Trends and developments
Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?
The Danish Medicines Council was established in 2017. The council is independent and responsible for assessing whether new medicinal products and indications are recommendable as standard treatment within the healthcare system in the Danish regions. Since its inception, the council's strict rules on member impartiality have been subject to much controversy. Initially, healthcare professionals refused to become members of the council’s committees because their membership would inadvertently limit their potential to cooperate with pharmaceutical companies.
In January 2018 discussions on the council’s rules on impartiality arose in connection with the Danish regions’ new guidelines on pharmaceutical companies' financial contributions to relevant training of healthcare professionals in the public health service. The guidelines stipulate that companies may no longer address healthcare professionals in the public sector directly with offers on relevant courses and conferences. Instead, companies must address such offers to the hospital management, which will then decide at its own discretion whether any hospital employees will participate in the offered course or conference. In this regard, when making its decision the hospital management will consider healthcare professionals’ participation in advisory committees such as the Danish Medicines Council to ensure that no healthcare professional inadvertently becomes incompetent in regard to his or her other appointed tasks.
In 2018 a new statutory pilot programme on medicinal cannabis came into force in Denmark with the purpose of establishing a safe framework for use of medicinal cannabis in the healthcare system. The pilot programme primarily concerns cannabis-based products imported from European Economic Area member states and allows the import and manufacture of so-called ‘cannabis primary products’ or ‘cannabis intermediate products’, which technically are different from medicinal products that are subject to marketing authorisation. Further, a separate development programme will run parallel to the pilot programme, making Denmark one of the first countries in Europe to allow cannabis to be grown for medical use. Both programmes run for four years (as of January 1 2018) and an overall evaluation of the programmes will be made with a view to making a political decision about a permanent medicinal cannabis scheme in Denmark.
As in many other jurisdictions, biosimilars are a hot topic in Denmark, and the biosimilar market has significantly expanded in recent years. As of December 2017, 12 biosimilars (referencing seven different innovator biologic products) are being marketed in Denmark and more are expected to follow.
What is the primary legislation governing medicinal products in your jurisdiction?
The primary piece of legislation governing medicinal products is the Danish Medicines Act, which implements various EU legislation, including the EU Directive on the Community Code Relating to Medicinal Products for Human Use (2001/83/EC). The act is supplemented by numerous executive orders and guidelines governing various aspects of medicinal products, including:
- sales; and
Further, the Danish Act on Clinical Trials implements, among others, the EU Regulation on Clinical Trials on Medicinal Products for Human Use (526/2014). The act is supplemented by several executive orders and guidelines.
Are any legislative changes proposed or expected in the near future?
The government’s 2018 legislative agenda contains no legislative proposals of significant relevance to the life sciences sector.
Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?
The Danish Medicines Agency (DMA) supervises adherence to the Danish Medicines Act. The DMA is empowered to:
- authorise and inspect pharmaceutical companies and license medicinal products in the Danish market;
- monitor medicinal products’ side effects;
- authorise clinical trials;
- decide which medicinal products are eligible for reimbursement;
- appoint pharmacists and organise the national pharmacy structure;
- supervise pharmacies and medicinal product retailers; and
- monitor and supervise medical devices in the Danish market.
The DMA’s competence is supplemented by the National Committee on Health Research Ethics (and its regional sub-committees) regarding the ethical aspects of clinical trials and new fields of research. The committee’s tasks include;
- approving clinical trials (after performing an overall evaluation of the clinical trial’s ethical aspects);
- giving opinions on issues of a fundamental nature (provided that it is not related to the approval of a specific research project);
- monitoring the development of health sector research and raising awareness of any associated ethical issues (eg, regarding health services and biomedical research environments); and
- making recommendations to the minister of health.
Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?
Yes. The following legal regimes also apply:
- data protection;
- marketing practices; and
- consumer protection.
Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?
According to the Danish Medicines Act, the term ‘medicinal product’ covers products that can be used either to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis.
Related products such as dietary supplements and foodstuffs are not covered.
However, while a product by its characteristics may be exempt from regulation, if it is presented as having the properties for treating or preventing a disease, it will be regulated.
Complementary and alternative medicinal products (eg, natural medicinal products and strong vitamin and mineral products, are subject to specific regulation and require DMA authorisation).
What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?
The manufacture of medicinal products requires a licence from the Danish Medicines Agency (DMA). Therefore, companies wishing to manufacture medicinal products must apply for a Manufacturing and Importation Authorisation.
