Medicines, Treatment and Health

4 Medicines, Treatments and Health

Central copy clearance is required. These Rules regulate the advertising and not the medicines, treatments (including veterinary products and services), and health claims themselves, which are regulated by the health regulators, such as the Medicines and Healthcare products Regulatory Agency (MHRA), the Department of Health and Local Health Authorities.

Because of the introduction of new or changed products, the diverse licensing requirements of the Medicines Act 1968 and changes in medical opinion on particular issues, this Rule cannot provide a complete conspectus of required standards in relation to health claims or the advertising of particular products or classes of medicines and treatments. The general principles governing the advertising of medicines, treatments and health claims (including veterinary products and services) are set out below.

4.1 Legal Responsibility

Advertisements for products subject to licensing under the Medicines Act 1968 must comply with the requirements of the Act, Regulations made under it and any conditions contained in the current marketing authorisation.

4.2 Advertisers, Treatments, Products, Services and Claims

Advertisers in this category, and/or the treatments, products and services they offer and all claims made for them, require very close scrutiny. Whenever a proper assessment of such claims can only be made by an appropriate independent qualified expert, whether medical or other health specialist, such advice must be sought before seeking clearance.

4.3 EC Council Directive 92/28/EEC
The Directive 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. The ASA is obliged to consider complaints about alleged breaches of Regulation 9 of The Medicines (Advertising) Regulations 1994 and take appropriate action if necessary. The BCAP Executive may raise and investigate challenges regarding possible breaches identified through monitoring.  The requirements of Regulation 9 are incorporated in this part of the Code. Directive 2001/82/EC as amended deals with veterinary medicinal products and its provisions have been implemented in the Veterinary Medicines Regulations 2005, which contain requirements for the advertising of such products.

4.4 Prescription-Only Medicines (POMs)

Advertisements for medicinal products or treatments available only on prescription are not acceptable.

4.5 Products Without a Marketing Authorisation

Advertisements for products which do not hold a marketing authorisation under the Medicines Act 1968 must not include medical claims.

(Registered homeopathic products are dealt with seperately, at 4.13 below).

4.6 Mandatory Information

Advertisements for medicinal products must include the following information:

a) the name of the product and an indication of what it is for;

b) the name of the active ingredient, if it contains only one;

c) where necessary, the information needed for the correct use of the product;

d) wording such as ‘always read the label’ or ‘always read the leaflet’, as appropriate.

4.7 Unacceptable References

Advertisements must not suggest that a product is special or different because it has been granted a marketing authorisation or contain any reference to the European Commission or the MHRA (unless the MHRA requires such a reference).

No advertisement for a medicinal product may suggest that health can be enhanced by taking the medicinal product, or suggest that health could be affected by not taking the medicinal product.

4.8 Medicines and Children

Advertisements for medicinal products and treatments must not be directed exclusively or principally at children (for this purpose, those aged below 16 years).

4.9 Conditions Requiring Medical Advice

Advertisements must not offer any product or service for conditions for which qualified medical advice should be sought, or give the impression that a medical consultation or surgical operation is unnecessary (this excludes advertisements for spectacles, contact lenses and hearing aids), in particular by offering a diagnosis or by suggesting treatment by post, fax, telephone or email.

4.10 Services or Clinics Offering Advice and/or Treatments in Medical or Personal Welfare or other Health Matters

Advertisers will only be acceptable if they can provide suitable bona fides, such as evidence of relevant professional expertise or qualifications, or accreditation to a recognised professional body. Advertising must also comply with the rules of relevant professional bodies. Advertisers may be asked to show that clinics are registered with the Local Health Authority, and/or may be referred to the RACC’s medical consultant, or other advisors as required by the ASA or the BCAP Executive as a result of monitoring.

Advertisers must show that they have meaningful bona fides, for example that they belong to a body which has systems for dealing with complaints and for taking disciplinary action; that registration is based on minimum standards for training and qualifications, that there are systems in place for regular review of membersí skills and competencies, and that they have suitable professional indemnity insurance covering all services provided.

4.11 Advice by Correspondence

Advertising for services offering one-to-one advice by correspondence (including telephone, post, email and fax) on medical/health matters will only be acceptable where:

i such advice is given by suitably qualified health professionals acting in accordance with their relevant professional Codes of conduct; and

ii those professional Codes are recognised by the ASA and BCAP.

No advertisement may contain any offer to prescribe or treat by correspondence.

