Q&A: pharma & medical device regulation in Denmark

Health services framework and competent authorities

Healthcare bodies

Describe the bodies and their responsibilities (public and private sector) concerned with the delivery of healthcare and appropriate products for treatment.

The Danish healthcare system can generally be divided as follows:

• State: the Ministry of Health is responsible for establishing the overall framework of the Danish healthcare, including legislation on the organisation of healthcare services, medicinal products and medical devices.
• Regions: the five regions are responsible for public hospitals and general practitioners. The vast majority of the medicinal products and medical devices dispensed at public hospitals are purchased through a company named Amgros, which is a partnership between the five regions. Amgros carries out tendering procedures and purchases medicinal products and medical devices for all public hospitals. Further, the regions are responsible for the hospital pharmacies.
• Municipalities: the 98 municipalities are responsible for home care.
• The private sector: Denmark has a number of private hospitals operating alongside public hospitals within many therapeutic areas. Private pharmacies are privately owned, and have monopoly on the sale of prescription-only medicinal products and some over-the-counter (OTC) medicinal products.

Competent authorities for authorisation

Identify the competent authorities for approval of the marketing of medicinal products and medical devices. What rules apply to deciding whether a product falls into either category or other regulated categories?

Generally, the Danish rules in this area correspond to other EU countries and are subject to a great deal of harmonisation.

The Danish Medicines Agency (DMA) is the competent authority for approval of the marketing of medicinal products. There is no requirement for manufacturers of medical devices to obtain a marketing authorisation.

A medicinal product is defined as any product presented as having properties for treating or preventing disease in human beings or animals or that may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis (see section 2 of the Danish Medicines Act). Thus, to decide whether a product is a medicinal product, attention should be paid to how the product is advertised and to how it affects the body.

According to section 1 of the Danish Executive Order on Medical Devices (No. 1263 of 15 December 2008), ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic or therapeutic purposes, or both, and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
• investigation, replacement or modification of the anatomy or of a physiological process; and
• control of conception.

The definition also includes any of the above that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means. Thus, a product is subject to the rules for medical devices only if the intention of the manufacturer was to develop the product for use for medical purposes.

Ultimately, the DMA decides whether a product falls into either the category of medicinal products or medical devices or if the product is instead a cosmetic or dietary supplement, for example.

Approval framework

Describe the general legislative and regulatory framework for approval of marketing of medicinal products and medical devices.

Medicinal products

The Danish Medicines Act is the primary piece of legislation concerning medicinal products, which lays down the general criteria for approval of marketing of medicinal products. The criteria relate to the safety, efficacy and quality of the medicinal product. Generally, the benefits of the medicinal product must outweigh the risks. The Danish Executive Order on Marketing Authorisation for Medicinal Products (No. 1239 of 12 December 2005) contains comprehensive rules on the requirements of marketing authorisations for medicinal products.

The Danish Executive Order on Labelling etc of Medicinal Products (No. 869 of 21 July 2011) contains comprehensive and detailed packaging and labelling requirements for medicinal products. Among other things, the rules stipulate that labelling must be easily readable, understandable and indelible, and - with few exceptions - must be in Danish. Further, the packaging of medicinal products must contain a patient information leaflet and must carry a product number that makes each individual package identifiable.

Medical devices

The marketing of medical devices is regulated in Danish Executive Order No. 1263. Medical devices must be CE marked to be marketed in Denmark. The CE mark shows that the product meets the legal requirements for medical devices.

Medical devices are categorised in four risk classes: I (Im, Is), IIa, IIb and III, with the latter class being the category for devices associated with the highest risk. The device must be categorised into one of these risk classes. To obtain CE marking, the manufacturer must be able to document the device’s quality, safety and performance.

For medical devices in classes II and III, a Notified Body must be involved in the documentation and certification process. A Notified Body is a private entity authorised by the relevant authorities to review and assess whether a manufacturer’s technical documentation meets the legal requirements. If the requirements are met, the Notified Body issues a certificate allowing the manufacturer to place a CE mark on the product. As for medical devices in class I, the manufacturer is responsible for the certification process itself (with few exceptions).

The manufacturer must ensure that the device is accompanied by the information necessary for safe and proper use of the device and that the requirements for labelling instructions for use are met; for example, that the labelling includes:

• the manufacturer’s name and address;
• information necessary for the end user to identify the device and the content of the packaging;
• the CE mark (and identification number of the authorised body); and
• warnings to heed and precautions to take when using the device.

