The Danish pharma and life sciences industry consist of large pharmaceutical companies, with Novo Nordisk being the clear Danish leader, and a large number of medical device companies, most of them listed on the Copenhagen Stock Exchange (Nasdaq OMX Copenhagen). In addition, there are many biotech companies and various medtech companies including a significant number of start-ups. The life sciences sector plays a significant role in the Danish economy.

There is a strong tradition of collaboration between the industry and universities. Many life sciences companies have effectively been founded or are based on inventions created at universities or in hospitals.

There is a large number of venture funds and business angels investing into the Danish life sciences sector including the State's Growth Fund (VækstFonden) which can also provide high risk early-stage loans.

In addition, it is possible to receive grants from public funds. The Danish Innovation Fund (Innovationsfunden) in particular aims for product development in co-operation with universities, including the innobooster programme.

The health care system in Denmark operates across three administrative levels: the state, the regions and the municipalities (national, regional and local levels). The state (Ministry of Health) holds the overall regulatory and supervisory functions. The five regions are primarily responsible for hospitals, general practitioners, and psychiatric care. The 98 municipalities are responsible for several primary health care services, as well as for elderly care.

The national health care system is largely publicly financed through general taxes and regulated by the Health Act.

The system in the primary sector is as follows:

In the public hospital sector, all medicines are given to hospitalised persons free of charge and paid for by the region operating the hospital.

Medical devices can be provided free of charge to patients under a special social service order. In this situation, the cost is borne by the municipalities.

Not applicable.

Prices charged by pharmacies are set by the MA holder for each individual product. The notified price is called the pharmacy purchase price (Apotekernes IndkøbsPris) (AIP). The AIP is set for two-week periods and is notified and uploaded on a special online register operated by the DMA, which can be accessed by health care personnel and any member of the public.

Profits made by pharmacies are regulated by the Pharmacies Act. The prices charged to patients for medicinal products must be the same in any retail outlet. Although AIPs are not negotiated between the MA holder and the DMA, the reimbursement status of novel medicines can be influenced by their price.

Pharmacies must substitute prescribed medicines with cheaper alternatives within defined generic groups, unless the patient objects to the substitution and pays the price difference. Substitutes for prescribed products can be generic versions or parallel imported products. Therefore, price competition is fierce for off-patent medicines for which generic alternatives are available. For other products, parallel trade also contributes to price competition. The two-week price system almost operates as an auction system, as the cheapest product takes all sales in a given two-week period.

The price for supply to public hospitals is set through a tender process and is determined as a rebate of the AIP price, typically for one year. There is a central purchasing body (AMGROS) for all public hospitals in each region. The Danish Association of the Pharmaceutical Industry (LIF), the Danish regions and the Ministry of Health have entered into an agreement on price reductions and a price cap for hospital-only medicinal products for the period between 1 April 2019 and 31 March 2023.

See Question 3. The cost of medicines eligible for reimbursement is funded by the state in the primary sector and by the regions in the hospital sector.

Pharmacies in Denmark have the exclusive right to sell prescription-only medicines and certain over-the-counter (OTC) medicines to consumers. Pharmacists can charge a regulated fee for dispensing medicinal products (Pharmacies Act). Pharmacists receive a dispensing fee when they sell a prescribed product (that is, a prescription medicine or OTC medicine sold on prescription).

Doctors are allowed to prescribe medicine and medicines can only be sold by pharmacies, except certain types of OTC products (such as painkillers of limited strength that are sold in small packages). Retailers must hold an authorisation from the DMA to sell OTC products.

Pharmacies can operate online pharmacies. Online pharmacies must notify their activities to the DMA. The DMA operates a specific online register of pharmacies engaged in online activities. Duly registered online pharmacies can conduct cross-border sales within the EU.

Wholesale distribution is regulated by Order no. 1541 of 18 December 2019 on the distribution of medicine.

Wholesale distribution of medicines in Denmark requires a licence from the DMA.

Applications for business licences for distribution of medicinal products can be made digitally on the Danish National Board of Health's secure access extranet, DKMAnet.

If a distributor is granted the licence, it can undertake wholesale distribution of medicine in Denmark. Wholesale distribution is defined as any activity consisting of buying, selling, receiving, storing or supplying medicinal products within the EU/EEA or exporting medicinal products to third countries, except for supplying medicinal products to users.

