Collaboration of WHO with the Regions and Countries Dr Cécile Macé Essential Medicines and Health Products Department Technical Briefing Seminar on Pharmaceutical Policies, Nov 2015 1 English TBS Nov 2015
WHO constitution Mandate and Resolutions Article 1: The objective of the World Health Organization shall be the attainment by all peoples of the highest possible level of health Article 2: (a) to establish and maintain effective collaboration 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 WHA Resolutions: Access to essential medicines, Regulatory System Strengthening for Medical Products, Rational Use, Essential Medicines for Children, Pricing, Availability Combating Antimicrobial Resistance, including antibiotic resistance, SSFFC, Strengthening of palliative care as a component of integrated treatment throughout the life course 2 English TBS Nov 2015
Operationalization at the three level of the organization EURO HQ (PHI, TSN, RSS, PQ, SAV, PAU) WPRO AMRO EMRO SEARO AFRO Countries 3 English TBS Nov 2015
Key principles for collaboration with countries Focus on country and regional needs and priorities ownership and country led planning & implementation Technical collaboration with individual countries: -to build evidence for policies and for monitoring progress and impact; -to provide guidance/support on policies, advocacy and best practices; -to strengthen pharmaceutical systems & build capacity; -to facilitate multi-stakeholders collaboration; Sustainability and continuity consolidating and expanding to new priorities High quality technical and strategic expertise backing up from HQ and Regional Offices Promoting regional and subregional collaboration: -sharing information, lessons learnt and expertise -Alignment of policies, regulations, methodologies and tools e.g.medicines lists & treatments guidelines 4 English TBS Nov 2015
WHO global approaches in support to countries Development of norms, standards, guidelines; (e.g. Expert Committees; Advisory Committees); Development of methodologies and tools for collection, analysis and dissemination of reliable information in the pharmaceutical sector for global advocacy and monitoring and evaluation of country policies; Maintenance of a pool of experts & Collaborating Centers for supporting advocacy, policy guidance and capacity building in countries; Convening power for effective collaboration, coordination and policy dialogue among national and international stakeholders; 5 English TBS Nov 2015
Expert Committees EMP is the Secretariat of 4 different committees: Expert Committee on the Selection and Use of Essential Medicines Expert Committee on drug dependence Expert Committee on specifications for pharmaceutical preparations Expert Committee on Biological Standardization Development of norms and standards through large consultations and provision of scientific evidence (review of scientific data available) Composed of Member States representatives, strict management of conflicts of interest with support from the WHO Legal Department 6 English TBS Nov 2015
Country pharmaceutical profiles New questionnaire developed by WHO to support profiles of the pharmaceutical sector in countries in 2016, based on the 2011 version, simplified; pre-filled online questionnaire Pilot phase in countries planned early 2016 (2 by region), coordination through WHO Country Offices and institutional focal points Important tool to document and validate the pharmaceutical sector situation in countries. Could be shared with all partners, to avoid multiple demands and circulation of non-official information. It allows also to show the trend in the sector by comparing data available in a database and with selected indicators. The electronic version of the tool will facilitate the analysis of available data and their statistical interpretation. 7 English TBS Nov 2015
Network of pharmaceutical advisers Their role: in countries To assess national pharmaceutical needs & priorities; To plan, implement and monitor policies To support policy dialogue and facilitate coordination of partners Contribute to WHO Regional work on pharmaceuticals and health systems 8 English TBS Nov 2015
WHO Collaborating Centres In various domains Pharmacovigilance (e.g. Uppsala and Ghana) Quality Assurance (e.g. Algeria) Quality Control (e.g. South-Africa) Pharmaceutical policies (e.g. Utrecht University) Pricing Policies and Reimbursement (e.g. Vienna, Austria) Rational Use (India) Establishment of a contract with WHO valid for 4 years 9 English TBS Nov 2015
EMP partners at global, regional and country levels Coordination mechanisms for a sustainable collaboration with countries WHO Regional Offices WHO Country Offices MoH 10 English TBS Nov 2015 WHO/HIS EMP Department Outside MOH: Drug regulatory agencies, national procurement centres, insurance, universities, missions, NGOs, consumers WHO: HIV, MAL, TB, RH, Collaborat. Centres UN: UNICEF, UNAIDS, UNFPA, WBank, GFATM, UNITAID NGOs: MSF, HAI, MSH, MDM, JSI, etc National programmes with improved access to quality medicines for patients IPC Private sector: IGPA, IFPMA, FIP, etc.
Technical Briefing seminar on pharmaceutical policies An activity to reinforce capacities and collaboration with countries 2 sessions per year (EN/FR) A place to exchange information and experiences with experts from the EMP Department and from regional offices and between country representatives, with representatives from collaborating centres, from NGOs, from the faith-based and private sectors. It is very important to be part of networks to enrich your practice, participants to the TBS could form a network! Being part of electronic forums is also helpful (E-drug) 11 English TBS Nov 2015
Highlights on major WHO Medicines Programmes in Countries Country Support programs for improved access to and use of medicines: EU/WHO/ACP Renewed Partnership (RP) in 15 African countries (2012-2016) Muskoka Initiative to improve access to and use of essential medicines for mothers and children in 9 African countries & contribute to achieving MGDs 4 and 5 (2011-2016) Support to Transparency and Good Governance in Pharmaceutical Sector: Good Governance for Medicines Programme (37 countries) Medicines Transparency Alliance initiative (7 countries) 12 English TBS Nov 2015
Renewed Partnership EU/ACP/WHO Collaboration between the 3 levels of WHO with national counterparts of the pharmaceutical sector in 15 countries through the WHO Pharmaceutical advisers in WHO Country Offices Technical support given by the Regional Office and Experts from HQ 5 main objectives: Improve availability and supply (national PSM systems) Reduce prices and increase financial mechanisms for financing and reimbursement systems Improve quality and safety of medicines (NRAs) and reduce the occurrence of SSFFC products Improve selection, prescribing, dispensing and use of medicines Support the implementation of pharmaceutical policies and enhance transparency and good governance in the pharmaceutical sector 13 English TBS Nov 2015
Good Governance for Medicines (GGM) program What is bad governance? corruption, influence from private sector, conflicts of interest, poor management, system inefficiencies Why improving governance? To improve health, health service delivery and access to quality and affordable medicines For the efficient implementation of medicines policies and the enforcement of laws and regulations To increase transparency, accountability and ethical practices To improve public trust and confidence on the health system To prevent misuse of public, patient and donor funds 14 English TBS Nov 2015
GGM Program Started on 2004 37 countries Based on a transparency assessment (WHO tool), countries identify interventions to improve transparency and accountability in the sector 15 English TBS Nov 2015
Challenges/Opportunities Specific contexts: Elections/Security/Emergencies (Mali, Guinea, Mozambique, Liberia ) Priorities not always well defined by countries and limited ownership and coordination WHO advisers in some countries have a very large mandate, not only on medicines or health products Limited financial and HR capacities in MoHs, and more particularly in pharmaceutical departments, NRAs Limited political will to support national pharmaceutical systems Only few partners/donors are willing to support systems (EU, USAID ) but we hope this could change following the Ebola crisis It is very important for countries to present to donors implementation plans of their National Pharmaceutical Policy with preliminary results 16 English TBS Nov 2015
Thank you! macec@who.int http://www.who.int/medicines 17 English TBS Nov 2015