The specific conditions and requirements for medicinal product manufacturing are regulated in the Danish Medicines Act and several executive orders, including Executive Order 1358 of December 18 2012 on the manufacture and import of medicinal products, including semi-finished products. Companies must comply with good manufacturing practice, among others.
The DMA website provides:
- licence application forms; and
- reader-friendly guidelines describing the information that must be included.
The DMA grants authorisation to manufacture medicinal products only to companies registered with a Danish address.
The DMA must decide whether to grant the licence no later than 90 days after receiving a complete application.
What is the fee for obtaining authorisation?
The DMA charges both application and annual fees for its services. As of 2018, fees for obtaining a manufacturing authorisation in Denmark are Dkr47,957.
If the DMA grants manufacturing authorisation within the first nine months of the calendar year, the applicant must pay the annual fee for that year in full. However, if the authorisation is granted within the last three months of the calendar year, the applicant need not pay an annual fee until the next calendar year. No matter what time of year an authorisation expires, the annual fee is payable for the year of expiration.
The DMA’s fees are annually adjusted according to the price index.
What is the validity period for authorisation?
On September 1 2012 the DMA changed its practice so that company authorisations are no longer issued with an expiry date. Therefore, a manufacturing authorisation is valid until it is amended or terminated. Companies holding an authorisation with an expiry date must apply for renewal within six months and no later than three months before the expiry date.
How robust are the standard good manufacturing practices followed in your jurisdiction?
The DMA ensures compliance with good manufacturing practice by regularly conducting inspections at manufacturing sites. Good manufacturing practice compliance is crucial and cases of non-compliance are relatively rare.
What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?
The consequences vary depending on the type of violation. For example, manufacturing medicinal products without a valid manufacturing authorisation is a criminal offence punishable by fine or up to 18 months’ imprisonment.
Where good manufacturing practice non-compliance is discovered during an inspection of a manufacturing site, the DMA may proceed in several ways depending on the severity of the violation. After the inspection, the inspector prepares an inspection report, describing any deviations. Based on the inspection report, minor deviations may be remedied by the manufacturer.
However, if deviations are severe the DMA may:
- fine the company;
- place medicinal products in quarantine;
- withdraw medicinal products from the market; or
- suspend or withdraw the manufacturing authorisation.
How are the distribution and storage of medicinal products regulated?
Wholesale distribution and storage of medicinal products require a DMA licence. Therefore, companies wishing to store and distribute medicinal products must apply for wholesale distribution authorisation, which is granted for specifically identified premises.
The specific conditions and requirements for the wholesale distribution of medicinal products are regulated by the Danish Medicines Act and several executive orders, including Executive Order 1359 of December 18 2012 on the distribution of medicinal products. Companies must comply with good distribution practices, which include requirements on how medicinal products are handled and distribution chain control.
Import and export
How are the import and export of medicinal products regulated?
Imports of medicinal products from third countries outside the European Union or the European Economic Area require a valid manufacturing authorisation from the DMA.
Exports of medicinal products to third countries outside the European Union or the European Economic Area require a wholesale distribution authorisation from the DMA. Exports of medicinal products manufactured by the exporting company are included in a manufacturing authorisation.
Medicinal product imports are regulated under Executive Order 1358 of December 18 2012 on the manufacturing and importation of medicinal products, including semi-finished products.
Wholesale distribution of medicinal products, including export, is regulated by Executive Order 1359 of December 18 2012 on the distribution of medicinal products.
Companies can obtain an export certificate from the DMA certifying the medicinal product or the manufacturer when exporting medicinal products. Export certificates are issued in accordance with the World Health Organisation certification scheme.
Are parallel imports permitted in your jurisdiction?
Yes. However, parallel imports of medicinal products within the European Union and the European Economic Area require DMA marketing authorisation.
According to Section 35 of Executive Order 1239 of December 12 2005 on marketing authorisation to medicines, the DMA can issue marketing authorisation for parallel imports under the following conditions:
- The directly imported 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 imported medicinal product and the parallel imported medicinal product) must have the same active ingredient and pharmaceutical form;
- The exporting country must be a member of the European Union or the European Economic Area;
- The parallel imported product must have valid marketing authorisation from an EU or EEA member state (being the exporting state); and
- No therapeutic differences must exist between the parallel imported product and the equivalent directly imported product.
Marketing authorisation is valid for five years from the date of issue of the first marketing authorisation for parallel import of the concerned medicinal product. The authorisation may be continuously renewed for further five-year periods.
