1. The concept of essential drugs and the
WHO Model List of Essential Medicines
Hans V. Hogerzeil, MD, PhD, FRCP Edin
Department of Essential Drugs and Medicines Policy
World Health Organization, September 2003

2. Essential medicines The concept of essential medicines
A limited range of carefully selected essential medicines leads to better health care, better drug management, and lower costs
Definition of essential medicines
Essential medicines are those that satisfy the priority health care needs of the population
(Report to WHO Executive Board, January 2002)

3. 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
2002 Revised procedures approved by WHO
Last revision (April 2003) contains 315 active substances
The first list was a major breakthrough in the history
of medicine, pharmacy and public health
Médecins sans Frontières, 2000

4. Full description of essential drugs (Expert Committee Report, April 2002)
Definition: Essential medicines are those that satisfy the priority health care needs of the population
Selection criteria: Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness
Purpose: 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 at a price the individual and the community can afford.
Implementation: The implementation of 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.

5. The Essential Medicines Target
National list of
essential medicines
Registered medicines
All the drugs
in the world
Levels of use
CHW S S
dispensary
Health center
Supplementary
specialist
medicines
Hospital
Referral hospital
Private sector

6. List of common diseases and complaints
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

7. Number of countries with a national list of essential medicines
156 countries with EDLS
1/3 within 2 years
3/4 within 5 years
National Essential Drugs List
< 5 years
(127)
> 5 years
(29)
No NEDL
(19)
Unknown
(16)

8. Use of the WHO Model List of Essential Drugs
156 countries have a national list of essential drugs, of which 81% have been updated in the last 5 years
Major international agencies (UNICEF, UNHCR, IDA) base their catalogue on the WHO Model List
Sub-sets: UN list of recommended essential drugs for emergency relief (85 drugs); interagency New Emergency Health Kit (55 drugs for 10,000 consultations)
Normative tools: WHO Model Formulary, International Pharmacopoea, Basic Quality Tests, and development of reference standards follow the WHO Model List

9. Example of challenge: New essential drugs are expensive (1)
Antibiotics for gonorrhoea: x price of penicillins
Antimalarial drugs: chloroquine $0.10 per treatment coartem® $3/pp developing country (30x) malarone® $40 per dose (400x)
Antituberculosis: $10 for DOTS vs $250 for MDR (25x)
Antiretrovirals: $ /year; but 38 countries with a drug budget <$2 pp/year

10. New essential drugs are expensive (2) also in industrialized countries!
Canada: 55% of prescription cost rise of 93% over was due to introduction of new drugs
USA: Pharmaceuticals market grew with 16% in 1999, 18% in 2000 and 17% in 2001; volume rise in 2000 only 5.5%
Growth due to * elderly population * new therapies * increased prescriptions by managed care * direct-to- consumer advertising
Australia: Annual increase in drug costs for Pharmaceutical Benefit Scheme could pay for two new teaching hospitals

11. Perceived problems with the WHO Model List prior to 2002 revision of procedures (Expert Committee, 1999)
Range of diseases covered by the Model List is not clear
Discrepancies between Model List and treatment guidelines
Selection is more consensus-based than evidence-based
Use of data on cost and cost-effectiveness unclear
Reasons for selection insufficiently recorded
Drugs included without pharmacopoeal standard or supplier
Official report comes out too late, and in English only

12. *e.g. cytotoxics, hormones, diagnostic agents, gastrointestinal drugs
WHO Model List of Essential Drugs 1999 compared with drugs included in WHO Treatment Guidelines
306 active substances on drugs
WHO Model List mentioned in WHO
of Essential Drugs Treatment Guidelines
56*
250
155
*e.g. cytotoxics, hormones, diagnostic agents, gastrointestinal drugs

13. Example of a link: chloramphenicol
Chloramphenicol is recommended for the following indications:
Injectable: Severe pneumonia in children*, severe asthma-pneumonia*, brain abscess*, meningitis in children with ARI*, epiglottitis*, granuloma inguinale*, mastoiditis*, meningitis (various kinds), obstetrics, septicaemia*
Oral: severe pneumonia in children, asthma pneumonia*, meningitis in children*, cholera*, louse borne typhus*, measles pneumonia, meningitis (empirical and meningococcal), abortion care, plague*, relapsing fever*, Rickettsia, typhoid fever*
*recommended as alternative drug

14. Outcome of the revised procedures: The WHO Model List of Essential Medicines is a model process, model product and public health tool
Independent Membership of the Committee, careful consideration of conflict of interest
Transparent process, standard application, review
Link to evidence-based treatment recommendations, in accordance with WHO Recommended Process for Developing Clinical Practice Guidelines
Systematic review of comparative efficacy, safety and cost-effectiveness, and review of public health relevance
Rapid dissemination, electronic access
Regular review

