§ Mr. Ashleyasked the Secretary of State for Social Services (1) if he will take steps to ensure that adverse drug reactions occurring in volunteers or in patients taking part in clinical trials are included in the register of adverse reactions and made readily available;
(2) if he will seek to obtain comprehensive information about the number of volunteers taking part in early studies of drug substances and the incidence of adverse reactions, including deaths;
(3) what information he has on the number and nature of adverse reactions suffered by volunteers taking part in early studies of drug substances; how reliable this information is; and how it was obtained.
§ Mr. Kenneth ClarkeI refer the right hon. Member to my reply to him on 12 June at column462.
To include adverse reactions which occur in clinical trials or pre-clinical studies on the register of adverse reactions would be statistically incorrect. The register contains only spontaneous adverse reactions reports, and its value for scientific reference could be undermined if these spontaneous reports and reports arising from such trials or studies were mixed together.
In the light of the recent advice of the Medicines Commission, we have no plans at present to collect information centrally on the number of volunteers taking part in early studies of drug substances or the incidence of any adverse reactions.
§ Mr. Ashleyasked the Secretary of State for Social Services, pursuant to his reply of 12 June, Official Report, column 462, which professional bodies give guidance on the use of volunteers in early drug studies; to what extent his Department, the British Medical Association, and student organisations were involved in the preparation of the guidance; whether it is publicly available; and if he will publish it in the Official Report.
§ Mr. Kenneth ClarkeThe main guidance was listed in my reply to the hon. Member for Bolsover (Mr. Skinner) on 10 February 1984, at column822, and copies have been placed in the Library. The guidance issued by the Medical Research Council was endorsed by the Ministry of Health in 1964 and that of the Royal College of Physicians by the Ministry of Health in 1968 and by our Department in 1975. These documents have been publicly available for comment by interested organisations. In 1970 417W the Association of British Pharmaceutical Industries published guidance for its member companies on tests on staff volunteers, and it has since recommended that the principles be applied, so far as they are relevant, to non-employee volunteers. The association has also published guidelines on compensation for medicine-induced injuries. Copies have been placed in the Library. I understand that the Royal College of Physicians and the Association of British Pharmaceutical Industries are currently revising their guidelines. The Medicines Commission will no doubt consider the revisions when they are available.