Pharmaceutical Advertising 2024 Comparisons

The following regulate advertising of medicinal products in Denmark:

• Chapter 7 of the consolidated Danish Medicines Act No 339 of 15 March 2023 (the “Act”); and
• Executive Order No 849 of 29 April 2021 on Advertising of Medicinal Products (the “Advertising Order”), as amended by Executive Order No 134 of 25 January 2022.

The Advertising Order is supplemented by Guideline No 9400 of 20 April 2022 on Advertising on Medicinal Products (the “Guidelines”) (collectively, the “Legislation”). The Danish Medicines Agency (the “Agency”) and the Danish Ministry of Health (the “Ministry”) monitor compliance with the Legislation.

In addition, the consolidated Danish Marketing Practices Act No 866 of 15 June 2022 (the “Marketing Practices Act”) sets out the general standards for advertising in Denmark and authorises the Danish Consumer Ombudsman to monitor advertising activities and sanction non-compliance with the Marketing Practices Act.

The self-regulatory body within the pharmaceutical industry in Denmark is the Ethical Committee for the Pharmaceutical Industry (ENLI). ENLI has issued the Pharmaceutical Industry’s Code of Practice on Advertising, etc of Medicinal Products aimed at Healthcare Professionals (the “Promotion Code”). The provisions in the Promotion Code are in line with the Legislation, although in some cases the Promotion Code provides for stricter requirements. The Promotion Code is supplemented by guidelines (the “Promotion Code Guidelines”).

The Promotion Code applies to:

• members of the Danish Association of the Pharmaceutical Industry (LIF);
• members of the Danish Generic Medicines Industry Association (IGL);
• members of the Danish Association of Parallel Distributors of Medicines;
• the Danish Association of Parallel Distributors of Pharmaceuticals; and
• a number of other companies that have voluntarily agreed to comply with ENLI’s rules.

The rules thus apply to the majority of pharmaceutical companies on the Danish market, and from a compliance perspective the legal importance of these rules is quite high.

The provisions of the Promotion Code are only applicable with respect to activities that are partially or fully directed at Danish healthcare professionals. However, the provisions also apply to activities that are exclusively directed at foreign healthcare professionals, provided that these activities are held in Denmark.

The term “advertising” in the context of medicinal products is defined in Section 1 of the Advertising Order as follows:

“Advertising of medicinal products means any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.”

The definition in the Advertising Order is thus identical to the definition in Article 86(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (the “Directive”).

The Promotion Code incorporates the same definition of advertising by direct reference to the Advertising Order.

In line with case law from the European Court of Justice (eg, case C-421/07, Frede Damgaard), the term “advertising” is interpreted broadly under Danish law. Thus, all types of advertising regardless of media used (eg, written materials, direct mails, activities by employees, use of the internet and social media, electronic media, videos, brochures, product samples, gifts and hospitality) are covered by the definition.

The Advertising Order specifically lists a number of areas where the provisions regarding advertising do not apply; see its Section 2. By default, these areas are found to be “informational” rather than “promotional”:

• labelling of medicinal products and package leaflets;
• individual correspondence that responds to a specific query about a specific medicinal product;
• necessary specific information or documentation that serves safety and not advertising purposes;
• price lists, product catalogues, etc;
• informative material on health and disease provided there is no direct or indirect reference to specific medicinal products;
• patient information leaflets accompanying a prescription as part of prescribing a medicinal product or supplied by the pharmacy when dispensing medicinal products (which only contain factual information of importance to patients and their relatives);
• press releases (provided that certain requirements are fulfilled – see 2.3 Restrictions on Press Releases Regarding Medicines); and
• unedited and unabbreviated reproduction of a package leaflet, the officially approved product summary or publicly available evaluation report (see Section 72(1) of the Act) or an image of a medicine package, provided that the information is made available in such a way that users have to search actively for this information.

From these exemptions it can be seen that the rules on advertising of medicinal products do not apply to information material regarding health and diseases, assuming there is no direct or indirect reference to specific medicinal products. Accordingly, disease awareness activities and other patient-facing information do not qualify as advertising, provided they are not deemed to be indirectly “designed to promote” a medicinal product.

In addition to the above, scientific exchange with healthcare professionals at congresses in Denmark is also exempted from the definition of advertising, provided that certain criteria are fulfilled (see 3.2 Provision of Information During a Scientific Conference).

Other examples of communication exempted from the definition of advertising are advisory board activities and other consultancy arrangements based on legitimate needs.

The Promotion Code incorporates the same exemptions by direct reference to the Advertising Order; see Section 2(2) litra c.

According to the Advertising Order, Section 2(7) (see 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information), the rules on advertising of medicinal products do not apply to press releases to the extent that these:

• contain objective (saglig in Danish) and brief information regarding a medicinal product;
• have general news value;
• have the press as the target group; and
• are sent or made available to a multitude of journalists and media with a view to journalistic assessment and processing prior to publication.

Thus, under Danish law, press releases are seen as information exempted from the rules on the advertising of medicinal products provided they comply with the above and do not contain advertising of medicinal products. Whether the latter is the case will depend on a case-by-case assessment. Recent Danish case law indicates that the courts interpret Section 2(7) narrowly and that each of the above-mentioned requirements must be clearly met if the press release is not to be seen as advertising.

If a pharmaceutical company has paid for a press release in the media, the press release will not fall under the “press release exemption” but rather be seen as advertising. According to the Guidelines, a pharmaceutical company is only allowed to make a press release available in its online news section for approximately three weeks. Following this period, but subject to requirements under, for example, Danish financial securities legislation, the press release will typically no longer be covered by the exemption.

Comparative advertising for medicinal products is allowed, but is subject to a number of restrictions. According to Section 16 of the Advertising Order, comparative advertising must clearly state which medicinal products the comparison concerns. The comparison must only concern medicinal products that are relevant to compare (as a rule, medicinal products that share the same indication(s)), and the comparison must be made on the basis of the information in the products’ Summary of Product Characteristics (SmPC).

Further, comparisons relating to price must always include the current prices of the products; cf Section 63 of the Act. With respect to a comparison concerning prices of pharmacy-only medicinal products, the comparison can be made based on the prices published on medicinpriser.dk.

