Contributed By Gorrissen Federspiel
Chapter 7 of the consolidated Danish Medicines Act No 99 of 16 January 2018 (the “Act”) and Executive Order No 1153 of 22 October 2014 on the Advertising of Medicinal Products (the “Advertising Order”) regulate the advertising of medicinal products in Denmark. The Advertising Order is supplemented by Guideline No 10356 of 29 December 2014 on Advertising of Medicinal Products (the “Guidelines”) (collectively the “Legislation”). The Danish Medicines Agency (the “Agency”) and the Danish Ministry of Health (the “Ministry”) oversee compliance with the Legislation.
The self-regulatory body within the pharmaceutical industry in Denmark is the Ethical Committee for the Pharmaceutical Industry (the “ENLI”). The 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 (“Promotion Code Guidelines”).
In addition, the consolidated Danish Marketing Practices Act No 426 of 3 May 2017 (the “Marketing Practices Act”) sets out 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 Promotion Code and other rules issued by the ENLI apply 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 the ENLI’s rules. The rules thus apply to the majority of the pharmaceutical companies on the Danish market and the legal value of these rules is quite high.
According to Section 2 of the Promotion Code, the code applies to the activities of pharmaceutical companies inside and outside the borders of Denmark, regarding the advertising of and communication about medicinal products aimed at healthcare professionals and the interaction with healthcare professionals on medicinal products. The provisions of the Promotion Code are only applicable with respect to activities that are partially or fully directed against Danish healthcare professionals. However, the provisions also apply to activities that are exclusively directed towards 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 shall include 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 identical to the definition found in Article 86 (1) of Directive 2001/83/EC 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 the type of medium used (ie, written, direct mails, any activities by employees, any use of the internet, electronic media, films, videos, brochures, product samples, gifts and hospitality) are covered by the term.
Under Danish law, advertising of (as opposed to other types of information on) prescription-only medicinal products must only be directed towards healthcare professionals, which the Legislation defines broadly as doctors, dentists, veterinarians, pharmacists, nurses, veterinarian nurses, pharmaconomists, midwives, bio-analysts, clinical dieticians, radiographers, social and healthcare workers and students within these professions, cf. Section 1(3) of the Advertising Order. Accordingly, the distinction between “advertising” and (other) “information” is paramount depending on the target audience of the communication.
The Advertising Order specifically lists a number of areas where the advertising provisions do not apply, cf. Section 2. By default, these areas are found to be “informational” rather than “promotional”:
From the above exemption it can be seen that the rules on the 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 campaigns that comply with this requirement do not qualify as advertising to the extent they are not deemed to be indirectly “designed to promote” a medicinal product. Thus, disease awareness campaigns can legally be directed towards the general public as well as healthcare professionals.
Similar exemptions are incorporated in the Promotion Code, Section 2 (2) litra c.
According to the Advertising Order, Section 2 (7) (see 2.2 Difference Between Information and Advertising above), the rules on advertising of medicinal products do not apply to press releases to the extent that these contain objective (in Danish: “saglig”) 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 clearly be met, if the press release is not to be seen as advertising.
If a pharmaceutical company has paid for a press release in a media, the press release will not fall under the “press release exemption” but rather be seen as advertising. According to the Guidelines of the Agency, a pharmaceutical company is only allowed to make a press release available in its online news section for approximately three weeks. Following this period, the press release will typically no longer be covered by the exemption.
The “press release exemption” is also incorporated in the Promotion Code, cf. Section 2 (2) litra c.
Comparative advertising for medicinal products is allowed, but is subject to 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 and must be made on the basis of the information in the product’s Summary of Product Characteristics (“SmPC”). Further, comparisons relating to price must always include the current prices of the products.
When comparing over-the-counter (“OTC”) products in advertising directed towards 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 not legal to promote unauthorised medicinal products. In addition, information in advertising for authorised products must always be in accordance with the SmPC, including the approved indication(s).
On the basis of 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.
Similar to the Legislation, the Promotion Code also contains a prohibition against pre-launch and off-label advertising (see Section 4).
Again, the critical point will be to distinguish between “advertising” and “information”. In previous cases, the Agency has clarified that not all references to a medicinal product will be seen as advertising. This is the case, for example, in relation to presentations of scientific data in a scientific forum (eg on an international congress for healthcare professionals), where there is no intention to promote the product. Such exchange of scientific information will, as a starting point, not be considered advertising and will therefore be allowed. However, whether the information in question will be deemed "information" or "advertising" will be subject to a case-by-case assessment, taking into account the form, content and context.
