As a result of the above two-stage consultation process, new procedures for updating and disseminating the Model List have been drawn up. The main features of the new procedures are as follows:
- the use of the term “essential medicines” instead of “essential drugs” to reflect the common use of the term “medicines” to describe pharmaceutical preparations used in clinical health care practice;
- a more systematic approach to inviting and dealing with applications for medicines to be included in, or deleted from, the Model List;
- a more transparent process for selecting medicines for inclusion in the Model List, including a systematic analysis of the evidence that supports the medicines proposed for use in the care of different health conditions (e.g. comparative evidence of efficacy, safety and, where possible and appropriate, cost-effectiveness);
- opportunities for interested parties to comment on both the application and its review to the Expert Committee;
- full involvement of different WHO departments in the application and selection process, and in the linking of the process to clinical guidelines published and disseminated by WHO;
- development of a new WHO Essential Medicines Library which facilitates access to information about medicines on the Model List (see section 3.5);
- 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 of medicines within Member States).
The new procedures were presented in a report by the WHO Secretariat (6) at the 109th session of the WHO Executive Board in January 2002 and discussed. The Board noted the report, including the attached Annex that sets out the new procedures (7). The Director-General decided to organize the next meeting of the Expert Committee on the Use of Essential Drugs in April 2002, taking into account the above-mentioned discussions on the new procedures while recognizing the fact that, owing to the relatively short time frame involved, not all of the proposed improvements could be implemented immediately.