The WHO Medicines Strategy 2008-2013
اسلاید 1: www.tabaye.ir
اسلاید 2: The WHO Medicines Strategy 2008-2013Richard LaingBased on materials produced by Hans V. Hogerzeil, Essential Medicines and Pharmaceutical PoliciesNovember 2011
اسلاید 3: Outline of the presentationTrends in the pharmaceutical scene, strategic landscapeThe WHO Medicines Strategy for 2008-2013: AccessQualityRational useThe Essential Medicines FamilyPotential areas of collaboration
اسلاید 4: Trends in global pharmaceutical situation, new challenges for 2008-2013 (1)Recognition that vertical programmes need an integrated approach with horizontal health systems, supply systemsMore interest in medicine quality and quality assurance systems; this implies the need for practical global standards and support to national regulatory agenciesSeveral new global funding mechanisms for essential medicines; these need global health policy direction, global standards and technical support from WHOMore players and partnerships, complicating the landscape; these need a multi-stakeholder (MOH-plus) approach and coordination at country level
اسلاید 5: Trends in global pharmaceutical situation, new challenges for 2008-2013 (2)IPR interest shifting from global TRIPS discussion towards technical support to countries; new focus on innovation and public health, inter-governmental processMore interest of Middle Income Countries in medicine issues such as pricing, reimbursement and quality; need for relevant standards and high-level technical supportDG priorities (PHC, Africa, women) implies the need to re-shape PHC, renewed focus on public sector and essential medicines, new focus on reimbursement schemes Recent WHA resolutions (prices, IPR, rational use, medicines for children); this implies the need for fundraising and recruitment to expand work in these areas
اسلاید 6: Example of impact of earlier Medicine Strategies:
اسلاید 7: Examples of country progress in supply:
اسلاید 8: WHO Medicines Strategy 2008-2013 Strategic landscapeExperiences from 2000-03 and 2004-07 Medicine StrategiesMillennium Development Goals 2000-2015WHO Medium Term Strategic Plan 2008-2013Strategic Objective 11 covers access, quality, rational useRecent WHA resolutionsRational use, EMs for children, IGWG Strategic Plan 2008-15Stated priorities of the new Director-GeneralMDGs, Universal Access through PHC/Health Systems; evidence-based policies; partnerships; health-in-all-policies Other country needs (if not included in above)
اسلاید 9: Strategic landscape: Medicine-related Millennium Development Goals
اسلاید 10: New standard set of indicators for measuring access for WHO/MTSP, UNDP/MDG8 Gap Analysis and Lancet assessmentGovernment commitment:Access to essential medicines/technologies as part of the fulfillment of the right to health, recognized in the constitution or national legislation (S)Existence and year of a published national medicines policy (S)Rational selection:Existence and year of a published national list of essential medicines (S)Affordable prices:Legal provisions to allow generic substitution in private sector (S) Median consumer price ratio of 30 selected EMs in pub/private facilities (P)Percentage mark-up between manufacturers and consumer price (P)Sustainable financing:Public and private per capita expenditure on medicines (P)% of population covered by national health service or health insurance (P)Reliable systems:Average availability of 30 selected EMs in public/private health facilities (O)(Quantified intuition)
اسلاید 11: WHO strategic directions in medicines 1: Policy, access (1)National medicine policies: Continue national policies; new focus on comprehensive PHC, health insurance; in countries more focus on strategic components of medicines policyIntellectual Property Rights: Continue technical support; new focus on IPR and innovation, new approach to medicine patentsTraditional medicine: Continue support on regulating quality and safety; new focus on integrating with allopathic medicine policies, promoting evidence on efficacy, regulating products and professionalsAccess: New focus on separate access indicators and on activities to promote availability, price and affordability
اسلاید 12: WHO strategic directions in medicines 1: Policy, access (2)Comprehensive supply systems: Continue promotion of best practices; new focus on private sector, transparency and regulatory approachTransparency and good governance: New policy guidance on transparency and good governance in pricing, procurement, registration; use to strengthen comprehensive systemsInformation and planning: Improve indicators and household surveys; new link with NHAs, IMS-data, IEP surveys to create package of country data and improve planning; new focus on sex-disaggregated statisticsNew global funding mechanisms: Continue country support; new focus on guidance and technical support to global funds
اسلاید 13: WHO strategic directions in medicines 2: QualityNomenclature: Continue INN and other nomenclatures; new focus on methods to assign names to biological productsControlled drugs: Continue treaty obligations on scheduling; new focus on improving access to controlled medicinesQuality: Continue normative work (Expert Committees); new focus on missing EMs for priority diseases and children; tools for assessment of regulatory and supply agencies; regional coordination (link to economic blocs)Prequalification: Continue PQ of priority medicines; new focus on QClabs, APIs, CROs; advice to diagnostics, RH commodities, vaccines; strong focus on capacity buildingCombating counterfeits: Continue developing IMPACT partnership; focus on practical implementation of strategy
اسلاید 14: WHO strategic directions in medicines 3: Rational useSelection: Continue evidence-based Model List and EM Library; new focus on EMs for children, methodological guidance within WHO (Guidelines Development Group)Rational use: Continue global database; new focus on national RU programmes (situation analysis, multi-stakeholder approach, comprehensive health systems, national RU body); new focus on antimicrobial resistance and adherence to chronic treatment; fund-raising Pharmacovigilance: Continue global ADR programme; new focus on disease-specific cohort methods for priority diseases (malaria, HIV) and active steering of new global interest in pharmacovigilance
اسلاید 15: World Medicines Situation 2011The third edition of the World Medicines Situation Report brings together new data on 24 key topics relating to pharmaceutical production and consumption, innovation, regulation and safety - in one place. Topics include selection, procurement, supply management, rational use, financing and pricing. Cross-cutting chapters cover household medicines use, access and human rights, good governance, human resources and national medicines policies.Each chapter of this report is written by a different author. Chapters are being published electronically, in batches, between April and December 2011. The new report updates the 1988 and 2004 reports.
