Transcript 25 Years of Essential Medicines - WHO archives

25 Years of Essential Medicines
… achievements… unfinished agenda…
promising developments
Jonathan D. Quick, MD, MPH
Essential Drugs and Medicines Policy
World Health Organization
September 2002
Health impact
Essential medicines save lives and improve health
AIDS
14%
Other causes
35%
In Africa and S E Asia:
ARI
11%
 1/2 of deaths among children,
young adults due to 6 diseases
 prompt diagnosis and
treatment could save over
3 million lives per year
Diarrhoeal
diseases
11%
Maternal &
perinatal
conditions
13%
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Malaria
8%
TB
2%
Measles & its
complications
6%
History of the WHO Model List of Essential Medicines

1975 - World Health Assembly: “essential drugs” “national
drug policy”

1977 - First Model list published, 208 active substances

List is revised every two years by WHO Expert Committee

2002 - Latest revision, 325 active substances
The first list was a major breakthrough in the history
of medicine, pharmacy and public health
Médecins sans Frontières, 2000
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The concept of essential medicines
Essential medicines are those that satisfy the priority health
care needs of the population.



They are selected with due regard to public health relevance,
evidence on efficacy and safety, and comparative costeffectiveness.
Essential medicines are intended to be available within the
context of functioning health systems at all times in adequate
amounts, in the appropriate dosage forms, with assured
quality and adequate information, and at a price the individual
and the community can afford.
The concept of essential medicines is intended to be flexible
and adaptable to many different situations; exactly which
medicines are regarded as essential remains a national
responsibility.
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25 years of Essential Medicines The road traveled… the road ahead...
Achievements
Unfinished business
Promising developments
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25 years of Essential Medicines The road traveled… the road ahead...
Achievements
Unfinished business
Promising developments
6 25 years ED - TechBrief.ppt
Achievements
National drug policies are being introduced at a growing
pace in every region - guides for 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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DAP’s role
Ethical criteria for medicinal drug promotion - to
improve health care through rational use of drugs

Adopted by the World Health Assembly, 1988

define proper promotion based on truthfulness

apply to prescription, OTC, traditional medicines

refer to all informational and persuasive activities
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DAP’s role
Achievements
Training in rational prescribing has expanded in
universities throughout the world





Problem-based pharmacotherapy
In 18 languages
For medical students,
clinical officers, other prescribers
Measurable improvement in
prescribing
Now also: Teacher’s Guide to
Good Prescribing
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Achievements
Treatment guidelines and formulary manuals put the
essential medicines concept into clinical practice
 135 countries have treatment guidelines, formularies
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Achievements
The essential medicines concept nearly universal a floor not a ceiling - applied differently in different settings
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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Achievements
The number of people with access to essential
medicines has nearly doubled in 20 years
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
25 years of Essential Medicines The road traveled… the road ahead...
Achievements
Unfinished business
Promising developments
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Unfinished agenda
Health and drug financing is unfair - the burden falls
heaviest on those most in need, but least able to pay
Medicines are the largest health expenditure for poor households
Azerbaijan
Drugs
61%
Fees,
Other
39%
Bangladesh
Mali
Inequity in health and pharmaceutical financing:
Drugs

Drugs
high income
countries:
50-90
%
publicly
funded
73%
80%

low/middle income countries: 50-90 % out-of-pocket

government health spending has declined

treatment of simple pneumonia - 3 months’ wages in Africa
Fees,
Other
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
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Fees,
Other
20%
Unfinished agenda
WTO TRIPS Agreement - Trade-Related Aspects of
Intellectual Property Rights


World Trade Organization - WTO - since 1995 - 142 members
Before TRIPS: diversity in national patent laws



After TRIPS: minimal uniformity in national patent laws



patents for pharmaceutical products, processes, or both
patent term protection varied from no protection to over 20 years
minimum 20 years
both “product” and “process” patents required
What’s at stake?



