The WHO Medicines Strategy 2008 -2013 and the

The WHO Medicines Strategy 2008 -2013, and the Global Action Plan on Public Health, Innovation and Intellectual Property Hans V. Hogerzeil, MD, Ph. D, FRCP Edin Director, Essential Medicines and Pharmaceutical Policies November 2010

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 n The relation between WMS and IGWG n The Essential Medicines Family n 2 The Global Action Plan of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property Potential areas of collaboration WHO Essential Medicines

Trends in global pharmaceutical situation, new challenges for 2008 -2013 (1) n 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 3 Recognition that vertical programmes need an integrated approach with horizontal health systems, supply systems More players and partnerships, complicating the landscape; these need a multi-stakeholder ("MOH-plus") approach and coordination at country level WHO Essential Medicines

Trends in global pharmaceutical situation, new challenges for 2008 -2013 (2) n 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 reshape PHC, renewed focus on public sector and essential medicines, new focus on reimbursement schemes n 4 IPR interest shifting from global TRIPS discussion towards technical support to countries; new focus on innovation and public health, inter-governmental process Recent WHA resolutions (prices, IPR, rational use, medicines for children); this implies the need for fundraising and recruitment to expand work in these areas WHO Essential Medicines

Example of impact of earlier Medicine Strategies: 5 WHO Essential Medicines

Examples of country progress in supply: 6 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 n Recent WHA resolutions ä n 7 Rational use, EMs for children, IGWG Strategic Plan 2008 -15 Stated priorities of the new Director-General ä n Strategic Objective 11 covers access, quality, rational use MDGs, Universal Access through PHC/Health Systems; evidence-based policies; partnerships; health-in-all-policies Other country needs (if not included in above) WHO Essential Medicines

Strategic landscape: Medicine-related Millennium Development Goals MDGs Medicine-related targets by 2015 Medicine-related indicators Goal 4: Reduce child mortality Target 5: Reduce <5 mortality rate by 2/3 13. Under-five mortality rate 14. Infant mortality rate Goal 5: Improve maternal health Target 6: Reduce maternal mortality by ¾ 16. Maternal mortality ratio Goal 6: Combat HIV/AIDS, malaria and other diseases Target 7: Reversed spread of HIV/AIDS 18. HIV prevalence in pregnancy 19. % condom use in contraception Target 8: Reversed malaria incidence 21. 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 8 WHO Essential Medicines 46: Proportion of population with sustainable access to affordable essential drugs

(Quantified intuition) New standard set of indicators for measuring access for WHO/MTSP, UNDP/MDG 8 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) 9 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 10 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 sexdisaggregated statistics n New global funding mechanisms: Continue country support; new focus on guidance and technical support to global funds 11 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 12 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; fundraising 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 13 WHO Essential Medicines

Intergovernmental Working Group on Public Health, Innovation and Intellectual Property n n n 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 ä ä 14 Aim: Promote innovation, build capacity, improve access, mobilize resources Global Plan of Action has 8 components (see next slides) WHO Essential Medicines

The Global Strategy on Public Health, Innovation and Intellectual Property 1. 2. 3. 4. 5. 6. 7. 8. 15 Prioritizing research and development needs Promoting research and development Building and improving innovative capacity Transfer of technology Management of IPR to contribute to innovation and promote public health Improving delivery and access Promoting sustainable financing mechanisms Establishing monitoring and reporting systems 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 16 WHO Essential Medicines

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, Quality norms, prequalification, standards, traditional medicines, medicine regulatory support, policies, transfer of technology, rational use, production, PHC, human access, rights, good supply governance 17 IPR issues, R&D capacity, vaccines, technology, health care financing 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 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 18 Six Expert Advisory Panels (quality, policy, narcotics, selection, etc) Interagency Pharmaceutical Coordination (all UN agencies) WHO Essential Medicines

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

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

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) 21 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 ä Government contributions stable, foundations strongly increasing ä 22 RB 12 -20%, CVC 10 -12%, Specified Project Funding >70% No donor interest in rational use, comprehensive country support WHO Essential Medicines