National Strategy for Pharmaceutical Manufacturing Development in Ethiopia

National Strategy for Pharmaceutical Manufacturing Development in Ethiopia developing industry to improve access Zafar Mirza IPC 11 th Dec 2015, Geneva

WHO Vision about Access to Medicines will wehave do? access to the People. What everywhere essential they need; that theaccess to Wemedicines will continue to improve medicines are safe, , effective, and of good effective safe, quality, affordable and effective quality; ; and that the medicines are medicines. We will support innovation prescribed and used rationally. . for affordable health technology, local production and national regulatory authorities

WHO Bulletin, June 2014 • "We welcome the surge of interest in the manufacturing of essential health technologies in Africa. " • "UNAIDS, UNIDO and WHO are working closely with the AUC to better coordinate inter-agency efforts to support African governments. " • "Africa’s development partners, especially the BRICS countries (Brazil, the Russian Federation, India, China and South Africa), have a special role in supporting this critical phase of African development. "

"We will support local production" 12 th General Program of work …but what is local production? § Local production: geography and/or ownership – we use jurisdiction as a basis for defining local production rather than ownership § Transfer of technology: broadly defined to include education, training, licensing, know- how, movement of persons, supply of materials and equipment, through various mechanisms

improving quality & access WHO's Approach to Supporting Local Production 1. Political commitment of government to develop local industry 2. Clear vision, coherent policy framework, action plan § "Health-industry complex" : explicitly linking local industry with local needs § Development of industry overtime along the value chain: from imports to local R&D 3. Zero-tolerance on quality § Corresponding investment in strengthening NRAs § Development of national GMP road map and its honest and forceful implementation 4. Time-bound government incentive package § Preferential support to local industry in short to medium term § Fiscal and non-fiscal incentives

improving quality & access WHO's Approach to Supporting Local Production 5. Facilitating technology transfer § North-south and south-south cooperation § Strategic joint ventures § better licensing arrangements 6. Building human resource § Education, training, retention § Attracting expertise from diaspora 7. Supporting management of IP to support local production § Use of transitional period under WTO/TRIPS § benefitting from flexibilities 8. Ongoing monitoring and evaluation § Reliable and sustainable market data gathering system § Regular reports 9. Working with partners § AUC § UNIDO, UNAIDS, UNFPA 10. One WHO approach § HQ, ROs, Country offices working together

National Strategy for Pharmaceutical Manufacturing Development in Ethiopia developing industry to improve access

This Presentation is about

developing local pharmaceutical industry to improve access Ethiopia Vision - 2025 § Middle Income Country by 2025. the economy has been growing at > 10% for > 10 years § Investing economic growth in human development § Universal healthcare and universal access to medicines enhancing local manufacturing is to achieve this vision § Leading nation in light manufacturing in Africa industrial Development Roadmap (2013 -2025)

developing local pharmaceutical industry to improve access Growth Transformation Plan (GTP) 5 Year National Development Plan G T P – I (2010 -15) § Targeted 50% of demand for essential medicines through locally produced medicines, only 20% could be managed § Only $ 2 million exports; only 50% production capacity utilization; limited product portfolio § Key lesson learnt: There was no specific sector strategy G T P – II (2015 -20) § National Strategy and Action Plan for Pharmaceutical Manufacturing Development in Ethiopia part of GTP-II

developing local pharmaceutical industry to improve access Conducive Factors for the Strategy § Government considers pharmaceuticals as strategic commodities in line with AU’s Pharmaceutical Manufacturing Plan for Africa § Sizeable internal market (93 million) and expanding economy pharmaceutical sector growth rate 25%, market $ 1 billion by 2018 § Huge investment in health sector by the government introduction of social health insurance § Government has created attractive investment environment

developing local pharmaceutical industry to improve access National Strategy & Plan of Action for Pharmaceutical Manufacturing Development in Ethiopia (2015 -25) “To transform the Ethiopian pharmaceutical manufacturing sector into a fully GMP-compliant, competitive and innovative industry that meets the national needs of essential medicines through local production by 2025” A strategy based on the value chain approach

developing local pharmaceutical industry to improve access Pharmaceutical Value Chain

developing local pharmaceutical industry to improve access Strategic Objectives 1 Improving access to medicines through quality local production – implementing GMP roadmap 2 Strengthening the national medicine regulatory system 3 Creating incentives designed to move companies along the value chain 4 Developing human resources through relevant education and training

developing local pharmaceutical industry to improve access Strategic Objectives 5 Encouraging cluster development and production of active pharmaceutical ingredients (APIs) 6 Creating a research and development platform 7 Attracting foreign direct investments (FDIs) in the pharmaceutical sector 8 Exploiting the LDC Status to locally produce patented products

developing local pharmaceutical industry to improve access Implementing GMP Road Map § Currently 9 pharmaceutical manufacturers only 2 are GMP certified § By 2018 all manufacturers have to be GMP-complaint § 4 WHO prequalified products by 2020

developing local pharmaceutical industry to improve access Selected targets 2020 & 2025 Current 2020 2025 § § Public procurement of locally produced EMs (%) Joint ventures with int. GMP compliant companies 20 3 50 8 60 15 § API manufacturers 0 § Bioequivalence studies at local bioequivalence center 0 10 25 § Locally developed traditional medicines 0 5 20 § No. of graduates in industrial pharmacy and regulatory sciences 0 200 1 3 1500

developing local pharmaceutical industry to improve access Incentives to move companies along the value chain – some examples Time-bound incentives to help industry stand on its own feet and compete in the market place § 70 % loan for GMP set-up costs for FFP, packaging and API production § 25% preference and 30% pre-payment by public sector procurement agency § 5 year contract to local producers by public procurement agency § Facility for pooled procurement of APIs by a government agency § Technology acquisition grant § 3 years income tax exemption § Zero tax from export income for 5 years

developing local pharmaceutical industry to improve access

THANK YOU for more information and accessing publications: http: //www. who. int/phi/publications/local_production/en/