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25 Years of Essential Medicines … progress … unfinished agenda … promising developments

25 Years of Essential Medicines … progress … unfinished agenda … promising developments. Jonathan D. Quick, MD, MPH, Director Essential Drugs and Medicines Policy World Health Organization September 2003. The WHO Model List of Essential Medicines. 1975 - World Health Assembly introduces

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25 Years of Essential Medicines … progress … unfinished agenda … promising developments

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  1. 25 Years of Essential Medicines … progress … unfinished agenda … promising developments Jonathan D. Quick, MD, MPH, Director Essential Drugs and Medicines Policy World Health Organization September 2003

  2. The WHO Model List of Essential Medicines • 1975 - World Health Assembly introduces • essential drugs • national drug policy • 1977 - 1st Model List • 208 active substances • 2002 - 12th Model List • 325 active substances

  3. National drug policies Achievements 1977 - “NDP” concept barely know 2002 - over 100 countries have policies in place or under development - guiding collective action * Includes countries with current NDPs, draft policies or policies or policies > 10 years old.

  4. 156 countries with EDLS 1/3 within 2 years 3/4 within 5 years National Essential Medicines List < 5 years (127) > 5 years (29) No NEDL (19) Unknown (16) Essential medicines lists 1977 - perhaps a dozen countries with national lists 2002 - at least 156 countries with national / provincial lists for procurement, reimbursement, training, other uses 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.

  5. Treatment guidelines 1977 - few countries had objective drug information 2002 - 135 countries, many NGOs have treatment guidelines and formulary manuals

  6. Clinical Guidelines Evidence, Systematic Reviews Model Formulary WHO Model List Price Information Drug Quality Information Monitoring safety & use Selection process 1977 - informal and not linked other information 2002 - model list - hub for evidence & information base

  7. Becoming a standard in universities around the world For medical students, clinical officers, other prescribers Now also: Teacher’s Guide to Good Prescribing Medical training 1977 - little systematic training on rational use, generics 2002 - problem-based pharmacotherapy training in 18 languages - measurable improvements in prescribing

  8. Member countries (68) Associate member countries (8) Medicine safety 1977 - only 18 national centres monitoring drug safety 2002 - 76 members and associate members in WHO Programme for International Drug Monitoring

  9. Survey methods for drug price comparisons Pricing information 1977 - virtually no publicly available price information 2002 - more information, much more widely available • Over a dozen countries withprices on public web sites • Five WHO-UN-partner pricing services

  10. Access to essential medicines 1977 - less than 1/2 with access - 2 billion people 2002 - the number of people with access has doubled due to a combination of public, private, NGO efforts

  11. …but...

  12. Two billion people still lack regular access to essential medicines

  13. Closing the gap …a huge unfinished agenda…

  14. 1. Unfair financing - the burden falls heaviest on those most in need, but least able to pay Medicines are the largest health expense for poorer households Source: Azerbaijan - UNICEF-Bamako Technical Report No. 35 ; Bangladesh 1995 - National Accounts 1996/97 Mali (1986) - Diarra K and Coulibaly S. Financing of recurrent health costs in Mali. Health Policy and planning; 1990, 5(2);126-138

  15. Medicines covered by public health insurance (74) Promising developments- Increasing number of countries with drug benefits in public health insurance public financing employers Global Fund voluntary sector development funds

  16. 222% 33% 108% 423% 21% 176% 186% 271% Armenia Brazil Ghana Kenya Peru Philippines S. Africa Sri Lanka (n=7) (n=8) (n=5) (n=10) (n=14) (n=9) (n=15) (n=10) 2. High prices - Highly variable & often unaffordable producer prices, distribution fees, taxes, and tariffs Brand median MPS Most sold generic median MPS 33% Generic savings Source: MSF (1999)

  17. Equitable pricing arrangements • medicines for HIV/AIDS, malaria Promising developments- Progress on priceinformation, policies, analysis • Competition - generic and therapeutic • Legislation, quality, acceptance, economics • Application of World Trade Organization TRIPS patent agreement safeguards • Doha Declaration - “access to medicines for all”

  18. 3. Unreliable systems - procurement and distribution lapses result in shortages, diversion Source: SEAM, December, 2001

  19. E. Caribbean Drug Service Thailand, India: Pooled procurement Gulf States Pacific Islands Guatemala: Direct delivery Non-profit Essential Drugs Services Northern Province, SA: Contract distributor National Sub-regional NGO Promising developments- lessons can be drawn from every region, using all effective channels

  20. 4. Poor quality – Antibiotics and other anti-infectives often substandard – half of substandard drugs have no active ingredient Quality problems325 cases of substandard drugs less than 1 in 3 developing countries have well-functioning drug regulation 10-20% of drugs fail QC testing (10 countries) global trade brings global quality assurance challenges

  21. Improving Good Manufacturing Practices (GMP) • For regulators and producers • For local productions and importation • WHO pre-qualification system: • AIDS, tuberculosis, malaria medicines • Laboratories • Model system for procurement agencies Promising developments- capacity-building, practical tools, information support • Focus on effective drug regulation • Political commitment • Human, financial, organizational resources

  22. 5. Irrational use - Overuse, under-use, and mis-use of medicines remains a widespread hazard to health • Only 1-in-2 countries actively regulate drug promotion • 15 billion injections per year - half unsterile, many unneeded • 25-75% of antibiotic prescriptions are inappropriate • 50% of people worldwide fail to take medicines correctly

  23. Interactive group discussion Seminar District-wide monitoring Promising developments- injection use dramatically reduced - by talking to mothers, training, monitoring Source: Long-term impact of small group interventions, Santoso et al., 1996

  24. Much has been achieved in 25 years- but a huge unfinished agenda remains Priority actions for closing the access gap include: 1. Fair financing 2. Affordable prices 3. Reliable systems 4. Effective regulation 5. Rational use

  25. The concept of essential medicines remains a global necessity for saving lives and improving health Integration Sustainability Equity

  26. IMPROVE PUBLIC HEALTH www.who.int / medicines

  27. 25 Years of Essential Medicines

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