As a rule, a comparison is only permissible if it covers all generic (and any parallel imported) medicinal products that do not differ in therapeutic form or strength, or that do not differ substantially in pack size. Medicinal products with an insignificant market share can be excluded from the comparison. A market share of up to 2–3% is generally considered as insignificant.

Section 16(2) of the Advertising Order provides that comparative advertising must be prepared on the basis of the information appearing from the SmPCs of the products being compared – in so far as the SmPCs include information about the particulars being compared.

When comparing over-the-counter (OTC) products in advertising directed at the general public, it is not legal to give the impression that the effect of a product is better or just as good as the effect of another product; cf Section 16(3) of the Advertising Order.

In addition to the above, comparative advertising will also be subject to the general provisions of the Legislation, the Promotion Code (Section 8 concerning comparative advertising) and the Marketing Practices Act (for example, the prohibition against misleading and/or disparaging advertising).

According to Section 64 of the Act and Section 3(1) of the Advertising Order, it is prohibited to advertise for medicinal products that are not sold or dispensed in Denmark. A new medicinal product cannot be sold or dispensed until it has been approved by means of a marketing authorisation granted by the Agency or the European Commission.

Additionally, anyone placing a pharmacy-only medicinal product on the Danish market must notify its price to the Agency no later than 14 days prior to the price’s effective date; cf Section 77(1) of the Act. Thus, the price can be notified earlier than 14 days before the price is to take effect. For some non-pharmacy medicinal products, it is required that their available pack sizes have been notified to the Agency, also at 14 days’ notice; cf Section 78(1) of the Act.

Based on these provisions, and considering that the term “advertising” is interpreted broadly, providing information on unauthorised products or unauthorised indications will often be seen as illegal pre-launch advertising or off-label advertising. The permissibility must in any case be assessed on a case-by-case basis.

The Promotion Code also contains a prohibition against pre-launch and off-label advertising, and ENLI has also issued a guide on pre-launch to aid in the assessment of whether the mention of a medicine that has not been authorised will be considered as illegal pre-launch advertising or neutral information (eg, scientific mentioning).

The Legislation does not regulate this separately. ENLI has, however, issued a guideline regarding participation of pharmaceutical companies in international congresses in Denmark which in many ways also reflects the Agency’s practice in this area.

When providing information during scientific conferences, the critical point will be to distinguish between “advertising” and “scientific information”. In previous cases, both the Agency and ENLI have clarified that not all references to a medicinal product will be seen as advertising and may be permissible, for example in the context of company-sponsored symposia including presentations of scientific data in a scientific forum (eg, on an international congress for healthcare professionals).

The Agency and ENLI consider that such a symposium may be seen as scientific, if the following criteria are fulfilled:

• the symposium is a part of the congress programme;
• the content of the symposium is approved by an impartial congress committee; and
• the external speaker has developed the content, formulation and perspective of the subject(s) in the presentation.

Moreover, it may be of importance how the symposium is branded as this can lead to it being seen as promotional.

Exhibition stands are considered as commercial areas. Information on unauthorised products available in exhibition stands can therefore very easily be seen as illegal pre-launch promotion.

Mention of scientific studies and data to healthcare professionals relating to Phase I and II studies is generally seen as scientific information, as it is by no means certain that the development will lead to a marketing authorisation for a specific medicinal product. To avoid this being seen as advertising, the information must, however, be presented in a neutral and non-promotional way.

As mentioned, ENLI has issued a guide on pre-launch, according to which each of the following factors may indicate that specific material will be seen as unlawful pre-launch advertising:

• the pharmaceutical company has published the results of Phase III studies;
• the pharmaceutical company has submitted its application for marketing authorisation to the relevant authorities;
• the pharmaceutical company has obtained a “positive opinion” from the European Medicines Agency/the Food and Drug Administration (FDA) – if the product is approved by the FDA, mentioning this product in Denmark will be seen as advertising for a product not yet approved in Denmark/the EU;
• the pharmaceutical company knows the results from Phase III studies and/or has positive interim results; and/or
• the pharmaceutical company is working on an indication expansion study on an already approved product.

A pharmaceutical company’s unsolicited/proactive approach to a healthcare professional regarding medicinal products or its indications will typically be seen as advertising. If the products and/or indications in question are unauthorised, this will in itself constitute illegal advertising (pre-launch or off-label advertising). Further, unsolicited contact with a healthcare professional without prior consent may also, depending on the circumstances, constitute a violation of the Marketing Practices Act.

As mentioned in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information, individual correspondence (accompanied by documents of a non-promotional nature, if necessary) that responds to a specific query about a medicinal product is exempted from the advertising rules. Therefore, in the case of a reactive reply to a question from a healthcare professional, the company could be allowed to answer – in writing – a specific question relating to, for example, off-label use. However, it must be ensured that the answer does not go beyond the question asked as this could constitute advertising (including unlawful advertising claims for off-label use). Also, the correspondence must be “individual” and the exemption will therefore not cover, for example, emails to several recipients, replies given in a forum of healthcare professionals, or the company’s response to queries made on the internet in a blog or similar forum (as such correspondence may be accessed by anyone). The Agency has stated that the exemption does not apply to verbal queries and responses.

As previously noted, initiating unsolicited contact with healthcare professionals regarding unauthorised medicines or unauthorised indications will generally constitute illegal pre-launch or off-label advertising.

Depending on the circumstances, the exemption regarding price lists set out under 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information may be relevant. According to this exemption, price lists, product catalogues, etc, containing no other information about the medicinal products besides their names, pharmaceutical form, strengths, pack sizes, prices and images of the product packaging will not be covered by the advertising rules.

Again, unsolicited contact with a healthcare professional without prior consent may also, depending on the circumstances, constitute a violation of the Marketing Practices Act. In any case, the Marketing Practices Act provides that prior consent is required before approaching anyone – including healthcare professionals – by means of electronic mail for the purposes of direct marketing.

In principle, it is permitted to publish the availability of compassionate use programmes. However, pursuant to Section 3 of the Advertising Order, it is not legal to promote a medicinal product sold or dispensed according to a compassionate use permit.