The manufacturer must ensure that all information both printed and electronic is in Danish at the time the medical device is made available to the end user.

Manufacturers, importers and distributors of medical devices and special stores offering medical devices for sale must register with the DMA.

Clinical practice

Applicable rules

What legislation controls and which rules apply to ethics committee approval and performance of clinical trials in your territory for medicinal products and medical devices?

Pursuant to the Danish Act on Research Ethics Review of Health Research Projects (No. 1083 of 15 September 2017), clinical trials must - with very few exceptions - be reported to the National Committee on Health Research Ethics. The Act stipulates that clinical trials cannot be initiated without authorisation from the competent scientific ethics committee. Further, clinical trials must, in accordance with the Danish Medicines Act, also be authorised by the DMA.

It is the sponsor of the clinical trial that must apply to the ethical committee and the DMA for authorisation to conduct the clinical trial. Under certain circumstances, the sponsor may delegate this task.

The sponsor of the trial is responsible for the conduct and quality of a clinical trial and must ensure that the trial is planned and performed in accordance with good clinical practice.

Reporting requirements

What requirements exist for reporting the commencement of a trial and its results to the competent authorities or the public?

The sponsor must report the completion of a trial to the DMA no later than 90 days after its completion. For multinational trials, the DMA must also be informed when the trial is completed in Denmark.

As for clinical trials of medicinal products, the trial results must be entered into the European Clinical Trials Database (EudraCT) as soon as possible and no later than one year after the trial has ended. The data will be made publicly available on the clinical trials register. Although the register does not publish Phase 1 trials, results of such trials must still be submitted to the DMA within one year of completion.

As for trials of medical devices, the trial results must be reported to the DMA no later than one year after the trial has ended.

Consent and insurance

Are there mandatory rules for obtaining trial subjects’ consent to participate? Must sponsors arrange personal injury insurance to a particular limit?

There are mandatory rules for obtaining trial subjects’ consent to participate in clinical trials. Subjects participating in a clinical trial must receive both written and oral information about the trial. Before the trial is initiated, participants must provide their written informed consent to participate.

Subjects under the age of 15 may participate in clinical trials only with the consent of their legal custodian. As for subjects under guardianship, the legal guardian must consent to the patient’s participation in a clinical trial.

The sponsor must ensure that there is adequate and appropriate insurance in place to cover its responsibility towards any participant suffering harm.

Marketing authorisation

Time frame

How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?

The average processing time for a fully documented application under the national procedure is 128 days from submission of application to grant.

In 2019, the DMA’s fee for a fully documented application under the national procedure is 188,903 Danish kroner. The fee for a fully documented application under the de-centralised procedure and the mutual recognition procedure is 262,698 Danish kroner.

A marketing authorisation must be renewed after five years. The renewal application must be submitted no later than nine months before expiry of the authorisation. Once renewed, it is valid for an unlimited period of time unless the DMA decides that an additional five-year renewal is required.

The renewal fee to be paid for an application under the national procedure is 6,969 Danish kroner.

Protecting research data

What protection or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add indications or pharmaceutical forms?

Data submitted by originators enjoy eight years of data exclusivity protecting against the filing of generic or biosimilar applications, and an additional two years of marketing exclusivity protecting against marketing of generics and biosimilars.

The exclusivity period may be extended by an additional year if the marketing authorisation holder (MAH), during the first eight years of the exclusivity period, obtains an authorisation for one or more additional therapeutic indications, which brings a significant clinical benefit compared to existing therapies.

There exists no data and marketing protection for medical devices similar to the protection for medicinal products.

Freedom of information

To what extent and when can third parties make freedom of information applications for copies of research data submitted by applicants for authorisation to market medicinal products or medical devices?

In accordance with the Danish Freedom of Information Act, third parties may apply for access to research data when the research data is submitted to the DMA as part of an application for a marketing authorisation for a medicinal product. However, the applicant for a marketing authorisation (if granted, the MAH) may object to the disclosure of such information; for example, on the grounds that the information contains:

• information on the personal affairs, including economic affairs, of individuals; or
• commercially confidential information, including information on technical matters or procedures or operating or commercial matters, etc, insofar as it is of material economic importance to the owner that it remains confidential.

