At its previous meeting held in 1999, the Committee reviewed past experience with the Model List and discussed future needs (2). It noted that:
- with regard to the selection process for essential medicines, efforts to link the selection of medicines for inclusion in the Model List to WHO treatment guidelines should be further encouraged;
- decisions on whether or not to include medicines in the Model List should be based on properly identified evidence, and the reasons for their inclusion or otherwise should be carefully recorded;
- proposals to include medicines in the Model List need to be better defined, and should include a valid analysis of the cost-effectiveness of each medicine;
- available evidence supporting the inclusion of medicines already on the Model List should be identified and made available;
- more explicit criteria for determining which diseases or conditions should be covered by the Model List are required, as are clearer descriptions of the criteria for selecting medicines for inclusion in the Model List;
- the Model List should not only identify priority conditions and those medicines for which equitable availability and affordability should be ensured before resources are spent on other treatments (i.e. a “core” list of essential medicines), but should also indicate medicines that are cost-effective and safe but which are not necessarily affordable and/or for which special training or health care services would be needed for their proper use (i.e. a “complementary” list of essential medicines).
On the basis of these discussions, the Committee recommended that the methodology for its decision-making be reviewed as a matter of some urgency. It was agreed that, following such a review, a methodology for use by the Committee at its subsequent meetings should be prepared and that this methodology should include a description of the process for submitting a proposal to include a medicine in the Model List (2).
In May 2001, an information document proposing a timetable for developing new procedures for updating the Model List was presented to the Executive Board at its 108th session (3). In June 2001, Member States were invited to comment on a discussion paper, “Updating and disseminating the WHO Model List of Essential Drugs: the way forward” (4). Once comments from Member States had been taken into account, a revised version of the discussion paper was sent out for wider review in August 2001, this time 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. Over 140 comments were received in response to the circulation of the paper.
The proposals for revising the procedures were discussed at the Forty-third Directing Council of the Pan American Health Organization (the Fifty-third Session of the WHO Regional Committee for the Americas) in September 2001. Participants raised a number of concerns and constructive comments were duly noted. The proposals were also discussed at the Forty-eighth Session of the WHO Regional Committee for the Eastern Mediterranean in October 2001, which strongly endorsed, by resolution EM/RC48/R.2, the proposed new procedures for updating the WHO Model List and requested the Director-General to finalize them as soon as possible (5).