§ Mr. Ashleyasked the Secretary of State for Social Services, pursuant to his answer of 25 January, Official Report, c. 397, if he will list in the Official Report the statutory requirements related to the advertising of medicines; if he will give the number and qualifications of his Department's staff scrutinising advertisements; how many complaints about such advertisements have been received by his Department in the last year; what action was taken; whether his Department takes action as a result of its own scrutiny regardless of whether or not a complaint is received; and, if so, how many times it has done so.
§ Mr. Kenneth ClarkeThe main regulatory powers are contained in the Medicines Act 1968 under which it is an offence to issue false or misleading advertisements or to make false or misleading oral representations. Advertising claims have to be consistent with the details set out in the product licence and the Act empowers Ministers to make regulations for controlling the content of advertisements.
There are separate regulations governing advertising to the public and advertising to medical and dental practitioners. The regulations are contained in statutory instrument 1978 No. 41 and 1978 No. 1020. The regulations relating to medical and dental practitioners require advertisements to contain certain specified information so that these practitioners may be fully informed about the medicines they are likely to prescribe. In addition, advertisements or representations directed to practitioners may be sent only if a data sheet has teen sent 487W to the practitioner. The form and content of data sheets are laid down in regulations—SI 1972 No. 2076—so that practitioners are provided with a uniform document containing the essential information about uses, doses, administration, contra-indications, warnings and so on. So far as the public are concerned, advertisements may not be issued that would be likely to lead to self-diagnosis or self-treatment for certain defined serious conditions, for which proper medical advice should be obtained. In some cases, self-treatment could be harmful or dangerous, and the advertising to the public of medicines that are available only on prescription is prohibited.
Since 1968 Departmental staff carry out random scrutinies of various journal advertisements. This is done by three officers in the administrative section of the Department's Medicines Division which deals with matters relating to advertising, labelling, packaging, and leaflets for medicines. In addition, other staff within the division, particularly medical officers and pharmacists, recognise the need for vigilance, and they report any doubtful practices which they themselves observe, to the section concerned. No record is kept of the numbers of complaints received, but valid complaints of substance on infringements against the Act or regulations are infrequent.
All allegations or complaints about advertisements are investigated regardless of whether the complaint originates from within or outside the Department but no record is kept of the numbers of internal complaints. Where the details in an advertisement are not consistent with either the product licence or the regulations, the Department usually first makes an informal approach to the company. In the rare cases where a speedy correction is not agreed, the matter is normally referred for investigation to the administrator of one of the self-regulating codes of practice operated by trade associations. In serious cases, the Department will consider taking legal action and has conducted two successful prosecutions in the last two years.