prices of new products
prompt marketing of generics when patent expires
research and development for new products
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Unfinished agenda
Substandard drugs are common - over half are
antibiotics, antimalarials, other anti-infectives
Percent breakdown - 325 cases
of substandard drugs
Incorrect
ingredient
16%
Incorrect
amount
17%
Other
problems
7%
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No active
ingredient
60%
Unfinished agenda
The quality of antimalarial products differs greatly
among countries - content and dissolution problems
Ga
bo
Gh n
an
Ke a
ny
a
Mo
M
za
mb ali
iqu
Su e
Zim dan
ba
bw
e
100
80
60
40
20
0
Content
Dissolution
* Samples were judged to have “failed” if content
was <93% or >107%, and dissolution <80% in 45
minutes.
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Sulphadoxine/pyrimethamine - %
failure*
100
80
60
40
20
0
Ga
bo
n
Gh
an
a
Ke
ny
a
Mo
za Mali
mb
iqu
Su e
Zim da n
ba
bw
e
Chloroquine tablets- % failure*
Content
Dissolution
* Samples were judged to have “failed” if content was
<90% or >110%, and dissolution <65% in 30 minutes.
Unfinished agenda
Irrational use of drugs remains a widespread hazard to
health

Only 50% of countries report regulating drug promotion

15 billion injections per year - half of them unsterile

25-75% of antibiotic prescriptions are inappropriate

50% of people worldwide fail to take medicines correctly
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Unfinished agenda
Nearly a 100-fold variation in pharmacists per million
population - affects the whole supply and use chain
Italy
Canada
United Kingdom
Denmark
Europe, N. America
Thailand
Asia
Sri Lanka
(150 to 940 per million)
(10 to 70 per million)
Philippines
Myanmar
Bhutan
Swaziland
Benin
Pharmacists per million population
Africa
Malawi
(1 to 30 per million)
Ethiopia
Central African Republic
0
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200
400
Source: WHO/HST/GSP/94.1 (1994)
600
800
1000
Unfinished agenda
Financing, delivery, and other constraints still limit
access to essential medicines
Percentage of population with regular access to essential medicines (1997)
1 = <50%
1 = <50%
2 = 50-80%
3 = 80-95%
4 = >95%
5 = No data available
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Source: WHO/DAP (1998)
(36)
(36)
(68)
(33)
(41)
(1)
25 years of Essential Medicines The road traveled… the road ahead...
Achievements
Literally millions are needlessly suffering and
dying because essential drugs are:
available
Unfinished
business
unaffordable
unsafe
wrongly prescribed, dispensed, or consumed
Promising
developments
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25 years of Essential Medicines The road traveled… the road ahead...
Achievements
Unfinished business
Promising developments
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Promising developments
WHO Essential Medicines Library evidence and information for action
Clinical
Guidelines
Evidence,
Systematic
Reviews
Model
Formulary
WHO
Model List
Cost
Information
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Monitoring
safety & use
Drug Quality
Information
Promising developments
Expanding drug financing options - increasing number
of countries with drug benefits in health insurance
Medicines covered by public health insurance (74)
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Promising developments
Successful experiences with local supply systems and
regional bulk procurement
E. Caribbean
Drug Service
Guatemala:
Direct delivery
Northern Province, SA:
Contract distributor
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Gulf States
Thailand, India:
Pooled procurement
Non-profit Essential
Drugs Services
Promising developments
Proportion of visits
with injection
Injection use in Indonesia dramatically reduced - by
talking to mothers, training, and monitoring
100%
Interactive group discussion (IGD only)
Seminar (both groups)
80%
District-wide monitoring
(both groups)
60%
40%
20%
0%
1
3
5
7
9
11
13
15
17
19
21
23
Months
Comparison group
Interactive group discussion
Source: Long-term impact of small group interventions, Santoso et al., 1996
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25
Conclusion
25 years of Essential Medicines The road traveled… the road ahead...
Achievements - considerable progress has been made in
the 25 years since the essential medicines concept adopted
Unfinished agenda - millions of people suffer and die
needlessly - problems are with access, quality, rational use
Promising developments - initiatives show better selection,
fairer financing, increased access, rational use are possible
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Thank you
www.who.int / medicines
25 Years of Essential Medicines
Unfinished agenda
Substandard drugs often no active ingredient - over
half are antibiotics, antimalarials, antituberculars
Percent breakdown - 325 cases Quality and safety standards exist,
of substandard medicines, Asia enforcement varies greatly:
Incorrect
ingredient
16%
Incorrect
amount
17%
Other
problems
7%
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only 1 in 3 developing countries have
well-functioning drug regulation
 10-20% of drugs fail quality testing

