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

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

4. 4 WHO Essential Medicines Trends in global pharmaceutical situation, new challenges for 2008-2013 (2) n IPR interest shifting from global TRIPS discussion towards technical support to countries; new focus on innovation and public health, inter-governmental process n More interest of Middle Income Countries in medicine issues such as pricing, reimbursement and quality; need for relevant standards and high-level technical support n 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 n 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. 5 WHO Essential Medicines Example of impact of earlier Medicine Strategies:

6. 6 WHO Essential Medicines Examples of country progress in supply:

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

8. 8 WHO Essential Medicines Strategic landscape: Medicine-related Millennium Development Goals MDGsMedicine-related targets by 2015Medicine-related indicators Goal 4: Reduce child mortality Target 5: Reduce <5 mortality rate by 2/313. Under-five mortality rate 14. Infant mortality rate Goal 5: Improve maternal health Target 6: Reduce maternal mortality by ¾16. Maternal mortality ratio Goal 6: Combat HIV/AIDS, malaria and other diseases Target 7: Reversed spread of HIV/AIDS18. HIV prevalence in pregnancy 19. % condom use in contraception Target 8: Reversed malaria incidence21. Malaria prevalence and death rates 22. Use of malaria prevention and treatment 23. TB prevalence and death rates 24. Proportion cured with DOTS Goal 8: Develop a global partnership for development Target 12: Open, rule-based, predictable, non-discriminatory trading and financial system Target 13: Address special needs of least developed countries Target 17: In cooperation with pharmaceutical companies, provide access to affordable, essential drugs in developing countries 46: Proportion of population with sustainable access to affordable essential drugs

9. 9 WHO Essential Medicines New standard set of indicators for measuring access for WHO/MTSP, UNDP/MDG8 Gap Analysis and Lancet assessment Government commitment: n Access to essential medicines/technologies as part of the fulfillment of the right to health, recognized in the constitution or national legislation (S) n Existence and year of a published national medicines policy (S) Rational selection: n Existence and year of a published national list of essential medicines (S) Affordable prices: n Legal provisions to allow generic substitution in private sector (S) n Median consumer price ratio of 30 selected EMs in pub/private facilities (P) n Percentage mark-up between manufacturers' and consumer price (P) Sustainable financing: n Public and private per capita expenditure on medicines (P) n % of population covered by national health service or health insurance (P) Reliable systems: n Average availability of 30 selected EMs in public/private health facilities (O) (Quantified intuition)

10. 10 WHO Essential Medicines WHO strategic directions in medicines 1: Policy, access (1) n National medicine policies: Continue national policies; new focus on comprehensive PHC, health insurance; in countries more focus on strategic components of medicines policy n Intellectual Property Rights: Continue technical support; new focus on IPR and innovation, new approach to medicine patents n 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 n Access: New focus on separate access indicators and on activities to promote availability, price and affordability

11. 11 WHO Essential Medicines WHO strategic directions in medicines 1: Policy, access (2) n Comprehensive supply systems: Continue promotion of best practices; new focus on private sector, transparency and regulatory approach n Transparency and good governance: New policy guidance on transparency and good governance in pricing, procurement, registration; use to strengthen comprehensive systems n 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 n New global funding mechanisms: Continue country support; new focus on guidance and technical support to global funds

12. 12 WHO Essential Medicines WHO strategic directions in medicines 2: Quality n Nomenclature: Continue INN and other nomenclatures; new focus on methods to assign names to biological products n Controlled drugs: Continue treaty obligations on scheduling; new focus on improving access to controlled medicines n 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) n Prequalification: Continue PQ of priority medicines; new focus on QClabs, APIs, CROs; advice to diagnostics, RH commodities, vaccines; strong focus on capacity building n Combating counterfeits: Continue developing IMPACT partnership; focus on practical implementation of strategy

13. 13 WHO Essential Medicines WHO strategic directions in medicines 3: Rational use n Selection: Continue evidence-based Model List and EM Library; new focus on EMs for children, methodological guidance within WHO (Guidelines Development Group) n 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 n 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. 14 WHO Essential Medicines Intergovernmental Working Group on Public Health, Innovation and Intellectual Property n WHO Commission on Intellectual Property Rights, Innovation and Public Health established in 2004, report in April 2006 (53 recommendations) n 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 n WHA resolution (2008) endorses Global Plan of Action ä Aim: Promote innovation, build capacity, improve access, mobilize resources ä Global Plan of Action has 8 components (see next slides)

15. 15 WHO Essential Medicines 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. 16 WHO Essential Medicines The Global strategy on Public Health, Innovation and Intellectual Property Follow-up action n WHO prepares timeframes, progress indicators and estimated funding needs for Executive Board and WHA in 2009 n WHO expert working group on R&D financing for expertise and strategic guidance n Quick Start Programme to implement a number of specific actions under the responsibility of WHO ä (i) mapping of global R&D activities, identification of research gaps ä (ii) supporting R&D and standards setting for traditional medicines ä (iii) strengthening regulatory capacity in developing countries ä (iv) development of a monitoring and reporting framework n Create a database of possible sources of financing for R&D n Global costing of the Global Action Plan

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

18. 18 WHO Essential Medicines Global Medicines Family n Geneva: Department of Essential Medicines and Pharmaceutical Policies EMP (about 100 staff) n Six regional offices: 2-5 professionals per office n 40 of 100 WHO country offices have full-time pharmaceutical policy experts (about half of them funded through EC funds) n Many external networks: ä Six Expert Advisory Panels (quality, policy, narcotics, selection, etc) ä About 50 WHO Collaborating Centres (centres of excellence) ä Regulators, inspectors, laboratories, INRUD, HAI, safety, INN, pricing ä E-drug, Re-med, e-farmacos, india-drug, etc (over 8000 subscribers) ä Interagency Pharmaceutical Coordination (all UN agencies)

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

20. 20 WHO Essential Medicines Essential Medicines and Pharmaceutical Policies (EMP) MAR Medicine Access and Rational Use C.Ondari, Coordinator TRM Traditional Medicine X.Zhang, Coordinator QSM Quality and Safety: Medicines L.Rägo, Coordinator Hans V. Hogerzeil Director MIE Medicine Information and Evidence for Policy R.Laing, Team Leader International Medical Products Anti Counterfeit Taskforce (IMPACT) Secretariat V.Reggi, Executive Secretary 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 MPC Medicine Programme Coordination G.Forte, Coordinator

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

22. 22 WHO Essential Medicines Conclusion: Essential Medicines in March 2009 Good news: n World Medicines Strategy 2008-2013 nearly complete n Better access indicators now used for UN/MDGs, MTSP, others n 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: n WHO Medicines Programme has nearly become an NGO ä RB 12-20%, CVC 10-12%, Specified Project Funding >70% ä Government contributions stable, foundations strongly increasing ä No donor interest in rational use, comprehensive country support