This Rule does not preclude advertising containing offers to distribute general information on health-related matters, such as leaflets or information packs.

4.12 Unacceptable Impressions of Professional Support and Advice

The following are not acceptable:a) presentations by doctors, nurses, midwives, dentists, pharmaceutical chemists, veterinary surgeons, etc. which give the impression of professional advice or recommendation;

b) statements which give the impression of professional advice or recommendation by people who feature in the advertisements and who are presented as being qualified to do so;

c) references to approval of, or preference for, a product or its ingredients or their use by the professions listed at (a).

4.13 Homeopathic Medicinal Products

Advertisements for homeopathic medicines are acceptable, subject to all relevant requirements of EC Council Directive 2001/83/EC (as amended by 2004/27/EC) on homeopathic medicinal products implemented in the UK by the Medicines (Advertising) Regulations 1994 (as amended).

In particular:

a) advertisements are only acceptable for products which have been registered in the UK;

b) product information must be confined to that which appears in Schedule 5 of the Medicines (Advertising) Regulations 1994. Advertisements may not, therefore, include medicinal or therapeutic claims or refer to a particular ailment;

c) advertisements must include wording such as ‘always read the label’ or ‘always read the leaflet’ as appropriate.

4.14 Celebrities

Advertisements for medicines and medical products which require legal marketing authorisation must not be presented by, or include testimonials from, persons well known in public life, sport, entertainment, etc. The Medicines (Advertising) Regulations 1994 prohibits "recommendations by persons who because of their celebrity, could encourage the consumption of medicinal products." This includes persons corporate as well as singular, and would prohibit, for example, recommendations by medical charities, patient groups and health/sport organisations.

4.15 Cure

Unless otherwise allowed by its marketing authorisation, words or phrases that claim or imply the cure of any ailment, illness, disease or addiction, as distinct from the relief of its symptoms, are unacceptable. (Words such as ‘help’ or ‘relieve’ should be used).

4.16 Tonic

Unless otherwise allowed by its marketing authorisation, the word ‘tonic’ is not acceptable in advertisements for products making health claims.

4.17 Unacceptable Descriptions

Advertisements must not suggest that any medicinal product is a foodstuff, cosmetic or other consumer product.

4.18 Self-Diagnosis

Advertisements for medicinal products must not contain any material which could, by description or detailed representation of a case history, lead to erroneous self-diagnosis.

4.19 Guarantee of Efficacy

Advertisements for medicinal products must not claim or imply that the effects of taking the product are guaranteed.

4.20 Side Effects

Advertisements for medicinal products must not suggest that the effects of taking the product are unaccompanied by side effects. (It is acceptable to highlight the usual absence of a specific side effect, eg. ‘no drowsiness’).

4.21 ‘Natural’ Products

Advertisements for medicinal products must not suggest that the safety or efficacy of the product is due to the fact that it is natural.

4.22 Claims of Recovery

Advertisements for medicinal products must not refer to claims of recovery in improper, alarming or misleading terms.

4.23 Appeals to Fear or Exploitation of Credulity

a) No advertisement may cause those who hear it unwarranted anxiety if they are suffering or may suffer (if they do not respond to the advertiser’s offer) from any disease or condition of ill health.

b) Advertisements must not falsely suggest that any product is necessary for the maintenance of health or the retention of physical or mental capacities (whether by people in general or by particular groups) or that health could be affected by not taking the product.

4.24 Encouragement of Excess

Advertisements must not imply or encourage indiscriminate, unnecessary or excessive use of any medicinal product or treatment.

4.25 Exaggeration

Advertisements must not make any exaggerated claims, in particular through the selection of testimonials or other evidence unrepresentative of a product’s effectiveness, or by claiming that it possesses some special property or quality which cannot be substantiated.

4.26 Comparisons

Advertisements for medicinal products or treatments must not suggest that the effects of taking the product are better than, or equivalent to, those of another identified or identifiable medicinal product or treatment.

4.27 Analgesics

A ‘tension headache’ is a recognised medical condition and analgesics may be advertised for the relief of pain associated with it. However, no simple or compound analgesic may be advertised for the direct relief of tension or stress. In such advertisements there must be no references to depression.

4.28 Sales Promotions

Advertising for medicinal products which need a marketing authorisation must not contain references to sales promotions (including competitions, premium offers and samples).

4.29 Jingles

Jingles may be used but must not incorporate any medical/health claim.