§ Mr. Ashleyasked the Secretary of State for Social Services (1) how many deaths or pernicious side effects are known to his Department as having occurred in volunteers taking part in drug trials;
(2) how his Department decides whether a new drug has reached the stage when it is safe enough to be tried on human volunteers; and if drug companies are required to inform his Department of their preliminary work or any adverse reactions that may occur.
§ Mr. Kenneth Clarke[pursuant to his replies, 6 June 1984, c. 199]: Early studies of drug substances in healthy volunteers are not covered by the Medicines Act and there is no requirement to report adverse reactions occurring in the volunteers to our Department. This question was recently considered by the Medicines Commission, which concluded that legislation was not required but recommended that professional bodies revise and update their existing guidance to members and to the industry. I understand that this is now being done.
Companies however wishing to conduct clinical trials on patients are obliged under the Medicines Act to submit information about any adverse reactions experienced by healthy volunteers who have taken part in earlier studies. Information on these reactions is not included in the register of adverse reactions and is not therefore readily available. Companies are also required to submit reports of adverse reactions occurring in patients involved in clinical trials. Information on these reactions, too, is not readily available.