1. 25 Years of Essential Medicines 1977 - 2002 Jonathan D. Quick, MD, MPH Hans V. Hogerzeil, MD, PhD WHO Essential Drugs and Medicines Policy May 2002

2. 2 25 years Overview of the presentation 1. Achievements 1977 - 2002 2. Unfinished agenda 3. The selection of essential medicines 4. Promising developments Overview

3. 3 25 years National drug policies are being introduced at a growing pace in every region - guides for collective action * Includes countries with current NDPs, draft policies or policies or policies > 10 years old. Achievements

4. 4 25 years National Essential Drugs List < 5 years (127) > 5 years (29) No NEDL (19) Unknown (16) By Dec.1999: 156 countries with EDLS 1/3 within 2 years 3/4 within 5 years The essential drugs concept is nearly universal a floor, not a ceiling - applied differently in different settings Countries with an official selective list for training, supply, reimbursement or related health objectives. Some countries have selective state/provincial lists instead of or in addition to national lists. Achievements

5. 5 25 years  135 countries have treatment guidelines, formularies Achievements Treatment guidelines and formulary manuals put the essential drugs concept into clinical practice

6. 6 25 years Training in rational prescribing has expanded in universities throughout the world DAP’s role n Problem-based pharmacotherapy n In 18 languages n For medical students, clinical officers n Measurable improvement in prescribing n Now also: Teacher’s Guide to Good Prescribing Achievements

7. 7 25 years The number of people with access to essential drugs has nearly doubled in 20 years Achievements The poor have remained poor

8. 8 25 years Much has been achieved in 25 years......but…..

9. 9 25 years Percent breakdown - 325 cases of substandard drugs Substandard drugs are common - over half are antibiotics, antimalarials, other anti-infectives Unfinished agenda

10. 10 25 years Unfinished agenda Irrational use of drugs is a widespread hazard to health n Half of 102 countries surveyed regulate drug promotion n By age 2 children in some areas have had > 20 injections n 15 billion injections per year - half of them unsterile n 25-75% of antibiotic prescriptions are inappropriate

11. 11 25 years Financing, delivery, and other constraints still limit access to essential drugs Source: WHO/DAP (1998) Percentage of population with regular access to essential drugs (1997) 1 = <50% (36) 2 = 50-80% (68) 3 = 80-95% (33) 4 = >95% (41) 5 = No data available (1) Unfinished agenda

12. 12 25 years Example of challenge: New essential drugs are expensive Antibiotics for gonorrhoea: 50-90x price of penicillins Antimalarial drugs: chloroquine $0.10 per treatment artemether-lumefantrine $2.50/pp (25x) atovaquone-proguanil $40/pp (400x) Antituberculosis: $15 for DOTS vs $300 for MDR (20x) Antiretrovirals:$300-600/year; but 38 countries with a drug budget <$2 pp/year Selection

13. 13 25 years The Essential Medicines Target SS All the drugs in the world Registered medicines National list of essential medicines Levels of use Supplementary specialist medicines CHW dispensary Health center Hospital Referral hospital Private sector Selection

14. 14 25 years Clinical guidelines and a list of essential medicines lead to better prevention and care Health Technology and Pharmaceuticals List of common diseases and complaints Training and Supervision Financing and Supply of drugs Treatment guidelines Treatment choice Prevention and care Selection Essential medicines list / National formulary

15. 15 25 years History of the WHO Model List of Essential Drugs n 1977 First Model list published, ± 200 active substances n List is revised every two years by WHO Expert Committee n Last revision (April 2002) contains 325 active substances n 2002 Revised procedures approved by WHO The first list was a major breakthrough in the history of medicine, pharmacy and public health Médecins sans Frontières, 2000 Selection

16. 16 25 years Use of the WHO Model List of Essential Drugs n 156 countries have a national list of essential drugs n Major agencies (UNICEF, UNHCR, IDA) base their catalogue on the WHO Model List n Sub-sets of the Model List: ä UN list of essential drugs for emergencies: 85 drugs ä New Emergency Health Kit: 55 drugs for 10,000 people/3m n Normative tools follow the Model List: ä WHO Model Formulary ä International Pharmacopoea ä Basic Quality Tests and reference standards Selection

17. 17 25 years The WHO Model List of Essential Medicines is a model product, model process and public health tool n Independent Membership of the Committee, careful consideration of conflict of interest n Transparent process, standard application, web review n Link to evidence-based clinical guidelines n Systematic review of comparative efficacy, safety, cost- effectiveness and public health relevance n Rapid dissemination, electronic access n Regular review Selection

18. 18 25 years WHO Essential Medicines Library Combining information from various partners WHO Model List Summary of clinical guideline Reasons for inclusion Systematic reviews Key references WHO Model Formulary Cost: - per unit - per treatment - per month - per case prevented Quality information: - Basic quality tests - Intern. Pharmacopoea - Reference standards Clinical guideline BNF WHO clusters MSH UNICEF MSF WHO/EDM WHO/EC, Cochrane Statistics: - ATC - DDD WCCs Oslo/Uppsala Selection

19. 19 25 years Practical implications of the access framework 1. Rational selection 4. Reliable systems 2. Affordable prices 3. Sustainable financing ACCESS TO ESSENTIAL MEDICINES Promising developments

20. 20 25 years n MSH-WHO essential drugs price indicator n Drugs and diagnostics for HIV/AIDS n Pharmaceutical starting materials n Antiretroviral drugs in the Americas n AFRO Essential Drugs Indicative price information promotes transparency and competition Promising developments

21. 21 25 years UN Drug Access Initiative Domestic production Accelerated access initiative Generic offers Advocacy, corporate responsiveness and competition have reduced antiretroviral prices 95% in 3 years ?? Promising developments

22. 22 25 years Medicines covered by public health insurance (74) Expanding drug financing options - increasing number of countries with drug benefits in health insurance - Public funds - Insurance - Global fund - Out-of-pocket - Donations Promising developments

23. 23 25 years Successful experiences with local supply systems and regional bulk procurement Guatemala: Direct delivery Northern Province, SA: Contract distributor Gulf States E. Caribbean Drug Service Mission for Essential Drugs Thailand, India: Pooled procurement

24. 24 25 years Conclusion The essential drugs concept - more valid than ever n Much has been achieved in 25 years n Yet the unfinished agenda is large - quality, access, use n The Model List of Essential Medicines remains a strong public health tool n There are promising developments for access - pricing, financing, supply systems and quality