Trends and developments
Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?
As in many other jurisdictions, pricing and reimbursement of medicinal products are hot topics in Denmark due to increased public health costs – including increased costs of medicinal products and limited public funds. Pricing in Denmark is also important due to significant Danish export of medicinal products. As a result, the Danish pharmaceutical industry focuses strongly on pricing and reimbursement legislation, as well as its administration.
What is the primary legislation governing medicinal products in your jurisdiction?
The primary legislation on medicinal products is the Medicines Act (Consolidated Act 506, April 20 2013, as amended), which implements, among other things, the EU code relating to medicinal products for human use (EU Directive 2001/83/EC, as amended) and other EU legislation. The Medicines Act is supplemented by more than 50 executive orders regarding:
- sale and advertising; and
- a large number of additional documents and guidelines.
Are any legislative changes proposed or expected in the near future?
The government has not indicated that it will submit any significant proposals involving changes to the Medicines Act during 2017. However, the government has stated that it will seek to change, among other things, legislation relating to the use of certain health data for treatment purposes. A proposal seeking to improve consumer access to medicinal products (particularly over-the-counter products) is also expected during 2017.
Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?
Medicinal products and all aspects thereof – including development, licensing, manufacturing, distribution, sale and advertising – are regulated and supervised by the Medicines Agency. The agency’s website includes relatively detailed information in English on the agency, its activities and rules (see http://laegemiddelstyrelsen.dk/en).
The agency has significant powers and discretion in matters relating to medicinal products. Generally, its decisions may be appealed to the Ministry of Health.
Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?
Yes, the legislation regarding competition, data protection, marketing practices and consumer protection also applies to the trade of medicinal products.
Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?
Generally, alternative medicines (eg, natural medicinal products, traditional herbal medicinal products and homeopathic products) are covered by the Medicines Act. The same applies to strong vitamin and mineral products.
Other products, such as food supplements, are not covered by the Medicines Act. However, the Medicines Agency can include such products under the act if the product:
- is presented as having properties for treating or preventing disease;
- can be used with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action; or
- can be used to make a medical diagnosis.
What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?
Manufacturing medicinal products must be authorised by the Medicines Agency. The agency grants authorisation only to companies with a Danish address. However, under specific circumstances, foreign companies (eg, companies with a Danish branch office) may obtain authorisation.
In order to obtain authorisation, companies must comply with good manufacturing practice. The specific conditions are provided in a number of executive orders, including Executive Order 1358 (December 18 2012) on manufacture and import of medicinal products and intermediary products and Executive Order 1360 (December 18 2012) on manufacture, import and distribution of active pharmaceutical ingredients.
An application is processed by the Medicines Agency within 90 days.
What is the fee for obtaining authorisation?
The Medicines Agency charges an application fee and an annual fee for certain company authorisations and company registrations. A list of the fees is available on the agency’s website.
What is the validity period for authorisation?
From September 1 2012 authorisation has been issued without an expiry date and is therefore valid until it is modified or revoked. Companies which have been granted authorisations before this date may submit an application for renewal within six months, and no later than three months, before the expiry of the authorisation.
How robust are the standard good manufacturing practices followed in your jurisdiction?
Executive Order 1358 (December 18 2012) on the manufacture and import of medicinal products and intermediary products regulates the standard of good manufacturing practice.
The Medicines Agency regularly inspects companies which have been granted manufacturing authorisations in order to ensure compliance with good manufacturing practice. Deviation from good manufacturing practice is rarely seen.
What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?
In case of breach of a manufacturing authorisation and good manufacturing practice, the Medicines Agency may impose enforcement orders and withdraw manufacturing authorisation. In a recent case involving significant violations of good manufacturing practice, the agency suspended the company’s manufacturing authorisation and reported the company to the police in order to impose a fine. The agency has stated publicly that it has a strong focus on ensuring compliance with good manufacturing practice.
How are the distribution and storage of medicinal products regulated?
