In the Netherlands, the regulatory framework for pharmaceutical advertising is laid down in both international and national legislation and self-regulation.

Legislation

The EU rules on advertising and promotion of medicinal products as set out in Directive 2001/83/EC on the Community code relating to medicinal products for human use (as amended) have been implemented in Chapter 9 of the Dutch Medicines Act. Therefore, the Dutch Medicines Act is the primary national legislation governing pharmaceutical advertising.

In addition, the general rules on unfair commercial practices and on misleading or comparative advertising as laid down in Articles 6:193a-193j and 6:194-196, respectively, of the Dutch Civil Code (DCC) must be taken into account.

Self-Regulation

In the Netherlands, the self-regulatory landscape is diverse.

More detailed rules for pharmaceutical advertising are laid down in self-regulatory codes, such as the CGR Code of Conduct for Pharmaceutical Advertising (CGR Code of Conduct), which contains details on medicinal advertising, and the Code for Advertising Medicinal Products to the General Public (Code AGP), which is part of the Dutch Advertising Code and lays down the rules with regard to advertising of medicinal products to the general public.

In the Netherlands, self-regulation is a system of private regulation which is in principle only binding on those who have subscribed to it.

The Dutch Advertising Code, which includes the Code AGP, is a self-regulatory instrument drawn up by representatives of advertisers, advertisement producers and distribution channels, consumer organisations, and civil-society actors. This code is non-binding; nevertheless, it is broadly supported and enforced.

The CGR Code of Conduct is drawn up by the Foundation for the Code for Pharmaceutical Advertising Commission. This foundation was established by various trade associations in the pharmaceutical industry. The CGR Code of Conduct is only binding on those parties who are members of the aforementioned trade associations.

However, Dutch courts have ruled that the CGR Code of Conduct is widely supported and have used (ie, through case law) the Code of Conduct to interpret relevant open norms in the Dutch Civil Code (DCC), and have held non-regulatees to the CGR Code of Conduct, meaning that the CGR Code of Conduct has generally binding force in practice.

Slightly different definitions of “advertising” are used in Directive 2001/83/EC, the Dutch Medicines Act, the Code AGP and the CGR Code of Conduct, respectively.

As the majority of cases involving pharmaceutical advertising are conducted before the CGR Code Commission, the following definition of “advertising” as included in the CGR Code of Conduct is worth mentioning: “any form of public and/or systematic, direct or indirect commendation of medicinal products and any services or images connected therewith, including offering or solicitation of goods or services in the interactions between authorisation holders and healthcare professionals” (Rule 3.1h CGR Code of Conduct).

It should be clear from this definition that the term “advertising” may be understood and interpreted very broadly.

Information or Advertising

Determining what should be considered information and what should be considered advertising is not easy. The objective of the communication is the decisive element in distinguishing advertising from mere information. If the objective is promotional in nature, then the communication will be qualified as advertising. If there is no promotional objective, the communication will be classified as mere information.

The question whether a communication concerns information or advertising must be determined on a case-by-case basis, in which connection the following factors are (or could be) taken into account (Rule 5.1.3 CGR Code of Conduct):

• the addressee;
• the content, presentation and design of the communication; and
• the context of the communication.

Disease Awareness Campaigns

Information relating to human health or diseases will not be considered advertising, provided that there is no reference, even indirect, to medicinal products. If there is such a reference, whether it qualifies as advertising or mere information will be dependent on the content of the communication.

Package Leaflets

Labelling and accompanying package leaflets for medicinal products are not considered advertising. This exemption only applies to the literal and complete reproduction of the labelling or package leaflet. When this information has been selected and rewritten by the authorisation holder, the information may be considered advertising.

As previously stated, every communication must be judged individually to determine whether it qualifies as advertising or mere information. Therefore, press releases, press conferences and interviews cannot, by definition, be considered as advertising.

However, a press release regarding a medicinal product would be regarded as an advertisement if the purpose of the message and the objective pursued is to promote the prescription, supply, sale or consumption of that medicinal product. If, in this case, the press release concerns a prescription-only medicinal product, the general prohibition on the advertising of prescription-only medicinal products to the general public would be breached.

Any advertising that explicitly or by implication makes reference to a competitor or competing medicinal products or substances is considered comparative advertising. According to both the Code AGP and CGR Code of Conduct, comparative advertising is in principle allowed, provided that certain conditions are satisfied, most notably that the comparison:

• cannot be misleading;
• cannot be detrimental to the value of the medicinal products in question;
• must be demonstrably scientifically correct and in line with the most recent state of the science (this must be demonstrated by means of one or more scientific studies); and
• must relate to all relevant characteristics of the medicinal products.

