Technical cooperation with countries Technical Cooperation for essential drugs and traditional medicines September 2005

Mission Statement for working with countries ………using the WHO Medicines Strategy as a framework collaborate with countries to build a sustainable environment where quality, safe and effective essential medicines, including traditional medicines, are available, affordable and used appropriately ………….

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

Strategic direction of TCM Department Ethical practices Collaboration/cooperation/ Building complementarities Values and Principles Key Areas Good governance/ accountability/ transparency Support countries to attain sustainable, uninterruptible, supply and appropriate use of affordable, quality, safe, efficacious medicines (including TM) for public health problems 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 Promote appropriate and safe use of EML and traditional medicines Guide policies on local production and innovation (R&D) of new medicines for public health needs Assist in strengthening Pharmaceutical Human Resources Provide technical guidance and support on TM Support countries to develop, implement, evaluate & integrate NMP in health systems plan Assist countries in developing medicines financing mechanisms Strengthen national capacity in drug and herbal medicines regulation to ensure quality, safety, efficacy Guide countries to protect public health negotiation and implementation of trade agreements. Guide pricing policies and drug supply management

HTP TCM PSM Other WHO Clusters Linkages with 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 Collaborative Activities Supporting WHO Medicine 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. Strategic planning, implementation, monitoring

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

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 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 a subset of the following areas: policy; access; quality, safety & efficacy; and rational use 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.

Evidence based planning and interventions Data & evidence used, objectives and targets set, implementation plan developed, resources identified Regional/country plans & strategies implemented in coordination with partners: bilateral and multilateral agencies, NGOs, and other stakeholders Level I, Level II core indicators, household survey + other tools assess & monitor structures, processes, outcomes and specific pharmaceutical components

Indicators for monitoring and evaluation of pharmaceutical sector Level I Core indicators On structures & processes Level II Core indicators on outcomes/impact & household survey Level III Indicator tools for specific components of the pharmaceutical sector Pricing HIV/AIDS TRIPS Traditional medicine Etc, etc.

Monitoring and assessment to measure progress over time

Rationale for seeking evidence Raise awareness on realities and actual situation (qualitative observation with evidence) Provide numbers for advocacy to convince policy-makers, donors Identify problem areas and set priorities among possible areas for intervention Assess country medicines situation and trends over time Measures impact of interventions

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

WHO-HAI Africa Regional collaboration for action on essential medicines in Africa 1.Increased access to quality essential medicines through improved policies and advocacy – collaboration on affordability of medicines 2.Increased capacity and participation of NGOs and consumers in the development and implementation of medicines policy 3.Expanded participation in and strengthened coordination of the HAI Africa Network 4.Project countries: Uganda, Kenya and Ghana

Rationale for WHO-CSO collaboration in countries Synergy of expertise & know how Complementary mandates and approaches Enhance CSO participation in policy development & implementation Empower CSO and build capacity in the medicines field Increase impact on decision & policy makers Forge dialogue & links-changed NGO-MOH dynamics - helped close the NGO credibility gap Improve co-ordination and efficient use of resources