Pursuant to the Act, the advertising of prescription-only medicinal products towards the general public is prohibited. The “general public” is defined in the Legislation as anyone who is not a doctor, dentist, veterinarian, pharmacist, nurse, veterinarian nurse, pharmacologist, midwife, bio-analyst, clinical dietician, radiographer, social and healthcare worker, or a student within one of these professions.

Advertising of OTC products towards the general public is allowed subject to certain restrictions.

As a general rule, all advertising of medicinal products (prescription-only and OTC) must be complete and objective (saglig in Danish) and must not be misleading or exaggerate the qualities of the product. Furthermore, information in advertising material must be in accordance with the SmPC; cf Section 63 of the Act.

It is prohibited to advertise towards the general public medicinal products that are inappropriate for use unless the patient has first consulted a doctor with a view to diagnosis or monitoring of the treatment; cf Section 66(1)(2) of the Act. Furthermore, it is prohibited to advertise towards the general public medicinal products that are covered by the Danish Act on Euphoriant Drugs; cf Section 66(1)(3) of the Act.

Section 10(1) of the Advertising Order further sets out a number of specific restrictions as to the content of advertisements to the public. An advertisement must not:

• give the impression that it is unnecessary to consult a doctor;
• give the impression that a surgical operation is unnecessary;
• give the impression that the effects of taking the medicinal product are guaranteed, are without adverse reactions or are better than or equivalent to the effect of another treatment, including a medicinal product;
• give the impression that general health can be enhanced by taking the medicine;
• give the impression that health could deteriorate by not taking the medicinal product;
• be directed exclusively or principally at children;
• include recommendations by health professionals, scientists or other persons, associations of persons, institutions, companies, etc, who by virtue of their prestige could encourage the consumption of medicinal products;
• compare the medicinal product with a foodstuff, cosmetic or other consumer product;
• give the impression that the safety or efficacy of the medicinal product is due to the fact that its active substances are natural;
• be such that it might lead to erroneous self-diagnosis;
• contain exaggerated, alarming or misleading claims of recovery; or
• use, in exaggerated, alarming or misleading terms, visual representations (pictures, illustrations, etc) of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof.

Pursuant to the Advertising Order, it must be clear from the advertising towards the general public that the communication constitutes advertising (ie, disguised advertising is prohibited) and it must be clear that the advertising concerns a medicinal product.

The specific requirements regarding mandatory information that must be provided in connection with advertising of OTC medicinal products towards the general public are described in more detail in 4.2 Information Contained in Pharmaceutical Advertising to the General Public.

The Promotion Code does not apply to promotion to persons who are not healthcare professionals – eg, patients and citizens; cf Section 2(2) of the Promotion Code.

Advertising material directed at the general public must, as a rule, contain the following:

• the name and international non-proprietary name (INN) of the medicinal product;
• information on the size of the packaging;
• references to an up-to-date price on medicinpriser.dk, if it is a pharmacy-only medicinal product;
• the indication(s), as specified in the SmPC;
• side effects;
• dosing;
• a request to read the information on the package leaflet or the package; and
• other information deemed necessary in relation to correct and proper use of the product.

It is at the discretion of the marketing authorisation holder to determine which particulars are necessary to include to enable consumers to form a correct and adequate picture of the medicinal product and its use; cf Section 63 of the Act.

In general, any contraindications, special precautions for use, drug interactions, relevant overdose risks and special warnings that are mentioned in the SmPC should be included. Information which, based on objective criteria, is considered irrelevant to give to the public can be omitted. If requested by the Agency, the marketing authorisation holder must explain why one or more particulars from the SmPC have been omitted.

Specific information requirements apply in relation to outdoor advertising and advertising in movies, on the radio and on television; cf Sections 6–7 of the Advertising Order.

The relationship between pharmaceutical companies and patients is not specifically regulated by the Legislation, but is covered by the provisions regarding advertising to the general public (patients are part of the “general public”). For example, it is not legal to provide any type of hospitality, accommodation or the like when advertising medicinal products to the public; cf Section 20 of the Advertising Order.

As previously mentioned, the Promotion Code covers only the interaction between a pharmaceutical company and healthcare professionals and is, therefore, not relevant in relation to patient interaction.

The term “patient organisations” is defined in the Advertising Order, Section 1(7) and the Act, Section 71d, and covers organisations of patients and relatives that have the purpose of catering for a group of patients’ interests. However, the Ethical Rules for the Collaboration between Patient Organisations, etc and the Pharmaceutical Industry issued by ENLI (the “Patient Organisation Code”) apply to a wider scope of patient and consumer organisations.

Regarding the pharmaceutical industry’s interaction with patient organisations, it follows from Section 21 in the Advertising Order that a patient organisation must disclose all funding or benefits in kind that the organisation receives from pharmaceutical companies. Accordingly, funding can be provided to such patient organisations.

The Patient Organisation Code lays down various provisions on contract terms and transparency. Contracts under which the organisations provide any type of services to pharmaceutical companies are permitted only if such services are provided for the purpose of supporting healthcare or research. Also, it is permitted to engage organisations as experts or advisers for services; for example, in relation to participation at advisory board meetings and/or speaker services. This requires, however, that the form and content requirements in the code regarding the contract as such are fulfilled.

Specific restrictions apply in relation to financial support from pharmaceutical companies to patient organisations. In principle, support can be granted for all types of activities, projects and purposes within the sphere of the organisation’s work, provided that “professional activities” are the main intention of the collaboration and that any services to be provided are proportionate to the compensatory measures. Support must not be made conditional upon the organisation taking specific stands regarding professional or political topics. The company must naturally also not require organisations to favour specific products and no exclusivity agreements may be concluded. Organisations are thus always free to collaborate with other pharmaceutical companies and pharmaceutical companies may collaborate with one or several organisations. The Patient Organisation Code also sets out provisions on disclosure of support as well as levels of accommodation and hospitality.