In the case of comparative advertising for over-the-counter medicinal products aimed at the general public, no brand names may be used (Rule 26 Code AGP). The use of brand names is allowed in comparative advertising for medicinal products aimed at healthcare professionals.

A medicinal product is not authorised if no marketing authorisation has been granted for it. Use of an authorised medicinal product by a healthcare professional to treat a patient in a manner that is not covered by the marketing authorisation and is not described in the SmPC is considered “off-label” use.

In the Netherlands, advertising for medicinal products that have not been authorised and/or for off-label use of authorised medicinal products is in principle prohibited.

Information about unauthorised medicinal products, such as unauthorised medicinal products that have been prepared magisterially, is permitted. The same applies for information on off-label use, provided that the information is based on the latest state of scientific knowledge and practice and within the bounds laid down in the Dutch Medicines Act (Rule 5.7.1.a CGR Code of Conduct).

During scientific conferences directed at healthcare professionals, the same principles as discussed in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications apply: information about unauthorised medicinal products and off-label use thereof is permitted, and advertising is not.

However, an exception applies in a strictly international context. Advertising for unauthorised medicinal products is permitted during a scientific meeting only if all three conditions below are satisfied (Rule 5.2.1.1b CGR Code of Conduct):

• the advertisement is published during a meeting which has a truly international nature in terms of organisation, and where a significant proportion of the speakers and participants are from countries outside the Netherlands;
• the advertisement is undeniably not targeting the Netherlands; and
• the medicinal product to which the advertisement refers is registered in at least one major industrialised country.

In principle, it is permitted to provide information on unauthorised medicinal products and off-label use of authorised medicinal products to healthcare professionals, provided the information does not qualify as advertising.

Reactive correspondence, possibly accompanied by material of a non-promotional nature, and needed to answer a specific question about a particular medicinal product, qualifies as information. The same applies to proactive communication of frequently-asked questions (FAQs), provided that the questions and answers:

• concern the correct, safe and responsible use of medicinal products; and
• cannot be deemed to be advertising in view of their content, presentation and design.

In the Netherlands, the government is responsible for setting the basic health insurance package, the maximum prices for authorised medicinal products and the available resources. Therefore, there is no reason to send information on unauthorised medicinal products and off-label use of authorised medicinal products to healthcare institutions for budget reasons.

In the Netherlands, the Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen) can give permission for bringing a medicinal product on the market which has not (yet) been granted a marketing authorisation, if it involves a severe condition for which no alternative medicinal product is available on the market. This is known as a compassionate use programme.

In the assessment of the admissibility of the compassionate use programme within the framework of the advertising rules, the following three aspects are relevant:

• the rules for public advertising of prescription-only medicinal products – ie, to what extent the patient is involved in the programme;
• the rules for payment for services provided by healthcare professionals in the context of the implementation of the programme; and
• whether the programme promotes the rational use of the medicinal product in question.

As a result of the way the programme is set up, the following should be prevented:

• the relevant patients being confronted with advertising for prescription-only medicinal products;
• a financial relationship being entered into between the authorisation holder and the healthcare professional with the apparent object of promoting the prescription of the medicinal product; and/or
• the financial interests of patients negatively affecting the rational use of the medicinal product.

Advertising of medicinal products to the general public is prohibited if:

• such products are exclusively available on prescription;
• such products are available without prescription, but contain psychotropic substances or narcotics as referred to in List I and II of the Dutch Opium Act; and
• 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) (Rule 3 Code AGP).

Thus, only advertising for over-the-counter medicinal products is permitted. These are:

• over-the-counter medicinal products that may only be sold at a pharmacy (Pharmacy-only PH, Uitsluitend Apotheek UA);
• over-the-counter medicinal products that may be sold in pharmacies and drugstores (Pharmacy and Drugstore-only PDO, Uitsluitend Apotheek of Drogist UAD); and
• over-the-counter medicinal products that may be sold freely and, therefore, also in “standard” shops, webshops and supermarkets (General Sales GS, Algemene Verkoop AV).

Advertising for over-the-counter medicinal products to the general public must include the following information (Rule 8.1 Code AGP):

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

Advertising for over-the-counter medicinal products to the general public may not mention the reimbursement status, as that might encourage people to not buy the product themselves, but to request prescription (Rule 12 Code AGP).

An authorisation holder is allowed to support an activity undertaken by a patient organisation in the form of grants or sponsorship, if the following is taken into account (Rule 6.6.2 CGR Code of Conduct):

• the support must relate to innovative and/or quality-improving activities and have as a goal the direct or indirect improvement of patient care or the advancement of medical science;
• direct or indirect advertising for one or more specific prescription-only medicinal products is prohibited; and
• the information on prescription-only medicinal products must comply with the requirements for information.

