The session was opened by Dr A. Asamoa-Baah, Executive Director, Health Technology and Pharmaceuticals, WHO, who informed participants that WHO is justly proud of the success of the essential medicines concept, as evidenced by its recent twenty-fifth anniversary. He stressed that careful selection of essential medicines for the Model List remains at the heart of the programme, given that the Model List provides not only the moral basis for national drug policies but also a technical basis for the procurement, quality assurance and promotion of the rational use of medicines. The future success of the essential medicines programme depends on the credibility of the work of its Expert Committee, which, in turn, depends very much on the implementation of the new procedures for updating and disseminating the Model List, outlined at the previous meeting of the Committee (2). Dr Asamoa-Baah reminded participants that all comments made during the open session would be noted and taken into account by the Committee when formulating their final recommendations in subsequent private sessions.

As part of the open session, participants were briefed about various activities relating to the Model List (see section 3). Presentations outlining the simplified or "fast-track" deletion procedure adopted for selected items on the Model List (see section 5.1) and the results of various review exercises that had been undertaken since the previous meeting - including a review of the definition of "core" and "complementary" list medicines (see section 5.2) and a review of the use of the square box symbol (see section 5.3) - were also made. Comments made during the open session on these matters were noted and are reported under the appropriate sections of the meeting report.

A number of issues not on the agenda were raised and debated during the open session. The International Federation of Pharmaceutical Manufacturing Associations (IFPMA) made a statement of concern about the lack of transparency in the Committee's decision-making process, which it felt was, in part, related to the way in which members of the Committee are selected. It was suggested that potential con-flicts of interest should be publicized and applied to all members of the Committee, including special advisors. The breadth of expertise should also be expanded. It was also suggested that technical advice from industry had not been effectively sought during the preparation period for the present meeting and thus industry's expertise had effectively been excluded from the Committee's deliberations. The IFPMA welcomed WHO's efforts to promote the provision of quality drugs through its new pre-qualification system, but cautioned against the promotion of untested fixed-dose regimens, for example, selected combinations of antiretroviral medicines that may actually harm some patients.

A representative of the United States Mission expressed satisfaction with the principle of the open session, and requested that it be established as a permanent part of the procedure. He also stressed the need for the Committee to have permanent access to expertise in drug regulation and quality assurance.

In the ensuing discussion, the Committee cited the case of tuberculosis, where the advice of WHO had led to full standardization in the dosage of fixed-dose combination medicines, now followed by most manufacturers; it is anticipated that the WHO clinical guidelines for the treatment of HIV/AIDS with antiretroviral therapy will serve the same purpose. The Committee commented on the lack of technical contributions from pharmaceutical companies despite having posted information about the formal applications for changes to the Model List, together with details of relevant systematic reviews, on the WHO web site well in advance of the meeting. Finally, with regard to the matter of potential conflicts of interest by members of the Committee, the Secretary explained the standard procedure for declarations of interest, which is rigorously applied. Dr Asamoa-Baah added that the credibility of the Committee is, to a large extent, derived from the scientific basis and transparency of its recommendations.