medicines policies and standards strategic direction 2006-2007
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Medicines Policies and Standards Strategic Direction 2006-2007. Department of Medicines Policy and Standards 5 July 2005. Main challenges in the Area of Work (1) Essential Medicines. One-third of the world has no regular access to essential medicines - PowerPoint PPT PresentationTRANSCRIPT
Medicines Policies and StandardsMedicines Policies and StandardsStrategic Direction 2006-2007Strategic Direction 2006-2007
Department of Medicines Policy and Standards5 July 2005
2 SDCR, 5 July 2005
Main challenges in the Area of Work (1)Essential Medicines
One-third of the world has no regular access to essential medicines
27,000 deaths/day due to lack of access to existing drugs Substandard and counterfeit medicines are widespread
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
70-90% primary resistance in dysentery, gonorrhoea, pneumonia New essential medicines are expensive: ARVs, ACTs, MDR-TB
Medicines work is often undervalued and underfunded Most countries spend 20-40% of health budgets on medicines; but WHO
spends less than 2% of its budget on medicines work
3 SDCR, 5 July 2005
But …..
Medicines standards are essential for all Member States Medicines are essential for most other programmes
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
4 SDCR, 5 July 2005
WHO Medicines Strategy 2004 – 2007: 4 objectives, 7 components, 44 expected outcomes
OBJECTIVES Policy
Access
Quality and safety
Rational use
COMPONENTS1. Implementation and monitoring of medicines policies2. Traditional and complementary medicine
3. Fair financing and affordability4. Medicines supply systems
5. Norms and standards6. Regulations and quality assurance systems
7. Rational use by health professionals and consumers
5 SDCR, 5 July 2005
EDM became PSM and TCM
QSM Quality and Safetyof Medicines
TRM TraditionalMedicine
DAP Drug ActionProgramme
PAR Policy, Access andRational Use
Medicines Policy and Standards Technical Cooperation on Essential Drugs and Traditional Medicine(current structure)
Area of work: Essential Medicines
PSM TCM33 P-staff$22 million (23% RB)
6 SDCR, 5 July 2005
Core function of the department of Medicines Policy and Standards (PSM)
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."
and many WHA resolutions
7 SDCR, 5 July 2005
Specific functions of PSM
Develop and promote policies and standards for quality, safety and efficacy, covering the full life-cycle of medicines
Provide all global stakeholders with information Promote global coordination and consistency Support the International Narcotic Control Board and UN bodies
(international treaty obligation[2]) 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
8 SDCR, 5 July 2005
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)
QSM (18 P-staff)Quality Assurance and Safety: Medicines
Nomenclature* Quality norms and standards Drug safety and information Prequalification of priority medicines* International harmonization
PAR (14 P-staff)Policy, Access and Rational use
National medicine policies Selection and rational use* Supply systems Affordable prices, sustainable financing Evidence for medicines policy
9 SDCR, 5 July 2005
Example 1: Essential and unique global function The prequalification programme is essential for all partners in 3by5, RBM and Stop-TB
Strict procedures and global standards by WHO Expert Committees Used by GFATM, World Bank, UNICEF, MSF and Member States Repeated strong EB/WHA demand to increase its services Much capacity building for producers and regulators Business plan to forecast demand and required resources Planned expansion:
More medicines for TB, malaria; add reproductive healthDrug quality control laboratories; active ingredients Harmonize within WHO (diagnostics, donations) and UN (condoms)
$5m in 2004-05$12m in 2006-07
10 SDCR, 5 July 2005
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
WHOModel List
Summary of clinical guideline
Reasons for inclusionSystematic reviewsKey references
WHO Model Formulary
Link to price information
Quality information:- INNs in 6 languages- Basic quality tests- Intern. Pharmacopoeia- Reference standards
WHO clinical guideline RPS
WHO clusters
MSHUNICEF
MSF
WHO/QSM
WHO/PAR
WHO/ExpCee, Cochrane, BMJ
Statistics:- ATC- DDD
WCCs Oslo/Uppsala
$1.6m
11 SDCR, 5 July 2005
Example 2b: Promote consistency within WHO and within UN agencies
Essential medicines for Reproductive Health:Discrepancies in international RH lists
75 on UNFPA List316 on WHO Model List
150 on Interagency RHmedical commodities
194
65
63
66
22
$0.8 m
12 SDCR, 5 July 2005
Example 3: Essential and unique global function
Every new medicine in the world needs an INN (generic name) – from WHO
Nomenclature work by PSM INNs are assigned by WHO following a standardized and transparent
global consultation procedure; a service fee is charged Assigning INNs to biological and biogenetic products is very
complicated Other classification programmes:
Anatomical Therapeutic Chemical (ATC) Classification codes Daily Defined Doses (DDD) for drug use studies WHO Drug Dictionary used for adverse drug reactions
$1.6m
13 SDCR, 5 July 2005
Standards apply to all medicines
PSM is willing to serve all other departments
LEGENDA: ML=Model List; PQ= Prequalification; SP=Sources and Prices
HIV TB MAL RH MSD CDS EHT TDRDrug development X X Safety X X X X X X XClinical guidelines X X X X X X Selection ML ML ML ML ML ML Forecasting need X X X X Quality assessment PQ PQ PQ (PQ) X (PQ) XPrice negotiation/info SP X SP X X XHelp GFATM proposals X X X Procurement X X X X XSupply management X X X X X
14 SDCR, 5 July 2005
PSM has many clients and implementation channels
TCM
MOH Outside MOH: Drug regul. agency, insurance, collab.centers, universities, missions, NGOs, consumers
Regional Offices
WHO:
HIV, MAL, TB, RH, MSD,CAH
UN:
UNICEF, UNAIDS, UNFPA, WBank, GFATM,WIPO, etc
Country Offices
PSM policies and standards
NGOs:
MSF, HAI, MSH, JSI churches, networks, WMA, FIP, IGPA, IFPMA, WSMI, etc
National programmes for health professionals, patients and consumers
IPC?
15 SDCR, 5 July 2005
Strategic directions
Implement the Medicines Strategy in close collaboration with TCM and other partners; develop Medicines Strategy 2008-2013
Develop and promote WHO's global normative functions Expand prequalification programme in response to need,
implement business plan Expand work on drug safety and rational use, with focus on
pharmacovigilance in resource-poor settings, chronic treatments and containing antimicrobial resistance
Promote consistency within WHO and within UN (e.g. clinical guidelines, selection, quality assessments, medicine policies)
16 SDCR, 5 July 2005
Conclusion
PSM runs a well-established programme with mature processes to develop and update global norms and standards, in close consultation with all Member States
Medicines policies and standards serve all 192 Member States, and many other WHO and UN programmes
Most PSM functions are truly global and make WHO unique The department can successfully continue its work only in case
of sufficient funding