The parallel distribution of medicinal products, which has been authorised by the European Commission under the centralised authorisation procedure, does not require a separate Danish marketing authorisation. Instead, the parallel distributor must notify the European Medicines Agency of the intended parallel distribution and await its confirmation that parallel distribution of the product is permitted.
Sale and purchase
What rules govern the dispensing, sale and purchase of medicinal products?
The Pharmacy Act governs the dispensing, sale and purchase of medicinal products. A distinction must be drawn between over-the-counter medicinal products and prescription-only medicinal products. The Pharmacy Act stipulates that pharmacies have exclusive rights to sell prescription-only medicinal products to consumers; likewise, many over-the-counter medicinal products are permitted for sale only in pharmacies.
However, shops outside the pharmacy sector can obtain authorisation to sell certain over-the-counter medicinal products, which are suitable for sale outside pharmacies. The DMA decides which medicinal products can be sold outside pharmacies.
Are there any restrictions on the online sale and purchase of medicinal products?
In Denmark, medicinal products may legally be purchased online from pharmacies or certain retailers. Pharmacies selling medicinal products online must comply with all of the standard rules applicable to pharmacies’ sale of medicinal products to consumers.
Further, Executive Order 675 of May 20 2015 sets out specific rules on pharmacies’ and retailers’ online sale and distribution of medicinal products. For example, pharmacies must offer oral and written advice on the website from which it sells medicinal products, which permits consumers to contact the pharmacy by telephone or in writing via the website.
It is illegal for consumers to import medicinal products into Denmark if such products are dispatched from a country outside the European Union or the European Economic Area. Imports of medicinal products dispatched from an EU or EEA country is legal provided that the medicinal product:
- treats a human disease;
- was legally purchased in the relevant country;
- is for the consumers’ personal use; and
- contains no doping or euphoriant substances.
Named patient supply
What rules govern named patient supply of pre-launch medicinal products?
The DMA may, under special circumstances and to a limited degree, authorise the sale or dispensing of a medicinal product which is not covered by a marketing authorisation or not marketed in Denmark (named patient supply) by issuing a compassionate use permit.
Physicians, veterinarians and dentists may apply for a compassionate use permit for human and veterinary medicinal products.
What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Before the start of a clinical trial, approvals must be obtained from both the Danish Medicines Agency (DMA) and the competent regional research ethics committee.
The sponsor (ie, the person, company or institution which takes overall responsibility for the clinical trial) must apply to the DMA for authorisation to conduct the clinical trial. Under certain circumstances, the sponsor may delegate this task.
Before authorising the clinical trial, the DMA evaluates both the quality of the investigation and the patient safety of the clinical trial. The regional research ethics committee will perform an overall evaluation of the clinical trial’s ethical aspects.
How robust are the standard good clinical practices followed in your jurisdiction?
The standard good clinical practices are highly robust. The DMA has the legal right to control any natural person, company or institution that conducts clinical trials of medicinal products in Denmark. It regularly performs trial site inspections of clinical trials to ensure compliance with the standards of good clinical practice.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
The sponsor must report to the DMA that the trial has been completed no later than 90 days after its completion. For multinational trials, the DMA must be informed when the trial is completed in Denmark.
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 a year of completion.
What are the informed consent obligations with respect to clinical trial subjects?
Patients participating in a clinical trial must receive both written and oral information about the trial. Before the trial starts, participants must provide their informed consent to participate.
Patients under 15 years’ old may participate in clinical trials only with the consent of their legal custodian. As for patients under guardianship, the legal guardian must consent to the patient’s participation in a clinical trial.
What are the insurance requirements for clinical trials?
The sponsor must ensure that there is adequate and appropriate insurance in place to cover its responsibility towards any participant suffering harm.
What data protection issues should be considered when conducting clinical trials?
In general, Danish data protection legislation applies to the processing of personal data in connection with conducting clinical trials. As of May 25 2018, Danish data protection legislation comprises the General Data Protection Regulation. Therefore, the applicable data protection rules (whether the Danish data protection legislation or, as of May 25 2018, the General Data Protection Regulation) must be complied with.
Under existing Danish data protection legislation and the forthcoming General Data Protection Regulation, clinical trials need not be notified to or authorised by the Danish Data Protection Agency. However, until the entry into force of the General Data Protection Regulation, the processing of personal data in connection with non-interventional trials, storage of biological material for future use (ie, biological material that is not part of the individual clinical trials but stored for future research purposes) and research and statistics projects must be notified to the Danish Data Protection Agency.
