(2002; 91 pages)
New procedures for updating the Model List of Essential Medicines
At its previous meeting in 1999, the Expert Committee on Selection and Use of Essential Drugs proposed that methods for updating and disseminating the Model List of Essential Drugs be revised with regard to (i) advances in the science of evidence-based decision-making; (ii) the increasing link between essential medicines and guidelines for clinical health care; and (iii) 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 WHO Executive Board and all Member States were invited to comment on a discussion paper “Updating and disseminating the WHO Model List of Essential Drugs: the way forward”. Comment was also requested from WHO collaborating cen-tres, 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.
Key features of the new procedure
As a result of the consultation process, a new procedure for updating and disseminating the Model List has been developed. Major features 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.
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 WHO Executive Board in January 2002 the new procedures were presented in a Report by the Secretariat (1). The Board noted the report and its Annex with the new procedures and the Department of Essential Drugs and Medicines Policy was requested to organize the next meeting of the Expert Committee according to the new procedures while recognizing that due to the relatively short time these could not all be implemented immediately.
1. 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”. http://www.who.int/medicines
2. Guidelines for Scaling Up Antiretroviral Therapy. http://www.who.int/medicines
3. 2002 WHO Model List of Essential Drugs. http://www.who.int/medicines