Code for advertising medicines to the general public 2019 (CPG)
1. The following definition apply to this Code:
Advertising to the general public: advertising of medicines 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.
Beyond the scope of this Code fall:
• The information leaflet and the labels;
• A letter or e-mail message sent to comply with a request for information about medicines;
• Information concerning health and illness in people.
Text on labels, in the information leaflet and on the packaging is laid down by law and reviewed and approved by the Dutch Medicines Evaluation Board Agency (MEB Agency). Therefore, it can never be under discussion within the framework of this Code, or the Board of Supervision.
Public advertising for medicines is prohibited:
a. If they are exclusively available on prescription;
b. If they are available without prescription, but contain substances as referred to in list I and II of the Opium Act;
c. If the advertising message is not provided with a valid approval number, issued by the Inspection Board for the Advertising of Medicinal Products to the General Public (KOAG), pursuant to her bylaws.
Pursuant to the Dutch Medicines Act, all non-prescription medication may be advertised regardless of the availability. Therefore, this applies not only to the Pharmacy and Chemists-only-Medicine and General Sales Medicines, but also to the over-the-counter remedies of the Pharmacy-only medicine category. The medication mentioned under b) was added in accordance with the Medicines Act. The item under c) formerly belonged to the special Advertising Code sub a.
Advertising of medicines, for which the marketing authorization required by law has not been granted, is prohibited.
Advertising of homeopathic medicines without approved therapeutic indications is prohibited.
For homeopathic medicines registered with the Dutch Medicines Evaluation Board (MEB) based on Article 42, paragraph 3 of the Dutch Medicines Act, there is no therapeutic indication. Unlike the homeopathic medicines registered by therapeutic indication, in accordance with Article 42, paragraph 4 of the Medicines Act, a leaflet was not required for this “classical homeopathica”. These homeopathica are therefore not considered appropriate to be used entirely on its own authority. Therefore advertising of these products is not allowed.
An advertising message may not contravene the SmPC text from the medicine’s register file. Neither may it contravene the text in the information leaflet and/or on the package.
The SmPC text is the summary of the registration file approved by the Dutch Medicines Evaluation Board Agency. In this document a description is given of the clinical and pharmaceutical characteristics of the medicine relevant for the medical practice. The therapeutic characteristics in the advertisement attributed to the medicine must be in accordance with the SmPC text. This does not mean, however, that the indications should be copied literally from the I-B-1-text, since the SmPC text is written in professional language. The text for the information leaflet and the package, approved by the Dutch Medicines Evaluation Board Agency, has been transcribed into understandable language for the layman. The rule of non-conflicting with the SmPC text also applies, should other views be published in the scientific literature. Only when the Dutch Medicines Evaluation Board Agency has approved the new views in the SmPC-text, they may be mentioned in an advertisement.
Characteristics of a medicine not directly related to the therapeutic effect are in principle not depicted in the SmPC text. Should one wish to mention such characteristics in an advertisement they must be plausible and shall never conflict with the SmPC texts. Examples are: “pills made easy to swallow”, “with a taste of thyme”, or “easy to rub on”.
Advertising that does not stimulate the rational use of a medicine is prohibited. It is therefore not permitted to:
· Hand out samples of medicines free of charge;
· Make direct or indirect price offers, hand out coupons or organize ‘refund campaigns’;
· Make the purchase of the medicine a condition to participate in competitions and games and to receive small presents.
The distribution of small presents is only permitted as long as there is no obligation to purchase and the words ‘no purchase obligation’ are incorporated in a readable font in the corresponding advertisement. This text must also comply with the current Code. An advertisement in which both medicines and health products are presented must explicitly state that ‘no purchase obligation’ applies to all medicines mentioned in the advertisement. Price offers such as ‘from/for’, ‘get 4, pay 3’, ‘with us for…’, or that suggest a price offer by, for example, depicting the price of the medicine in a large font or with the prefix ‘only’, are in conflict with the principles of this article. They can induce the consumer to use the product concerned unnecessarily or to purchase larger quantities than necessary. The above applies not only to a specific medicine, but also to specific categories such as medicines from a certain manufacturer or medicines for a certain ailment. General (price) offers for a retail range, such as savings systems or a certain discount on the total retail range, are allowed. It is not necessary to make an exception for medicines. This is not regarded as an incentive for additional purchases or higher use of a particular medicine or group of medicines. The retail price of a medicine may only be displayed in a non-conspicuous manner. The criterion of the price size is that the price indication may not exceed the name of the medicine. The large display of the price is an indirect price offer.