The ENLI has issued a Pre-Launch Guide that can be helpful in making the above assessment. According to this guide, each of the following may indicate that the material will be seen as unlawful pre-launch advertising:
A pharmaceutical company’s unsolicited 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 constitute illegal advertising (pre-launch or off-label advertising). Further, such unsolicited contact to a healthcare professional without prior consent may also, depending on the circumstances, constitute a violation of Section 10 of the Marketing Practices Act.
As mentioned in 2.2 Difference Between Information and Advertising, individual correspondence (if necessary accompanied by documents of a non-promotional nature) that responds to a specific query about a medicinal product is exempted from the advertising rules. Therefore, in case of a 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 (as such correspondence may be accessed by anyone). In a recent case, the Agency has stated that the exemption does not apply to verbal queries and responses.
As set out above, 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 Difference Between Information and Advertising may be relevant. According to this exemption, price lists, product catalogues, etc containing no other information about the medicinal products than their names, pharmaceutical form, strengths, pack sizes, prices and images of the product packaging will not be covered by the advertising rules.
Again, note Section 10 of the Marketing Practices Act, which sets out requirements regarding companies’ unsolicited marketing communications. For example, prior consent is normally required before approaching anyone – including healthcare professionals – by means of email for the purposes of direct marketing.
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, pharmaconomist, 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, however, allowed subject to certain restrictions.
As a general rule, all advertising of medicinal products (prescription-only and OTC) must be complete and “saglig” 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)(ii) 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)(iii) of the Act.
Pursuant to the Advertising Order, it must be clear from the advertising towards the general public that the communication constitutes advertising (i.e. 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 Advertising to the General Public below.
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 towards the general public must, as a rule, contain the following:
Specific information requirements apply in relation to outdoors advertising and advertising in movies, on the radio and on television, cf. Sections 6-7 of the Advertising Order.
Further, advertising towards the general public must not:
Furthermore, it is not legal to make comparisons with regard to the effects of medicinal products in the context of advertising towards the general public, as it is not legal to give the impression that the effect of a medicinal product is better or just as good as the effect of another product, cf. Section 16(3) referencing Section 10(1)(3) of the Advertising Order.
The relationship between pharmaceutical companies and patients is not specifically regulated by the Legislation, but is covered by the provisions laid down regarding advertising to the general public (patients are included in the term “general public”). For example, it is not legal to provide any type of hospitality or accommodation or the like when advertising medicinal products to the public, cf. Section 20 of the Advertising Order.
As mentioned above the Promotion Code covers only the interaction between a pharmaceutical company and healthcare professionals, and is therefore not relevant in relation to patient interaction.
With regard to 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, it is assumed in the Advertising Order that funding can be provided to such patient organisations.
The ENLI has issued Ethical Rules for the Collaboration between Patient Organisations, etc. and the Pharmaceutical Industry (“Patient Organisation Code”). 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 the group of patients’ interests. However, the Patient Organisation Code also applies to a wider scope of patient and consumer organisations (the Patient Organisation Code, Section 2(b)).
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.
In relation to financial support from pharmaceutical companies to patient organisations, specific restrictions apply. 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 level of accommodation and hospitality.
The provisions laid down in the Marketing Practices Act will also apply to a pharmaceutical company’s interaction with patients and patient organisations, etc.
Advertising towards the general public must not contain a recommendation from healthcare professionals, scientists or other persons, unions of persons, institutions, companies or the like that could induce the use of medicinal products via their standing, cf. Section 10(1)(7) of the Advertising Order.
The term "standing” covers both the standing that comes from a specific education or profession (eg, doctors and professors) as well as the standing that could come from being “famous” (eg, actors, singers or politicians).
The prohibition applies to both the endorsements of individual persons and the endorsements of associations of persons, institutions and businesses.
The term “recommendation” mentioned above is not to be interpreted as an explicit recommendation. For example, the mere illustration of a person in a white laboratory coat may result in non-compliance with Section 10.
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:
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 publications, professional journals or similar. Further, the research must, prior to publication, have been subjected to an independent assessment (peer review). Data on file normally does not satisfy these requirements and can consequently not be used as documentation.
That being 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 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.
Pursuant to the Guidelines, it is not regarded as advertising when a pharmaceutical company issues scientific articles and reprints on clinical trials on medicinal products to a healthcare professional on the healthcare professional’s request, provided that these 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. However, please see the above in relation to potential pre-launch and off-label promotion.
