1. Public Health, Innovation and Intellectual Property Improving access to medicines through local production: Some New Development I P C Meeting, Copenhagen (through VC) Zafar Mirza 18 June 2015, Brussels

2. Public Health, Innovation and Intellectual Property WHO/EC Project: “Improving access to medical products in developing countries through building capacity for local production and related technology transfer” Phase I - Identified main trends and barriers to local production of pharmaceuticals, vaccines and diagnostics. Published 8 reports. (2009-2011) Phase II - Activities to promote greater policy coherence between government policies that affect the local production in order to improve access. (2012-2014)

3. "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." WHO Bulletin, June 2014

4. Public Health, Innovation and Intellectual Property WHO Director General's Strategic Grant for local production To work with AUC and other development partners for implementation of Ppharmaceutical Manufacturing Plan for Africa (Business Plan) Provide assistance to countries on request in strengthening their pharmaceutical production for improving access

5. Framework for Local Production for Improving Access INDUSTRIAL POLICY Competitive Reliable Innovative Productive Responsible Strategic INDUSTRIAL POLICY Competitive Reliable Innovative Productive Responsible Strategic HEALTH POLICY Access (Availability Affordable) Quality Supply Rational Use HEALTH POLICY Access (Availability Affordable) Quality Supply Rational Use SHARED GOALS HEALTH + INDUSTRY Strategic selection of essential medical products Pricing of local products that governments & people can afford. Strict compliance to quality standards Effective NRAs. Health security Innovation. SHARED GOALS HEALTH + INDUSTRY Strategic selection of essential medical products Pricing of local products that governments & people can afford. Strict compliance to quality standards Effective NRAs. Health security Innovation. Government Support Direct support to reduce the cost of manufacture Indirect support of local production for improving access Government Support Direct support to reduce the cost of manufacture Indirect support of local production for improving access

6. Pre-requisites for strengthening pharmaceutical manufacturing 1.Government political and financial commitment 2.Vision and coherent policy framework a.With clear health and industrial policy objectives b.Development of industry overtime along the value chain Time-bound action plan 3.GMP roadmap and political guts to follow-up 4.Time-bound government incentive package 5.Ongoing monitoring and evaluation

7. Public Health, Innovation and Intellectual Property Work with AUC and Interagency collaboration for pharmaceutical manufacturing in Africa:  WHO is supporting development of Collaborative Framework for development partners to work with AUC & NEPAD in implementation of PMPA  Current partners include: UNAIDS, WHO, UNFPA, UNDP, UNECA, USP, ANDI, FAPMA, ADB, coordinated through UNIDO  A multi-year workplan is being developed  WHO is supporting PMPA Technical Committee Meeting in November

8. Public Health, Innovation and Intellectual Property 10 Year National Strategy & 5 Year Plan of Action for Pharmaceutical Manufacturing Development in Ethiopia  Ministry of Health and Ministry of Industry are equal partners  The strategy and plan of action is directly feeding into next 5 year national development plan (GTP II 2015-20) and new Health Sector Transformation Plan  a comprehensive, visionary and ambitious program to transform the pharmaceutical sector in the country.  The vision is to progressively move pharmaceutical companies along the value chain and the goal is to achieve a vertically integrated, GMP compliant and R&D based pharmaceutical sector by 2025.  The government is recommended to provide a well spelled-out and time-bound incentives package to pharmaceutical companies

9. Public Health, Innovation and Intellectual Property 10 Year National Strategy & 5 Year Plan of Action for Pharmaceutical Manufacturing Development in Ethiopia - II  Some key targets include e.g.  by 2020, 60% local needs of essential medicines will be met by locally produced medicines;  there will be 8 to 10 new joint ventures;  all companies will be fully GMP compliant by 2018;  there will be at least 1 API manufacturing unit in place;  exports of pharmaceuticals will be in excess of USD 30 million;  there will be at least 200 trained professionals in industrial pharmacy and regulatory  The Prime Minister of Ethiopia and WHO DG will be launching the S&PA during the UN Financing for Development Conference in Addis Ababa.

10. Thank you For More Information and Accessing Publications: http://www.who.int/phi/publications/local_production/en/