The Pharma Legal Handbook: Denmark

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The Pharma Legal Handbook: Denmark answers essential questions about the legal and regulatory environment for pharmaceuticals in Denmark. It is a must-have for any company operating in the country or looking to enter the market.

Prepared in association with Gorrissen Federspiel, one of the leading corporate law firms in Denamrk, it should answer any questions linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents, medical cannabis, cannabinoid medicines, opioids, and orphan drugs.

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July 2019

1. Biosimilars and Biologics: Denmark

Key legal info on biosimilars & biologics in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.

1. Are biosimilar medicines considered the same as generic medicines in your country?

No.

A biosimilar medicinal product is a new version of an existing biological medicinal product (i.e. a medicinal product is derived from a biological source). Biosimilar products are developed by establishing i) a therapeutic effect, ii) a safety profile, and iii) a stability profile that is similar to the reference biological medicinal product. However, since biological medicinal products have a more complex molecular structure than chemically produced medicinal products (non-biological products), biosimilar medicinal products are not identical to their reference product and may exhibit minor differences in the molecule in relation to the reference medicinal products.

By comparison, generic medicinal products are “copies” of small molecule medicinal products (medicinal products that are normally produced by way of chemical synthesis), in the sense that the medicinal product must have the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product. The bioequivalence with the reference medicinal product must have been demonstrated by appropriate studies.

Due to the nature of generic medicinal products, an abridged procedure is available for marketing authorizations for generic medicinal products. The Danish legislation implements the applicable EU directives on medicinal products, in including the rules on the abridged procedure, which means that applicants for generic medicinal products will not be required to provide the results of pre-clinical tests and clinical trials if it is possible to demonstrate that the medicinal product is a generic of a reference medicinal product that is or has been authorised for not less than eight years in a country of the EU/EEA.

In principle, the abridged procedure is also available to biosimilar medicinal products. However, because it is not possible to manufacture an identical biological medicinal product, biosimilar medicinal products are subject to more restrictive and stringent regulatory requirements with regard to clinical studies.

2. Are all biologic medicines, including biosimilar medicines patentable in your country?

Yes, provided the general patentability requirements are met (the three main criteria being novelty, industrial application, and inventiveness).

Naturally, as biosimilar medicinal products are new versions of existing biological medicinal products, it may be more difficult to establish that the patentability requirements are met for biosimilar products.

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

No, there is no specific regulatory framework for the marketing authorisation of biosimilar medicinal products in Denmark.

Biological medicinal products must as a starting point be approved by the European Commission under the centralised procedure in case the biosimilar medicinal product is produced by biotechnological processes. The European Medicines Agency (the “EMA”) has issued a number of guidelines on biological medicinal products to assist developers prepare marketing authorisation applications.

The Danish Medicines Act and secondary legislation issued under this act do not contain substantially different provisions on the authorisation of biological medicinal products.

As a starting point, biosimilar medicinal products are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines.

The relevant EU legislation provides that derogations from the requirements for a full marketing authorisation may be made for generic and biosimilar medicinal products. However, if a biosimilar medicinal product does not meet the conditions in the definition of generic medicinal products due to differences in raw materials or differences in manufacturing processes of the biosimilar medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The relevant supplementary data that may be required is set out in Annex I of Directive 2001/83/EC.

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

The main objective when assessing applications for biosimilar medicinal products is to determine the similarity of the reference biological medicinal product to the biosimilar medicinal product. According to the EMA, the comparability exercise should be a robust head-to-head comparison between the similar biological medicinal product and the reference medicinal product performed at the levels of quality, safety and efficacy.

Annex I of Directive 2001/83/EC provides that the information to be supplied in order to establish the comparability will be determined on a case-by-case basis in accordance with the EMA’s scientific guidelines. Thus for example, both pharmaceutical, chemical and biological data, supplemented with bio-equivalence, bio-availability data, and toxicological and other non-clinical and appropriate clinical data must be provided.

5. What are the requirements for the choice of the reference comparator product?

The reference medicinal product must have been authorised under Article 6 of Directive 2001/83/EC (based on a complete dossier) for not less than 8 years in a Member State or in the Union.

The EU legislation provides that an application for marketing authorisation of a biosimilar medicinal product can be submitted after expiry of the data exclusivity period for the reference biological medicinal product (i.e. 8 years after the date of notification of the authorisation of the reference medicinal product, cf. Article 14(11) of Regulation (EC) No 726/2004).

However, the biosimilar medicinal product cannot be placed on the market until the 10 years (or 11 years) of market exclusivity of the reference biological medicinal product have expired.

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

The reference medicinal product must have been authorised under Article 6 of Directive 2001/83/EC for not less than 8 years in an EU member state or in the European Union.

However, the EMA has published procedural advice for users of the centralised procedure for similar biological medicinal products applications, which provides that it may be possible for an applicant for a marketing authorisation of a biosimilar medicinal product to compare the biosimilar medicinal product in certain clinical studies and in in vivo non-clinical studies (where needed) with a non-EEA authorised version of the reference medicinal product.

The non-EEA reference medicinal product must be authorised by a regulatory authority with similar scientific and regulatory standards as EMA.

The EMA’s guidance provides that it will be the applicant’s responsibility to establish that the batches sourced outside the EEA is representative of the reference medicinal product authorised in the EEA through an extensive analytical comparison.

7. How are the prices of biosimilar medicines regulated? Is this any different to the requirements for the original Biologics drug?

The Danish Medicines Act and secondary legislation issued under this act do not contain substantially different provisions on pricing of biosimilar medicinal products.

At manufacturing level, the company placing the medicinal product on the market (or the importer of the medicinal product) is free to determine the prices for prescription medicinal products when selling to wholesalers, pharmacies and/or other authorised retail sellers.

It should be noted, however, that the Danish Association of the Pharmaceutical Industry on behalf of its members have entered into agreements with the Danish Ministry of Health and the Danish Regions which introduce so-called “price ceilings” for medicinal products used in the hospital sector and for medicinal products eligible for reimbursement.

8. What is the reimbursement policy for biosimilar medicine? Is this any different to the requirements for the original Biologics drug?

The Danish Medicines Act and secondary legislation issued under the Medicines Act do not contain substantially different provisions on reimbursement of biological and biosimilar medicinal products.

In Denmark, the DKMA decides on the reimbursement status of each medicinal product. The DKMA determines what medicinal products are eligible for reimbursement based on an application from the company placing a medicinal product on the market. The DKMA may determine that reimbursement should be conditional, e.g. on it being prescribed to certain patient groups or specific diseases.

The DKMA may establish so-called substitution groups/reimbursement groups of medicinal products with the same indication and comparable treatment effects, for the purpose of calculating the same reimbursement price for all medicinal products within the same reimbursement group. For medicinal products within a reimbursement group, the applicable reimbursement price will be the cheapest medicinal products in the group. The purpose of the system is to encourage patients to purchase the most inexpensive medicinal product available.

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

As described in question 8 above, the DKMA decides on the reimbursement status of medicinal products, and also determines whether to establish substitution groups. For medicinal products within a substitution/reimbursement group, the applicable reimbursement price will be the price of the cheapest medicinal products in the group. The purpose of the system is to encourage patients to purchase the most inexpensive medicinal product available.

Therefore, if the DKMA establishes a substitution group for certain biological medicinal products, and the cheaper biosimilars are entered into this group, then this would most likely influence the price of the reference biological medicinal product. However, as described in Question 11 below, there is not a clear-cut policy on substitution of biological medicinal products under Danish law.

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

In Denmark, a pharmacy must always offer the cheapest “synonymous” medicinal product to the patient, unless the patient’s physician has indicated otherwise on the patient’s prescription.

However, physicians have discretion to prescribe the biologic or biosimilar versions of medicinal products, and, as described in further detail in Question 11 below, there is no clear-cut Danish regulation regarding substitution of biologics and biosimilar medicinal products. Therefore, pharmacists are as a starting point not permitted to switch patients from biologics to biosimilar medicinal products.

11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?

The system is based on physician-led switching.

The EMA does not regulate interchangeability, switching and substitution of a reference biological medicinal product by its biosimilar. The substitution of medicinal products is regulated on national level.

In Denmark, the DKMA determines whether a biological medicinal product and a biosimilar medicinal product are suitable for substitution. Danish legislation does not provide a definitive answer on whether biological medicinal products and biosimilar medicinal products are suitable for substitution.

The previous Danish Council for the Use of Expensive Hospital Medicines (“RADS”, which has now been replaced by the Danish Medicines Council) has expressed its opinion that reference biological medicinal products are suitable for substitution without further consideration. It seems the Danish Medicines Council also believes patients can be switched from a biologic/originator medicine to a biosimilar medicine as the biosimilar medicines should not deviate from the reference biologic medicine when it comes to efficacy, safety and quality.

However, this opinion has been countered by the Danish Association of the Pharmaceutical Industry (“Lif”). In Lif’s opinion, there is no basis for automatic substitution of biological medicinal products and biosimilar medicinal products.

Likewise, the Danish Institute of Rational Pharmacotherapy (an institute established under the Danish Health Authority) has expressed that automatic and frequent switching between biosimilar medicinal products would be inappropriate and should be avoided.

On the EU level, the EMA has underlined that there may be differences between the reference biological medicinal product and the biosimilar product, and that any switching should be carried out with due caution.

Therefore, biological medicinal products and biosimilar medicinal products are as a starting point not suitable for pharmacy-level substitution.

12. What are the post-authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?

The Danish Medicines Act provides that the holder of a marketing authorisation must, i) keep records of suspected adverse reactions, ii) make such records available to the DKMA, iii) report information on adverse reactions to the DKMA, and iv) prepare and submit periodic safety update reports to the DKMA.

The DKMA oversees and monitors the rules on pharmacovigilance. To this end, the DKMA handles and analyses adverse reaction reports from citizens, healthcare professionals and the industry. The DKMA also conducts routine inspections both with respect to pharmacovigilance, adverse reaction reporting and quality management.

As part of its pharmacovigilance system, the DKMA conducts scientific evaluations of the benefit-risk balance of the medicinal products based on the information submitted to it. The DKMA determines whether it is necessary to implement safety measures, and may also decide to change, suspend or withdraw a marketing authorization if the benefit-risk balance calls for it.

The DKMA’s pharmacovigilance system also covers biosimilar medicinal products, and the post-authorisation requirements for biosimilar medicines are substantially identical to the requirements for other medicinal products.

However, the DKMA currently has increased focus on the monitoring of adverse reactions concerning biological (and biosimilar) medicinal products, including such reactions as may occur when switching between biosimilar medicinal products and the reference medicinal products.

Therefore, biological products are monitored on a product-by-product level, and, there are specific requirements applicable when reporting adverse reactions in connection with biological products. For example, the Danish Executive Order on reporting of side effects on medicinal products, etc. (Executive Order no. 1823 of 15 December 2015), provides that an adverse reaction report from a doctor, dentist or midwife must, to the extent possible, include the name and batch number of the medicinal product if the report concerns a biological medicinal product appearing from the list made by the DKMA (the list can be found on the DKMA’s website).

13. Are there specific policies and requirements in terms of biosimilar medicines labelling in the event of second medical use patents? Is this any different to the requirements for the original Biologics drug?

A biological (or biosimilar) medicinal product, for which there is limited post-marketing experience (e.g. if approved after 1 January 2011), is subject to additional monitoring. Such medicinal products must be marked with a black triangle in the summary of product characteristics (“SmPC”) and the package leaflet together with an explanation and an encouragement to report side effects.

The labelling of biosimilar medicinal products is currently governed by the EMA’s QRD guidance “general principles regarding the SmPC information for a generic/hybrid/biosimilar product” dated June 2018. This guidance does not distinguish between biosimilar medicinal products and generics products in terms of labelling.

Pursuant to the guidance, the SmPC content for a hybrid or biosimilar medicinal product has to be consistent with the reference medicinal product for the common information applicable to the hybrid or biosimilar product, meaning that the information from the reference medicinal product’s SmPC that applies to the biosimilar medicinal products should be included in the SmPC of the biosimilar medicinal product.

The EMA’s approach is based on an assumption that the labelling of a biosimilar medicinal product should be identical to that of the reference biological medicinal product. However, as is also expressed by EuropaBio (Europe’s largest and most influential biotech industry group), as the development of each distinct biosimilar medicinal product requires generating specific pre-clinical and clinical data, there are ongoing deliberations on whether the labelling of the biosimilar medicinal products should include information on both the biosimilar medicinal product and the reference product.

