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



1977 - 1st Model List


208 active substances
2002 - 12th Model List

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essential drugs
national drug policy
325 active substances
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
(NDPs)*
35
30
25
19
20
15
18
10
10
12
10
5
0
Africa
Americas
1985
E.Med
1990
Europe
1995
S-E. Asia W. Pacific
1999
* Includes countries with current NDPs, draft policies or policies or policies > 10 years old.
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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.
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Treatment guidelines
1977 - few countries had objective drug information
2002 - 135 countries, many NGOs have treatment
guidelines and formulary manuals
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Selection process
1977 - informal and not linked other information
2002 - model list - hub for evidence & information base
Clinical
Guidelines
Evidence,
Systematic
Reviews
Model
Formulary
WHO
Model List
Price
Information
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Monitoring
safety & use
Drug Quality
Information
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
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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)
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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
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Reference Prices
Country Data
Consolidation Procurement
Sector Summary
Consolidation Public
Drug Summary
Consolidation Private
Consolidation Other Sector

Survey methods for drug price comparisons
Affordability
Price Mark-ups
Price Composition
Press button to perform maintenance function
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Erase Reference Prices
Erase Country Data
Erase Procurement Data
Erase Public Data
Erase Affordability Data
-profit
Erase Mark-ups Data
Erase Private Data
Erase Composition Data
Erase Other Sector Data
Erase & Reset All Data
-profit
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
access to
essential
drugs
3
2
1
0
1977
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1987
1997
…but...
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Two billion people still lack regular access to
essential medicines
Number of people (billions)
6
5
No
regular
access
4
3
Regular
access to
essential
drugs
2
1
0
1977
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1987
1997
Closing the gap
…a huge unfinished agenda…
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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
Drugs
61%
Drugs
73%
Fees,
Other
39%
Mali
Bangladesh
Burkina Faso
Drugs
85%
Drugs
80%
Fees,
Other
27%
Fees,
Other
20%
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
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Fees,
Other
15%
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)
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2. High prices - Highly variable & often unaffordable
Median MPR Across Medicine Pairs
producer prices, distribution fees, taxes, and tariffs
222%
70
60
50
Brand median MPS
Most sold generic median MPS
33% Generic savings
40
33%
30
108%
20
10
176%
21%
186%
271%
0
Armenia
(n=7)
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423%
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Brazil
(n=8)
Ghana
(n=5)
Kenya
(n=10)
Source: MSF (1999)
Peru
(n=14)
Philippines S. Africa
(n=9)
(n=15)
Sri Lanka
(n=10)
Promising developments - Progress on price
information, policies, analysis

Competition - generic and therapeutic


Equitable pricing arrangements


medicines for HIV/AIDS, malaria
Application of World Trade Organization
TRIPS patent agreement safeguards

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Legislation, quality, acceptance, economics
Doha Declaration - “access to medicines for all”
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3. Unreliable systems - procurement and
distribution lapses result in shortages, diversion
% of prescribed drugs actually dispensed
- public sector facilities
100
90
80
70
60
50
40
30
20
10
0
80
72
84
58
Brazil
(prov)
Cambodia El Salvador
Source: SEAM, December, 2001
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Ghana
63
India
(state)
73
Tanzania
Promising developments - lessons can be drawn from
every region, using all effective channels
National
NGO
E. Caribbean
Drug Service
Guatemala:
Direct delivery
Northern Province, SA:
Contract distributor
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Sub-regional
Gulf States
Thailand, India:
Pooled procurement
Non-profit Essential
Drugs Services
Pacific
Islands
4. Poor quality – Antibiotics and other anti-infectives
often substandard – half of substandard drugs have no
active ingredient
Quality problems
325 cases of

less than 1 in 3 developing
countries have wellfunctioning drug regulation

10-20% of drugs fail QC
testing (10 countries)

global trade brings global
quality assurance
challenges
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Incorrect
ingredient
16%
substandard drugs
Incorrect
amount
17%
Other errors
7%
No active
ingredient
60%
Promising developments - capacity-building, practical
tools, information support

WHO pre-qualification system:




Improving Good Manufacturing Practices (GMP)



For regulators and producers
For local productions and importation
Focus on effective drug regulation


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AIDS, tuberculosis, malaria medicines
Laboratories
Model system for procurement agencies
Political commitment
Human, financial, organizational resources
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5. Irrational use - Overuse, under-use, and mis-use
of medicines remains a widespread hazard to health
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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
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Proportion of visits
with injection
Promising developments - injection use dramatically
reduced - by talking to mothers, training, monitoring
100%
Interactive group discussion
Seminar
80%
District-wide monitoring
60%
40%
20%
0%
1
3
5
7
9
11
13
15
Months
Source: Long-term impact of small group interventions, Santoso et al., 1996
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17
19
21
23
25
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
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The concept of essential medicines remains a global
necessity for saving lives and improving health
Integration
Sustainability
Equity
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IMPROVE PUBLIC HEALTH
www.who.int / medicines
25 Years of Essential Medicines
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25 years of essential medicines