The support needs to be recorded in a written agreement, which includes the following (Rule 6.6.3 CGR Code of Conduct):

• a description of the object of the support;
• a detailed description of the rights and obligations of the patient organisation and the authorisation holder;
• the scope of the support (in cash or kind), expressed in euros; and
• the patient organisation’s obligation to communicate that the relevant activity has been sponsored in whole or in part by the authorisation holder.

Advertising for medicinal products aimed at healthcare professionals must state the following, in conformity with the summary of product characteristics (SPC) (Rule 5.4.1 CGR Code of Conduct):

• the name of the product;
• the name and address of the party responsible for marketing the product;
• the qualitative and quantitative composition of the active ingredients;
• the pharmaco-therapeutic group;
• the pharmaceutical form;
• the therapeutic indications;
• the principal adverse reactions;
• the principal warnings;
• the contraindications; and
• the classification of the medicine with respect to its dispensing.

Article 91(1) of Directive 2001/83/EC states that member states may also require advertising to, among others, indicate the selling price and/or the conditions for reimbursement by social security institutions. However, such a requirement has not been included in the Dutch Medicines Act or in the CGR Code of Conduct.

Advertising of medicinal products must be consistent with the information contained in the summary of product characteristics (SPC) of the relevant medicinal product. An advertisement may not include claims that contradict the SPC of the relevant medicinal product (Rule 5.2.1.2 CGR Code of Conduct).

However, there is room for information about new developments, such as clinical studies that are not (yet) included in the SPC, provided that the information is compatible with the SPC (Rule 5.7.1 CGR Code of Conduct).

There are no specific rules that govern the advertising of a combination of medicinal products. In principle, the advertising of a combination of medicinal products is permitted, if that combined use is included in the summary of product characteristics (SPC) and is in conformity with the other requirements for advertising.

In case law, the CGR Code Commission has ruled that where the combination is not included in the SPC, the advertising would falsely suggest that the combined use of the medicinal product has been assessed and permitted by the registration authorities and would thus amount to unlawful advertising of an unauthorised medicinal product.

In principle, authorisation holders may provide reprints of journal articles to healthcare professionals. However, in most cases this will be deemed a form of advertising, meaning that the content of the journal article (in addition to any accompanying materials) must conform with the applicable advertising rules.

For example, in one case where the reprint was used to provide more detail about the safety profile of a medicinal product, the provision of the reprint was allowed, as it communicated relevant information to healthcare professionals.

In another case, where in the reprint a medicinal product was compared on effectiveness with another medicinal product, the provision of the reprint by the authorisation holder to healthcare professionals was qualified as unlawful comparative advertising, as the article involved related to a study that, according to the CGR Code Commission, was incomprehensive, because the adverse reactions (in the long-term) were not assessed as well. 

Although the CGR Code of Conduct contains various rules regarding medical sales representatives (MSRs, artsenbezoekers), (the actions of) medical sales liaisons (MSLs) are not explicitly regulated. 

As it is generally accepted that the actions of MSRs are (partly) aimed at the promotion of medicinal products and thus qualify as advertising, MSRs are limited to having on-label proactive discussions with healthcare professionals about the authorised medicinal products they support.

As MSLs are generally seen as non-promotional, reactively having in-depth scientific discussions with healthcare professionals, they are able to reactively discuss yet unauthorised (pipeline) medicinal products, as well as to have off-label discussions. However, it is also prohibited for MSLs to promote an unauthorised medicinal product or to promote an authorised medicinal product for off-label use. Therefore, proactive communication in this respect and/or the dissemination of such information in a promotional context (eg, during an event) should be avoided.

A distinction should be made between advertising of prescription-only or over-the-counter medicinal products to healthcare professionals and advertising of over-the-counter medicinal products to the general public.

All advertising to the general public must be approved in advance by the Inspection Board for the Public Promotion of Medicines (Keuringsraad KOAG) (ex Rule 3 under c Code AGP).

In the case of advertising to healthcare professionals, it is the responsibility of the authorisation holder to ensure proper compliance with the relevant advertising rules.

Each authorisation holder must establish a scientific service. The scientific service must include a medical doctor or a pharmacist who will be responsible for approving any promotional material before release.

The authorisation holder is further obliged to keep a detailed administration of all its advertising, including a sample of each advertising, an overview of the persons to whom it was addressed, the method of distribution and the first date of dissemination. The administration must remain available for at least five years.

Internet Advertising

The rules that apply “offline” also apply “online”. Therefore, websites which are accessible to the general public may not contain advertising of prescription-only medicinal products, as that would amount to unlawful promotion of prescription-only medicinal products to the general public. No specific rules apply for advertising on the internet of over-the-counter medicinal products.