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)

Because the patent protection, data exclusivity and market exclusivity of the original biological medicinal products are starting to expire, new biosimilar medicinal products have entered onto the market in the most recent years. The introduction of new products has also given rise to judicial cases concerning patents involving biological medicinal products and biosimilar medicinal products. However, these cases are still of a relatively limited number.

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?

The DKMA has emphasized the increased focus that the DKMA will have on biological and biosimilar medicinal products due to the increasing number of products in development and expiry of patent protection of the original biological medicinal products.

To ensure a targeted and product-specific monitoring of biological and biosimilar medicinal products, the DKMA and the Danish Ministry of Health have prepared an action plan on biological and biosimilar medicinal products (the action plan can be found on the DKMA’s website).

Also from this Legal Handbook

2. Localization: Denmark

Keen to learn more about localization in Denmark? Read on! Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.

1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?

No, as a starting point there are no rules or regulations formally requiring localization in Denmark. However, there are certain requirements as to registration with and/or authorisation from the Danish Medicines Agency (“DKMA”).

Authorisation requirements

Pursuant to Section 39 of the Danish Medicines Act, any manufacture, import, export, storage, resale, distribution, dispensing, splitting and packaging of medicinal products is subject to authorisation from the DKMA.

Likewise, the manufacture, import, export, storage, resale and distribution of intermediate products intended for further processing into medicinal products, is subject to an authorisation from the DKMA.

Import of medicinal products and/or intermediate products from non-EU/EEA countries requires a manufacturing and importation authorisation pursuant to Section 39 of the Danish Medicines Act, as such import is considered a manufacturing activity. Also, medicinal products imported from third countries must be batch released by a qualified person.

The Danish Medicines Agency only grants authorisations under Section 39 to entities with an address in Denmark. However, depending on the circumstances, foreign applicants may be able to obtain an authorisation (for example, foreign companies with a branch office/representative in Denmark).

Registration requirements

A company that wants to manufacture, import and distribute active pharmaceutical ingredients for the manufacture of human medicines that are covered by a marketing authorisation, must be registered with the DKMA, cf. Section 50a(1) of the Danish Medicines Act.

Clinical trials

In order to initiate and conduct a clinical trial involving humans in Denmark, the person or entity in charge of the initiation, monitoring and financing of the trial (the sponsor) must apply for an approval from the DKMA as well as from the competent Danish Research Ethics Committee or State Medical Ethics Committee.

However, clinical trials are not required to be conducted locally as a condition for obtaining a marketing authorization in Denmark.

2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?

There have not been any recent significant changes involving localization.

3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

To some extent, the process of obtaining a marketing authorization is impacted by localization policies, as medicinal products may only be marketed in Denmark if a marketing authorisation has been granted by the DKMA or by the European Commission, cf. Section 7(1) of the Danish Medicines Act.

As a general rule, foreign marketing authorizations are not recognized in Denmark. However, Denmark recognizes authorizations granted by the European Commission under the centralized procedure. In addition, under the mutual recognition procedure, the DKMA generally recognizes authorizations granted by the regulatory authorities of other EU/EEA member states.

The Danish Medicines Act provides that applicants for and holders of marketing authorizations must be established in an EU/EEA country, cf. Section 18. However, the holder may designate a local representative.

Additional fees

Certain additional fees are applicable for medicinal products manufactured by a company outside the EU/EEA.

For example, the DKMA charges additional fees for application for marketing authorisation of the medicinal products manufactured outside the EU/EEA area, and the DKMA is obliged to inspect the company.

4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the company placing the medicinal product on the market (or the importer of the medicinal product) is free to determine the prices for prescription medicinal products when selling to wholesalers, pharmacies and/or other authorised retail sellers.

5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

The reimbursement of pharmaceutical products is not impacted by localization policies in Denmark.

6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No. In a public tender in Denmark, the contracting entity may require the tenderer to have the necessary authorizations to market the products concerned. However, the contracting entity will not be able to require the tenderer to be a Danish registered company. Any company may submit offers for public tenders in Denmark.

In Denmark, the company Amgros is responsible for securing the supply of drugs and hearing aids to public Danish hospitals and hearing clinics. Thus, if a company wants to supply a product to the public Danish hospitals, the tendering procedures will be conducted by Amgros on behalf of Danish Regions.

Amgros’ tendering procedures are regulated by the EU Public Procurement Directive and the Danish Public Procurement Act. Generally, Amgros requires that companies must set up user profiles in Amgros’ online portal before the company can submit a bid in a tender. The portal is open to both Danish and non-Danish companies.

7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country ? If yes, how so?

Import and export

Please see Question 1 above. Any import and/or export of medicinal products is subject to authorisation from the DKMA.

The DKMA only authorises companies with an address in Denmark (companies within the EU/EEA must have similar authorisations granted by the competent national authority). Companies outside the EU/EEA must have an authorised representative within the EU/EEA.

Taxation

Denmark offers certain attractive taxation schemes for companies involved in research and development. For example, Danish tax law enables companies to apply for a tax credit of 22% on R&D costs of up to DKK 25 million (i.e. the maximum tax credit available is DKK 5.5 million a year).

Furthermore, the tax incentive is also available in case the research and development is performed outside Denmark.

8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?

In recent years, the Danish government has implemented a number of incentives to attract foreign investment in the pharmaceutical industry, e.g. by reducing the corporate tax rate and allowing foreign companies to apply for the government’s funding and other financial incentives for research and development activities.

9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?

There is currently no discussion about the possibility of implementing further localization policies in Denmark.

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3. Orphan Drugs and Rare Diseases: Denmark

An insight into orphan drugs and rare diseases in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.

1. What is the definition of Rare Diseases in your country?

Pursuant to Regulation (EC) no. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (“Orphan Drug Regulation”), a medicinal product may be designated as an orphan medicinal product if its sponsor can establish that

it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the community (the prevalence criterion), or
it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Community and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necessary investment (the insufficient return on investment criterion), and
there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.

Applications for orphan medicinal product designations are assessed by the Committee for Orphan Medicinal Products.

Denmark has adopted the European Commission definition of rare disease, but the National Strategy for Rare Diseases (“National Strategy”, as published by the Danish Health Authority in 2018), uses a different definition of the term rare diseases (Danish: sjældne sygdomme). The definition used in the National Strategy is:

A number of rare usually congenital, hereditary complex and serious diseases and conditions that require special knowledge and skills, and who needs a highly specialized especially well-planned coordinated efforts in the form of highly specialized diagnosis, treatment, monitoring and control 1- 2 places in the hospital service,
Rare diseases occur with a prevalence of no more than 1-2 in 10,000 persons, i.e., up to approximately 500-1,000 people in Denmark. The diseases often cannot be cured, but with appropriate effort, the consequences of the diseases might be prevented, restricted or treated and patients thus ensured better quality of life and survival.

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

Denmark has adopted the Orphan Drug Regulation.

3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

A designation as an orphan medicinal product under the Orphan Drug Regulation does not mean that the product can be marketed. As for other medicinal products, a marketing authorization must be obtained prior to placing the orphan drug on the market.

As mentioned above, the centralized procedure is mandatory for orphan drugs. The application for a centralized marketing authorization must submitted to the EMA who is responsible for review of the application, and the European Commission oversees final authorization.

In its publication “Rare diseases, orphan medicines” dated 28 February 2018, the EMA has stipulated that an orphan drug designation granted outside the EU does not count within the EU.

4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

No, there are no relaxed clinical trial requirements special to orphan drugs. However, the Orphan Drug Regulation contains several incentive schemes intended to support research, development, and availability of orphan medicinal products. For example, the EMA offers “protocol assistance” which is a specific type of scientific advice for the sponsors once a medicinal product has received the designation as an orphan medicinal product.

Sponsors of orphan medicinal products may also apply for reduced fees for regulatory activities.

Furthermore, as a starting point, authorised orphan medicinal products benefit from ten years of protection from market competition with similar medicines.

According to the National Strategy, there are no special incentives provided in Denmark, and the Danish Health Authority is not aware of any plans for future incentives. However, with regard to measures to support the availability of orphan medicinal products, a compassionate use permit may also be applied for with respect to orphan medicinal products.

5. Is there an expedited pathway for Orphan Drugs?

The maximum timeframe for evaluation of marketing authorizations under the centralized procedure is 210 days.

The EMA has stated that orphan drugs will not automatically qualify for accelerated assessment. However, in exceptional cases, the Committee for Medicinal Products for Human Use may initiate an accelerated evaluation.

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

As a general rule, foreign marketing authorizations are not recognized in Denmark. However, Denmark recognizes authorizations granted by the European Commission under the centralized procedure.

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan drugs?

There is no specific reimbursement procedure for orphan drugs. However, orphan drugs may be determined eligible for reimbursement under the general reimbursement system. Please see Question 2 onRegulatory, Pricing and Reimbursement Overview.

8. How are the prices of Orphan Drugs regulated?

Please see Question 2 on Regulatory, Pricing and Reimbursement Overview.

9. In case of reference price based on a basket of countries, what countries are included?

N/A

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

N/A

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

The Danish Health Authority’s National Strategy of 2018 contains a large number of initiatives to support rare diseases in Denmark. With respect to orphan medicinal products, the Danish Health Authority makes references to the Danish Medicines Council (which was established in 2017) as having a significant role in ensuring access to medicinal products for rare diseases and patient groups.

The Danish Medicines Council has established a number of committees within specific disease areas, e.g. haemophilia. The committees will assess and evaluate new medicinal products and indications. Furthermore, the Danish Medicines Council is are wording on a model for ensuring that the Danish Regions make expedient decisions on taking new medicinal product for rare diseases into service.

The Danish Health Authority conducts continuous evaluation of the strategy for rare diseases and orphan medicinal products in Denmark to ensure that the strategies are implemented. The next National Strategy is expected in 2021.

Click the following links to read more legal articles from Denmark:

Also from this Legal Handbook

4. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Denmark

An intro to the legal situation for cannabinoid drugs, medicinal cannabis and opioid drugs in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Cannabinoid drugs, i.e. medicinal products where the active substance is cannabinoids, can be authorised in Denmark in accordance with the general rules on development, manufacture and marketing under the Medicines Act.

This means that in order to obtain a marketing authorization for a medicinal product that is cannabis-based, the company must show that the benefits of the medicinal product outweigh the risks and side effects, that the medicinal product is safe and that it is of a sufficiently high and consistent quality. To document benefits, safety and quality, the company must as a starting point conduct laboratory trials, animal trials, and clinical trials in humans. For further information on marketing of medicinal products, please see Chapter 1, Question 3.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The DKMA is responsible for authorising the sale of Cannabinoid Drugs on the Danish market.

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

Please see Question 1 on authorization.

Please see Chapter 1, Question 12 on pricing and Chapter 1, Question 13 on reimbursement.

The company that places the medicinal product on the market can apply for the product becoming eligible for reimbursement. The DKMA determines whether a medicinal product should be eligible for reimbursement on a case-by-case basis. So far, the only medicinal product containing cannabinoids authorised in Denmark (please see Question 4 below) is not eligible for reimbursement.

However, the doctor prescribing the medicinal product may submit an application for single reimbursement for individual patients.

4. Which are the cannabinoid drugs that have received market approval to date?

One medicinal product containing cannabinoids has been authorised in Denmark and one medicinal product containing cannabidiol has been authorised in Denmark/EU.

The medicinal product containing cannabinoids is called Sativex® and is an oromucosal spray. The product is available on prescription only from specialists in neurology. It is indicated as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis.

There is no reimbursement for Sativex®.

The product containing cannabidiol is Epidyolex®.

5. Who can prescribe Cannabinoid Drugs?

Only neurologists are allowed to prescribe Sativex®.

A doctor may also apply for a compassionate use permit where a medicinal product is not marketed in Denmark. In the context of cannabinoid drugs, a doctor may apply for a compassionate use permit for the products Marinol or Nabilone. The DKMA will decide whether to grant such permits on a case-by-case basis.

A doctor may also prescribe a magistral preparation where the active substance is cannabis.

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

No.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

No specific approvals or notifications are required to prescribe cannabinoid drugs. However, please note that only neurologists are allowed to prescribe Sativex®.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

The wholesale and distribution of medicinal products requires an authorization from the DKMA.

Sale of prescription only medicinal products to patients/consumers are reserved for the pharmacies.