An assessment must be made on a case-by-case basis of whether these exemptions apply.

As for medical devices, marketing authorisation from the DMA is not a requirement to place a device on the Danish market, and third parties cannot obtain research data by way of a freedom of information application to the DMA.

Regulation of specific medicinal products

Are there specific rules for approval, and rewards or incentives for approval, of particular types of medicinal products, such as traditional herbal and homeopathic products, biologicals and biosimilars, controlled drugs, orphan drugs and those for paediatric use?

Traditional herbal medicines must be approved by the DMA before being marketed. If certain requirements are fulfilled, the application process may follow a special procedure where the documentation requirements are less stringent than those for ordinary medicinal products.

Likewise, homeopathic products that fulfil certain criteria may be approved under a special simplified procedure (registration) where no evidence of therapeutic effect is required.

Applications for marketing authorisation for biotechnological medicines (including biosimilars) must be submitted to the European Medicines Agency (EMA) under the centralised application procedure.

Regulation (EC) No. 1901/2006 of 12 December 2006 on Medicinal Products for Paediatric Use provides special incentives and rewards to develop and market such medicinal products. The same is true for orphan drugs, which may be authorised under the special procedure under Regulation (EC) No. 141/2000 of 16 December 1999 on Orphan Drugs (see the EU chapter for more information).

In addition to this, a special four-year Danish pilot programme for medical cannabis has been in place since 1 January 2018.

Post-marketing surveillance of safety

What pharmacovigilance or device vigilance obligations apply to the holder of a relevant authorisation once the product is placed on the market?

Medicinal products

An MAH must operate a pharmacovigilance system to:

• monitor medicinal product safety;
• assess the possibilities for mitigating risks; and
• take appropriate measures.

This entails appointing a qualified person responsible for pharmacovigilance who must meet certain requirements in regard to education and qualification and must reside in the EU.

Among other things, the MAH must:

• keep a detailed description of the applied pharmacovigilance system (pharmacovigilance system master file) and on request make a copy of such description available to the DMA;
• keep records of suspected adverse reactions and make these available to the DMA;
• electronically report information on suspected serious adverse reactions to the DMA or EMA, as the case may be, within 15 days of receiving knowledge of such suspected reaction;
• electronically report information on suspected non-serious adverse reactions to the DMA or EMA, as the case may be, within 90 days of receiving knowledge of such suspected reaction; and
• prepare and submit periodic safety update reports to the DMA.

Medical devices

The manufacturer of a medical device must operate a post-market surveillance system on a continuous basis to ensure the safety and performance of the products.

The system must be designed in a way to systematically collect and assess the experiences gained from the use of the device on the market (eg, clinical experience, complaints and customer feedback) or from the manufacturer’s own experiences (eg, production and quality control). The information should be used to improve the device’s safety and performance, as well as to prevent any incidents.

The manufacturer must report to the DMA certain incidents whereby personal damage is caused or could have been caused by the device:

• immediately, and within two calendar days, if the incident poses a serious threat to public health;
• immediately, and within 10 calendar days, of deaths and unexpected events (events not included in the risk analysis); and
• immediately, and within 30 calendar days, of other incidents (incidents that are included in the risk analysis but do not pose a serious public health threat and have not resulted in deaths).

Other authorisations

What authorisations are required to manufacture, import, export or conduct wholesale distribution and storage of medicinal products and medical devices? What type of information needs to be provided to the authorities with an application, what are the fees, and what is the normal period of validity?

Manufacture or import of medicinal products requires a manufacturing and importation authorisation (MIA) from the DMA. The information to be provided with the application includes:

• a description of the medicinal product, including its form, or intermediates, to be manufactured or imported;
• an organisation chart;
• a site master file (describing the manufacturing site or sites);
• documents for the authorisation of a qualified person; and
• an overview of contract acceptors (if any).

The DMA charges both application and annual fees for its services. In 2019, the fee for obtaining an MIA and the annual fee are both 48,389 Danish kroner.

Wholesale distribution and storage of medicinal products require a wholesale distribution authorisation (WDA) from the DMA, which is granted for specifically identified premises. The information to be provided with the application includes:

• a specification of the types of medicinal products that the applicant will be responsible for distributing by wholesale;
• information on the activities to be performed by the applicant;
• an organisation chart; and
• details of contract acceptors (if any).