What is the marketing authorisation procedure for medicinal products in your jurisdiction?
There are four different procedures for obtaining marketing authorisation for medicinal products in Denmark:
- The centralised procedure – the application is submitted to the European Medicines Agency and the medicinal product is authorised by the European Commission in the entire European Union simultaneously. The centralised procedure is mandatory for certain kinds of medicinal products, including biological medicinal products.
- The decentralised procedure – companies can apply for authorisation in more than one EU or EEA country. One country is chosen as the ‘reference member state’ and will be responsible for the procedure and the scientific evaluation of the application.
- The mutual recognition procedure – marketing authorisation has already been obtained in another EU or EEA member state and this authorisation forms the basis for authorisation in another EU or EEA country.
- The national procedure – the application is submitted to the Danish Medicines Agency (DMA), which authorises the medicinal product to be marketed solely on the Danish market.
What criteria are considered in granting marketing authorisation?
The criteria primarily relate to the safety, efficacy and quality of the medicinal product. Generally, the benefits of the medicinal product must outweigh the risks.
What is the fee for obtaining marketing authorisation?
As of 2018, the DMA’s fee for a fully documented application under the national procedure is Dkr187,218. The fee for a fully documented application under the de-centralised procedure and the mutual recognition procedure is Dkr260,335. All fees are adjusted annually.
A full list of the applicable fees can be found on the DMA's website.
What is the validity period for marketing authorisation?
Marketing authorisations are granted with an initial validity period of five years. The authorisation may be renewed provided that the marketing authorisation holder submits a renewal application no later than nine months for human medicinal products or six months for veterinary medicinal products 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.
What are the consequences of failure to obtain marketing authorisation?
A medicinal product must not be placed on the Danish market unless a marketing authorisation has been issued by a competent authority. It is a severe violation of Danish legislation and a criminal offence punishable by fine or up to 18 months’ imprisonment to put a medicinal product on the market without marketing authorisation.
What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?
A market authorisation holder 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. Among others, the marketing authorisation holder 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 Danish Medicines Agency (DMA);
- keep records of suspected adverse reactions and make these available to the DMA;
- electronically report information on suspected serious adverse reactions to the European Medicines Agency’s database for adverse reactions within 15 days of receiving knowledge of such suspected reaction;
- electronically report information on suspected non-serious adverse reactions to the European Medicines Agency’s database for adverse reactions within 90 days of receiving knowledge of such suspected reaction; and
- prepare and submit periodic safety update reports to the DMA.
What data protection issues should be considered when conducting pharmacovigilance activities?
In general, Danish data protection legislation applies to the processing of personal data in connection with conducting safety monitoring. As of May 25 2018, Danish data protection legislation comprises the General Data Protection Regulation. Therefore, the applicable data protection rules (whether the Danish data protection legislation or, as of May 25 2018, the General Data Protection Regulation) must be complied with.
Under existing Danish data protection legislation and the forthcoming General Data Protection Regulation, safety monitoring need not be notified to or authorised by the Danish Data Protection Agency.
Pricing and reimbursement
Are there rules governing the pricing of medicinal products in your jurisdiction?
Yes. The pharmacy purchase price of pharmacy restricted medicinal products is set by the (pharmaceutical) company placing the medicinal product in question on the market. The price must be set no later than 14 days before putting the medicinal product on the market and may be adjusted every two weeks by notice to the Danish Medicines Agency (DMA).
Based on the pharmacy purchase price, the consumer price is calculated in accordance with Executive Order 1631 of December 20 2017 on calculation of consumer prices on medicinal products. Its calculation model ensures that medicinal products are sold at the same prices by all pharmacies in Denmark.
However, the identical price scheme does not apply to certain non-pharmacy restricted over-the-counter medicinal products. The pricing of such products is at the discretion of the pharmacist or shop owner.
What is the structure for state reimbursement of medicinal product costs?
The pharmaceutical company marketing a medicinal product in Denmark may apply to the DMA for general reimbursement of costs. ‘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 the reimbursement price for specific medicinal products, the size of reimbursement may often be lower than the actual cost of the medicinal product. This is due to cheaper generic versions of the medicinal product being available. Full reimbursement is solely available for the cheapest generic medicinal product.
