Pharmaceutical advertising regulation and medical device advertising in the Netherlands

1.1 Medicines

• The Medicines Act is the primary law on advertising of medicines. In addition, the Dutch Civil Code (6:194-196) on misleading or comparing advertising must be taken into account.

1.2 Medical devices

• The Medical Devices Act is the primary law on medical devices, but the law does not have a specific section on advertisement. Advertising is regulated in some self-regulatory codes. The Dutch Civil Code (as mentioned above) must also be taken in consideration.

2.1 Medicines

The details on medicine advertisement are regulated in the Code of conduct on Pharmaceutical Advertisement (‘‘Code PA’’). With regard to advertisement to the public of medicines that are not prescription-only or Opium Act-listed, the Code for Advertising of Medicinal Products to the General Public (‘‘Code AGP’’) is applicable.

2.2 Medical devices

The Code on Advertisement for Medical (self-care) Devices (‘‘Code AMD’’) sets out the standards on advertisement to the public of medical devices in pharmaceutical form with physical effect (medical devices that are very similar to medicines), to the extent that such medical devices are intended to be used by the public without the intervention of a healthcare professional. 

Advertisement regarding all other sorts of medical devices or advertisement to healthcare professionals is unregulated at the moment, except for the general clauses on misleading or comparing advertising in the Dutch Civil Code.

3.1 The general public

All permitted (see under 4) advertisements on medicines to the general public must have a valid authorisation number issued by the Inspection Board for the Public Promotion of Medicines (Keuringsraad Openlijke Aanprijzing Geneesmiddelen or KOAG).

This rule does not apply to medical devices, but in case of a conflict it will be taken in consideration if a medical device does have a valid authorisation number.

3.2 Healthcare professionals

There is no licensing-system in the Netherlands for advertising of medicines or medical devices to healthcare professionals. The criteria and rules are set out in legislation and codes (if any) and the industry is expected to comply with them.

Prescription-only medicines

Prescription-only medicines and medicines that are not prescription-only but do contain a forbidden (but regulated) substance as mentioned in list I or II of the Opium Act may never be advertised to the general public.

Over-the-counter medicines

Over-the-counter medicines are divided into three groups:

• UA – only available at pharmacies;
• UAD – only available at pharmacies and drugstores;
• AV – freely available.

Advertisement for over-the-counter medicines is permitted, except for medicines that contain a forbidden substance as mentioned in list I or II of the Opium Act.

5.1 Medicines

Advertising of prescription-only and Opium Act-listed medicines to the general public is prohibited and advertisement of medicines that have not received a market authorisation is always prohibited.

For all other medicines; advertisement must comply with the Medicines Act (art. 87/88/89), the advert may not conflict with the SmPC text from the registration file of the medicine, neither may it be contrary to the information in the package leaflet and on the packaging.

Advertising that does not promote the rational use of a medicine is prohibited, for example:

• To provide free samples of medicines;
• To make direct or indirect price offers, issue vouchers or hold ‘‘refund promotions’’;
• Make the purchase of the medicine a condition for participation in competitions.

5.2 Medical devices

There are no restrictions applicable to the advertising of medical devices to the general public, except for medical devices in pharmaceutical form with physical effect (medical devices that are very similar to medicines), to the extent that such medical devices are intended to be used by the public without the intervention of a healthcare professional. The main restrictions applicable to such advertising:

• The product itself must be compliant with the Medical Devices Act and delegated legislation;
• Advertising is only permitted for self-care relating to indication that can be determined by the user himself without the intervention of a doctor/healthcare professional, or that has been determined once by a doctor and treated with other means;
• Advertisement may not conflict with the information on the packaging and the enclosed instructions;
• It is forbidden to state the extent or speed of weight loss that could be lost by using medical self-care aids intended for weight management/slimming. (Neither may a competition element occur.)

6.1. Medicines

Advertisement of medicines that have not received a market authorisation is prohibited. Other restrictions applicable to advertising of medicines to healthcare professionals are:

• It is prohibited to provide a sample containing a substance as referred to on list I or II of the Opium Act;
• The advertisement may not be misleading or deceiving;
• The advertising shall be designed in such a way that its promotional nature is recognised;
• Also see under 9 of this questionnaire.

