At the open session a number of participants expressed their support for a survey of medicines on national lists of essential medicines as a means of identifying potential medicines for deletion from the WHO Model List, with those medicines appearing on only a few national lists qualifying as candidates for deletion. A simplified review process for medicines proposed for deletion was also suggested. Proposals for deletion could be posted on the WHO web site and comments invited. If no positive arguments for maintaining the medicine on the Model List were submitted, it could be deleted at the next session of the Committee after due consideration of the available evidence. It was felt that this approach would not only encourage active participation in the new procedures for updating the Model List but would also allow WHO to devote its resources to the systematic review of medicines proposed for inclusion.
Table 1
Standard review procedure for an application to include an item in the Model Lista
Steps of the procedure |
Webb |
1. The application is submitted to the Secretariat of the Expert Committee. |
X |
2. The Secretariat of the Expert Committee: |
|
| |
i) checks whether the application is complete; |
|
| |
ii) logs receipt of the application; |
X |
| |
iii) forwards the application, together with any supporting documentation to the appropriate WHO technical department or WHO Collaborating Centre (i.e. the “Assessor”); |
|
| |
iv) posts a summary of the application on the WHO web site for general |
X |
| |
comment; |
|
| |
v) monitors the progress of the application. |
|
3. The Assessor nominates an expert, preferably a member of the Expert Committee, to oversee the assessment of the application and to become the “Presenter”. |
X |
4. On the basis of his/her preliminary assessment, the Assessor makes a recommendation either: |
X |
| |
i) not to proceed with further assessment; or |
|
| |
ii) to proceed with a full assessment. |
|
5. In the case of a full assessment, the Assessor: |
|
| |
i) conducts a search for evidence relevant to the application; |
X |
| |
ii) assesses data on comparative efficacy, safety and cost-effectiveness; |
|
| |
iii) formulates a summary and a draft recommendation to the Expert Committee; |
|
| |
iv) when inclusion of a medicine in the Model List is recommended, provides information on: |
|
| |
|
- the individuals for whom the medicine will be used; |
|
| |
|
- the conditions in which the medicine will be used; |
|
| |
|
- the circumstances in which the medicine will be used, the dose, formulation, strength, route of administration, duration of treatment and details of the monitoring required; |
|
| |
|
- whether the medicine should be included in the core or complementary list; |
|
| |
|
- whether any other medicine should be removed from the Model List. |
|
6. On completion of the full assessment, the Secretariat posts the results and the draft recommendation on the WHO web site for comment. |
X |
7. Draft text for inclusion in the WHO model formulary is drawn up and posted on the WHO web site for comment. |
X |
8. At the next meeting of the Expert Committee, the Presenter outlines the Assessor’s recommendation regarding the medicine in question and the evidence supporting its inclusion or otherwise in the Model List. |
|
9. The Expert Committee decides whether to accept the Assessor’s recommendation and comments on the draft version of the text to be included in the WHO model formulary. |
|
10. The Model List and WHO model formulary are updated according to the recommendations of the Expert Committee. |
X |
a Replaces the standard review procedure as given in Box 2, Annex 1 of document EB109/8 (7).
b An X in this column indicates that the step or the relevant information should be posted on the WHO web site.
During the open session, several participants submitted proposals for the deletion or review of medicines on the Model List. The comment was made that as many of the medicines on the Model List are frequently registered for over-the-counter use, medicines should only be deleted after a careful review of all the available information.
In its discussions, the Committee acknowledged that the new procedures for handling applications for additions to the Model List were not particularly well suited to dealing with deletions from the Model List, and that separate procedures for this purpose were required. The Committee recommended that decisions to delete an item from the Model List should, as far as possible, be evidence-based while recognizing the fact that evidence from clinical trials may not always be available for some of the older medicines on the Model List. The Committee recommended separate procedures for applications for deletions made by the Expert Committee (i.e. Committee-initiated applications) and those made by other organizations and individuals (i.e. other applications).
Committee applications for deletion
Applications to delete items from the Model List might be initiated by the Committee in the following cases:
- if a medicine has been superseded by other products in terms of efficacy, safety or cost-effectiveness;
- if drug regulatory authorities have withdrawn the medicine, usually for reasons of safety;
- if new WHO clinical guidelines have been published that no longer recommend the medicine;
- if the medicine is rarely used or purchased from international suppliers such as the United Nations Children’s Fund (UNICEF).
In such cases, details of the medicine(s) proposed for deletion, together with a statement of the reasons for the deletion and supporting evidence, should be posted on the WHO web site, whenever possible at least 6 months in advance of the next meeting of the Committee. In its assessment of the medicine proposed for deletion, the Committee would take into account all comments and any additional data received in response to the proposal.
Other applications for deletion
Applications to delete an item from the Model List may be made by any organization or individual and would be expected to occur in the following circumstances:
- within the context of a systematic review of a therapeutic group of medicines;
- in relation to an application for inclusion of another product;
- on the basis of experiences of significant concerns about safety or efficacy arising from use in different settings.
In the case of applicant-led proposals, an application for deletion should be submitted to the Secretariat of the Expert Committee; the application should contain a review of data on efficacy and safety and any other relevant evidence. This information would be posted on the WHO web site for comment. At its next meeting, the Committee would consider the application for deletion and any comments received as a result of the circulation of the proposal.
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