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

There is no specific list of wholesale distributors of cannabinoid drugs. However, the DKMA publishes lists of companies having authorizations pursuant to Section 39 of the Danish Medicines Act (i.e. companies that are authorized to manufacture, import, export, store, resell, distribute, dispense, split and package medicinal products).

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

No. However, please see the section on Medicinal Cannabis below.

11. When are they likely to come into force?

N/A

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Yes. A pilot programme for medicinal cannabis (“Pilot Programme”) was established in Denmark in January 2018. Initially, the Pilot Programme was intended to be a four-year program. However, the Pilot Program has been prolonged until 31 December 2025.

The DKMA assesses that medicinal cannabis should be considered only for the following indications for which there is some supporting evidence of the effect of medicinal cannabis:

painful spasms caused by multiple sclerosis,
painful spasms caused by spinal cord damage,
nausea after chemotherapy, and
neuropathic pain.

Under the Pilot Programme, it is possible for companies to apply for

a licence to cultivate and manufacture cannabis bulk (i.e. processed cannabis for further processing into primary cannabis products),
a licence to import and/or manufacture cannabis primary products, and/or
a licence to manufacture cannabis intermediate products (i.e. products that are manufactured by labelling cannabis primary products and which may be distributed to pharmacies for processing into products for end-users).

Further, it has become possible for Danish pharmacies and hospital pharmacies to manufacture and dispense cannabis end-products (i.e. cannabis products that may be dispensed to individual patients based on doctors’ prescriptions) based on specific cannabis intermediate products that have been admitted to a list established by the DKMA.

Under the Pilot Programme, patients can now legally to obtain medicinal cannabis on the basis of a prescription from a doctor. The medicinal cannabis must be dispensed by a pharmacy.

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

The DKMA is the main regulatory authority with jurisdiction over the Pilot Programme on medicinal cannabis.

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Authorization

Cannabis products that are to be comprised by the Pilot Programme must be reviewed by the DKMA. The DKMA has a published list of the cannabis products that have been admitted to the Pilot Programme.

The requirements for admission of cannabis intermediate products and cannabis primary products are laid down in the Danish Act on a Medicinal Cannabis Pilot Programme (Consolidated Act no. 1668 of 26 December 2017, as amended, the “Pilot Programme Act”).

The cannabis products on the DKMA’s list are not necessarily available for prescription and dispensing. The products available for prescription and dispensing are listed on the website medicinpriser.dk (medicine prices).

Pricing

Pricing of medicinal cannabis under the Pilot Programme is governed by the Danish Executive Order no. 2503 of 14 December 2021 on calculation of prices on cannabis end-products.

The manufacturer of a cannabis intermediate product must submit the pharmacy purchase price to the DKMA. The prices for the cannabis end-products will be calculated on the basis of this pharmacy purchase price per packaging, with an addition of 7,9 per cent of the pharmacy purchase price and DKK 5,46.

Based on the register price, the pharmacy may add prescription fees the manufacture fee, and/or certain other fees, e.g. delivery and invoicing fees.

Reimbursement

A special reimbursement scheme for medicinal cannabis has been introduced in January 2019 in connection with the Pilot Programme.

Under the reimbursement programme, patients that have been prescribed medicinal products as part of the Pilot Programme are eligible for reimbursement. The reimbursement is automatically deducted when the medicinal cannabis is purchased in the pharmacy. The reimbursement thresholds and reimbursement rates applicable to medicinal cannabis can be found on the DKMA’s website.

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

As mentioned under Question 12, the production and import of cannabis products is subject to authorization from the DKMA.

The manufacture and import is regulated by the Pilot Programme Act and a number of supplementing executive orders.

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

Please see Question 1 of Medicinal Cannabis on the different types of authorization that must be obtained when importing, manufacturing and cultivating medicinal cannabis.

As cannabis is a euphoriant substance, a company must – in addition to the licence to import, manufacture and/or cultivate the different cannabis products – also obtain an authorization to handle euphoriant substances.

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

A manufacturer of intermediate cannabis products must only distribute cannabis intermediate products to pharmacies, hospital pharmacies and companies authorised to distribute medicinal products in accordance with Section 39 of the Danish Medicines Act and an authorization for activities regarding euphoriant substances.

It is not permitted to advertise for cannabis products included under the Pilot Programme.

18. How can patients obtain Medicinal Cannabis?

Patients may obtain medicinal cannabis from licensed pharmacies on the basis of a doctor’s prescription.

19. Who can prescribe Medicinal Cannabis?

Medicinal cannabis can be prescribed by doctors. However, doctors are not obligated to prescribe medicinal cannabis.

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

No. As any doctor may in principle prescribe medicinal cannabis, there is not specific list of doctors authorised to prescribe medicinal cannabis.

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

There is no approval or notification required to prescribe medicinal cannabis.

22. Where is Medicinal Cannabis available?

Medicinal cannabis may be dispensed by pharmacies. If the patient is treated in a hospital, it is the hospital pharmacy that dispenses the product to the patient.

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

Medicinal cannabis must be sold by licensed pharmacies. There is no specific list of pharmacies selling medicinal cannabis.

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

The Pilot Programme became effective on 1 January 2018 and was initially set to continue for four years until 31 December 2021. Based on continuous evaluations, the Pilot Programme has been prolonged until 31 December 2025.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Yes. Opioid drugs, i.e. medicinal products where the active substance is a euphoriant substance, can be developed, manufactured, distributed, prescribed and dispensed in compliance with the applicable regulatory framework on medicinal products.

Medicinal products where the active substance is a euphoriant substance are not only subject to the Danish Medicines Act but also to the Danish Act on Euphoriant Substances (Consolidated Act no. 715 of 13 June 2016 on euphoriant substances, “Euphoriant Substances Act”), and the Danish Executive Order on Euphoriant Substances (Executive Order no. 557 of 31 May 2011 on euphoriant substances, “Euphoriant Substances Order”).

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

The regulatory authority with overall jurisdiction over opioid drugs is the DKMA.

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

Opioid drugs may be authorised in accordance with the rules on authorization of medicinal products. Please see Question 3 on Regulatory, Pricing and Reimbursement Overview.

A company that wishes to engage in activities with euphoriant substances covered by the Euphoriant Substances Order, including import, export, distribution, and manufacture, must obtain an authorization from the DKMA. This requirement does not apply to licensed pharmacies.

The rules on pricing and reimbursement applicable to regular medicinal products, also apply to opioid drugs. Please see Question 2 on Regulatory, Pricing and Reimbursement Overview.

28. Which are the Opioid drugs that have received market approval to date?

Searches in the Danish medicinpriser.dk, shows that some opioid drugs that have received market approval to date include fentanyl, hydromorphone, morphine, methadone, ketamine, and opium.

29. Who can prescribe Opioid Drugs?

As a starting point, opioid drugs are only available on doctors’ prescription.

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

There is no specific list of doctors authorized to prescribe opioid drugs.

Medicinal products with addictive properties to be used as part of treatment of persons suffering from drug addiction may as a starting point only be prescribed by doctors employed at specific municipal, regional or private institutions.

31. What approvals or notifications are required to prescribe Opioid Drugs?

There is no special approvals or notifications required to prescribe opioid drugs.

However, please see Question 29.

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

Only pharmacies, including hospital pharmacies, doctors and veterinarians are permitted to dispense opioid drugs.

Only pharmacies, including hospital pharmacies, and persons or entities that have received an authorization from the DKMA may distribution/sell opioid drugs. Specific rules apply with respect to pharmacies’ account of sales and stock of euphoriant substances.

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

No, as a starting point, any pharmacy can dispense opioid drugs based on a prescription.

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

No.

35. When are they likely to come into force?

N/A

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5. Regulatory Reforms: Denmark

The ins and outs of regulatory reforms in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.

1. Are there proposals for reform or significant change to the healthcare system?

N/A.

2. When are they likely to come into force?

N/A.

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6. Patents and Trademarks: Denmark

The low-down on the situation regarding patents and trademarks in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.

1. What are the basic requirements to obtain patent and trademark protection?

Patents

In Denmark, a patent can be obtained by i) filing of a patent application with the Danish Patent and Trademark Office (“DKPTO”), ii) filing a patent application according to the Patent Cooperation Treaty (“PCT”) system, or iii) filing a European patent application with the European Patent Office (“EPO”).

Danish patents and supplementary protection certificates are granted by the DKPTO. After a patent has been granted by the EPO, the patent must be validated in Denmark within three months. The DKPTO undertakes such validation. Under the PCT system, the DKPTO acts as receiving office for Danish nationals, resident or legal entities.

Trademarks

Applications for the registration of a trademark must be filed with the DKPTO subject to payment of a fee

In Denmark, a trademark right can also be established through use.

2. What agencies or bodies regulate patents and trademarks?

The DKPTO is a governmental office under the Danish Ministry of Industry, Business and Financial Affairs, and is responsible for patent and trademark regulation.

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

Patents

A patent confers on the patent holder an exclusive right to exploit the patented invention commercially. The right of exclusivity entails that the patent holder may restrict others from exploiting the invention, including by:

producing, offering for sale, putting on the market or using a patented product or importing products for such purposes;
using or offering for use a patented process in Denmark, if the person offering the process knows or has reason to believe, that the process must not be used without consent of the patent holder; or
offering, putting on the market or using a product manufactured by a patented process, or importing or possessing the product for such purposes.

Certain exemptions to the exclusivity apply. For example, the exclusivity of a patent right does not include:

non-commercial activities,
activities concerning products which have been placed on the market in Denmark or the EU/EEA by the patent holder or with his consent,
experimental activities relating to the subject matter of the patented invention,
acts limited to the subject-matter of the patented invention, which are necessary for obtaining a marketing authorization for a medicinal product for humans or animals in the EU, in an EU member state or in other countries, or
an individual preparation in a pharmacy of remedies according to a prescription.

Patentability

The three main criteria for patentability are novelty, industrial application, and inventiveness.

As a starting point, inventions may be patented within all areas of technology. However, certain subject matters are inherently not patentable.

The Danish Patent Act (Consolidated Act no. 90 of 29 January 2019, “Patent Act”) provides the following examples of subject matters that will not be regarded as patentable inventions:

discoveries, scientific theories and mathematical methods,
aesthetic creations,
schemes, rules or methods for performing mental acts, games or doing business or programs for computers,
presentations of information,
methods for the treatment of the human or animal body by surgery or therapy or diagnostic methods practiced on the human or animal body,
plant or animal varieties,
biological processes for the production of plants or animals, and
the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene.

Furthermore, patents will not be granted for inventions for which the commercial exploitation will be contrary to ordre public or morality.

Trademarks

A trademark confers on the proprietor an exclusive right, which entitles the proprietor to prevent others from using commercially any sign that:

is identical with the trademark and is used in relation to goods or services which are identical with those for which the trademark is registered,
is identical with, or similar to, the trademark and is used in relation to goods or services which are identical with, or similar to, the goods or services for which the trademark is registered, if there exists a likelihood of confusion on the part of the public (including likelihood of association between the sign and the trademark),
is identical with, or similar to, the trademark irrespective of whether it is used in relation to goods or services which are identical with, similar to, or not similar to, those for which the trademark is registered, where the latter has a reputation in Denmark and where use of that sign without due cause takes unfair advantage of, or is detrimental to, the distinctive character or the repute of the trademark.

According to the Danish Trademark Act (Consolidated Act no. 88 of 29 January 2019, “Trademark Act”), a trademark may consist of any signs, in particular words, including personal names, or designs, letters, numerals, colours, the shape of goods or of the packaging of goods, or sounds, provided that such signs are capable of:

distinguishing the goods or services of one undertaking from those of other undertakings, and
being represented on the register in a manner which enables the competent authorities and the public to determine the clear and precise subject matter of the protection afforded to its proprietor.

A trademark will not be registered if there are absolute grounds for refusal, for example if the trademark:

is devoid of any distinctive character,
consists exclusively of signs or indications which may serve, in trade, to designate the kind, quality, quantity, intended purpose, value, geographical origin, or the time of production of the goods or of rendering of the service, or other characteristics of the goods or services,
is contrary to law, ordre public or to accepted principles of morality,
is likely to deceive the public or is otherwise contrary to law.

Also, signs which consist exclusively of i) the shape of the goods themselves, ii) shapes of the goods which are necessary to achieve a technical result, and iii) shapes which provide the goods with substantial value, are rejected from registration.

