Medicines Policies and Standards Strategic Direction 2006-2007

1. Medicines Policies and Standards Strategic Direction 2006-2007 Department of Medicines Policy and Standards 2007

2. 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. 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. OBJECTIVES Policy Access Quality and safety Rational use COMPONENTS Implementation and monitoring of medicines policies Traditional and complementary medicine Fair financing and affordability Medicines supply systems Norms and standards Regulations and quality assurance systems Rational use by health professionals and consumers WHO Medicines Strategy 2004 – 2007: 4 objectives, 7 components, 44 expected outcomes

5. EDM became PSM and TCM Area of work: Essential Medicines Technical Cooperation on Essential Drugs and Traditional Medicine (current structure) Medicines Policy and Standards QSM Quality and Safety of Medicines PAR Policy, Access and Rational Use TRM Traditional Medicine DAP Drug Action Programme PSM TCM 33 P-staff $22 million (23% RB)

6. 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."

7. 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. 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. Example 1: Essential and unique global functionThe prequalification programme is essential for all partners in 3by5, RBM and Stop-TB $5m in 2004-05 $12m in 2006-07 • 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 health • Drug quality control laboratories; active ingredients • Harmonize within WHO (diagnostics, donations) and UN (condoms)

10. Example 2a: Service to all WHO clusters and the outside worldEvery WHO clinical guideline is accessible through the WHO Essential Medicines List web site $1.6m WHO clusters WHO/PAR WHO clinical guideline Summary of clinical guideline RPS WHO Model Formulary WHO/ExpCee, Cochrane, BMJ Reasons for inclusion Systematic reviews Key references WHO Model List WHO/QSM Quality information: • INNs in 6 languages • Basic quality tests - Intern. Pharmacopoeia - Reference standards Statistics: - ATC - DDD Link to price information MSH UNICEF MSF WCCs Oslo/Uppsala

11. Example 2b: Promote consistency within WHO and within UN agenciesEssential medicines for Reproductive Health:Discrepancies in international RH lists $0.8 m 75 on UNFPA List 6 316 on WHO Model List 6 194 63 150 on Interagency RH medical commodities 65 22

12. Example 3: Essential and unique global functionEvery new medicine in the world needs an INN (generic name) – from WHO $1.6m 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

13. Standards apply to all medicinesPSM is willing to serve all other departments LEGENDA: ML=Model List; PQ= Prequalification; SP=Sources and Prices

14. PSM has many clients and implementation channels TCM PSM policies and standards ? IPC WHO: HIV, MAL, TB, RH, MSD,CAH UN: UNICEF, UNAIDS, UNFPA, WBank, GFATM, WIPO, etc NGOs: MSF, HAI, MSH, JSI churches, networks, WMA, FIP, IGPA, IFPMA, WSMI, etc Regional Offices Country Offices MOH Outside MOH: Drug regul. agency, insurance, collab.centers, universities, missions, NGOs, consumers National programmes for health professionals, patients and consumers

15. 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. 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