In the Netherlands, the regulatory framework for pharmaceutical advertising is laid down in both international and national legislation and self-regulation.
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.
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):
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.
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:
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 184.108.40.206b CGR Code of Conduct):
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:
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:
As a result of the way the programme is set up, the following should be prevented:
Advertising of medicinal products to the general public is prohibited if:
Thus, only advertising for over-the-counter medicinal products is permitted. These are:
Advertising for over-the-counter medicinal products to the general public must include the following information (Rule 8.1 Code AGP):
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 needs to be recorded in a written agreement, which includes the following (Rule 6.6.3 CGR Code of Conduct):
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):
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 220.127.116.11 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.
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.
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 or banners on product sites and corporate sites to third-party websites are allowed, provided that:
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:
Further, a distinction should be made between provision of such information to:
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.
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 18.104.22.168 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.
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:
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):
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.
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 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”.
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:
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 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).
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:
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:
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.
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).
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:
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 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.
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).
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.
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.
Where a complaint that is brought before the CGR Code Commission is ruled founded, the CGR Code Commission can impose the following sanctions:
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:
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.
In proceedings on the merits, Dutch courts can, among others:
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.
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”.
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).
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