Life Science Update: September 2022

Denmark Update

Executive orders amended in light of IVDR

In light of the In Vitro Diagnostic Medical Devices Regulation ((EU) 2017/746) (IVDR), which came into force on 26 May 2022, the Danish Ministry of Health has amended a number of executive orders related to medical devices. The amended executive orders are intended to facilitate application of the IVDR in Denmark by supplementing the IVDR where required.

As a result of the amendments, many of the previous rules governing medical devices and in vitro diagnostic devices have been consolidated in a single executive order to ensure mutual consistency and make access to the executive orders easier. 

Moreover, the rules governing fees applying to importers and distributors that handle devices without a medical purpose have been repealed, as the Ministry of Health has become aware that, according to the Medical Devices Regulation ((EU) 2017/745) (MDR), these rules are not applicable in Denmark until six months after the European Commission has laid down a number of common specifications. 

Further, the rules exempting stores that are specialised in retail sale of medical devices have been repealed as the Ministry of Health has become aware that such retail sale conflicts with the European Commission's interpretation of the definition of a distributor under the MDR and IVDR. However, such stores will continue to be exempt from the rules on registration and fees to ensure that no additional burdens are imposed on retailers. 

The new Executive Order on medical devices and in vitro diagnostic devices is available here (in Danish).

Executive orders and guidelines on new 4-year pilot programme on reimbursement of medicines on a shared risk basis

In addition to the Bill introducing the new 4-year pilot programme on reimbursement of medicines based on shared risk, which was described in our Life Science Update of May 2022, new executive orders and guidelines on the pilot programme entered into force on 1 June 2022. 

The purpose of the pilot programme is i.a. to give patients easy access to reimbursement of prescription-only medicines, while allowing them faster and easier use of new innovative medicines, as well as to obtain experience with risk sharing in the Danish medicine reimbursement system. 

The new pilot programme increases the number of medicines involved from two to five. As the applications are treated on a first-come-first served basis, the first five medicines for which applications are filed with the Danish Medicines Agency will be comprised by the pilot programme if they meet the requirements for general reimbursement for prescription-only medicines on a shared risk basis.

The Bill is available here, the executive orders are available here and here, and the guidelines are available here (all in Danish).

New guidelines on variations of marketing authorisations for medicinal products for human use

On 15 September 2022, new guidelines on variations of marketing authorisations for medicinal products for human use were issued by the Danish Ministry of Health. The new guidelines were prompted by the new rules on variations of marketing authorisations for veterinary medicinal products in Regulation (EU) 2019/6 on veterinary medicinal products and the wish to separate the guidelines applying to human use products and veterinary products. Thus, the new guidelines will supplement the new guidelines no. 9259 on variations of marketing authorisations for veterinary medicinal products of 11 March 2022 and replace and update the existing combined guidelines no. 9846 of 24 November 2020 on variations of marketing authorisations.

The guidelines specify the rules on changes to marketing authorisations and offer practical instructions for special cases, e.g. where the name of a medicinal product is changed.

The new guidelines are available here (in Danish).

Revised practice codes and guidelines on promotion, donations, patient organisations and lobbying as well as penalties and fees regulations related to medicinal products

The Ethical Committee for the Pharmaceutical Industry in Denmark ("ENLI") has adopted four revised practice codes and guidelines on promotion, donations, patient organisations and lobbying as well as penalties and fees regulations related to medicinal products. The new codes and guidelines are available on ENLI's website. 

The amendments are i.a. prompted by the revised guidelines on the Danish Executive Order on Advertisement of Medicinal Products (in Danish) published by the Danish Medicines Agency. 

The amendments are mainly minor linguistic adjustments to the practice codes and the addition of a "rule box" for each provision in all guidelines, so that it is possible to read the provision in question together with the relevant guideline. All amendments have been described in further detail in ENLI's newsletter of 14 June 2022 (in Danish). 

Nordic criteria for more sustainable healthcare products

To take better care of the environment and climate, Danish Regions have, in collaboration with stakeholders responsible for public procurement in Norway, Sweden, Iceland and the Faroe Islands, launched the new Nordic Criteria for More Sustainable Packaging for Healthcare Products of March 2022. 

The criteria aim to reduce climate and environmental impacts of packaging used for products that are sold to the healthcare sector by encouraging manufacturers and suppliers to reduce waste by designing reusable packaging, using materials from sustainable sources, and considering whether packaging is necessary for each specific product.

All five Danish regions have included the criteria in the tender material in connection with their first hospital procurement processes and so have several Nordic public procurement organisations. The industry association for medical device companies in Denmark, Medicoindustrien, takes part in ongoing discussions to optimize environmental benefits and supports the initiative.

The Nordic Criteria for More Sustainable Packaging for Healthcare Products are available here.

