§ Mr. Pavittasked the Secretary of State for Social Services if he will authorise the Committee on Safety of Medicines to accept the evidence of clinical trials in drugs which have taken place overseas in the licensing of new drugs if it can be satisfied upon the validity of such trials.
§ Sir K. JosephThe Committee on Safety of Medicines has accepted and will continue to accept evidence of clinical trials conducted overseas when it is satisfied with the conduct and competence of the trial.
§ Mr. Pavittasked the Secretary of State for Social Services if he will issue instructions to all drug companies supplying the National Health Service in accordance with Section 96 of the Medicines Act 1968 that data sheets must appear with all advertisements printed in controlled circulation journals issued free to doctors.
§ Sir K. JosephUnder Section 96 of the Medicines Act a pharmaceutical company 279W is required to send a data sheet where it advertises its product by direct mail or by oral representations to practitioners. It appears, however, that in general products advertised in controlled circulation journals are the subject of data sheets. I have recently consulted the Medicines Commission about the desirability of regulations about products advertised solely in controlled circulation journals. It has advised me that no immediate action is necessary but that it proposes to keep the matter under review.
§ Mr. Pavittasked the Secretary of State for Social Services if he will investigate the incidence of cholestic jaundice which may have arisen in patients for whom Ilosone has been prescribed and ensure that the provisions of Section 96 of the Medicines Act 1968 are followed in all advertising for drugs which have been the subject of yellow warning leaflets from the Committee on Safety of Medicines.
§ Sir K. JosephIn June this year the Committee on Safety of Medicines notified medical practitioners of the results of its investigation of reports of jaundice associated with the use of erythromycin, all but one of which were related to the use of erythromycin estolate ("Ilosone"). This matter is being kept under review as part of the committee's on-going investigations into reports of adverse reactions associated with the use of medicinal products. The data sheet for Ilosone does in fact contain a warning about reports of jaundice. I am, however, considering the general question of warnings in advertisements.
§ Mr. Pavittasked the Secretary of State for Social Services if he will introduce legislation to make it a criminal offence for clinical trials of new drugs which have not been studied fully and have not passed the Committee on Safety of Drugs to be given to those volunteering to act as human guinea pigs.
§ Sir K. JosephI do not consider that such legislation is necessary. The supply of drugs for clinical trials on patients is subject to the Medicines Act 1968, and the Committee on Safety of Medicines is consulted on applications for clinical trial certificates. In general, the provisions of the Act do not apply to the supply of drugs to be used in human280W pharmacology studies, by or on behalf of the manufacturer, on healthy volunteers in a laboratory or research establishment. Such studies are normally conducted in accordance with the recommendations of a committee under the chairmanship of Professor Sir Charles Stuart-Harris, a copy of whose report to the Association of British Pharmaceutical Industry I am sending to the hon. Member.