Product Sites

So-called product sites, which are websites with a brand name of a prescription-only medicinal product in their URL addresses, and corporate websites which are accessible to the general public, are permitted, provided that only general technical user information about the prescription-only medicinal product and brief information of a subordinate nature about the relevant disease is provided there (Rule 5.8.12 CGR Code of Conduct). 

Hyperlinks

Hyperlinks or banners on product sites and corporate sites to third-party websites are allowed, provided that:

• the link leads to the homepage/landing page of that third-party website;
• the content of the third-party website complies with the CGR Code of Conduct; and
• it is clear for the visitor of the website that the hyperlink or banner leads to a third-party website that is not the responsibility of the party whose website the visitor is leaving.

As advertising of prescription-only medicinal products to the general public is prohibited in the Netherlands, any advertisements of such products on websites intended for healthcare professionals may not reach the general public. In practice this will mean that such websites need to be password-protected, and the passwords should not be easily guessable or available for the general public. A password that consists of the (brand) name of the prescription-only medicinal product, for example, will therefore most likely not be enough.

Types of Information

A distinction should be made between two types of information on public health or human diseases:

• information that contains no reference, not even indirectly, to a prescription-only medicinal product; and
• information which refers, directly or indirectly, to a prescription-only medicinal product.

Targeted Public

Further, a distinction should be made between provision of such information to:

• the general public; and
• patients who have already been prescribed a prescription-only medicinal product.

The first type of information is generally allowed.

Consistent, Complete and Balanced Information

The CGR Code of Conduct only covers the type of information which refers, directly or indirectly, to a prescription-only medicinal product (Rule 5.7.1 CGR Code of Conduct). The provision of this type of information to the general public online is allowed, provided that the information does not qualify as disguised advertising and certain requirements have been met, most importantly that the information is consistent with the government-approved texts (such as the package leaflet and the SPC), is not misleading and is complete and balanced. The latter means that if information on different forms of therapies is given, all the relevant treatments must be mentioned.

Technical and Specific User Information

An exception to the main rule that information must be complete and balanced, and thus that all relevant treatments must be mentioned, applies for technical and specific user information on the relevant prescription-only medicinal product targeting patients who have already been prescribed that prescription-only medicinal product (Rule 5.8.10 CGR Code of Conduct). In this case, the alternative treatments do not have to be mentioned. However, there is a requirement that this information may not be generally available. For the internet, this means that this information must be placed behind a password.

(Online) Scientific Meetings

The Netherlands does not have a specific set of rules that governs online scientific meetings. There is one set of rules that applies for physical as well as virtual/online scientific meetings (see also 9.3 Sponsorship of Scientific Meetings).

Relevant Hospitality Costs for Online Meetings

There will be no recreational costs or travel or accommodation costs in the case of online scientific meetings. Relevant hospitality costs can be the registration costs, for example where physical course materials are sent to the participants. Where the course materials are distributed digitally, the associated costs cannot be individualised, and those costs do not then qualify as hospitality costs, but will then qualify as general organisational costs. The latter will also apply for other costs made for the development and offering of the online scientific meeting.

International Events

An online scientific meeting can qualify as an “international event” if it has a truly international nature in terms of organisation and a significant proportion of the speakers and participants are from countries outside the Netherlands.

Advertising of medicinal products which is communicated to participants of an online international event may refer to medicinal products which are not registered in the country where participating healthcare professionals are based, or which are registered under different conditions, as long as the advertising is accompanied by a suitable statement indicating the countries in which the medicinal product is registered and makes clear that the medicinal product or indication is not registered locally (Rule 5.2.1.1 CGR Code of Conduct).

As previously mentioned, the main rule is that all which applies “offline” also applies “online” (Rule 5.5.1 CGR Code of Conduct).

Aimed at the Dutch Public

As the reach of social media knows no national borders, and as the CGR Code of Conduct only applies to expressions that are accessible in the Netherlands and are unmistakably aimed at the Dutch public, whether this is the case for each specific social media post must be ascertained.

General Requirements

The mere fact that the medicinal product the social media post is about is also available in the Netherlands is not decisive. The following aspects may be relevant:

• the language of the social media post;
• the nationality of the sender;
• the question whether and (if so) in what manner reference is made in national media to the social media post;
• the presence of references to the use, availability or price of the advertised medicinal product in the Netherlands; and
• the presence of a typically Dutch setting and/or other associations with the Netherlands.

Advertising of Prescription-only Medicines

Advertising for prescription-only medicinal products on social media is only possible if it is made certain that the advertising is only directed towards those healthcare professionals that have an interest in obtaining the information. Social media has technical possibilities for this purpose by means of pre-registration and/or the use of usernames and passwords. Use must be made of these technical possibilities.

Further, it is important to note that any information that the authorisation holder obtains via social media about the adverse effects of a particular medicinal product must be followed up according to the applicable pharmacovigilance rules.

