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MEDICINES, MEDICAL DEVICES, TREATMENTS AND HEALTH
The rules in this section are designed to ensure that advertisements that include health claims (please see Section 13 for health claims made on foods) and advertisements for medicines, medical devices and treatments receive the necessary high level of scrutiny. Health claims may, for example, relate to the therapeutic or prophylactic effects of products, including toiletries and cosmetics.
The rules apply to advertisements and not the products or services, which are regulated by health regulators such as the Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMEA), the Care Quality Commission and the Department of Health. Advertisements for those products or services must comply with the rules and professional codes of conduct of relevant professional bodies.
Medical advisory panels
For television advertisements, Clearcast retains a panel of consultants to advise it on health and medical aspects of products or services before they are advertised. For information, see “Contact us” at www.clearcast.co.uk.
Further details on Clearcast’s consultants can be found
at http://www.clearcast.co.uk/our- consultants.html
For radio advertisements, the RACC retains a panel of consultants to advise it on health and medical aspects of advertising. For information, see “Services” at www.racc.co.uk
The ASA or BCAP may seek a medical opinion if there is a significant challenge to an ad that has been accepted by a broadcaster on the advice of a member of the panels.
Advertisements for products subject to licensing under the Medicines Act 1968 must comply with the requirements of the Act. That includes regulations made under the Act and any conditions contained in the marketing authorisation, certificate, licence or traditional herbal registration for the advertised product.
Title VIII of European Directive 2001/83/EC as amended by Directive 2004/27/EC concerns “The Advertising of Medicinal Products for Human Use” and has been implemented in the UK by The Medicines (Advertising) Regulations 1994 and The Medicines (Monitoring of Advertising) Regulations 1994 (both as amended). ASA (Broadcast) is obliged to consider complaints about breaches of Regulation 9 of the Advertising Regulations, which has been incorporated in these rules.
With the introduction of new or changed products, the diverse licensing requirements of the Medicines Act 1968 and changes in medical opinion, this Code cannot provide a complete guide to all requirements for health claims or the advertising of products or classes of medicines and treatments.
The rules governing the advertising of medicines, treatments, medical devices and health claims are set out below; they apply also to advertisements for veterinary products and services. Directive 2001/82/EC on the Community code relating to veterinary medicinal products (as amended by Directive 2004/28/EC), which has been implemented in the UK via The Veterinary Medicines Regulations, contains provisions relating to the advertising of such products. The Veterinary Medicines Regulations are revoked and remade annually.
For more information on medicinal products and treatments, go to: www.mhra.gov.uk.
For the purposes of this section, “licence” includes certificate, authorisation or registration.
11.1 Radio Central Copy Clearance – Radio broadcasters must ensure advertisements subject to this section are centrally cleared.
11.2 If they are necessary for the assessment of claims, broadcasters must, before the ad is broadcast, obtain generally accepted scientific evidence and independent expert advice.
Clearcast will require sight of an advertised product’s Summary of Product Characteristics (SPC). As well as making its own assessment of material, Clearcast will refer substantiation submitted in support of claim for medicines, medical devices, treatments and health to one of its panel of consultants, if those claims go beyond those outlined on the advertised products’ SPC. Consultants are tasked with assessing evidence and advising Clearcast on the extent to which claims are supported.
Evidence must be comprehensive and well-organised and in order to assist advertisers and their agencies in supporting their claims Clearcast has devised the Claims Support Model (CSM) to be completed advertisers. Clearcast strongly recommends its use, particularly for supporting claims of a technical and/or scientific nature The CSM and its Guidance Notes are available here:
Members of the Proprietary Association of Great Britain (PAGB) are required to submit ads to the PAGB for review and approval before they are broadcast. Advertisers should note, however, that because both the PAGB and BCAP Codes must be satisfied, separate Clearcast approval is also required and that PAGB approval does not guarantee Clearcast approval.
11.3 Advertisements 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 (see rule 11.9). That does not prevent advertising for spectacles, contact lenses or hearing aids.
11.4 Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA or EMEA, or for a CE-marked medical device. 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.
Products that have an MHRA or EMEA licence can make claims as set out in the SPC without further reference to consultants because the evidence for these claims are assessed through the licensing process. There is, however, no such assessment process for CE-marked medical devices; Clearcast, therefore, expects to see any clinical evidence for claims made which; such evidence is it submitted to a consultant for assessment.
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
Cosmetic products, are defined as any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition. Cosmetics should not be confused with those products which have a physiological effect and thus be considered as a medical treatment.
Particular care is needed to ensure that no implied claims are made through an advertised product’s name.
