Life Science Update: November 2021

Denmark Update

Proposed amendment to the Danish act introducing a Medicinal Cannabis Pilot Programme

On 7 October 2021, the Danish Minister for Health presented the proposed amendment to the Act introducing a Medicinal Cannabis Pilot Programme which was published for consultation on 7 July 2021 (as described in our first edition Life Science Update). The proposed amendment will enter into force on 1 January 2022.

The main elements of the proposal are the following:

• The current Medicinal Cannabis Pilot Programme allowing doctors to prescribe products containing medicinal cannabis to patients will be extended by four years, i.e. until 31 December 2025.
• The current possibility for companies to obtain a license to cultivate and manufacture medicinal cannabis products in Denmark e.g. for purposes of export will be made permanent.
• The rules on reimbursement of patients' expenses for medicinal cannabis products will be replaced by an authorisation for the Minister for Health to regulate patients' reimbursement through executive legislation.
• Medicinal cannabis companies manufacturing intermediate cannabis products will be required to include in the product packing an appropriate measuring device if there are no existing measuring devices on the market.
• A number of provisions authorising the Minister for Health to introduce executive legislation on technical features will be transferred to the Danish Medicines Agency.

The proposal can be found here (in Danish).

New 2-year pilot programme for digital retention samples of repackaged, parallel imported medicine 

On 1 October 2021, the Danish Medicines Agency introduced a new 2-year pilot programme allowing parallel importers to provide retention samples digitally in the form of high-quality photos or a 3D digital presentation of the medicine after repackaging instead of an actual physical sample.

However, the digital retention sample must meet the following requirements:

• The digital retention sample must comprise all sides of the package and both inner and outer packaging. The batch number and expiration date must be clearly visible on the sample.
• The competent person must include the digital sample as part of the release process.
• The digital sample must be accessible throughout the entire retention period, have a time stamp and be stored in an access-controlled system that protects against alteration and deletion (validated according to a requirements specification).
• A written procedure on the taking of digital samples must be prepared and saved.
• A piece of the packaging material that constitutes the repackaging must accompany the batch/repackaging journal.
• One physical retention sample (as per the current requirements) must be taken for each medicine from each country of origin from the first time the medicine is repackaged. The sample must be kept until the medicine is no longer parallel imported.

A more detailed description of the pilot programme can be found here (in Danish).

Updated guidance on implementation of decentral elements in clinical trials

The Danish Medicines Agency has revised its guidance on the implementation of decentral elements in clinical trials with medicinal products in a number of ways, including with regard to data integrity, prevention of system breakdowns, contracts, record-keeping obligations, renewed requirements for applications and the new possibility of verifying source data remotely by implementing Remote Source Data Verification (rSDV) processes.

The updated guidance was published on 10 September 2021 and can be found here (in Danish).

Proposed amendment to the Danish Act on Clinical Trials with Medicine etc.

On 13 October 2021, the Danish Ministry of Health launched a public consultation on a proposal to amend the Danish Act on Clinical Trials with Medicine. The Act was adopted in 2016 but has not yet come into force. The proposal aims at ensuring compliance with the Clinical Trials Regulation (Regulation (EU) No 536/2014), which will enter into force on 31 January 2022, and with other Danish acts which have entered into force since 2016. The proposed amendments are of a purely technical character, clarifying uncertainties in the national law without changing the state of the law. The proposed amendments are suggested to come into force at the same time as the Regulation, i.e. on 31 January 2022.

The proposal can be found here (in Danish).

Re-evaluation of recommendations to include data on life quality with effect from 1 June 2022

The Danish Medicines Council (DMC) provides guidance on new medicines for use in the Danish hospital sector. Its recommendations are used by healthcare professionals when deciding on form of treatment and medicine for their patients. 

Since January 2021, the DMC has systemically included data on the patient's life quality in its assessment of the value of a medicinal product by using the Quality-Adjusted Life Year (QALY) method. QALY is a standardized measurement which provides a number based on the patients' life quality and survival.

The DMC has announced that from 1 June 2022, it will also base any reassessments of the recommendations that become relevant because of new substantial data or significantly lower prices on the QALY method regardless of when the recommendation was first made.

The announcement of 8 September 2021 can be found here (in Danish).

Danish national partnership for health data has started its work

The partnership, which includes all relevant operators that handle health data, including data controlling authorities, regions, municipalities, universities, healthcare organisations, patient associations and trade organisations within the life science industry, was created as part of the Danish Government's life science strategy presented in April 2021. 

The partnership started its work on 30 August 2021 and has as its overall objective to improve innovation, research and development within the life science and healthcare sectors. The members of the partnership will share knowledge and experience in relation to the use of health data and discuss needs, challenges and possible initiatives for better use of data without compromising individual's right to confidentiality and privacy.

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

Proposal to make temporary tax deduction scheme for research and development activities permanent

As part of its new policy programme for the next 10 years, the Danish Government has proposed to make the current temporary tax deduction scheme permanent. The scheme allows businesses to deduct R&D expenses by 130% up to a maximum of DKK 50 million. 