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.
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 for the practice of the healthcare professional and it directly benefits patients. Overall, reprints must also be of an insignificant value (see below).
The Legislation does not contain any requirements with regard to prior notification of or approval from the authorities with regard to advertising for medicinal products.
However, pharmaceutical companies that are subject to the Promotion Code are obliged to notify the following activities to the ENLI: (i) 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 against Danish healthcare professionals; (ii) activities where a pharmaceutical company provides financial support (sponsor support) to a third-party event that is fully or partially directed against Danish healthcare professionals or to the participation of Danish healthcare professionals; and (iii) activities where a pharmaceutical company buys an exhibition stand at a congress in Denmark.
Further, pharmaceutical companies are obliged 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 companies are obliged to file a report online via the ENLI’s website using a standard form. The company is obliged 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: (i) the target group, (ii) the way of distribution, (iii) an overview of the media where the advertising has been shown and (iv) the period of time where the advertising has been used.
Therefore, 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 hereof, as documentation must be presented if requested by the authority.
The Advertising Order Sections 18 and 19 sets 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 (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:
Danish provisions that apply to advertising material “on paper” apply equally to internet advertising, cf. Section 9 of the Advertising Order, Section 9. The provisions should, however, be interpreted with due consideration to the special nature of the internet.
Content on the internet is to be seen as directed towards the general public unless access to such content is restricted in an effective manner to healthcare professionals only.
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 material, eg the requirements regarding compulsory information. Companies must generally be cautious due to the challenges and risk of non-compliance within this area.
The ENLI has issued a guide regarding the use of digital media in advertising activities (“Digital Media Guide”). The guide is helpful when companies wish to use social media in their marketing activities.
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 user name, authorisation number or similar) and an individual password. A password that is similar for all users is not sufficient.
Section 299 (2) of the consolidated Danish Criminal Code No 1156 of 20 September 2018 (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 his or her 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 a “legal entity”).
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 allowed 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, the ENLI has issued ethical rules for dialogue and negotiations with decision-makers (“Lobby Code”) that applies to pharmaceutical companies’ dialogue and negotiations with politicians and authorities. According to Section 12 of this 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. Also, the purpose of the 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. The ENLI Donation Code also sets out that donations, grants and benefits in kind to institutions or organisations, comprising 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 his or her 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 he or she were to purchase it on the market. Items that could be used in the practice of the healthcare professional are, 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 as described below.
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 office supplies such as pens or calendars (even though these are inexpensive). However, in 2014 it was clarified that certain articles 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 in a 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 Section 15 on payment of healthcare professionals in relation to consultancy services. These are mentioned in more detail below.
According to the Executive Order on the Provision of Samples of Medicinal Products (No 1244 of 12 December 2005; the “Sample Order”), samples can be provided (for free) only if certain requirements are fulfilled:
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 with regard to 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 to these events. Pharmaceutical companies can provide or offer a healthcare professional (i) representation 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 (ii) professional information and training in the form of payment of direct costs of professional relevant courses, conferences, training, etc. Specific requirements apply with regard to 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 above, the Promotion Code generally provides for stricter regulation than the Legislation when it comes to the prohibition against gifts and the exemptions hereto. 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 i) organise/co-organise events directed at healthcare professionals or ii) 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 the like). Companies must keep within the following thresholds if providing meals (food and beverages) to healthcare professionals: DKK400 for lunch, DKK700 for dinner or DKK1,200 covering all meals at all-day meetings/conferences, cf. Section 13(8) of the Promotion Code. 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: (i) 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 (ii) 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 professionals is subject to the rules of the jurisdiction where such a healthcare professional carries out his or her 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 case of gifts of insignificant value, cf. Section 22 (2)) or in relation to representation and sponsorships, cf. Section 26.
Pursuant to Section 6 of ENLI’s ethical rules for the pharmaceutical industry’s donations and grants (“Donation Code”), it is not permitted to give donations and grants to hospitals, to individual healthcare professionals, associations of healthcare professionals or members of the hospital administration. The Donation Code defines “grant” and “donations” as any kind of support given for projects, activities, equipment, units, etc. 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 Donation Code, donations, grants and benefits in kind to such institutions or organisations comprising healthcare professionals and/or that provide healthcare or conduct research are allowed if (i) they are made for the purpose of supporting professional activities; (ii) they are documented and kept on record by the donor/grantor; and (iii) they do not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer specific medicinal products.
