Pharmaceutical advertising regulation and medical device advertising in the Netherlands

1.1 Medicines 

The Medicines Act (Geneesmiddelenwet- Gmw) 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. Furthermore, the self-regulatory codes as mentioned under question 2 are applicable.

1.2 Medical devices 

The Medical Devices Act (Wet medische hulpmiddelen - Wmh) 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 mentioned under question 2.

The Dutch Civil Code (with respect to the general advertising provisions) must also be taken in consideration. 

2.1 Medicines 

The details on medicine advertisement are regulated in the Code of conduct on Pharmaceutical Advertisement (Gedragscode Geneesmiddelenreclame – CGR ). 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 voor de Publieksreclame voor Geneesmiddelen - CPG) is applicable. 

2.2 Medical devices 

Advertisement regarding all sorts of medical devices or advertisement to healthcare professionals is regulated by the Code of Conduct for Medical Devices (Gedragscode Medische Hulpmiddelen –GMH) The Code on Advertisement for Medical (self-care) Devices  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. 

3.1 The general public 

Sellers of medicinal product can apply for a review and authorisation of an advertisement (claim) by the (self-regulatory) Inspection Board for the Public Promotion of Medicines (Keuringsraad Openlijke Aanprijzing Geneesmiddelen or KOAG). All advertisements on medicines to the general public that have a valid authorisation number issued by the KOAG and are considered to be compliant. The Dutch governing authorities in this respect (Nederlandse Voedsel en Waren Autoriteit or NVWA and Inspectie Gezondheidszorg en Jeugd or IGJ) have arrangement with the KOAG that supervision on those claims will be performed by the KOAG. 

The option to submit an advertorial or claim to KOAG for review is not available for medical devices. 

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. 

Prescription-only medicines 

Prescription-only medicines and medicines that are not prescription-only but do contain a 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 substance as mentioned in list I or II of the Opium Act. 

 5.1 Medicines 

Under the Medicines Act and supplementary industry codes (CGR/CPG), the following key restrictions apply to advertising medicines to the general public. 

Public advertising is not permitted for prescription-only medicines or for non-prescription medicines containing substances listed under the Opium Act. Medicines without a marketing authorisation may also not be advertised, nor may homeopathic medicines lacking approved therapeutic indications. 

Advertisements must not suggest that:

• Medical consultation or surgery is unnecessary due to the product.
• The product has no side effects, or is equal or superior to other treatments.
• Normal good health can be improved by using the product, or harmed by not using it.
• Safety or efficacy derives from the product being a "natural" substance. 

Public advertisements must not:

• Be aimed exclusively or primarily at children. 
• Include endorsements from scientists, professionals, or public figures. 
• Equate the product with food, cosmetics, or other consumer goods.
• Encourage incorrect self-diagnosis through detailed depictions of medical histories.
• Refer to claims of cure in a misleading manner, or use frightening imagery of illness, injury, or bodily changes.
• State that statutory social health insurance covers the product. 

All advertising must be consistent with the government-approved Summary of Product Characteristics (SPC) and must promote the rational, pharmacotherapeutically sound use of the medicine. It must not mislead the audience in any way. 

The following promotional activities are not permitted: 

• Distributing free samples of medicines. 
• Making direct or indirect price offers, issuing vouchers, or running refund promotions. 
• Tying purchase of the product to competitions, contests, or gifts. 

Note: Certain prohibitions above do not apply to public advertising that promotes participation in a vaccination programme. 

5.2 Medical devices 

Under the GMH and CMH codes, the following restrictions apply to advertising medical devices to the general public. 

Statements about medical devices must not be misleading in any way. They must be accurate, up to date, truthful, correct, and verifiable, and must not compromise standards of good taste and decency or the reputation of the industry, healthcare professionals, or medical devices. 

The CMH imposes further restrictions on medical devices in pharmaceutical form with a physical effect that are intended for use by the public without professional intervention. 

Forbidden advertisement:

• Advertising is prohibited for devices that do not comply with the Medical Devices Act and Decree.
• Advertising must not conflict with the information on packaging or enclosed instructions for use.
• Advertisements may not provide any guarantee regarding performance. 

