§ Mr. Ashleyasked the Secretary of State for Social Services (1) what official and unofficial relationship the Committee on Safety of Medicines has with similar bodies in other countries;
(2) whether the Committee on Safety of Medicines automatically receives information on drugs and warning notices from EEC countries and the United States of America.
§ Mr. MoyleMy Department maintains contact with appropriate regulatory authorities in the EEC through the EEC Pharmaceutical Committee and the Committee on Proprietary Medicinal Products. Official contacts have also been established with the corresponding authorities in the United States of America, Canada, Sweden and other countries. Arrangements exist under the auspices of the World Health Organisation for the exchange of information about regulatory action and the issue of warning notices.
The extent and timing of such exchanges are not uniform; differences 231W in national practice and arrangements as to confidentiality of information affect the position.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) if he will give details of the size and composition of the Committee on Safety of Medicines staff for each year since it was established, together with the numbers working on the testing of old drugs and the numbers working on the testing of new drugs in each year;
(2) what has been the cost of the Committee on Safety of Medicines for each of the last five years in 1978 prices.
§ Mr. MoyleInformation in the form requested by my hon. Friend is not available. The implementation of the Medicines Act in relation to human medicines is assigned to the medicines division of my Department; the staff engaged on work relating to the activities of the Committee of Safety of Medicines form part of the division. The total number of staff of the division at 31st December 1977 was 219, of which 92 were professional staff. Details for earlier years are given in the published annual reports.
An approximate indication of the division of work among the 92 professional staff is as follows:
The total cost of operating the licensing system for the current licence year is estimated at £3.3 million. Of this, about £1.8 million relates to the cost of processing applications for product licences.
Assessment of new medicinal products 26 Compilation of British Pharmacopoeia 23 Inspection of manufacturers 19 Other, including review of existing products 24