Companies wishing to perform wholesale distribution must obtain an authorisation from the Medicines Agency. This authorisation covers wholesale issues (ie, reception, storage and delivery), complaints handling and recalls within the European Economic Area.
Distribution of medicinal products is regulated in the Medicines Act and several executive orders, including Executive Order 1359 (December 18 2012) on distribution of medicinal products and Executive Order 1399 (December 2 2015) on medicine prices and supply conditions.
Import and export
How are the import and export of medicinal products regulated?
Import of medicinal products from outside the European Economic Area must be authorised by the Medicines Agency.
The import of medicinal products is regulated by Executive Order 1358 on the manufacture and import of medicinal products and intermediary products and Executive Order 1360 (December 18 2012) on manufacture, import and distribution of active pharmaceutical ingredients.
On request, the Medicines Agency issues export certificates to companies exporting medicinal products. The certificates are issued in accordance with the World Health Organisation certification scheme.
Are parallel imports permitted in your jurisdiction?
Yes. Parallel imports are regulated by Executive Order 1239 (December 12 2005) on marketing authorisation for medicinal products, as amended. In addition, the Medicines Agency has issued a detailed guidance document on parallel imports of medicinal products.
Generally, the Medicines Agency can issue a marketing authorisation for parallel import of a medicinal product, provided that:
- the directly imported medicinal product has a marketing authorisation in Denmark and the two products have the same active ingredient and same pharmaceutical form;
- the parallel-imported product has been imported from another country in the European Union or European Economic Area;
- the parallel-imported product is covered by a marketing authorisation in another EU or European Economic Area country; and
- there are no differences in therapeutic effect between the parallel-imported and directly imported product.
The executive order does not apply to parallel distribution of medicinal products authorised by the European Commission under the centralised procedure.
Sale and purchase
What rules govern the dispensing, sale and purchase of medicinal products?
The main legislation is the Pharmacies Act (Act 1040, September 3 2014, as amended). Pursuant to the act, pharmacies have the exclusive right to sell prescription-only medicinal products to patients and customers. In addition, a large number of over-the-counter medicinal products may be sold only at pharmacies.
The Medicines Agency determines whether a medicinal product should be available on prescription only and whether an over-the-counter medicinal product is suitable for sale outside pharmacies. Certain over-the-counter products may be sold outside the pharmacies in shops which have been authorised by the agency to sell such products.
Are there any restrictions on the online sale and purchase of medicinal products?
Generally, most medicinal products can be purchased by consumers from pharmacies online and be delivered to the consumer by mail.
Consumers are allowed to import medicinal products purchased online from a country in the European Economic Area when the product:
- is for the treatment of disease in humans;
- is purchased from an authorised retailer or pharmacy;
- is for the personal use of the consumer; and
- does not contain certain substances (eg, euphoriant substances).
It is illegal to import medicines dispatched from a country outside the European Economic Area.
Named patient supply
What rules govern named patient supply of pre-launch medicinal products?
Pursuant to the Medicines Act, the Medicines Agency may in certain circumstances authorise the sale or dispensing to a specific patient of a medicinal product that is not marketed in Denmark (a so-called ‘compassionate use permit’).
Doctors, veterinarians and dentists may apply to the agency for a compassionate use permit.
What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Clinical trials involving humans must be authorised by the Medicines Agency on the basis of an application submitted by the individual, company or group that takes overall responsibility for the trial (ie, the sponsor). A doctor or dentist must always participate in the conduct of the trial. The agency evaluates both the quality of the investigation and patient safety issues.
In addition, clinical trials must be authorised by the competent regional research ethics committee, which performs an overall assessment of the trial’s ethical aspects.
Both approvals must be obtained before the initiation of the trial.
How robust are the standard good clinical practices followed in your jurisdiction?
The Medicines Act expressly provides that all clinical trials must comply with good clinical practices. Detailed regulation of good clinical practice is also provided in secondary legislation, including Executive Order 695 (June 12 2013) on good clinical practice in clinical trials of medicinal products for humans.