It is a condition of approval that the company has adequate facilities and can demonstrate appropriate procedures to ensure the handling of medicinal products. It is moreover a condition that a person responsible for quality be appointed and be responsible for ensuring that the activity is carried out in accordance with the provisions of the Order. The responsible person must be present in the establishment to a sufficient extent having regard to the activity of the establishment or the pharmacy.

A wholesale distributor must also comply with the principles of Good Distribution Practices (GDP), such as implementing a quality system and an organisation chart, which are further outlined in the Order.

A wholesale distributor operating in Denmark's most important role in the distribution process, must make sure that medicines are available and as such, their role is one of logistics.

Companies authorised to distribute medicines through wholesale methods are supervised regularly by the DMA. Inspections are carried out according to the GDP standards. The inspections aim to ensure that companies, research teams and the like comply with the rules and implement best practices for the benefit of patient safety.

The DMA usually gives notice of inspections 14 days or more before visiting, but in certain cases it can also show up unannounced. Along with a notice of inspection, the DMA will usually also request material to prepare the inspection.

An inspection can be carried out by one or several inspectors who may be accompanied by experts from the DMA, depending on the area to be inspected.

An inspection can last a few hours or several days, depending on the area's complexity and risks. During an inspection, the inspectors from the DMA will normally review the quality system, procedures and workflows against the rules in the area. The inspectors will also make random checks to review compliance with procedures and rules.

After an inspection, the DMA issues an inspection report that highlights any deficiencies. If the deficiencies are detrimental to patient safety, the DMA can:

When following up on an inspection report, the distributor must submit a description of how they plan to solve any deficiencies. The inspector concludes the inspection once this action plan is deemed to be adequate.

Medicinal products can be imported into Denmark, provided that the importer holds a wholesale distribution licence and that the medicine products are eligible for distribution, for example, have been granted a relevant marketing authorisation.

Parallel imports and parallel distribution in Denmark are allowed for products legally put on the market within the EU. The importer must have a valid manufacturing licence and the parallel imported product holding a national MA must obtain its own MA, which is based on the one covering the original medicinal product. For centrally approved products, a mere notification to a central register of parallel distributed products kept by the EMA is required.

IP rights can be used to oppose parallel imports subject to limits set by the Court of Justice of the European Union (CJEU). There is extensive case law on this issue, mostly related to claims against repackaged or relabelled imported products, and most often based on the jurisprudence of the CJEU.

Parallel imported products benefit from the mandatory substitution regime at the pharmacy level (see Question 4, Price Regulation).

There is a specific regime governing parallel imports of patented products from EU member states that joined the EU in 2004 and 2007. This regime allows patent holders to invoke their rights to oppose parallel imports if patent protection was not available in the country of export to the same extent when the product was first put on the market there. The regime is based on the EU Accession Treaties and will come to an end once all the relevant patents have expired.

The main regulations are the Medicines Act and Ministerial Order no. 849 of 29 April 2021 on Advertising of Medicines, which are supplemented by guidelines issued by the DMA. The DMA is the enforcing authority.

The advertising of medicinal products includes any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products. The definition of advertising is interpreted broadly and the person advertising a medicinal product need not have a special, typically economic, interest in promoting the sale of the product. Public statements made by a person or company which clearly aim to induce others to buy a certain medicinal product, are considered to be advertising, even if the person or company is acting on their own initiative and is fully independent, legally and practically, of the MA holder of the medicinal product.

The Ethical Committee for the Pharmaceutical Industry (ENLI) is the main self-regulatory body for advertising to health care professionals. The ENLI enforces the relevant legislation and a number of industry codes of conduct that incorporate the codes issued by the European Federation of Pharmaceutical Industries and Associations.

Advertising of medicinal products is defined as any form of outreach, canvassing or influencing of attitudes aimed at promoting the prescription, supply, sale or consumption of medicinal products.

The definition of advertising is not limited to specific senders or media. There is no requirement that a message about a medicinal product must be disseminated in connection with a commercial activity to be considered advertising, or that the disseminator of the message must be connected with the pharmaceutical company or marketing authorisation holder. The senders of advertising for medicinal products can be both pharmaceutical companies and others.

