Note: This advice is given by the CAP Executive about non-broadcast advertising. It does not constitute legal advice. It does not bind CAP, CAP advisory panels or the Advertising Standards Authority.
The Medicines Act 1968 and its regulations, as well as regulations implementing European Community Directive 92/28/EEC, govern the advertising and promotion of medicines and the conditions of ill health that they can be offered to treat. Guidance on the legislation is available from the Medicines and Healthcare products Regulatory Agency (MHRA).
A “medicinal product” is defined broadly in two ways. Firstly, a product might be medicinal by presentation: “any substance or combination of substances presented as having properties for treating or preventing disease in human beings”. And secondly, a product might be medicinal by function: “any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis”.
Medicines must have a marketing authorisation from the MHRA before they are sold and claims made for products must conform with the authorisation. Medicinal claims should not be made for unauthorised products (Rule 12.11). Sometimes deciding whether a claim is medicinal is difficult (Nicogel Ltd, 22 November 2006) so marketers should check with the MHRA. Some advertisers have inadvertently made medicinal claims for products that have no marketing authorisation (GlaxoSmithKline UK Ltd, 14 March 2007; and Advanced Formulations (Europe) Ltd, 10 January 2007); some advertisers seem to have over-stated claims to imply physiological effects for their products and some seem to have deliberately made medicinal claims without due regard to the Code (Knightsbridge Medical, 29 November 2006) (see ‘Medicinal Claims’).
Marketing communications should state the name of the product, an indication of what it is for, a statement that users should “always read the label” and should use the common name of a sole active ingredient (Rule 12.13). Marketing communications for medicines should not be addressed to children (Rule 12.16) and should not be endorsed by health professionals or celebrities (Rule 12.18 and ‘Medicines: Celebrities and Health Professionals’).
Prescription-only medicines (POMs) should not be advertised to the public; that includes products such as Viagra and Botox (see ‘Medicines: Prescription-only and Disease Awareness Marketing’). Medicines may be advertised to the medical, dental, veterinary and allied professions.
Marketers should not use fear or anxiety to promote medicines (Rule 12.14) and should not claim one medicine is as good as or better than other, identifiable products (Rule 12.19)
See ‘Medicinal Claims’, ‘Medicines: Prescription-only and Disease Awareness Marketing’ and Medicines: Celebrities and Health Professionals’.
Last modified : 26 July 2010