The rules in this Section are designed to ensure that marketing communications for medicines, medical devices, treatments, health-related products and beauty products receive the necessary high level of scrutiny. The rules apply to marketing communications and not the products, which are regulated by health regulators such as the Health Products Regulatory Authority (HPRA) www.hpra.ie, the European Medicines Agency (EMA), www.ema.europa.eu, and the Department of Health, www.health.gov.ie.
Claims about health and beauty products and treatments should be backed by substantiation. Where relevant, this should include the results of robust and reputable trials on human subjects, of sufficient rigour, design and execution as to warrant general acceptance of the results.
Medicinal or medical claims and indications may be made for a medicinal product that is authorised by the HPRA or EMA, 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 should be backed by substantiation. These are limited to any preventative action of the product and may not include claims to treat disease.
Any scientific information in a marketing communication should be presented in an accurate manner. Scientific terminology should be appropriate, clearly communicated and be capable of being readily understood by the audience to whom it is directed.
No reference should be made to tests, trials or endorsements by any college, hospital, clinic, laboratory or similar establishment unless there exists a bona fide establishment corresponding to the description used and it is under the effective supervision of a registered medical practitioner or other appropriate professional. Reference to such establishment should be made only with the express permission of the appropriate authorities.
Marketing communications for health and beauty products or treatments should not include representations of individuals that give the impression of professional advice or recommendations unless such persons are suitably qualified and have relevant and recognised qualifications.
Advertisers should not discourage essential treatment for conditions for which medical supervision should be sought. For example, they should 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. Accurate and responsible general information about such conditions may, however, be offered.
Health professionals are considered suitably qualified if they are regulated by a statutory body recognised by the Irish State.
Marketing communications for medical services should not cause unwarranted or disproportionate anxiety or suggest that any product or treatment is necessary for the maintenance of health.
(a) Advertisers offering individual treatments, particularly those that are physically invasive, may be asked by the media and the ASAI at any time to provide full details of the treatments, together with information about those who would supervise and administer them. Practitioners should have relevant and recognised qualifications. Consumers should be
encouraged to take independent medical advice before committing themselves to significant treatments, including those that are physically invasive.
(b) Marketing communications for individual treatments should take care not to minimise, trivialise or create unrealistic expectations, in particular in the use of photographs.
Marketing communications for a health and beauty product or treatment:
(a) Should not encourage consumers to use a product or treatment to excess and should hold substantiation before suggesting their product or therapy is guaranteed to work, is absolutely safe, or is without side effects (subject to 11.19 for Medicinal Products).
(b) Should not suggest that the product or treatment is safe or effective merely because it is “natural”, nor should it refer to the omission of any ingredient in a way that suggests that the ingredient is unsafe or harmful.
(c) Should not use unfamiliar scientific terms for common conditions.
References to the relief of symptoms or the superficial signs of ageing are acceptable if they can be substantiated. Unqualified claims such as “cure” and “rejuvenation” are not generally acceptable.
Marketing communications should not suggest that a product or treatment will achieve success in every case or that the outcome can be other than dependent on the particular circumstances of the individual person.
Advertisers inviting consumers to diagnose their own minor ailments should not make claims that might lead to a mistaken diagnosis.
Marketing communications for any products offering to deter the habit of smoking or other addictions should make it clear that they offer only assistance, are not cures, and that any success will necessarily be dependent on the willpower of the user.
Title VIII of European Directive 2001/83/EC (as amended) concerns “The Advertising of Medicinal Products for Human Use” and has been implemented in Ireland by the Medicinal Products (Control of Advertising) Regulations, 2007 (S.I. No. 541/2007). Advertisements for medicinal products must comply with the requirements of these Regulations and any conditions contained in the marketing authorisation, certificate, licence or traditional herbal registration for the advertised product. For more information on the advertising of medicinal products, see the HPRA’s website www.hpra.ie.
Medicines should have an authorisation from the HPRA or under the auspices of the EMA before they are advertised. Marketing communications for medicines should conform with the authorisation and the product’s summary of product characteristics.
Marketing communications should not suggest that a product is “special” or “different” because it has been granted an authorisation by the HPRA or under the auspices of the EMA.
Prescription-only medicines may not be advertised to the public.
Marketing communications for medicinal products should not contain any offer to diagnose, advise, prescribe or treat by correspondence (correspondence includes by phone, post, internet, email and fax).
Marketing communications for medicines should not imply, directly or indirectly, that a medical consultation or surgical operation is unnecessary.
Marketing communications for a medicine should not claim that its effects are guaranteed, that it is absolutely safe or without side-effects, or as good as or better than those of another identifiable product.
Marketing communications for a medicine should not claim that a product is able to cure illness, dysfunction or malformations if this is not the case.
Marketing communications should not refer, in improper, alarming or misleading terms, to claims of recovery.
Marketing communications should not use, in improper, alarming or misleading terms, images of changes in the human body caused by disease, injury or a medicinal product.
Marketing communications should not suggest that using or avoiding a product can affect normal health. This rule does not apply to vaccination campaigns provided such campaigns have been approved by the Minister for Health.
Marketing communications for a medicine should not be addressed to children.
Marketing communications for medicinal products should not contain material that refers to a recommendation by scientists, health professionals or celebrities.
Marketing communications should not suggest that a medicinal product is either a food or a cosmetic.
Marketing communications for medicinal products should not present a description or detailed representation of a case history that could lead to erroneous self-diagnosis.
Marketing communications for a medicinal product should not contain an offer to refund money to dissatisfied customers.
Marketing communications which include a product claim for a medicinal product (including legible on-pack product claims within a pack shot) should include the name of the product, an indication of what it is for, text such as “Always read the label” and the common name of the sole active ingredient, if it contains only one.
Illustrations of the effect or action of a product should be accurate.
Marketing communications for a medical device should be consistent with its intended purpose.
Consumer prize promotions for medicinal products should not encourage or require purchase of the products which would be greater than that associated with a rational use of the product and should not encourage the unnecessary purchase of the product.
Marketing communications should not offer free samples of medicinal products.
Marketing communications for a traditional herbal medicinal product should include mandatory information as required under S.I. No. 541/2007.
Marketing communications for a homeopathic medicinal product should include mandatory information as required under S.I. No. 541/2007.
Homeopathic medicinal products should be registered in Ireland. Any product information given in the marketing communication should be confined to what appears on the label. Marketing communications should include a warning to consult a doctor if symptoms persist.
Alternative and Complementary Medicine
Marketing communications for alternative and complementary products and services, including those for natural, herbal and traditional remedies, are subject to the requirements of the Code.
Marketing communications for counselling services for unplanned pregnancies should not mislead in any way as to the nature or scope of the counselling service being offered.
Hair and Scalp
Marketing communications should not claim that a particular product or treatment can prevent baldness or slow it down, arrest or reverse hair loss, stimulate or improve hair growth, nourish hair roots, strengthen the hair, or improve its health (as distinct from its appearance) unless the claim can be substantiated in accordance with the requirements of 11.1 above.
Hair transplantation and repositioning should both be regarded as physically invasive treatments (see 11.7 above).
Claims about the effect that a cosmetic has on, or in, the skin should distinguish between the composition of the product and any effects caused by the mode of application, such as massage.
Non-users of a cosmetic product should not be shown in a negative light.
Marketing communications should not claim that a product has been authorised or approved by a competent authority within the EU.
Note: Attention is drawn to the requirements of the Guidelines to Commission Regulation (EU) No. 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products.
The advertising of medicinal products and cosmetic products is governed by a number of other codes and Statutory Regulations, some of which are listed on www.asai.ie.