Furthermore, a trademark may be rejected from registration if an objection based on are any relative grounds of refusal is made, for example

if there are similar or identical earlier rights (e.g. national trademarks, EU trademarks, trademarks registered under the Madrid Protocol which have effect in Denmark, well-known trademarks), or
If the trademark may be prohibited due to another earlier right, such as a right to a name, personal portrayal, and copyright

4. How can patents and trademarks be revoked?

Patents

If the annual renewal fee is not paid, the patent will lapse as from the beginning of the fee year for which the fee has not been paid.

A patent may be revoked by a court decision if:

it has been granted despite that the patentability requirements were not complied with (e.g. unpatentable subject matter, lack of utility, novelty, or inventive step),
it relates to an invention which is not disclosed in a manner sufficiently clear to enable a person skilled in the art to carry out the invention on the basis of the description,
its subject matter of the patent extends beyond the contents of the application, or
the scope of the protection conferred by the patent has been extended after the DKPTO has notified the applicant of the patent grant.

Trademarks

A trademark may be invalidated on the basis of the absolute and relative grounds mentioned above. Furthermore, a trademark can be invalidated on the grounds of non-use or degeneration.

A trademark may be revoked following a request for cancellation. A request for cancellation may be based on claims for invalidity due to an absolute or relative ground of refusal (please see above). Furthermore, a request for cancellation may be based on claims regarding lack of use of the trademark or degeneration of the trademark.

For Danish trademarks or trademarks based on the Madrid Protocol with effect in Denmark, the request for cancellation must be filed with the DKPTO. In case of request for cancellation of EU trademarks, the request must be filed with the European Intellectual Property Office (“EUIPO”). A revocation of the trademark can also be effected by way of a court decision. Proceedings must be instituted against the proprietor by anybody with a legal interest.

With regard to non-use, the Trademark Act states that if within a period of five years from the termination of the registration procedure the proprietor of a registered trademark has not put the trademark to genuine use in connection with the goods and services for which it is registered, the registration can be revoked. A condition for invalidation due to non-use is that a third party must make a request for invalidity. Subsequently, the proprietor must prove that there are proper reasons for the non-use, or prove that the trademark has been genuinely used.

5. Are foreign patents and trademarks recognized and under what circumstances?

Patents

Patents are territorial rights. Therefore, as a starting point, a Danish patent will only confer exclusive rights in Denmark, and a patent will only be recognised in Denmark if issued in accordance with the Danish rules.

As mentioned in Question 1, a patent in Denmark can be obtained by i) filing of a patent application with the Danish Patent and Trademark Office (“DKPTO”), ii) filing a patent application according to the Patent Cooperation Treaty (“PCT”) system, or iii) filing a European patent application with the European Patent Office (“EPO”).

International and European patents applied to Denmark have the same effect as national patents, unless otherwise provided in Patent Act.

International patents under the PCT system and European patents must be validated and maintained in the individual designated countries.

However, with the upcoming system for European patents with unitary effect, patents may be given unitary effect for the territory of up to 26 member states participating tin the unitary patent system. The system will enter into force when the Agreement on a Unified Patent Court enters into force (i.e. when the members have all ratified the agreement). The prospect for entry into force of the Unified Patent Court is currently dependent on Germany’s ratification of the agreement.

Trademarks

Traditionally, the protection conferred by a trademark right is only enforceable in the specific jurisdiction in which the rights have been granted.

In Denmark, a trademark may be obtained by i) by submitting an application to the DKPTO, ii) submitting a EUTM application, or iii) by submitting an application based on the Madrid Protocol (which is administered by the World Intellectual Property Organisation (“WIPO”)).

As mentioned above, in Denmark, a trademark right can also be established through use. Trademarks established through use will only cover the goods and services for which the trademark has commenced to be used and for which it is continuously used, and provided the range of use of such trademark is beyond a mere locally delimited use. If, however, the trademark is excluded from registration due to its nature, the use of the mark does not establish any trademark rights. If the trademark is devoid of the required distinctive character at the commencement of use, the right shall only be established when and if a distinctive character is acquired by the use of the mark.

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

Data exclusivity

Following expiry of patent protection, or in case no patent has been obtained, innovative medicinal products may be ‘copied’ and generic versions may enter the market.

It is imperative for manufacturers of generic medicinal products to be able to rely on the data established by the reference medicinal product. The possibility of relying on established data – as opposed to having to carry out costly trials to establish the required documentation – means that the generic manufacturers can penetrate the market much quicker and with fewer expenses.

As mentioned above in Question 6 on Regulatory, Pricing and Reimbursement, abridged procedures are available for marketing authorizations for generic medicinal products (i.e. products that have the same qualitative and quantitative composition in active substances and the same pharmaceutical form as a specific authorised reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies).

Pursuant to the rules on the abridged procedure, a generic applicants will not be required to provide the results of pre-clinical tests and clinical trials if it is possible to demonstrate that the medicinal product is a generic of a reference medicinal product that is or has been authorised for not less than eight years in a country of the EU/EEA.

This means that a manufacturer of a generic medicinal product will not be able to obtain a marketing authorization on the basis of an abridged procedure until the reference medicinal product has been authorised in the EU/EEA for at least eight years. Essentially, the reference medicinal product’s data is protected during this eight year period.

Furthermore, a generic medicinal product may not be placed on the market until ten years have passed from the initial authorization of the reference medicinal product. This rule confers a market exclusivity for the reference medicinal product of ten years from its authorization.

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

Patents

Please see Question 3 above on patentability requirements and patentable subject matters.

Trademarks

The Trademark Act does not contain special provisions relating to trademarks for pharmaceutical products, and DKPTO does not keep a separate registry.

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

Patents

The licensing of patents is regulated by Chapter 6 of the Patent Act. Generally speaking, licence agreements will be subject to normal contractual rules.

The Patent Act provides that, unless otherwise agreed, a licensee is not allowed to assign his rights to anyone else. In some cases a compulsory licence may be obtained.

The transfer of a patent or the grant of a licence, must on request be entered in the DKPTO’s patent register.

A trademark may also be licensed. If a trademark has been licensed, the license agreement may be registered with the DKPTO.

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7. Product Liability: Denmark

All legal aspects surrounding product liability. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.

1. What types of liability are recognized in your jurisdiction?

Generally, a person or company may incur liability by way of (i) contractual liability or (ii) civil liability due to violations of statutory law and/or culpable behaviour. Depending on the wording of the contractual terms giving rise to a contractual liability, separate claims for the same incident may be raised based on contractual liability as well as non-contractual types of liability, primarily in this context statutory product liability law.

Further, we note that the Danish Act on the Right to Receive Compensation (Consolidated Act no. 995 of 14 June 2018, the “Compensation Act”) within the Health Service Sector applies to injuries (i) occurring in private and public hospitals, (ii) caused by authorised professionals in private practice, (iii) suffered by participants in clinical trials, and iv) suffered by patients who receive treatment in hospitals abroad in accordance with the Danish Health Act.

It is not a prerequisite for compensation under the Compensation Act that proof of fault must be attributable to an individual person. Decisions for compensation are made by the Danish Patient Safety Authority,

Under the Compensation Act, damages are paid if: (i) given the specific circumstances, an experienced specialist in the relevant field would have acted differently in examination or treatment (i.e. if the damage could have been avoided), (ii) if the injury is caused by a failure of technical equipment used in connection with examinations or treatment, (iii) a subsequent assessment shows that the injury could have been avoided using an alternative treatment method, or (iv) if the injury is more extensive than what the patient can reasonably be expected to tolerate.

Claims for medicinal product liability under the Compensation Act are usually paid for by the Danish state. The state can claim indemnity from the manufacturer/importer of the medical device if there is a legal basis to do so under the Danish Product Liability Act.

Medicinal product liability claims are rarely brought under the general Danish Product Liability Act and are instead sought under the patient compensation scheme under the Compensation Act.

Contractual Liability

A party to an agreement may raise a claim for damages and/or penalties against a counterparty who is in breach of the agreement. A claimant may raise claims for breach of express terms or – to some extent – trade customs or general rules of law. Unless a specific penalty or liquidated damages are agreed between the parties, the actual damages shall be calculated according to applicable Danish law. Damages are limited to proven damages incurred by the claimant, i.e. punitive damages cannot be awarded under Danish law. To the extent that sales take place directly to consumers it should be kept in mind that consumers are protected by certain mandatory law.

Non-contractual liability

Liability outside of claims following from a contract can arise from statutory law requirements or culpable behavior.

The Danish Product Liability Act (which implements the EU Product Liability Directive) covers injury to persons, loss of income/loss of capacity for work, loss of a financial provider and damage to goods intended and used for non-commercial purposes. Damage to the defective product itself is not covered by the Danish Product Liability Act but may be covered by the Danish Act on Sale of Goods, if applicable. The Danish Product Liability Act cannot be opted out of.

In addition to the statutory rules of the Danish Product Liability Act, case law has developed an additional aspect of product liability. As these extended rules generally only apply to damage to other products (i.e. not persons), they will rarely be relevant to manufacturers of medicines and devices.

Under the Danish Product Liability Act, manufacturers of products are liable based on strict liability for the above-mentioned types of damage. For the liability to be established, the loss, defect and causality must be proven. As a rule, a monetary deductible of DKK 4,000 applies to damages to goods caused by product defects.

Manufacturers

Not only the actual manufacturer of the products is subject to the Danish Product Liability Act as also parties bringing the product to market in such parties’ own name as well as importers of non-EU products may be liable for defect products. If an end-user cannot identify the EU-based manufacturer or the importer of non-EU products, a claim may be raised against any seller or distributor of the product within the supply chain. Such seller or distributor may within reasonable time give the claimant notice of the identity of the importer or manufacturer within the EU in order to avoid the derived liability.

Sellers and distributors

Subject to rigorous fault-based negligence standards, sellers and distributors may incur liability for damages to goods and persons caused by defective products sold or distributed by them, unless the seller or distributor is able to prove that the damages were not caused by fault or negligence of the seller or distributor. As a rule, the seller or distributor is liable towards a claimant for the fault and negligence of the manufacturer and previous sellers and distributors within the supply chain of the product. In case damages are paid, recourse may be sought from such manufacturer or previous distributor. Consequently, sellers and distributors act as a form of guarantors towards purchasers for the obligations of prior links in the supply chain.

Culpability

Under Danish law, a claimant may generally raise a claim for damages outside of contractual relationships and, if not already covered by statutory law, if the conditions for liability based on fault-based negligence standards are met. For liability to be incurred, the claimant must (i) have incurred a monetary loss and be able to prove the existence and size of such loss, (ii) prove that the defendant had acted negligently or with intent in causing the damages, and (iii) prove causation and foreseeability.

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

Contractual liability

A manufacturer of medicines and devices may be liable for breaches of agreements entered into with customers and suppliers. For example, any representations made in a contract of sale may lead to a liability claim if not upheld.

Non-contractual liability

Non-contractual liability may arise from, for example, damage caused to persons or objects due to defects in the manufactured products under applicable product liability law as described above.

As a rule, manufacturers of medicines and devices are held to a very high standard and are subject to a number of specific regulations as described herein, which may affect the manufacturer’s liability. As described, the definition of “manufacturer” under applicable product liability law is quite wide.

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

Generally, corporate liability is limited to the legal entity that has caused the damage. In theory, individuals may also become liable based on their negligence or intentional acts or omissions. Further, if corporate executives or officers have negligently or intentionally caused the company, its creditors or public authorities to incur a loss, the executives or officers may potentially become personally liable for such losses, although this is rarely seen in practice.

In certain serious cases where a product defect has been concealed or where the defective products have been sold despite a person’s actual knowledge of the defect and bodily injury has been suffered as a consequence of such defect, criminal liability may be imposed on the involved persons.

4. How can a liability claim be brought?

Barring an agreement on arbitration, claims must be brought before the Danish courts of law. Generally, a case can be tried in two instances and certain cases may be escalated to the Supreme Court as a third instance.

If a group of claimants with similar claims, which are all subject to the jurisdiction of the courts of Denmark meet a number of criteria, a class action suit may be filed against the defendant.

Finally, patients may seek compensation at the Danish Patient Compensation Association which handles claims for damage from medicines. Decisions made by the Association can be brought before a higher administrative instance and ultimately before the courts.

5. What defenses are available?

Limitation period

Claims for product liability damages are generally time-barred 3 years after the cause of the damage occurred with certain extensions available. All claims against the manufacturer are time-barred 10 years after the defective product was placed on the market.

Outside of the Danish Product Liability Act, the default limitation period is 3 years. Certain claims, e.g. personal injury are time-barred 30 years after commencement of the limitation period.

