World Health Organization Strategy for working with countries Work in progress Dr Gilles Forte Essential Medicines and Pharmaceutical Policies WHO Geneva Technical Briefing Seminar Geneva, 20 November.
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World Health Organization Strategy for working with countries Work in progress Dr Gilles Forte Essential Medicines and Pharmaceutical Policies WHO Geneva Technical Briefing Seminar Geneva, 20 November 2008 Better access to medicines through health systems Strengthening Quality health service delivery Well performing health workforce Robust information systems and evidence Leadership and Governance OBJECTIVE Support countries for strengthening systems and capacity to achieve sustainable availability of affordable, quality, safe, efficacious medicines and their appropriate use Based on country needs strategy & plans Enhanced capacity in regions and countries Multi stakeholders approach Sustainable health financing Coordinated efforts within WHO for efficient and sustainable collaboration with Countries AFRO Other WHO Clusters AMRO NPO NPO EMRO Country Offices HSS EURO EMP NPO SEARO NPO WPRO Roles and responsibilities for supporting implementation of WHO Medicine Strategy Strategy, policy guidance, support and collaborations Planning, implementation, monitoring Headquarters: Regional Offices: Country Offices: Ministries of Health: •Strategy and • Oversee country • Assess needs and • Identify needs & policy making operations •Planning & monitoring • Planning and •Partnerships and Collaboration •Resource Mobilisation •Provide specific technical & policy support • Support in HR development & training monitoring of country support • Technical, policy and management support to countries • Human resources development & training • Partnerships and collaborations at regional level identify priorities for technical support • Plan & implement priorities • Plan, implement and monitor action WHO work • Coordinate with other •Provide technical and policy support to countries • Assist in coordination •Partnerships & collaborations in countries •Feedback and report Ministries and national bilateral and multilateral agencies and CSO's. Economic Country Groupings in the EMR Low income countries US $ 765 or less 1. 2. 3. 4. 5. Afghanistan Pakistan Somalia Sudan Yemen Lower middle income countries Upper middle income countries from $ 3036 to 9385 from US $ 765 to 3035 1. 2. 3. 4. 5. 6. 7. 8. Djibouti Egypt Iran Iraq Jordan Morocco Syria Tunisia World Bank list of economies, July 2004 1. 2. 3. 4. Lebanon Libya Oman Saudi Arabia High income countries $ 9385 or more 1. 2. 3. 4. Bahrain Kuwait Qatar UAE Country Groupings in the EMR Countries in emergencies 1. Afghanistan 2. Iraq 3. Pakistan 4. Somalia 5. Sudan 6. oPt Big countries with sizable pharma industry 1. Egypt 2. Iran 3. Pakistan Non-Arabic countries • 1. 2. 3. Afghanistan Iran Pakistan GCC countries 1. 2. 3. 4. 5. 6. Bahrain Kuwait Oman Qatar Saudi Arabia UAE Arab League • 20 / 22 countries of the League are in the EMR OIC 22 / 57 countries are in the EMR Franchophone countries 1. Morocco 2. Tunisia 3. Djibouti Out of 22 EMR countries 14 are in Asia and 8 are in Africa Enhanced expertise in countries & sub regional economic blocks in Africa WHO Medicines advisers in 16 countries, in sub regional economic blocks to assist in: UEMOA Burundi Cameroon Central African Rep. Chad Congo Democratic Rep. of the Congo Ethiopia Ghana Kenya Mali Nigeria Rwanda Senegal Uganda United Rep. of Tanzania Zambia EAC • Assessment of needs and priorities • Support planning, implementation and monitoring of medicines policies • Coordination of stakeholders involved in pharmaceuticals WHO CC Drug Policies Regional Office Subregional post Central America WHO CC Drug Supply Subregional post Intl Caribbean WHO CC Drug Supply Sub-regional offices for the Program of Essential Medicines, in the Americas Subregional post Intl MERCOSUR WHO CC Drug Policies Subregional post National Officer WHO CC Rational Use Pacific island countries 1. Cook Islands 2. Fiji 3. Kiribati 4. Marshall Islands 5. Micronesia 6. Nauru 7. Niue 8. Palau 9. Papua New Guinea 10. Samoa 11. Solomon Islands 12. Tonga 13. Tuvalu 14. Vanuatu Support to policy changes based on evidence WHO developed Level I, Level II, level III indicators & tools to assess & monitor pharmaceutical sector in countries (structures, process & outcomes) Regional/country plans implemented in coordination with all partners: bilateral and multilateral agencies, NGOs, and other stakeholders 1. Assess and Monitor 3. Implement 2. Plan data used to identify gaps - set objectives & priority interventions – develop work plans and estimate resource needed 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 Type A: Situation analysis & Monitoring Type B: Specific technical support Type C: Comprehensive programme support Type IC: Inter-country • Assessment of • • Time frame may • Ad hoc or regular 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 support involving two or more countries often in the same region • Usually focused on specific areas: policy; access; quality, safety & efficacy; and rational use pharmaceutical