The advertising rules apply to any information, customer search or behaviour affecting the prescription, delivery, sale or consumption of medicines. The rules do not apply to the following:

The rules distinguish between advertising addressed to the public and advertising directed to health care professionals (HCPs). HCPs include doctors, dentists, veterinarians, pharmacists, midwives, bio analysts, clinical dieticians, radiographers, social and health care assistants, and students in these disciplines. Any other person is considered to be part of the public, except persons who, without being HCPs, are engaged in commercial medicines business.

Vaccine campaigns are exempt from the ban. They are subjected to permission from the DMA.

Lastly, medicinal products which cannot be legally sold or supplied in the country cannot be advertised or promoted.

For prescription-only medicinal products, it is a requirement that the DMA is notified of the price for the medicinal product at least 14 days before the price takes effect (section 77(1), Danish Medicines Act). This can be done by sending an e-mail with information on the expected price and the date of entry into force to [email protected]. Before this happens, a prescription-only medicine cannot be promoted.

An MA holder must keep a copy of all promotional material for the medicinal product for least two years. The material must be made available to the DMA on request (section 68, Danish Medicines Act).

In accordance with Order on the advertisement of medicines, the person advertising a medicinal product must keep information on how the advertisement has been used in practice, including:

The ENLI monitors compliance of its affiliated pharmaceutical companies with Danish legislation and industry ethics. ENLI's Promotion Code imposes more stringent rules than those of the Order and the Danish Medicines Act, such as a reporting requirement on advertisements (see Question 12).

Promotional materials do not have to be authorised, notified or submitted to regulators in Denmark.

However, to the extent that the pharmaceutical company in question is affiliated with ENLI, the Promotion Code requires that the company report all kinds of printed promotional material aimed at health care professionals on the Danish market, whether in print, leaflets, handouts or electronically. Electronic texts are comparable with printed texts.

The reporting takes place through www.enli.dk using a standard report form.

If an advertisement contains a comparison between several medicinal products, it must be clearly stated which medicinal products are included in the comparison. The comparison can only include medicinal products for which it is objectively relevant to make the comparison (that is, medicinal products with a similar field of application) (Article 16(1), Statutory Order on Advertising).

An advertisement containing a price comparison is only adequate if it contains information on the current prices covered by the price comparison (Article 63, Medicines Act).

As a general rule, a comparison is only adequate if it includes all synonymous (and any parallel imported) medicinal products that do not differ in pharmaceutical form or strength or differ significantly in package size (Article 63, Medicines Act). However, medicinal products with a negligible market share can be excluded from the comparison. A market share of 2% to 3% (or less) is normally considered negligible.

Under Article 16(2) of the Advertising Order, comparative advertising must be based on the information contained in the summaries of product characteristics of the medicinal products included in the comparison. This applies to the extent that the summaries of products contain information on the subject of the comparison. In the case of a comparison of, for example, prices of pharmacy-provided medicinal products, a comparison may be made on the basis of the current prices published on www.medicinpriser.dk.

Since it is prohibited to give the impression to the general public that the effect of one medicinal product is better than or equal to the effect of another medicinal product, comparisons between the effects of several medicinal products cannot be made in advertising to the general public (Article 16(3), Advertising Order).

It is forbidden to advertise medicines that are unlicensed in Denmark (Article 6, Danish Medicines Act). This also applies to unapproved indications.

However, not all information sharing constitutes advertisement (see Question 9).

Advertising medicines on the internet and social media must meet the same requirements as advertising in other media.

The advertising rules apply both to banner advertisements and internet advertisements which appear to be advertising, and to mentions of medicinal products on, for example, the websites of pharmaceutical companies or on social media.

Advertising on the internet and on social media that is accessible to anyone must meet the requirements for advertising to the general public. This means that prescription-only medicines cannot be advertised in this way as it is contrary to section 66 of the Danish Medicines Act.

The rules on advertising to HCPs apply to sites that are accessible only to them and persons engaged in the sale of medicinal products outside pharmacies.

Access to these sites must be effectively restricted to specific groups of persons by requiring a personal access code.

Non-compliance of the rules on advertising pharmaceuticals can result in a fine or in some cases criminal liability.

The rules are enforced by the DMA but there are also self-regulatory enforcement procedures in place. Complaints can be sent to the DMA. Complainants cannot, as a rule, expect anonymity, as the complaint is covered by the rules in the Public Access Act and the Administrative Procedure Act on access to documents held by public authorities.