substandard and counterfeit drugs
continue to kill

No active
ingredient
60%
Promising developments
The new Global Fund to Fight AIDS, TB, Malaria international solidarity for prevention and treatment
1,600
1,400
45% of first $600 million in grants for
medicines, other health products
1,200
1,000
800
600
400
Pledges May-August 2001
200
US $ millions
0
3May
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10May
17May
24May
31May
7Jun
14Jun
21Jun
28Jun
5Jul
12Jul
19Jul
26Jul
2Aug
?
Promising developments
Advocacy, competition, & corporate responsiveness
have reduced antiretroviral prices 95% in 3 years
Indicative annual cost per person for triple therapy in
Africa (US $)
$10,000
$8,000
UN Drug Access Initiative
$6,000
$4,000
Domestic production
$2,000
Accelerated access initiative
??
Generic offers
$0
1996
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1997
1998
1999
2000
2001
2002
Achievements
Through committed action much has been achieved in
other areas - despite difficulties

100+ countries - national drug policies adopted or in
progress

88 countries - include essential medicines concept in the
curricula for medicine, nursing, pharmacy students

dozens of operational national essential medicines
programmes
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Economic impact
In poorer countries medicines are largest household
and second largest public expenditure for health
Pharmaceutical spending, as % of total health spending
Greece
Germany
Italy
France
Spain
Denmark
UK
United States
Netherlands
Norway
Developed countries
(7 - 30 %)
Bulgaria
Czech Rep.
Hungary
Croatia
Poland
Estonia
Slovenia
Lithuania
Transitional economies
(15-30 %)
Mali
Egypt
China
Indonesia
Thailand
Tunisia
Jordan
Argentina
South Africa
Developing countries
(24 - 66 %)
0
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10
20
30
40
50
60
70
Between 1990 and 2000, the generic market fell sharply
in middle and high income countries
% by value
100%
80%
60%
40%
60%
64%
62%
54%
42%
20%
29%
0%
1990
2000
Low Income
1990
2000
Middle Income
Generic
Originator
Source: World Drug Situation, WHO, 2002, IMS Health, 2001
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1990
2000
High Income
Promising developments
WHO Essential Medicines Library evidence and information for action
WHO/EC, Cochrane
Clinical WHO clusters
Guidelines
BNF
Evidence,
Systematic
Reviews
Model
Formulary
WHO
Model List
MSH
UNICEF
MSF
WHO/EDM
Cost
Information
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Monitoring
safety & use
Drug Quality
Information
WCCs
Oslo/Uppsala
Selection
The Essential Medicines Target
National list of
essential medicines
Registered medicines
All the medicines
in the world
Levels of use
S
CHW
S
dispensary
Health center
Hospital
Referral hospital
Private sector
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Supplementary
specialist
medicines
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
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Promising developments
Ensuring access to essential medicines
- framework for collective action
2. Affordable
prices
2. Affordable
prices
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financing
3. Sustainable
financing
ACCESS
4. Reliable
health and
supply
systems
selection
1. Rational
selection and use
ACCESS
1. Rational
3. Sustainable
4. Reliable
health and
supply systems
Promising developments
Antimalarial treatment in Kenya has become more
prompt and appropriate through shopkeeper training
% of surrogate shoppers
70%
60%
50%
40%
30%
20%
10%
0%
Training
1998
1999
Training
2000
Southern zone
Fevers treated with antimalarials
Source: Marsh et al, 2001
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1998
1999
2000
Northern zone
Antimalarials given appropriately
Promising developments
Competition is highly effective in reducing prices - the
example of antiretrovirals
Cost per capsule or tablet (US $)
No competition
5
Competition (2 to 6 producers per product)
4
2.90
3
2
2.00
1.72
1.85
1.55
1.31
1.04
1
0.83
0.51
0.08
0
Product A
Product B
1996
Source = UNAIDS, B. Samb, 2000
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Product C
1997
1998
Product D
1999
2000
Product E
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, costeffectiveness and public health relevance
Rapid dissemination, electronic access
Regular review
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Transparent process - standard application, web review
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