Department of Technical Cooperation for Essential Drugs and Traditional Medicine (TCM) Roles and responsibilities in implementing the WHO Medicines Strategy Technical Briefing Seminar, Geneva, September 2006 World Health Organization

WHO Medicines Strategy 2004 – 2007: 4 objectives, 7 components, 44 expected outcomes OBJECTIVES Policy Access Quality and safety Rational use COMPONENTS 1.Implementation and monitoring of medicines policies 2.Traditional and complementary medicine 3.Fair financing and affordability 4.Medicines supply systems 5.Norms and standards 6.Regulations and quality assurance systems 7.Rational use by health professionals and consumers

Support countries to attain sustainable, uninterruptible, supply of affordable, quality, safe, efficacious medicines and their appropriate use 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 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

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

HTP TCM PSM Other WHO Clusters Interactions with HQ Departments, Regions & Country Offices Primary interaction Secondary interaction AFRO AMRO EMRO EURO SEARO WPRO Country Offices NPO

Headquarters (TCM): Support in planning and management and collaborations Provide and coordinate policy and technical support Support in HR development & training Assist in country assessments & monitoring Roles and responsibilities for Supporting implementation of WHO Medicine Strategy Roles and responsibilities for Supporting implementation of WHO Medicine Strategy Strategy, guidance, support and collaborations Regional Offices: Oversee countries policies and support Planning and monitoring of country support Technical, policy and management support to countries Human resources development & training Partnerships and collaborations at regional level Country Offices: Assess needs and identify priorities for technical support Plan & implement WHO work Provide technical and policy support to countries Assist in coordination Partnerships & collaborations in countries Feedback and report Ministries of Health: Identify needs & priorities Plan, implement and monitor action Coordinate with other Ministries and national bilateral and multilateral agencies and CSO's. Planning, implementation, monitoring

Country Groupings in the EMR Non-Arabic countries GCC countries Arab League Countries in emergencies Big countries with sizable pharma industry 1. Afghanistan 2. Iraq 3. Pakistan 4. Somalia 5. Sudan 1. Afghanistan 2. Iran 3. Pakistan 22 / 57 countries are in the EMR 1. Egypt 2. Iran 3. Pakistan 1. Bahrain 2.Kuwait 3.Oman 4. Qatar 5. Saudi Arabia 6. UAE 20 / 22 countries of the League are in the EMR Franchophone countries OIC 1. Morocco 2.Tunisia 3.Djibouti Out of 22 EMR countries 14 are in Asia and 8 are in Africa

Economic Country Groupings in the Region Low income countries US $ 765 or less High income countries $ 9385 or more Lower middle income countries from US $ 765 to 3035 Upper middle income countries from $ 3036 to Afghanistan 2. Pakistan 3. Somalia 4. Sudan 5. Yemen 1. Djibouti 2. Egypt 3. Iran 4. Iraq 5. Jordon 6. Morocco 7. Syria 8. Tunisia 1. Lebanon 2. Libya 3. Oman 4. Saudi Arabia 1. Bahrain 2. Kuwait 3. Qatar 4. UAE World Bank list of economies, July 2004

Type B: Specific technical support Ad hoc or regular support usually focused on a specific 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 EMS areas: policy; access, quality, safety & efficacy, and rational use Type A: Situation analysis & Monitoring Assessment of pharmaceutical situation, identify priority needs – recommendations for interventions Type IC: Inter-country Ad hoc or regular support involving two or more countries often in the same region Usually focused on specific areas: policy; access; quality, safety & efficacy; and rational use Activities Driven by Country Needs & Priorities activities are identified in conjunction with countries and responsive to country needs activities are also based on WHA & EB Resolutions

Enhanced expertise in countries assessing needs and priorities planning, implementation and monitoring support on medicines policies coordination of stakeholders involved in pharmaceuticals feedback and reporting WHO Medicines advisers in about 30 countries to assist in:

Subregional post Intl Caribbean WHO CC Drug Supply Subregional post Intl MERCOSUR Subregional post National Officer Subregional post Central America WHO CC Drug Policies WHO CC Rational Use WHO CC Drug Supply WHO CC Drug Policies Sub-regionalization of the Program of Essential Medicines, Vaccines and Technologies Regional Office

HQ Regional Offices Country Offices Ministries of Health 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 Links with other partners WHOCountries

Support to policy changes based on evidence data used to identify gaps - set objectives & priority interventions – develop work plans and estimate resource needed Regional/country plans implemented in coordination with all partners: bilateral and multilateral agencies, NGOs, and other stakeholders Level I, Level II, level III core indicators and tools to assess & monitor pharmaceutical sector in countries

WHO hierarchical approach to monitoring and assessing country pharmaceutical situations Level I Core structure & process indicators Level II Core outcome/impact indicators Level III Indicator tools for specific components of the pharmaceutical sector ● Household survey for access ● Pricing●Traditional medicine ● Assessing regulatory capacity ● Procurement and supply management ● Medicines for children Systematic survey Questionnaire (Health Officials) Objectives To develop prioritized pharmaceutical policy objectives based on evidence To determine the effects, impact of pharmaceutical policy implementation over time To establish pharmaceutical situation evidence for advocacy ( managers, policy makers, donors) Indicator for evidence based planning Systematic data gathering Enables comparisons between facilities, districts, regions, countries depending on sampling Facilitates measuring trends Provides evidence for prioritising, planning and identifying interventions Use as indicators for & WHO Medicines Strategy

Medicines prices surveys to inform policy changes Surveys carried out using WHO/HAI methodology in 12 countries in the WHO African Region - March 04/05 Collecting and analyzing medicines prices in 3 sectors - measuring availability, affordability and price components Surveys carried out by countries to inform policy decisions & change for improving availability and affordability Cameroon, Chad, Ethiopia, Ghana, Kenya, Mali, Nigeria, Senegal, South Africa, Tanzania, Uganda & Zimbabwe

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

Functions: Team A POLICY AND MEDICINES SUPPLY MANAGEMENT Development, implementation, evaluation of National Medicines Policy (NMP) and integration in health systems plans Improvement of procurement and supply management, of drug pricing policies and monitoring Identify and implement strategies to promote appropriate use of medicines Identify mechanisms to ensure that qualified staff are available to help meet the objectives of the pharmaceutical sector

Functions: Team B MEDICINE FINANCING AND TRADE Protection of public health interests in negotiations and implementation of international, regional and bilateral trade agreement Development/strengthening of financing and cost containment mechanisms for medicines

Functions: Team C MEDICINE REGULATORY SUPPORT Development/strengthening of national medicine regulatory and quality assurance systems, to enable them to ensure the safety, quality and efficacy of medicines and combat the circulation of substandard and counterfeit medicines Assessment of local production capacity and support

Functions: Team D TRADITIONAL MEDICINE Provide guidance on policy and technical support on Traditional Medicine Support inter-country, interregional and international sharing experiences and information and harmonization