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The WHO Medicines Strategy 2008-2013, and

The WHO Medicines Strategy 2008-2013, and the Global Action Plan on Public Health, Innovation and Intellectual Property. Hans V. Hogerzeil, MD, PhD, FRCP Edin Director, Essential Medicines and Pharmaceutical Policies March 2009. Outline of the presentation.

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The WHO Medicines Strategy 2008-2013, and

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  1. The WHO Medicines Strategy 2008-2013, and the Global Action Plan on Public Health, Innovation and Intellectual Property Hans V. Hogerzeil, MD, PhD, FRCP Edin Director, Essential Medicines and Pharmaceutical Policies March 2009

  2. Outline of the presentation • Trends in the pharmaceutical scene, strategic landscape • The WHO Medicines Strategy for 2008-2013: • Access • Quality • Rational use • The Global Action Plan of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property • The relation between WMS and IGWG • The Essential Medicines Family • Potential areas of collaboration

  3. Trends in global pharmaceutical situation,new challenges for 2008-2013 (1) • Recognition that vertical programmes need an integrated approach with horizontal health systems, supply systems • More interest in medicine quality and quality assurance systems; this implies the need for practical global standards and support to national regulatory agencies • Several new global funding mechanisms for essential medicines; these need global health policy direction, global standards and technical support from WHO • More players and partnerships, complicating the landscape; these need a multi-stakeholder ("MOH-plus") approach and coordination at country level

  4. 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 process • More interest of Middle Income Countries in medicine issues such as pricing, reimbursement and quality; need for relevant standards and high-level technical support • DG 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

  5. Example of impact of earlier Medicine Strategies:

  6. Examples of country progress in supply:

  7. WHO Medicines Strategy 2008-2013Strategic landscape • Experiences from 2000-03 and 2004-07 Medicine Strategies • Millennium Development Goals 2000-2015 • WHO Medium Term Strategic Plan 2008-2013 • Strategic Objective 11 covers access, quality, rational use • Recent WHA resolutions • Rational use, EMs for children, IGWG Strategic Plan 2008-15 • Stated priorities of the new Director-General • MDGs, Universal Access through PHC/Health Systems; evidence-based policies; partnerships; health-in-all-policies • Other country needs (if not included in above)

  8. Strategic landscape:Medicine-related Millennium Development Goals

  9. (Quantified intuition) New standard set of indicators for measuring access for WHO/MTSP, UNDP/MDG8 Gap Analysisand Lancet assessment Government 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)

  10. WHO strategic directions in medicines1: 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 policy • Intellectual Property Rights: Continue technical support; new focus on IPR and innovation, new approach to medicine patents • Traditional medicine: Continue support on regulating quality and safety; new focus on integrating with allopathic medicine policies, promoting evidence on efficacy, regulating products and professionals • Access: New focus on separate access indicators and on activities to promote availability, price and affordability

  11. WHO strategic directions in medicines1: Policy, access (2) • Comprehensive supply systems: Continue promotion of best practices; new focus on private sector, transparency and regulatory approach • Transparency and good governance: New policy guidance on transparency and good governance in pricing, procurement, registration; use to strengthen comprehensive systems • Information 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 statistics • New global funding mechanisms: Continue country support; new focus on guidance and technical support to global funds

  12. WHO strategic directions in medicines2: Quality • Nomenclature: Continue INN and other nomenclatures; new focus on methods to assign names to biological products • Controlled drugs: Continue treaty obligations on scheduling; new focus on improving access to controlled medicines • Quality: 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 building • Combating counterfeits: Continue developing IMPACT partnership; focus on practical implementation of strategy

  13. WHO strategic directions in medicines3: Rational use • Selection: 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

  14. Intergovernmental Working Group on Public Health, Innovation and Intellectual Property • WHO Commission on Intellectual Property Rights, Innovation and Public Health established in 2004, report in April 2006 (53 recommendations) • WHA resolution (2006) establishes an Intergovernmental Working Group (IGWG) to draw up a global strategy and plan of action for needs-driven, essential health research and development for diseases that disproportionately affect developing countries • WHA resolution (2008) endorses Global Plan of Action • Aim: Promote innovation, build capacity, improve access, mobilize resources • Global Plan of Action has 8 components (see next slides)