Further, a doctor may apply to the DMA for individual reimbursement of costs so that reimbursement is granted to a specific patient. This may be relevant in cases where:
- a medicinal product does not have general reimbursement;
- an increased reimbursement is required due the medicinal product being expensive; or
- the patient is terminally ill.
A reimbursement committee consisting of specialist doctors advises the DMA in cases regarding the reimbursement of prescription medicinal products (both general and individual reimbursement).
The reimbursement system is financed through the tax system.
Advertising and labelling
How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?
The Medicines Act and Executive Order 1153 of October 22 2014 on advertising for medicinal products regulate the advertising of medicinal products towards both healthcare professionals and the public. The Medicines Act contains a statutory prohibition against the advertising of prescription medicinal products towards the general public. Generally, the rules for advertising for medicinal products are strict and complex. Complaints regarding advertising of medicinal products may be brought before the Danish Medicines Agency (DMA), which supervises the statutory provisions on advertising for medicinal products.
In addition, advertising aimed at healthcare professionals is self-regulated with the Ethical Committee for the Pharmaceutical Industry (ENLI) as the competent authority. ENLI has published several industry codes and guidelines, which regulate the relevant aspects on advertising of medicinal products and communication aimed at healthcare professionals.
ENLI is competent to rule in cases involving members of:
- the Association of the Pharmaceutical Industry;
- the Generic Medicines Industry Association; and
- the Parallel Importer’s Association.
Certain provisions of the ENLI Code on Promotion of Medicinal Products aimed at healthcare professionals entail an even stricter regulation than the corresponding provisions in Danish law. Due to the stricter regulation and ENLI’s broad competence, disputes regarding advertising for medicinal products aimed at healthcare professionals are brought before ENLI.
Do any special rules apply to online advertising of medicinal products?
In general, both the statutory rules on advertising of medicinal products and ENLI’s industry codes apply to any form of marketing, including online advertising.
To elaborate on online promotional activities, ENLI recently issued a new set of guidelines regarding the use of digital media for advertising purposes.
Companies must ensure that the general public is restricted from accessing any online advertising for prescription medicinal products aimed at healthcare professionals; otherwise, the online advertising will constitute a violation of the Medicines Act’s statutory prohibition against advertising of prescription medicinal products towards the general public.
What are the packaging and labelling requirements for medicinal products?
Executive Order 869 of July 21 2011 on labelling of medicines contains comprehensive and detailed packaging and labelling requirements for medicinal products. Essentially, these rules implement the mandatory information requirements under Title V of EU Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Uuse, as amended by EU Directive 2004/27/EC.
Among others, the rules stipulate that labelling must be easily readable, understandable and indelible, and – with few exceptions – must be in Danish.
Further, specific national requirements stipulate that the packaging of medicinal products must carry a product number which makes each individual package identifiable.
How is the promotion of off-label use regulated?
According to the Medicines Act, any advertising for medical products must comply with the product’s summary of product characteristics, hereunder the approved indication. Therefore, advertising for off-label use is illegal.
Relations with healthcare professionals
Gifts and incentives
What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?
The provision of gifts, discounts and other incentives to healthcare professionals is regulated by the Medicines Act and Executive Order 1153 of October 22 2014 on advertising of medicinal products.
Further, the field is heavily self-regulated under the Code of Practice for the Pharmaceutical Industry on the promotion of medicinal products aimed at healthcare professionals; the Ethical Committee for the Pharmaceutical Industry (ENLI) is the competent authority.
Among others, this code implements the European Federation of Pharmaceutical Industries and Associations code on the promotion of prescription-only medicinal products to and interactions with healthcare professionals.
With a few narrow exceptions, pharmaceutical companies are prohibited from supplying, offering or promising healthcare professionals any gifts or financial benefits, in the form of either cash or benefits.
However, under certain circumstances pharmaceutical companies may offer hospitality and pay direct expenses to healthcare professionals participating in training and professionally relevant events or courses, and may also act as an organiser, co-organiser or sponsor of such events.
Danish regions have adopted new guidelines stipulating that companies wishing to contribute financially to the relevant training of healthcare professionals in the public health service must now approach the hospital management and not the individual healthcare professional directly.
A pharmaceutical company’s assignment of informational or educational materials to healthcare professionals may be permitted, provided that the materials are:
- directly relevant to the practice of medicine or pharmacy business; and
- directly beneficial to patient care.
Further, under certain circumstances pharmaceutical companies may use healthcare professionals as consultants and advisers for services including:
- speaking at and chairing meetings;
- involvement in medical and scientific studies, clinical trials or training services;
- advisory board meeting participation; and
- market research participation.