Specific defenses

Depending on the type of claim (i.e. contractual or civil), a defendant may resort to a number of defenses, see below.

Contractual liability

If the claim is contractual, the defendant may argue, inter alia, that the terms of the contract have not been breached or – barring a fixed penalty – that the claimant has not suffered any losses due to the breach of the contract. Any limitations of liability agreed in the contract may also act as defenses.

Non-contractual liability

In case of civil claims, the main defense will be (i) that the claimant is not able to document a loss and/or (ii) that the defendant has not acted negligently or intentionally.

For product liability claims under applicable Danish law, the defendant may, inter alia, argue that:

the defect is caused by mandatory requirements from public authorities,
that it was not possible for the manufacturer to discover the defect due to the scientific or technical knowledge available at the time the product was marketed,
that the manufacturer did not put the product in question on the market,
the defect was not present when the product was put on the market, or
the claimant has itself acted negligently in the use of the product, thus reducing the liability of the manufacturer/distributor.

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8. Traditional Medicines and OTC Products: Denmark

Key legal info on traditional medicines and OTC products in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Natural medicinal products, traditional herbal medicinal products, homeopathic medicinal products, and strong vitamin and mineral products are all special categories of medicinal products and are as a starting point governed by the Danish Medicines Act.

Natural medicinal products

Pursuant the Executive Order on natural medicinal products and traditional herbal medicinal products (Executive Order no. 1233 of 12 December 2005 on natural medicinal products and traditional herbal medicinal products, as amended), natural medicinal products are defined as medicinal products:

i. The active substances of which are only naturally occurring substances in doses that are not significantly higher than those found in the environment,

ii. That are meant for a) oral consumption, b) application on skin, or c) local application on mucous membranes,

iii. That are non-prescription products,

iv. With indications that only cover the treatment of minor diseases.

The requirements that apply to manufacturers of regular medicinal products apply equally to manufacturers of natural medicinal products.

Natural medicinal products must be authorized by the DKMA before they can be marketed in Denmark.

It is permitted to sell natural medicinal products outside pharmacies. Such retail sales do not require an authorization from the DKMA.

Herbal medicinal products and traditional herbal medicinal products

Herbal medicinal products are medicinal products the active substances of which consist solely of one or more plant based substances, one or more plant preparations, or a combination of the two.

Traditional herbal medicinal products are defined as herbal medicinal products that:

v. Are meant for humans,

vi. Have indications exclusively appropriate to traditional herbal medicinal products that, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes, prescription or monitoring of treatment,

vii. Are exclusively for administration in accordance with a specified strength and posology,

viii. Are oral, external and/or inhalation preparations, and

ix. Fulfil the requirements on the period of traditional use (i.e. that the product must have been in medical use for at least 30 years, including 15 years in the EU).

The data on traditional use of the product must be sufficient. In particular, the product must prove not to be harmful in the specified conditions of use, and the pharmacological effects or efficacy of the product must be plausible on the basis of longstanding use and experience.

Traditional herbal medicinal products must be approved before being placed on the market. However, a traditional herbal medicinal product can receive an approval for marketing by way of a simplified procedure (registration).

Vitamin and mineral products

Strong vitamins and minerals are a category of medicinal products where the active substances consist exclusively of vitamins and/or minerals, and where the content of vitamins and minerals is considerably higher than the normal daily requirement of adult humans.

Strong vitamin and mineral products may only be sold in Denmark if an authorization has been issued by the DKMA. In the process of authorization, the DKMA generally sets out the same requirements on manufacturing, quality and documentation of safety apply with regard to vitamin and mineral products as with natural medicinal products.

Vitamin and mineral products may be authorized by way of the rules on so-called bibliographical procedure, i.e. an abridged procedure where the applicant may rely on well-established medicinal use for at least ten years, supported by bibliographic literature.

Strong vitamin and mineral products can only be authorised to prevent and cure cases of deficiency.

Strong vitamin and mineral products are exempt the exclusivity of pharmacies, meaning that the products may be sold to end users outside pharmacies.

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

The advertising rules on medicinal products apply to all types of medicinal products for human beings and animals, including natural medicinal products, herbal medicinal products, traditional herbal medicinal products, and strong vitamins and minerals.

As mentioned above, natural medicinal products, traditional herbal medicinal products, and vitamin and mineral products may be sold outside pharmacies, and they are not prescription-only medicinal products. Consequently, they may be advertised directly to the general public provided the relevant requirements are complied with. For further information on advertising of medicinal products, please see Question 17 of Marketing, Manufacturing, Packaging & Labeling, Advertising.

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

The regulatory requirements applicable to over-the-counter medicinal products are generally the same as prescription medicinal products. Please see Question 3 of Regulatory, Pricing and Reimbursement, on the regulatory requirements in connection with development, manufacture and marketing, as well as Question 17 and 18 of Marketing, Manufacturing, Packaging & Labeling, Advertising, on advertising and sale.

A list of non-pharmacy restricted over-the-counter medicinal products can be found on the website of the DKMA. The list is updated daily.

5. Are there any limitations on locations or channels through which OTC products may be sold?

Yes, as a starting point, over-the-counter medicinal products are only permitted to be sold by licensed pharmacies. However, the DKMA may decide that certain over-the-counter medicinal products are to be exempted from the pharmacies’ exclusivity. Such medicinal products may be sold to end users by retail sellers that have been authorized by the DKMA.

6. What health, advertising, and marketing claims may be made for OTC products?

Please see Question 17 of Marketing, Manufacturing, Packaging & Labeling, Advertising.

7. Can OTC products be marketed or advertised directly to the public?

Yes. Please see Question 17 of Marketing, Manufacturing, Packaging & Labeling, Advertising.

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

The DKMA may determine if an over-the-counter medicinal product which is reserved for exclusive sale in pharmacies should be available for sale outside pharmacies.

9. What are the requirements for the importation of either traditional medicines or OTC products?

Import of natural medicinal products, strong vitamin and mineral products, and over-the-counter products requires an authorization from the DKMA.

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9. Marketing, Manufacturing, Packaging & Labeling, Advertising: Denmark

A brief overview of the situation regarding marketing, manufacturing, packaging & labeling, advertising in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

Please see Question 3 of Regulatory, Pricing and Reimbursement Overview.

2. What is the authorization process for the marketing of generic versions of these products?

An abridged procedure is available for marketing authorizations for generic medicinal products. Please see Question 6 of Regulatory, Pricing and Reimbursement Overview.

3. What are the typical fees for marketing approval?

Please see Question 4 of Regulatory, Pricing and Reimbursement Overview.

4. What is the period of authorization and the renewal process?

As a starting point, a marketing authorization for a medicinal product will be valid for 5 years. Please see Question 5 of Regulatory, Pricing and Reimbursement Overview.

5. What are the requirements, if any, for post-approval pharmacovigilance?

Please see Question 8 of Regulatory, Pricing and Reimbursement Overview.

6. Are foreign marketing authorizations recognized?

Please see Question 6 of Regulatory, Pricing and Reimbursement Overview.

7. Are parallel imports of medicines or devices allowed?

Parallel import and parallel distribution in Denmark is permitted with respect to products that are lawfully placed on the market within the EU.

Parallel import, i.e. the import of medicinal products that have already received a marketing authorization from the DKMA via other distribution channels than the ones approved by the rights holder, is monitored by the DKMA.

The DKMA may grant an authorization for parallel import, provided (i) the medicinal product, in relation to which an application for parallel import has been made, must be covered by a valid marketing authorization in Denmark, (ii) the parallel imported medicinal product must be imported from an EU/EEA country, (iii) the parallel imported medicinal product must be covered by a valid marketing authorization from an EU/EEA country, and (iv) there must not be any significant therapeutic differences between the medicinal product that is directly distributed and the parallel imported medicinal product.

An authorization for a parallel import authorization must also be obtained in each country of export.

Parallel distribution, i.e. the distribution of centrally authorized medicinal products from one member state to another independently of the marketing authorization, a separate marketing authorisation is not required. However, the EMA must be notified and the Danish parallel distributor must register with the DKMA.

Medical devices are not subject to an authorisation by a governmental agency. Thus, if a medical device has been affixed with a CE mark and is lawfully marketed in another EU/EEA country, then the medical device can be imported into Denmark (provided certain Danish language and labelling requirements are met). However, there are certain restrictions as to re-packaging of medical devices. If a parallel distributor enters into the areas that fall under the manufacturers responsibility (e.g. if the parallel distributor opens or re-package the imported products), then the parallel distributor will assume the full responsibility for the devices as a manufacturer.

Intellectual property rights can be used as a basis of opposing parallel imports with respect to relabelling and repackaging.

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

Framework

For medicinal products, the rules governing marketing practices such as gifts, sponsorships, consultancy agreements, hospitality, etc., towards healthcare professionals etc., are set out mainly in the Danish Medicines Act and the Danish Executive Order on Advertising of Medicinal Products (Executive Order no. 849 of 29 April 2021, “Advertising Order”).

Furthermore, the industry codes and guidelines published by the Ethical Committee for the Pharmaceutical Industry in Denmark (“ENLI”) also contain detailed restrictions on such practices when directed towards healthcare professionals. ENLI has issued the Pharmaceutical Industry’s Code of Practice on Advertising, etc. of Medicinal Products aimed at Healthcare Professionals (“Promotion Code”). ENLI’s rules, including the Promotion Code, apply to:

Members of the Danish Association of the Pharmaceutical Industry,
Members of the Danish Generic and Biosimilar Medicines Industry Association,
Members of the Danish Parallel Importers’ Association,
Other companies that have accepted to be bound by ENLI’s rules.

For medical devices, the relevant restrictions are set out in the Act on Medical Devices and the Danish Executive Order on Advertising of Medical Devices (Executive Order no. 715 of 24 May 2022).

Gifts, sponsorships, consultancy and hospitality

As a starting point, the provision or offering of financial benefits to healthcare professionals – including gifts – is prohibited.

A limited number of exemption to this general prohibition apply.

For example, it may be lawful to provide gifts if these are of an insignificant value and can be used in the recipient’s practice. According to the guidelines on the Advertising Order and the Executive Order on Advertising of Medical devices, the term “insignificant value” is construed as meaning a value not exceeding DKK 300 in a given calendar year.

As another exemption to the general prohibition, it is permitted to provide healthcare professionals reasonably payment in return for professional services if such payment is proportionate to the services offered.

It is also permitted to provide payment for direct expenses in connection with professionally relevant courses, conferences and supplementary training attended or conducted by healthcare professionals, and to provide payment for direct expenses for meals, travel and accommodation in connection with advertising of or professional information on medicinal products and medical devices.

Notification, Disclosure and transparency

Relationships and collaborations (“affiliations”) between pharmaceutical companies, medical devices companies and stores specialised in the sale of medical devices and healthcare professionals (including proprietary pharmacists, doctors, nurses, and dentists) must – depending on the nature of the relationship in question – be either notified to or approved by the DKMA.

The rules on affiliations apply to i) pharmaceutical companies that have a marketing authorization pursuant to Section 7 of the Danish Medicines Act or an authorization to manufacture, import, export, store and distribute, etc. medicinal products pursuant to Section 39 of the Danish Medicines Act, ii) Danish representatives of non-Danish pharmaceutical, iii) manufacturers (and representatives), importers and distributors that are established in Denmark and that market medical devices within classes IIa, IIb, III or in vitro diagnostic devices or active implantable devices, and iv) stores specialised in sale of medical devices that are established in Denmark, and v) manufacturers, importers and distributors of devices without an intended medical purpose. Such companies are required to notify the DKMA when establishing affiliations with healthcare professionals. Likewise, the healthcare professionals must notify or seek approval from the DKMA of the affiliation with the above-listed companies.

Information on relationships and collaboration must be disclosed to the DKMA and will also be published by the DKMA.

In addition to the rules on affiliations, the pharmaceutical companies and medical device companies must also inform healthcare professionals (and certain specialists engaging in the buying and selling of medical devices) of such persons’ duty to inform the Danish Medicines Agency about financial support received from a pharmaceutical company or a medical device company in connection with participation in professional events abroad. Please see Question 66 below on the upcoming amendments to the rules concerning financial benefits.

9. How is the manufacturing of medicines and devices regulated and by which agencies?

Please see Question 3 of Regulatory, Pricing and Reimbursement Overview.

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?

