5.1 Legislation - medicinal products
Over-the-counter medicines may be advertised to the public. Prescription only medicines cannot be advertised to the general public except in the context of a campaign, approved by the UK Government, that relates to the use of a medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation or an approved vaccination campaign.
Advertisements for medicinal products must;
- comply with the particulars of the Summary of Product Characteristics (“SmPC”);
- not be misleading; and
- encourage the rational use of the product by presenting it objectively and without exaggerating its properties.
The marketing authorisation holder, or, if applicable, the holder of another registration or certificate necessary to put the product on the market, must retain a sample of each advertisement for which the person is responsible, and a statement indicating the persons to whom the advertisement is addressed, the method of its publication and the date when it was first published.
If a medicinal product is available to the public over the counter in Great Britain, but, in Northern Ireland, is either a prescription only medicine or not authorised for sale or supply, any advertisement to the public must include a statement that the product is not available without a prescription, or is not available at all (as applicable), in Northern Ireland.
Certain narcotic or psychotropic drugs may not be advertised to the public.
Advertisements for medicinal products directed to the public must not:
- state or imply that a medical consultation or surgical operation is unnecessary;
- offer to provide a diagnosis or suggest a treatment by post or by means of an electronic communications network;
- by a description or detailed representation of a case history, lead to erroneous self-diagnosis;
- suggest that the effects of taking the medicinal product:
- are guaranteed;
- are better than or equivalent to those of another identifiable treatment or medicinal product; or
- are not accompanied by any adverse reaction;
- use, in terms that are misleading or likely to cause alarm, pictures of:
- changes in the human body caused by disease or injury; or
- the action of the medicinal product on the human body;
- refer, in terms that are misleading or likely to cause alarm, to claims of recovery;
- suggest that the health of a person who is not suffering from any disease or injury could be enhanced by taking the medicinal product;
- suggest that the health of a person could be affected by not taking the medicinal product;
- suggest that the medicinal product is a foodstuff, cosmetic or other consumer product;
- suggest that the product is safe or effective because it is natural;
- refer to a recommendation by a scientist, a healthcare professional or a celebrity; or
- contain any material that is directed principally at children; or
- be likely to lead to the use of a medicinal product for the purpose of inducing an abortion.
Advertisements for medicinal products directed to the public must:
- make clear that they are advertisements;
- clearly identify the product as a medicinal product;
- include:
- the name of the product;
- if the product contains only one active ingredient, the common name of the active ingredient;
- the information necessary for the correct use of the medicinal product; and
- an express and clear invitation to read carefully the instructions on the package or in the package leaflet (as the case may be).
Please see response to question 3 above regarding materials within the scope of the PAGB Consumer Code being submitted for pre-vetting by the PAGB.
5.2 Legislation - medical devices
In Northern Ireland, misleading claims for medical devices are prohibited under the EU Regulations.
The EU Regulations do not apply in Great Britain (see question 1 above). There is therefore no sector-specific legislation which applies to the promotion of medical devices in Great Britain, although general consumer advertising rules will apply (see below).
5.3 General consumer advertising rules
The Consumer Protection from Unfair Trading Regulations 2008 (“CPRs”)
The CPRs are not specific to medicines or medical devices, but apply to all marketing communications made to consumers (i.e., individuals acting outside the course of their business). The CPRs prohibit unfair marketing to consumers, including misleading and aggressive advertising.
Schedule 1 of the CPRs contains a list of commercial practices that are always considered unfair, even if they do not cause the consumer to change their buying decision. The list includes making a false claim that a product is able to cure illnesses, dysfunction or malformations.
The CAP Code and the BCAP Code
The CAP Code contains numerous general rules that apply to advertising of medicines and medical devices to the public. These include, in general terms, that:
- Advertisements must be prepared with a sense of responsibility to consumers and to society.
- Advertisements must be obviously identifiable as advertisements.
- Advertisements may not be misleading.
- Before publishing an advertisement, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation.
- Advertising claims must state significant limitations and qualifications. Qualifications may clarify but must not contradict the claims that they qualify.
- Advertisements must not contain anything that is likely to cause serious or widespread offence, or cause fear or distress without justifiable reason.
The CAP Code also includes section 12 on Medicines, medical devices, health-related products and beauty products. In addition to restating a number of the restrictions set out in legislation (see above), section 12 includes the following specific rules, which apply to both medicines and medical devices:
- Objective claims must be backed by evidence, if relevant consisting of trials conducted on people.
- Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered.
- Marketers must not confuse consumers by using unfamiliar scientific words for common conditions.
- Marketers inviting consumers to diagnose their minor ailments must not make claims that might lead to a mistaken diagnosis.
The BCAP Code contains similar restrictions in the context of broadcast advertising.
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