25 years of essential medicines … progress … unfinished agenda … promising developments...
TRANSCRIPT
25 Years of Essential Medicines25 Years of Essential Medicines… … progress … unfinished agendaprogress … unfinished agenda
… … promising developmentspromising developments
Jonathan D. Quick, MD, MPH, DirectorEssential Drugs and Medicines Policy
World Health OrganizationSeptember 2003
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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
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Cumulative number of national drug policies (NDPs)*
40
19
10
18
10 12
0
5
10
15
20
25
30
35
40
45
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.
Achievements
19771977 - “NDP” concept barely know
20022002 - over 100 countries have policies in place or under development - guiding collective action
National drug policiesNational drug policies
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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.
19771977 - perhaps a dozen countries with national lists
20022002 - at least 156 countries with national / provincial lists for procurement, reimbursement, training, other uses
Essential medicines listsEssential medicines lists
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19771977 - few countries had objective drug information
20022002 - 135 countries, many NGOs have treatment guidelines and formulary manuals
Treatment guidelinesTreatment guidelines
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WHOModel List
ClinicalGuidelines
Evidence,SystematicReviews
ModelFormulary
Drug QualityInformation
PriceInformation
Monitoringsafety & use
19771977 - informal and not linked other information
20022002 - model list - hub for evidence & information base
Selection processSelection process
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Becoming a standard in universities around the world
For medical students, clinical officers, other prescribers
Now also: Teacher’s Guide to Good Prescribing
19771977 - little systematic training on rational use, generics
20022002 - problem-based pharmacotherapy training in 18 languages - measurable improvements in prescribing
Medical training Medical training
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19771977 - only 18 national centres monitoring drug safety
Member countries (68)Associate member countries (8)
20022002 - 76 members and associate members in WHO Programme for International Drug Monitoring
Medicine safetyMedicine safety
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Over a dozen countries withprices on public web sites
Survey methods for drug price comparisons
Version 9 Release 01 October 2002
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International Drug Price Worksheet
Consolidation Public
Consolidation Private
Consolidation Other Sector
Sector Summary
Affordability
Reference Prices
Price Mark-ups
Drug Summary
Erase Public Data
Erase Private Data
Erase Other Sector Data
Erase Affordability Data-profit
Erase Reference Prices
Erase Mark-ups Data
Erase & Reset All Data-profit
Consolidation Procurement
Erase Procurement Data
Price Composition
Country Data
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Five WHO-UN-partner pricing services
19771977 - virtually no publicly available price information
20022002 - more information, much more widely available
Pricing informationPricing information
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Number of people (billions)
0
1
2
3
4
5
6
1977 1987 1997
Regularaccess toessentialdrugs
19771977 - less than 1/2 with access - 2 billion people
20022002 - the number of people with access has doubled due to a combination of public, private, NGO efforts
Access to essential medicines Access to essential medicines
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…but...
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Number of people (billions)
0
1
2
3
4
5
6
1977 1987 1997
Noregularaccess
Regularaccess toessentialdrugs
Two billion people still lack regular access to Two billion people still lack regular access to essential medicinesessential medicines
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…a huge unfinished agenda…
Closing the gap
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Source: Azerbaijan - UNICEF-Bamako Technical Report No. 35 ; Bangladesh 1995 - National Accounts 1996/97Mali (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
AzerbaijanDrugs61%
Fees, Other39%
Bangladesh
Drugs73%
Fees, Other27%
Burkina Faso
Fees, Other15%
Drugs85%
Mali
Fees, Other20%
Drugs80%
1. Unfair financing 1. Unfair financing - the burden falls heaviest on those most in need, but least able to pay
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Medicines covered by public health insurance (74)
Promising developmentsPromising developments - Increasing number of countries with drug benefits in public health insurance
public financing
employers
Global Fund
voluntary sector
development funds
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2. High prices 2. High prices - Highly variable & often unaffordable producer prices, distribution fees, taxes, and tariffs
Source: MSF (1999)
0
10
20
30
40
50
60
70
Me
dia
n M
PR
Ac
ros
s M
ed
icin
e P
air
s
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
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Promising developmentsPromising developments - Progress on priceinformation, policies, analysis
Competition - generic and therapeutic Legislation, quality, acceptance, economics
Equitable pricing arrangements medicines for HIV/AIDS, malaria
Application of World Trade Organization TRIPS patent agreement safeguards Doha Declaration - “access to medicines for all”
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3. Unreliable systems 3. Unreliable systems - procurement and distribution lapses result in shortages, diversion
% of prescribed drugs actually dispensed- public sector facilities
7280 84
58 6373
0102030405060708090
100
Brazil(prov)
Cambodia El Salvador Ghana India(state)
Tanzania
Source: SEAM, December, 2001
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Promising developmentsPromising developments - lessons can be drawn from every region, using all effective channels
Guatemala:Direct delivery
Northern Province, SA:Contract distributor
Gulf StatesE. CaribbeanDrug Service
Non-profit Essential Drugs Services
Thailand, India: Pooled procurement
Pacific Islands
National NGO Sub-regional
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4. Poor quality 4. Poor quality – Antibiotics and other anti-infectives often substandard – half of substandard drugs have no active ingredient
Incorrect amount
17%
No active ingredient
60%Other errors7%
Incorrect ingredient
16%
Quality problems
325 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
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
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Promising developmentsPromising developments - capacity-building, practical tools, information support
Focus on effective drug regulation Political commitment Human, financial, organizational resources
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
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5. Irrational use 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
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Promising developmentsPromising developments - injection use dramatically reduced - by talking to mothers, training, monitoring
Source: Long-term impact of small group interventions, Santoso et al., 1996
0%
20%
40%
60%
80%
100%
1 3 5 7 9 11 13 15 17 19 21 23 25
Months
Pro
po
rtio
n o
f vi
sits
wit
h i
nje
ctio
nInteractive group discussion
Seminar
District-wide monitoring
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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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EquityEquity
SustainabilitySustainability
IntegrationIntegration
The concept of essential medicines remains a global necessity for saving lives and improving health
www.who.int / medicines
IMPROVE PUBLIC HEALTH
25 Years of Essential Medicines25 Years of Essential Medicines