Transcript X - World Health Organization

Medicines Policies and Standards
Strategic Direction 2006-2007
Department of Medicines Policy and Standards
2007
Main challenges in the Area of Work (1)
Essential Medicines
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One-third of the world has no regular access to essential
medicines
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Substandard and counterfeit medicines are widespread
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70-90% primary resistance in dysentery, gonorrhoea, pneumonia
New essential medicines are expensive: ARVs, ACTs, MDR-TB
Medicines work is often undervalued and underfunded
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2007
Only 1/5 medicines pass WHO prequalification standards
Millions die each year due to safety and other drug-related problems
Irrational selection and use lead to suboptimal treatment and
waste
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27,000 deaths/day due to lack of access to existing drugs
Most countries spend 20-40% of health budgets on medicines; but WHO
spends less than 2% of its budget on medicines work
But …..
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Medicines standards are essential for all Member States
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Medicines are essential for most other programmes
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2007
PHC, MDGs, GFATM, 3by5 and most disease control
programmes depend on medicines
There is lack of consistency of medicine policies and standards
within WHO and between UN agencies
WHO Medicines Strategy 2004 – 2007:
4 objectives, 7 components, 44 expected outcomes
OBJECTIVES
 Policy
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Access
COMPONENTS
1. Implementation and monitoring of medicines policies
2. Traditional and complementary medicine
3.
4.
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2007
Quality and safety
Rational use
Fair financing and affordability
Medicines supply systems
6.
Norms and standards
Regulations and quality assurance systems
7.
Rational use by health professionals and consumers
5.
EDM became PSM and TCM
Area of work: Essential Medicines
Medicines Policy and Standards
Technical Cooperation on Essential
Drugs and Traditional Medicine
(current structure)
QSM
Quality and Safety
of Medicines
PAR
Policy, Access and
Rational Use
PSM
33 P-staff
$22 million (23% RB)
2007
DAP
Drug Action
Programme
TRM
Traditional
Medicine
TCM
Core function of the department of
Medicines Policy and Standards (PSM)
and many WHA resolutions
Fulfill WHO’s constitutional obligation[1] to develop, validate,
disseminate and promote global policy guidance, norms and
standards on pharmaceuticals, including essential medicines.
[1] WHO Constitution, Art 2(u): "In order to achieve its objective, the functions of the
Organisation shall be (…) to develop, establish and promote international standards
with respect to food, biological, pharmaceutical and similar products."
2007
Specific functions of PSM
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Develop and promote policies and standards for quality, safety and
efficacy, covering the full life-cycle of medicines
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Provide all global stakeholders with information
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Promote global coordination and consistency
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Support the International Narcotic Control Board and UN bodies
(international treaty obligation[2])
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Promote operational research leading to new approaches, guidelines
and resource materials in support of pharmaceutical policies
[2] The 1961 Single Convention on Narcotic Drugs, the 1971 Convention on
Psychotropic Substances and the 1988 United Nations Convention Against Illicit
Traffic in Narcotic Drugs and Psychotropic Substances
2007
Structure of the PSM department
Office of the Director (1 D-staff)
Overall strategic direction
 Consistency of medicine policies within WHO and UN agencies
 Managerial functions (staff, planning, budget)
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QSM (18 P-staff)
Quality Assurance and Safety:
Medicines
PAR (14 P-staff)
Policy, Access and Rational use
Nomenclature*
 Quality norms and standards
 Drug safety and information
 Prequalification of priority medicines*
 International harmonization
National
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2007
medicine policies
 Selection and rational use*
 Supply systems
 Affordable prices, sustainable financing
 Evidence for medicines policy
Example 1: Essential and unique global function
The prequalification programme is essential
for all partners in 3by5, RBM and Stop-TB
2007
$5m in 2004-05
$12m in 2006-07
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Strict procedures and global standards by WHO Expert Committees