An advertisement shall contain at least:
· The name of the medicine;
· The generic name of the active substance should the medicine contain only one active substance;
· The indications and contraindications;
· An explicit request to read the information leaflet, as the case may be the text on the outer package.
The name of a medicine is understood to mean the name entered in the register which is usually the brand name and the mode of administration, or the strength of the medicine. Advertising shall contain at least the most important therapeutic indication(s) and contraindications, as it is necessary to know beforehand what the medicine can be used for and who should not use it. This fits well with the existing legal obligation for the over-the-counter medicines to mention indications and contraindications on the outer package. The essential use information is to be mentioned in the information leaflet and/or on the package. Advertising messages shall refer to the instructions for use.
Contrary to paragraph 1, the generic name of the active substance does not have to be mentioned in a radio broadcast advertisement.
A difficult generic name used in a radio broadcast advertisement may lead to conflicts with Article 10 of the Dutch Advertising Code.
As to homeopathic medicines: in the registered indication must be explicitly stated that a homeopathic medicine is concerned. Therefore, this shall be mentioned in all advertising messages, except in radio broadcast advertising.
Where traditional herbal medicines are concerned, it shall be clearly mentioned that it is a traditional herbal medicine and that the indications are exclusively based on an already long existing use.
In the commendation of homeopathic medicines, contrary to paragraph 1b the active substance does not have to be mentioned if a mother tincture or a single dilution is concerned.
In derogations of paragraph 1 sub c and 1d, media with space or time constraints may contain the mention: ‘Please read the information on the package before buying’, instead of the contraindications, as long as this does not mislead the consumer. Should either the total instructions for use, or an encouragement to read the information leaflet before use, be mentioned on the outer package, then the requirements stated in paragraph 1 sub d are met as well.
Media with space or time constraints are understood to be e.g. radio and tv commercials. Since the contraindications are mentioned on the outer package, the consumer is encouraged explicitly to read these and also to ascertain whether the medicine is the right one for him to use. If the contraindications of a medicine are well-known, only the most important of these shall be included in a written advertising message (see explanation art. 8.1). Only very specific small groups of patients are supposed to be informed about certain contraindications of active substances (e.g. in the case of renal and liver failure). In this case mention of contraindications is not required. The latter does not apply to e.g. ‘patients using anticoagulants’ and ‘patients suffering from stomach diseases’. The contraindication ‘allergy for one of the substances’ needs not to be mentioned. This also applies to the contraindication ‘allergy for the active substances’, provided that the rest of the text makes clear which active substances the medicine contains (e.g. a packshot, on which the active substances are mentioned in a legible manner). If some forms of advertising are considered too casual or too small to properly convey the information about contraindications (e.g. wobblers), then the standard phrase ‘read the information leaflet before use’ shall be replaced by the text ‘Read the indications on the package before you buy this medicine’. In this case, the mention of contraindications can be left out. All obligatory information pursuant to art. 8 shall be clearly readable. In television commercials the information shall be visible as long as it takes a consumer to read the information aloud.
In derogation of paragraph 1 sub a through d advertising only has to include the name of the medicine and if applicable, the generic name, if the only purpose is to remind of the name or brand of the medicine.
Although the only purpose of the advertisement is to remember the name this does not mean that the advertising may consist exclusively of the name. Designations that may reinforce the recollection, such as: ‘trusted’ are very well in line with that purpose. However, as soon as different ways of use or other product qualities are given, the advertising message is no longer considered just a recollection advertisement. A recollection advertisement for an over-the-counter medicine with the same name as a medicine on prescription may be contrary to article 3 sub a.
An advertisement for a medicine shall give an objective presentation of facts and shall not mislead.
Advertising for medicines shall be truthful, shall not exaggerate its characteristics and shall not, directly or indirectly, incite to unnecessary or excessive use of that medicine. Therefore, claims as ‘the best’ are not permitted.
Advertising 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 effects of the medicine in the human body.
Advertising shall be reproduced in such a manner that the public perceives the message as an advertising message and that it is perfectly clear to the public that a medicine is concerned. It is not allowed to identify the medicine with a food product, cosmetic product or other consumer goods.
