25 Years of Essential Medicines25 Years of Essential Medicines1977 - 20021977 - 2002

Jonathan D. Quick, MD, MPHHans V. Hogerzeil, MD, PhD

WHO Essential Drugs and Medicines PolicyMay 2002

2 25 years

Overview of the presentation

1. Achievements 1977 - 2002

2. Unfinished agenda

3. The selection of essential medicines

4. Promising developments

Overview

3 25 years

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

National drug policies are being introduced at a growing pace in every region - guides for collective action

* Includes countries with current NDPs, draft policies or policies or policies > 10 years old.

Achievements

4 25 years

National Essential Drugs List

< 5 years (127)> 5 years (29)No NEDL (19)Unknown (16)

By Dec.1999:

156 countries with EDLS

1/3 within 2 years

3/4 within 5 years

The essential drugs concept is nearly universal a floor, not a ceiling - applied differently in different settings

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.

Achievements

5 25 years

135 countries have treatment guidelines, formularies

Achievements

Treatment guidelines and formulary manuals put the essential drugs concept into clinical practice

6 25 years

Training in rational prescribing has expanded in universities throughout the world

DAP’s role

Problem-based pharmacotherapy In 18 languages For medical students,

clinical officers Measurable improvement in

prescribing Now also: Teacher’s Guide to

Good Prescribing

Achievements

7 25 years

Number of people (billions)

0

1

2

3

4

5

6

1977 1987 1997

No regularaccess

Regularaccess toessentialdrugs

The number of people with access to essential drugs has nearly doubled in 20 years

Achievements

The poor have remained poor

8 25 years

Much has been achieved in 25 years...

...but…..

9 25 years

Incorrect amount

17%

No active ingredient

60%Other problems

7%

Incorrect ingredient

16%

Percent breakdown - 325 cases of substandard drugs

Substandard drugs are common - over half are antibiotics, antimalarials, other anti-infectives

Unfinished agenda

10 25 years

Unfinished agenda

Irrational use of drugs is a widespread hazard to health

Half of 102 countries surveyed regulate drug promotion By age 2 children in some areas have had > 20 injections 15 billion injections per year - half of them unsterile 25-75% of antibiotic prescriptions are inappropriate

11 25 years

Financing, delivery, and other constraints still limit access to essential drugs

Source: WHO/DAP (1998)

Percentage of population with regular access to essential drugs (1997)

1 = <50% (36)1 = <50% (36)2 = 50-80% (68)3 = 80-95% (33)4 = >95% (41)5 = No data available (1)

Unfinished agenda

12 25 years

Example of challenge:New essential drugs are expensive

Antibiotics for gonorrhoea: 50-90x price of penicillins

Antimalarial drugs: chloroquine $0.10 per treatment artemether-lumefantrine $2.50/pp (25x)atovaquone-proguanil $40/pp (400x)

Antituberculosis: $15 for DOTS vs $300 for MDR (20x)

Antiretrovirals: $300-600/year; but 38 countries with a drug budget <$2 pp/year

Selection

13 25 years

The Essential Medicines Target

S S

All the drugsin the world

Registered medicines

National list ofessential medicines

Levels of use

Supplementaryspecialistmedicines

CHWdispensary

Health center

Hospital

Referral hospital

Private sector

Selection

14 25 years

Clinical guidelines and a list of essential medicines lead to better prevention and care

Health Technology and Pharmaceuticals

List of common diseases and complaints

Training andSupervision

Financing and Supply of drugs

Treatment guidelines

Treatment choice

Preventionand care

Selection

Essential medicines list / National formulary

15 25 years

History of the WHO Model List of Essential Drugs

1977 First Model list published, ± 200 active substances List is revised every two years by WHO Expert Committee Last revision (April 2002) contains 325 active substances 2002 Revised procedures approved by WHO

The first list was a major breakthrough in the historyof medicine, pharmacy and public health

Médecins sans Frontières, 2000

Selection

16 25 years

Use of the WHO Model List of Essential Drugs

156 countries have a national list of essential drugs Major agencies (UNICEF, UNHCR, IDA) base their catalogue

on the WHO Model List Sub-sets of the Model List:

UN list of essential drugs for emergencies: 85 drugs New Emergency Health Kit: 55 drugs for 10,000 people/3m

Normative tools follow the Model List: WHO Model Formulary International Pharmacopoea Basic Quality Tests and reference standards

Selection

17 25 years

The WHO Model List of Essential Medicines is amodel 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, cost-

effectiveness and public health relevance Rapid dissemination, electronic access Regular review

Selection

18 25 years

WHO Essential Medicines LibraryCombining information from various partners

WHOModel List

Summary of clinical guideline

Reasons for inclusionSystematic reviewsKey references

WHO Model Formulary

Cost:- per unit- per treatment- per month- per case prevented

Quality information:- Basic quality tests- Intern. Pharmacopoea- Reference standards

Clinical guideline BNF

WHO clusters

MSHUNICEF

MSF

WHO/EDM

WHO/EDM

WHO/EC, Cochrane

Statistics:- ATC- DDD

WCCs Oslo/Uppsala

Selection

19 25 years

Practical implications of the access framework

1. Rational

selection

4. Reliable

systems

2. Affordable

prices

3. Sustainable

financing

ACCESS TO

ESSENTIAL MEDICINES

Promising developments

20 25 years

MSH-WHO essential drugs price indicator

Drugs and diagnostics for HIV/AIDS

Pharmaceutical starting materials

Antiretroviral drugs in the Americas

AFRO Essential Drugs

Indicative price information promotestransparency and competition

Promising developments

21 25 years

Indicative annual cost per person for triple therapy in Africa (US $)

$0

$2,000

$4,000

$6,000

$8,000

$10,000

1996 1997 1998 1999 2000 2001 2002

UN Drug Access Initiative

Domestic production

Accelerated access initiative

Generic offers

Advocacy, corporate responsiveness and competition have reduced antiretroviral prices 95% in 3 years

????

Promising developments

22 25 years

Medicines covered by public health insurance (74)

Expanding drug financing options - increasing number of countries with drug benefits in health insurance

- Public funds- Insurance- Global fund- Out-of-pocket- Donations

Promising developments

23 25 years

Successful experiences with local supply systems and regional bulk procurement

Guatemala:Direct delivery

Northern Province, SA:Contract distributor

Gulf StatesE. CaribbeanDrug Service

Mission for Essential Drugs

Thailand, India: Pooled procurement

24 25 years

Conclusion

The essential drugs concept -more valid than ever

Much has been achieved in 25 years

Yet the unfinished agenda is large - quality, access, use

The Model List of Essential Medicines remains a strong public health tool

There are promising developments for access - pricing, financing, supply systems and quality