WHO Medicines Strategy 2008-2013,
Reorganization of medicine programme
Hans V. Hogerzeil, MD, PhD, FRCP Edin
Director, Essential Medicines and Pharmaceutical Policies
November 2008
Outline of the presentation
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Progress with the WHO Medicines Strategy for 2008-2013
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Trends in the pharmaceutical scene, strategic landscape
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Strategic directions
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Latest update on process
Reorganization of medicine programme in WHO
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Merger of two medicines departments, move to Health Systems
and Services (HSS) cluster
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Organigram and tasks of the new department
Conclusion
WHO Essential Medicines
WHO Medicines Strategy 2008-2013
Objectives and target audience
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For WHO and major stakeholders to reflect on future needs and
on WHO's comparative strengths in the medicines area
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To develop and present priorities for action by WHO
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To create a tool for advocacy and information of stakeholders;
showing the overall picture within which WHO operates
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To guide future investment and planning decisions
Target audience: WHO, stakeholders, donors
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WHO Essential Medicines
Trends in global pharmaceutical situation,
new challenges for 2008-2013 (1)
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Recognition that vertical programmes need an integrated
approach with horizontal health systems, supply systems
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More interest in medicine quality and quality assurance
systems; this implies the need for practical global standards
and support to national regulatory agencies
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Several new global funding mechanisms for essential
medicines; these need global health policy direction, global
standards and technical support from WHO
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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)
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IPR interest shifting from global TRIPS discussion towards
technical support to countries; new focus on innovation and
public health, inter-governmental process
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More interest of Middle Income Countries in medicine issues
such as pricing, reimbursement and quality; need for relevant
standards and high-level technical support
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DG priorities (PHC, Africa, women) implies the need to reshape PHC, renewed focus on public sector and essential
medicines, new focus on reimbursement schemes
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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
WHO Medicines Strategy 2008-2013
Strategic landscape
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Experiences from 2000-03 and 2004-07 Medicine Strategies
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Millennium Development Goals 2000-2015
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WHO Medium Term Strategic Plan 2008-2013
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Strategic Objective 11 (SO-11)
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Organization-Wide Expected Results (OWERs 11.1, 11.2, 11.3)
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Recent WHA resolutions
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Stated priorities of the new Director-General
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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
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WHO Essential Medicines
46: Proportion of population with
sustainable access to affordable essential
drugs
Strategic landscape:
Priorities of the Director-General
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Fundamental needs: Health development and health security.
MDGs, pro-poor policies and fairness in health; health services to
reach the poor and underserved
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Strategic components: Strengthening health systems, and evidencebased policy guidance. PHC chosen as best strategy to ensure
affordable fair access to essential care. Underlying values: equity,
comprehensive care, local ownership, accountability
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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.
WHO Essential Medicines
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
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WHO Essential Medicines
Strategic directions
OWER 1: Policy, access (1)
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National medicine policies: Continue national policies; new focus on
comprehensive PHC, health insurance; in countries more focus on
strategic components of medicines policy
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Intellectual Property Rights: Continue technical support; new focus on
IPR and innovation, new approach to medicine patents
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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
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Access: New focus on separate access indicators and on activities
to promote availability, price and affordability
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WHO Essential Medicines
Strategic directions
OWER 1: Policy, access (2)
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Comprehensive supply systems: Continue promotion of best
practices; new focus on private sector, transparency and
regulatory approach
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Transparency and good governance: New policy guidance on
transparency and good governance in pricing, procurement,
registration; use to strengthen comprehensive systems
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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
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New global funding mechanisms: Continue country support; new
focus on guidance and technical support to global funds
WHO Essential Medicines
Strategic directions
OWER 2: Quality
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Nomenclature: Continue INN and other nomenclatures; new focus
on methods to assign names to biological products
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Controlled drugs: Continue treaty obligations on scheduling; new
focus on improving access to controlled medicines
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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
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Prequalification: Continue PQ of priority medicines; new focus on
QClabs, APIs, CROs; advice to diagnostics, RH commodities,
vaccines; strong focus on capacity building
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Combating counterfeits: Continue developing IMPACT partnership;
focus on practical implementation of strategy
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WHO Essential Medicines
Strategic directions
OWER 3: Rational use
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Selection: Continue evidence-based Model List and EM Library;
new focus on EMs for children, methodological guidance within
WHO (Guidelines Development Group)
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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
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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
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WHO Essential Medicines
WHO Medicines Strategy 2008-2013: next steps
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Consultation within EMP completed (HQ, GMC, NPOs)
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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
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Comments received, largely supportive
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Key question: relation with IGWG Global Plan of Action
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Final version to be endorsed by Director-General
IGWG
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WMS
WHO Essential Medicines
Reorganization of the WHO medicine programme
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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
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Dr Hans Hogerzeil is now Director, Essential Medicines and
Pharmaceutical Policies (EMP)
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The EMP department has become part of the WHO cluster of
Health Systems and Services (ADG: Dr Carissa Etienne)
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Six building blocks: Human Resources, Financing, Service
Delivery, Medicines and Technologies, Information, Good
Governance
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WHO Essential Medicines
Essential Medicines and Pharmaceutical Policies (EMP)
Hans V. Hogerzeil
Director
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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
QSM
TRM
Medicine Access
and Rational Use
C.Ondari, Coordinator
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
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• 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
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
Will
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
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WHO Essential Medicines
be split
New direction:
Continuity versus Change
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Organic growth, "logical incrementalism" (no political show)
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Continuity (many components listed in Strategy)
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New growth areas ("mature" global issues)
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New growth areas (creative, trying-out, "risk capital")
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EMc, IMPACT, pharmacovigilance, MeTA/pricing, rational use,
access to controlled medicines, anti-snake/anti-rabies sera)
Human rights, MDG reporting, reproductive health supplies,
PHC/HSS links, Expert Committee on NDPs, good governance
Information Management
WHO Essential Medicines
Conclusion
Good news:
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Merger successful, World Medicines Strategy nearly complete
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Better access indicators now used for UN/MDGs, MTSP, others
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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:
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WHO Medicines programme has nearly become an NGO
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RB 12-20%, CVC 10-12%, Specified Project Funding >65%
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Government contributions stable, foundations increasing
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No donor interest in rational use, country support
WHO Essential Medicines