Advertisements must not suggest that:

• Use of the device renders medical examination or treatment unnecessary, or discourages such treatment.
• Normal good health may be impaired without the device, or improved by using it.
• The device has no side effects (though the absence of a specific, distinctive, and demonstrable side effect may be mentioned).
• The device is safe, unless the relevant safety context is clearly explained.
• Safety or efficacy is due to "natural" materials, unless proven accurate and relevant compared to similar products. 

Advertisements must not: 

• Be aimed exclusively or primarily at children. 
• Contain endorsements from scientists, healthcare professionals, or public figures whose fame could encourage use. 
• Use frightening or misleading depictions of illness, injury, or bodily changes. 
• Encourage incorrect self-diagnosis through detailed medical histories, or refer misleadingly to claims of cure.
• State the extent or speed of weight loss per unit of time for weight-control devices, or include any element of competition.
• State that devices can be reimbursed on prescription.
• Use secondary characteristics of the device as the primary reason for purchase.
• Contain derogatory statements about other products, services, or ideas.
• Refer to a device as "new" for longer than two years after its introduction. 

6.1. Medicines 

Advertising a medicinal product is prohibited if: 

• No marketing authorization has been granted for the product.
• The advertising is misleading or fails to present the product objectively, thereby not promoting its rational use.
• It takes the form of teleshopping broadcasts. 

Free samples of prescription-only medicines may only be provided if all of the following conditions are met: 

• The prescribing professional has submitted a dated, personally signed request.
• The sample does not exceed the smallest commercially available package size.
• No more than two samples of the same product are supplied per professional per calendar year.
• The sample is labeled as free and not for sale, and a copy of the summary of product characteristics is included.
• The supplier maintains records of the recipient, date, and quantity. 

Samples containing substances listed under the Opium Act (Lists I or II) may never be supplied.

Providing financial or other incentives to promote the prescription, dispensing, or use of a medicinal product is prohibited, unless the arrangement falls within one of the following exceptions with respect to forbidden inducement:

• The professional provides a proportionate, written service in return that is relevant to their professional practice. 
• The benefit is limited to hospitality strictly necessary for participation in a professional meeting or event.
• The benefit is of minor monetary value, no counter-service is required, and it is relevant to the professional's practice. 
• The benefit consists of purchase-related discounts or bonuses granted to pharmacists, general practitioners, drugstore owners, or other legally designated persons or bodies.

Additional restrictions following from the CGR Code: 

• Telemarketing is only permitted based on a prior appointment with the professional. 
• The supplier must refrain from offering gifts, waiving invoices (other than upon full payment), tying medicine prices to other purchases, or providing any other incentive that could create an undue sense of obligation towards the supplier. 

6.2 Medical devices 

In relation to healthcare professionals, the Medical Device Act also prohibits gunstbetoon with respect to interactions between healthcare professionals and suppliers of medical devices unless: 

• it concerns the provision of services, provided that these are reasonable in relation to the money provided or offered or to the goods or services that can be valued in monetary terms, are laid down in a written agreement, and are relevant to the supplier or to the professional practice of the natural person involved in the use of a medical device or an in vitro diagnostic medical device;
• it concerns money or services or goods that can be valued in monetary terms, for which there is no corresponding service provided by the natural person involved in the application of a medical device or an in vitro diagnostic medical device, provided that these are of minor value and relevant to the practice of their profession;
• it concerns discounts and bonuses relating to the purchase of medical devices or in vitro diagnostic medical devices. 

The GMH has similar and more elaborate restrictions with regard to gunstbetoon when it comes to different sorts of interaction categories between suppliers and healthcare professionals, more specifically; 

1. Bonuses and discounts related to business transactions
2. Gifts 
3. Financial contributions to the costs of (participating in) meetings for healthcare professionals; 
4. Meetings organised by independent third parties 
5. Product related meetings organised by suppliers 
6. Accredited and other meetings organised by suppliers 
7. Remuneration for Services 
8. Sponsoring projects or activities other than meetings 

7.1 Medicines

All written advertising directed at healthcare professionals must include, at a minimum and in accordance with the SPC: 

