Limited List (Hansard, 15 February 1993)

§ Mr. Gale
To ask the Secretary of State for Health (1) what studies she has commissioned among practising clinicians to look into the clinical implications of extending the limited list to include 10 additional therapeutic categories; and if she will publish the results;

§ Sir Dudley Smith
To ask the Secretary of State for Health what studies she commissioned among practising clinicians to look into the clinical implications of extending the limited list proposals to 10 additional therapeutic categories; and whether she intends to publish the results of those studies.

§ Dr. Mawhinney
No such studies were commissioned. The changes do not affect the basic structure of the selected list scheme which has been in operation since 1985. It will be for the advisory committee on national health service drugs, when it considers individual drugs in the new categories, to ensure that the clinical needs of patients continue to be met.

§ Mrs. Ann Winterton
To ask the Secretary of State for Health at what stage in the regulatory process involving the Committee on the Safety of Medicines, and the relevant expert advisory committees on(a) the existing categories and (b) the 10 new proposed categories of the limited list prescribing system for pharmaceutical products, a new product for which a product licence was being sought would be considered for inclusion in the limited list; what timetable would be followed for such consideration; and whether such consideration would be automatic.

§ Dr. Mawhinney
The advisory committee on national health service drugs would only consider a new product which had been licensed and was available for prescription. New products in the specified categories are normally drawn to the committee's attention by its secretariat and the committee is asked whether it wishes to review them.

§ Mrs. Ann Winterton
To ask the Secretary of State for Health (1) what assessment has been made in respect of(a) the existing categories and (b) the 10 new proposed categories of the limited list prescribing system for pharmaceutical products, of the impact of the deterrent effect of a possible limited list inclusion upon the decision of companies considering whether or not to incur the costs of bringing forward a product licence application;
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(2) what specific steps are being taken by her Department to ensure that pharmaceutical companies are not deterred from bringing forward applications for new product licences by uncertainty about the possibility of a subsequent inclusion in the limited list.

§ Dr. Mawhinney
The advisory committee on national health service drugs is required to ensure that drugs to meet all clinical need in the specified categories can be provided as economically as possible. There is nothing in the provisions of the selected list scheme which need deter companies from bringing forward applications for new product licences.