Strategic Direction and Competency Review

1. World Health Organization Strategic Direction and Competency Review Department of Technical Cooperation for Essential Drugs and Traditional Medicine

2. Overview Context and background TCM Strategic Direction Core functions and structure Implications and next steps

3. Background • Newly created Department as a result of the DG's decision • Area of work - WHO Medicines Strategy 2004-2007 • Two Departments TCM and PSM work within this framework • PSM-Policy, Standards and Norms • TCM- Country support, horizontal and vertical collaboration • Improved coordination at country level within context of country focus and decentralization agenda • Reshaping and rebalancing responsibilities, between HQ and regional and country offices • Administrative and technical structures in countries for enhanced support, through National Professional Officers • Country Cooperation Strategy serves as a good approach • Global Medicines Council, regional structure for coordination

4. Issues • Medicines supply management remains a key challenge in ensuring availability, in a number of countries even those with National Medicines Policies • Affordability is still a barrier to access for some of the medicines needed for priority health problems • Only 69 countries have pricing policies that cover public sector and 55 countries have pricing policies for private sector • Poorer communities pay out of pocket for their medicines, some communities, e.g. in the African Region, have sought their own drug financing strategies

5. Support countries to attain sustainable, uninterruptible, supply and appropriate use of affordable, quality, safe, efficacious medicines (including TM) for public health problems OBJECTIVE Priorities Identified in WHA: 1. Maternal, neonatal, child and adolescent health 2. Reproductive health 3. HIV/AIDS 4. TB 5. Malaria 6. Non-communicable diseases

6. Support countries to attain sustainable, uninterruptible, supply and appropriate use of affordable, quality, safe, efficacious medicines (including TM) for public health problems OBJECTIVE Strategic direction of the Department Key Areas Values and Principles Support countries to develop, implement, evaluate & integrate NMP in health systems plan National medicine policies: Support countries to develop, implement, evaluate & integrate NMP in health systems plan Collaboration/cooperation/ Building complementarities Guide pricing policies and drug supply management Guide pricing policies and drug supply management Demand/need driven Promote appropriate and safe use of EML and traditional medicines Promote appropriate use of essential medicines including traditional medicines Strengthen national capacity in drug and herbal medicines regulation to ensure quality, safety, efficacy Strengthen national capacity in drug and herbal medicines regulation to ensure quality, safety, efficacy Ethical practices Assist countries in developing sustainable financing mechanisms Assist countries in developing medicines financing mechanisms Consistent message from WHO: HQ, RO's, CO's Guide countries to protect public health negotiation and implementation of trade agreements . Assist countries to protect public health in the negotiation and implementation of international, regional and bilateral trade agreement. Good governance/ accountability/ transparency Guide policies on local production and innovation (R&D) of new medicines for public health needs Guide promoting local production and innovation (R&D) of new medicines for public health needs Provide technical guidance and support on TM Provide technical guidance and support on TM Assist in strengthening Pharmaceutical Human Resources Assist in strengthening Pharmaceutical HR

7. Other WHO Clusters Country Offices NPO AFRO 17 AMRO 13 SMA EMRO 3 NPO HTP TCM PSM EURO 6 NPO SEARO 3 NPO WPRO 8 Linkages with Regions & Country Offices HQ: Guidance, Advocacy, Resource mobilization Regions: Country plans Country Office: needs assessment Primary interaction Secondary interaction

8. Enhanced expertise in country offices National Professional Officers in Africa: • Assess needs and priorities • Assist in planning, implementation and monitoring of medicines policies • Assist in coordination of stakeholders involved in pharmaceuticals • Feedback and report

9. Collaborative Activities Supporting WHO Medicine Strategy Guidance, Advocacy, Resource mobilization Implementation • Headquarters (TCM): • Partnerships and • technical collaboration • and cooperation • Medicines strategy • planning and assist • in policy • development • Support specific • technical & policy • Strategy in support • of HR development • & training • Assist in country • evaluation, • assessment & • monitoring, planning • Regional Offices: • Oversee country • operations • Planning and • monitoring • Technical, policy • and management • support • Human resources • development & • training • Partnerships and • collaborations • Country Offices: • Assess needs and • identify priorities for • technical support • Plan & implement • WHO work • Assist coordination • Partnerships & • collaborations • Feedback and report • Ministries of Health: • Identify needs & • priorities • Plan, implement and • monitor action • Coordinate with • bilateral and • multilateral agencies • and CSO's.