• Name of the medicinal product
• Name and address of the marketing authorization holder 
• Qualitative and quantitative composition of active ingredients 
• Pharmacotherapeutic group (where relevant) 
• Pharmaceutical form
• Main therapeutic indications and clinical efficacy
• Most important side effects (based on frequency and severity) 
• Most important warnings and precautions 
• Contraindications
• Classification regarding dispensing (prescription-only or not) 

Additional requirements for documents handed out or sent to healthcare professionals: 

• Whether the product is covered under statutory health insurance 
• The date the document was drawn up or last amended 

The general principle is that all advertising must be accurate, up-to-date, truthful, verifiable, and sufficiently complete to enable the healthcare professional to assess the product's therapeutic value. Quotations, tables, or illustrations from scientific publications must be accurately reproduced with precise source citations. 

The required information must be presented in a location and font that does justice to its importance. Where the information is too extensive for a standard format, reference may be made to its location elsewhere in the medium. 

Exception: These content requirements do not apply to reminder advertisements that only mention the name of the medicinal product. 

7.2 Medical devices 

There is no specific legislation or Code for the information that must appear in advertising advertisements of medical devices to healthcare professionals, other than that is not contrary to the general restrictions as provided above under 6.

8.1 Medicines

 The Gmw sets forth that advertising to the general public must meet the following requirements: 

1. the advertisement is presented in such a way that the message is clearly recognized as advertising by the public and it is clear to the public that it concerns a medicinal product; 
2. the advertisement includes the name as well as the generic name if the medicinal product contains only one active ingredient; 
3. the advertisement contains information essential for the proper use of the medicinal product; 
4. the advertisement contains an explicit request to read the package insert or the text on the outer packaging. 

Advertisements for herbal medicinal product as specified in the Gm, must state that it is a traditional herbal medicinal product, specify the indications for which it is used, and indicate that these indications are based solely on long-standing use.

The CGR and the CPG ,further specify these obligations. 

8.2 Medical devices 

The GMH sets forth the general principles with respect to communications (including advertisements) of medical devices. Communications regarding medical devices:

• must not be misleading in any way; 
• must be accurate, up-to-date and truthful; 
• must be correct and verifiable; 
• must not undermine the applicable standards of good taste and decency, nor the reputation of the industry, healthcare professionals and medical devices. 

The accuracy of claims must be substantiated by appropriate evidence. 

The CPMH contains the rules for 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. These include: 

• Advertising must not contradict the information on the packaging and in the enclosed instructions for use. 
• Advertisements must include at least the following (unless situations in which the use of the over-the counter medical device is not recommended need not be mentioned in media with space or time constraints, provided that this does not mislead the consumer): 
  • the name of the over-the-counter medical device; 
  • the statement “medical device”;
  • the main intended uses and the situations in which use is not recommended; 
  • an explicit request to read the instructions for use. 
  • The advertisement is presented in such a way that the message is clearly recognized as advertising by the public, and it is absolutely clear to the public that it concerns a medical self-care product.
• Testimonials should accurately reflect the user experience 
• Advertisements must be written in language that is understandable to the general public. Medical and scientific terminology should be avoided in order to prevent confusion or ambiguity. 

According to the Gmw: 

• Public advertising is prohibited if it contains an endorsement or a reference to an endorsement by scientists, professionals, or public figures. 
• In the documents for health professionals, any quotations, tables, or other illustrations taken from scientific publications or medical journals must be reproduced exactly and accompanied by precise citations. 

According to the CGR: 

• When using unpublished research the principal investigator in question has given prior consent;
• All quotations from publications must be accurate and properly cited; care has been taken to ensure that the use of these quotations does not conflict with the intent of the publication, and the cited publications reflect the current state of science and technology. 
• Information may include references to scientific studies and findings, provided they are drawn from published articles that are generally accepted by the scientific community. The source must always be cited. The studies and findings referred to must primarily come from sources other than the marketing authorization holder and must be verifiable. Selective referencing is not permitted. Prescription-only and Opium Act-listed medicine 

Medical devices in pharmaceutical form 

According to the CPMH advertisements must not, directly or indirectly, contain endorsements from scientists, healthcare professionals, or public figures who, by virtue of their fame and reputation, could encourage the use of over-the-counter medical products. 