The Medicines Agency performs inspections of clinical trials to ensure full compliance with the standards of good clinical practices. The agency inspects clinical trials both in Denmark and abroad. Deviation from good clinical practice is rarely seen in Denmark.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
The sponsor is required to notify the Medicines Agency of the completion of the clinical trial no later than 90 days after completion. In addition, on completion of the clinical trial the sponsor is required to disclose the clinical trial results to the agency as soon as possible and no later than one year after completion.
What are the informed consent obligations with respect to clinical trial subjects?
All patients participating in a clinical trial must receive both written and verbal information about the trial, and participants must give their informed consent before the trial begins. The legislation includes provisions on consent from participants who are not of age or legal capacity.
What are the insurance requirements for clinical trials?
It is the responsibility of the sponsor to ensure that adequate insurance schemes are in place.
What data protection issues should be considered when conducting clinical trials?
The Act on Processing of Personal Data (Act 429, May 31 2000, as amended) generally applies to the processing of personal data relating to an identified or identifiable person when the processing is conducted for medical or scientific purposes.
The act implements EU Directive 95/46/EC on data protection and is supervised by the Data Protection Agency.
However, pursuant to the Medicines Act and Executive Order 410 (May 9 2012) clinical trials of medicinal products need not be notified to or authorised by the Data Protection Agency.
The exemption does not apply to processing sensitive personal data in connection with non-interventional trials, research and statistics projects or biological material for future use if the biological material is expected to be used in trials of medical products or in the testing of medical devices.
Pharmaceutical companies conducting ongoing non-interventional trials, or other research subject to the notification requirement, can file a general notification and obtain authorisation from the Data Protection Agency to process sensitive data. It is also possible to file a general notification of the processing of biological material for future research.
Notwithstanding that notification is not required, the Act on Processing of Personal Data and any other relevant legislation must still be complied with. Accordingly, clinical trials are subject to the rules of the act and the data subject’s rights.
What is the marketing authorisation procedure for medicinal products in your jurisdiction?
Companies can apply for marketing authorisation through:
- the centralised procedure;
- the decentralised procedure;
- the mutual recognition procedure; and
- the national procedure.
Danish marketing authorisations under the decentralised procedure, the mutual recognition procedure and the national procedure are granted by the Medicines Agency in accordance with Executive Order 1239 (December 12 2005) on marketing authorisation for medicinal products, as amended. This legislation implements applicable EU directives.
An application for marketing authorisation is processed by the Medicines Agency within 210 days.
What criteria are considered in granting marketing authorisation?
Applications for marketing authorisation must include documentation on the efficacy, safety and quality of the medicinal product. The criteria correspond to the conditions set out in the EU code relating to medicinal products for human use (EU Directive 2001/83/EC, as amended).
What is the fee for obtaining marketing authorisation?
A list of the current fees is available on the Medicines Agency’s website.
What is the validity period for marketing authorisation?
Marketing authorisations are granted for a period of up to five years. The marketing authorisation may be renewed, provided that a renewal application is submitted to the Medicines Agency at least nine months before the expiration of the marketing authorisation. If the marketing authorisation is renewed, it will not be issued with an expiry date and is therefore valid for an unlimited period.
What are the consequences of failure to obtain marketing authorisation?
A medicinal product which is not covered by a marketing authorisation valid for Denmark may not be placed on the market in Denmark unless covered by a compassionate use permit with respect to a specific patient.
If a medicinal product not covered by a valid marketing authorisation is nevertheless placed on the market, the Medicines Agency will order that the marketing be stopped. The agency may also seek to impose other penalties (eg, fines).
What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?
Pursuant to the Medicines Act and Executive Order 898 (June 23 2016) on pharmacovigilance, the holder of a marketing authorisation must:
- maintain a pharmacovigilance system;
- appoint a person responsible for the pharmacovigilance system;
- immediately report new and significant information regarding the product's risk/benefit balance to the Medicines Agency;
- report suspected or unexpected serious adverse reactions to the Medicines Agency and other bodies within 15 days.;
- report non-serious adverse reactions within 90 days; and
- submit periodic safety update reports to the Medicines Agency.