In 2019, the fees for obtaining a WDA and the annual fee are both 14,933 Danish kroner.

The export of medicinal products to third countries outside the EU or European Economic Area (EEA) requires a WDA from the DMA. The export of medicinal products manufactured by the exporting company itself are included in an MIA.

On 1 September 2012, the DMA changed its practice so that company authorisations are no longer issued with an expiry date. Therefore, an authorisation is valid until it is amended or terminated. Companies holding an authorisation with an expiry date must apply for renewal within six months of, and no later than three months before, the expiry date.

No authorisations are required from the DMA to manufacture, import, export or conduct wholesale distribution and storage of medical devices. However, registration with the DMA is required.

The DMA charges a registration fee of:

• 1,159 Danish kroner for manufacturers of medical devices in class I, which are custom made, for in vitro diagnostic, as well as system and procedure, packages; and
• 1,147 Danish kroner for importers and distributors.

Additionally, the DMA charges two annual fees. The first fee, for manufacturers, varies between 2,056 and 216,490 Danish kroner, depending on the risk class of the medical device and on the number of employees of the company registered in the Danish Central Business Register on 31 January in the relevant calender year. For importers and distributors, the fee varies between 1,384 and 34,461 Danish kroner, depending only on the number of employees. The second fee amounts to 2,751 Danish kroner. The fees are adjusted annually.

Sanctions

What civil, administrative or criminal sanctions can authorities impose on entities or their directors and officers for breach of the requirements concerning controlled activities?

Medicinal products

The sanctions vary from fines and injunctions to withdrawal of authorisations and imprisonment, depending on the type and severity of the violation. The DMA may, for example:

• recall a medicinal product from the market if the medicinal product is marketed by a company that does not hold a valid company authorisation; or
• withdraw a marketing authorisation to a medicinal product if the MAH has breached the conditions applying to the marketing authorisation.

Directors and officers of companies that do not comply with the Danish Medicines Act (eg, by manufacturing medicinal products without a valid manufacturing authorisation) may be punished with a fine or up to 18 months’ imprisonment.

Medical devices

As for medical devices, if the Notified Body (ie, the entity responsible for the assessment of whether a medical device can be CE marked) becomes aware that a manufacturer of a medical device does not comply with the legislative requirements, it may limit, suspend or withdraw the relevant device’s CE marking certificate.

The sanctions vary from fines and injunctions to prohibitions on marketing and market recalls. For example, if the DMA becomes aware that the CE mark has been placed on a medical device illegitimately, it may order the manufacturer or its representative to remedy such violation or may limit or prohibit the marketing of the product, or arrange for its withdrawal from the market.

Directors and officers of companies that do not comply with the Regulation (eg, by not complying with an injunction) may be punished by a fine.

Exemptions

What, if any, manufacture and supply of medicinal products is exempt from the requirement to obtain an approval to market?

A marketing authorisation is not required for the manufacture and supply of medicinal products prepared at a pharmacy for an individual patient on the prescription of a physician (magistral medicines).

Pharmacies must, however, not manufacture or supply magistral medicines if a medicinal product with similar therapeutic effect is marketed in Denmark. In certain situations, the DMA may, upon application by the patient’s physician, authorise a pharmacy to manufacture a magistral medicinal product, even though the magistral medicine has the same therapeutic effect as a medicinal product already marketed in Denmark.

If no medicinal product with the same therapeutic effect is being marketed, no authorisation is required. The same applies if the (normally) marketed medicinal product is temporarily on back order.

Parallel trade

Are imports allowed into your jurisdiction of finished products already authorised in another jurisdiction, without the importer having to provide the full particulars normally required to obtain an authorisation to market? What are the requirements?

Parallel imports of medicinal products from other EU or EEA member states are allowed. Such products may be marketed on the Danish market with a marketing authorisation issued by the DMA.

An applicant for an authorisation to market parallel imported medicinal products does not have to provide full documentation when the DMA has already issued a marketing authorisation for the directly traded medicinal product.

