HC Deb 20 January 1983 vol 35 cc197-8W
Mr. Ashley

asked the Secretary of State for Social Services in how many cases has the Committee on Safety of Medicines been given access to the records of a research study submitted by a pharmaceutical company applying for a product licence.

Mr. Kenneth Clarke

The CSM receives reports and summaries of clinical trials as part of the submission in support of applications for product licenses. The CSM may request raw data derived from those clinical trials, or any other detailed data which they believe are relevant to the application. The number of times this has been done is not recorded.

Mr. Ashley

asked the Secretary of State for Social Services what was the gross and net expenditure of his Department, in 1982 prices, on the Committee on Safety of Medicines and its work for the last three years for which figures are available.

Mr. Kenneth Clarke

The table below gives the gross expenditure by the Department on the Committee on Safety of Medicines at 1982–83 prices, and the cost after taking into account the recovery of 80 per cent. of the costs of the committee from fees charged to applicants for licences.

Licensing year Gross DHSS expenditure at 1982–83 prices Net DHSS expenditure at 1982–83 prices
£000s £000s
1979–80 1,101 220
1980–81 1,101 220
1981–82* 1,182 236
* Estimate.

Mr. Ashley

asked the Secretary of State for Social Services if he will give the number of qualified people, employed by his Department, supporting the work of the Committee on Safety of Medicines for the last three years for which figures are available; and if he will categorise them according to their qualifications.

Mr. Kenneth Carlisle

Fifteen professionally qualified pharmacists have been employed in 1979, 1980 and 1981 in support of the Committee on Safety of Medicines. Medically qualified staff are not allocated exclusively to this work. The total number of doctors available for the same three years in the Medicines Division of the Department, which provides the medical secretariat for the Committee, was as follows:

Numbers
1979 18
1980 20
1981 21