Life Science Update: February 2022

Denmark Update

Proposal to allow mentioning of serious illnesses in medical device advertising 

On 31 January 2022, the Danish Ministry of Health published for consultation a proposal for amendment of the executive order on advertising etc. of medical devices, which currently prohibits the mentioning of serious illnesses in advertisements for medical devices. The purpose of the proposed amendment is to provide the Danish Medicines Agency (DMA) with a right to allow the mentioning of serious illnesses in advertisements for medical devices in extraordinary cases where it is deemed appropriate for public health considerations (e.g. in case of a pandemic). 

The deadline for providing comments on the proposed amendment was 14 February 2022. 

The proposal can be found here (in Danish). 

Proposal for guidelines on advertisement of veterinary medicines and updated guidelines on advertisement of medicinal products for humans

Following the new provisions on advertisement of veterinary medicines in the new Veterinary Medicines Regulation (Regula-tion (EU) 2019/6), the Danish Medicines Act and the Danish executive order on advertisement etc. for veterinary medicines which entered into force on 28 January 2022, the Danish Ministry of Health has published for consultation a proposal for two separate guidelines on i) advertisement of veterinary medicines and ii) advertisement of medicinal products for human use. These guidelines will replace the combined guideline on the subjects currently in force (no. 10356 of 29 December 2014 on advertising of medicinal products). 

Apart from the provisions on advertisement for veterinary medicines that are omitted, the proposed guideline contains new sections on i.a. the following: 

• The definition of advertising.
• Advertising for medicinal products on the internet and social media.
• Vaccination campaigns.
• Compulsory texts.
• Documentation requirements.
• Payment for advertising space.
• Financial benefits for patient associations, health professionals and other professionals.
• Advertisement for medicinal products at international congresses and conferences in Denmark. 
• Dispensing samples of medicinal products.    

The proposed guidelines can be found here and here (in Danish).

Proposal to adjust Danish legislation in light of the IVDR

On 12 January 2022, the Danish Ministry of Health published for consultation a legislative proposal to adjust relevant Danish legislation in light of the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), but without "goldplating", i.e. going beyond the IVDR provisions.

The IVDR will enter into force on 26 May 2022 and will i.a. introduce a new risk classification system, stricter requirements for clinical evidence and a requirement that member states must approve certain types of applications from manufacturers before they may initiate performance studies of in vitro diagnostic medical devices. 

The Danish legislative proposal establishes a legal basis for stipulating requirements for:

• Granting approvals to conduct performance studies. 
• Reporting serious adverse events. 
• Notifying the Danish Medicines Agency (DMA) of any cessations or terminations of performance studies.
• Performing scientific ethical reviews of performance studies of in vitro diagnostic medical devices in connection with applications for approval to conduct such studies.  

Moreover, the proposal specifies and creates a clearer legal basis for the DMA's surveillance powers for medical devices.

The proposal can be found here (in Danish).  

Extension of Danish Medicinal Cannabis Pilot Programme 

At the beginning of December 2021, the Danish Parliament voted in favour of implementing the legislative proposals (L 44 A and L 44 B (in Danish)) to amend the Act Introducing a Medicinal Cannabis Pilot Programme. The legislative proposals ex-tend the Medicinal Cannabis Pilot Programme for a period of four years from 1 January 2022 until 31 December 2025. 

The continuation of the Pilot Programme entails the following:

• That doctors may continuously prescribe products containing medicinal cannabis to patients.
• That the scheme for companies to obtain a licence to cultivate, manufacture and export medicinal cannabis prod-ucts in and from Denmark will be made permanent.
• That the authorisations issued pursuant to the previous Pilot Programme must be reissued. 

In addition, a new executive order on the labeling of cannabis products entails that companies must be aware of using the updated product sheet and template for patient information sheets when applying for registration of their products. 

The Danish Ministry of Health will evaluate the Pilot Programme once again before the end of 2024. 

More information on the Pilot Programme can be found in our first edition of Life Science Update.  

Danish research tax deduction scheme made permanent 

The temporary research tax deduction scheme has been made permanent by virtue of a political agreement with the Danish Government of 21 January 2022. The scheme serves as a research and development (R&D) tax incentive for companies that now may deduct R&D expenses by 130% up to a maximum of DKK 50 million. 

Note that the incentive scheme will enter into force when the political parties to the agreement have decided on the necessary funding measures of the scheme.

More information on the tax deduction scheme can be found in our second edition of Life Science Update. 

The political agreement on the tax deduction scheme can be found here (in Danish). 

The Danish Government presents new Life Science Council 

On 16 December 2021, the Danish Minister for Industry, Business and Financial Affairs introduced a new Life Science Council. The Council was established in connection with the Danish Government's life science strategy presented in April 2021, which aims at securing a world class life science industry in Denmark.

The purpose of the Council is to enhance innovation and development by strengthening cooperation between the private and public actors in the life science sector. The Council consists of 20 members from both the national healthcare system and the life science industry. It is the intention that the Council will meet twice a year to discuss the framework for the life science industry and examine how the industry can create better patient care in the national healthcare system.