The DMA can issue a marketing authorisation for parallel imports under the following requirements:

• the relevant medicinal product (ie, the directly traded medicinal product), on the basis of which the parallel imported medicinal product is imported, has a marketing authorisation in Denmark;
• the two medicinal products in question (ie, the directly traded medicinal product and the parallel imported medicinal product) have the same active ingredient and pharmaceutical form;
• the exporting country is an EU or EEA member state;
• the parallel imported product has a valid marketing authorisation from an EU or EEA member state (being the exporting state); and
• no therapeutic differences exist between the parallel imported product and the directly traded medicinal product.

The marketing authorisation is valid for five years and may be continually renewed for further five-year periods.

The originator must be informed of the contemplated parallel import.

Parallel distribution of medicinal products that have been authorised by the European Commission under the centralised authorisation procedure does not require a separate Danish marketing authorisation. The parallel distributor must notify the EMA of the intended parallel distribution and await its confirmation that parallel distribution of the product is permitted.

As for medical devices, no marketing authorisation from the DMA is required for parallel import; when a medical device is duly CE marked, it can be marketed on the Danish market without any national approval. However, the parallel importer must register with the DMA.

Amending authorisations

Variation

What are the main requirements relating to variation of authorisations for medicinal products and medical devices?

Pursuant to the Danish Medicines Act, the holder of a marketing authorisation issued by the DMA must apply for approval of changes to the summary of product characteristics and the documents forming the basis of the marketing authorisation in accordance with the rules of Regulation (EC) No. 1234/2008 (the Variation Regulation).

After approval of the variation, the MAH will be provided with a deadline to implement the relevant variation. The deadlines vary depending on the nature of the variation. The implementation of the variation must be made for all package sizes covered by the authorisation (including any packages that are not marketed).

As for variations not covered by the Variation Regulation, the MAH must apply for the DMA to approve the variation.

As the marketing of medical devices is not subject to marketing authorisation, no requirements exist in this regard. However, if a company contemplates changing the characteristics of the device, it may be necessary to initiate a new procedure for the device’s CE marking.

Renewal

What are the main requirements relating to renewal of authorisations for medicinal products and medical devices?

Marketing authorisations for medicinal products are granted with an initial validity period of five years. The authorisation may be renewed provided that the MAH submits a renewal application no later than nine months before expiry. After renewal, the validity period of the marketing authorisation will usually be unlimited. However, in some situations, the DMA may decide that an additional five-year renewal is required based on an assessment of the ratio between the medicinal product’s benefits and risks.

As the marketing of medical devices is not subject to marketing authorisation, no requirements exist in this regard.

Transfer

How easy is it to transfer the existing approvals or rights to market medicines and medical devices? How long does this take in general?

In Denmark, an application for the transfer of a marketing authorisation for a medicinal product must be submitted to the DMA. The application must include confirmation from both the transferor (ie, the MAH) and the recipient of the marketing authorisation together with a revised summary of product characteristics, leaflet and labelling in electronic and editable format. The transfer must include the entire medicinal product (ie, all forms and strengths).

If the name of the MAH is part of the name of the medicinal product (the generic name), an application to change the name of the medicinal product must be made at the same time as the application for transfer of the marketing authorisation.

From the time of approval of the transfer by the DMA, there is a notification period of one year in which a notification of the change of the MAH must be made to medicinpriser.dk, a website operated by the DMA containing prices for medicinal products available in Denmark. From the time this notification takes effect, there is an implementation period of two years during which both new and old packages may be released on the Danish market.

As the marketing of medical devices is not subject to marketing authorisation, no requirements exist in this regard. However, if the company marketing a device is subject to changes, the company registration with the DMA shall be changed accordingly.

Recall

Defective and unsafe products

What are the normal requirements for handling cases of defective or possibly unsafe products, including approvals required for recall and communication with health professionals?

A manufacturer of a medicinal product must have in place a system that makes it possible to recall medicinal products or intermediates in the distribution network immediately and at any time.

The manufacturer must register and investigate any complaint regarding product deficiencies, and must notify the DMA of any deficiency that may lead to a recall of the product or extraordinary supply restrictions in the distribution chain. Such notification shall be made electronically using the DMA’s online form, and it must, inter alia, include information on all countries of destination and experimental sites, if any.

The DMA will assess the gravity of a report of a product defect in relation to patient safety. If the DMA decides to initiate a recall of the affected batches, this will be done in collaboration with the company. As for the execution of the recall towards the recipients of the defective products, the DMA’s online form must be used. The DMA assesses in which part of the supply chain the recall must be initiated (wholesaler, hospital pharmacy, standard pharmacy, patient) and whether other countries’ authorities should be informed.

