MEDICINES, MEDICAL DEVICES, TREATMENTS AND HEALTH

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Notes of Guidance

11. Medicines, medical devices, treatments and health

Background
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 http://www.clearcast.co.uk page.

CLEARCAST GUIDANCE
Further details on Clearcast’s consultants can be found here.

For radio advertisements, the Radiocentre retains a panel of consultants to advise it on health and medical aspects of advertising. For information, see “Services” at http://www.radiocentre.org

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.

Law

Title VIII of European Directive 2001/83/EC (as amended) concerns "The Advertising of Medicinal Products for Human Use" and has been implemented in the UK by the Human Medicines Regulations 2012. ASA (Broadcast) is obliged to consider complaints about breaches of Regulations 286 to 290, which have been incorporated into these rules. With the introduction of new or changed products, diverse licensing requirements 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.

Advertisements for products subject to licensing under the Human Medicines Regulations 2012 must comply with the requirements of the Regulations and any conditions contained in the marketing authorisation, certificate, license or traditional herbal registration for the advertised product.

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.

For more information on medicinal products and treatments, see the MHRA's guidance, The Blue Guide: Advertising and promotion of medicines in the UK at:

http://www.mhra.gov.uk/Howweregulate/Medicines/Advertisingofmedicines/BlueGuide

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 regularly.

For more information on veterinary medicinal products and treatments, please see Veterinary medicines Guidance Note 4 Controls on advertising at:

http://www.vmd.defra.gov.uk/public/vmr_vmgn.aspx

The European legislation governing medical devices is made up of Directive 90/385/EEC relating to active implantable medical devices, Directive 93/42/EEC on medical devices (as amended by Directive 2000/70/EC) and Directive 98/79/EC on in-vitro diagnostic medical devices. The MHRA is the body responsible for ensuring medical devices work and are safe. Generally, all devices covered by the scope of the relevant Directive should carry a CE mark, which is a public representation of the manufacturer's claim that its device satisfies the relevant Essential Requirements of the Directives, is fit for its intended purpose and, if required, has been independently assessed by a Notified Body. For more information, go to:

www.mhra.gov.uk

Definition
For the purposes of this section, “licence” includes certificate, authorisation or registration.

Rules

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 GUIDANCE
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 claims for medicines, medical devices, treatments and health to one of its consultants, if those claims go beyond those outlined on the advertised product’s 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 by 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.

CLEARCAST GUIDANCE
The ASA has ruled on this issue. The ruling can be found here.

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.

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.

CLEARCAST GUIDANCE
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; such evidence is it submitted to a consultant for assessment.

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:

  1. 11.5.1 Presentations, by doctors, dentists, veterinary surgeons, pharmaceutical chemists,
  2. nurses, midwives and the like that imply professional advice or recommendation

  1. 11.5.2 statements that imply professional advice or recommendation by people who are
  2. presented, whether directly or by implication, as being qualified to give that advice or recommendation

  1. 11.5.3 references to approval of, or preference for, any relevant product or their use by the
  2. professions covered by rule 11.5.1.

11.6 Advertisements other than those for medicinal products may feature or refer to health professionals covered by rule 11.5.1, if those professionals are suitably qualified in the relevant subject.

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 statement in a testimonial that is likely to be interpreted as a factual claim must be substantiated.

11.9 Services including Clinics, Establishments and the like Offering Advice on, or Treatment in, Medical, Personal or other Health Matters – Advertisements are acceptable only if the advertiser can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of their skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.

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

  1. 11.11.1 Radio only – Advertisements for family planning centres are not acceptable unless the family planning centre has been approved by a Local Health Authority, the Central
  2. Office of Information or other appropriate NHS body.

  1. 11.11.2 Radio Central Copy Clearance – Radio broadcasters must ensure advertisements
  2. for family planning centres are centrally cleared.

11.12 Television only – Teleshopping for these products or services is not acceptable:

  1. 11.12.1 medicinal products that are for human use and that are subject to a marketing
  2. authorisation within the meaning of Directive 2001/83/EC (as amended by Directive 2004/27/EC) and are on the General Sale List (GSL) as a pharmacy medicine (P) or as a prescription-only medicine (POM)

  1. 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
  2. available as an authorised veterinary medicine on the General Sales List (AVMGSL) as a non-food animal medicine from a veterinarian, pharmacist or suitably qualified person or as a prescription-only medicine from a veterinarian (POM-V) or from a veterinarian, pharmacist or suitably qualified person (POM-VPS)

  1. 11.12.3 medical treatments for humans or animals.


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).

  1. 11.13.1 Advertisements must not contain offers to prescribe or treat remotely (including by phone, post, e-mail or other means of an electronic communications network) unless the advertisers can demonstrate that the service offered complies with rule 11.9. Advertisements for medicinal products must not include such offers. That does not preclude advertisements containing offers to distribute general information on health-related matters, such as leaflets or information packs.

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:

  1. 11.18.1 must make clear that the indispensable factor in giving up smoking is willpower

  1. 11.18.2 must not claim that smoking is safer while the habit is being reduced. Harm reductions claims may be made, if authorised by the MHRA.

