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 World Health Organization

Better access to medicines through health systems Strengthening Multi stakeholders approach Enhanced capacity in regions and countries Support countries for strengthening systems and capacity to achieve sustainable availability of affordable, quality, safe, efficacious medicines and their appropriate use OBJECTIVE Based on country needs strategy & plans Robust information systems and evidence Quality health service delivery Well performing health workforce Sustainable health financing Leadership and Governance

HSS EMP Other WHO Clusters Coordinated efforts within WHO for efficient and sustainable collaboration with Countries AFRO AMRO EMRO EURO SEARO WPRO Country Offices NPO

Headquarters: Strategy and policy making Planning & monitoring Partnerships and Collaboration Resource Mobilisation Provide specific technical & policy support Support in HR development & training Roles and responsibilities for supporting implementation of WHO Medicine Strategy Roles and responsibilities for supporting implementation of WHO Medicine Strategy Strategy, policy guidance, support and collaborations Regional Offices: Oversee country operations 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

Economic Country Groupings in the EMR 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. Jordan 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

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 6.oPt 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

Enhanced expertise in countries & sub regional economic blocks in Africa Assessment of needs and priorities Support planning, implementation and monitoring of medicines policies Coordination of stakeholders involved in pharmaceuticals WHO Medicines advisers in 16 countries, in sub regional economic blocks to assist in: 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 UEMOA

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-regional offices for the Program of Essential Medicines, in the Americas Regional Office

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 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 WHO developed Level I, Level II, level III indicators & tools to assess & monitor pharmaceutical sector in countries (structures, process & outcomes)

Type B: Specific technical support Ad hoc or regular support usually focused on 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

Seeking evidence for transparency and policy making in countries Collaborate with countries & build capacity to: 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 Level I 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 Medicines for children. Supply chain Assessing regulatory capacity Systematic surveys (facilities, HH) Questionnaire (Health officials)

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 In all middle income countries a NMP has been available in both 2003 and 2007 Among the low income countries an increase in countries with NMP can clearly be noted

2007 Level 1 survey in the African Region STGs Comparison Both middle and low income country show an increase of all STGs

Level 2 surveys for setting targets Ministry Target = 90%

House hold surveys indicators of geographic access

Procurement prices – public sector Lowest Priced Generic Procurement prices – public sector of Lowest Priced Generic

Patient price vs procurement price in the public and private sector (LPG) - matched pairs of same medicines

Components of medicines prices ComponentKenya*Uganda** Manufacturer’s selling price (MSP) 43-59%24-77% Landed costs 2-4%5-14% Wholesale1-43%3-23% Retail17-50%0-68% Dispensed (final) price: VAT, GST 0%0% Price components and essential medicines in Kenya. WHO 2006 **Levison L. Investigating price components, WHO 2006

Ethiopia: 71 days Kenya: 24 days Nigeria: 30 days Ghana: 107 days South Africa: 9 days Affordability of medicines in the private sector for a family* : Originator Brand * an asthmatic child with a respiratory infection, an adult with diabetes and hypertension and another adult with a peptic ulcer It would take more than 2 weeks wages in 6 out of 7 countries for a month treatment (where Originator brands were found) Cameroon 47 days Senegal: 18 days

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

HQ Regional Offices Country Offices Ministries of Health Ministries of Health Partners in Country Support WHO operational partners UN agencies e.g. UNDP, UNFPA, UNICEF; NGOs, CSOs 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 e.g. EU, DFID, pharmaceutical industry, WTO, WIPO, TGF, UNITAID Links with partners at global, regional & country level Links with partners at global, regional & country level WHOCountries

WHO/HAI Africa Regional Collaboration GoalImproved policies and practices to increase ATM PurposeImproved 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 WHO TCM – EDM AFRO & national advisers HAI Africa CS members Improved collaboration for impact on better policies and practices for ATM

WHO/HAI Africa Regional Collaboration- qualitative 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

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 The MeTA “model”

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.

32 Incentives for MeTA stakeholders Ministrie s & Gov. agencies Civil society Private sector Int. institutions DPs 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 Improve health systems efficiency & access to medicines Commitment to good governance & transparency agenda Promote multi stakeholders inclusive approach 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 Promote transparency & good governance agenda Improve health systems efficiency & access to medicines Wholesales, distributors, retailers Access to more information Opportunity for building capacity & improve business practices Active role in policy agenda