Advertising code for self-care medical products (CMH) 2019
In this Code the following is understood to mean:
Self-Care Medical Product: medical product in a pharmaceutical form having a physical effect, as far as intended to be used by the public itself without the intervention of a health professional.
It is clear from the definition above that in-vitro diagnostic products are not covered by the Code. The Code regards self-care medical products in a pharmaceutical form (liquids, capsules, tablets, creams, ointments, shampoos, lotions, sprays, powders, etc.) having a physical effect. This mode of operandus distinguishes self-care medical products from medicines. In fact, the latter have a pharmacologic, metabolic or immunologic effect.
Advertising: advertising within the meaning of Article 1 of the Dutch Advertising Code for a self-care medical product as defined in this code which apparently, by reason of its content and the manner in which it is expressed, is also intended for other persons than professionals, i.e. doctors, pharmacists, dentists, obstetricians, nurses and chemists.
The scope of this Code does not cover the data in labelling and instructions of use as laid down by law.
The labelling, instructions of use and exterior packaging are advertisement carriers. And so, the Code applies to this. The law requires specific data to be stated on it. That is why, within the context of this code or the supervision, they can never be questioned.
The Advertising Code Committee takes into account a valid admission number issued by the Keuringsraad Openlijke Aanprijzing Geneesmiddelen (KOAG – Dutch Inspection Board of Public Advertising of Medical Products), on the basis of its bylaws.
All communications for self-care medical products (including packaging and directions of use) can acquire an admission number. As to the packaging and directions of use of a self-care medical product classified in risk class 1 the supplementary condition for obtaining a valid admission number applies that the ’CE Check’ must have been passed. The CE check is a check by an expert of the plausibility of:
• the legal status of the product as self-care medical product;
• the classification specified by the manufacturer as class I;
• the clinical, scientific substantiation of the claims required by law.
It is prohibited to advertise self-care medical products which do not meet the legal conditions of the Dutch Act on Self-Care Medical Products and the Decree on Self-Care Medical Products.
Advertising is only allowed for self-care of indications that can be diagnosed by the user himself without the intervention of a physician or that were once diagnosed by a physician or as supplementary self-care for indications diagnosed by a physician and treated with other medical products.
Advertising shall not contravene the information on the package and in the information leaflet.
Advertising has a different purpose than the instructions of use. That is why they are of a different nature. However, they should not be contradictory, if so, false expectations can be created on the part of the consumer or Article 4 of this Code can be violated in another sense.
It is prohibited to state the degree or rate of the weight one could lose per time unit in respect of self-care medical products intended for weight control and/or slimming. Nor shall they involve a competitive element.
Mention of the weight unit per time unit is not allowed, because this suggests that this effect will always occur in everybody to such a degree.
Advertising must include at least:
a. the name of the self-care medical product;
b. the mention “self-care medical product”;
c. the most important purposes of use and the situations in which the use is advised against;
d. an explicit request to read the instructions of use.
It should be clear that it concerns a self-care medical product.
Advertising comprises in any case the major purposes of use and the situations in which the use is advised against. After all, the purchase decision requires to know what the self-care medical product can be used for and who should not use it. This is in line with the mention of the major therapeutic indications and contra-indications required for self-care medicines. The situations in which is advised against the use shall be in conformity with the contra-indications. In commercial communications reference shall be made to such instruction of use. All the requirements under Article 8 should be clearly legible. Television commercials must be displayed long enough in order to enable the consumer to read them aloud.
In derogation of paragraph 1, the situations in which the use of the self-care medical product is advised against, do not have to be stated in specific media (volatile media and/or media with very limited space), under that condition that this does not mislead the consumer.
Examples of limited media are radio commercials and television commercials. As such information is stated in the directions of use, the consumer is also induced, with an express exhortation to read this, to verify whether the self-care medical product is suitable to be used by him. Such exhortation should be clearly legible or audible. Television commercials must be displayed long enough in order to enable the consumer to read them aloud
In derogation of paragraph 1 sub a-d advertising only has to include the name of the self-care medical product, if the only purpose is to remind of the name or brand of the self-care medical product.
Reminder advertising has as sole purpose to remind of the name and usually exclusively consists of mentioning the name in the communication. Indications which may reinforce the reminder values, such as for instance “this is familiar”, are fully in line with such purpose. However, as soon as options of use or any other product characteristics are stated, it no longer concerns reminder advertising.
Advertising for a self-care medical product shall give an objective presentation of facts and shall not mislead.
Advertising for a self-care medical product shall be truthful and shall not exaggerate its characteristics. Furthermore, claims such as ‘the best’ are not allowed, because they are hardly ever demonstrably correct.
Advertising for self-care medical products shall not use in a deterrent or misleading manner pictures or descriptions of changes of the human body as a result of illness or injury, nor of the effect of the self-care medical product in the human body.
In advertising for self-care medical products it is not allowed to use any images which are deterrent and terrifying, in that case it does not concern self-care anymore. Pictures should fall within the scope of the self-care medical product.
Advertising shall be represented in such manner that the public perceives the message as an advertising message, and that it is perfectly clear to the public that a self-care medical product is concerned. It is not allowed to identify the self-care medical product with a medicine, health product, food product, cosmetic product or any other consumer good.
