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 USD 99.
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 requiring and/or encouraging localization in Denmark. However, there are certain requirements as to registration with and/or authorisation from the Danish Medicines Agency (“DKMA”).
Pursuant to Section 39 of the Danish Medicines Act (Act no. 99 of 16 January 2018), 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).
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.
In order to initiate and conduct a clinical trial involving humans, 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.
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.
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 bit 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). For companies outside the EU/EEA must have an authorised representative within the EU/EEA.
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.