To the extent that a person wishes to complain about an advertisement on the radio or television, the complaint should be sent to the Danish Radio and Television Board. The Radio and Television Board obtains an opinion from the DMA before deciding on cases concerning the advertising of medicinal products.

The DMA's control activities in the field of advertising are complemented by industry self-regulatory bodies, which will monitor the legality of advertising activities in parallel with the DMA and co-operate in this respect. The main self-regulatory body is the ENLI.

Even though a complaint about an advertisement falls within the scope of one of the four self-regulatory bodies, a complainant can at any time choose to complain to the DMA instead. The DMA may seek an opinion from the relevant self-regulatory body as part of its consideration of the complaint.

A decision taken by a self-regulatory body cannot be appealed to the DMA. However, a dissatisfied party is not precluded from bringing a case before the DMA even if it has already been dealt with by another body. In these cases, the decision of the self-regulatory body will be taken into account in the DMA's assessment of the case.

There is an absolute prohibition on advertising prescription drugs to the public, and a general prohibition on advertising medicines that cannot be legally marketed or delivered in Denmark. Additionally, there are specific requirements around the contents of advertisements.

The advertising rules apply to any information, customer search or behaviour affecting the prescription, delivery, sale or consumption of medicines. The rules do not apply to the following:

The rules distinguish between advertising addressed to the public and advertising directed to HCPs. HCPs include doctors, dentists, veterinarians, pharmacists, midwives, bio analysts, clinical dieticians, radiographers, social and health care assistants, and students in these disciplines. Any other person is part of the general public.

It is not permitted to provide free samples to the public (section 67(1), Danish Medicines Act). For free samples to HCPs, see Question 21. The DMA may, on a case-by-case basis, grant an exemption provided that the free samples are not considered to be advertising.

It follows from Ministerial Order no. 849 of 29 April 2021 and the relevant guidelines to the order, that patient organisations can be granted financial benefits, such as sums of money and benefits in kind from pharmaceutical companies. However, they must publish on their website all their financial benefits and it must be published so that it is possible to identify the amounts from each pharmaceutical company.

The information must be made available on the website within one month after the patient association has received the financial benefit and the information must be available on the website for at least two years.

The provision applies both when a patient association receives a financial benefit directly from a pharmaceutical company, and when it receives a financial benefit provided through a third party from a pharmaceutical company.

To the extent that the pharmaceutical company in question is a member of Danish Association of the Pharmaceutical Industry, then the ENLI's Donation Code applies, which poses significantly more stringent requirements.

HCPs include doctors, dentists, veterinary surgeons, pharmacists, nurses, veterinary nurses, pharmacists, midwives, bio-analysts, clinical dieticians, radiographers, social and health workers and students in these professions.

The term "health care organisations" is undefined.

It follows from Article 11 of the Advertisement Order, that the following information must be included:

Under Ministerial Order no. 849 of 29 April 2021, HCPs are prohibited, except for very low-value gifts of up to DKK300 that can be used by HCPs in their professional activities.

The definition of "gift" does not include payments of costs for participation in scientific events, provided that these are kept to a modest level.

Special rules apply to events held outside Denmark. HCPs receiving sponsorships for participation in events outside Denmark must notify the DHA of the sponsorship. The DHA will then make the information public.

Samples are regulated by Ministerial Order on Medical Samples, which allows one small pack of samples per year.

All forms of co-operation between HCPs and the health care industry (such as consultancy, participation in advisory board meetings, speaking engagements, and taking part in clinical trials) are subject to either prior approval by the DMA or compliance with transparency rules. Under the transparency rules, all forms of co-operation between HCPs and the health care industry must be notified to the DMA and published in a special register kept by the DMA that is accessible to the public.

The ENLI monitors compliance of its affiliated pharmaceutical companies with Danish legislation and industry ethics. ENLI also sets stricter and more detailed rules in this area (for example, a total ban on gifts).

Pharmaceutical companies must report and provide information when they associate with a health care professional by agreement. This follows from Order no. 716 of 24 May 2022 on health professionals' affiliation with pharmaceutical companies, medical device companies and specialty medical device stores.

ENLI's Donation Code poses strict rules in this area.