While the medicinal product is marketed, the marketing authorisation holder must notify the Medicines Agency in case of any permanent or temporary cessation of marketing, and of the reasons for such cessation. In addition, the holder must notify and explain any decision:
- to withdraw the product from the market;
- to withdraw the marketing authorisation; and
- not to renew the marketing authorisation.
What data protection issues should be considered when conducting pharmacovigilance activities?
The Act on Processing of Personal Data applies to pharmacovigilance activities when the processing of personal data relating to an identified or identifiable person is conducted for medical or scientific purposes.
However, pursuant to the Medicines Act and Executive Order 410 (May 9 2012) mandatory safety monitoring of medicinal products need not be notified or authorised by the Data Protection Agency.
The exemption from notification does not apply to the processing of sensitive personal data in relation to non-interventional trials, research and statistics projects and the collection of biological material for future research if the biological material is expected to be used in trials of medical products or in the testing of medical devices.
Notwithstanding that notification is not required, the Act on Processing of Personal Data and any other relevant legislation must still be complied with. Accordingly, pharmacovigilance activities will be subject to the act and the data subject’s rights.
Pricing and reimbursement
Are there rules governing the pricing of medicinal products in your jurisdiction?
The price of a medicinal product is set by the holder of the marketing authorisation. The price can be adjusted every 14 days and changes must be reported to the Medicines Agency. All prices, which must apply throughout the country, are published on a separate section of the agency's website.
In principle, the marketing authorisation holder is free to set the price. However, due to agreements between the Association of the Pharmaceutical Industry, the Ministry of Health and the Danish regions, price increases are subject to several conditions. The agreements will expire in December 2018 and March 2019.
There is no regulation of wholesale margins and the pharmaceutical companies and wholesale distributors can freely negotiate pricing, discounts and other terms.
Pricing between wholesalers and retailers/pharmacies is regulated to some extent, since only certain types of discounts, bonuses and similar pricing mechanisms are allowed.
The calculation of consumer sale prices is subject to Executive Order 1650 (December 2016) on consumer prices of medicinal products.
What is the structure for state reimbursement of medicinal product costs?
The holder of a marketing authorisation of a medicinal product can apply to the Medicines Agency for general reimbursement or individual reimbursement (ie, reimbursement on a patient-by-patient basis). The Medicines Agency then determines the reimbursement status of the product, usually following consultations with the agency’s Reimbursement Committee.
If a product is eligible for reimbursement, the agency will set a reimbursement price which is then used for calculating the reimbursement and the patient's own payment. The reimbursement is paid by the Danish regions and financed through the Danish tax system.
The reimbursement price can be either the product price or the lowest price of substitutable products in the relevant reimbursement group (ie, the group of products to which the product belongs). The use of such reimbursement groups is intended to encourage patients to buy a product in each group at the lowest price. Consequently, if the patient chooses to buy a more expensive product, the patient must pay the difference, regardless of whether the patient is eligible for reimbursement under the principles described above.
Pharmacies are compensated mainly through the retail margin and handling fees. The retail margin is the difference between the pharmacy purchase price and the consumer sale price. The retail margin is calculated by the Medicines Agency.
Advertising and labelling
How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?
The main legislation is the Medicines Act and Executive Order 1153 (November 22 2014) on advertising of medicinal products. Advertising to healthcare professionals and the general public is supervised by the Medicines Agency.
In addition, the Ethical Committee for the Pharmaceutical Industry has published a number of industry codes and guidelines. The committee has competence in cases involving member companies of the Association of the Pharmaceutical Industry, the Generic Medicines Industry Association and the Parallel Importers' Association.
In practice, most disputes regarding the advertising of medicinal products directed at healthcare professionals are brought before committee.