General Anti-bribery Rules

In the Netherlands, general anti-bribery rules are incorporated in the Dutch Penal Code. A distinction is made between bribery of public officials and bribery of others working under an employment contract or acting as an agent. Further, as there are two parties to a bribe – the briber (the one who offers the bribe) and the person being bribed (the one who has to do something in exchange) – a distinction is made between active bribery (bribing someone) and passive bribery (being bribed):

• general bribery – Article 328ter Dutch Penal Code (both active and passive bribery); and
• bribery of public officials – Article 177 (active bribery) and Article 363 (passive bribery) Dutch Penal Code.

Anti-bribery Rules Applicable to Healthcare Professionals

A healthcare professional can be affiliated with a healthcare institution, such as a hospital, on various legal grounds. The healthcare professional may have a civil service appointment, an employment contract or can also be self-employed.

A healthcare professional who has a civil service appointment, for example a healthcare professional working in a university medical centre, is also a public official. In this case, the above-mentioned articles applicable to bribery of public officials apply.

Where the healthcare professional is working under an employment contract, the above-mentioned article applicable to general bribery applies.

Where the healthcare professional is self-employed, technically none of the above-mentioned articles apply.

Sanctions

General bribery (both active and passive) is punishable by a prison term not exceeding four years or a fine of the fifth category (EUR90,000). Bribery of public officials (both active and passive) is punishable by a prison term not exceeding six years or a fine of the fifth category (EUR90,000).

The CGR Code of Conduct makes a distinction between inducements and other financial relations.

Inducement

Inducement is one of the means of influencing the behaviour of persons or organisations with the apparent goal of sales promotion. Inducement is defined as a “financial relation with the apparent object of promoting the prescription, supply or use of a medicinal product”.

Exemptions

In general, inducements are prohibited by the Dutch Medicines Act (Article 94) and the CGR Code of Conduct (Rule 6.1.1). Specific exemptions for relations with healthcare professionals are provided for:

• inexpensive gifts that may be relevant to the practice of the healthcare professional (Rule 6.2.2 CGR Code of Conduct);
• discounts granted for the supply of medicinal products, if, in the case of discounts in kind, such discounts are awarded in the form of bonus supplies of the same medicinal product, or, in the case of cash discounts, if these discounts are recorded explicitly and in writing (Rule 6.2.3 CGR Code of Conduct);
• a limited number of free samples of medicinal products (Rule 6.2.4 CGR Code of Conduct);
• services that may be provided by healthcare professionals, or a grouping of healthcare professionals and/or an institute in which healthcare professionals participate or by which they are employed, to pharmaceutical companies, provided that the service agreement must be recorded in writing in advance and the services are subject to reasonable payment for the services provided (subsection 6.3 CGR Code of Conduct); and
• certain hospitality costs as part of meetings and manifestations (subsection 6.4 CGR Code of Conduct).

Other Financial Relations

Other financial relations that serve a healthcare interest and/or are considered to be normal in legal transactions do not fall under the definition of inducement. The CGR Code of Conduct distinguishes three types of “other financial relations”:

• financial relations with parties other than healthcare professionals (Rule 6.5.2 CGR Code of Conduct);
• sponsorship of projects relating to innovative and/or quality-improving activities (Rule 6.5.3 CGR Code of Conduct); and
• (partly) making scientific awards for care-improving and/or medical scientific performances possible (Rule 6.5.4 CGR Code of Conduct).

Financial relations with parties other than healthcare professionals are not subject to the prohibition on inducements and are therefore permitted, in short, if there is no apparent goal of sales promotion (Rule 6.5.2 CGR Code of Conduct).

Sponsorship of healthcare activities and projects, and contributions to scientific awards, are permitted if it is determined that an apparent goal of sales promotion is lacking. It is presumed that there is no apparent goal of sales promotion if the relevant cumulative conditions, which are provided for by the CGR Code of Conduct for these categories, are met.

The guiding principle is that an authorisation holder must refrain from offering gifts to healthcare professionals. An exception is made for inexpensive gifts that are relevant to the practice of the healthcare professional (Rule 6.2.2 CGR Code of Conduct). 

A gift is considered inexpensive if the value does not exceed EUR50, including VAT, with a maximum of EUR150 per year. These sums apply per healthcare professional and per authorisation holder.

In principle, no samples of medicinal products should be given, other than on an exceptional basis. For medicinal products containing psychotropic substances or narcotics, it is prohibited to provide samples altogether. For other medicinal products, healthcare professionals may not receive more than two samples of the same medicinal product per calendar year. After a period of two years after a healthcare professional has requested a sample, no new samples of the same medicinal product may be provided.

Authorisation holders must keep adequate records of the samples of medicinal products they have provided and of the healthcare professionals to whom they have provided the samples, and on which date and in what quantities. These records are subject to a retention period of five years.

