WHO Medicines Strategy 2008-2013, Reorganization of medicine programme

1. WHO Medicines Strategy 2008-2013, Reorganization of medicine programme Hans V. Hogerzeil, MD, PhD, FRCP Edin Director, Essential Medicines and Pharmaceutical Policies November 2008

2. Outline of the presentation • Progress with the WHO Medicines Strategy for 2008-2013 • Trends in the pharmaceutical scene, strategic landscape • Strategic directions • Latest update on process • Reorganization of medicine programme in WHO • Merger of two medicines departments, move to Health Systems and Services (HSS) cluster • Organigram and tasks of the new department • Conclusion

3. WHO Medicines Strategy 2008-2013Objectives and target audience • For WHO and major stakeholders to reflect on future needs and on WHO's comparative strengths in the medicines area • To develop and present priorities for action by WHO • To create a tool for advocacy and information of stakeholders; showing the overall picture within which WHO operates • To guide future investment and planning decisions Target audience: WHO, stakeholders, donors

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 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

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 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

6. 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 (SO-11) • Organization-Wide Expected Results (OWERs 11.1, 11.2, 11.3) • Recent WHA resolutions • Stated priorities of the new Director-General • Other country needs (if not included in above)

7. Strategic landscape:Medicine-related Millennium Development Goals

8. Strategic landscape:Priorities of the Director-General • Fundamental needs: Health development and health security. MDGs, pro-poor policies and fairness in health; health services to reach the poor and underserved • Strategic components: Strengthening health systems, and evidence-based policy guidance. PHC chosen as best strategy to ensure affordable fair access to essential care. Underlying values: equity, comprehensive care, local ownership, accountability • Operational principles: manage partnerships and improve performance. WHO to channel the global political enthusiasm and unprecedented funding for health in developing countries; WHO to set global health agenda; WHO to coordinate, focus on unique activities. Within WHO: accountability, measuring performance and impact on people most in need.

9. Strategic landscape:Medium-Term Strategic Plan 2008-2013 Strategic Objective (SO-11): To ensure improved access, quality and use of medical products and technologies Organization-Wide Expected Results (OWERs): 11.1 Formulation and monitoring of comprehensive national policies on access, quality and use of essential medical products and technologies advocated and supported 11.2 International norms, standards and guidelines for the quality, safety, efficacy and cost-effective use of medical products and technologies developed and their national and/or regional implementation advocated and supported 11.3 Evidence-based policy guidance on promoting scientifically sound and cost-effective use of medical products and technologies by health workers and consumers developed and supported within the Secretariat and regional and national partners

10. Strategic directionsOWER 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 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. Strategic directionsOWER 1: 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. Strategic directionsOWER 2: 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, and tools for assessment of regulatory and supply agencies • 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. Strategic directionsOWER 3: 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. WHO Medicines Strategy 2008-2013: next steps • Consultation within EMP completed (HQ, GMC, NPOs) • Draft 9 sent out for comments to Member States, WRs, NGOs, donors, WCCs, WHO departments, external experts, UN agencies, put on e-drug, e-med etc. Comments due by 15 October 2008 • Comments received, largely supportive • Key question: relation with IGWG Global Plan of Action • Final version to be endorsed by Director-General IGWG WMS

15. Reorganization of the WHO medicine programme • Two WHO/HQ medicine departments (Medicine Policy and Standards – PSM, and Technical Cooperation in Essential Medicines and Traditional Medicine – TCM) have been merged into one single medicines department • Dr Hans Hogerzeil is now Director, Essential Medicines and Pharmaceutical Policies (EMP) • The EMP department has become part of the WHO cluster of Health Systems and Services (ADG: Dr Carissa Etienne) • Six building blocks: Human Resources, Financing, Service Delivery, Medicines and Technologies, Information, Good Governance

16. 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

17. Headquarters OSERs for 2008-09 11.001.HQ02: Policy, access OOD OSER 11.001.HQ02.PSM01: Advocacy, planning and management EIP, MPC OSER 11.001.HQ02.PSM02: Evidence for policy guidance; regional planning and coordination MAR/PRF OSER 11.001.HQ02.PSM12: Medicine price survey methodology and reporting MAR/PRF OSER 11.001.HQ02.PSM14: Health insurance & social security MAR/SUP OSER 11.001.HQ02.PSM15: Management of medicines supply systems: best practices. MAR/GGM OSER 11.001.HQ02.PSM16: Good governance and transparency assessment TRM OSER 11.001.HQ02.PSM18: Traditional, Complementary and Alternative Medicines Policies QSM/ACM OSER 11.001.HQ02.PSM19: Enhanced access to controlled medicines for long-term pain treatment MAR/SUP OSER 5.001.HQ03.PSM**: Medicine donations and emergency medical supplies guidelines 11.002.HQ02: Quality QSM/QUA OSER 11.002.HQ02.PSM10: Pharmaceuticals: Norms and Standards QSM/SAE OSER 11.002.HQ02.PSM11: Safety information and Classification Systems QSM/INN OSER 11.002.HQ02.PSM12: INN programme QSM/PQP OSER 11.002.HQ02.PSM13: Prequalification programme QSM/RES OSER 11.002.HQ02.PSM14: Global regulatory harmonization promoted QSM/ACM OSER 11.002.HQ02.PSM15: Psychotropic and narcotic medicines QSM/QSD OSER 11.002.HQ02.PSM16: Blood & blood products: norms & standards QSM/TRM OSER 11.002.HQ02.PSM22: Traditional, Complementary & Alternative medicines' guidelines QSM/RES OSER 11.002.HQ02.PSM25: Regulatory systems and capacity strengthened QSM/IMP OSER 11.002.HQ02.PSM26: Counterfeit medical products - IMPACT QSM OSER 11.002.HQ99.PSM99: Overall management and administration QSM/PQP OSER 02.003.HQ01.PSM**: Priority medicines for HIV/AIDS prequalified QSM/PQP OSER 02.003.HQ02.PSM**: Priority medicines for TB prequalified QSM/PQP OSER 02.003.HQ03.PSM**: Priority medicines for malaria prequalified 11.003.HQ02: Rational Use MAR/RUM OSER 11.003.HQ02.PSM01: Rational Use of Medicines promoted & supported MAR/SEL OSER 11.003.HQ02.PSM14: Evidence-based clinical guidelines and selection of essential medicines MAR/RUM OSER 11.003.HQ02.PSM16: Containment of antimicrobial resistance promoted MAR OSER 11.003.HQ99.PSM99: Overall management and administration Will be split

18. New direction: Continuity versus Change • Organic growth, "logical incrementalism" (no political show) • Continuity (many components listed in Strategy) • New growth areas ("mature" global issues) • EMc, IMPACT, pharmacovigilance, MeTA/pricing, rational use, access to controlled medicines, anti-snake/anti-rabies sera) • New growth areas (creative, trying-out, "risk capital") • Human rights, MDG reporting, reproductive health supplies, PHC/HSS links, Expert Committee on NDPs, good governance • Information Management

19. Conclusion Good news: • Merger successful, World Medicines Strategy 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 >65% • Government contributions stable, foundations increasing • No donor interest in rational use, country support