Pharmaceutical companies are obliged (in connection with any donation exceeding DKK5,000 whether it be financial or in kind) to publish an overview on their website, where they as a minimum must disclose the following:

The overview must be published when the donation is granted and be available on the website for at least two years or longer if it is relevant in relation to the donation.

A copy of the list must be made available to ENLI on request when it is no longer available on the pharmaceutical company's website.

Pharmaceutical companies must annually submit an overview to ENLI containing all the company's donations in the past year. That summary is published on ENLI's website.

Non-compliance may result in fines or even criminal liability.

The main legislation on patentability requirements is the Patent Act (Consolidated Act no. 90 of 29 January 2019), which incorporates the rules of international treaties and EU law, including the:

The conditions for obtaining a patent are:

Any invention relating to a substance, process or application is patentable. This includes inventions relating to biological material, but not genetic sequences.

The following are not patentable:

The exclusion of human embryos has given rise to important litigation before the CJEU.

It is possible to apply for a national patent issued by the Danish Patent and Trademark Office (Patent- og Varemærkestyrelsen) or a European patent issued by the European Patent Office (EPO) in accordance with the EPC.

A European patent gives the same rights as a national patent for each designated state. European patents must be distinguished from unitary patents, which will be valid in the whole of the EU and are to be introduced by EU regulation. Unitary patents are not available yet.

Under international treaties, it is possible to obtain priority in treaty states from the date of filing of the earlier application if patents are applied for in other treaty states within a 12-month period.

Patents are available for inventions that can be exploited industrially. Inventions can include processes.

A patent creates a monopoly right to use the invention.

The patent holder can prohibit the unauthorised use of the patented invention, except:

See above, Conditions and Legislation.

Applications for national patents must be filed with the Danish Patent and Trademark Office. It is also possible to file an international application with another national patent authority under the PCT, to which Denmark is a party.

European patent applications must be filed with the EPO.

The authorities' websites provide information on the application procedures and fees.

The applicant must provide information on the inventor's name, including when the application is filed by an assignee. In this case, the authority can ask for further proof of the assignment.

The application must include a description and drawings (when relevant) and a precise description of the patent claims.

The principal stages of an application for a national patent are:

It normally takes one to three years to obtain a Danish patent.

In an international application, there is an international phase followed by a national phase before the national patent authority of each country designated by the applicant. Denmark is also a member of the international Patent Prosecution Highway programme.

A decision to issue or reject a patent can be appealed to a specific Appeal Board (Patentankenævnet).

Patent protection lasts for 20 years from filing of the priority application. A patent cannot be renewed.

Patent monopoly rights can be extended for up to five years by a supplementary protection certificate (SPC) in accordance with the Medicinal Products SPC Regulation (469/2009), which is directly applicable in all EU member states.

The patent grants the patentholder an exclusive right to exploit the patented invention commercially.

Infringement of a patent takes place through any form of unauthorised commercial use of a patented invention. Use of a patented invention for research purposes does not constitute infringement. Under the Patent Act, the research exemption also covers research for obtaining documentation to be filed in support of a marketing authorisation for a medicinal product. This provision is in line with Directive 2001/83/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Directive).

The main defences available are:

Denmark is party to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Denmark has signed up to the following:

The following apply in Denmark:

The applicable legislation is the Danish Trademarks Act (Consolidated Act no. 88 of 29 January 2019), which implements the Trade Marks Directive ((EU) 2015/2436). The Trademarks Act is supplemented by implementing regulations. Denmark is a party to several international treaties for the protection of IP rights, including trade marks.

It is possible to seek registration of either a national Danish trade mark or an EU trade mark (EUTM), which is valid in the whole of the EU.

Danish trade mark rights can be obtained through use of the mark in commerce, while an EUTM can only be obtained through registration.

In principle, all distinctive features that can be represented in the register in a manner that enables the Danish Patent and Trademark Office, other relevant authorities and the public to determine the subject matter can be registered as trade marks, in particular words, graphic devices and three-dimensional shapes, colours, smells, and sound and images sequences.

There are certain absolute grounds for refusal of registration. It is not possible to obtain trade mark rights for signs that, among others:

There are also relative grounds for refusal of trade mark registration, including prior rights of third parties to an identical or similar trade mark for the same classes of goods or services.