11.5 These are not acceptable in advertisements for medicinal products:
11.5.1 Presentations, by doctors, dentists, veterinary surgeons, pharmaceutical chemists,
11.5.2 statements that imply professional advice or recommendation by people who are
11.5.3 references to approval of, or preference for, any relevant product or their use by the
11.6 Advertisements other than those for medicinal products may feature or refer to health
11.7 Unless it is obvious from the context, advertisements that include a health professional must make clear if he or she has a direct financial interest, or equivalent reciprocal interest, in the sale of the advertised product or service.
11.8 Testimonials or endorsements by health professionals must be genuine and supported by documentary evidence. Fictitious testimonials must not be presented as genuine. Any
11.9 Services including Clinics, Establishments and the like Offering Advice on, or
11.10 Advertisements for hypnosis-based procedures (including techniques commonly referred to as hypnotherapy), psychiatry, psychology, psychoanalysis or psychotherapy are acceptable subject to rule 11.9. Broadcasters must take particular care over advertisements for publications employing those techniques.
11.11.2 Radio Central Copy Clearance – Radio broadcasters must ensure advertisements
11.11.3 Rule removed on 30 April 2012
11.12 Television only – Teleshopping for these products or services is not acceptable:
11.12.1 medicinal products that are for human use and that are subject to a marketing
11.12.2 veterinary medicinal products that are subject to a marketing authorisation within the meaning of Directive 2001/82/EC (as amended by Directive 2004/28/EC) and are
11.12.3 medical treatments for humans or animals.
The ASA has adjudicated on this issue. The adjudication is available here:
11.13 Broadcasters may accept advertisements for services offering remote personalised advice on medical or health matters only if all staff providing that advice are suitably qualified and subject to regulation by a statutory or recognised medical or health professional body and the advice given is in accordance with its relevant professional codes of conduct (see rule 11.9).
11.13.1 Advertisements must not contain offers to prescribe or treat remotely (including by phone, post, e-mail or fax). That does not preclude advertisements containing offers to
11.14 No ad may encourage indiscriminate, unnecessary or excessive use of products or services covered by this section.
11.15 Unless allowed by a product licence, words, phrases or illustrations that claim or imply the cure of an ailment, illness, disease or addiction, as distinct from the relief of its symptoms, are unacceptable.
11.16 Unless authorised by the relevant product licence, the word “tonic” is not acceptable in advertisements that make health claims. Claims must not suggest that a product has tonic properties. That does not prevent the use of the word “tonic” in the description “Indian tonic water” or “quinine tonic water”.
11.17 Jingles may be used. Those that incorporate a medical or health claim must be substantiated.
11.18 Advertisements for smoking deterrents:
11.18.1 must make clear that the indispensable factor in giving up smoking is willpower
11.19 Medicines must have a licence from the MHRA before they are advertised. Advertisements for medicinal products must conform with the licence. Advertisements must not suggest that a product is “special” or “different” because it has been granted a licence from the MHRA. For the avoidance of doubt, by conforming with the product’s indicated use, an ad would not breach rule 11.3.
11.20 Advertisements for medicinal products which include a product claim (including legible
on- pack product claims within a pack shot) must include this information:
11.20.1 the name of the product
11.20.2 the name of the active ingredient, if it contains only one
11.20.3 relevant wording such as “always read the label” or “always read the leaflet”
11.20.4 the indication (what the product is for). Advertisements for traditional herbal medicinal products and homeopathic medicinal products must include mandatory information, which can be found in the MHRA Blue Guide at
Section 4.7 of the MHRA Blue Guide sets out what that mandatory information is for traditional herbal medicines (THMs). Section 4.8 deals with homeopathic medicines and both can be found at http://www.mhra.gov.uk/home/groups/pl- a/documents/publication/con2022589.pdf Additional guidance on homeopathic medicines can be found at http://www.mhra.gov.uk/home/groups/pl-a/documents/publication/con179787.pdf
11.21 Advertisements for these are not acceptable:
11.21.1 medicinal products or medical treatments available only on prescription
11.21.2 Products for the treatment of alcohol or substance misuse or dependence. An
11.22 No ad may suggest that a medicinal product is a foodstuff, cosmetic or other consumer product.
11.23 No ad for a medicinal product may claim its effects are guaranteed. That does not prevent the offering of refunds, if the ad does not suggest that efficacy is guaranteed.
11.25 Advertisements must not, without good reason, make the audience anxious that they are or might be suffering from disease or ill-health or might do so if they do not respond to the ad.
11.25.1 Advertisements must not falsely suggest that a product is necessary for the
11.26 Advertisements must not, in improper, alarming or misleading ways, use images of changes in the human body caused by disease, injury or a medicinal product.