Advertisement must give an objective representation of facts and may not be dissaving or exaggerate its characteristics. 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. Comparative advertising of medicines and medical devices is permitted, but it must follow specific rules set out in the CGR (Code of Conduct for Pharmaceutical Advertising). Whenever an advertisement compares one medicinal product with another—whether naming a competitor explicitly or referring to one implicitly—the following conditions must all be met: 

1. The comparison must not be misleading. Only products that meet the same need or serve the same purpose may be compared. The comparison must objectively address one or more essential, relevant, verifiable, and representative characteristics of the products, such as their clinical efficacy. 
2. The comparison must not unnecessarily diminish the value of other products. 
3. Competitors must not be discredited. 
4. The comparison must not create confusion. 
5. Products must not be presented as imitations.
6. No unfair advantage may be taken from a competitor's reputation. The comparison must not exploit the goodwill associated with a competitor's trademark, trade name, or other distinctive features. 
7. The comparison must be scientifically accurate and up to date. All comparative claims must be demonstrably supported by one or more scientific studies published in peer-reviewed journals that are of sufficient quality and persuasiveness, and must reflect the latest scientific knowledge.
8. The comparison must be comprehensive and balanced. It must address the effects, side effects, indications, contraindications, and other relevant data of the products being compared.

According to the CPG:

• Advertisements must not state, or imply through their wording or images, that the product is more effective than, or equally effective as, another medicine or medical treatment. 
• Any implicit or explicit comparison with other medicinal products must be demonstrably accurate and must not detract from the value of other substances or preparations. The following conditions also apply to comparisons: 
  • No use of brand names; 
  • The products compared must be comparable;
  • The comparison must cover all relevant characteristics. 

According to the CPMH:

• Advertisements must not contain derogatory statements about other products, services, or ideas, nor must they use wording or images that give that impression.
• Any implicit or explicit comparison with other medical (self-care) devices or other products must be demonstrably accurate and must not detract from the value of those other products. The following conditions also apply to comparisons: 
  • No use of brand names; 
  • The products must be comparable; 
  • The comparison must cover all relevant characteristics. 

Lastly the GMH states that statements regarding medical devices may not harm the accepted norms of good taste and decency and the reputation of the industry, healthcare professionals and medical devices. 

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. 

According to the CGR (Article 5.5.1) advertising at exhibitions and trade fairs or via audio, visual, audio-visual and/or other methods (such as 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 these methods. 

The Health and Youth Care Inspectorate (IGJ) monitors compliance with the legal regulations governing the compliance with the Medicines Act and the Medical devices Act. It also oversees the operations of self-regulatory bodies. There are two self-regulatory organizations, each with their own area of responsibility: 

1. CGR – Foundation for the Code on Medicinal Product Advertising that supervises of advertising aimed at healthcare professionals and is supervised by the IGJ 
2. KOAG/KAG – Review Board for Public Promotion of Medicines / Promotion of Health Products that supervises public advertising for medicines (e.g., advertising on TV, radio, online) and is supervised by the IGJ. 

The IGJ, the CGR and the KAG/KOAG have made working agreements in which they have divided the different competences. In general, the CGR deals with all complaints or violations of the advertisement rules. This is only different when the IGJ 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 IGJ will take over. 

The Advertising Code Committee (Reclame Code Commissie- RCC) (CGR and the Board of Appeal are responsible for assessing whether advertising is made in accordance with the provisions of the the Dutch Advertising Codes (meaning in this case: the CCPG and the CPMH)). 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. 

In case of a violation of the Medicines Act, the sanction can be a fine, :

• to suspend or terminate the trade or provision of a medicinal product or to withdraw a medicine or substance from the market. g is made in accordance with the provisions of 0 

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 (as good as) final texts of the new Regulation and Directive on medicinal product for human use (the Pharma Package) have been published and will introduce a new legal framework on a European level. The preliminary review indicates that there will not be a major change in the advertisement regime, but minor tweaks in the legislation on advertisement can be expected.