If a medicinal product is assigned a new indication, this medicinal product is qualified as new and samples may be provided (Rule 6.2.4 CGR Code of Conduct).

Scientific meetings may be sponsored by authorisation holders, but only within certain limits. The most important rules regarding financial contributions by pharmaceutical companies are as follows (subsection 6.4 CGR Code of Conduct).

• Social/recreational costs (entertainment) may not be paid for.
• Restrictions apply for any costs that can be traced to an individual (these are “hospitality costs”); examples are registration fees, meals and drinks for participants, hotel stays and travelling expenses, as well as the costs of printing handouts, programme booklets and conference bags for participants. These hospitality costs must remain limited to what is strictly necessary for their participation in the event. In addition, the sponsoring of the hospitality costs of healthcare professionals may in no event exceed EUR500 per occasion (otherwise the participant must cover at least half of the hospitality costs) and EUR1,500 annually for every separate therapeutic class.
• In general, no limits apply for the sponsoring of general organisational costs, which are costs that cannot be individualised, such as the costs of hiring conference rooms, preparations, and the costs and expenses of the speakers.
• As a matter of principle, a surplus/positive balance without a specific destination is not permitted, if it is formed by the sponsoring of pharmaceutical companies. In any event such a surplus/positive balance may not be used for social/recreational activities. In order to judge whether sponsoring is permitted, a budget must be prepared before the scientific meeting and a final settlement must be made after the scientific meeting.

Any hospitality offered or provided by an authorisation holder may not include relaxation. This includes visiting museums and/or sport events.

However, certain hospitality may be offered or provided in relation to manifestations. If events do not qualify as (scientific) meetings and the programme still meets the information needs of healthcare professionals, then they will qualify as manifestations.

Hospitality in relation to manifestations should also be strictly limited to what is necessary for participation (Rule 6.4.8 CGR Code of Conduct), whereby:

• the costs incurred by the authorisation holder for the hospitality per healthcare professional may not exceed the amount of EUR75 per occasion and EUR375 per year; and
• the arrangements for the hospitality provided are laid down in a written agreement, in which the performance must be clearly defined – this requirement does not apply if the hospitality only concerns participation in a manifestation organised by the authorisation holder concerned, without reimbursement of travel and/or accommodation costs.

Under the CGR Code of Conduct, a “donation” or “grant” is considered “sponsorship”. Sponsorship is understood to include all forms of support (monetary or in kind).

In principle, sponsorship may not benefit an individual healthcare professional. In such a case, an apparent object of promoting the prescription, supply or use of a medicinal product is assumed, making the sponsorship subject to the prohibition of inducement (Rule 6.5.3c CGR Code of Conduct).

Subject to certain conditions, such as that the sponsorship relates to innovative and/or quality-improving activities and has as a goal the direct or indirect improvement of patient care or the advancement of medical science, sponsorship may be awarded to collaborations of healthcare professionals, such as partnerships or other legal entities in which healthcare professionals are active (Rule 6.5.3c CGR Code of Conduct). This does not apply for Pharmacotherapeutic (Transmural) Consultation (Farmacotherapeutisch (transmural) overleg), for the reason that it is not considered desirable that FT(T)Os be sponsored by authorisation holders. 

Discounts in kind (provided they are given in the form of bonus supplies of the same medicinal products) or discounts in cash are permitted (Rule 6.2.3 CGR Code of Conduct), provided the discounts are granted in a transparent way.

Giving 100% discounts on supplies of medicinal products is considered permissible in principle.

There is in principle no objection to the provision of services by health professionals to authorisation holders, on the condition that:

• such services are relevant to the practice of medicine, pharmacy, dentistry, nursing or midwifery – these services can be of a different nature, and may include lecturing, consulting or participating in pharmaceutical research;
• the service agreement is recorded in writing in advance; and
• the services are subject to a reasonable hourly rate and to payment of reasonable expenses.

For services provided by healthcare professionals, maximum hourly rates have been determined. These rates are indexed yearly. In 2023, the maximum hourly rates range from EUR87 (eg, for a nurse with a post-secondary vocational education (MBO)) to EUR267, for a professor.

If the hospitality provided for by an authorisation holder relates to a meeting/manifestation taking place abroad, the meeting/manifestation must be submitted to the CGR Code Commission for prior approval.

Foreign meetings are exempt from this prior approval requirement where they are truly international in scope, have a significant proportion of speakers and participants from countries other than the Netherlands, and are organised by an association of healthcare professionals by a scientific organisation or other groups or bodies independent of the pharmaceutical industry, or the content of which has been classified as scientific by a scientific association or a body independent of the pharmaceutical industry and recognised by the profession concerned.       