Provisions on obligatory information in advertising for healthcare professionals are contained in the Advertising Order. Advertising material directed at healthcare professionals must include the following information:

• the name and the INN of the medicinal product;
• the name of the marketing authorisation holder;
• indication(s) as specified in the SmPC (in advertising material exclusively directed at a limited group of healthcare professionals, the indication text may be reduced to the extent relevant to the group concerned);
• contraindications;
• adverse reactions and risks;
• dosage;
• pharmaceutical forms;
• pack sizes;
• reference to the current price on medicinpriser.dk, if it is a pharmacy-only medicinal product;
• dispensing group;
• reimbursement status; and
• the date on which the advertising material was generated or last revised.

A similar provision regarding compulsory information is contained in Section 5 of the Promotion Code. However, according to this section the name and address of the pharmaceutical company or its representative must also be included.

According to Section 7(6) of the Promotion Code, words that indicate that the medicinal product is “safe” may not be used to describe the product. Likewise, words that indicate that a medicinal product is “new” may not be used to describe a product or packaging that has been generally available or for a therapeutic indication for which there has been widespread use of advertising measures for more than one year. Also, it is not legal to state that a medicinal product has no adverse reactions, no toxic effects or no risk of addiction.

Claims regarding a medicinal product that are not substantiated by the SmPC can be made only by reference to scientifically substantiated research; cf Section 13(4) of the Advertising Order and Section 7(5) of the Promotion Code. The research must have been published in established and independent Danish or foreign professional journals or similar. Further, the research must, prior to publication, have been subjected to an independent assessment (peer review). References such as “data on file”, posters and abstracts normally do not satisfy these requirements and consequently cannot be used as documentation.

That said, the Guidelines provide that data on file that has been made subject to an independent review similar to the review undertaken prior to acceptance by a recognised scientific journal and that has been acknowledged as credible in peer review may be used as documentation until comparable information has been published, publication of the information has been rejected or new information has disproved the scientific validity of the material.

ENLI has issued a guide on information material and documentation which sets out the requirements for documentation, including examples of what is considered as permissible documentation.

Advertising for medicinal products must always be in accordance with the SmPC. Thus, advertising for use in combination with another product must be in accordance with the SmPC. However, reference to another product in advertising may be permissible if supported by scientifically substantiated research, provided that it is not inconsistent with the SmPC.

Pursuant to Danish law, advertising of companion diagnostics is regulated in accordance with the rules on advertising for medical devices. Advertising for medical devices is regulated in Executive Order No 715 of 24 May 2022 on Advertising of Medical Devices, and the Executive Order is supplemented by Guideline No 10357 of 29 December 2014 on Advertising on Medical Devices.

Although advertising for medical devices is regulated separately from medicinal products, the rules are in many ways similar in Denmark. Thus, all advertising of medical devices must be complete and objective (saglig in Danish) and must not be misleading or exaggerate the qualities of the device.  Furthermore, information in advertising material must be in accordance with the purpose and intended use of the device as declared by the manufacturer; cf Section 2 of the Executive Order on Advertising of Medical Devices.

Pursuant to the Guidelines, it is not regarded as advertising when a pharmaceutical company provides scientific articles to a healthcare professional on request, provided that such articles are sent without comment and without supplementary materials, and provided that the articles have already been published in a recognised, independent Danish or international journal.

The important distinction is whether the reprints are distributed based on the pharmaceutical company’s or on the healthcare professional’s initiative, as the company’s unsolicited distribution of scientific articles will normally be considered advertising. In such cases, the advertising must be in accordance with the SmPC and the materials distributed must be enclosed with the compulsory information mentioned in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals.

It must also be considered whether the reprint will be seen as a gift (ie, value to be clarified according to applicable rules). Typically, supplying reprints to a healthcare professional is permitted on condition that this is directly relevant to the practice of the healthcare professional and directly benefits patients. Overall, reprints must also be of an insignificant value (see 9.1 Gifts to Healthcare Professionals).

The term “Medical Science Liaisons” is not used in the Legislation. However, the Advertising Order uses the term “medical sales representatives”, meaning persons who provide information about and promote medicinal products to healthcare professionals on behalf of pharmaceutical companies.

The Advertising Order provides that medical sales representatives must have completed adequate training and possess sufficient scientific knowledge enabling them to give precise and adequate information about the products they promote.

Essentially, the activities of medical sales representatives must observe the general rules concerning advertising of medicinal products. Any unsolicited/proactive approach to a healthcare professional on behalf of a pharmaceutical company regarding medicinal products or its indications will highly likely be seen as advertising. If the products and/or indications in question are unauthorised, this will constitute illegal advertising (pre-launch or off-label advertising).

Further, dissemination of materials of a promotional nature to healthcare professionals must observe the requirements described in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals, meaning, inter alia, that the advertising must be in accordance with the SmPC and that the materials distributed must be enclosed with the mandatory information.

However, as previously mentioned, it is permitted to engage organisations as experts or advisers for services; for example, in relation to participation at advisory board meetings. This requires that the form and content requirements in the code regarding the contract as such are fulfilled.

The Legislation does not contain any requirements concerning prior notification of or approval from the authorities as regards advertising for medicinal products.

However, pharmaceutical companies that are subject to the Promotion Code are obligated to notify the following activities to ENLI:

• activities that are organised or co-organised by a pharmaceutical company (eg, meetings, congresses, conferences, symposia, courses, etc) and that are partially or fully directed at Danish healthcare professionals;
• activities where a pharmaceutical company provides financial support (sponsor support) to a third-party event that is fully or partially directed at Danish healthcare professionals or to the participation of Danish healthcare professionals; and
• activities where a pharmaceutical company buys an exhibition stand at a congress in Denmark.

Further, pharmaceutical companies are obligated to report all kinds of printed advertising material (printed leaflets, handouts, website material, etc) aimed at healthcare professionals on the Danish market.

Notification deadlines for each of the above are set out in Section 21 of the Promotion Code. The company is obligated to file a report online via ENLI’s website using a standard form, and is obligated to ensure that the notification is complete and that all relevant documentation is submitted.

A pharmaceutical company seeking a pre-publication vetting of an activity and its compliance with the Promotion Code may also apply for a pre-approval. Applications are submitted online and are subject to a fee.

Pursuant to Section 68 of the Act, the pharmaceutical company must store a copy (printed or digital) of any marketing material for a medicinal product for at least two years.

Pursuant to Section 17 of the Advertising Order, the following additional information must also be stored:

• the target group;
• the means/method of distribution;
• an overview of the media where the advertising has been shown; and
• the period of time when the advertising has been used.