A manufacturer of a medical device is obliged to immediately notify the DMA of any defective or possibly unsafe medical device:

• promptly, if it has resulted or may have resulted in the death of a patient or a user or a serious deterioration in the patient or user’s health; or
• as soon as possible, if any technical or medical reasons have led the manufacturer to systematically withdraw the medical device from the market.

Promotion

Regulation

Summarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising?

Medicinal products

The Danish Medicines Act and the Executive Order on Advertising etc for Medicinal Products (No. 1153 of 22 October 2014) regulate the advertising of medicinal products towards both the general public and healthcare professionals (HCPs). The DMA supervises this area.

Advertising is defined as ‘any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products’. Generally, the rules on advertising for medicinal products are strict and complex, and the definition of advertising is interpreted in a broad manner.

There is a statutory prohibition against the advertising of prescription medicinal products towards the general public while advertising for non-prescription medicinal products towards the general public is allowed. Advertising for prescription medicinal products towards HCPs is allowed, but the field is heavily regulated.

For example, all advertising must be adequate, factual and objective, and it must not be misleading or exaggerate the properties of the medicinal product. All information in the advertising shall be in accordance with the approved summary of product characteristics, and certain compulsory information must be provided. Also, strict rules apply to comparative advertising and the use of documentation in advertising.

Certain information falls outside the scope of Executive Order No. 1153 if it is merely corporate or financial information (eg, press releases and similar), provided that such content does not contain any (direct or indirect) advertising. Press releases must, for example, give factual and concise details about a medicinal product, be generally newsworthy, have the press as its target audience and be distributed or made available to a multitude of reporters or media with a view to obtaining a journalistic assessment and examination prior to publication.

In addition to the statutory provisions, companies affiliated with the Ethical Committee for the Pharmaceutical Industry (ENLI) must comply with the ENLI’s Promotion Code, which is generally stricter than the corresponding legislation.

Online advertising must generally satisfy the same requirements as promotional activities in other media. As advertising on the internet is available to anybody, it must comply with the rules on advertising towards the general public. However, if access to the relevant web page is effectively restricted to HCPs only (eg, by use of a personal unique username and password), the rules on advertising towards HCPs apply.

Medical devices

The Danish Executive Order on Advertising etc for Medical Devices (No. 1155 of 22 October 2014) regulates the advertising of medical devices.

The distinction between advertising and corporate and financial information and press releases is similar to that of medicinal products (described above).

Generally, advertising aimed at persons that are not commercially buying, selling or using the advertised equipment must not (i) contain any recommendation from scientists, HCPs or other well-reputed actors within healthcare; (ii) directly or indirectly refer to serious diseases; or (iii) contain references to surveys, research, literary work, periodicals, etc.

As with medicinal products, all advertising must be adequate and factual and must not be capable of compromising the safety of patients, users or any third party. Also, the advertising must not give the impression that consulting an HCP is irrelevant or that the use of the product is free from risk.

Disputes regarding promotional activities may be brought before the DMA. In addition, advertising aimed at HCPs is regulated by the Medtech Europe’s Code of Ethical Business Practice Part I (Guidelines on the Interaction with Healthcare Professionals and Healthcare Organisations), which has been adopted by the Danish Medtech Industry Association, Medicoindustrien. Therefore, members of Medicoindustrien must, in addition to the legislation, comply with this Code.

Online advertising of medical devices must generally satisfy the same requirements as promotional activities in other media. If access to the relevant web page is effectively restricted to HCPs only (eg, by use of a personal unique username and password), the rules for advertising towards HCPs must be complied with.

Inducement

What regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?

The provision of gifts, discounts and other incentives to HCPs is regulated by the Danish Medicines Act, Danish Executive Order No. 1153 and Danish Executive Order No. 1155.

Further, the field is regulated under the ENLI’s Promotion Code and in Medtech Europe’s Code of Ethical Business Practice Part I (Guidelines on the Interaction with Healthcare Professionals and Healthcare Organisations). Companies affiliated with ENLI or subject to Medtech Europe’s Code must act in accordance with these.