Transparency Register

Since 25 April 2013, financial relationships between healthcare professionals registered in the Dutch BIG Register (a legal, online and public register for Professions in Individual Health Care (Beroepen in de Individuele Gezondheidszorg)) and pharmaceutical companies must be disclosed in the online Dutch Healthcare Transparency Register (DHTR). Since 1 January 2015, financial relationships between patient organisations that are established in the Netherlands and pharmaceutical companies must also be disclosed in the DHTR.

The DHTR has no formal basis in Dutch law, but is the result of self-regulation. The DHTR is governed and operated by the Foundation Transparency Register Care (Stichting Transparantieregister Zorg).

Financial Relationships

A financial relationship is defined as a direct or indirect financial compensation in cash or in kind or otherwise, provided by an authorisation holder to a healthcare professional practising in the Netherlands, respectively, to a patient organisation that is established in the Netherlands.

All above-defined financial relationships must be recorded in written agreements. These written agreements do not need to be disclosed. Only the following must be provided for in the DHTR:

• the name of the healthcare professional involved (doctor, pharmacist or nurse), the partnership (eg, scientific association or partnership) or the institution (hospital, patient organisation);
• the name of the authorisation holder concerned;
• the nature of the financial relationship (eg, services agreement or sponsorship);
• the total amount or fee paid by the authorisation holder that year per individual financial relationship; and
• the year in which the financial relationship took place.

As mentioned, the Dutch Healthcare Transparency Register (DHTR) has no formal basis in Dutch law, but is the result of self-regulation.

Currently, the affiliated organisations behind the following have joined the DHTR:

• the Foundation for the Code for Pharmaceutical Advertising (CGR);
• the Foundation for the Code of Conduct for Medical Devices (GMH); and
• the Code of Commendation of Veterinary Products (CAVP).

The above means that only the members of the CGR, GMH and CAVP have to disclose their relevant financial relationships with healthcare professionals practising in the Netherlands, respectively, with patient organisations established in the Netherlands in the DHTR, regardless of whether those members are foreign companies or already have products on the market.

It must be noted, though, that through memberships, the CGR, GMH and CAVP by and large cover the Dutch (veterinary) pharmaceutical and medical devices industry as well as healthcare professionals practising in the Netherlands.

For supervision of the rules regarding pharmaceutical advertising, the Netherlands has a dual system: legislation and self-regulation.

Legislation

As previously stated (see 1.1 Laws and Self-Regulatory Codes Regulating Advertising on Medicines), the Dutch Medicines Act is the primary national legislation governing pharmaceutical advertising. Compliance with the Dutch Medicines Act is monitored and enforced by the Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd).

Self-Regulation

Compliance with the Dutch Advertising Code is monitored by the Advertising Code Committee (Reclame Code Commissie). There is also an Appeals Board, which can assess complaints in the second instance. Compliance with the CGR Code of Conduct is monitored by the CGR Code Commission (Codecommissie CGR) and in the second instance by the Appeals Committee of the CGR Code Commission.

The Inspection Board for the Public Promotion of Medicines (Keuringsraad KOAG) is charged with the preventative supervision of self-regulation of advertising for (over-the-counter) medicinal products to the general public (ex Rule 3 under c Code AGP).

As the Code AGP is both a special code of the NRC and an integral part of the CGR Code of Conduct (ex Rule 5.6.1 CGR Code of Conduct), for reactive supervision, a complainant can turn to both the Advertising Code Committee as well as to the CGR Code Commission. Although the CGR Code Commission mainly focuses on pharmaceutical advertising aimed at healthcare professionals, the CGR Code Commission also handles complaints about allegedly prohibited advertising for prescription-only medicinal products to the general public.

When confronted with a (competing) authorisation holder that infringes the rules for pharmaceutical advertising, in most cases, there are various bodies one can turn to and various sets of rules one can invoke.

The options include the following.

• Reporting the infringement of the Dutch Medicines Act to the Health and Youth Care Inspectorate, which can subsequently take action.
• Filing a complaint with one of the following self-regulatory bodies:
1. the CGR Code Commission for breach of the CGR Code of Conduct; or
2. the Advertising Code Committee for breach of the Code AGP and/or the NRC. 
• Initiating civil proceedings before the Dutch courts against the authorisation holder for breach of the relevant rules on unfair commercial practices and/or on misleading or comparative advertising as laid down in the DCC. As, under Dutch law, the violation of a statutory provision only establishes civil liability for damage caused to another person if the statutory provision concerned aims to protect against the damage (Schutznorm-principle), and it is established in case law that the advertising rules of the Dutch Medicines Act do not aim to protect the (commercial) interests of competing pharmaceutical companies, those advertising rules cannot be invoked by an authorisation holder against a competitor, at least not directly.