situation, identify priority needs – recommendations for interventions Ad hoc or regular support usually focused on specific areas: policy; access: quality, safety & efficacy; and rational use Seeking evidence for transparency and policy making in countries Collaborate with countries & build capacity to: • Level I Questionnaire (Health officials) Systematic surveys (facilities, HH) Core structure & process indicators Level II Core outcome/impact indicators: access to, rational use of medicines • • Level III In-depth assessment of specific components of the pharmaceutical sector . Pricing . Supply chain Medicines for children Assessing regulatory capacity • Establish evidence on strengths & weaknesses of country pharmaceutical sector, prioritize policy and advocacy interventions for improving efficiency of pharmaceutical systems (policy makers, donors) Measure trends of pharmaceutical sector over time and among countries Make information available for increased transparency & accountability and improving governance Household survey – Cost, availability, affordability – Patients attitudes – Rational use for acute and chronic conditions Assessing pharmaceutical situations in 2008 At global level: 2007 Level 1 survey completed and analysed – WMS 2009; Level 2 package finalised and published At Regional level: Training on monitoring in St Vincent and Accra At country level: Level 2 & House Hold piloted in 9 countries (Gambia, Ghana, Kenya, Uganda, Nigeria, Jamaica, The Philippines, Trinidad & Tobago, Tonga) 2007 Level 1 survey in the African Region NMP Comparison 2003 - 2007 Countries with NMPs in 2003-2007a Among the low income countries an increase in countries with NMP can clearly be noted Countries with NMP by income level In all middle income countries a NMP has been available in both 2003 and 2007 8 Middle income 8 2003 30 Low income 25 50.0% a aFor 2007 countries with data on both years . for countries with data on both years 75.0% Percentage 100.0% 2007 Level 1 survey in the African Region Hospital STGs Countries with hospital STGs by income level STGs Comparison 2003 - 2007 Both middle and low income country show an increase of all STGs 5 Middle income 2 0.0% 2007 2003 7 Low income 13 25.0% 50.0% 75.0% 100.0% Percentage a for countries with data on both years a Primary Health Care STGs Countries with PHC STGs by income level National STGs Countries with national STG by income level a 7 Middle income 6 2007 2003 25 Low income 0.0% 19 25.0% 50.0% 75.0% 100.0% a for countri es wi th da ta on both 4 14 25.0% 50.0% Percentage for countri es wi th da ta on both 2007 2003 15 Low income 0.0% a 7 Middle income Percentage a 75.0% 100.0% Level 2 surveys for setting targets % availability of key drugs in public sector Ministry Target = 90% 100% 78% 80% 60% 40% 73% 75% 72% 55% Health Facility Warehouse 46% 25% 15% 20% 0% Rural 1 Rural 2 Rural 3 Kampala House hold surveys indicators of geographic access Procurement prices – public sector Lowest Priced Generic 6 75th percentile 25th percentile Median 4 Procurement prices – public sector of Lowest Priced Generic Price (MPR) n= number of medicines 3.29 2 1.69 1.3 0.95 0.8 0.88 0.66 0.61 0.57 0.71 0 da an Ug ) 33 ) 32 n= (n= ( nia nza Ta l ga ne Se ) 18 n= a( e ri Nig ) 33 n= li ( Ma ) 24 n= a( ny Ke ) 26 ) 22 (n = (n= ia iop a an Gh Eth ) 12 n= n( ) 17 n= ( ad Ch roo me Ca Patient price vs procurement price in the public and private sector (LPG) - matched pairs of same medicines 16 P rivate 14.9 P ublic P ric e (MP R ) 12 n = number of medicines 9.3 7.3 8 5.3 4.0 3.5 4 4.0 3.3 3.1 2.0 2.4 1.8 1.3 2.9 2.1 3.9 3.5 2.9 2.6 2.0 1.3 0 0 C ameroon (n=17) C had (n=5) Mali (n=30) Tanzania (n=28) S enegal (n=20) G hana (n=30) E thiopia (n=36) K enya (n=28) Zimbabwe (n=25) Nigeria (n=19) Uganda (n=38) (*) Components of medicines prices Component Kenya* Uganda** Manufacturer’s selling price (MSP) 43-59% 24-77% Landed costs 2-4% 5-14% Wholesale 1-43% 3-23% Retail 17-50% 0-68% 0% 0% Dispensed (final) price: VAT, GST Price components and essential medicines in Kenya. WHO 2006 **Levison L. Investigating price components, WHO 2006 Affordability of medicines in the private sector for a family* : Originator Brand It would take more than 2 weeks wages in 6 out of 7 countries for a month treatment (where Originator brands were found) Senegal: 18 days Nigeria: 30 days Ghana: 107 Cameroon 47 days days Ethiopia: 71 days Kenya: 24 days South Africa: 9 days * an asthmatic child with a respiratory infection, an adult with diabetes and hypertension and another adult with a peptic ulcer Affordability and financing in 2008 • At global level: update of the medicines prices surveys methodology and tools • At regional level: UEMOA, EAC • At country level: Support provided to monitor and disclose medicines prices: Ghana, Uganda, Tanzania, Kenya Support for establishing sustainable financing including through health insurance: Burundi, Ghana, Kenya, Nigeria, Tanzania, Uganda Surveys on patients prices and & components: Zambia, Malawi, Mauritius, Rwanda; Barbados, Bahamas, Trinidad & Tobago Sub regional collaboration - expected benefits and opportunities • Sharing information and experience on medicines policy • Sharing information on medicines quality & suppliers performance • Promoting transparency and good governance • Efficient pooling of resources & expertise – financial, technical and human • Stronger negotiating & purchasing power – economies of scale • Joint assessments, inspections, dossier evaluation • Alignment of policies and regulations for improving access • Harmonize standard treatment guidelines and medicines lists Pre requisites for efficient sub regional collaboration • • • • • • • • • Shared political commitment from countries Regional structures and capacity Coordination mechanisms among countries Human resources available in countries Countries medicines policies and guidelines developed and endorsed e.g. PSM; EML Legal and regulatory framework - disparities Information sharing mechanisms e.g. regulation, pricing & patents Sustainable financing mechanisms Capacity building plan Collaboration with sub regional groups • CEMAC, Caribbean, PIC: medicines policy assessments (Level 1 & 2) & alignment • EAC, SADC, Caribbean, PIC: procurement & regulations • UEMOA: medicines policies & regulations Links with partners at global, regional & country level HQ WHO Regional Offices WHO operational partners UN agencies e.g. UNDP, UNFPA, UNICEF; NGOs, CSOs Country Offices Partners in Country Support WHO scientific partners WHO Collaborating Centres in pharmaceuticals, universities, research centres, international health professional associations Countries Ministries of Health WHO strategic partners World Bank and development banks, Donor Agencies e.g. EU, DFID, pharmaceutical industry, WTO, WIPO, TGF, UNITAID WHO/HAI Africa Regional Collaboration Goal Improved policies and practices to increase ATM Purpose Improved collaboration among MOH, WHO and HAI Africa/network of CSOs (to increase availability and affordability of medicines in selected countries) Output 1 Activities Collaboration mechanisms operational at global and country level Management mechanisms in place at global and country levels Effective processes implemented for collaborative planning, budgeting, management, implementation and monitoring Output 2 Activities Access to quality information and collaborative activities related to affordability, availability and rational use increased Research and data collection: Pricing surveys and medicines price monitoring Policy advocacy and communications: At least two communication and advocacy activities per country; policy and guidelines revision; rational drug use promotion; intellectual property rights and public health safeguards in place/maintained. WHO/HAI Africa Regional Collaboration MOH Pharmacy Division EDP Improved collaboration for impact on better policies and practices for ATM WHO TCM – EDM AFRO & national advisers HAI Africa CS members WHO/HAI Africa Regional Collaborationqualitative analysis Hypothesis: collaborative working enhances the impact of diverse stakeholders on common goals The review found the Collaboration added value as: • a forum to generate synergies among stakeholders with diverse interests and expertise • an enabling mechanism for the MOH and civil society to increase mutual trust and respect and to engage as strategic partners in policy processes • a dynamic process for consultative, policy-relevant research to meet country needs and increase the likelihood of policy implementation The MeTA “model” Goal: increased access to medicines Purpose: promote a multi-stakeholder approach to improve transparency, governance, efficiency and accountability, and encourage responsible business practices. Objectives: establish multi-stakeholder process in 7 countries and internationally; encourage progressive disclosure of data on availability, price, quality and promotion of medicines; use the evidence to improve policies and practice; design a sustainable approach MeTA’s Focus • MeTA’s focus will be on strengthening country capacity to collect, analyse, disseminate and use data on medicine quality, availability, pricing and promotion/use. • This will help improve transparency and accountability around the way medicines are selected, regulated, procured, distributed, supplied and then sold to and used by patients. Incentives for MeTA stakeholders Pharmaceutical companies (generic and patent) •Access to more information on medicines needs •Active role in national policy agenda •Visibility & concerned by public health issues •Address quality matters Ministrie s & Gov. agencies Civil society Private Wholesales, distributors, sector retailers •Access to more information Opportunity for building capacity & improve business Int. practices •Active role in policy agenda institutions •Promote transparency & good governance agenda •Improve health systems efficiency & access to medicines •Improve health systems efficiency & access to medicines •Commitment to good governance & transparency agenda •Promote multi stakeholders inclusive approach DPs • Active role in national policy agenda •Supportive environment for advocacy •Financial and other support •Improved dialogue with public and private sectors Good governance agenda Tackle corruption Increase access to medicines Support responsible business 32