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 and, where relevant, animals.
Background and Brexit
As a result of Brexit, the Legislation on which many of the rules in Section 12 in the Committee of Advertising Practice (CAP) Code and Section 11 in the Broadcast Committee of Advertising Practice (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.
- Determine the classification of your product
Medicinal or medical claims and indications can only be made for a medicinal product licensed by the MHRA, VMD or under the auspices of the EMA, or for a medical device with the applicable conformity marking.
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.
Medicinal claims for foods are prohibited but some disease risk reduction claims are permitted if they are authorised for an ingredient in that food on the GB NHC Register.
Establishing the nature of the product (and the relevant applicable regulations) isn’t always straightforward and advertisers who are unsure should review guidance from the Medicines and Healthcare products Regulatory Agency’s (MHRA) Borderlines team to establish the classification of their product prior to marketing it.
- It’s a medicine
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 the MHRA classifies a product as a medicine, marketers need to obtain the appropriate licence and marketing authorisation before selling or marketing that medicinal product in the UK. Once the appropriate licence has been obtained, marketing communications for that medicine must conform with the licence and the accompanying Summary of Product Characteristics (SPC).
The MHRA Blue Guide explains more about the advertising of medicines in the UK.
Marketers are reminded that Prescription-only medicines cannot be advertised to the public.
See: CAP Advice on Healthcare: Prescription-only medicines, Healthcare: Prescription-only-medicines (websites) and Healthcare: Medicines.
- It’s a device.
If the product is determined to be a medical device, that device must be appropriately certified through the relevant applicable conformity marking and must be registered with the MHRA prior to being sold and advertised. See CAP Advice on Medical Devices.
Marketers are reminded that even if they hold the appropriate certification and MHRA registration for their medical device, they must also hold robust clinical trial evidence to support the claims. This CAP Guidance explains the types and levels of evidence the ASA would expect to see to support efficacy claims for medical devices.
Marketers are advised that irrespective of the evidence held, claims to treat some medical conditions could be seen to discourage essential medical treatment unless that treatment is being carried out under the supervision of a suitably qualified health professional (Rule 12.2). See this CAP Guidance for advice on referencing medical conditions in ads for health, beauty and slimming products.
- It’s a food.
Marketers may make reduction of disease risk claims for ingredients in food products but only those that appear on the GB NHC Register. Claims to treat or prevent human disease with food or food supplements are prohibited for foods and food supplements.
For more information about such claims, see Food: Reduction of disease risk claims.
- It’s a cosmetic.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These secondary medicinal claims 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 more likely to be considered problematic unless the product has an appropriate marketing authorisation.
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.
- It’s a therapy
Therapies are not typically classified by legislation in the same way as medicines, medical devices, foods and cosmetics. However, objective medical claims for therapies must be backed by evidence consisting of trials conducted on people.
This CAP Guidance explains the types and levels of evidence the ASA would expect to see for support medical claims for therapies. If convincing clinical trial evidence is not held to support claims for therapies, marketers are advised to instead focus on the subjective sensory nature of the therapy – as explained in this CAP Guidance.
- Discouraging essential medical treatment.
Marketers are advised that irrespective of the evidence held, claims to treat some medical conditions could be seen to discourage essential medical treatment, unless that treatment is being carried out under the supervision of a suitably qualified health professional (Rule 12.2). This rule does not apply to licensed medicines, provided the claims are in line with the products indicated use.
See this CAP Guidance for advice on referencing medical conditions in ads for health, beauty and slimming products.
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 (ASA). CAP’s AdviceOnline entries provide guidance on interpreting the UK Code of Non-broadcast Advertising and Direct & Promotional Marketing.
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