§ Dr. Vaughanasked the Secretary of State for Social Services, if he will take steps to provide that all drug trials on humans should be notified to the Medicines Commission, including those involving small numbers of patients organised through GPs, and that the results of these trials should be sent by the GP concerned to the Medicines Commission.
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§ Mr. MoyleAt the present time there is no general requirement under the Medicines Act or any other legislation for a medical practitioner to report the results of drug trials to the licensing authority or any other body such as the Medicines Commission. However, where a trial involves a new product or an existing product for treatment of a condition not covered by the product licence, a clinical trial certificate is required authorising the supply of the product for the trial. The product licence holder, who is responsible for organising a trial of a product already on the market, is under an obligation to report any adverse effects encountered during the trial to the licensing authority. I have no proposals to make any changes in these procedures.