A medicinal brand can be registered as a trade mark.

Trade marks are registered for one or more classes of goods or services. A valid trade mark protects against the use of an identical or similar mark for the same or similar goods or services. Famous or well-known trade marks may obtain protection beyond the classes for which they are registered or used.

A trade mark may be revoked for lack of use.

Trade marks for medicines are subject to approval from the DMA. Trade marks must have a sufficient distinctive character to be registered.

There are no legal prohibitions against the use of specific symbols or words for pharmaceutical trade marks.

Applications for national trade marks must be filed with the Danish Patent and Trademark Office.

Application for national trade marks for medicines can be filed regardless of the process of obtaining approval of the name by the DMA. When assessing the distinctive character of the trade mark applied for, the Office will carefully consider whether the trade mark does in fact describe the content or the effect of the medicine.

Under the WIPO Madrid Agreement Concerning the International Registration of Marks 1891 (Madrid Agreement) and the Protocol Relating to the Madrid Agreement 1989, to which Denmark is a party, it is possible to file an international application that allows for simultaneous applications in multiple jurisdictions. Information on the application procedures and fees is available at www.dkpto.dk.

Applications for EUTMs must be filed with the European Union Intellectual Property Office (EUIPO). An EUTM grants trade mark rights covering all EU member states through a single registration. Fees and other information are available on the EUIPO's website.

Applications for Danish trade marks and EUTMs must refer to one or more classes of goods or services. The classification of goods and services is harmonised by the WIPO Trademark Law Treaty 1994 and the WIPO Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks 1957.

A Danish trade mark application creates a right of priority. This means that applications for the same trade mark can be filed in other jurisdictions with priority from the Danish application, provided that the other application is filed within six months from the Danish filing.

Likewise, applications based on a prior trade mark in another jurisdiction have priority from the filing date with the first registration body, provided that the Danish filing takes places within six months from the filing of the foreign application.

A Danish trade mark is usually approved for publication within three to eight weeks from filing of the application. The Danish Patent and Trademark Office will check compliance with formalities and absolute grounds for refusal. The Office issues a search report citing prior registered rights that may be obstacles to registration. Publication can take place despite these rights on the applicant's request.

An opposition can be filed within two months after publication of the trade mark application. If the opposition is successful, the registration will be declined.

An action against the refusal or grant of a trade mark can be brought before an Administrative Appeal Board (Ankenævnet for Patent og Varemærker) and/or a national court.

The key stages of an application for an EUTM filed with the EUIPO include:

The time limit for filing an opposition with the EUIPO is three months from publication of the application.

An action against the refusal or grant of an EUTM can be brought before the Appeal Board of the EUIPO and the General Court of the CJEU.

The Danish Competition Act largely mirrors EU law and practice. Articles 101 and 102 of the TFEU apply directly by Denmark in cases that have a community dimension. The Competition Act notably prohibits:

The Competition Act also provides for the control of mergers meeting certain turnover thresholds.

The Danish Competition and Consumer Authority (DCCA) has been focusing on the pharmaceuticals and health care sector for several years. Initiatives taken by the DCCA and Danish Competition Council (DCC) in the last ten years include the following:

The Danish Competition Act (Consolidation Act No. 360 of 4 March 2021) is enforced by the:

The DCCA handles the day-to-day administration of the Competition Act on behalf of the DCC. Within the DCCA, the unit responsible for the pharmaceutical sector is the Retail, Industry, Primary Sector and Health Division (DIPS).

The DCCA has several regulatory powers, including the following:

The DCC can issue orders to put an end to infringements of the Competition Act and can decide that commitments made by an undertaking are binding. However, the DCC cannot impose fines.

Infringements of the Competition Act can be punished by fines, which can be imposed on undertakings and natural persons. Prison terms can also be imposed for hard-core cartel infringements. The Danish district courts have authority to impose fines and prison terms. Investigation and prosecution of criminal infringement cases involving fines (and prison terms) must be undertaken by the SEIC. The DCCA does not have authority to investigate or prosecute criminal cases before the Danish courts.

Competition between originator products and generic or biosimilar versions has attracted significant interest at the EU level.

Unilateral actions to use the regulatory system to stop or delay generic entry or parallel imports may constitute abuse of dominant position. Agreements between owners of originator products and generic competitors to stop or delay generic entry ("pay for delay") are illegal, regardless of whether the originator product's owner holds a dominant position.