Medicines

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:

  1. 11.20.1 the name of the product

  1. 11.20.2 the name of the active ingredient, if it contains only one

  1. 11.20.3 relevant wording such as “always read the label” or “always read the leaflet”

  1. 11.20.4 the indication (what the product is for).

  2. Advertisements for traditional herbal medicinal products and homeopathic medicinal products must include mandatory information, which can be found in the MHRA Blue Guide at www.mhra.gov.uk.

CLEARCAST GUIDANCE
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 here.

Additional MHRA guidance on homeopathic medicines can be found here.

11.21 Advertisements for these are not acceptable:

  1. 11.21.1 medicinal products or medical treatments available only on prescription

  1. 11.21.2 Products for the treatment of alcohol or substance misuse or dependence. An
  2. exception is made for smoking deterrents (see rule 11.18).

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.

11.24 No ad for a medicinal product or treatment may be directed at children. See also Section 5: Children and Section 32: Scheduling.

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.

  1. 11.25.1 Advertisements must not falsely suggest that a product is necessary for the
  2. maintenance of physical or mental health or that health could be enhanced by taking the product or affected by not taking it.

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.

11.27 No ad for a medicinal product or treatment may include a recommendation by a person well-known in public life, sport, entertainment or similar or be presented by such a person. That includes persons corporate as well as singular and would prohibit, for example, recommendations by medical charities, patient groups and health or sport organisations.

11.28 No ad for a medicinal product may refer in improper, alarming or misleading terms to claims of recovery.

11.29 Advertisements for medicinal products must not contain material that could, for example, by description or detailed representation of a case history, lead to a wrong self-diagnosis.

11.30 Although it may refer to the likely absence of a specific side effect, for example, “unlikely to cause drowsiness”, no ad for a medicinal product may suggest that a product has no side effects.

11.31 No ad for a medicinal product or treatment may suggest that the effects are better than, or equivalent to, those of another identifiable medicinal product or treatment.

11.32 No ad for a medicinal product may suggest that the safety or efficacy of the product is due to it being “natural”.

11.33 Only homeopathic medicinal products that are registered in the UK may be advertised. Mandatory information for homeopathic advertisements can be found in the MHRA Blue Guide at http://www.mhra.gov.uk

11.34 A tension headache is a recognised medical condition; analgesics may be advertised for the relief of pain associated with that condition but no ad for a simple or compound analgesic may claim the direct relief of tension or refer to depression.

CLEARCAST GUIDANCE

Medical Efficacy and Sales Claims

Advertisements should not confuse high sales of products with their medical efficacy. Sales claims should be clearly presented as such and advertisements should not suggest or imply that advertised products are superior because they outsell others.

Testimonials are acceptable only if they reflect the degree of change or benefit that an average user can reasonably expect. Advertisers must be able to substantiate the claims that are made or implied in testimonials. All claims must be in line with the product’s Marketing Authorisation.

Analgesics

Symptoms of Over-Indulgence and Hangovers General purpose analgesics should not be advertised for the relief of hangovers. Products specifically designed for the relief of the symptoms of mild overindulgence in food and drink may, however, be advertised for that purpose, provided that:

(a)       the advertised products are not seen taken in anticipation of discomfort, e.g. before going to party;
(b)       there is no suggestion that over-indulgence in food or drink is acceptable if the product is taken, or that a hangover is a regular or commonplace occurrence;
(c)       only the results of unintentional and mild over-indulgence are shown; there should be no suggestion of deliberate over-indulgence

Comparative Speed of Action

There is no conclusive medical evidence that any medicines invariably relieve pain faster than solid tablets; it is accepted, however, that they can be absorbed more quickly. This may be indicated, although care is needed not to make categorical statements about speed of pain relief unless robust evidence is provided. Comparisons between the time taken for soluble tablets to dissolve in a glass and non-soluble tablets to dissolve in the stomach are acceptable.

Skin Ailments and Treatments/'Spots'

The audio visual treatment of an ad should not imply that a non-licensed/cosmetic product can treat more serious/medical conditions such as acne.

Mildness Claims for Detergents

Advertisements for soaps and detergents (e.g. washing-up liquids) may claim that the advertised products have a mild effect but should not imply a positive cosmetic or therapeutic benefit (e.g. alleviation of chapped, rough or sore skin). Claims for 'mildness' should be confined to lack of harshness and avoidance of rough skin.

Anti-Ageing claims for Skin Creams

Clearcast accepts claims such as “anti-ageing” and “anti-wrinkle” for skin creams provided there is no implication that the effects are permanent. Care is needed to ensure claims are made in the context of the appearance of the skin e.g. “reduce the appearance of fine lines and wrinkles”. Claims to help prevent lines and wrinkles or to temporarily delay premature ageing are accepted provided the cream contains a minimum of 15SPF. Particular care should be taken with product names to ensure they do not imply any permanent or physiological effect.

Penetration Claims for Skin Creams

Advertisements for skin creams should not make claims that the advertised products can penetrate beyond the stratum corneum, which is the outermost layer of the epidermis.