15. Model process (1): Seven steps to get a new medicine on the WHO Model List of Essential Drugs
1. Identification of public-health need for a medicine
2. Development of the medicine; phase I - II - III trials
3. Regulatory approval in a number of countries
> Effective and safe medicine on the market
4. More experience under different field circumstances; post-marketing surveillance
5. Price indication for public sector use
6. Review by WHO disease programme; define comparative effectiveness and safety in real-life situations, comparative cost-effectiveness and public health relevance
> Medicine included in WHO treatment guideline
7. Submission to WHO Expert Committee on Essential Drugs
> Medicine included in WHO Model List

16. Systematic and transparent process
Model process (2): Link to Guidelines for Guidelines (approved by WHO Cabinet in January 2001)
Systematic and transparent process
Guideline development group with wide representation
Careful consideration of conflict of interest
Systematic computer search for evidence
Evaluation of strength of evidence
Systematic cost-effectiveness analysis
for WHO: evaluation of public health considerations
Graded recommendations with linked references
External review of draft recommendations
If there is insufficient evidence: consensus expert opinion

17. Model process (3): Steps in review of applications to the Model List
1 Summary of application posted on WHO Medicines web site
2 Specialist assessment of comparative efficacy, safety and cost-effectiveness
3 Review of assessments by Expert Committee member (“presenter”); formulation of draft recommendation
4 Review of draft recommendation by relevant Expert Advisory Panel members; and posted on WHO Medicines web site
5 Review by presenter, prepares final draft recommendation
6 Discussion of draft recommendation and proposed text for WHO Model Formulary by the Expert Committee

18. Model process (4): Role of treatment cost and global cost-effectiveness analyses
High cost alone should not exclude an essential medicine
Cost-effectiveness (C/E) comparisons will be made among alternative medicines within the same therapeutic group
Price information from existing UN sources will be used; all information sources will be identified
Simple indicators will be used: cost per unit, cost per treatment/month, cost per cure, cost per case prevented
Emphasis on usual outcome measures, and use of existing and published comparative cost-effectiveness analyses
New C/E calculations will be transparent and can be adapted

19. Model process (5): Presentation of recommendations, report
Summary of reasons for each recommendation
Reference to underlying evidence and systematic reviews
Reference to existing clinical guidelines
Inclusion in WHO Essential Medicines Library
Report, web site, translations:
Report of the meeting published on WHO Medicines web site
Report issued in WHO Technical Report Series
List and recommendations translated into other languages

20. Summary of clinical guideline
The WHO Model List of Essential Medicines is a model process, model product and public health tool The WHO Essential Medicines Library
WHO clusters
WHO/EDM
Clinical guideline
Summary of clinical guideline
BNF
WHO Model
Formulary
WHO/EC, Cochrane
Reasons for inclusion
Systematic reviews
Key references
WHO
Model List
WHO/QSM
MSH
UNICEF
MSF
Cost:
- per unit
- per treatment
- per month
- per case prevented
Statistics:
- ATC
- DDD
Quality information:
- Basic quality tests
- Intern. Pharmacopoea
- Reference standards
WCCs
Oslo/Uppsala

21. WHO Model Formulary
First edition launched at FIP, Nice (September 2002)
WHO priced publication (SFr 40, SFr 20)
Web version as PDF file and searchable database
First print run of 7000 exhausted; second print January 2003
CD-ROM (searchable and downloadable) available June 2003
Translations ongoing in Arabic, Chinese, French, Russian, Spanish; maybe electronic versions only (on CD)
Revision in 2003 (follows 13th Model List)
5-year commitment to RPS and BMJ
Manual “How to develop a national formulary” in preparation

22. The New Emergency Health Kit 1984, 1990, 1998
Essential medicines and supplies
for 10,000 people for three months
Consensus between WHO, UNICEF,
UNHCR, UNFPA, Red Cross,
MSF, OXFAM, missions, IDA

23. Selection of emergency relief items
325
WHO Model List 2002
UN List of
Emergency
Relief Items 88
UNDP
WHO
ICRC
FRC
MSF
UNICEF
UNHCR
UNFPA
IDA
EPN
OXFAM
New Emergency
Health Kit 1998 55
Adaptation needed: ORS,
antimalarials, syringes,
emergency contraception

24. Essential medicines for Reproductive Health: Discrepancies in international RH lists
75 on UNFPA List 6
325 on WHO Model List 6
194 63
150 on Interagency RH
medical commodities 65 22

25. The WHO Model List of Essential Medicines is a model process, model product and public health tool
Main public health advocacy messages:
Essential drugs are the most cost-effective drugs for a given condition
A limited range of carefully selected medicines can cater for most health care needs
There is much waste through irrational selection and use
Access to health care is a Human Right to be progressively realized. This includes access to essential medicines
The essential medicines concept is globally applicable

26. Conclusion The concept of essential medicines is a global concept
WHO clinical guidelines are the foundation for the Model List of Essential Drugs; the Model List remains a strong public health tool
The WHO Essential Medicines Library is a valuable information base for all Member States, international organisations, drugs and therapeutic committees and health insurance organisations

27. Essential Drugs and Medicines Policy
WHO Department of
Essential Drugs and Medicines Policy
/ medicines
Thank you