Accordingly, even though there is no specific requirement to adopt standard operating procedures or similar internal policies, pharmaceutical companies must be able to handle the collection of relevant material and the storage thereof, as documentation must be presented if requested by the authorities.

The Advertising Order Sections 18 and 19 set out certain requirements for consultants and sales representatives of pharmaceutical companies. For example, such consultants and sales representatives must have received appropriate training and possess the knowledge to be able to provide precise and complete information on the medicinal products in question.

The Promotion Code Section 20 contains similar provisions regarding consultants and lists additional information and requirements applicable to such employees. In addition, pharmaceutical companies to which the Promotion Code applies must also appoint one senior employee to be responsible for ensuring that a company and its subsidiaries comply with the Promotion Code (see Section 20 of the Promotion Code). Further, a “scientific service” in charge of information about its medicinal products must be established. The scientific service must include a medical doctor (or, if appropriate, a pharmacist) who will be responsible for approving any advertising material before release. This employee is responsible for certifying that:

• they have reviewed the final form of the advertising material;
• it is in accordance with the requirements of the applicable Legislation and industry regulations;
• it is consistent with the SmPC; and
• it is a fair and truthful presentation of the facts regarding the medicinal product.

Danish provisions that apply to advertising “on paper” apply equally to internet advertising; cf Section 9 of the Advertising Order. The provisions should, however, be interpreted with due consideration to the special nature of the internet.

As advertising on the internet will usually be considered advertising to the general public, access restrictions are required if the website contains advertising of prescription-only medicinal products. According to Section 9(3) of the Advertising Order, the access must be restricted in an “effective manner” via user identification (ie, unique username, authorisation number or similar) and an individual password. A password that is similar for all users is not sufficient.

ENLI has issued a guide regarding the use of digital media in advertising activities (the “Digital Media Guide”). The Digital Media Guide provides different examples of effective access restriction methods.

As previously mentioned, disease awareness activities that do not contain any direct or indirect reference to specific medicinal products do not qualify as advertising (provided they are not deemed to be indirectly “designed to promote” a medicinal product). Thus, websites that exclusively provide disease awareness information will not be deemed advertising.

However, the Digital Media Guide provides that the pharmaceutical company should carefully consider the purpose of the website in question. Whether or not the website will be considered advertising will depend on a case-by-case assessment, taking into consideration the entire website.

Furthermore, the Digital Media Guide provides that a website containing permissible disease awareness information may change into an advertising website due to users’ interactions on the website. Therefore, the company should monitor any activities on the website carefully. In ENLI’s view, the company that is responsible for the creation of the website will – as a starting point – also be responsible for all communication on the website, including third-party communication.

As a starting point, the rules on advertising for medicinal products apply to both physical and virtual meetings or congresses. As described in more detail under 9.3 Sponsorship of Scientific Meetings, pharmaceutical companies can sponsor relevant (online) scientific meetings or congresses and/or attendance by healthcare professionals.

The Guidelines provide that scientific meetings or congresses held in Denmark are considered “international” when several participants or speakers come from abroad. 

ENLI has issued a guide regarding the participation of pharmaceutical companies in international congresses held in Denmark (the “International Congresses Guide”). The International Congresses Guide provides that pharmaceutical companies may live-stream scientific meetings or congresses and have on-demand solutions where the presentations can be made available provided that the web access to the presentations does not contain advertising for medicinal products.   

It is legal for pharmaceutical companies to use social media for advertising purposes, provided that the content is gated in an effective manner so that it can only be accessed by healthcare professionals if the advertising relates to prescription-only medicinal products. Also, it is a requirement that the content complies with the applicable requirements on advertising materials – eg, the requirements regarding compulsory information. Companies must generally be cautious due to the challenges and risk of non-compliance within this area.

It follows from the Guidelines that employees have a special connection to the pharmaceutical company and that the affiliation is relevant for the assessment of whether an employee has advertised for the company’s medicinal product. In recent years there have been several cases against employees concerning illegal advertising on social media (eg, about liking and sharing posts on social media containing positive mention of a medicinal product).

The Guidelines and ENLI’s Digital Media Guide provide helpful guidance when companies may wish to use social media in marketing activities.

Section 299(2) of the consolidated Danish Criminal Code No 1360 of 28 September 2022 (the “Criminal Code”) prohibits bribery in the private sector. This provision applies to any person who receives/requests/accepts a gift or benefits in kind contrary to their duty in relation to the management of the property matters of another. The person who provides/promises/offers such gift or benefit in kind is also liable, and the sanction for the “recipient” and the “provider” is a fine or imprisonment of up to four years.

Under the Criminal Code, a legal entity can also be made subject to a fine to the extent that a crime has been committed by the legal entity in question and this crime can be attributed to one or several persons employed in the company. The rules on bribery will apply to benefits provided to individuals and organisations (to the extent that such organisations are seen as “legal entities”).

In addition to the Criminal Code’s provision on bribery, the question of public servants receiving gifts and other benefits is regulated by general principles in Danish administrative law and by a guide on good behaviour in the public sector issued by the Danish authorities in collaboration with the Danish Regions.

According to the Marketing Practices Act, businesses must comply with good marketing practices. Providing bribery to induce the sale of medicinal products is contrary to such good marketing practices and will thus also be illegal under the Marketing Practices Act.

As described in more detail under 9.1 Gifts to Healthcare Professionals, it is not permitted to supply, offer or promise any healthcare professionals gifts or financial benefits except as specifically provided for in the Legislation. The reasoning behind this prohibition is that such gifts or benefits could be seen as inducements to prescribe certain medicinal products and such inducements would be illegal.

Similarly, the overall purpose of the Promotion Code is to create a framework for collaboration between the pharmaceutical industry and healthcare professionals. This collaboration must be made in such a manner that professional standards and ethics are paramount and that pressure opportunities and dependency between the parties are excluded.

In addition, ENLI has issued ethical rules for dialogue and negotiations with decision-makers (the “Lobby Code”) that apply to pharmaceutical companies’ dialogue and negotiations with politicians and authorities. According to Section 12 of the Lobby Code, there must never be any kind of financial dependency between pharmaceutical companies and the decision-makers. Similarly, company representatives must not act in a way that may cause suspicion of bribery.