Actions in this area are mainly brought at the EU level, where enforcement is vigilant and active, especially after the European Commission issued a report in 2009 on its competition inquiry into the pharmaceutical sector, followed by several reports on the same issue. For example, one case relating to pay for delay involved the Danish company Lundbeck, which had been fined EUR93.8 million by the European Commission in 2013 (Case AT.39226 Lundbeck). It was the DCCA that had alerted the Commission of the existence of patent settlement agreements entered into by Lundbeck. The decision was upheld by the General Court of the European Union in 2016 (Lundbeck v European Commission (Case T-472/13)). An appeal is pending before the CJEU (Lundbeck v Commission (Case C-591/16 P)).

Third party use of patented pharmaceuticals for research and development work carried out in relation to generics is regulated by the Patent Act, which implements the Code for Human Medicines Directive. Such use by a generic competitor is legal, even if it is for the sole purpose of securing a marketing authorisation.

In a decision of 31 January 2018, the DCC held that CD Pharma had abused its dominant position by charging excessive prices for the drug Syntocinon, infringing section 11 of the Danish Competition Act and Article 102 of the TFEU. Syntocinon is given to pregnant women in connection with childbirth. The drug has existed since the 1950s and its patent has long expired.

Orifarm, a parallel importer of pharmaceuticals, won a contract to supply the drug Syntocinon to Amgros, the wholesale purchaser of medicines for Danish public hospitals, from 1 April 2014 to 31 March 2015. However, before the contract started, Orifarm informed Amgros that it was unable to supply the amounts required by the contract. Amgros purchased the residual amount from the only available source, CD Pharma, a distributor of pharmaceuticals that had an exclusive distribution agreement with the manufacturer of Syntocinon. Under the contract between Orifarm and Amgros, Orifarm had to compensate Amgros for any additional costs resulting from purchasing from an alternative supplier. On 28 April 2014, CD Pharma increased the price of Syntocinon from DKK45 (EUR6) to DKK945 (EUR127) (a price increase of 2,000%). As a result, Amgros paid about DKK6 million (EUR780,000) more than the price agreed in its original contract with Orifarm.

In its decision, the DCC found that CD Pharma held a dominant position due to:

The DCC found that CD Pharma had abused its alleged dominant position by charging excessive prices for the drug Syntocinon. In assessing whether CD Pharma's price was excessive, the DCC applied the United Brands test, a two-prong test set out by the ECJ. Under the first prong (excessive test), the DCC estimated CD Pharma's profit margin and mark-up. Based on seven different analyses, the DCC estimated CD Pharma's profit margin to be between 80% and 90%, and that its mark-up was between 500% and 600%. Under the second prong (unfair test), the DCC carried out several analyses, including price comparison over time, between countries and between competitors.

The DCC has submitted the case to the SEIC with a view to having fines imposed by a court of law.

The decision was upheld by the Competition Appeals Tribunal in November 2018 and by the Maritime and Commercial Court in March 2020.

In December 2018, Amgros filed a lawsuit against CD Pharma seeking damages based on the decision of the DCC.

Parallel imports have raised IP and competition law issues in Denmark, particularly in relation to exhaustion of trade mark rights after relabelling or repackaging of imported products.

Several cases litigated before the Danish courts gave rise to preliminary referral procedures before the CJEU. The leading case on repackaging, case C-427/93 Bristol Myers Squipp v Paranova, was decided on 11 July 1996. This case was one of three joined cases initiated by the Danish parallel importer Paranova. Other relatively large Danish companies are engaged in large scale parallel imports and parallel distribution of pharmaceuticals in the EU, and new issues arise from time to time. The basic principle developed by the CJEU is that a trade mark owner can oppose repackaging and re-application of the original trade mark on reboxed packages, unless repackaging is "necessary" to obtain access to the market. Danish courts have interpreted the rulings of the CJEU to imply, among other things, that:

The CD Pharma case also gave rise to parallel import issues. The DCC found indications that CD Pharma's excessive prices would be harmful to parallel importers of pharmaceuticals. In the future, when a supplier tenders for a contract that obliges it to cover loss resulting from delivery failure, the supplier will need to take into consideration the risk of a significant claim for compensation. Parallel importers are at greater risk of delivery failure because they usually do not have a stable source of delivery. Therefore, the DCC found that bids from parallel importers were likely to be less competitive as a result of CD Pharma's actions.