Upon simultaneous recommendation of self-care medical products with a medicine or health product, cosmetic product or any other consumer good they shall be positioned individually and it shall be clear what claim regards what product. Since it is only allowed to make pharmaceutical/medical claims for medicines and medical products and precisely not for health products, it is important to make a specific distinction in this. Furthermore, as to the self-care medical products it shall be expressly stated that it concerns a “self-care medical product”, as to the medicine that it concerns a “medicine” and as to the health product that it concerns a “health product”.
Advertising of self-care medical products shall not state that the costs of self-care medical products can be reimbursed on doctor’s prescription.
Should the reimbursement status be advertised, it might stimulate people not to buy the product themselves, but to request prescription.
Advertising shall neither state nor suggest by its phrasing or pictures that the use of the self-care medical product renders a medical examination or a medical treatment unnecessary, or discourage it.
Therefore, the following is prohibited:
• Suggestions that medical examination or surgical intervention is not necessary;
• Offering a personal diagnosis, advice, prescription, or distant healing.
Suggestions are prohibited which suggest that:
• the normal good health can be seriously affected if the self-care medical product is not used;
• the normal good health of a person can be improved by using the self-care medical product.
Advertising shall not comprise any statements which, by means of description or detailed presentation of a disease history, might lead to a wrong self-diagnosis, nor may it refer to claims of recovery in a misleading manner.
Testimonials shall be a correct account of the user experience.
Advertising shall not comprise, directly or indirectly, a recommendation of scientists, health care professionals or persons known to the public who could promote the use of self-care medical products by means of their renown and reputation.
Health care professionals in this respect are physicians, pharmacists, chemists, obstetricians, nurses and dentists. The background of this provision is that the public has a special confidence in scientists and health care professionals which causes their commendations to carry disproportionally great weight. An indirect recommendation may be the mention or depiction of items that are strongly associated with them (such as doctors’ white coats or the Aesculapius staff), the name of the instituttions they work for (university, clinic, institute, laboratory, etc.) or the kind of work they perform (research, diagnosis). This does not mean that such matters related to scientists and health care professionals shall never occur in public advertising. After all, it concerns the reference to a recommendation. For instance, there is no such reference if it is stated that “research” has shown that X% of the population occasionally suffers from disorder Y. “Persons known to the public” concern persons who although they are not scientists or professionals themselves, do enjoy a certain trust of the public, for instance actors known for playing a specific doctor character or persons of much authority and prestige.
Advertising shall neither state nor suggest that (self-care) medical products are safe. However, it is allowed, within a relevant context, to explain the word ‘safe’ and comment on the safety of the product, if such relevant context is clearly stated.
For instance, it is allowed to state “safe when used in conformity with the instructions of use”.
Advertising shall neither state nor suggest that the safety or effectiveness of the (self-care) medical product is due to the fact that the materials and/or substances used are “natural” or of “natural origin”, unless this proven to be correct and relevantly distinct from other similar products.
Advertising shall neither state nor suggest by its phrasing or pictures that the (self-care) medical product does not have any side- effects. The absence of a specific, recognizable to the user side-effect may be mentioned, if it is distinct and demonstrable.
A specific side-effect of which the absence can be relevant to the potential user, concerns a known side-effect of similar products. In that case, such adverse effect shall be recognizable to the user and clinically relevant. The adverse effect concerned should be stated in the official documentation of such similar products.
Advertising of a self-care medical product shall not be exclusively or primarily directed at children.
‘Directed at children’ is defined as: encourage children to buy or to use the medical (self-care) product, or cause children to persuade their parents/ caretakers to purchase the medical (self-care) product. Advertising for the use of medical (self-care) products for children shall exclusively be directed at their parents/ caretakers. Children are defined as persons of the age of 12 or younger. This provision does therefore not refer to teenagers. Nonetheless, the provisions in the Code for Advertising directed at Children and Young People remain in full force.
The therapeutic use shall be presented as primary reason for use in advertising of self-care medical products. Any secondary characteristics of the (self-care) medical product shall not be used as primary reason to purchase.
The distinction between (self-care) medical products and other products is the use for a medical indication. This shall be the primary reason of use. Any other product characteristics are secondary to such medical indications, but can be important to the user. The taste of the (self-care) medical product is an example of this. Stating the taste as product benefit shall, however, be done in a manner which renders it secondary to such medical indication. If not, there is a risk of abuse or misunderstanding as to the nature of the product (see also Article 11).
Advertising may not contain any guarantee with regard to the therapeutic efficacy.
Use of expressions as “permanent result” and “efficacy guaranteed” is not allowed.
Advertising shall not comprise any derogatory comments on other products, services or ideas, or suggest so by its phrasing or pictures.
Any implicit or explicit comparison with other (self-care) medical products or other products shall be demonstrably correct and shall not denigrate such other products. Furthermore, the following conditions apply to comparisons:
• no use of brand names;
• it shall concern similar products;
• the comparison must relate to all relevant characteristics.
In (self-care) medical products advertising to the public, (self-care) medical products shall no longer than 2 years after introduction be depicted as new.
This code is part of the Dutch Advertising Code since 1 January 2015 and has been amended on 1 February 2019.