EDM support to countries example of the African Region Gilles Forte WHO/EDM Drug Action Programme.
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EDM support to countries example of the African Region Gilles Forte WHO/EDM Drug Action Programme Objectives of this session At the end of the session participants will understand: the WHO global strategy for working with countries the EDM strategy for country support how EDM work with countries is co-ordinated across WHO (country offices, regional offices, and headquarters) the types of support to countries how EDM works with other organisations to achieve common goal 2 WHO/EDM - Regional & country collaboration Mission statement for country support Support countries for the development, implementation and monitoring of relevant medicines policies and programmes and for building sustainable environment and capacity that will ensure that quality, safe and effective essential medicines are available, affordable to the population and are used appropriately. 3 WHO/EDM - Regional & country collaboration Maximising Country Support 5 principles guiding WHO country support in medicines: 1. Co-ordinated efforts within WHO 2. Enhanced expertise in country offices. 3. Support to countries based on needs and priorities 4.Evidence based planning and interventions 5. Collaboration with partners 4 WHO/EDM - Regional & country collaboration 1-Co-ordinated efforts within WHO Headquarters: Strategy & policy making Planning & monitoring Specific technical & policy support Strategy for development & training Partnerships and collaboration Regional Office: Oversee country operations Planning and monitoring Technical, policy and management support Human resources development & training Partnerships and collaborations 6 WHO/EDM - Regional & country collaboration Country Offices: Assess needs and identify priorities for technical support Plan & implement WHO work Assist Coordination Partnerships &collaborations Feed back and report Ministries of Health: Identify needs & priorities Plan, implement and monitor action Co-ordinate with bilateral and multilateral agencies and CSOs. Maximising Country Support 5 principles guiding WHO country support in medicines: 1. Co-ordinated efforts within WHO 2. Enhanced expertise in country offices. 3. Support to countries based on needs and priorities 4.Evidence based planning and interventions 5. Collaboration with partners 7 WHO/EDM - Regional & country collaboration 2-Enhanced expertise in country offices There are 11 medicine advisors in Africa Medicines Advisors to: Assist in planning, implementation and monitoring of medicines policies Assist in coordination of partners involved in pharmaceuticals 8 WHO/EDM - Regional & country collaboration Maximising Country Support 5 principles guiding WHO country support in medicines: 1. Co-ordinated efforts within WHO 2. Enhanced expertise in country offices. 3. Support to countries based on needs and priorities 4.Evidence based planning and interventions 5. Collaboration with partners 10 WHO/EDM - Regional & country collaboration 3-Support to countries: based on needs & priorities Country needs and priorities Type A: Situation analysis & monitoring Type A. assessment of pharmaceutical situation, identify priority needs - recommendations for interventions Type B: Specific technical support Ad hoc or regular support Usually focusedType on B. a subset of the following areas: policy; access; quality, safety & efficacy; and rational use 11 WHO/EDM - Regional & country collaboration Needs and priorities from countries or regions Type IC: Intercountry Type C: Comprehensive programme support Time frame may cover one or more biennia Usually involves a full-time pharmaceutical adviser in the country Covers most or all of the following areas: policy; access; quality, safety & efficacy; and rational use Ad hoc or regular support involving two or more countries often from the same region Usually focused on a subset of the following areas: policy; access; quality, safety & efficacy; and rational use 3-Support to countries: based on needs and priorities Improving access to information on medicines Providing technical advise for policy, tools and guidelines Supporting capacity building and training programmes Strengthening institutions Assisting in assessments & surveys-gathering evidence Contributing to planning, management and monitoring Facilitating partnerships & collaborations 12 WHO/EDM - Regional & country collaboration Maximising Country Support 5 principles guiding WHO country support in medicines: 1. Co-ordinated efforts within WHO 2. Enhanced expertise in country offices. 