Department of Technical Cooperation for Essential Drugs and Traditional Medicine (TCM)

1. World Health Organization Department of Technical Cooperation for Essential Drugs and Traditional Medicine (TCM) Roles and responsibilities in implementing the WHO Medicines Strategy 2004-2007 Technical Briefing Seminar, Geneva, September 2006

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

3. 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

4. Support countries to attain sustainable, uninterruptible, supply of affordable, quality, safe, efficacious medicines and their appropriate use OBJECTIVE Strategic areas of work and principles Principles Support countries to develop, implement, evaluate NMP& integrate them in health systems plans National medicine policies: Support countries to develop, implement, evaluate & integrate NMP in health systems plan Collaboration/cooperation/ Building complementarities Assist in implementing relevant pricing & supply management policies Guide pricing policies and drug supply management Demand/need driven Assist countries in developing medicines financing mechanisms Promote appropriate use of essential medicines including traditional medicines Help strengthen national capacity in 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 Promote appropriate and safe use of Essential Medicines Consistent message from WHO: HQ, RO's, CO's Guide countries to protect public health and implement flexibilities 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 Support initiatives on local production & innovation (R&D) for fulfilling 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

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

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

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

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

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

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

11. WHO hierarchical approach to monitoring and assessing country pharmaceutical situations 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 2000-03 & 04-07 WHO Medicines Strategy Questionnaire (Health Officials) Level I Core structure & process indicators Systematic survey 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

12. 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

14. 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

15. 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

16. 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

17. 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

18. 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