6.2 Medical devices

There is no specific legislation or Code for advertising of medical devices to healthcare professionals.

7.1 Medicines

All written advertising to healthcare professionals shall comply with the requirements in de Code PA and shall include, in conformation with the SPC, information about:

• The name of the medicinal product;
• The name and address of the party responsible for marketing the products;
• The qualitative and quantitative composition of the active ingredients;
• The pharmaco-therapeutic group, to the extent relevant;
• The pharmaceutical form;
• The principal:
  • therapeutic indications;
  • adverse reactions (according to frequency and severity);
  • warnings (precautions connected with prescription and use);
• the contra-indications; and
• the classification of the medicinal product (prescription-only or not) for the purposes of supply.

The information must be provided in a position and in a font justified by the importance of the information.

7.2 Medical devices

There is no specific legislation or Code for advertising of medical devices to healthcare professionals.

8.1 Medicines

Advertisement to the public of medicinal products is regulated in the Code AGP and must include the following information:

• The name of the medicinal product;
• The generic name of the active substance, if the product contains only one active ingredient;
• The indications and contra-indications;
• An explicit request to read the package leaflet or the text on the outer packaging

8.2 Medical devices

Advertisements on medical devices in pharmaceutical form with physical effect (medical devices that are very similar to medicines), to the extent that such medical devices are intended to be used by the public without the intervention of a healthcare professional must include the following information:

• The name of the medical self-care device;
• The notion ‘medical device’;
• The main uses and the situations in which use is discouraged;
• An explicit request to read the instructions.

Prescription-only and Opium Act-listed medicines

The advertising must be consistent with the government-approved SPC of the medicinal product, as prescribed by or pursuant to the act. In promoting the rational use of the medicinal product, vague terms or superlatives must be avoided. The claim must be accurate, up-to-date and truthful, correct and verifiable in its detail.

The advertisement must give the healthcare professional comprehensive and accurate impression of the (clinical) efficacy of the medicinal product according to the authorisation information, the adverse reactions and the contra-indications. All passages must provide source references, be accurately quoted from the publications and the use of the quote may not detract from the tenor of the publication. 

The quoted publication must reflect the latest state of scientific knowledge and technology. No general restrictions on the data must be used.

Advertisement of medicines to the general public

Advertisement of medicines (Code AGP) must give an objective representation of facts and may not be dissaving or exaggerate its characteristics. It must be made clear that it is a medicinal product. The medicine cannot be equated with a food, cosmetic product or other consumer good. Furthermore, claims as ‘‘best’’ are not allowed because they are almost never truly correct and ‘‘natural (in origin)’’ may only be used when it is proven to be correct and relevant to differentiate from similar products.
The therapeutic indication should appear in the advertising as the primary reason for use. Secondary qualities should not be used as a primary reason for purchasing. 

The advertisement may not promise a certain outcome or result. A medicine may only be promoted as ‘new’ for a period of two years.

Medical devices in pharmaceutical form

Advertisement for a medical device in pharmaceutical form with physical effect (medical devices that are very similar to medicines), to the extent that such medical devices are intended to be used by the public without the intervention of a healthcare professional (Code AMD) must give an objective representation of facts and may not be dissaving or exaggerate its characteristics. It must be made clear that it is a medical device. It cannot be equated to a medicinal product, health-product, food, cosmetic product or other consumer good. Furthermore, claims as ‘‘best’’ are not allowed because they are almost never truly correct and ‘‘natural (in origin)’’ may only be used when it is proven to be correct and relevant to differentiate from similar products.

The therapeutic indication should appear in the advertising as the primary reason for use. Secondary qualities should not be used as a primary reason for purchasing.

The advertisement may not promise a certain outcome or result. A medical device may only be promoted as ‘new’ for a period of two years.

Yes, there are specific rules for comparative advertising.

