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




           Jonathan D. Quick, MD, MPH
        Essential Drugs and Medicines Policy
            World Health Organization
                  21 October 2002
                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




2 25 years ED 21Oct02 Seminar.ppt
                National drug
                Achievements                              policies
                 1977 - “NDP” concept barely know
                 2002 - over 100 countries have policies in place or
                 under development - guiding collective action

                        45                40
                        40                              Cumulative number of national drug policies
                        35                                              (NDPs)*
                        30
                        25
                                                           19                                 18
                        20
                        15                                                   10                                 10             12
                        10
                          5
                          0
                                    Africa        Americas            E.Med           Europe           S-E. Asia W. Pacific

                                                          1985          1990           1995          1999
                              * Includes countries with current NDPs, draft policies or policies or policies > 10 years old.

3 25 years ED 21Oct02 Seminar.ppt
                 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




    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)
                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.

4 25 years ED 21Oct02 Seminar.ppt
                 Treatment guidelines
                 1977 - few countries had objective drug information
                 2002 - 135 countries, many NGOs have treatment
                 guidelines and formulary manuals




5 25 years ED 21Oct02 Seminar.ppt
                 Selection process
                 1977 - informal and not linked other information
                 2002 - model list - hub for evidence & information base

                                            Clinical
                                           Guidelines
                    Evidence,
                                                                  Model
                    Systematic
                     Reviews                                    Formulary
                                            WHO
                                           Model List


                                Price                     Drug Quality
                             Information                  Information
                                            Monitoring
                                           safety & use
6 25 years ED 21Oct02 Seminar.ppt
                 Medical training
                 1977 - little systematic training on rational use, generics
                 2002 - problem-based pharmacotherapy training in 18
                 languages - measurable improvements in prescribing


             Becoming a standard in
              universities around the world
             For medical students,
              clinical officers, other prescribers
             Now also: Teacher’s Guide to
              Good Prescribing




7 25 years ED 21Oct02 Seminar.ppt
                 Medicine safety
                 1977 - only 18 national centres monitoring drug safety
                 2002 - 76 members and associate members in WHO
                 Programme for International Drug Monitoring




                                    Member countries          (68)
                                    Associate member countries (8)


8 25 years ED 21Oct02 Seminar.ppt
                 Pricing information
                 1977 - virtually no publicly available price information
                 2002 - more information, much more widely available

                Over a dozen countries with
                 prices on public web sites


                Five WHO-UN-partner pricing services
                                                                    International Drug Price Worksheet
                                                                                  Version 9 Release 01 October 2002



                                                                                  Press button to jump to page

                                                                    Reference Prices                             Country Data

                                                                Consolidation Procurement                      Sector Summary

                                                                   Consolidation Public                         Drug Summary

                                                                  Consolidation Private                           Affordability

                                                                Consolidation Other Sector                      Price Mark-ups




                Survey methods for drug price comparisons                                                    Price Composition




                                                                         Press button to perform maintenance function


                                                                 Erase Reference Prices                       Erase Country Data

                                                                 Erase Procurement Data                    Erase Affordability Data
                                                                                                                    -profit
                                                                    Erase Public Data                       Erase Mark-ups Data

                                                                    Erase Private Data                     Erase Composition Data

                                                                 Erase Other Sector Data                    Erase & Reset All Data
                                                                                                                    -profit




9 25 years ED 21Oct02 Seminar.ppt
                 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
                   Number of people (billions)
                   6
                   5
                   4
                                                               Regular
                   3                                           access to
                                                               essential
                   2                                           drugs

                   1
                   0
                                     1977   1987   1997

10 25 years ED 21Oct02 Seminar.ppt
                                     …but...




11 25 years ED 21Oct02 Seminar.ppt
                 Two billion people still lack regular access to
                 essential medicines

                        Number of people (billions)
                   6
                   5
                                                             No
                                                             regular
                   4                                         access
                   3
                                                             Regular
                   2                                         access to
                                                             essential
                   1                                         drugs

                   0
                                     1977   1987      1997

12 25 years ED 21Oct02 Seminar.ppt
                Closing the gap




                      …a huge unfinished agenda…




13 25 years ED 21Oct02 Seminar.ppt
                 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


                Azerbaijan                               Bangladesh                                          Mali                            Burkina Faso
                   Drugs                                                                                                                   Drugs
                    61%                                Drugs                                   Drugs                                        85%
                                                        73%                                     80%