10. Activities Driven by Country Needs & Priorities Initiation of most activities are in response to requests by Member States. Other activities are based on WHA Resolutions, country specific needs. • Type A: • Situation analysis & • Monitoring • Assessment of • pharmaceutical • situation, identify • priority needs – • recommendations • for interventions • Type B: • Specific technical • support • Ad hoc or regular • support usually • focused on a • subset of the • following areas: • policy; access: • quality, safety & • efficacy; and • rational use • Type C: • Comprehensive • programme support • Time frame may • cover one or more • biennia • Usually involves a • full-time national • programme officer • Covers most or all • of the following • areas: policy; • access, quality, • safety & efficacy, • and rational use • Type IC: • Inter-country • Ad hoc or regular • support involving • two or more • countries often in • the same region • Usually focused on • a subset of the • following areas: • policy; access; • quality, safety & • efficacy; • and rational use

11. Links with other partners WHO Countries HQ Regional Offices Country Offices Ministries of Health Partners in Country Support WHO operational partners UNAIDS, bilateral and multilateral agencies, public interest NGOs in health, UNDP, UNFPA, UNCTAD UNICEF, EU WHO scientific partners WHO Collaborating Centres in pharmaceuticals, universities, research centres, international health professional associations WHO strategic partners World Bank and development banks, Donor Agencies, pharmaceutical industry, WTO, WIPO

12. Core Functions • Work with regional and country offices to establish a unified vision of WHO goals and priority areas of work in medicines strategy, in partnership with PSM, Country Focus Initiative & other relevant departments. • Provide technical support in regions and countries and collaborate on various activities identified as priorities to improve access to essential medicines.

13. Department of Technical Cooperation for Essential Drugs and Traditional Medicine Director: TCM Director: TCM Director: TCM Director: TCM Associate Director: Finance & Trade Associate Director: Finance & Trade Associate Director: Finance & Trade Associate Director: Finance & Trade Documentation & Information Centre Documentation & Information Centre Documentation & Information Centre Traditional Medicines Traditional Medicines Traditional Medicines Medicine Policy & Supply Management Medicine Policy & Supply Management Medicine Policy & Supply Management Medicine Regulatory Support Medicine Regulatory Support Medicine Regulatory Support Traditional Medicine Medicine Policy & Supply Management Medicine Regulatory Support

14. Functions: Team A POLICY AND MEDICINES SUPPLY MANAGEMENT • Support countries to develop, implement, evaluate and integrate National Medicines Policy (NMP) in health systems plan • Assist countries in identifying and implementing strategies to promote appropriate use of medicines • Assist countries to improve access by strengthening drug supply management and improved drug pricing mechanism • Assist countries in identifying mechanisms to ensure availability of qualified staff to meet the objectives of the pharmaceutical sector

15. Functions: Team B MEDICINE FINANCING AND TRADE • Assist countries to protect public health in the negotiation and implementation of international, regional and bilateral trade agreement • Guide countries on cost containment mechanisms and measures • Assist countries to establish/develop a system to monitor drug prices in public and private sector

16. Functions: Team C MEDICINE REGULATORY SUPPORT • Support countries to develop/strengthen their national medicine regulatory and quality assurance system in order to enable them to ensure the safety, quality and efficacy of medicines and combat the circulation of substandard and counterfeit medicines • Guide promoting local production and innovation (R&D) of new medicines for public health needs

17. Functions: Team D TRADITIONAL MEDICINE • Provide guidance of policy and technical support on Traditional Medicine • Strengthen links between countries and WHO technical and normative work • Support inter-countries, interregional and international harmonization on sharing national experience and information in the field of TM/CAM