The possible sanctions that can be imposed for violation of medicinal products advertising rules and rules on inducements to prescribe differ in nature and severity depending on the enforcement body dealing with the violation.

Health and Youth Care Inspectorate

In the case of a violation of the advertising rules included in the Dutch Medicines Act, the sanction can be an administrative fine, which is dependent on the size of the company (for a big company the maximum fine is EUR150,000) and on whether it regards a first offence or a repeated offence (for the third offence the maximum fine is EUR450,000).

Further, in order to prevent damage to public health, the public officials of the Health and Youth Care Inspectorate are authorised to seize medicinal products and/or suspend or terminate the trade of medicinal products.

It is, however, current practice for the Health and Youth Care Inspectorate to only impose a fine in the case of a violation of the medicinal products advertising rules.

Self-Regulatory Bodies

Where a complaint that is brought before the CGR Code Commission is ruled founded, the CGR Code Commission can impose the following 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 CGR Code of Conduct;
• an order to take the measures necessary to guarantee compliance with the CGR Code of Conduct in the future;
• a rectification order;
• an order to recall distributed material; and
• publication of the decision on different media including the sanction or measure imposed.

A decision of the Appeals Committee of the CGR Code Commission qualifies as a binding advice (ex Article 7:900(2) DCC) between parties that:

• are members of an organisation belonging to the Foundation for the Code for Pharmaceutical Advertising (CGR); or
• have voluntarily submitted to the authority of said Appeals Committee.

The authors believe the same applies for a decision of the CGR Code Commission in the first instance, if said decision is not (timely) appealed.

The Advertising Code Committee can rule that a complaint is founded, unfounded or inadmissible. If the complaint is ruled as founded, a recommendation can be issued to the advertiser to refrain from advertising in the way that was found in breach of the rules. The Advertising Code Committee can also decide to provide non-binding advice or to issue a press release.

Dutch Courts

In proceedings on the merits, Dutch courts can, among others:

• render an injunction, for example to refrain from the contested advertising;
• award damages suffered by the claimant, for example as a result of the contested advertising by the defendant;
• render a declaratory judgment; and
• rule that compliance with the court order is subject to penalties (dwangsommen).

Dutch procedural law also provides parties with opportunities to request short-term measures (provisional remedies) in preliminary relief proceedings. The most common and significant provisional remedies issued in preliminary relief proceedings include the preliminary prohibitory injunction (verbod in kort geding), such as the order to refrain from the contested advertising, and the preliminary mandatory injunction (gebod in kort geding), such as a rectification order. These injunctions can be subject to a penalty, if so requested.

There is a difference in the binding power of the judgments rendered by courts and those rendered by self-regulatory bodies.

The Advertising Code Committee can only provide non-binding advice. Judgments by the CGR Code Commission (and its Appeals Committee) are only binding on those parties who have subscribed to it, through memberships of trade associations, who in turn are the member organisations of the Foundation for the Code for Pharmaceutical Advertising.

However, as the Dutch Civil Code contains various open (and as a result vague) norms – such as “misleading advertising” – that need to be filled in/developed in case law, which Dutch civil courts have not hesitated to do with the content of self-regulatory codes and/or the judgments of self-regulatory bodies, the scope of self-regulation is extended, so that it has generally binding force in practice.

There is already an example of a case concerning pharmaceutical advertising in which a non-regulatee to the CGR Code of Conduct was held to comply with its content, as the court held that the use of the code in the sector was so omnipresent that the court adopted the self-regulation as being the norm applicable in the pharmaceutical sector.

In 2021, two separate cases were brought before Dutch civil courts in proceedings between competing pharmaceutical companies regarding the use of refund schemes for medicinal products not (yet) included in the so-called basic package, meaning that the costs of those products were not (yet) reimbursed via the statutory health insurance in the Netherlands. The central question brought before the courts was whether such a refund scheme in itself qualified as unacceptable advertising. This question was answered in the negative.

In 2022, for the first time, a case was brought the CGR Code Commission regarding an advertisement about the carbon footprint of a medicinal product. One of the central questions to be answered was whether this type of advertising fell within the scope of the CGR Code of Conduct. This question was answered in the positive.

Prohibited Advertising

Advertising veterinary medicines that have no market authorisation is prohibited.

Advertising of prescription-only and Opium Act-listed veterinary medicines to the “public” is prohibited. Veterinarians, dealers in veterinary medicines and professional animal keepers are not regarded as “public”.

Authority

The Royal Dutch Society for Veterinary Medicine (KNMvD) and the Association of Manufacturers and Importers of Veterinary Medicines in the Netherlands (FIDIN) have jointly established a code for promoting veterinary products and have set up a disciplinary committee to handle complaints about violations of this code, the Committee on the Promotion of Veterinary Products (CAVP).