It is a fundamental rule that a pharmaceutical or medtech company’s provision of financial benefits to HCPs must never constitute an inducement to recommend, prescribe, buy, supply, sell or administer specific medicinal products or recommend the use of a particular medical device.

With a few exceptions, companies are therefore prohibited from supplying, offering or promising HCPs any gifts or financial benefits in the form of either cash or benefits.

However, hospitality and payment of direct expenses may, under certain circumstances, be offered to HCPs participating in training and professionally relevant events or courses, and the company may also act as an organiser, co-organiser or sponsor of such events.

Reporting transfers of value

What requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?

Depending on the specific nature of the relationship between an HCP and a pharmaceutical or medtech company, the HCP must either notify the DMA of the relationship or apply for the DMA’s permission to establish such relationship with the company.

Notice of the relationship must also be reported to the DMA by the pharmaceutical or medtech company. Information about the relationship will be made publicly available on the DMA’s website.

These rules do not apply to medtech companies only supplying medical devices in risk class I.

Additionally, as provided in the ENLI Promotion Code, pharmaceutical companies must report certain transfers of value to HCPs to the ENLI, including information regarding events organised, co-organised or sponsored by the company. Also, as provided in the ENLI’s Donation Code, an annual overview of the company’s donations and grants to hospitals must be submitted to the ENLI.

Enforcement of advertising rules

Enforcers

Describe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.

The DMA is the public authority responsible for supervising the statutory provisions on advertising for medicinal products and medical devices.

In addition hereto, the following entities monitor and ensure compliance with the self-regulatory framework:

• the ENLI supervises pharmaceutical companies’ compliance with the self-regulatory framework on advertising for medicinal products and related industry ethical rules; and
• Medicoindustrien handles complaints regarding member companies’ compliance with Medicoindustrien’s ethical guidelines.

Sanctions

What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?

Violations of the statutory advertising rules for medicinal products and medical devices are punishable by fine, the size of which may vary depending on the nature of the violation.

Violations of the ENLI Promotion Code are punishable by fine. Further, the ENLI may also, among other sanctions, issue a public reprimand of a company for breach of the rules, impose a company to correct incorrect information, revoke illegal advertising material, or cancel or change events, etc. The ENLI can only impose sanctions upon companies affiliated with it.

Violations of Medicoindustrien’s ethical guidelines are punishable by fine. Medicoindustrien may also, among other sanctions, issue an injunction to cease or change the unlawful activities or issue a public reprimand for breach of the rules, or both. Medicoindustrien can only impose sanctions upon companies affiliated with it.

Pricing and reimbursement

Pricing

What are the controls imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?

Pricing

Prices of pharmacy-restricted medicinal products are fixed by the MAH. The MAH must notify the DMA of the pharmacy purchase price when the medicinal product is marketed. The retail price to end users is then calculated by adding a prescription fee and a fixed gross profit margin. The price may be amended every fortnight by online notification to notification to medicinpriser.dk. This way, products are sold at the same price from all pharmacies. However, these fixed, identical prices do not comprise medicinal products that are permitted for sale outside pharmacies. No controls on pricing are imposed on such products.

Procurement of medicinal products to public Danish hospitals is carried out through public tender procedures.

There are no controls imposed on the pricing of medical devices.

Reimbursement

The MAH may apply to the DMA for general reimbursement. General reimbursement means that all citizens buying a certain medicinal product will receive reimbursement from the government by means of an automatic deduction from the price charged at the pharmacy.

The reimbursement is calculated according to certain reimbursement thresholds set by the DMA, which entails that the more expenses for reimbursable medicinal products a citizen has, the more reimbursement that citizen will receive within a period of one year.

As for medical devices, there is no system under which companies may apply for general reimbursement of costs. However, if certain requirements are met, end users have the right to full or partial reimbursement of costs for medical devices from the municipalities of Denmark.

Off-label use and unlicensed products

Off-label use

May health professionals prescribe or use products for ‘off-label’ indications? May pharmaceutical companies draw health professionals’ attention to potential off-label uses?

As part of the right to issue prescriptions, physicians may prescribe medicinal products for unapproved indications (off-label use) to the extent such prescription complies with the Danish Act on the Authorisation of Healthcare Professionals and on Healthcare Activities (No. 731 of 8 July 2019) according to which physicians in general must act diligently and conscientiously in their treatment of patients.

