WHO Medicines Strategy 2008-2013, Reorganization of medicine programme

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 WHO Essential Medicines

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


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


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


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


WHO Medicines Strategy 2008-2013 Strategic 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)


Strategic landscape:Medicine-related Millennium Development Goals

MDGs Medicine-related targets by 2015 Medicine-related indicatorsGoal 4: Reduce child mortality

Target 5: Reduce <5 mortality rate by 2/3 13. Under-five mortality rate14. 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 pregnancy19. % condom use in contraception

Target 8: Reversed malaria incidence 21. Malaria prevalence and death rates22. Use of malaria prevention and treatment23. TB prevalence and death rates24. 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


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.


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


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


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


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


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


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


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


Essential Medicines and Pharmaceutical Policies (EMP)

MARMedicine Accessand Rational Use

C.Ondari, Coordinator

TRMTraditionalMedicine

X.Zhang, Coordinator

QSMQuality and Safety:

MedicinesL.Rägo, Coordinator

Hans V. HogerzeilDirector

MIEMedicine Information

and Evidence for PolicyR.Laing, Team Leader

International Medical ProductsAnti Counterfeit Taskforce

(IMPACT) SecretariatV.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

MPCMedicine Programme

CoordinationG.Forte, Coordinator


11.001.HQ02: Policy, accessOOD OSER 11.001.HQ02.PSM01: Advocacy, planning and managementEIP, MPC OSER 11.001.HQ02.PSM02: Evidence for policy guidance; regional planning and coordinationMAR/PRF OSER 11.001.HQ02.PSM12: Medicine price survey methodology and reportingMAR/PRF OSER 11.001.HQ02.PSM14: Health insurance & social securityMAR/SUP OSER 11.001.HQ02.PSM15: Management of medicines supply systems: best practices.MAR/GGM OSER 11.001.HQ02.PSM16: Good governance and transparency assessmentTRM 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 treatmentMAR/SUP OSER 5.001.HQ03.PSM**: Medicine donations and emergency medical supplies guidelines 11.002.HQ02: QualityQSM/QUA OSER 11.002.HQ02.PSM10: Pharmaceuticals: Norms and StandardsQSM/SAE OSER 11.002.HQ02.PSM11: Safety information and Classification SystemsQSM/INN OSER 11.002.HQ02.PSM12: INN programme QSM/PQP OSER 11.002.HQ02.PSM13: Prequalification programmeQSM/RES OSER 11.002.HQ02.PSM14: Global regulatory harmonization promotedQSM/ACM OSER 11.002.HQ02.PSM15: Psychotropic and narcotic medicinesQSM/QSD OSER 11.002.HQ02.PSM16: Blood & blood products: norms & standardsQSM/TRM OSER 11.002.HQ02.PSM22: Traditional, Complementary & Alternative medicines' guidelinesQSM/RES OSER 11.002.HQ02.PSM25: Regulatory systems and capacity strengthenedQSM/IMP OSER 11.002.HQ02.PSM26: Counterfeit medical products - IMPACTQSM OSER 11.002.HQ99.PSM99: Overall management and administrationQSM/PQP OSER 02.003.HQ01.PSM**: Priority medicines for HIV/AIDS prequalifiedQSM/PQP OSER 02.003.HQ02.PSM**: Priority medicines for TB prequalifiedQSM/PQP OSER 02.003.HQ03.PSM**: Priority medicines for malaria prequalified11.003.HQ02: Rational UseMAR/RUM OSER 11.003.HQ02.PSM01: Rational Use of Medicines promoted & supportedMAR/SEL OSER 11.003.HQ02.PSM14: Evidence-based clinical guidelines and selection of essential medicinesMAR/RUM OSER 11.003.HQ02.PSM16: Containment of antimicrobial resistance promotedMAR OSER 11.003.HQ99.PSM99: Overall management and administration

Headquarters OSERs for 2008-09

Will be split


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


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

Documents

WHO Medicines Strategy 2008-2013, Reorganization of medicine programme