Local Production and A ccess to Medicines

1. Local Production and Access to Medicines EMP - Technical Briefing Seminar1 November, 2013WHO HQ, Geneva Zafar Mirza Public Health, Innovation and Intellectual Property Unit Essential Medicines & Health Products Department

2. What is local production ?

3. What is local production ? Does LP improve access?

4. What is local production ? Does local production improve access? Should WHO support LP?

5. Local production, transfer of technology and access – some definitions Local production: geography and/or ownership – this project uses jurisdiction as a basis for defining local production rather than ownership Transfer of technology: broadly defined to include education, training, licensing, movement of persons, supply of materials and equipment, through various mechanisms

6. To increase access, especially for the poor in developing and least developed countries to medicines, vaccines and diagnostics of importance to public health, and especially for neglected diseases of the type II and type III categories as well as the specific needs of developing countries in relation to type I diseases. Element 4: Promote the transfer of technology and production of health products in developing countries…

7. Local Production and Access to Medicines and other Health Technologies • Surge of interest in local production e.g. BP.PMPA • More international agencies supporting LP • High political interest vs weak economic feasibility • Is local production good for public health? • Long standing work of WHO in supporting quality production (NRA strengthening; GMP trainings etc.) • Our renewed involvement in local production issues through WHO/EC project

8. WHO Perspective on LP It is Government's decision, But we have to ensure… Quality GMP Compliance Effective National Regulatory Authorities Access Essential Medicines Enhanced Public Procurement Security of Supply Affordable Prices

9. WHO/EU Project on LP &improvement in ATM Linked with GSPA-PHI and EU Parliament resolution on improving access to medicines through supporting local production in developing countries • Phase I - Identified main trends and barriers to local production of pharmaceuticals, vaccines and diagnostics. Published 8 reports. (2009-2011) • Phase II - Activities envisaged to promote greater policy coherence between government policies that affect the local production in order to improve access. (2012-2014)

10. Outputs from Phase I of the Project Local production for access to medical products: Developing a framework to improve public health Local production and access to medicine in low- and middle-income countries: A literature review and critical analysis Trends in local production of medicines and related technology transfer Pharmaceutical production and related technology transfer: Landscape report Local production of pharmaceuticals and related technology transfer: A series of case studies Increasing access to vaccines through technology transfer and local production Increasing access to diagnostics through technology transfer and local production Local production and technology transfer to increase access to medical devices Available online: www.who.int/phi/publications/local_production

11. The need for a framework • Industrial development alone is insufficient to leverage the potential benefits of greater access to medical products in developing countries • To help develop and foster a common understanding for policy coherence for both industrial and health development • To help ensure that public investments in national regulatory bodies are made to ensure locally-produced medical products comply with quality standards • To assist governments to identify and justify incentives to local manufacturers • To address a possible future scenario where the global supply of affordable generic medicines may be uncertain. • To better coordinate international support for complementary industrial and health development policies

12. Development of a framework for local production • Phase 1 Activities • Analysis: • Pharmaceuticals • Vaccines • Diagnostics • Mapping the landscape, and trends in Local Production (LP) and Transfer of Technology (ToT) in developing countries • Examine in detail examples local manufactures in developing countries • Regional workshops with stakeholders • Reports • Literature Review • Mapping & Landscape trends in LP and ToT • Country case studies • Pharmaceuticals • Vaccines • Diagnostics PUBLIC HEALTH FRAMEWORK FOR ACCESS

13. The Framework for local production for improving access: Policy coherence and government support FRAMEWORK • INDUSTRIAL • POLICY • Competitive • Reliable • Innovative • Productive • Responsible • Strategic • HEALTH • POLICY • Access • Availability • Affordable • Quality • Supply • Rational +

14. The Framework for local production for improving access: Policy coherence and government support • SHARED GOALS HEALTH POLICY + • INDUSTRIAL POLICY • Strategic selection of essential medical products • Pricing of local products • that governments & people can afford • Strict compliance to quality standards • Effective National Regulation Authorities • Health security • Innovation for local adaptation FRAMEWORK

15. Role for government • INDUSTRIAL • POLICY • Competitive • Reliable • Innovative • Productive • Responsible • Strategic Government Support Direct support to reduce the cost of manufacture Indirect support of local production for improving access • 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 for local adaptation • HEALTH • POLICY • Access • Availability • Affordable • Quality • Supply • Rational

16. Phase II of the project Learning from Phase I Guided by the shared goals of the framework Cross-WHO, WHO regional offices, partner agencies, governments and governmental bodies Align with the African Union and its Pharmaceutical Manufacturing Plan for Africa (PMPA) Full range of medical products: Medicines, vaccines, in-vitro diagnostics, blood derived therapeutic products and medical devices

17. Phase II - Promote and support public health oriented local production in developing countries • Policy analysis for policy coherence • Global resources on local production, technology transfer and access to medical products • Advocacy for the policy framework • Capacity building and technical assistance for local production of selected essential medical products

18. Current Phase II activities • Examine countries’ policy coherence between industrial and health policies • Analyse the patent landscape for a number of medicines suitable for local production • Provide good country case studies on policies and practices on local production: Cuba and Brazil • Develop a price comparison methodology between locally produced and imported medicines • Provide training and capacity building for manufacturers and national regulatory authorities on quality production of medical products • Identify a set of essential medicines most suitable for local production • Examine the local production potential of blood products and selected medical devices

19. This project is supported with funding from the European Union and undertaken with many partners World Health Organization Public Health, Innovation and Intellectual Property http://www.who.int/phi