Additionally, the purpose of ENLI’s Patient Organisation Code is, among other things, to ensure that the collaboration between the parties is conducted in such a way as to exclude any possibility of pressure or dependency. ENLI’s Donation Code also sets out that donations, grants and benefits in kind to institutions or organisations, comprised of healthcare professionals and/or that provide healthcare or conduct research (not otherwise covered by ENLI codes), are only allowed if, inter alia, they do not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer specific medicinal products.

As a starting point, the supply, offer or promise to healthcare professionals of gifts or financial benefits is prohibited; cf Section 22(1) of the Advertising Order.

However, according to Section 22(2) of the Advertising Order it is legal to provide gifts if these are of an insignificant value and can be used by the healthcare professional in their practice. According to the Guidelines, the term “insignificant value” is interpreted as DKK300 per calendar year. This limit is not based on the price paid by the company, but is to be calculated on the basis of what the healthcare professional should have paid for the item if they were to purchase it on the market. Items that can be used in the practice of the healthcare professional include, for example, pens, clinical thermometers and calendars, but not art, lamps, radios or similar.

Additional specific exemptions to the prohibition against providing gifts are set out in the Advertising Order; for example, pursuant to Section 24 it is permitted to provide healthcare professionals reasonable payment in return for their consultancy services, and pursuant to Section 26 it is permitted to provide payment for healthcare professionals’ professional training and information. Further, specific rules apply to rebates and samples (see 9.2 The Provision of Samples of Medicinal Products to Healthcare Professionals).

In the Promotion Code, the prohibition against providing financial benefits and gifts is set out in Section 12(1). These provisions are generally stricter than the corresponding provisions in the Legislation and generally do not even allow for the provision of inexpensive office supplies such as pens or calendars. However, in 2014 it was clarified that certain gifts of practical relevance (for example, paper and pens at professional symposia, congresses or the like) are acceptable if the items comply with the requirement to be of insignificant value.

According to Section 14 of the Promotion Code, the transmission of informational or educational materials to healthcare professionals is permitted, provided it is inexpensive, directly relevant to the practice of medicine or pharmacy business and directly beneficial to the care of patients. Such material or items must not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer specific medicinal products. In addition, medical equipment aimed directly at the education of healthcare professionals and patient care can legally be provided to the extent that it is inexpensive and does not influence the business practices of the recipient. Similar to the Advertising Order, the term “inexpensive” means that the total value of gifts to an individual healthcare professional must not exceed DKK300 per calendar year.

Other exemptions to the prohibition against providing gifts are also set out in the Promotional Code, for example:

• in Section 13 regarding the payment of healthcare professionals’ professional training and information, and organising or sponsoring of specific events; and
• in Section 15 on payment of healthcare professionals in relation to consultancy services.

See also 9.3 Sponsorship of Scientific Meetings and 9.7 Payment for Services Provided by Healthcare Professionals.

According to the Executive Order on the Provision of Samples of Medicinal Products No 1244 of 12 December 2005 (the “Sample Order”) and the Guidelines, samples can be provided for free only if certain requirements are fulfilled:

• samples can only be provided to doctors and dentists, and only to the extent that they are certified to prescribe the product (provided that this is legal as part of their practice);
• samples can be supplied only in response to a written request – the request must be dated and signed by the doctor or dentist;
• only one sample a year can be provided to each doctor or dentist;
• the product must not be larger than the smallest package marketed;
• the sample must be marked “Free sample – not for sale”;
• a sample must always be provided following a written (dated and signed) request from the recipient in question;
• the sample must only be provided by the owner of the marketing authorisation (or its representative) and provision must not be made via the pharmacy;
• every sample must be escorted by the SmPC; and
• no samples covered by the Act on Euphoriant Drugs must be provided.

The marketing authorisation owner must keep accounts of samples provided and such documentation must be stored for at least two years.

The Promotion Code incorporates the Sample Order and sets out a few additional requirements regarding the supply of samples of medicinal products. For example, samples must not be supplied for more than two years after the date of introduction (meaning the date on which the medicinal product is placed on the market for the first time); cf Section 19(1)–(2).

Pursuant to Section 26 of the Advertising Order, pharmaceutical companies can sponsor relevant scientific meetings or congresses and/or attendance by healthcare professionals at these events. Pharmaceutical companies can also provide or offer a healthcare professional:

• hospitality in the form of payment of direct costs for food, travel, accommodation, etc, in connection with advertising for and professional information on medicinal products; and
• professional information and training in the form of payment of direct costs of professional relevant courses, conferences, training, etc.

Specific requirements apply regarding the level of hospitality and accommodation.

If the event takes place abroad, pharmaceutical companies can only pay for the healthcare professional’s participation if substantial reasons (eg, practicable or economic circumstances) for having the event in other countries can be identified; cf Section 26(4) of the Advertising Order.

As mentioned, the Promotion Code generally provides for stricter regulation than the Legislation when it comes to the prohibition against gifts and the exemptions thereto. Detailed guidance can be found in the Promotion Code Guidelines.

For companies to which the Promotion Code applies, it is possible to give or offer a healthcare professional training and professional information in the form of payment of direct expenses in connection with professional relevant courses, conferences, training, etc, in which the healthcare professionals participate or arrange; cf Section 13(1) of the Promotion Code.

The pharmaceutical company may also either:

• organise/co-organise events directed at healthcare professionals; or
• sponsor events organised by a third party responsible for the professional content.

Sponsorships must not be subject to the pharmaceutical company influencing the professional content of the programme.

All advertising, scientific or professional meetings, congresses, etc, that are organised or sponsored by, or on behalf of, a pharmaceutical company must take place at appropriate venues that are conducive to the main purpose of the event. It is, for example, not legal to use venues that are known for their extravagance or entertainment facilities; cf Section 13(3) of the Promotion Code.