  15. The Global Strategy on Public Health, Innovation and Intellectual Property 1. Prioritizing research and development needs 2. Promoting research and development 3. Building and improving innovative capacity 4. Transfer of technology 5. Management of IPR to contribute to innovation and promote public health 6. Improving delivery and access 7. Promoting sustainable financing mechanisms 8. Establishing monitoring and reporting systems

  16. The Global strategy onPublic Health, Innovation and Intellectual PropertyFollow-up action • WHO prepares timeframes, progress indicators and estimated funding needs for Executive Board and WHA in 2009 • WHO expert working group on R&D financing for expertise and strategic guidance • Quick Start Programme to implement a number of specific actions under the responsibility of WHO • (i) mapping of global R&D activities, identification of research gaps • (ii) supporting R&D and standards setting for traditional medicines • (iii) strengthening regulatory capacity in developing countries • (iv) development of a monitoring and reporting framework • Create a database of possible sources of financing for R&D • Global costing of the Global Action Plan

  17. Relation between the WHO Medicines Strategy 2008-2013 and the Global Plan of Action for 2008-2015 Global Strategy on Public Health, Innovation and Intellectual Property Rights WHO Medicines Strategy R&D gaps, selection, prequalification, traditional medicines, regulatory support, transfer of technology, production, access, supply Quality norms, standards, medicine policies, rational use, PHC, human rights, good governance IPR issues, R&D capacity, vaccines, technology, health care financing

  18. Global Medicines Family • Geneva: Department of Essential Medicines and Pharmaceutical Policies EMP (about 100 staff) • Six regional offices: 2-5 professionals per office • 40 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)

  19. WHO/EMP has many implementation channels WHO Department of EMP IPC WHO: HIV, MAL, TB, RH, MSD,CAH UN: UNICEF, UNAIDS, UNFPA, WBank, GFATM, WIPO, etc NGOs: MSF, HAI, MSH, JSI churches, networks, WMA, FIP, IGPA, IFPMA, WSMI, etc Regional Offices Country Offices MOH Outside MOH: Drug regul. agency, insurance, collab.centers, universities, missions, NGOs, consumers National programmes for health professionals, patients and consumers

  20. Essential Medicines and Pharmaceutical Policies (EMP) Hans V. Hogerzeil Director International Medical Products Anti Counterfeit Taskforce (IMPACT) Secretariat V.Reggi, Executive Secretary MPC Medicine Programme Coordination G.Forte, Coordinator MIE Medicine Information and Evidence for Policy R.Laing, Team Leader MAR Medicine Access and Rational Use C.Ondari, Coordinator QSM Quality and Safety: Medicines L.Rägo, Coordinator TRM Traditional Medicine X.Zhang, Coordinator • Selection of ess. medicines • Pricing and financing • Supply management • Rational Use • Good governance • INN programme • Quality Assurance • Safety and Efficacy • Prequalification • Assessment • Inspection • Capacity building • Regulatory support • Controlled medicines • Blood products and related biologicals • Norms and standards • Policy and regulation • Technical Support

  21. New areas of work (currently unfunded) • Combating counterfeit medicines • Access to controlled medicines (analgesics, drug abuse) • Promoting rational medicine use, antimicrobial resistance • Access to therapeutic sera (antirabies, snake, scorpions) • Production of global reference standards (Sweden withdrew) Recently (partly) funded • Essential Medicines for Children (Gates Foundation) • Pharmacovigilance for new EMs for HIV (Gates Foundation) • Good Governance for Medicines (Germany)

  22. Conclusion: Essential Medicines in March 2009 Good news: • World Medicines Strategy 2008-2013 nearly complete • Better access indicators now used for UN/MDGs, MTSP, others • Global norms/standards, prequalification, WHO/HAI pricing methods, 80 country projects and innovative public health thinking lead to solid international reputation, trust by Member States Bad news: • WHO Medicines Programme has nearly become an NGO • RB 12-20%, CVC 10-12%, Specified Project Funding >70% • Government contributions stable, foundations strongly increasing • No donor interest in rational use, comprehensive country support

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