Prescription-only and Opium Act-listed medicines

If the advertising makes a comparison with another substance or another medicinal product and if it names a competitor or a medicinal product marketed by a competitor, explicitly or implicitly, it is necessary to consider whether care has been taken:

• That the comparison is not misleading: that the medicinal products being compared provide for the same need or are intended for the same purpose, and that the comparison objectively compares one or more of the medicinal product’s fundamental, relevant, verifiable and typical properties, for example their (clinical) efficacy;
• That the comparison does not unnecessarily prejudice the value of those other substances or medicinal products;
• That the comparison does not discredit the authorisation holder of those other substances or preparations, its trade name and/or the brand name of those other substances or medicinal products;
• That the comparison does not cause any confusion between the substances or medicinal products being compared and their brand names and/or between the relevant authorisation holders and/or their trade names;
• That the comparison does not present medicinal products as an imitation or copy of medicinal products with a protected trade mark or a protected trade name;
• That the advertising does not constitute an unfair advantage as a result of the reputation of a competitor’s brand name or trade name or as a result of other distinctive characteristics of a competitor;
• That the comparison is scientifically verifiable as accurate and in conformity with the latest state of the art;
• That the comparison is comprehensive in terms of the effect, adverse reactions, indications, contra-indications and the other relevant data of the substances or medicinal products being compared, and, in general, has otherwise attempted to observe due care not only vis-à-vis the other parties in the industry, but also vis-à-vis the party targeted by the advertising.

Advertisement of medicines to the general public and medical devices in pharmaceutical form

Any implicit or explicit comparison with other medicines or medical devices should be demonstrably correct and should not detract from the value of other products. Furthermore, comparisons are subject to the following conditions: no use of brand names is allowed, it has to regard similar products and the comparison should cover all relevant features.

The main rule is that conditions that apply “offline” also apply “online”. Advertising via social media shall be conducted in conformity with and in the spirit of the rules of conduct for oral and written advertising, taking account of the specific nature of this method. The range of social media is not limited to national borders. The Dutch Codes are only applicable to advertisement accessible in the Netherlands and aimed at the Dutch audience.

General rules that apply to social media as well:

• Advertising must always be recognizable as such;
• The person who sends the message or is (partly) responsible for its content must be recognizable;
• Quantification of the addressees;
• Responsibility for the content of their own websites and referenced / linked media

Compliance with the Medicines Act is monitored by the Inspection for Health and Youth Care (Inspectie voor gezondheidszorg en jeugd).

In case of a vialation of the Act, the sanction can be:

• An administrative fine till the maximum of €450.00.
• To suspend or terminate the trade or provision of a medicinal product.
• Withdraw a medicine or substance from the market.
  • It is current practice that the Inspection only imposes a fine in case of a violation of the advertisement provisions.
  • Compliance with the Code of Conduct for Pharmaceutical Advertising is monitored by the Code Commission (Codecommissie CGR). If a complaint has been ruled valid, the Code Commission can impose the following measures or sanctions:
• A reprimand;
• An order to immediately cease the act complained of and/or to (further) refrain from doing the act, or in the case of a challenged omission, to act in accordance with the Code of Conduct;
• An order to take the measures necessary to guarantee compliance with the Code in the future;
• A rectification order;
• An order to recall distributed material;
• Publication of the decision on different media including the sanction or measure imposed.

The Inspection for Health and Youth Care, the Code Commission and the KOAG have made working agreements in which they have divided the different competences. In general, the Code Commission deals with all complaints or violations of the advertisement rules. This is only different when the Inspection beliefs the violation causes an imminent threat to the public health or safety, or when it concerns another serious violation of the advertisement provisions. In that case, the Inspection will take over.

The Advertising Code Committee (Reclame Code Commissie) (Code Committee and the Board of Appeal are responsible for assessing whether advertising is made in accordance with the provisions of the Dutch Advertising Codes (meaning in this case: the Code AGP and the Code AMD)). The Advertising Code Committee can judge a complaint as unfounded or founded.

If the complaint is found founded by the Commission, then they can do a ‘‘recommendation’’ in which they recommend the advertiser to no longer advertise in such way. The Commission can also decide to provide a ‘‘non-binding advice’’ or to issue a press release.

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