The life science industry in Denmark is responsible for approximately 33% of all private investments in R&D activities. 

The full policy programme was published on 7 September 2021 and can be found here (in Danish).

Political agreement on public funding of research in 2022

A political agreement (in Danish) on distribution of the almost DKK 3 billion research funds pool in 2022 has been reached. In total, DKK 430 million of the pool have been earmarked for life science, health and clinical research. Of these, DKK 300 million will be spent on life science, health and welfare technology to be administered by the Innovation Fund Denmark. It is stated in the agreement that the research may contribute to the development of customised medicine, development of digital healthcare, including in the health data area, artificial intelligence, digital preventive and treatment offers for people with mental diseases, and knowledge about use of medicinal cannabis. The remaining DKK 130 million will be spent on strengthening clinical and independent research, including in areas of little commercial interest, to be administered by the Independent Research Fund Denmark. According to the agreement, the funds may e.g. be spent on patients suffering from chronic or mental diseases and on measures to combat loneliness, health inequality and infertility.

The political agreement of 28 October 2021 can be found here (in Danish)

EU and UK Update

European Commission proposal for progressive roll-out of the IVDR

The European Commission has proposed an amendment to the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746) (IVDR) for purposes of changing the transitional provisions to allow for a progressive roll-out. The amendment is intended to prevent a bottleneck situation when the IVDR enters into force and thus prevent disruption in the supply of essential medical devices. It is feared that this may be the consequence of the increased involvement of notified bodies. Currently, only a small number of designated notified bodies under the new Regulation exist. It is estimated that around 80% of in vitro diagnostic medical devices will be under the control of a notified body under the IVDR - against approx. 8% under the current legislation.

The progressive roll-out will extend the transition period, depending on the classification (and thus the risk assessment) of the device. According to the proposal, the following transition 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 proposal was presented on 14 October 2021. The full text is available here.

Reform of EU's general pharmaceutical legislation

As part of the European Commission's plan to review and reform existing pharmaceutical legislation on medicines for human use as presented in the Pharmaceutical Strategy for Europe in November 2020, the Commission has launched a public consultation to seek the views of stakeholders and the general public. The Commission works toward ensuring a future-proof and crisis-resistant medicines regulatory system.

The consultation builds further on the public consultation conducted before preparation of the Pharmaceutical Strategy for Europe. The reform strategy has the following four main goals:

1. to ensure access to affordable medicines for patients and addressing unmet medical needs;
2. to support competitiveness, innovation and sustainability of the pharmaceutical industry in EU and the development of high quality, safe, effective and greener medicine;
3. to enhance crisis preparedness and response mechanisms and address security of supply issues; and
4. to ensure a strong EU voice in the world by promoting a high level of quality, efficacy, and safety standards. 

The consultation, which can be found here, was launched on 28 September 2021 and will continue until 21 December 2021. The European Commission's press release regarding the consultation can be found here. The actual proposal for revision of the current legislation is expected to be presented around year-end of 2022. More information on the reform strategy can be found here.

EU measures to enhance health emergency preparedness and response

On 16 September 2021, the European Commission published a Commission Decision to establish the Health Emergency Preparedness and Response Authority (HERA) for purposes of improving preparedness and responding to serious cross-border threats. The HERA will conduct and support advanced R&D for medical countermeasures, boost industrial capacity and strengthen knowledge and skills. This will be done through collaboration with relevant stakeholders, including national authorities, global partners as well as stakeholders from the industry. In addition, an Advisory Forum will be established with external stakeholders (appointed by the Member States) from the industry, academia and civil society.

The Decision can be found here.

The Commission has also published a proposal for Council Regulation on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level on 16 September 2021. The measures contained in the Regulation include, amongst other:

• activation of emergency research and innovation plans, including the use of union wide clinical trial networks and data sharing platforms;
• emergency funding and financing;
• measures concerning the production, availability and supply of crisis-relevant medical countermeasures, including the establishment of relevant inventories and measures aimed at increasing their production in the EU.

The proposal can be found here.

Finally, on 28 October 2021 the European Parliament and Council reached a provisional agreement to make the European Medicines Agency (EMA) more effective in tackling shortages of medicines and medical devices. As part thereof, two "shortages steering groups" for medicines and medical devices, respectively, will be set up to strengthen the EMA's capacity to manage the availability of such products.

The press release from the European Commission can be found here. The actual proposal to strengthen the mandate of the EMA, which was set forth on 11 November 2020, can be found here. The Regulation will have to be formally adopted by the Council and the European Parliament before it can enter into force.

Consultation on future medical device regulation published in the UK

Following Brexit, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) is looking into revising the current legislation on medical devices. As a first step, the MHRA has launched a public consultation on future medical device legislation in the United Kingdom. The consultation is comprehensive and covers a broad range of regulatory issues, including requirements for clinical investigations, assessment of devices before being placed on the market, importer and distributor obligations, post-market surveillance, transparency, the role of patients, etc.

The consultation paper was published on 16 September 2021 and can be found here.

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