3. Support to countries based on needs and priorities 4.Evidence based planning and interventions 5. Collaboration with partners 13 WHO/EDM - Regional & country collaboration 4-Evidence based planning and interventions WHO has developed indicator-based tools to evaluate structures, processes, outcomes and several specific pharmaceutical components Interventions should be implemented in coordination with partners, including bilateral and multilateral agencies, NGOs, and other stakeholders 1. Assess and Monitor Based on assessing and monitoring the pharmaceutical situation, objectives can be established and targeted interventions planned 3. Implement 14 WHO/EDM - Regional & country collaboration 2. Plan Rationale for an evidence-based approach Raise awareness about real situation (i.e. MOH, WHO) Provide “numbers for advocacy” to convince policymakers of changes Set priorities among possible areas for intervention Assess country medicines situation and trends over time Measure impact of interventions 15 WHO/EDM - Regional & country collaboration Core indicators to monitor national pharmaceutical situations Level I Structures & processes Level II Outcomes Level III Indicator tools for specific components of the pharmaceutical sector such as • Pricing •Regulatory capacity • HIV/AIDS •Traditional medicine • TRIPS • etc. 16 WHO/EDM - Regional & country collaboration Affordability of medicines Affordability of Treatment of Pneumonia in 5 African Countries: Average Number of Day's Wage of Lowest Government Salary Needed to Pay for Treatment 12 10 8 6 4 2 0 10.5 5.8 3.3 Public Health Facility Pharmacies Adults Country 1 17 WHO/EDM 1.3 1.3 1.1 - Regional & country collaboration Private Pharmacies Country 2 1.6 1.5 0.4 1.4 1.5 Public Health Facility Pharmacies Children Country 3 Country 4 1.4 0.7 1.4 Private Pharmacies Country 5 Interventions to improve affordability of medicines Affordability Improve access to price information & monitoring of drug prices Ensure inclusion of TRIPS safeguards in intellectual property legislation Promote use of generic medicines of assured quality 18 WHO/EDM - Regional & country collaboration 1. Assess and Monitor 3. Implement 2. Plan Core indicators to monitor national pharmaceutical situations Level I Structures & processes Level II Outcomes Level III Indicator tools for specific components of the pharmaceutical sector such as • Pricing •Regulatory capacity • HIV/AIDS •Traditional medicine • TRIPS • etc. 20 WHO/EDM - Regional & country collaboration WHO/HAI pricing project in countries Promote analysis of medicines affordability Make reliable, up-to-date information on medicines prices available particularly in low income countries Improve price transparency and empower actors concerned with health and medicines policy Compare retail drug prices both within, among countries and over time 21 WHO/EDM - Regional & country collaboration Price components (total markup as % CIF price) Peru private, observed maximum Kenya private, observed maximum Kenya private, observed minimum Armenia private, observed maximum Armenia private, observed minimum Sri Lanka private Sri Lanka public South Africa public procurement 0 % 20 % 40 % 60 % 80 % 100 % 120 % customs, fees, insurance, clearance import tax importer mark-up distribution/wholesale mark-up retail mark-up VAT 22 WHO/EDM - Regional & country collaboration 140 % 160 % Policy options to correct higher prices Goverment to establish price regulation - from Manufacturer selling price (MSP) to margins in WHOLESALE and RETAIL and/or profesional fees Perform (international) price comparisons and price surveys routinely Competition likely to be more effective than regulation in many settings Need to introduce degressive mark-ups to encourage the dispensing of generics Countries should cease taxing essential medicines 23 WHO/EDM - Regional & country collaboration Brand versus generic price ratiosciprofloxacin Price ratio 100 90 80 70 60 50 40 30 20 10 0 Originator brand Generic Armenia 24 WHO/EDM - Regional & country collaboration Brazil Peru Sri Lanka Policy options to reduce originator brand premiums Governments to use the flexibilities of TRIPS for patentted medicines to introduce generics while patents are in force Generic Policy on : - substitution - prescribing - consumer education on availability and acceptability of generics Change remuneration policy to dispensing fees and degressive margins 25 WHO/EDM - Regional & country collaboration WHO policy and technical support on TRIPS to over 60 countries - health, trade and patent officials Meeting on TRIPS in OAPI countries (Yaoundé, May 2002) (15) Meeting on the impact of globalization (Jakarta, May 2000) (9) Briefing on TRIPS (SADC) South Africa, June 2000) (7) Workshop on TRIPS (Harare, August 2001) (4) Participants in both, South Africa and Harare meetings (11) Intercountry meeting on the TRIPS Agreement (Warsaw, September 2001) (22) Country support 26 WHO/EDM - Regional & country collaboration (9) Country pricing surveys in the African Region Training and planning workshop, Tunis February 2004: Algeria, Chad, Cameroon, Mali, Morocco, Tunisia Training and survey to start in Uganda 20 April and in Chad 25 April 2004 Regional training and planning workshop for Anglophone African countries in June-July 2004: Ethiopia, Tanzania, Ghana, Kenya... 