More information on the Council can be found here (in Danish). 

EU Update

Clinical Trials Regulation in force 

The Clinical Trials Regulation (Regulation (EU) No 536/2014), applying to clinical trials of medicinal products for human use, entered into force on 31 January 2022.

The Regulation aims to ensure that the EU offers an attractive and favourable environment for carrying out clinical research on a large scale. It introduces a number of new requirements regarding application, deadlines, and communications with the competent authorities and ethics committees, and builds on the same central principles of good clinical practice as the current Directive (2001/20/EC) on good clinical practice in the conduct of clinical trials on medicinal products for human use. 

According to the Regulation, and in order to harmonise and streamline the processes for application and supervision of clinical trials throughout the EU, all clinical applications for trials with medicinal products in humans (as well as amendments and other changes to ongoing clinical trials) must be submitted through a new Clinical Trial Information System (CTIS). 

During a transitional period, applicants may still apply for clinical trials based on the former legislation. Moreover, if an ongoing clinical trial has not been completed before 31 January 2025, the clinical trial must be transferred to the new Regulation. 

Information on amendments to the Danish legislation on clinical trials resulting from the Clinical Trials Regulation can be found in our second edition of Life Science Update.

The Clinical Trials Regulation can be found here, and the European Commission's Q&A on the Regulation of January 2022 can be found here.

New transitional provisions for IVD 

New transitional provisions for in vitro diagnostic medical devices (IVD) were published in the Official Journal for the Europe-an Union in (Regulation (EU) 2022/112) on 28 January 2022. The purpose of these transitional provisions is to allow for a progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). 

The progressive roll-out extends the transitional periods applying to the medical devices depending on their risk classification.

According to the new provisions, the following end dates for the transitional periods will apply: 

• Class D devices: 26 May 2025 
• Class C devices: 26 May 2026 
• Class B devices: 26 May 2027 
• Class A devices: 26 May 2027 (if placed on the market in sterile condition) 

The new transitional provisions also apply to devices that are manufactured and used internally at health institutions to address the specific needs of target patient groups (i.e. in house-devices).

More information on the transitional periods can be found in our second edition of Life Science Update.

The new transitional provisions can be found here.

EMA in a reinforced role 

On 25 January 2021, the European Parliament and Council adopted the Regulation on a reinforced role for the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices (Regulation (EU) 2022/123).

The Regulation aims to ensure a high level of protection of human health by ensuring the smooth functioning of the internal market in relation to medicinal products and medical devices. Moreover, the new rules will enable the EMA to closely monitor and remedy deficiencies in medicines and medical devices, particularly during health emergencies and major events. 

 The EMA will facilitate the following: 

• Monitor and remedy the risk of critical medicinal products and medical devices.
• Promote a faster approval of medicines that can treat or prevent diseases that may cause a public health crisis.
• Provide scientific advice on medicinal products that may have a potential to treat, prevent or diagnose the diseases that cause a crisis.
• Coordinate studies and clinical trials to monitor the effect and safety of medicines for the treatment, prevention or diagnosis of diseases related to the public health crisis.

The Regulation can be found here. 

New EU-wide framework for health technology assessment

On 15 December 2021, the European Parliament and the Council adopted the Regulation (EU) 2021/2282 on health technology assessment. The Regulation establishes a framework and procedures for cooperation between member states in relation to health technology at Union level and shall apply from 12 January 2025.

The Regulation sets up a mechanism determining that any information, data, analyses and other evidence required for the joint clinical assessment of health technology should be submitted only once at Union level by the health technology developer.

The Regulation can be found here. 

New Regulation on electronic instructions for MDR-covered devices

On 14 December 2021, the European Commission adopted the Implementing Regulation (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 (MDR) as regards electronic instructions for use of medical devices. 

The main elements of the Implementing Regulation are the following:  

• The Regulation extends the scope of the definition of "instructions for use in electronic form" for medical devices to cover medical devices made available through a software or a website. 
• The electronic instruction shall be subject to a specific risk assessment by the manufacturer.
• All manufacturers must clearly inform the users that the instructions for use of the device is supplied in an electronic form instead of in paper form. If the instructions are available through a software, the information communicated to the users must be provided at the location from where access to the software is granted.

The Implementing Regulation can be found here.

Regulation on the EUDAMED 

On 26 November 2021, the European Commission published an Implementing Regulation laying down rules for the application of Regulation (EU) No 2017/745 on medical devices (MDR) as regards the European Database on Medical Devices (EUDAMED) (Regulation (EU) No 2021/2078). The Implementing Regulation stipulates the detailed arrangements that are necessary for establishing and maintaining the EUDAMED, which is intended to provide a living picture of the lifecycle of medical devices that are made available in the EU, and to enhance overall transparency. 

The Implementing Regulation governs the following:

• EUDAMED accessibility with the purpose of allowing data exchanges between European and national databases.
• Technical and administrative support from the European Commission to promptly assist EUDAMED users.
• Measures which the European Commission must adopt in case EUDAMED ceases to function. 

The Implementing Regulation can be found here.