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Used by GFATM, World Bank, UNICEF, MSF and Member States
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Repeated strong EB/WHA demand to increase its services
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Much capacity building for producers and regulators
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Business plan to forecast demand and required resources
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Planned expansion:
 More medicines for TB, malaria; add reproductive health
 Drug quality control laboratories; active ingredients
 Harmonize within WHO (diagnostics, donations) and UN (condoms)
Example 2a: Service to all WHO clusters and the outside world
Every WHO clinical guideline is accessible through the
WHO Essential Medicines List web site
WHO clusters
WHO clinical
guideline
WHO/ExpCee, Cochrane, BMJ
Reasons for inclusion
Systematic reviews
Key references
MSH
UNICEF
MSF
2007
Link to price
information
$1.6m
WHO/PAR
Summary of clinical guideline
RPS
WHO Model
Formulary
WHO
Model List
WHO/QSM
Statistics:
- ATC
- DDD
WCCs
Oslo/Uppsala
Quality information:
- INNs in 6 languages
- Basic quality tests
- Intern. Pharmacopoeia
- Reference standards
Example 2b: Promote consistency within WHO and within UN agencies
Essential medicines for Reproductive Health:
Discrepancies in international RH lists
$0.8 m
75 on UNFPA List
6
316 on WHO Model List
6
194
63
65
2007
22
150 on Interagency RH
medical commodities
Example 3: Essential and unique global function
Every new medicine in the world
needs an INN (generic name) – from WHO
$1.6m
Nomenclature work by PSM
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INNs are assigned by WHO following a standardized and transparent
global consultation procedure; a service fee is charged
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Assigning INNs to biological and biogenetic products is very
complicated
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Other classification programmes:
 Anatomical
2007
Therapeutic Chemical (ATC) Classification codes
 Daily
Defined Doses (DDD) for drug use studies
 WHO
Drug Dictionary used for adverse drug reactions
Standards apply to all medicines
PSM is willing to serve all other departments
HIV
TB
Drug development
MAL
MSD CDS EHT
X
X
X
X
X
X
X
Clinical guidelines
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X
X
X
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X
ML
ML
ML
ML
ML
ML
X
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X
X
Quality assessment
PQ
PQ
PQ
(PQ)
Price negotiation/info
SP
X
SP
X
Help GFATM proposals
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X
Procurement
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Supply management
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Forecasting need
LEGENDA: ML=Model List; PQ= Prequalification; SP=Sources and Prices
TDR
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Safety
Selection
2007
RH
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(PQ)
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PSM has many clients and implementation channels
TCM
PSM policies and standards
Regional Offices
Country Offices
MOH
WHO: ?
UN:
HIV, MAL,
TB, RH,
MSD,CAH
UNICEF,
UNAIDS,
UNFPA,
WBank,
GFATM,
WIPO, etc
Outside MOH:
Drug regul. agency, insurance,
collab.centers, universities,
missions, NGOs, consumers
IPC
NGOs:
MSF, HAI,
MSH, JSI
churches,
networks,
WMA, FIP,
IGPA,
IFPMA,
WSMI, etc
National programmes for health professionals, patients and consumers
2007
Strategic directions
2007
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Implement the Medicines Strategy in close collaboration with
TCM and other partners; develop Medicines Strategy 2008-2013
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Develop and promote WHO's global normative functions
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Expand prequalification programme in response to need,
implement business plan
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Expand work on drug safety and rational use, with focus on
pharmacovigilance in resource-poor settings, chronic
treatments and containing antimicrobial resistance
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Promote consistency within WHO and within UN (e.g. clinical
guidelines, selection, quality assessments, medicine policies)
Conclusion
2007
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PSM runs a well-established programme with mature processes
to develop and update global norms and standards, in close
consultation with all Member States
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Medicines policies and standards serve all 192 Member States,
and many other WHO and UN programmes
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Most PSM functions are truly global and make WHO unique
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The department can successfully continue its work only in case
of sufficient funding