Yes. The Danish Executive Order on Manufacture and Import of medicinal products and intermediary products (Executive Order no. 1358 of 18 December 2012, “GMP Order”) contains provisions implementing the EU directives on good manufacturing practice in respect of medicinal products.

11. What is the inspection regime for manufacturing facilities?

Please see Question 8 of Regulatory, Pricing and Reimbursement Overview.

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

Since 2018, Denmark has been covered by the mutual recognition agreement between the regulatory authorities in the EU and the US, which means that the authority may rely on each other’s GMP inspection systems.

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

The Danish rules on GMP, including the Danish GMP Order include requirements on storage, packaging and handling of medicinal products.

14. What information must be included in medicine and device labeling?

Medicinal products

Pursuant to the Danish Executive Order on Labelling Of Medicinal Products (Executive Order no. 869 of 21 July 2011 on labelling of medicinal products, “Labelling Order”), the labelling of medicinal products must include, i.a.,:

The name of the medicinal products,
The strength of the product,
The pharmaceutical form,
Contents by weight, volume or doses,
A statement of the active substances,
Method of administration and if necessary route of administration,
Warnings regarding storage,
Batch number and expiry date,
Name and address of the holder of the marketing authorization,
Specific precautions relating to the disposal of unused medicinal products or waste,

Additional labelling requirements may apply to herbal medicinal products. The Labelling Order also provides that as a rule all labelling as well the patient information leaflets must be provided in Danish.

Medical Devices

For medical devices, the labelling must include the following information:

Name and address of the EU manufacturer (in case of a non-EU manufacturer both the name and address of the non-EU manufacturer and its EU representative must be listed),
Information necessary for identifying the device,
The purpose of the device,
Information on batch number, expiry date, date of manufacture, indications that the device is meant solely for clinical trials, CE-marking, number of the notified body, if relevant,
Information on handling and storage,
Precautions and warnings,

The labelling and instructions for use of all medical devices must be in Danish, when the device is made available to any end user in the Danish market. Under certain circumstances, the DKMA can grant exemptions from the language requirement.

15. What additional information may be included in labeling and packaging?

Additional labelling, e.g. symbols or pictograms (including logos of the holder of the marketing authorisation and its representative), may be included if the information is of a non-promotional nature, does not mislead and does not compromise user safety, readability, and is in accordance with the SmPC.

16. What items may not be included in labeling and packaging?

For medicinal products, the labelling may not contain elements of a promotional nature.

Furthermore, the labelling must not be misleading or make the product susceptible of confusion with other medicinal products, types or strengths.

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

Medicinal products

The Danish Medicines Act provides that advertising of a medicinal product shall be adequate and objective, and must not mislead or exaggerate the characteristics of the medicinal product. The information provided in connection with advertising must be in accordance with the authorised SmPC.

In Denmark, prescription medicinal products may not be advertised towards the general public, but only towards healthcare professionals (defined broadly as doctors, dentists, veterinarians, pharmacists, nurses, veterinary nurses, pharmaconomists or students within one of these fields).

Advertising towards the general public must not, i.a.:

give the impression that it is not necessary to consult a healthcare professional,
give the impression that use of the medicinal product is safe, without side effect or better than or just as good as the effect of another treatment or another medicinal product,
give the impression that average well-being can improve by use of the product, or that the average well-being can decrease if the product is not used,
only or mainly be directed towards children,
contain a recommendation from healthcare professionals, scientists or other persons, unions of persons, institutions, companies or the like that could induce the use of medicinal products via their standing,
give the medicinal product equal status with food, cosmetics or other consumer goods,
contain exaggerating, scary or misleading statements on cure,
make exaggerating, scary or misleading use of visual presentations of changes in the human body caused by diseases or injuries or of a medicinal product’s effects on the human body or parts thereof.

Specific requirements apply with regard to advertising in film, on the radio, and in the television, and with regard to advertising directed towards healthcare professionals.

Medical devices

For medical devices, the advertising must also be adequate and objective, and must not be misleading or exaggerating. The information must be in accordance with purpose and scope of use of the device and it must be verifiable, and it must not constitute a risk to the health and safety of patients, users or any third persons.

The majority of the prohibited elements listed above for medicinal products also apply with regard to advertising of medical devices. For example, advertising of medical devices must not i) give the impression that it is unnecessary to consult a doctor, dentist or other persons who use the device as part of their profession if the treatment or diagnosis by such person is relevant, ii) give the impression that using the medical device is without risk, iii) give the impression that the general health could deteriorate by not using the medical device, iv) be directed exclusively or principally at children, v) be such that it might lead to erroneous self-diagnosis, or vi) use, in exaggerated, alarming or misleading terms, images, illustrations, etc. of changes in the human body caused by disease or injury, or of the effect of the medical device on the human body.

Further, it is prohibited to advertise medical devices intended for the exclusive use by doctors or dentists towards the general public, and additional restrictions apply when advertising medical devices towards the general public, e.g. with respect to use of recommendations by professionals, mention of serious diseases, and references to studies.

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Medicinal products

As a starting point, pharmacies have the exclusive right to sell prescription medicines to end users. Likewise, a number of over-the-counter/non-prescription medicinal products may only be sold at the pharmacies.

The DKMA may decide that certain over-the-counter medicinal products are to be exempted from the pharmacies’ exclusivity. Such medicinal products may be sold to end users by authorised retail sellers outside pharmacies.

Danish pharmacies and authorised retail sellers are permitted to sell prescription only-products and over-the-counter products online. Prescription only-products are sold on the basis of electronic prescriptions, which are issued electronically in “The Shared Medicine Card” (a central database monitored by the Danish Health Data Authority). Products bought online may be distributed by mail or courier services.

Medical devices

Medical devices may be sold in specialized stores (stores specialized in medical devices within class IIa, IIb and III, active implantable devices and devices for in vitro diagnostics) or in normal retail stores. Specialized stores must be registered by the DKMA.

Medical devices may be sold online.

19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?

The rules and restrictions applicable to advertising of medicinal products and medical devices also apply to advertising on the internet, on social media, etc.

For medicinal products, it should be noted that advertising on the internet will be considered as directed towards the general public, unless access to the content is restricted in a securely and effective manner to healthcare professionals only.

With regard to advertising by way of e-mail or by way of direct messaging on social media, the restrictions of the Danish Marketing Practices Act (Consolidated Act no. 426 of 3 May 2017) on unsolicited marketing communication apply. As a starting point, it is not permissible to send unsolicited electronic marketing communications (e.g. by e-mail or by direct messaging on social media) without the prior consent of the recipient.

20. May medicines and devices be advertised or sold directly to consumers?

Please see Questions 17 and 18 above.

21. How is compliance monitored?

The DKMA and the Danish Ministry of Health monitors compliance with the rules on manufacture, packaging, labelling and advertising.

In practice, disputes regarding the advertising of medicinal products directed at healthcare professionals may also be brought before the self-regulatory body within the pharmaceutical industry.

22. What are the potential penalties for noncompliance?

Violation of the rules on advertising is subject to fines. The DKMA may also issue orders to the effect that the non-compliant advertising must be stopped, materials withdrawn and rectified.

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10. Preclinical and Clinical Trial Requirements: Denmark

Preclinical and clinical trial requirements in Denmark – an overview. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

No, clinical trials are not required to be conducted locally as a condition for a marketing authorization.

As a starting point, an application for a marketing authorization must include results of physico-chemical, biological or microbiological tests, pre-clinical (e.g. pharmacological and toxicological) tests, and clinical trials. However, there is no requirement that such tests and trials must be conducted in Denmark in order to obtain a marketing authorization in Denmark.

2. How are clinical trials funded?

Clinical trials may be funded privately, publicly or in private-public cooperation.

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

Both preclinical and clinical trials are subject to authorization from the DKMA.

The requirements applicable to preclinical trials are found, i.a., in the Executive Order no. 1245 of 12 December 2005 on good laboratory practice and Executive Order no. 2028 of 14 December 2020 on experiments on animals.

The requirements applicable to clinical trial protocols are found in the Clinical Trials Regulation (Regulation EU no 536/2014), the Danish Act on Clinical Trials with Medicinal Products (Act no. 1252 of 31 October 2018), the Danish Executive Order on Clinical Trials (Executive Order no. 12 of 6 January 2022) and in the Danish Executive Order on Good Clinical Practice (Executive Order no. 695 of 12 June 2013).

Clinical trials must be subjected to both prior scientific and ethical evaluation.

In Denmark, clinical trials on medicinal products may only be conducted if the DKMA has given an authorization for the trial. Furthermore, clinical trials with medicinal products or medical devices must be approved by the competent State Medical Committee.

As mentioned above, all applications for clinical trials initiated after 31 January 2022 (and amendments and other changes to ongoing clinical trials) must as a starting point be submitted through the new centralized EU portal – the Clinical Trials Information System (CTIS). This also applies in case of clinical trials that will only take place in Denmark.

Detailed guidance on how to submit applications for clinical trials under the Clinical Trials Regulation and the CTIS can be found on the DKMA’s website (https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/new-european-clinical-trial-regulation-from-the-31th-january-2022/#) and the EU Commission’s website (https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support).

The new requirements regarding application dossiers (and requirements applicable to protocols) are found in Annex I of the Clinical Trials Regulation

4. What are the requirements for consent by participants in clinical trials?

The matter of consent in connection with clinical trials will as a starting point be subject to both the regulatory legislation and the data protection legislation.

Pursuant to the regulatory legislation, a clinical trial may not be conducted before the informed consent of the participants have been obtained. Such informed consent must be obtained based on detailed written and orally provided information on the contents, anticipated risks and benefits of the trial. It must also be made clear to the participants that the consent can be withdrawn at any time.

The informed consent required pursuant to the regulatory legislation must not be confused with the consent required as a legal ground for the processing of personal data under Regulation (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (“GDPR”). Pursuant to the GDPR, a consent must be freely given, specific, informed and an unambiguous indication of the subject’s wishes.

In a recent opinion of 23 January 2019 regarding the interplay between the regulation of clinical trials and the GDPR, the European Data Protection Board has emphasized the use of other legal bases beside consent in the context of clinical trials. Therefore, the use of consent as the legal basis for processing clinical trial data may be limited and other more appropriate legal bases should be identified.

5. May participants in clinical trials be compensated?

As a starting point, it is not permitted to pay subjects for participation in clinical trials. However, subject to strict limitations, it may be permitted to provide compensation for i) loss of income, ii) travel expenses, and iii) discomfort. However, it must be ensured that any compensation provided to trial participants does not affect the giving of consent.

The Danish National Research Ethics Committee has published guidelines on the permitted compensation of participants in health research projects.

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

The Committee Act provides that it is a requirement that there is a compensation or indemnification arrangement if the trial subject suffers any harm or dies as a consequence of the trial, and that an insurance must be taken out or other compensation arrangement must be put in place to cover the liability of the investigator and the sponsor towards the participants.

In Denmark, the Danish Patient Compensation Scheme covers all trial subjects that participate in health research trials in Denmark, which are conducted at public hospitals, with authorised healthcare professionals in the primary healthcare sector, or with private companies under the responsibility of authorised healthcare professionals.

For trials conducted outside the scope of the public healthcare sector, a mandatory patient insurance must be taken out.

The information provided to participants in clinical trials must include information on the rights to file complaints, and the possibility of seeking damages and compensation in case of any harm resulting from the trial.

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Please note that the current system for application for clinical trial authorization will be modified and subject to greater coordination and harmonization across the EU once the new clinical trial regulation becomes applicable.

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11. Regulatory, Pricing and Reimbursement: Denmark

The legal framework for regulatory, pricing and reimbursement of drugs in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The Danish Ministry of Health is responsible for defining the overall framework for the national healthcare system. As a governmental body under the Ministry of Health, the Danish Medicines Agency (“DKMA”) is the Danish authority responsible for monitoring medicinal products for human and veterinary use, including biological medicinal products, and medical devices.

The DKMA is responsible for authorizing and inspecting pharmaceutical companies and other distributors, authorizing clinical trials, authorizing medicinal products, deciding whether medicinal products are eligible for reimbursement, overseeing adverse event reporting, and monitoring medical devices.

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

Medicinal products

The main Danish legislation on authorization, pricing, and reimbursement of medicinal products is the Danish Medicines Act (Consolidated Act no. 99 of 16 January 2018, “Medicines Act”) and the Danish Pharmacies Act (Consolidated Act no. 801 of 12 June 2018).

The Medicines Act is supplemented by a large number of executive orders and guidelines issued by the DKMA.

