§ Mr. Ashleyasked the Secretary of State for Social Services (1) if he will publish in the Official Report the regulatory requirements placed upon the pharmaceutical industry with regard to the advertising of their products;
(2) what use has been made of powers under section 95(1) of the Medicines Act 1968 to prohibit advertising relating to specified classes of drugs.
§ Mr. NewtonUnder the Medicines Act 1968 it is an offence to issue false or misleading advertisements and advertising has to be consistent with the product licences governing the marketing of particular medicines.
The relevant subordinate legislation is as follows:
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Reference Brief Description and Effect SI 1972 No. 2076 Form and content of data sheets.
Reference Brief Description and Effect SI 1975 No. 2981 Restrictions on advertisements for medicines with product licences or right. SI 1975 No. 1326 Advertisements to be consistent with data sheets; other data sheets provision. SI 1978 No. 411 Governing advertisements of medicines to the public. SI 1978 No. 1020 Format of advertisements to medical and dental practitioners. SI 1979 No. 1760 Application to contact lens fluids. 1 Made under S95(1) and other powers.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) what study there has been of the number and nature of the pharmaceutical industry's breaches of the requirements regarding advertising;
(2) if his Department and the Medicines Commission will together review the procedures governing the advertising of pharmaceutical drugs in the light of the successful prosecution of a drug company for an advertising offence in December 1986.
§ Mr. NewtonThe Department carefully studies the published reports of the Association of British Pharmaceutical Industry (ABPI) code of practice committee. The Department prosecutes companies where the evidence warrants this. The prosecution referred to in the second question is the subject of appeal and it would therefore be inappropriate to comment upon it, or to review related issues, before the appeals are determined in court.
§ Mr. Ashleyasked the Secretary of State for Social Services how many complaints regarding advertising have been referred by his Department to the pharmaceutical industry's code of practice committee; and what percentage have been rejected by the committee.
§ Mr. NewtonIn 1984–1986, three complaints were referred by the Department to the code of practice committee of the Association of the British Pharmaceutical Industry (ABPI).
The ABPI began communicating the findings of the committee to the Department of Health and Social Security, the British Medical Association, the Pharmaceutical Society of Great Britain, the British Medical Journal, and the Pharmaceutical Journal in 1984. Since then it has investigated 117 allegations of breach of the code, of which 52 were upheld (including two of the cases referred by the Department).
§ Mr. Ashleyasked the Secretary of State for Social Services if he will introduce legislation to provide a definition of the term legibility with regard to the statutory requirements relating to drug advertising.
§ Mr. NewtonWe have no plans to do so. The Medicines (Advertising to Medical and Dental Practitioners) Regulations 1978 already require that statements on side effects, precautions, contra-indications, dosage, and any warnings required by the licensing authority or its appropriate advisory body should be printed in a clear and legible manner and be placed in such a position that relationship to the claims for the product can readily be appreciated by the reader.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will take steps to ensure that no drug 124W advertisements are published before they have been approved by the pharmaceutical industry's code of practice committee.
§ Mr. NewtonWe have no plans to do so. I do not believe that compulsion of this kind is necessary, given the statutory requirements and the self-regulatory systems developed by the pharmaceutical industry to meet its own circumstances.
§ Mr. Ashleyasked the Secretary of State for Social Services how many prosecutions there have been for infringements of the provisions of the Medicines Act which relate to advertising; who was prosecuted; and when the prosecutions took place.
§ Mr. NewtonSince 1980, the latest date from which information is readily available, there have been four prosecutions for infringements of the provisions of the Medicines Act 1968 and regulations made thereunder which relate to advertising. These are detailed in the table.
Person/Company prosecuted Date Intimates Mail Regd. 25 September 1981 L. S. Troop 15 March 1982 Kent Private Clinic and Dr. B. Richards 17 January 1986 Roussel Laboratories Ltd. and Dr. C. S. Good1 19 December 1986 1Appeals against conviction are pending.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will refer to the Committee on Safety of Medicines the question as to whether drug companies should be allowed to claim, in their advertisements, safety aspects for a drug solely on the basis of animal studies.
§ Mr. NewtonMeaningful advice cannot be given in general terms, but only in relation to particular medicines after considering all available information about them. When granting, reviewing or varying licences for particular medicines the licensing authority considers all factors relevant to safety in use, and consults as necessary the appropriate advisory body.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will appoint a new advisory committee with responsibility for the advertising of medicines and with powers similar to those of the Committee on Safety of Medicines and the Committee on Review of Medicines.
§ Mr. NewtonWe have no plans to do so. The functions of the Committees on Safety of Medicines and on Review of Medicines are to give professional scientific advice on the intrinsic safety, quality and efficacy of medicines. This governs the content of licences for particular medicines which must be adhered to in any advertisements.