Upon simultaneous recommendation of medicines with food products, health care products, self-care medical products, cosmetic products or other consumer goods, the medicines must be positioned separately and it should be clear which claim relates to which product. Moreover, in case of a medicine it shall be explicitly stated that it concerns a ‘medicine’, and the same rule applies to a ‘health care product’ or a ‘medical self-care product’.
Medicine advertising shall not mention the reimbursement status.
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 use of the medicine will render medical examination or 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 treatment per letter at a distance.
Suggestions are prohibited which suggest that:
• The normal good health may be seriously affected if the medicine is not used.
• A person’s normal good health may improve by the use of the medicine.
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. Also the mention that a certain medicine is now available without prescription does not contravene the purport of this provision. The expression ‘people well-known to the public’ refers to persons who are not scientists nor health care professionals indeed, but enjoy a certain confidence among the public at large: e.g. actors, who are famous for their role as a doctor, or persons with great authority and power.
Advertising shall neither state nor suggest that medicines are safe. However, it is allowed within a relevant context to use the word ‘safe’ and comment on the safety of the medicine, if such relevant context is clearly stated.
However, ‘confident feeling’ may be used, if relevant.
Advertising messages shall neither state nor suggest that the safety or effectiveness of the medicine is due to the fact that a medicine is ‘natural’ or of ‘natural origin’, unless this is proven correct and relevantly distinct from similar products.
Advertising shall neither state nor suggest by its phrasing or pictures that the medicine does not produce any side-effects. The absence of a specific, recognizable to the user side-effect may be mentioned.
A specific side-effect the absence whereof may be relevant to a possible user, refers to a well- known side-effect in other medicines of the same product group. These side-effects must be clinically relevant, which is manifest in the I-B-1 text of the other similar medicines. As far as the recognisability is concerned: the criterion is also, that the user experiences the side-effect as unpleasant, e.g. perceptible changes in the blood.
Advertising may not be exclusively or primarily directed at children.
‘Directed at children’ is defined as: encourage children to buy or to use the medicine, or cause children to persuade their parents/ caretakers to purchase the medicine. Advertising for the use of medicines for children shall exclusively be aimed at their parents/ caretakers. Children are defined as persons of the age of 12 or younger. This provision does therefore not refer to teenagers and adolescents. Nonetheless, the provisions in the Code for Advertising directed at Children and Young People remain in full force.
In advertising for medicinal products the therapeutic indication must be presented as the primary reason for use. Secondary characteristics of the medicine may not be used in an advertisement as the primary reason to purchase.
Secondary characteristics are defined as other than the registered therapeutic characteristics. The distinction between medicines and other products is the therapeutic efficacy, which should be the primary reason for use. Other product characteristics are subsidiary to the therapeutic efficacy, but may be of importance to the user: e.g. the taste of the medicine. Mention of the taste as an advantage of the product shall, however, be done in a way that makes it subordinate to the therapeutic efficacy. Otherwise there will be a risk of misuse or misunderstanding of the product’s nature (see also art. 11).
Other secondary characteristics which may be a product asset are e.g. the user-friendliness and the absorption speed. Apart from the fact that these characteristics may not contravene the SmPC text (see art. 6) these product assets may also be solely put forward in a way subsidiary to the therapeutic characteristics.
Advertising may not contain any guarantee with regard to the therapeutic efficacy.
Use of expressions as ‘permanent result’ and ‘guaranteed efficacy’ are not allowed.
In an advertisement, it is not allowed to mention or suggest in wording or depiction that the efficacy is better than or equal to the efficacy of another medicine or medical treatment.
The following advertising messages are not allowed:
• Advertising messages in which is stated that a medicine does not contain a certain active/effective ingredient which is used in other medicines.
• Advertising messages in which dissatisfaction with competing products is expressed.
• Advertising messages in which a medicine is denoted as unique, unless is indicated which characteristic is unique and only if this is demonstrably correct and significantly deviant from similar medicines.
Any implicit or explicit comparison with other medicines shall be demonstrably correct and may not denigrate the value of other substances or preparations. 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 medicine advertising to the public, medicines shall no longer than 2 years after introduction be depicted as ‘new’.
This code is since 2011 part of the Dutch Advertising Code and has been amended on 1 January 2015 and 1 January 2019.