Hospitality may only be offered when relevant. However, all forms of hospitality offered to healthcare professionals must be on a reasonable level and be strictly limited to the main purpose of the advertising or professional event; cf Section 13(7) of the Promotion Code. Any hospitality extended must be limited to travel, meals, accommodation and genuine registration fees, and must only be extended to the healthcare professional (eg, not the wife, spouse, children or similar). Companies must keep within the following thresholds if providing meals (food and beverages) to healthcare professionals; cf Section 13(8) of the Promotion Code:

• DKK450 for lunch;
• DKK850 for dinner; or
• DKK1,400 covering all meals at all-day meetings/conferences.

These thresholds apply to meals in Denmark, but if providing meals in other European countries, the thresholds laid down by the pharmaceutical industry associations in such countries prevail.

Similar to what is provided for under the Legislation, the Promotion Code, Section 13(4) sets out that no pharmaceutical company may organise or sponsor any events that take place outside the pharmaceutical company’s home country, unless:

• most of the invitees come from abroad and it makes significantly more logistical sense to hold the event in another country (eg, considering the countries of origin of most of the invitees); or
• given the location of the relevant resource or expertise relevant to the event, it makes significantly more logistical sense to hold the event outside Denmark.

Section 13(12) of the Promotion Code provides that in the case of international events where a pharmaceutical company is sponsoring the participation of a healthcare professional, any funding provided to such healthcare professional is subject to the rules of the jurisdiction where such healthcare professional carries out their profession (and not the rules of where the international event takes place). To the extent that Danish legislation is applicable, such provisions must, of course, still be abided by.

Hospitality by a pharmaceutical company in relation to scientific congresses (organised or sponsored events) must not include organisation or sponsorship of entertainment or other non-scientific events.

As a starting point, a pharmaceutical company may not provide donations and grants to individual healthcare professionals or groups of healthcare professionals (cf Section 22(1) of the Advertising Order) unless specifically regulated (eg, in the case of gifts of insignificant value; cf Section 22(2)) or in relation to representation and sponsorships; cf Section 26.

Pursuant to Section 4 of ENLI’s ethical rules for the pharmaceutical industry’s donations and grants (the “Donation Code”), donations, grants and benefits to hospitals, hospital wards, private clinics or institutions and organisations comprised of healthcare professionals and/or that provide healthcare or conduct research are allowed if:

• they are made for the purpose of supporting professional activities;
• they are documented and kept on record by the donor/grantor; and
• they do not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer specific medicinal products.

The Donation Code defines “grant” and “donations” as any kind of support given for projects, activities, equipment, units, etc.

According to Section 4(2), support for individuals is not allowed. The matter of financial contributions or sponsorships, the granting of payments in kind for services, the sponsoring of participation in congresses or other educational professional activities are not regulated by the Donation Code but by the Promotion Code.

According to the Promotion Code, donations and grants to individual healthcare professionals or groups of healthcare professionals (even for professional purposes, including distributing material or making a treatment database) are, as a rule, not legal. Explicit exemptions must also be found here to legally provide grants or donations – eg, in Section 13 (see 9.3 Sponsorship of Scientific Meetings) or Section 14. According to the latter, the donation of medical equipment aimed directly at the education of healthcare professionals and patient care can legally be provided to the extent that it is inexpensive and does not offset the business practices of the healthcare professional.

The general prohibition on gifts mentioned in 9.5 Grants or Donations to Healthcare Professionals or Healthcare Institutions will, as a rule, ensure that rebates and discounts cannot be provided to healthcare professionals.

However, under Section 37 of the Advertising Order, it is permissible for a supplier (eg, a pharmaceutical company) to provide rebates to a purchaser of medicinal products (eg, a pharmacy) to the extent that the rebate is based on a cost saving on the side of the supplier and the rebate is a direct consequence of a purchase behaviour by the recipient that deviates from the supplier’s standard terms (eg, if fewer deliveries are made or more products are being ordered). Such rebates are referred to as “rebates based on costs” (omkostningsbegrundede rabatter in Danish).

Rebates based on costs must be proportionate in relation to the cost saving and a supplier must use similar principles of calculation of rebates to recipients who have the same purchase pattern. Rebates based on costs must further not be provided if they are:

• calculated on the basis of the supplier’s cost price, or calculated with the supplier’s cost price as an element in the calculation;
• based on cost relief as a consequence of rationalisation internally with the supplier; or
• based on rebates provided by others to the supplier.

It follows from Section 38 that rebates based on costs can be made only in the form of a rebate in the retailer’s cost price.

The supplier must store certain information regarding the rebates (as described in detail in Section 40 of the Advertising Order) for three years. Also, the supplier is obligated to provide a statement of warranties and representations (ledelseserklæring in Danish) regarding the legality of the rebates provided; cf Section 42.

It is permitted to use healthcare professionals as consultants or advisers (in groups or individually) in relation to the following; cf Section 24 of the Advertising Order and Section 15 of the Promotion Code:

• professional services such as speaking at and chairing meetings;
• in clinical trials or training services; and
• participation in advisory board meetings or market research, and also when this participation involves remuneration and/or travel activity.

According to the Promotion Code, a prior written contract must be entered into between the pharmaceutical company and the healthcare professional, specifying the nature of the services and the basis of payment for these services.

Pursuant to Section 202(a) of the Danish Health Act (Consolidated Act No 1011 of 17 June 2023) and Section 43(b) of the Medicines Act, collaboration between a healthcare professional and a pharmaceutical company concerning education or research and development must be notified to the Agency. A similar notification requirement applies to ownership by the healthcare professional of shares of up to DKK200,000 in the pharmaceutical company.

Other collaborations, or ownership by the healthcare professional of shares above DKK200,000 require approval from the Agency.

Executive Order No 841 of 20 June 2023 on Healthcare Professionals’ Affiliation with Pharmaceutical and Medical Companies, etc (the “Disclosure Order”) contains quite detailed requirements regarding notifications and applications for approval, and regarding publication of notifications and approvals.

Section 202(b) of the Health Act and Section 27 of the Advertising Order provide that if a healthcare professional receives payments from a pharmaceutical company to attend professionally relevant activities abroad, the person must notify the Agency. Such notifications will be published by the Agency on its website; cf Section 202(c). In this connection, a pharmaceutical company that has an authorisation under Section 7(1) or 39(1) of the Act, and that is undertaking the payments, is obligated to inform the healthcare professional about this notification duty; cf Section 43c of the Act.

