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

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

2 TBS 25 years EM Sep03.ppt

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


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


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


19771977 - few countries had objective drug information

20022002 - 135 countries, many NGOs have treatment guidelines and formulary manuals

Treatment guidelinesTreatment guidelines


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


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


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


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


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


…but...


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


…a huge unfinished agenda…

Closing the gap


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


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


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


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”


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


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


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


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


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


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


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


EquityEquity

SustainabilitySustainability

IntegrationIntegration

The concept of essential medicines remains a global necessity for saving lives and improving health

www.who.int / medicines

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25 Years of Essential Medicines25 Years of Essential Medicines

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

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