E-DRUG: updating the WHO EDL/EML
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[taken from www.who.int/medicines
Please note below there are two documents:
first the background and then a recent update. WB]
Background to procedures for updating and disseminating the Model List of
Essential Medicines
In 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.[1] 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".
Numerous studies have documented the impact of clinical guidelines and
lists of essential medicines[2] on the availability and proper use of
medicines within health care systems.[3] 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.
Most 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.
The 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
List.
WHO Model List of Essential Medicines
Every two years since 1977 the Model List has been updated by the WHO
Expert Committee on the Use of Essential Drugs.[4] 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.
Revised procedures for updating the WHO Model List of Essential Drugs
At 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.
In 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.[5] 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.
The 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.[6] 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).
Key features of the new procedure
As 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 List;
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, cost-effectiveness);
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; and
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).
WHO Essential Medicines Library
Since 1975, WHO has been asked by Member States to provide information on
medicine quality, prices,[7] 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 recommendation.
The 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.
Notes
[1] WHO Technical Report Series, No. 615, 1977.
[2] 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 "medicines" to describe pharmaceutical
preparations used in clinical health care practice.
[3] 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 WHO/CDS/CSR/DRS/2001.9).
[4] 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.
[5] Document EB108/INF.DOC./2.
[6] See document CD 43/5.
[7] For example, resolutions WHA49.14, WHA52.19, WHA53.14 and WHA54.11.
Last update:04-Apr-2002
------------------------
[the update]
(EDM/PAR, 28 March 2002)
Agenda Item 1
Update on current situation - new procedures for updating and disseminating
the Model List of Essential Drugs
At 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.
In 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.[1] 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.
The 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.[2] 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).
Key features of the new procedure
As a result of this two-stage consultation process, a new procedure for
updating and disseminating the Model List has been developed (see Annex).
Major features of the new procedure include:
(1) 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;
(2) A more systematic approach to encouraging and handling
applications for medicines to be included in or deleted from the Model
List;
(3) 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, cost-effectiveness);
(4) Opportunities for interested parties to comment on both an
application and the draft recommendations of the Expert Committee;
(5) The full involvement of different WHO departments in the
application and selection process, linking the process to clinical
guidelines disseminated by WHO;
(6) Development of a new WHO essential medicines library which
facilitates access to information about medicines on the Model List; and
(7) 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).
At the 109th session of the WHO Executive Board in January 2002 the new
procedures were presented in a Report by the Secretariat (document EB109/8)
and discussed. The Board noted the report and its Annex with the new
procedures. In the light of the outcome of the discussion at the Executive
Board, the Director-General requested the Department of Essential Drugs
and Medicines Policy to organize the next meeting of the Expert Committee
according to the new procedures, recognizing the fact that, due to the
relatively short time, not all new procedures could be implemented
immediately.
Annex 1
See the Annex to Document EB109/8 (WHO, 2002), also reproduced on the
WHO/Medicines website as "Procedures to update and disseminate the WHO
Model List of Essential Medicines"
[1] Document EB108/INF.DOC./2.
[2] See document CD 43/5.
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