Expert Committee on the Use of Essential Drugs Meeting
1 March 2002)
for updating and disseminating the Model List of Essential Medicines
1975, the Twenty-eighth World Health Assembly requested the
Director-General to assist Member States by ?advising on the
selection and procurement, at reasonable cost, of essential drugs of
established quality corresponding to their national health needs?
(resolution WHA28.66). The first WHO Model List of Essential Drugs was
prepared by a WHO Expert Committee in 1977.
In 1978, the Thirty-first World Health Assembly (in resolution
WHA31.32) requested the Director-General, inter
alia, ?to continue to identify the drugs and vaccines which, in
the light of scientific knowledge, are indispensable for primary
health care and control of diseases prevalent in the population, and
to update periodically this aspect of the report of the WHO Expert
Committee on the Selection of Essential Drugs and to cooperate
with Member States in formulating drug policies and management
programmes that are relevant to the health needs of populations and
are aimed at ensuring access of the whole population to essential
drugs at a cost the country can afford?.
studies have documented the impact of clinical guidelines and lists of
on the availability and proper use of medicines within health care
Careful selection of a limited range of essential medicines results in
a higher quality of care, better management of medicines (including
improved quality of prescribed medicines), and more cost-effective use
of health resources.
countries require that a pharmaceutical product be approved on the
basis of efficacy, safety and quality before it can be prescribed. In
addition, the majority of health care and insurance schemes cover only
the costs of medicines on a selected list. The medicines on such lists
are selected after a study of the medicines used to treat particular
conditions, and a comparison of the value they give in relation to
their cost. The WHO Model List of Essential Medicines is an example of
such a list.
Model List is a guide for the development of national and
institutional essential medicine lists. It was not designed as a
global standard. However, over the past 25 years the Model List has
led to a global acceptance of the concept of essential medicines as a
powerful means to promote health equity. By the end of 1999, 156
Member States had official essential medicines lists, of which 127 had
been updated in the previous five years. Most countries have national
lists and some have provincial or state lists as well. National lists
of essential medicines usually relate closely to national guidelines
for clinical health care practice which are used for the training and
supervision of health workers. Lists of essential medicines also guide
the procurement and supply of medicines in the public sector, schemes
that reimburse medicine costs, medicine donations, and local medicine
production. Many international organizations, including UNICEF and
UNHCR, as well as nongovernmental organizations and international
non-profit supply agencies, have adopted the essential medicines
concept and base their medicine supply system mainly on the Model
Model List of Essential Medicines
two years since 1977 the Model List has been updated by the WHO Expert
Committee on the Use of Essential Drugs.
The current Model List (November 1999) lists 306 active ingredients,
of which 250 are included in WHO clinical guidelines. Among the 306
active ingredients are vaccines, contraceptives, preventive agents
such as insect repellents and some diagnostic agents.
procedures for updating the WHO Model List of Essential Drugs
its meeting in 1999, the Expert Committee proposed that the methods
for updating and disseminating the Model List be revised because of
(1) advances in the science of evidence-based decision-making; (2) the
increasing link between essential medicines and guidelines for
clinical health care; and (3) the high cost of many new and effective
medicines. The Expert Committee concluded that current procedures do
not define the range of conditions covered with adequate specificity,
nor are the reasons for inclusion recorded with sufficient clarity.
May 2001 an information document containing a proposed timetable for
developing revised procedures to update the Model List was presented
to the Executive Board at its 108th session.
In June 2001 all Member States were invited to comment on a discussion
paper ?Updating and disseminating the WHO Model List of Essential
Drugs: the way forward?. Comments were analysed and, in August 2001,
a revised paper was sent for comments to Member States, WHO
collaborating centres, members of expert advisory panels,
organizations of the United Nations system, nongovernmental
organizations, professional associations, national essential medicines
programmes, universities, representatives of the pharmaceutical
industry, and patients? organizations.
issue was discussed at the 43rd Directing Council of the Pan American
Health Organization (the 53rd session of the WHO Regional Committee
for the Americas) in September 2001.
It was also discussed at the Forty-eighth session of the Regional
Committee for the Eastern Mediterranean in October 2001, which
strongly endorsed the revised procedure for updating the WHO Model
List of Essential Drugs and requested the Director-General to finalize
it as soon as possible (resolution EM/RC48/R.2).
features of the new procedure
a result of this two-stage consultation process, a new procedure for
updating and disseminating the Model List has been developed. Major
features of the new procedure include:
use of the term ?essential medicines? as an alternative to
?essential drugs? with immediate effect, reflecting the common use
of the term ?medicines? to describe pharmaceutical preparations
used in clinical health care practice;
a more systematic approach to encouraging and handling
applications for medicines to be included in or deleted from the Model
a more transparent process for selecting medicines to be
included in the list, including systematic analysis of medicines
proposed for use in the care of different health conditions (comparing
efficacy, safety and, where possible and appropriate,
opportunities for interested parties to comment on both an
application and the draft recommendations of the Expert Committee;
the full involvement of different WHO departments in the
application and selection process, linking the process to clinical
guidelines disseminated by WHO;
development of a new WHO essential medicines library which
facilitates access to information about medicines on the Model List;
steps to ensure that the Expert Committee operates with full
scientific independence as it makes its final recommendations (in line
with current practice for decisions on regulatory approval,
procurement, and reimbursement within Member States).
Essential Medicines Library
1975, WHO has been asked by Member States to provide information on
medicine quality, prices,
and therapeutic aspects of individual pharmaceutical products within
the Model List. In 1999, the Expert Committee stressed the importance
of the link between selection of medicines for the Model List and
clinical guidelines. It encouraged wider dissemination of the evidence
used in the Expert Committee's work and recommended the careful
recording of the reasons for the Expert Committee's final
revised procedure proposes the creation, by WHO, of an essential
medicines library to make such information more widely available using
CD-ROMs and the Internet. Links to WHO clinical guidelines, the WHO
Model Formulary, existing United Nations price information services
and information on international nomenclature and quality standards
are also proposed.
WHO Technical Report Series, No. 615, 1977.
As part of the revised procedure for updating the Model List, the term
"essential medicines" is used in preference to
"essential drugs". This reflects the common use of the term
describe pharmaceutical preparations used in clinical health care
For example, WHO medicines strategy: framework for action in essential
drugs and medicines policy 2000-2003 (document WHO/EDM/2000.1) and
Interventions and strategies to improve the use of antimicrobials in
developing countries (document
In 1977 and 1979 the name of the committee was the Expert Committee on
the Selection of Essential Drugs. Since 1982, the committee has been
named the Expert Committee on the Use of Essential Drugs.
See document CD 43/5.
For example, resolutions WHA49.14, WHA52.19, WHA53.14 and WHA54.11.