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. 2 TBS 25 years EM Sep03.ppt The WHO Model List of Essential Medicines n 1975 - World Health Assembly introduces ä essential drugs ä national drug policy n 1977 - 1 st Model List ä 208 active substances n 2002 - 12 th Model List ä 325 active substances

3. 3 TBS 25 years EM Sep03.ppt * Includes countries with current NDPs, draft policies or policies or policies > 10 years old. Achievements 1977 1977 - “NDP” concept barely know 2002 2002 - over 100 countries have policies in place or under development - guiding collective action National drug policies

4. 4 TBS 25 years EM Sep03.ppt National Essential Medicines List < 5 years (127) > 5 years (29) No NEDL (19) Unknown (16) 156 countries with EDLS 1/3 within 2 years 3/4 within 5 years 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. 1977 1977 - perhaps a dozen countries with national lists 2002 2002 - at least 156 countries with national / provincial lists for procurement, reimbursement, training, other uses Essential medicines lists

5. 5 TBS 25 years EM Sep03.ppt 1977 1977 - few countries had objective drug information 2002 2002 - 135 countries, many NGOs have treatment guidelines and formulary manuals Treatment guidelines

6. 6 TBS 25 years EM Sep03.ppt WHO Model List Clinical Guidelines Evidence, Systematic Reviews Model Formulary Drug Quality Information Price Information Monitoring safety & use 1977 1977 - informal and not linked other information 2002 2002 - model list - hub for evidence & information base Selection process

7. 7 TBS 25 years EM Sep03.ppt n Becoming a standard in universities around the world n For medical students, clinical officers, other prescribers n Now also: Teacher’s Guide to Good Prescribing 1977 1977 - little systematic training on rational use, generics 2002 2002 - problem-based pharmacotherapy training in 18 languages - measurable improvements in prescribing Medical training

8. 8 TBS 25 years EM Sep03.ppt 1977 1977 - only 18 national centres monitoring drug safety 2002 2002 - 76 members and associate members in WHO Programme for International Drug Monitoring Medicine safety

9. 9 TBS 25 years EM Sep03.ppt n Over a dozen countries with prices on public web sites n Survey methods for drug price comparisons n Five WHO-UN-partner pricing services 1977 1977 - virtually no publicly available price information 2002 2002 - more information, much more widely available Pricing information

10. 10 TBS 25 years EM Sep03.ppt 1977 1977 - less than 1/2 with access - 2 billion people 2002 2002 - the number of people with access has doubled due to a combination of public, private, NGO efforts Access to essential medicines

11. 11 TBS 25 years EM Sep03.ppt …but...

12. 12 TBS 25 years EM Sep03.ppt Two billion people still lack regular access to essential medicines

13. 13 TBS 25 years EM Sep03.ppt …a huge unfinished agenda… Closing the gap

14. 14 TBS 25 years EM Sep03.ppt 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 Medicines are the largest health expense for poorer households 1. Unfair financing 1. Unfair financing - the burden falls heaviest on those most in need, but least able to pay

15. 15 TBS 25 years EM Sep03.ppt Medicines covered by public health insurance (74) Promising developments Promising developments - Increasing number of countries with drug benefits in public health insurance n public financing n employers n Global Fund n voluntary sector n development funds

16. 16 TBS 25 years EM Sep03.ppt 2. High prices 2. High prices - Highly variable & often unaffordable producer prices, distribution fees, taxes, and tariffs Source: MSF (1999) 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) 33% 176% 186% 423%21% 222% 271% 108% Brand median MPS Most sold generic median MPS 33% Generic savings

17. 17 TBS 25 years EM Sep03.ppt Promising developments Promising developments - Progress on price information, policies, analysis n Competition - generic and therapeutic ä Legislation, quality, acceptance, economics n Equitable pricing arrangements ä medicines for HIV/AIDS, malaria n Application of World Trade Organization TRIPS patent agreement safeguards ä Doha Declaration - “access to medicines for all”

18. 18 TBS 25 years EM Sep03.ppt 3. Unreliable systems 3. Unreliable systems - procurement and distribution lapses result in shortages, diversion Source: SEAM, December, 2001

19. 19 TBS 25 years EM Sep03.ppt Promising developments Promising developments - lessons can be drawn from every region, using all effective channels Guatemala: Direct delivery Northern Province, SA: Contract distributor Gulf States E. Caribbean Drug Service Non-profit Essential Drugs Services Thailand, India: Pooled procurement Pacific Islands National NGO Sub-regional

20. 20 TBS 25 years EM Sep03.ppt 4. Poor quality 4. Poor quality – Antibiotics and other anti-infectives often substandard – half of substandard drugs have no active ingredient Quality problems 325 cases of substandard drugs n less than 1 in 3 developing countries have well- functioning drug regulation n 10-20% of drugs fail QC testing (10 countries) n global trade brings global quality assurance challenges n less than 1 in 3 developing countries have well- functioning drug regulation n 10-20% of drugs fail QC testing (10 countries) n global trade brings global quality assurance challenges

21. 21 TBS 25 years EM Sep03.ppt Promising developments Promising developments - capacity-building, practical tools, information support n Focus on effective drug regulation ä Political commitment ä Human, financial, organizational resources n Improving Good Manufacturing Practices (GMP) ä For regulators and producers ä For local productions and importation n WHO pre-qualification system: ä AIDS, tuberculosis, malaria medicines ä Laboratories ä Model system for procurement agencies

22. 22 TBS 25 years EM Sep03.ppt 5. Irrational use 5. Irrational use - Overuse, under-use, and mis-use of medicines remains a widespread hazard to health n Only 1-in-2 countries actively regulate drug promotion n 15 billion injections per year - half unsterile, many unneeded n 25-75% of antibiotic prescriptions are inappropriate n 50% of people worldwide fail to take medicines correctly

23. 23 TBS 25 years EM Sep03.ppt Promising developments Promising developments - injection use dramatically reduced - by talking to mothers, training, monitoring Source: Long-term impact of small group interventions, Santoso et al., 1996 Interactive group discussion Seminar District-wide monitoring

24. 24 TBS 25 years EM Sep03.ppt 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. 25 TBS 25 years EM Sep03.ppt Equity Sustainability Integration The concept of essential medicines remains a global necessity for saving lives and improving health

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

27. 25 Years of Essential Medicines