Medicines Policies and StandardsMedicines Policies and StandardsStrategic Direction 2006-2007Strategic Direction 2006-2007

Department of Medicines Policy and Standards5 July 2005

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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

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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

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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

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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)

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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

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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

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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

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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

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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

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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

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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

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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    

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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?

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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)

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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