According to the Promotion Code, donations and grants to individual healthcare professionals or groups of healthcare professionals (even for professional purposes, ie, distributing material or making a treatment database) is, as a rule, not legal. Explicit exemptions must also be found here to be able legally to provide grants or donations, eg, in Section 13 (reference is made to 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 above will, as a rule, ensure that rebates and discounts cannot be provided to healthcare professionals.
However, under Section 36 of the Advertising Order, it is allowed for suppliers (eg, a pharmaceutical company) to provide rebates to a purchaser of medicinal products (for example pharmacies) 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 (for example, if fewer deliveries are made or more products are being ordered). Such rebates are referred to as “rebates based on costs” (in Danish: “omkostningsbegrundede rabatter”).
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 (i) calculated on the basis of the supplier’s cost price or calculated with the supplier’s cost prise as an element in the calculation; (ii) based on cost relief as a consequence of rationalisation internally with the suppler; or (iii) based on rebates provided by others to the supplier.
It follows from Section 37 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 39 of the Advertising Order, for three years. Also, the supplier is obliged to provide a statement of warranties and representations (in Danish: “ledelseserklæring”) regarding the legality of the rebates provided, cf. Section 41.
It is permitted to use healthcare professionals as consultants or advisers (in groups or individually) in relation to professional services such as speaking at and chairing meetings, in clinical trials or training services, participation in advisory board meetings or market research, also when this participation involves remuneration and/or travel activity, cf. Section 24 of the Advertising Order and Section 15 of the Promotion Code.
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. Additional requirements are set out in Section 15, for example, certain arrangements require notification of or permission from the Agency (as further described in 10 below).
Pursuant to Section 202(a) of the Danish Health Act (Consolidated Act no. 1286 of 2 November 2018) 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 1154 of 22 November 2014 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 obliged to inform the healthcare professional about this notification duty, cf. Section 43c of the Act. Certain activities
The rules on transparency in connection with transfer of value are further described below in 10 Transparency.
In addition, under the Promotion Code, companies are obliged to notify the following activities to the ENLI: (i) activities that are organised or co-organised by the company (meetings, congresses, conferences, symposia, courses, etc), partially or fully directed against Danish healthcare professionals, (ii) activities where the company provides financial support (sponsor support) to a third-party event and (iii) activities where the company buys an exhibition stand at a congress in Denmark. Further, as mentioned above, pharmaceutical companies are obliged 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 obliged to notify online using a standard form.
Pursuant to the Disclosure Order, there are specific requirements applicable with regard to 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 professional (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 healthcare professional of such reporting (the Disclosure Order, Section 16-18a). 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 pharmacist, the pharmaceutical company must notify this to the Agency, cf. Section 16 of the Disclosure Order and Section 43b of the Act. Such notification must take place via the Agency’s website once a year (by January 31st) and must include the following information:
Also, the period of affiliation must be identified. 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 obliged to inform the healthcare professional in question about his or her 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.
These provisions on disclosure are also incorporated in the Promotion Code.
As mentioned above, the Disclosure Code’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, the ENLI and its Investigator Panel (as in the 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 the ENLI otherwise becomes aware of such activities; for example, via a complaint. Decisions from the ENLI Investigator Panel can be brought before the Board of Appeal.
Cases regarding non-compliance of the bribery provision in the Criminal Code will be investigated by the police and may result in a criminal case before the Danish courts.
On the basis of alleged non-compliance of competitors with the Legislation, pharmaceutical companies can file a complaint with the Agency. Decisions made by the Agency can be appealed to the Ministry.
Likewise, on the basis of alleged non-compliance with the Promotion Code, pharmaceutical companies can file a complaint with the ENLI’s Investigator Panel (provided the competitor is bound by the ENLI’s rules). Such decisions 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 the ENLI’s control (such as the ENLI Penalties and Fees Regulation) can result in any of the following penalties: (i) reprimand, (ii) fine or (iii) public reprimand. The ENLI may also require a pharmaceutical company to:
Procedures initiated with the ENLI can be filed in parallel with any proceedings before the Agency/Ministry. However, in such cases, the ENLI will often suspend the case to wait for a decision from the Agency.
With regard to the ENLI, the self-regulatory body typically focuses on one or two area(s) of compliance at a time. These focus areas are often announced in advance in the ENLI newsletters and pharmaceutical companies are thus able to give special attention to these issues.