Any advertising of medicinal products must be in accordance with the summary of product characteristics, including the approved indication. The same is true for documentation used in advertising. Promotion of off-label use is therefore not allowed.

There exist no specific rules for off-label use for medical devices. However, promotion of medical devices must be in accordance with the purpose for which the medical device is approved. Hence, it is prohibited to promote a medical device for purposes for which the product has not been approved.

Unlicensed products

What rules apply to the manufacture and importation and supply to healthcare providers of unlicensed medicines or medical devices?

Companies holding a manufacture and import authorisation or a wholesale authorisation may manufacture, import, distribute or export, as the case may be, unlicensed medicinal products (medicinal products for which no marketing authorisation has been issued in Denmark) to other companies in the distribution chain. Unlicensed medicinal products may also be supplied to pharmacies and hospital pharmacies.

Unlicensed medicinal products may, however, only be dispensed to patients on the basis of a compassionate use permit (see question 28).

There exist no similar rules for medical devices.

Compassionate use

What rules apply to the establishment of compassionate use programmes for unlicensed products?

The DMA may, in special circumstances and to a limited degree, authorise the sale or dispensing of medicinal products that are not covered by a marketing authorisation or not marketed in Denmark (compassionate use permit). Doctors, veterinarians and dentists may apply for a compassionate use permit. The permit will solely be granted if the medicinal product in question cannot be replaced by another medicinal product available in Denmark and provided that there is sufficient therapeutic reason for choosing a medicinal product that is not marketed in Denmark. Further, compassionate use permits are only issued for medicinal products manufactured by a pharmaceutical company.

There exist no specific rules for medical devices in this regard.

Sale and supply

Regulation

Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?

The DMA categorises medicinal products into a broad range of dispensing groups with different rules applying to each of them. Such dispensing groups include, for example:

• HF: OTC medicinal products to be sold in retail shops or in pharmacies;
• HA: OTC medicinal products to be sold in pharmacies; and
• NBS: only to be delivered to hospitals or upon prescription by medical specialists within the relevant field.

Further, physicians may prescribe certain types of cannabis-based medicinal products under a four-year statutory pilot programme, which was initiated on 1 January 2018. The DMA has issued a set of guidelines for physicians’ dispensing of cannabis-based medicinal products. Nevertheless, physicians prescribing medicinal cannabis under the pilot programme must take full responsibility for the prescription, including for any possible side effects of the medicinal cannabis product in question.

There exist no special rules governing the dispensing or sale of particular types of medical devices.

Online supply

What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?

The Danish Executive Order on Pharmacies and Retailers’ Online Sale and Dispatch of Medicinal Products (No. 675 of 20 May 2015) stipulates that only pharmacists and holders of a company authorisation are allowed to sell medicinal products online. Further, the Executive Order stipulates that such pharmacies and retailers must notify the DMA electronically prior to commencing online sale of medicinal products. Such notification must include certain information, including the relevant website and the date of commencement of the online sale.

No specific rules exist on the online dispensing, sale and supply of medical devices.

Update and trends

Forthcoming legislation and regulation

Is there any current or foreseeable draft legislation or other rules that will affect the regulation of pharmaceuticals and medical devices? What is likely to change, and what steps need to be taken in preparation?

Forthcoming legislation and regulation31 Is there any current or foreseeable draft legislation or other rules that will affect the regulation of pharmaceuticals and medical devices? What is likely to change, and what steps need to be taken in preparation?

EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices will enter into force from 2020 and will bring important changes to the regulation of medical devices (see the EU chapter for more information).

In January 2018, a new statutory pilot programme on medicinal cannabis came into force in Denmark. The purpose of the pilot programme is to establish a safe framework for the prescription and use of medicinal cannabis in the Danish healthcare system. Further, the programme provides new possibilities for companies to cultivate and process cannabis for the purpose of manufacturing cannabis products for medical use. Companies are also provided with the possibility to import cannabis products for medical use from abroad or to export processed cannabis or cannabis products for medical use abroad. The programme will be in effect for four years (ie, until January 2022), at which point it will be evaluated and possibly prolonged (with or without amendments), made permanent or discontinued.

Finally, litigation is currently pending in the Danish courts to clarify the interplay between parallel import and the rules of Directive 2001/62/EC on Falsified Medicines (as amended) regarding trademark holders’ rights to object to repackaging.