                                                                                                                             Fees,                     Fees,
                                 Fees,                                            Fees,                                      Other                     Other
                                 Other                                            Other                                      20%                       15%
                                  39%                                              27%




           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


14 25 years ED 21Oct02 Seminar.ppt
                Promising developments - Increasing number of
                countries with drug benefits in public health insurance


                                                                               public financing
                                                                               employers
                                                                               Global Fund
                                                                               voluntary sector
                                                                               development funds




                                     Medicines covered by public health insurance (74)

15 25 years ED 21Oct02 Seminar.ppt
                2. High prices - Highly variable & often unaffordable
                producer prices, distribution fees, taxes, and tariffs



                Thailand             0.37                             6-fold variation in wholesale
                 Canada              0.39
                                                                   price of zidovudine (AZT) among
                                                                    suppliers and countries (1999)
                Thailand               0.44
                 Canada                 0.48
                   Spain                           0.83
                   Spain                                    1.12
               Germany                                                          1.93
            Netherlands                                                            2.06

                        0.00         0.50            1.00           1.50        2.00       2.50
                                      Whole sale price of 100 mg capsules (US $)

                                                    Originator       Others

16 25 years ED 21Oct02 Seminar.ppt          Source: MSF (1999)
                Promising developments - Progress on price
                information, policies, analysis



                Competition - generic and therapeutic


                Preferential pricing arrangements
                       medicines for HIV/AIDS, malaria


                Application of WTO/TRIPS safeguards
                       Doha Declaration - “access to medicines for all”




17 25 years ED 21Oct02 Seminar.ppt
                3. Unreliable systems - procurement and
                distribution lapses result in shortages, diversion




                   % of prescribed drugs actually dispensed
                            - public sector facilities
                        100
                         90                       80          84
                         80           72                                                      73
                         70                                                58      63
                         60
                         50
                         40
                         30
                         20
                         10
                          0
                                     Brazil    Cambodia El Salvador       Ghana    India    Tanzania
                                     (prov)                                       (state)


                                           Source: SEAM, December, 2001

18 25 years ED 21Oct02 Seminar.ppt
                Promising developments - lessons can be drawn from
                every region, using all effective channels
                                National         NGO   Sub-regional




                                       E. Caribbean                   Thailand, India:
                                       Drug Service     Gulf States
                                                                      Pooled procurement



                                                                                  Pacific
          Guatemala:
                                                           Non-profit Essential   Islands
          Direct delivery
                                                           Drugs Services
                              Northern Province, SA:
                              Contract distributor




19 25 years ED 21Oct02 Seminar.ppt
                  4. Poor quality - The quality of products varies
                  greatly - content and dissolution are problems

                                                                                         Sulphadoxine/pyrimethamine
                          Chloroquine tablets
                                                                                                 % failure*
                               % failure*
     100                                                                  100
      80                                                                   80
      60                                                                   60
      40                                                                   40
      20                                                                   20
       0                                                                    0




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                      Content                  Dissolution                                  Content                  Dissolution
                   * Samples were judged to have “failed” if content   * Samples were judged to have “failed” if content was
                   was <93% or >107%, and dissolution <80% in 45       <90% or >110%, and dissolution <65% in 30 minutes.
                   minutes.
20 25 years ED 21Oct02 Seminar.ppt
                Promising developments - capacity-building, practical
                tools, information support


                    UN assessment of HIV/AIDS, malaria,
                     tuberculosis medicines - Model
                     quality assurance for procurement


                    Improving Good Manufacturing Practices (GMP)




                    Focus on effective drug regulation




21 25 years ED 21Oct02 Seminar.ppt
                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




22 25 years ED 21Oct02 Seminar.ppt
                Promising developments - injection use dramatically
                reduced - by talking to mothers, training, monitoring


                                               100%               Interactive group discussion
                        Proportion of visits

                                                                                Seminar
                           with injection
                                               80%

                                               60%                                                    District-wide monitoring

                                               40%

                                               20%

                                                0%
                                                      1   3   5   7    9   11    13     15       17   19   21   23   25
                                                                                Months




                   Source: Long-term impact of small group interventions, Santoso et al., 1996

23 25 years ED 21Oct02 Seminar.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




24 25 years ED 21Oct02 Seminar.ppt
                  The concept of “essential medicines” remains a global
                  necessity for saving lives and improving health



                                      Integration


                                     Sustainability


                                        Equity


25 25 years ED 21Oct02 Seminar.ppt
www.who.int / medicines
25 Years of Essential Medicines

				
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