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.
Background and Brexit
As a result of Brexit, the Legislation on which many of the rules in Section 12 in the CAP Code and Section 11 in the BCAP Code are based, has changed. Whilst this has not resulted in significant changes to the rules themselves, marketers need to ensure their products are appropriately licensed or certified for the territories in which they are going to market their product.
This advice article is primarily aimed at marketers planning to advertise in Great Britain. If ad campaigns are due to appear in Northern Ireland (in isolation, or in combination with a campaign in Great Britain), CAP recommends that marketers obtain legal advice due to the complexities of the Northern Ireland Protocol (NIP) and its impact on the Regulations.
Article 1 of Directive 2001/83/EC as amended defines a “medicinal product” as:
“Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; [the first/presentational limb]
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” [the second/functional limb].
If a product falls under either limb of the above definition it must have a marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) before it can be sold and marketed in the UK. Marketers who are unsure about the classification of their product under either limb of the definition should seek advice from the MHRA.
Medicinal products and licences
The CAP Code states that medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a medical device with the applicable conformity marking. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings (Rule 12.1).
Medicinal claims for unlicensed products.
It is not permitted to promote or make medicinal claims for unlicensed products.
Marketing communications for licensed medicines must conform with that licence and the product's summary of product characteristics, which sets out what the medicine is licensed to treat (Rule 12.11).
Marketers are advised that there are other requirements relating to the advertising of licensed medicines which are set out in rules 12.13 to 12.19 in the CAP Code.
Rule 12.12 indicates that products which are licenced as prescription-only-medicines (POMs) must not be advertised to the public, including on social media. Marketers who sell or administer POMs should instead advertise the consultation. For example, an ad for a clinic offering weight loss medicine Ozempic could refer to “A consultation for weight loss”.
There are some allowances for balanced factual references to specific POMs on some websites. This is explained in this CAP Advice on Healthcare: Prescription-only medicines (websites).
The genreal position on POMs is set out in this CAP Advice.
Celebrities and health professionals
Ads for medicines must not include the endorsement of a health professional or a celebrity. This CAP Advice on Health: Celebrities and health professionals explains the position in more detail, including how it relates to online influencers.
Homeopathic medicines must be registered in the UK under one of the two available schemes. CAP recommends that marketer’s read the MHRA guidance on how to Register a Homeopathic product alongside this MHRA Guidance on The Homeopathic National Rules Scheme. See CAP Advice on Homeopathic medicines for additional information.
Marketers of Herbal Medicines must apply for traditional herbal registration (THR) under the Traditional Herbal Medicines Registration Scheme before the product can be marketed in the UK.
This MHRA Guidance on how to register herbal medicines indicates that a THR is only granted if the medicine is used for minor health conditions where medical supervision is not required (e.g. a cold).
See CAP Advice on Medicines: Herbal medicines for additional information.
Medicinal claims and cosmetics.
Rule 12.1 includes the statement:
“Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease”.
In practice, this could mean that claims that a product cleanses the skin and subsequently prevent spots are likely to be acceptable (subject to evidence), but that claims to treat spots or acne (or any other skin condition) are likely to be considered problematic.
CAP recommends that marketers seek advice from the MHRA Borderlines team on the classification of the product and whether any medicinal claims are considered secondary, and therefore acceptable. Also see: CAP Advice on Health: Acne and Spots.