry Build quality into the product Quality-by-design principles Product selection Build quality into the system GMP in the design of the facility QMS is a leading factor in GMP non- compliance Strong partnership with the NRA

WHO supports Member States in strengthening local production with assured quality, safety and efficacy Setting strategies Conducting holistic situational analyses Support in developing and implementing national strategies and roadmaps Support in strategic selection of products Tool for risk-based selection of medicines for local production with assured quality Technical support and capacity building in collaboration with other WHO technical units and external partners Holistic training workshop Compliance with quality assurance standards Nurturing strategic partnerships

Interagency Statement on Promoting Local Production of Medicines and Other Health Technologies WHA Technical Briefing on Promoting Local Production of Medicines and other Health Technologies: Official Launch of the Interagency Statement

Thank you Jicui DONG (PhD, MS, MBA) Programme Manager (Local Production & Access to Health Commodities) Regulatory Systems Strengthening Regulation of Medicines and Other Health Technologies Access to Medicines, Vaccines and Pharmaceuticals

National Strategy and Plan of Action for Pharmaceutical Manufacturing Development in Ethiopia (NSPA-Pharma)A

Training Workshop on Key Enabling Factors for Successful Local Production and Supply of Quality-Assured Medicines

Let’s work together in partnership Looking forward Key ingredients for successful, reliable supply of quality-assured, locally-produced products to increase access: Overarching and holistic government strategy and plan An enabling business environment to build knowledge & skills of the medical product industry Robust regulatory systems that ensure quality, safety and efficacy (QSE) Let’s work together in partnership