§ Mr. Pavittasked the Secretary of State for Social Services if the code of practice of the pharmaceutical industry has to be observed by all manufacturers before permission is given by his Department to conduct clinical trials in NHS hospitals or tests by general practitioners on their patients.
§ Mr. MoyleClinical trials as such do not require the approval of my Department, but where a trial involves a new product, or an existing product for treatment of a condition not covered by the product licence, the manufacturer requires a clinical trial certificate authorising him to supply the product for the trial.
All members of the Association of the British Pharmaceutical Industry are expected to comply with its code of practice in all circumstances where it is relevant.
§ Mr. Pavittasked the Secretary of State for Social Services if, in view of the wide national coverage about a new medical product for the treatment of duodenal and gastric ulcers and related gastrointestinal disorders, he has satisfied himself, in the interests of national health, that all ethical steps had been taken before this publicity, including the strict reference to the code of practice for the phamaceutical industry with particular emphasis on clause 16-3 concerning the balanced presentation of a drug, in order to avoid the risks of unfounded hopes in the public mind.
§ Mr. MoyleI have noted with some concern the recent publicity about this product. The company concerned has been asked to furnish copies of all 63W advertisements issued in respect of the product, and when these have been examined I will pursue the matter with the company or the Association of the British Pharmaceutical Industry as appropriate.