In the following, we outline the significant initiatives of importance to the manufacturers and suppliers etc. of pharmaceutical products and medical devices.
1. Duty of disclosure and price fixing
Two new temporary executive orders, which both cease to exist on the 31 August 2020, have entered into force. The rules assign a series of wide-ranging capabilities to the Danish Medicines Agency (“DMA”), including issuing disclosure orders regarding the size of stock, orders to reduce stock as well as issuing orders to fix prices with a fixed percentage given by the DMA. Furthermore, the DMA is getting the opportunity to grant time-restricted authorisations to manufacture, sell etc. approved and non-approved medicinal products.
Please find the two regulations here and here (in Danish).
2. Fast-track approval of clinical trial investigations
As early as the 17 March 2020, the DMA informed of the launch of a fast-track procedure for processing applications for clinical trial investigations on medicinal products and vaccines for COVID-19, meaning that the processing time is reduced from 35 days to 3 days. On 20 March 2020, the DMA followed up with an updated instruction regarding the practical management of these trials, including the possibility of temporarily deviating from certain requirements for the conduction of clinical trials. The instruction can be read here.
3. Export of personal protective equipment (PPE)
As previously announced here, the EU Commission has adopted several measures which makes it possible for, during a time-limited period, limiting the export of certain types of medical devices (protective equipment) to countries outside the EU. The regulation means that a company, who wishes to export certain personal protective equipment, e.g. gloves, protective clothing and masks, must apply to the Danish Business Authority for an export license.
4. ”Denmark helps Denmark”
In order to prevent supply failure, the DMA has launched the campaign “Denmark helps Denmark”, where organisations, authorities, institutions and companies can join here if they have input or ideas on how to acquire additional protective equipment, tests and hand sanitizer etc. for the employees working in the healthcare system who are especially at risk. It is also possible to join if you as a company have a surplus of medical devices or hand sanitizer which can be donated to these purposes.
Furthermore, the DMA has requested the business and employer’s organisation “Dansk Industri” to coordinate a collaboration with the life science industry and the Danish Chamber of Commerce with a view to support a conversion of production of protective equipment. Companies able to convert their production are requested to get in contact.
LUNDGRENS OBSERVE
The new initiatives within life science and the medical industry - which in themselves have a spill-over effect on other businesses, who wants to convert the production to be able to contribute – are wide-ranging, numerous and complex. We advise companies to seek legal guidance before initiating work with new trials, conversion of production etc. with a view on ensuring own rights and freedom to operate in the best possible way.
For further questions, please do not hesitate to contact us.
Rasmus Vang
Email: rva@lundgrens.dk
Phone: +45 2628 9384
Emilie Lerstrøm
Email: eml@lundgrens.dk
Phone: +45 2615 8339
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