Further, as an EU member state Denmark is required to follow the union rules governing authorization of medicinal products. The provisions set out in the EU directives are transposed into Danish acts, and the applicable EU regulations, e.g. the Regulation (EC) no. 726/2004 on procedures for the authorisation and supervision of medicinal products for human and veterinary use, are directly applicable.

Biologicals

The Danish Medicines Act and secondary legislation issued under the Medicines Act also apply to biologicals.

Medical devices

The Danish Act on Medical Devices (Consolidated Act no. 139 of 15 February 2016, “Act on Medical Devices”) constitutes the main regulatory framework for the authorization, pricing and reimbursement of medical devices.

The Act on Medical Devices is supplemented by a number of executive orders issued by the DKMA, e.g. the two main executive orders on i) medical devices and products without a medical purpose, and ii) in vitro diagnostics medical devices.

As an EU member state Denmark is required to follow the union rules governing authorization of medicinal products and medical devices, e.g. Regulation (EU) 2017/745 of 5 April 2017 on medical devices and Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices.

3. What are the steps to obtaining authorization to develop, test, and market a product?

Medicinal products

Development and testing

In order to initiate and conduct a clinical trial with medicinal products, the person or entity in charge of the initiation, monitoring and financing of the trial (the sponsor) must apply for an authorisation from the DKMA. Furthermore, clinical trials involving humans must be approved by a competent state medical committees. Non-interventional trials may as a starting point be implemented without the authorisation from the DKMA.

Following the entering into force of the Clinical Trials Regulation (Regulation EU No 536/2014), all applications for clinical trials initiated after 31 January 2022 (and amendments and other changes to ongiong clinical trials) must as a starting point be submitted through the new centralized EU portal – the Clinical Trials Information System (CTIS). This also applies in case of clinical trials that will only take place in Denmark.

Guidance on how to submit applications for clinical trials under the Clinical Trials Regulation and the CTIS can be found on the DKMA’s website (https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/new-european-clinical-trial-regulation-from-the-31th-january-2022/#) and the EU Commission’s website (https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support).

Manufacturing

The manufacture, import, export, storage, distribution, provision, dispensing, splitting and packaging of medicinal products and intermediate products intended for further processing into medicinal products are subject to authorization from the DKMA.

Applications for authorizations to manufacture medicinal products must be submitted to the DKMA by way of the agency’s application form through the agency’s extranet DKMAnet or by way of e-mail to the DKMA.

The application form must contain information, i.a., on organization of the company, the site master file (in case of first application), the name and legally registered address of the manufacturer and address(es) of the manufacturing site(s), details of the manufacturing operations and of the products to be manufactured, information on quality control, any contract manufacturing sites and/or contract laboratories, qualified person(s), and details of the responsible management.

In order to manufacture, import and distribute active substances intended for use in the manufacture of medicinal products for human use that are covered by a marketing authorization, a company must also register with the DKMA.

Marketing

As a starting point, only medicinal products that have been authorized by the DKMA or the European Commission may be marketed and/or dispensed in Denmark.

In order to obtain a marketing authorization for a medicinal product, the applicant must show that the benefits of the medicinal product outweigh the risks and side effects, that the medicinal product is safe and that it is of a sufficiently high and consistent quality.

When applying for a marketing authorization, the manufacturer may choose between four types of procedures:

The centralized procedure,
The decentralized procedure,
The national procedure, or
The mutual recognition procedure.

While the European Medicines Agency (“EMA”) is responsible for the centralized procedure, the DKMA is responsible for granting of marketing authorizations through the decentralized procedure, the national procedure and the mutual recognition procedure.

Pursuant to the centralized procedure, the holder of the marketing authorization is allowed to market the medicine throughout the EU. The application for a centralized marketing authorization is submitted to the EMA who is responsible for review of the application, and the European Commission oversees final authorization. The centralized procedure is mandatory for new biological medicines, for medicines for orphan diseases, and medicines for certain defined indications (e.g. HIV, cancer and diabetes). In other circumstances, the centralized procedure can be chosen, e.g. in case of a new active ingredient.

Under the decentralized procedure, the applicant may submit identical applications in a number of chosen EU/EEA countries – the concerned member states. The applicant must request a reference member state to be responsible for the first assessment of the application, prepare a draft assessment report, a draft summary of product characteristics and a draft of the labelling and package leaflet. Once the reference member state has drafted an assessment report, etc., the concerned member states must as a starting point approve the assessment report, etc. If the any of the concerned member states are not able to do – on the grounds of potential serious risk to public health – then the matter of disagreement must be referred to settlement through a special coordination group procedure (the article 29 procedure).

The mutual recognition procedure follows the same procedure as the decentralized procedure with the main difference being that medicinal product in question has already received a marketing authorization at the time of application. The concerned member states are as a starting point obliged to recognize the assessment and the marketing authorization granted by the reference member state.

In special circumstances, the DKMA may permit the sale or dispensing of pharmaceutical products that are not covered by a marketing authorization. Such compassionate use permits are usually only granted if there is no relevant, alternative medicinal product marketed in Denmark, and if the product in question is authorized abroad.

Further, a marketing authorization is not required for medicinal products for use in clinical trials.

Medical devices

In Denmark, medical devices are not authorised by the authorities. The main legislation is found in the Danish Act on Medical Devices (Consolidated Act no. 139 of 15 February 2016)Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. These regulations include detailed rules on medical devices, including more strict obligations on the different actors (e.g. manufacturers, importers and authorised representatives) and requirements for clinical investigations.

Medical devices are categorized in four risk classes: class I (lowest risk), class IIa, class IIb, and class III (highest risk).

As a starting point, it is the manufacturer that is responsible for the classification and conformity assessments of a medical device in accordance, i.a., with the Act on Medical Devices and the supplementing Executive Orders.

For products in classes IIa-III, the conformity assessment of devices must be made in collaboration with a notified body.

A notified body is an organisation designated by an EU member state to assess the conformity of certain product before they can be placed on the market.

The following entities must register with the DKMA if they are headquartered in Denmark:

Manufacturers of medical devices in classes I, IIa, IIb and III, active implantable medical devices, custom made devices, and system and medical treatment packages (and Danish representatives of non-EU manufacturers),
Manufacturers of in vitro diagnostic devices (IVD),
Distributors and importers of medical devices, and
Stores specialising in the sale of medical devices.

Development

For medical devices within class I, the manufacturer is responsible for monitoring the efficacy and safety of the device. For medical devices within classes IIa, IIb and III, the technical documentation of the device must be reviewed and assessed by the notified body.

Clinical investigations involving medical devices must be authorized by the DKMA (and the relevant Danish State Medical Committee):

i) Where a clinical investigation is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking, and where the investigation will involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome, the sponsor must obtain an opinion from the applicable Danish State Medical Committee,

ii) Where a clinical investigation is to be conducted to assess, outside the scope of its intended purpose, a approval from the DKMA and the relevant Danish State Medical Committee must be obtained,

iii) Where a clinical investigation is carried out as part of the clinical evaluation for conformity assessment purposes, a approval from the DKMA and the relevant Danish State Medical Committee must be obtained, and

iv) For other clinical investigations not performed pursuant to the purposes mentioned above, the sponsor must obtain an opinion from the applicable Danish State Medical Committee.

Until the EU database Eudamed is available, the sponsor of a clinical investigation must submit its application directly to the Danish DKMA using the online format found on the DKMA’s website. The application can be submitted in Danish or English, except that certain documents must be submitted in Danish (a general abstract/summary for the investigation, the patient information and consent form, and other written information intended for the participants). The application must include, i.a., the clinical investigation plan, the investigator’s brochure, the subject information and informed consent form, statements certifying that the device complies with the essential requirements, a description of the intended use of the device, a copy of the approval from the research ethics committee, pictures of the device.

Marketing

Before a medical device may be placed on the market, the device must i) fulfil the requirements set out in the Executive Order on Medical Devices (i.e. requirements as to labelling, safety and performance), ii) be subject to an assessment of conformity, and iii) be CE marked.

For devices within class I, the manufacturer is responsible for the CE marking. For devices in classes IIa-III, a notified body must be involved in the certification. The purpose of the CE marking system is to ensure that the product meets the relevant EU requirements with regard to quality, safety and efficacy.

Other products

Natural medicinal products, herbal medicinal products and traditional herbal medicinal products

Natural medicinal products and traditional herbal medicinal products must be authorised or registered by the DKMA before they may be sold. Please see Chapter 4.

Vitamin and mineral products

Vitamin and mineral products are as a starting point not categorized as medicinal products. However, strong vitamin and mineral products where the content of vitamins and minerals are considerably higher than the normal daily requirement can be sold outside pharmacies in Denmark, provided they have been authorised by the DKMA. Such products may only be authorised to prevent and cure cases of deficiency.

When authorizing vitamin and mineral products, the DKMA sets out the same requirements as to manufacture, quality and safety as for natural medicinal products. Please see Chapter 4.

4. What are the approximate fees for each authorization?

Medicinal Products

The below is an excerpt of the overview of the current fees for new marketing authorizations and company registrations (2022):

TYPE OF PRODUCT	PROCEDURE	DELIMITATION	FEE (IN DKK)
Ordinary medicinal products (and vitamin and mineral preparations)	National	Fully documented application	196,559
	Decentralized	Fully documented application	273,346
	Mutual Recognition	Applications for new marketing authorization	28,096
Natural medicinal products (and herbal medicinal products)	National		83,605
	Decentralized		97,029
	Mutual Recognition		26,904

Separate fees are applicable for bibliographic applications, hybrid applications, analogues and generics, as well as for renewals and variations. Also, additional fees are applicable for applications for marketing authorizations and variations for companies outside the EU/EEA.

The following fees apply with respect to applications for authorization or registration of companies:

COMPANY AUTHORIZATIONS AND REGISTRATIONS	APPLICATION FEE (IN DKK)	ANNUAL FEE (IN DKK)
Authorization to manufacture and import medicinal products.	50,350	50,350
Authorization to wholesale distribution.	15,538	15,538
Authorization for retail sale of OTC medicinal products.	950	950
Authorization for retail sale of medicinal products for production animals.	48,425	0.065 per cent of the distributor’s total sale of medicinal products for production animals
API manufacturing.	50,350	50,350
API import and distribution.	15,538	15,538

Separate fees apply with respect to inspections conducted by the DKMA and for notification about prices.

Medical Devices

For companies that manufacture, import and distribute medical devices (as well as their EU representatives and stores specializing in medical devices), there are two applicable fees:

Registration fee for manufacturers and authorised representatives: DKK 1,188
Registration fee for importers and distributors: DKK 1,192

In addition to the registration fees, two annual fees will also be charged. These annual fees will depend on the number of employees of the company in question.

With regard to applications for clinical investigations for medicinal prod ucts, these are the current fees (2022):

Class I devices (non-implantable devices not intended for long term use): DKK 52,095
Class IIa devices (non-implantable devices not intended for long term use): DKK 52,095
Class IIb devices (non-implantable devices not intended for long term use): DKK 52,095
Class IIb devices (implantable devices and devices intended for long term use): DKK 70,017
Class III devices: DKK 70,017
Active implantable devices: DKK 70,017

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

Medicinal products

A marketing authorization for a medicinal product is valid for five years, subject to compliance with the requirements set out in the Danish Medicines Act. The DKMA may prolong the marketing authorization, if the risk/benefit analysis continues to be beneficial. The renewal application must be submitted at least nine months before the marketing authorization expires.

A prolonged marketing authorization is valid for an indefinite period of time (subject to compliance with the requirements set out in the Medicines Act), unless the DKMA specifically determines that the marketing authorization should only be prolonged for an additional five year period.

A marketing authorization will cease to be valid if not used for three consecutive years.

The renewal of a marketing authorization is subject to a fee payable to the DKMA.

Registration with the DKMA is also subject to annual fees. Please see Chapter 1, Question 4.

Medical devices

Registration with the DKMA for companies that manufacture, import and distributes medical devices (as well as their EU representatives and stores specializing in medical devices), is subject to annual fees.

6. How does the authorization process differ between brand- name products and generic products? Are there differences for local manufacturers versus foreign- owned manufacturers?

Generic products

As a starting point, the requirements for brand-name products and generic products are not different. However, an abridged procedure is available for marketing authorizations for generic medicinal products.

