WHO Essential Drugs and Medicines Policy 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

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

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

Achievements The essential drugs concept is nearly universal a floor, not a ceiling - applied differently in different settings By Dec.1999: 156 countries with EDLS 1/3 within 2 years 3/4 within 5 years National Essential Drugs List < 5 years (127) > 5 years (29) No NEDL (19) Unknown (16) 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 Treatment guidelines and formulary manuals put the essential drugs concept into clinical practice  135 countries have treatment guidelines, formularies

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

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

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

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

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

Unfinished agenda Financing, delivery, and other constraints still limit access to essential drugs Percentage of population with regular access to essential drugs (1997) 1 = <50% (36) 1 = <50% (36) 2 = 50-80% (68) 3 = 80-95% (33) 4 = >95% (41) 5 = No data available (1) Source: WHO/DAP (1998) 10 12

Example of challenge: New essential drugs are expensive Selection 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

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

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

History of the WHO Model List of Essential Drugs Selection History of the WHO Model List of Essential Drugs 1977 First Model list published, ± 200 active substances List is revised every two years by WHO Expert Committee Last revision (April 2002) contains 325 active substances 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

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

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

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

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

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

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

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

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

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

Thank you www.who.int / medicines