28 WHO/EDM - Regional & country collaboration Core indicators to monitor national pharmaceutical situations Level I Structures & processes Level II Outcomes Level III Indicator tools for specific components of the pharmaceutical sector such as • Pricing •Regulatory capacity • HIV/AIDS •Traditional medicine • TRIPS • etc. 29 WHO/EDM - Regional & country collaboration Support to improve drug regulation in Africa-some examples Review of drug regulatory situation in Ethiopia, Tanzania, Mali, Senegal, South Africa Three year work plan developed with Ethiopia, Tanzania, Mali and Senegal 30 WHO/EDM - Regional & country collaboration Support to the Drug Administration and Control Authority (DACA) of Ethiopia-Phase 1 Improving information management, communication, transparency and accountability Networking of computers of DACA and creation of website and training of web site operators Donation of computers Provision financial assistance to cover local cost Training of two staff in drug registration in Zimbabwe each for one month Two weeks training on GMP & drug regulation 27 people (DACA staff and industry production and quality assurance heads) Provision different publications and guidelines 31 WHO/EDM - Regional & country collaboration Support to Tanzanian Food and Drug Authority (FTDA) –Phase 1 Improving information management and communication, transparency and accountability Purchase of new computers Networking of computers Creation of website and training of web site managers Financial support to public and decision-makers awareness programmesRadio /TV spots, posters and brochures Financial support to quality surveillance Support to participation in GMP training Purchase of dissolution apparatus for QC lab. 32 WHO/EDM - Regional & country collaboration Promotion of drug regulation harmonization Technical and financial support to SADC harmonization Support the initiation of harmonization and technical cooperation in pharmaceuticals in UEMOA Member States (Economic and Monitory Union of West Africa) Sub-regional training courses on registration of generic drugs with emphasis on antiretroviral drugs Sub-regional training courses on GMP Training courses on the use of SIAMED Training in quality control of drugs 33 WHO/EDM - Regional & country collaboration Maximising Country Support 5 principles guiding WHO country support in medicines: 1. Co-ordinated efforts within WHO 2. Enhanced expertise in country offices. 3. Support to countries based on needs and priorities 4.Evidence based planning and interventions 5. Collaboration with partners 34 WHO/EDM - Regional & country collaboration Collaboration with partners World Health Organization HQ Regional Offices Country Offices Countries Ministries of Health Partners in Country Support WHO operational partners UNAIDS, bilateral and multilateral agencies, public interest NGOs in health, UNDP, UNFPA, UNCTAD 35 WHO/EDM - Regional & country collaboration WHO scientific partners WHO Collaborating Centres in pharmaceuticals, universities, research centres, international health professional associations WHO strategic partners World Bank and development banks, pharmaceutical industry, WTO, WIPO, EU WHO/EDM-HAI Africa Regional collaboration for action on essential medicines in Africa 1. Increased access to essential medicines through improved policies and practices - joint priority areas of work: pricing and IPR issues 2. Increased capacity and participation of NGOs and consumers in the development and implementation of medicines policy in countries 3. Expanded CSO participation in and strengthened coordination of the HAI Africa Network 4. Project countries: Uganda, Kenya and Ghana 36 WHO/EDM - Regional & country collaboration Rationale for WHO-CSO collaboration in countries Learn from our differences-mandates and approaches Synergy of expertise & know how- for a greater impact Enhance CSO participation in policy development & implementation Empower CSO and build capacity in the medicines field Forge dialogue & links between MOH & CSO-improve credibility 37 WHO/EDM - Regional & country collaboration Maximising Country Support 5 principles guiding WHO country support in medicines: 1. Co-ordinated efforts within WHO 2. Enhanced expertise in country offices. 3. Support to countries based on needs and priorities 4.Evidence based planning and interventions 5. Collaboration with partners 38 WHO/EDM - Regional & country collaboration