Various competition law issues can arise in relation to commercial contracts and other business arrangements relating to medicinal products, some of which are described below.

The following competition law issues can arise in relation to distribution agreements:

The licensing of technology may be restrictive of competition if it is a form of market sharing between competitors or forms part of a patent settlement.

Additionally, a licence agreement may contain restrictive terms. Export restrictions carving up the EU internal market into national markets are illegal in the EU. There is no significant case law specific to Denmark in this respect.

In principle, access to necessary medicines and vaccines can be a ground for the grant of compulsory licences, although there are no recent examples of such cases.

There are no restrictions on licensing or transferring patents to foreign parties under Danish law. Limitations may be included in the grant of funding.

There is no procedure for advance approval of patent and trade mark licences or payment of royalties, except where approval is relevant to obtain a tax ruling.

Both trade mark and patent licence agreements can be registered with the Danish Patent and Trademark Office. Registration mainly serves to inform third parties of the licence rights.

A licensee's right to enforce the trade mark or patent is governed by the licence agreement and is valid regardless of registration of the licence.

The Danish Act on the Right to Complain and Receive Compensation within the Health Service (Consolidated Act no. 995 14/06/2018) applies to:

Injuries include those that occur as a result of treatment, lack of treatment or late treatment and the consequences of harmful side effects caused by a medicinal product used in examination, treatment, and so on.

The Act does not require proof of a fault attributable to a named person.

Decisions under the Act are made by the Patient Safety Authority. In product liability cases relating to medicinal products, the DMA can amend, suspend or withdraw the product's marketing authorisation, or withdraw an authorisation to manufacture, import or distribute the product.

The Act on Liability for Damages (Consolidated Act no. 1070 of 24 August 2018) governs the methods for evaluating and calculating damages.

Medicinal product liability is governed by the:

Medicinal product liability claims are mainly processed by the Patient Insurance Agency and the Patient Safety Authority under the Act on the Right to Complain and Receive Compensation within the Health Service. Under this Act, damages are paid to patients who sustain physical injury as a result of properties in medicinal products used in connection with examination or treatment, or other pharmaceutical injuries. Damages suffered by patients' dependants are also covered.

As a general rule, compensation is granted if any of the following apply:

Recent case law from the Danish courts and decisions are available in Danish on the websites of the Patient Insurance Association and the Patient Safety Authority.

Medicinal product liability claims are rarely brought under the Product Liability Act. If they are, the injured party must prove the:

Claims relating to medicinal products brought under the Act on the Right to Complain and Receive Compensation within the Health Service are paid for by the Danish state. The state can claim indemnity from manufacturers or importers if there is a legal basis to do so under the Product Liability Act.

For claims that are not covered by the Act on the Right to Complain and Receive Compensation within the Health Service, potentially liable persons include the manufacturer and the marketing authoriation holder (or its representative).

The purpose of the compensation scheme under the Act on the Right to Complain and Receive Compensation within the Health Service is to improve patients' prospects of compensation for damages caused by medicinal products. Claims brought under this Act are paid for by the state. The main grounds for rejecting a claim are lack of causality or that the injury does not exceed reasonably advertised side effects.

The Act does not expand or limit the liability of pharmaceutical manufacturers (or importers or other intermediaries) under the Product Liability Act.

Defences under the Product Liability Act include the following:

Claims under the Act on the Right to Complain and Receive Compensation within the Health Service are filed with the Patient Insurance Association. Claims that are not covered by the Act are filed with the Danish courts (for example, claims under the Product Liability Act).

Claims must generally be filed within three years from the date when the injured party knew, or should have known, of the injury or damage and potential defect.

Class actions can be brought before the Danish courts, provided that the following conditions are met:

The court will designate a class representative who is a party to the case.

Class actions before the Danish courts are relatively rare, which is partly because most patients' claims are funded by the state.

The main remedy available is compensation for damages. Damages are normally calculated in accordance with the Act on Liability for Damages. Generally, the injured party can claim compensation for:

The amount of compensation depends on the injury in question. Danish law does not allow claims for punitive damages.