The Danish Government has recently issued two executive orders relating to the supply of medical devices, personal protective equipment and disinfectants in connection with the management of COVID-19. The purpose of the issuance of the executive orders is to ensure sufficient supply of medical devices, personal protective equipment and disinfectants to regions, municipalities and hospitals. In order to reach this purpose, the executive orders introduce wide powers for the Danish Medicines Agency to impose extensive obligations on Danish companies.
In connection with the COVID-19 crisis the Danish government has issued (i) executive order no. 253 of 22 March 2020 on special measures relating to the supply of medical devices and personal protective equipment in connection with the management of COVID-19 (“Executive Order No. 253”)[1] and (ii) executive order no. 277 of 25 March 2020 on specific measures relating to the supply of disinfectants in connection with the management of COVID-19 (“Executive Order No. 277”)[2] (collectively the “Executive Orders”).
The Executive Orders are issued pursuant to section 12(f) of the Danish Act on Measures against Infectious and Other Transmittable Diseases (the “Act”). According to section 12(f) of the Act, the Minister of Health may in situations involving the spread or the danger of spread of a dangerous disease lay down rules on special measures to ensure the supply of goods. The penalties laid down in the Executive Orders are issued pursuant to 29(2) of the Act.
The Executive Orders include a “sunset clause” and as such they are only in force until 30 August 2020, unless extended. While the Executive Orders also lay down obligations on Danish private hospitals, general practitioners, dentists, regions and municipalities, this newsletter focuses on the obligations, which apply to Danish manufacturers, importers and distributors.
The Executive Orders lays down an obligation for Danish manufacturers, importers and distributors to report on the size of their stock and expected consumption of their stock of certain types of medical devices, personal protective equipment and disinfectants, if required by the Danish Medicines Agency. The Danish Medicines Agency can lay down requirements for the form and content of such reporting.
Under the Executive Orders, the Danish Medicines Agency can order Danish manufacturers, importers and distributors of medical devices, personal protective equipment and disinfectants to build up their stock for distribution to regions and municipalities. The Danish Medicines Agency has a right to lay down a more detailed framework, including scope and deadline, for when such stock shall be established.
Under the Executive Orders, the Danish Medicines agency can order Danish manufacturers, importers and distributors, to supply certain types of medical devices, personal protective equipment and disinfectants to regions and municipalities against payment from the region or the municipality. The Danish Medicines Agency has a right to decide the terms of payment and delivery.
The Danish Medicines Agency has already established a so-called ‘logistics center’ where municipalities and regions must register their holdings of i.e. gloves and protective masks. The reason for establishing such logistics center is for the Danish Medicines Agency to be able to get a comprehensive overview of the holdings of medical devices and personal protective equipment, but also to ensure that medical devices and personal protective equipment can be re-distributed between municipalities, regions or hospitals in the event of an acute shortage.
Even though not much guidance is available on the new Executive Orders, the issuance seem to be a further initiative in order for the Danish Medicines Agency to get a more comprehensive overview of Danish stock of medical devices, personal protective equipment and disinfectants to prepare for the care of the people infected with COVID-19 in Denmark. Furthermore, the Executive Orders leaves the Danish Medicines Agency with an option to order medical devices, personal protective equipment and/or disinfectants to be distributed from a Danish company to a region and/or a municipality if needed.
The obligation to report on current stock of medical devices, personal protective equipment as well as disinfectants, will be essential in order for the Danish Medicines Agency to be able to determine which manufacturers, importers and distributors will be able to and should (i) build up a stock of medical devices, personal protective equipment and/or disinfectants, and/or (ii) deliver current and/or future holdings of medical devices, personal protective equipment and/or disinfectants to a region or municipality in need. Manufacturers, importers and distributors will most likely receive notice to report on current stock of medical devices, personal protective equipment and/or disinfectants, before being asked to either build up stock or distribute their stock.
The obligation to build up stock of medical devices, personal protective equipment and/or disinfectants may include an obligation for Danish manufacturers to rearrange production to be able to produce such products. Many Danish companies have already voluntarily started production of i.e. disinfectants and personal protective equipment, but now the Danish Medicines Agency has legal authority to require additional Danish companies to do so.
Danish manufacturers, importers and distributors that receive a notice from the Danish Medicines Agency to either report on stock, build up stock or distribute stock of medical devices, personal protective equipment and/or disinfectants, should be aware that the Danish Medicines Agency has far-reaching powers under the Executive Orders to determine how such reporting shall be made, potential deadlines for when stock shall be in place or how the distribution shall be carried out, including terms of payment and delivery.
The Executive Orders are relevant for all Danish manufacturers, importers and distributors of medical devices, personal protective equipment and disinfectants.
The obligation to supply – upon request from the Danish Medicines Agency – certain types of medical devices, personal protective equipment and/or disinfectants to regions and municipalities applies to all Danish manufacturers, importers and distributors (i.e. not only to those which already produce or distribute personal protective equipment or disinfectants etc.). Accordingly, the Danish Medicines Agency has been granted broad legal powers to require, for instance, that device manufacturers supply personal protective equipment and/or disinfectants to regions and municipalities should this become necessary. However, in our assessment it is unlikely that the Danish Medicines Agency will use these powers to require a change in supply from companies, which do not already produce relevant medical devices, personal protective equipment or disinfectants.
If a person fails to comply with the Executive Orders, the person may be punished with fine or imprisonment. Non-compliance by legal entities may be punished with fine pursuant to the provisions of chapter 5 of the Danish Criminal Code. Accordingly, compliance with the Executive Orders is mandatory and non-compliance is punishable.
[1] Executive Order No. 235 can be found here (in Danish)
[2] Executive Order No. 277 can be found here (in Danish)