12th Expert Committee on the Use of Essential Drugs Meeting
15-19 April 2002

(Revised, 1 March 2002)

 

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:

  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).

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.

 


[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.

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See also the Essential Medicines Library

 

 


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