The legislation implements Title VIII of EU Directive 2001/83/EC on the EU code relating to medicinal products for human use, as amended. According to case law from the European Court of Justice, Danish legislation cannot impose stricter rules than the Code for Human Medicines Directive unless such rights are authorised under the directive. Nevertheless, certain inconsistencies between Danish legislation and the directive still exist.
Also, some of the provisions enforced by the committee (ie, certain provisions in the committee’s code) are stricter than the rules under the directive (eg, relating to gifts to healthcare professionals).
Do any special rules apply to online advertising of medicinal products?
The rules on advertising in writing also apply to online advertising. Pursuant to the Medicines Act and Executive Order 1153 (November 22 2014) on advertising of medicinal products, advertising of prescription-only medicines to the general public is not permitted. Consequently, online advertising to healthcare professionals must be gated to ensure that only healthcare professionals can access it.
The Medicines Agency generally considers itself competent when online advertising is provided by a company or person domiciled in Denmark. Further, the Medicines Authority may consider itself competent in certain other cases where the advertising is deemed to be directed at Denmark.
What are the packaging and labelling requirements for medicinal products?
The main legislation is the Medicines Act and Executive Order 869 (July 21 2011) on labelling of medicinal products, as amended. These rules implement Title V of EU Directive 2001/83/EC on the EU code relating to medicinal products for humans. However, the legislation also includes certain specific national requirements.
Thus, every medicinal product must bear a specific product number issued by the Medicines Agency in accordance with Executive Order 767 (June 22 2016) on product numbers for medicinal products.
The labelling, including the outer and immediate packaging and the package leaflet, must be in Danish, unless an exemption is exceptionally granted by the Medicines Agency.
Special requirements also apply to the labelling of small packaging and blister packs.
The Medicines Agency supervises compliance with these requirements.
How is the promotion of off-label use regulated?
Pursuant to the Medicines Act, all advertising material must comply with the product’s summary of product characteristics. Accordingly, promotion of off-label use of a medicinal product is prohibited in Denmark.
Relations with healthcare professionals
Gifts and incentives
What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?
The Medicines Act and Executive Order 1153 (November 22 2014) on the advertising of medicinal products regulate the pharmaceutical industry's interactions with healthcare professionals.
In addition, the Ethical Committee for the Pharmaceutical Industry code on advertising of medicinal products to healthcare professionals is relevant. This code implements, among other things, the European Federation of Pharmaceutical Industries and Associations code on the promotion of prescription-only medicines to, and interactions with, healthcare professionals and its disclosure code.
Generally, no gifts or pecuniary advantages (in cash or kind) can be made, offered or promised to healthcare professionals. Pursuant to the executive order on the advertising of medicinal products, gifts of insignificant value which are of use for healthcare professionals' work are allowed. However, the Ethical Committee for the Pharmaceutical Industry code prohibits such gifts.
Pharmaceutical companies can offer healthcare professionals training and professional information related to medicinal products in the form of payment of direct expenses related to courses and other professional and scientific events that healthcare professionals attend or arrange.
Donations, grants and benefits in kind to institutions, organisations or associations which comprise healthcare professionals or which provide healthcare or conduct research are generally allowed, provided that they are made for the purpose of supporting healthcare or research.
Further, it is permitted to use healthcare professionals as consultants and advisers, in groups or individually, for services such as:
- speaking at and chairing meetings;
- taking part in medical and scientific studies, clinical trials or training services;
- participation at advisory board meetings; and
- participation in market research where such participation involves remuneration and travel.
The legislation provides that collaborations and certain other connections between a pharmaceutical company and an individual healthcare professional must be notified to or approved by the Medicines Agency. Such collaborations and connections (eg, ownership of shares in the pharmaceutical company) are also disclosed on the Medicines Agency’s website.
How can a liability claim for a defective medicinal product be brought?
