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, 2002

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
Last revision (Dec.1999) contains 306 active substances
2002 Revised procedures approved by WHO
The first list was a major breakthrough in the history
of medicine, pharmacy and public health
Médecins sans Frontières, 2000

4. 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

5. Relation between treatment guidelines and a list of essential medicines

6. 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)

7. 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

8. Example of challenge: New essential drugs are expensive
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: $20 for DOTS vs $400 for MDR (20x)
Antiretrovirals: $ /year; but 38 countries with a drug budget <$2 pp/year

9. Perceived problems with updating and dissemination the WHO Model List
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

10. *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

11. Review process of the new procedures (1): Process and time table
Nov ‘99 Seminar by WHO Expert Committee on Ess.Drugs
Jan ‘00 Cabinet decision to develop standard procedures
Mar ‘01 Informal consultation
Jun Presentation at MIP, Member States review
Sep Review by all stakeholders
Oct Discussion at Reg.C’ees in PAHO and EMRO
Nov Cabinet discussion
Jan ‘02 Report to Executive Board

12. Review process of the new procedures (2): Stakeholders consulted
WHO clusters, regional and country offices
Member States, essential drugs programmes
Members of WHO Expert Panels
UN agencies (UNICEF, UNFPA, UNHCR, UNAIDS)
NGO’s (ICRC, FRCS, WCC, Caritas Int, OXFAM, MSF, PSF)
Pharmaceutical industry (IFPMA, IGMA, WSMI)

13. The WHO Model List of Essential Medicines is a model product, model process and public health tool
Model product: list of essential drugs with information
Core list: minimum drug needs for a basic health care system, listing the most cost-effective drugs for priority conditions (selected on the basis of burden of disease and potential for safe and cost-effective treatment).
Complementary list: essential drugs for priority diseases which are cost-effective but not necessarily affordable or for which specialised health care facilities may be needed; and essential drugs for less frequent diseases

14. 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, 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. Systematic and transparent process
Model process (1): 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

16. Model process (2): 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

17. Model process (3): Presentation of recommendations, report
Summary of reasons for each recommendation
Reference to underlying evidence and systematic reviews
Reference to existing clinical guidelines
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

18. The WHO Model List of Essential Medicines is a model product, model process 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 - and includes access to life-saving medicines
The essential medicines concept is globally applicable

19. Remaining issues for the next Expert Committee: (1) Description of essential drugs
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

20. Remaining issues for the next Expert Committee: (2) 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

21. 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

22. WHO Essential Medicines Library
Clinical guideline
Summary of clinical guideline
WHO Model
Formulary
Reasons for inclusion
Systematic reviews
Key references
WHO
Model List
Cost:
- per unit
- per treatment
- per month
- per case prevented
Statistics:
- ATC
- DDD
Quality information:
- Basic quality tests
- Intern. Pharmacopoea
- Reference standards

23. Summary of clinical guideline
WHO Essential Medicines Library Combining information from various partners
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

24. Conclusion
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