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Department for Essential Medicines and Health Products (EMP) - areas of work

WHO Technical Briefing Seminar Geneva 29 October- 02 November 2012 WHO Strategy for working with and in countries Dr Gilles Forte Essential Medicines and Health Product Department Medicine Programme Coordination (MPC).

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Department for Essential Medicines and Health Products (EMP) - areas of work

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  1. WHO Technical Briefing Seminar Geneva 29 October- 02 November 2012WHO Strategy for working with and in countriesDr Gilles ForteEssential Medicines and Health Product Department Medicine Programme Coordination (MPC)

  2. Department for Essential Medicines and Health Products (EMP) - areas of work Medicines Policy, Information and Country Support Indicators and tools for pharmaceutical sector monitoring & assessment Medicines Policy; country collaboration and support Transparency & Good governance in medicines Publications & website Quality Assurance and Safety: Medicines Norms/standards (nomenclature) Quality assurance (incl. blood products) Safety / pharmacovigilance Prequalification of medicines; Regulation Medicines Access and Rational Use Rational use and ant-microbial resistance Selection of essential medicines Supply systems; Psychotropics & narcotics, including substance evaluation Access controlled meds Medical Devices and Diagnostics Policies, norms/standards Prequalification, quality and safety Management; Access & use; Regulation

  3. Mandate and Resolutions • WHO Constitution: Article 1: “The Objective of WHO shall be the attainment by all peoples of the highest possible level of health”; Article 2: “(a) to establish and maintain effective collaboration with governmental health administrations; (b) to assist Governments upon request, in strengthening health services; (c) to furnish appropriate technical assistance and, in emergencies, necessary aid upon the request or acceptance of Governments”; • Resolutions: Rational use WHA 60.16/2007; Essential Medicines for Children WHA 60.20/2007; Pricing: WHA 54.11/2001; Availability WHA 57.14/2004;

  4. Implementation of the WHO Medium-Term Strategic Plan 2008-2013 : Strategic Objective (SO-11) : To ensure improved access, quality and use of medical products and technologies Organization-wide expected results : (OWERs) 11.1 Formulation and monitoring of comprehensive national policies on access, quality and use of essential medical products and technologies advocated and supported; 11.2 International norms, standards and guidelines for the quality, safety, efficacy and cost-effective use of medical products and technologies developed and their national and/or regional implementation advocated and supported; 11.3 Evidence-based policy guidance on promoting scientifically sound and cost-effective use of medical products and technologies by health workers and consumers developed and supported within the Secretariat and regional and national programmes.

  5. WHO added value for working with countries • Development of norms, standards, guidelines; (e.g. Expert Committees; Advisory Committees) • Access to information and expertise in the health and pharmaceutical sector for global advocacy (e.g. pool of experts; collaborating centres). • Expertise and operational capacity at country level for advocacy, policy advice and capacity building in line with country needs; • Convening power for effective collaboration, coordination and policy dialogue among national and international stakeholders; • Monitoring and evaluation of policies: development of methodologies, tools and strengthening of countries' capacities.

  6. WHO: 193 Member States Regional and Sub-Regional Offices • Regional Office AFRO Regional Office EMRO Regional Office EURO Regional Office WPRO Regional Office SEARO Regional Office AMRO WHO HQ Geneva (Source: http://www.who.int/about/regions/en/index.html)

  7. WHO Country Medicines Advisers and Collaborating Centres Medicines Adviser Collaborating Centre

  8. Coordination mechanisms for a sustainable collaboration with countries Cameroon Mali Tanzania AFRO Uganda Ghana Zambia WHO Brazil AMRO HSS EMRO Pakistan Jordan Lybia Egypt Sudan EMP EURO SEARO WPRO

  9. The WHO Country Medicines Advisers Network for Africa • 50 Medicines Advisers in 40 countries (15 in Africa) contribute to: • Assessing national medicines needs & priorities; • Planning, Implementing, Monitoring and Evaluate WHO interventions; • Facilitating coordination of partners; • WHO Regional work on medicines and health systems; UEMOA Burundi Cameroon Central African Rep. Congo Democratic Rep. of the Congo Ethiopia Ghana Kenya Mali Nigeria Rwanda Senegal Uganda United Rep. of Tanzania Zambia CEMAC EAC SADC

  10. EMP partners at global, regional and country levelsCoordination mechanisms for a sustainable collaboration with countries WHO/HSS EMP Department IPC WHO: HIV, MAL, TB, RH, Collaborat.Centres UN: UNICEF, UNAIDS, UNFPA, WBank, GFATM, UNITAID NGOs: MSF, HAI, MSH, MDM, JSI, FIP, etc WHO Regional Offices WHO Country Offices Private sector: IGPA, IFPMA, etc MoH Outside MOH: Drug regulatory agencies, national procurement centres, insurance, universities, missions, NGOs, consumers National programmes with improved access to quality medicines for patients