Claims covered by the Act on the Right to Complain and Receive Compensation within the Health Service (Act 1113, November 7 2011) are filed with the Patient Insurance Association. Claims that are not covered by the act are filed with the Danish courts (eg, claims under the Product Liability Act (Act 261, March 20 2007)).
Product liability claims must be filed within three years of the date on which the injured party knew or should have known of the injury or damage and the potential defect. Claims lapse at the latest 10 years after the defective product was put on the market.
Class actions for uniform claims on behalf of a group of persons can be brought before the Danish courts, provided that:
- the claims are subject to the same jurisdiction and legal forum; and
- the claims are generally suitable for class actions under the Administration of Justice Act (Act 1257, October 13 2016, as amended).
Cases relating to medicinal product liability before the Danish courts are relatively rare, as almost all cases are processed by the Patient Insurance Association. As far as can be ascertained, no class action relating to medicinal product liability has yet been brought before the Danish courts.
Which parties can be held liable for a defective medicinal product?
Parties that are potentially liable for claims regarding medicinal product liability not covered by the Act on the Right to Complain and Receive Compensation within the Health Service and relating to medicinal products include:
- the marketing authorisation holder or its representative (eg, a Danish sales company); and
- the manufacturer.
In addition, depending on the circumstances, patients may also file claims against other persons (eg, the manufacturer of specific active pharmaceutical ingredients, excipients or the relevant wholesale distributors).
Claims brought under the act are paid by the Danish state.
What remedies are available to successful claimants?
The main remedy available to claimants is damages. Claims under the Act on the Right to Complain and Receive Compensation within the Health Service and claims not covered by the act (eg, claims under the Product Liability Act) are generally calculated in accordance with the Act on Liability for Damages (Consolidated Act 266, March 21 2014, as amended).
The amount of compensation depends on the injury in question. Generally, the injured party can claim compensation for:
- loss of earnings;
- recovery costs;
- pain and suffering; and
- other losses resulting from the injury.
In Denmark, claims for punitive damages are not allowed.
Exclusion and limitation
On what grounds can liability be excluded?
In cases not covered by the Act on the Right to Complain and Receive Compensation within the Health Service, the injured party must prove:
- the existence of the damage or injury;
- the existence of the defect; and
- that such damage or injury was caused by the defective product.
Generally, the defendant is excluded from liability if he or she proves one of the following:
- that the defendant did not place the product on the market, or did not place the product on the market as part of commercial activities;
- that the defect is caused by the obligation to conform to mandatory statutory requirements;
- that the scientific or technical knowledge available at the time that the product was placed on the market did not permit to discover the defect; or
- that the defect causing the injury or damage did not exist at the time that the product was placed on the market.
What preventive steps can be taken to limit liability?
In cases not covered by the Act on the Right to Complain and Receive Compensation within the Health Service, communication and marketing of the product generally seem to be of relevance when determining liability. Accordingly, depending on the circumstances, explicit information, warnings and instructions for use in the medicinal product labelling, including the outer and immediate packaging and the package leaflet, may limit liability claims.
Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
The Medicines Act and the more than 50 executive orders which supplement it grant the Medicines Agency significant powers and discretion in matters relating to medicinal products. The Medicines Agency is authorised to penalise violations of the legislation by means of, for example, enforcement orders and withdrawal of relevant authorisations. In addition, the agency collaborates with police and prosecutors in cases where it believes that fines or imprisonment are required. However, such cases are relatively rare.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
The Medicines Act includes provisions which implement, among other things, EU Directive 2011/62/EU relating to falsified medicinal products. The Medicines Agency cooperates with other regulatory authorities within and outside the European Union and the European Economic Area and the pharmaceutical companies in order to combat dishonest practices (eg, counterfeiting).
The legislation includes detailed rules on anti-bribery, fraud, collusion and similar activities. These rules are primarily found in the Criminal Code (Consolidated Act 1052, April 4 2016, as amended) and in certain other legislation, including the Competition Act (Consolidated Act 869, July 8 2015, as amended).