The rules on transparency in connection with transfer of value are further described in 10 Pharmaceutical Companies: Transparency.

In addition, under the Promotion Code, companies are obligated to notify the following activities to ENLI:

• activities that are organised or co-organised by the company (meetings, congresses, conferences, symposia, courses, etc), partially or fully directed at Danish healthcare professionals;
• activities where the company provides financial support (sponsor support) to a third-party event; and
• activities where the company buys an exhibition stand at a congress in Denmark.

Further, as mentioned, pharmaceutical companies are obligated to report all kinds of printed advertising material (leaflets, handouts, website material, etc) aimed at healthcare professionals on the Danish market.

Notification deadlines for each of the above are set out in Section 21 of the Promotion Code. The companies are obligated to notify online using a standard form.       

Pursuant to the Disclosure Order, there are specific requirements applicable regarding transparency when it comes to pharmaceutical companies’ affiliations with healthcare professionals.

While the main obligation to disclose information on the affiliation between the pharmaceutical companies and healthcare professionals is placed on the healthcare professionals (cf Chapter 61a of the Danish Health Act and the Disclosure Order), pharmaceutical companies have an obligation to report certain affiliations and transfers of value to the Agency and an obligation to inform the relevant healthcare professionals of such reporting (the Disclosure Order, Section 17–19). The rules apply to companies with permission subject to Section 7(1) (marketing authorisation) or Section 39(1) (company authorisation) of the Act.

When a pharmaceutical company has established a relationship and is affiliated with a doctor, dentist or prescribing and proprietary pharmacists, the pharmaceutical company must notify this to the Agency; cf Section 17 of the Disclosure Order and Section 43b of the Act. Such notification must take place via the Agency’s website once a year (by 31 January).

The pharmaceutical company must at the same time inform the individual healthcare professional in question about the notification made. Additional information regarding specific affiliations can be requested by the Agency.

Pharmaceutical companies are also obligated to inform the healthcare professional in question about their obligation to notify or apply for permission (in accordance with the rules set out in Sections 202a–202c of the Health Act and Sections 27 and 28 of the Advertising Order). The companies must also inform the healthcare professional that the Agency will publish information about the affiliation on its website.

The Disclosure Order’s provisions regarding notification and information apply to pharmaceutical companies that have a marketing authorisation (cf Section 7 of the Act) and companies that have an authorisation from the Agency to, inter alia, produce, import, export, store and trade medicinal products (as set out in Section 39(1) of the Act).

The Agency oversees compliance with the Legislation. Decisions made by the Agency can be brought before the Ministry via a complaint, and decisions made by the Ministry can be brought before the Danish courts. 

As a self-regulatory authority, ENLI and its Investigator Panel (as first instance) can impose penalties on a member company if the company notifies any advertising activities that are considered to be in breach of the Promotion Code or if ENLI otherwise becomes aware of such activities; for example, via a complaint. Decisions from ENLI’s Investigator Panel can be brought before the Board of Appeals.

Cases regarding non-compliance with the bribery provision in the Criminal Code will be investigated by the police and may result in a criminal case before the Danish courts.

Pharmaceutical companies can file a complaint against a competitor with the Agency on the basis of alleged non-compliance with the Legislation. Decisions made by the Agency can be appealed to the Ministry. 

In the case of alleged non-compliance with the Promotion Code, pharmaceutical companies can file a complaint with ENLI’s Investigator Panel (provided the competitor is bound by ENLI’s rules). Such decision can be appealed to the Board of Appeals.

Pharmaceutical companies can also request that the Danish Consumer Ombudsman takes up a case on the basis of alleged non-compliance with the Marketing Act (cases can also be taken up ex officio). Decisions made by the Consumer Ombudsman cannot be appealed to another administrative authority.

Companies also occasionally initiate proceedings before the Danish courts against competitors for alleged non-compliance with the advertising rules. Such proceedings include interim injunction proceedings. The Danish courts have issued interim injunctions against violations of the rules on advertising of medicinal products in a limited number of cases.

The penalties that can be imposed due to non-compliance of the advertising rules specified in the Act are a fine and imprisonment of up to four months; cf Section 104(1) of the Act. Further (and depending on the specific basis of non-compliance), it can be required that the advertising activity is ceased, that a decision is published and/or that correction notices are issued; cf Section 69 of the Act.

Non-compliance with the provisions in the Advertising Order can be punished by a fine. For non-compliance with the Legislation, sanctions for companies can be imposed as set out in detail under the Criminal Code, Chapter 5.

Non-compliance with the Promotion Code or any of the other codes under ENLI’s control (such as ENLI Penalties and Fees Regulation) can result in any of the following penalties:

• a reprimand;
• a fine; or
• a public reprimand.

ENLI may also require a pharmaceutical company to:

• rectify incorrect information;
• withdraw illegal advertising material;
• cease further use of illegal advertising materials;
• issue a corrective statement; or
• cancel or change a scheduled event (conferences, courses, etc).

Procedures initiated with ENLI can be filed in parallel with any proceedings before the Agency/Ministry. However, in such cases, ENLI will often suspend the case to wait for a decision from the Agency.

Under the Promotion Code, pharmaceutical companies must report all kinds of promotional material to ENLI. In 2022, ENLI carried out random controls in 38% of the reported cases. Further, ENLI’s focus areas have included preventative activities which, among other things, have been carried out by preparing and updating ENLI’s numerous guidelines that elaborate the interpretation of ENLI’s rules.

Chapter 7 of the Act applies to advertising of all medicinal products, including veterinary medicinal products. At the beginning of 2022, the new Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC came into force. As a result, a new Executive Order No 130 of 25 January 2022 on the advertising of veterinary medicinal products (the “Advertising Order on Veterinary Medicinal Products”) was issued. Further, the Agency issued two updated guidelines on advertising of medicinal products: one for medicinal products for human use and one for veterinary medicinal products.

Although advertising for veterinary medicinal products is regulated separately from medicinal products for human use (ie, in the Advertising Order on Veterinary Medicinal Products and the updated guideline on advertising on veterinary medicinal products), the rules are in many ways similar in Denmark.