  11. Highlights on major WHO Medicines Programmes in Countries • Country Support programmes for improved access to and use of medicines: • Support to individual countries upon demand (e.g. China; India; Viet Nam etc.); • Regional (multi-country) collaboration programmes: • EU/WHO/African Countries (15) for Health Related MDGs & UHC; • Muskoka Initiative to improve access to and use of essential medicines for women and children in 7 African countries & contribute to the achievements of MGDs 4 and 5; • Support to Transparency and Good Governance in Pharmaceutical Sector: • Good Governance for Medicines Programme • Medicines Transparency Alliance initiative Support to countries Regulatory Authorities and sub-regional Harmonization

  12. Renewed Partnership between EU, WHO & Countries in Africa (2012-2016) • To contribute to the achievement of health-related MDGs and of Universal Health Coverage in 15 countries in Africa; • By improving availability, affordability and use of safe, effective and quality assured essential medicines; • Key principles: • Focus on implementation of national pharmaceutical policies; • Focus on countries and regions' needs and priorities; • Build on work done, ensure sustainability and country ownership; • Improve coordination among key partners and donors; • Promote inter-country collaboration and sharing of expertise in order to strengthen capacity and reinforce regional integration; • Improve transparency and good governance of the pharmaceutical sector in countries;

  13. Renewed Partnership between EU, WHO & Countries in Africa (2012-2016) Expected results: 1) Mean availability of key essential medicines in the public sector increased by up to 10%; 2) Median consumer price ratio of key essential medicines in the public and private sector is reduced by up to 10%; 3) Proportion of essential medicines complying with required national quality & safety regulatory standards increased by up to 5%; 4) Number of prescriptions that comply with National Essential Medicines List/Standard Treatment Guidelines increased by up to 10%. 5) Reliable data on the pharmaceutical sector of countries is collected, analyzed and disseminated; trasparency and good governance improved;

  14. Result from the EU/WHO/ACP Partnership (2004-2010)Assessment of pharmaceutical situation and development of national policies and implementation plans • Data on pharmaceutical situation collected in 68 ACP countries in 2007, data analysed and Regional reports have been published. • In-depth assessment of pharmaceutical policy at health-centre and household levels of 20 ACP countries; Large quantity of data collected and analyzed by national experts for advocacy and for policy implementation and monitoring. • 40 countries supported to develop national medicine policies and implementation plans. 15 of them have officially approved their policies. Common policies have been developed in CEMAC and SADC.

  15. Result from the EU/WHO/ACP Partnership(2004-2010); Regulation and Quality Assurance Between 2004 and 2010: • More than 30 countries have received support to evaluate their Medicines Regulatory Authorities. • 10 countries have installed the software SIAMED for registering medicines. • 15 countries have been supported to produce laws aimed at better regulating their pharmaceutical sector (e.g. Mali, Nigeria, Senegal, Sudan, etc.). • 23 countries have received support to strengthen monitoring of adverse reactions to medicines. • 15 countries have received technical assistance to test quality of medicines in the market and to fight counterfeit medicines.

  16. Result from the EU/WHO/ACP Partnership (2004-2010)Measuring medicines availability

  17. Result from the EU/WHO/ACP Partnership (2004-2010)Selection and rational use of medicines Between 2004 and 2010: • 40 countries supported to create or update their Essential Medicines Lists and Standard Treatment Guidelines. • More than 1,000 national personnel trained in rational use of medicines. • Technical and financial support to establish Drugs and Therapeutics Committees in seven countries (Cameroon, Ethiopia, Ghana, Kenya, Nigeria, Senegal and Uganda. • Rational use campaigns in 9 countries (Mali, Sudan, Zambia, Uganda, Kiribati, Solomon Islands, Tonga, Tuvalu and Vanuatu). Between the interventions there is the approval of laws to regulate medicines promotion (Mali and Zambia) and information campaigns using mass-media like radio and journals (Sudan, Uganda and Zambia). Pacific Islands have used theatre to better involved the public in rational use issues.

  18. Result from the EU/WHO/ACP Partnership (2004-2010)Sub-regional collaboration • CEMAC and Caribbean: assessment and common pharmaceutical policy. • EAC, SADC, Caribbean: work on pooled procurement and on harmonization of registration of medicines. • UEMOA: work on pharmaceutical policies and harmonization of registration and inspection procedures. • PIC: work on pooled procurement of medicines and harmonization of essential medicines lists. • Caribbean: establishment of mechanism for joint monitoring of adverse reactions to medicines (VigiCarib). Potential for collaboration: CEMAC, ACAME, ISMED

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