Depending on the specific nature of the relationship between a healthcare professional and a pharmaceutical company, the healthcare professional must either notify the Danish Medicines Agency (DMA) of the relationship or apply for DMA permission to establish such a relationship with the pharmaceutical company. Notice of the relationship between the pharmaceutical company and the healthcare professional must also be reported to the DMA by the pharmaceutical company, and the relationship will be made publicly available by the DMA on its website.
Executive Order 1153 allows gifts to healthcare professionals of insignificant value provided that the gift is used during the healthcare professionals’ work. However, such gifts are prohibited under ENLI’s Promotion Code, which in practice is the most relevant regulation since most pharmaceutical companies operating in Denmark are bound by ENLI’s decisions.
How can a liability claim for a defective medicinal product be brought?
Patients sustaining physical injury following treatment with medicinal products in the Danish healthcare system may file a liability claim to the Patient Compensation Association, which has been entrusted with the administration of the Danish Act on the Right to Complain and Receive Compensation within the Health Service, hereunder cases involving harmful medicinal products. The patient compensation scheme entails a commitment from the public to provide compensation to injured patients regardless of whether negligence is involved. The system is financed through the tax system and most of medicinal product liability cases fall within the scope of the publicly funded compensation scheme.
As regards medicinal product liability claims that are not covered by the patient compensation scheme, the injured party may bring a product liability claim before the Danish courts.
Which parties can be held liable for a defective medicinal product?
The manufacturer or the marketing holder (or its Danish representative) may be held liable for a defective medicinal product in accordance with the rules of the Product Liability Act. Depending on the circumstances, the manufacturer or the wholesale distributor of the active pharmaceutical ingredient or an excipient may also be held liable.
In cases covered by the patient compensation scheme, the state pays compensation to the injured patient and may then bring a recourse claim against the responsible party in accordance with the Product Liability Act.
What remedies are available to successful claimants?
Successful claimants are entitled to recover damages. The specific amount of damages is calculated in accordance with the Liability for Damages Act. Depending on the circumstances, an injured party may claim damages and compensation for:
- lost earnings;
- recovery costs;
- pain and suffering;
- permanent injury;
- lost earning capacity; and
- other losses resulting from the injury.
Exclusion and limitation
On what grounds can liability be excluded?
In cases not covered by the patient compensation scheme, the Product Liability Act applies. Under the act, the defendant is relieved of liability if it proves that:
- it did not put the product into circulation;
- the product was neither manufactured, produced, collected nor put into circulation as part of commercial activities;
- the defect is due to compliance of the product with mandatory regulations issued by the public authorities;
- the state of scientific and technical knowledge at the time when it put the product into circulation was not such as to enable the existence of the defect to be discovered; or
- the defect which caused the damage likely did not exist at the time when the product was put into circulation or that this defect came into being afterwards.
What preventive steps can be taken to limit liability?
A pharmaceutical company may limit its liability by implementing effective compliance systems which ensure continuous compliance with all relevant regulatory requirements. It may also limit its liability by ensuring that the packaging, labelling and package leaflets of its medicinal products contain clear information, correct instructions for use and any appropriate warnings.
Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
The Danish Medicines Agency (DMA) is entrusted with a wide range of powers to enforce the law governing medicinal products, including:
- conducting inspections;
- ordering corrections;
- withdrawing authorisations;
- penalising violations; and
- reporting certain actions to the police as criminal offences.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
The DMA supervises companies manufacturing and distributing medicinal products in the legal supply chain in Denmark. Further, the agency cooperates with drug regulatory authorities both in and outside the European Union and the European Economic Area to prevent the distribution of falsified medicines.
The authorities in the European Union and the European Economic Area must inform the authorities in other EU and EEA countries if a suspicion of falsified medicinal products arises.
Further, under the Medicines Act, the holder of a manufacutring authorisation for a medicinal product must immediately notify the DMA and the marketing authorisation holder if it obtains information that a medicinal product that it manufactures is or may have been falsified.
Likewise, a holder of a wholesale distribution authorisation for medicinal products must immediately notify the DMA and the marketing authorisation holder if it receives or is offered to buy medicinal products that are or may have been falsified.
With the ongoing implementation of EU Directive 2011/62/EU on falsified medicines, further initiatives against falsified medicinal products will be introduced in 2019, hereunder a requirement that all prescription medicinal products and certain over-the-counter medicinal products must be labelled with a unique code.