The Danish legislation implements the applicable EU directives on medicinal products, in including Directive 2001/83/EC on the Community code relating to medicinal products for human use. Consequently, the Danish rules on the abridged procedure correspond to Articles 10-10c of that Directive. This means, for example, that applicants will not be required to provide the results of pre-clinical tests and clinical trials if it is possible to demonstrate that the medicinal product is a generic of a reference medicinal product that is or has been authorised for not less than eight years in a country of the EU/EEA.

A company applying for an authorisation of a generic medicinal product must prove that i) the active substances is the same as that contained in the original product, ii) the manufacturer is able to manufacture the medicine in accordance with applicable requirements, and iii) that the right amount of the active substance goes to the place in the body where is has an effect.

Further, while the manufacturer of a generic medicine is not required to repeat animal and human trials, the applicant will still be required to provide data on bioequivalence studies to confirm that the medicine’s active ingredient is absorbed and excreted by the body in the same speed as the original product.

Foreign products

Only medicinal products that have been authorized by the DKMA or the European Commission may be marketed and/or dispensed in Denmark.

Denmark recognizes authorizations granted by the European Commission under the centralized procedure.

In addition, under the mutual recognition procedure, the DKMA generally recognizes authorizations granted by the regulatory authorities of other EU/EEA member states. Non-EU authorizations are not recognized.

The import of medicinal products or intermediate products from third countries requires a manufacturing and importation authorization because the import of medicines is considered a manufacturing activity. The Danish Medicines Act provides that applicants for and holders of marketing authorizations must be established in an EU/EEA country. However, the holder may designate a Danish representative.

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

The Danish Medicines Act does not apply to foodstuffs, dietary supplements, animal feed, cosmetics, biocides, radionuclides, or medical devices.

However, the Danish Medicines Act provides that where a product (based on an overall assessment of characteristics) may be comprised by both the definition of a medicinal product and by the definition of a product within another legislative area, and it is not immediately clear which legislation the product should be governed by, the DKMA may decide that the product in question is to be governed by the Danish Medicines Act.

8. How is compliance with regulations monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

Pharmacovigilance

The DKMA has a division for pharmacovigilance, which handles and analyses adverse reaction reports from citizens, healthcare professionals and the industry.

Healthcare professionals must report any suspected adverse reactions and serious adverse reactions to the DKMA within 15 days after such reactions have come to their attention. Patients, relatives and animal owners may also report adverse reactions on a voluntary basis.

Pharmaceutical companies (the marketing authorization holders) must have in place a system for pharmacovigilance, and must register, monitor and report side effects. A marketing authorization holder (of medicinal products for humans) must submit all suspected adverse reactions to the EudraVigilance database. The companies must also submit regular periodic safety updates to the DKMA (the periodic safety updates must be submitted through the PSUR Repository). A pharmaceutical company must also appoint a qualified person responsible for pharmacovigilance.

The DKMA maintains a register of reported adverse reactions, and must also report such adverse reactions to the EMA and other national authorities responsible for medicinal products in the other EU/EEA countries. Also, the DKMA must keep the marketing authorization holder informed.

As part of its pharmacovigilance system, the DKMA conducts scientific evaluations of the benefit-risk balance of the medicinal products based on the information submitted to it. The agency determines whether it is necessary to implement safety measures, and may also decide to change, suspend or withdraw a marketing authorization if the benefit-risk balance calls for it.

Inspections

The DKMA conducts routine inspections both with respect to pharmacovigilance, adverse reaction reporting and quality management.

The DKMA also inspects companies that have an authorization under Section 39 of the Danish Medicines Act (i.e. companies that are authorized to manufacture, import, export, store, resell, distribute, dispense, split and package medicinal products) for compliance with the Danish Medicines Act and the related Executive Orders. The frequency of such inspections is based on the DKMA’s risk assessment of the company’s activities. Certain changes in the company’s activities may also give rise to an inspection.

After an inspection, the DKMA prepares an inspection report describing any deviations.

The DKMA may also issue GMP and GDP certificates or statements of non-compliance based on the agency’s GMP and GDP inspections. GMP certificates will as a starting point be valid for three years and GDP certificates will as a starting point be valid for five years from the date of the inspection.

Medical devices

Incidents with respect to medical devices must also be reported to the DKMA (and to the Danish Patient Safety Database).

On the basis of incident reports received (e.g. from healthcare professionals, manufacturers, distributors and/or importers), the DKMA ensures that the necessary measures are being implemented.

9. What is the potential range of penalties for noncompliance?

Medicinal products

The DKMA may change, suspend or withdraw a marketing authorization, e.g. in case the benefit-risk ratio is not favourable, or in case the information stated by the applicant in support of the marketing authorization application is incorrect or if the marketing authorization holder fails to fulfil any terms of the marketing authorization.

The DKMA may also change, suspend or withdraw a company authorization granted pursuant to Section 39 of the Danish Medicines Act (i.e. authorization to manufacture, import, export, store, resell, distribute, dispense, split and package medicinal products, e.g. if the conditions for the authorization or the terms of the authorization are not complied with, or if the holder of the authorization refuses to participate in the DKMA’s inspections.

The DKMA may also issue prohibitions against sale and dispensing of a medicinal product, order that the product should be withdrawn from the market, or order the manufacture or import of a medicinal product.

Violation of the rules on marketing authorizations, on authorizations pursuant to Section 39, or failure to comply with orders issued by the DKMA is liable to a fine or imprisonment for up to 18 months.

Medical devices

In the event of non-compliance with the rules on medical devices, a notified body may limit, suspend or withdraw an issued certificate.

The DKMA may also restrict or prohibit the marketing or use of a medical device or order a medical device withdrawn from the market in case the DKMA finds that the medical device constitutes a risk for patients’, users’ and/or any third parties’ health and safety.

Violation of the rules may be subject to fines.

10. Is there a national healthcare system? If so, how is it administered and funded?

Denmark has a national healthcare system based on the principles of free and equal access to healthcare for all citizens. The system is funded mainly by the Danish tax-payers supported by a system of governmental block grants, reimbursements and equalization schemes.

The Danish healthcare system operates on three levels:

the national level (i.e. the state, where the Danish Ministry of Health is responsible for the overall framework of the healthcare system);
the regional level (Denmark is divided into five regions governed by regional councils, which are responsible for hospitals and health services provided by general practitioners and specialists in private practices); and
the local level (Denmark consists of 98 municipalities; in the healthcare area the municipalities are responsible for local health and elderly care services, including disease prevention, home nursing, school health services, children’s dental treatment, and nursing homes).

11. How does the government (or public) healthcare system function with private sector healthcare?

In Denmark citizens may, within certain limits, freely choose any public hospital (and some private hospitals). Denmark also has a number of private hospitals and health clinics where the citizens pay for treatment themselves.

If a Region cannot ensure that treatment will be initiated within 30 days, patients have the right to a so-called extended free choice of hospital (Danish: udvidet frit sygehusvalg).

Many Danish citizens also have health insurance covering expenses for private healthcare services.

Private payments are generally applicable for dental services, optometry, medicinal products, cosmetic surgery, etc.

12. Are prices of drugs and devices regulated and, if so, how?

Pricing in the primary sector

The company placing the medicinal product on the market must report a so-called pharmacy purchase price (Danish: Apoteksindkøbspris) to the DKMA at least 14 days prior to launch of the product. All prices are published on the DKMA’s website www.medicinpriser.dk. The prices can be changed every 14 day by notifying the DKMA.

In Denmark, pharmacies have the exclusive right to sell prescription-only medicinal products (and most over-the-counter medicinal products) to consumers. The medicines reserved for the exclusive sale in pharmacies are sold at the same price from all pharmacies and the pharmacies must charge the so-called pharmacy retail price (Danish: Forbrugerpris) when selling to consumers. The pharmacy retail price is calculated on the basis of the pharmacy purchase price and consist of the pharmacy purchase price, a retail margin and potentially different handling fees.

The prices for over-the-counter medicines that are not reserved for the exclusive sale in pharmacies are not specifically regulated, and the pharmacies and other authorised retailers are free to determine the prices.

Pricing in the secondary sector

Within the secondary sector (medicines for hospitals) the pharmacies at the public Danish hospitals are monitored by the five Danish Regions. The Danish Regions have established a wholesale distribution company, Amgros, which handles price negotiations, tendering and procurement of the majority of the medicine used at the Danish public hospitals.

For new medicines, the Danish Medicines Council issues recommendations with prioritized list of medicines to be used for patients with specific diseases. For the purpose of the recommendations, the Danish Medicines Council starts by conducting a health economic assessment. Based on this assessment, Amgros negotiates the price of the medicine with the applicant. After negotiations with the applicant, Amgros drafts a negotiation memo for the Danish Medicines Council detailing, i.a., the price level compare with the existing market. Based on this memo, the Danish Medicines Council decides whether it will recommend the medicine as a possible standard treatment at the public hospitals.

Further, we note that the Danish Association of the Pharmaceutical Industry on behalf of its members have entered into agreements with the Danish Ministry of Health and the Danish Regions which introduce so-called “price ceilings” for medicinal products used in the hospital sector and for medicinal products eligible for reimbursement. The current agreements will remain in effect until April 2023.

13. How are the drugs and devices used by patients paid for? What roles do public and private payers play?

In Denmark, the DKMA decides on the reimbursement status of each medicinal product. The cost of medicines eligible for reimbursement is funded by the state in the primary sector and by the Danish Regions in the secondary/hospital sector.

The DKMA determines which medicinal products that are eligible for reimbursement based on an application from the company placing a medicinal product on the market. The DKMA may determine that reimbursement should be conditional, e.g. on it being prescribed to certain patient groups or specific diseases.

There are three types of general reimbursement i) reimbursement for prescription-only medicinal products, ii)) conditional reimbursement for prescription-only medicinal products, and iii) conditional reimbursement for over-the-counter medicinal products.

In special cases, the DKMA may also grant individual reimbursement for individual patients. Such reimbursements are granted on the basis of an application from the patient’s doctor. The DKMA may also grant a reimbursement for the terminally ill.

The DKMA determines the annual reimbursement thresholds (i.e. the amount a person must spend on medicinal products within a 12 month period before being eligible for reimbursement), and the reimbursement price. The reimbursement thresholds and the reimbursement prices are used when calculating the applicable reimbursement rate and the amount of co-payment of the patient.

As a starting point, the reimbursement price is the same as the pharmacy retail price. However, the DKMA may establish so-called substitution groups/reimbursement groups of “synonymous” medicinal products with the same indication, same active ingredient, and comparable treatment effects (usually, the substitution groups consists of an originator/reference medicine, generic medicines and parallel imported medicines).The prerequisite for a generic product to be used for substitution with another product is that it is proven that the generic product releases the active substance in the body in the same quantity and the same rate as the original medicinal product – alternatively, it must be shown that the same effect can be achieve in patients with the same illness/symptoms. The pharmacies are required to dispense the least expensive product in a substitution group to the patient, unless the patient’s doctor has specifically stated that the prescribed product is not to be substituted or if the patient opposes the substitution. For medicinal products within a substitution group/reimbursement group, the applicable reimbursement price will be based on the cheapest medicinal product(s) in the group. The purpose of the system is to encourage patients to purchase the most inexpensive medicinal product available and to ensure effective price competition. The DKMA’s website www.medicinpriser.dk includes information on the price, substitution groups and reimbursement status of all authorised medicinal products.

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

In Denmark, as a starting point only licensed pharmacies have the right to sell and dispense prescription-only medicinal products (and most over-the-counter medicinal products) to consumers. However, hospitals and other healthcare institutions may dispense medicinal products to be used in treatment, and – subject to certain limitations – doctors, veterinarians and dentists are also permitted to dispense medicinal products for use in their own practice.

As described above in Question 2, all pharmacies must charge the same pharmacy retail price (Danish: Forbrugerpris) when selling to consumers. The pharmacy retail price is calculated on the basis of the pharmacy purchase price and consist of the pharmacy purchase price, a retail margin and potentially different handling fees.

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

In Denmark, pharmacies must be run by a private individual -a pharmacist- who has been licensed by the DKMA. The proprietary pharmacist must bear the economic, legal and professional responsibility for the operation of the pharmacy. Hospital pharmacies may also be established by the state or a regional council.

The pharmacists, and hospital pharmacies play a central role in providing patient care, information and safety. Pharmacists must, i.a., ensure access to medicinal products, report the authorities in case they receive or are offered falsified medicinal products, provide information on medicinal products, including on prices, and on the use and storage of medicinal products to consumers, healthcare professionals and authorities. Pharmacies must also ensure consumers are informed of their ability to report adverse reactions.

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