اسلاید 16: World Medicines Situation 2011 Introduction Global health trends: global burden of disease and pharmaceutical needs Pharmaceutical consumption Medicine expenditures Released August 2011 Financing medicines Medicines prices, availability and affordability Released April 2011 Access to medicines at the household level (access to health care and medicines: burden of expenditures and risk protection) Research and development of medicines Intellectual property, trade and medicines Regulation of medicines Quality of medicines: the challenge of globalization Pharmacovigilance and Safety of Medicines Released August 2011 Selection of Essential Medicines Released August 2011 Rational use of medicines Released April 2011 Medicines Information and regulation of promotion Procurement of Medicines Released August 2011 Storage and supply chain management of medicines Traditional medicines: global situation, issues and challenges Released April 2011 Access to controlled medicines Released April 2011 Good governance of pharmaceutical Sector Released April 2011 Human resources in pharmaceuticals Access to Essential Medicines as Part of the Right to Health Released August 2011 National medicines policy Conclusion
اسلاید 17: Global Medicines Family Geneva: Department of Essential Medicines and Pharmaceutical Policies EMP (about 100 staff)Six regional offices: 2-5 professionals per office40 of 100 WHO country offices have full-time pharmaceutical policy experts (about half of them funded through EC funds)Many external networks:Six Expert Advisory Panels (quality, policy, narcotics, selection, etc)About 50 WHO Collaborating Centres (centres of excellence)Regulators, inspectors, laboratories, INRUD, HAI, safety, INN, pricing E-drug, Re-med, e-farmacos, india-drug, etc (over 8000 subscribers)Interagency Pharmaceutical Coordination (all UN agencies)
اسلاید 18: WHO/EMP has many implementation channels MOHOutside MOH: Drug regul. agency, insurance, collab.centers, universities, missions, NGOs, consumers Regional OfficesWHO: HIV, MAL, TB, RH, MSD,CAH, HSS (Trad Med)UN:UNICEF, UNAIDS, UNFPA, WBank, GFATM,WIPO, etcCountry OfficesWHO Department of EMP NGOs:MSF, HAI, MSH, JSI churches, networks, WMA, FIP, IGPA, IFPMA, WSMI, etcNational programmes for health professionals, patients and consumersIPC
اسلاید 19: Essential Medicines and Pharmaceutical Policies (EMP) MARMedicine Accessand Rational UseC.Ondari, CoordinatorQSMQuality and Safety:MedicinesL.Rägo, CoordinatorCarissa Etienne Acting Director Selection of ess. medicines Pricing and financing Supply management Rational Use INN programme Quality Assurance Safety and Efficacy Prequalification Assessment Inspection Capacity building Regulatory support Controlled medicines Blood products and related biologicalsMPCMedicine ProgrammeCoordinationG.Forte, CoordinatorIncorporating MIE Country programme coordination & supportPolicy guidanceCountry profiles Good governance & MeTAEHTEssential Health Technology & Medical devicesActing Coordinators Prequalification of DiagnosticsPolicy guidance on TechnologyCountry Surveys HTA
اسلاید 20: New areas of work (currently unfunded) Combating counterfeit medicinesAccess to controlled medicines (analgesics, drug abuse)Promoting rational medicine use, antimicrobial resistanceAccess to therapeutic sera (antirabies, snake, scorpions)Production of global reference standardsRecently (partly) fundedEssential Medicines for Children (Gates Foundation)Pharmacovigilance for new EMs for HIV (Gates Foundation)Good Governance for Medicines (Germany)
اسلاید 21: Conclusion: Essential Medicines in November 2011Good news:World Medicines Strategy 2008-2013 nearly completeBetter access indicators now used for UN/MDGs, MTSP, othersGlobal norms/standards, prequalification, WHO/HAI pricing methods, 80 country projects and innovative public health thinking lead to solid international reputation, trust by Member StatesBad news:WHO Medicines Programme has nearly become an NGORB 12-20%, CVC 10-12%, Specified Project Funding >70%Government contributions stable, foundations strongly increasingNo donor interest in rational use, comprehensive country support
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