The Danish government launches new digitization strategy

In May 2022, the Danish government presented a new digitization strategy to enhance the digital infrastructure in the Danish public sector. Especially one of the visions of the strategy - "The digital healthcare of the future" - may have an impact on the life science sector. It seeks to address the challenges of labour shortage and changing demography with more elderly people and people with multiple diseases by introducing digital solutions to reduce pressure on the Danish healthcare system.

The strategy aims to implement and further develop existing technology into the healthcare of the future. This includes the use of so-called tele-medic solutions and patient reported information, which may contribute to a better utilization of resources. Furthermore, the use of video consultations may help promote geographical equality throughout the healthcare system. Moreover, the strategy suggests making use of AI-based solutions to create a more flexible and efficient frame-work for provision of healthcare services.

Read more about the new digitization strategy here and here (both in Danish).

Danish Regions and the Confederation of Danish Industry propose new private-public foundation

Danish Regions and the Confederation of Danish Industry have proposed to establish a new private-public foundation, the so-called "Technology Foundation for a Healthier Denmark". The purpose of the new foundation is to ensure the development and use of new health technology in order to give citizens easy and equal access to prevention and high-quality treatment of illnesses across Denmark despite the increasing shortage of labour. The hope is that this new technology - in addition to being useful in Denmark - can be exported to the rest of the world that also faces major demographic healthcare challenges.

The foundation, which aims at enhancing cooperation between public and private actors, will be financed by other foundations and pension funds. Moreover, Danish Regions and the Confederation of Danish Industry hope to receive a considerable economic contribution to the foundation from the Danish government.

The foundation is established as an independent body with a competent and experienced management, which will facilitate development projects in order to solve major challenges in the healthcare system without political interference. For a project to qualify for funding from the foundation, it must include a labour-saving element.

Read more about the proposed foundation here (in Danish).

EU Update

European Commission proposes new regulation on standards of quality and safety for substances of human origin intended for human application ("SoHO") 

On 14 July 2022, the European Commission published a draft regulation on standards of quality and safety for substanc-es of human origin intended for human application ("SoHO") intended to harmonize and revise the legal framework for blood, tissues and cells by repealing the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC). 

The proposal is based on the existing legal framework and reflects the same basic principles, allowing member states full decision-making powers in organizational and ethical matters in connection with the provision of SoHO-based treatments. The general principle of voluntary and unpaid donation is upheld. However, the proposal also contains a number of important changes as described below.

By making a proposal for a regulation instead of renewed and updated directives, the Commission seeks to harmonize the regulation on the use of substances of human origin across member states. To this end, the Commission will set up an advisory body to support member states in implementing the regulation and thereby reduce disparities across the EU. Moreover, the scope of application will be largely extended, since the proposed regulation covers all substances of human origin with the exception of solid organs for transplantation, which will continue to be regulated separately under Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation. 

Another significant change concerns the preparation and handling of SoHO substances. Firstly, it is proposed to introduce technical standards for the preparation and treatments in order to ensure patients' safety. Secondly, it is proposed that an entity whose activities affect the safety and quality of SoHO, which includes processing and storage, must register with the national competent authority. Finally, the proposal provides for the creation of a digital platform at EU level with data on i.a. donations, clinical use, and possible adverse reactions. The platform is to facilitate easier data exchange and statistics to the benefit of various SoHO stakeholders. 

The public consultation period ended on 8 September 2022, and the European Parliament and Council will now discuss the proposal. If adopted, the regulation will come into force after a transition period of either 2 or 3 years.

Read the European Commission's press release here and read the new proposal here.

European Commission has laid down common specifications for certain class D in vitro diagnostic medical devices 

On 4 July 2022, the European Commission adopted Implementing Regulation (EU) 2022/1107 in accordance with Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The Implementing Regulation lays down common specifications for some types of class D, i.e. high-risk in vitro diagnostic medical devices.

The Implementing Regulation covers devices for detecting and/or quantifying human immunodeficiency virus (HIV), human T-call lymphotropic virus (HTLV), hepatitis B, C and D, variant Creutzfeldt-Jakob disease (vCJD), cytomegalovirus (CMV), Epstein-Barr virus (EBV), Treponema pallidum (syphilis), Trypanosoma cruzi (Chagas disease) and SARS-CoV-2, as well as for determining blood group antigens in the ABO, Rhesus, Kell, Kidd and Duffy blood groups. For these devices, the Implementing Regulation sets high and uniform requirements for device performance across the EU. 

To allow manufacturers of such devices to adapt to the new requirements, the Implementing Regulation will not apply until 25 July 2024. From 25 July 2022 to 25 July 2024, marketed devices that conform with the common technical specifications set out in Decision 2002/364/EC are presumed to be in conformity with the requirements regarding the performance characteristics set out in section 9.1 of Annex I to Regulation (EU) 2017/746. However, manufacturers of marketed devices that are not in conformity with the common specifications must duly justify that the level of safety and performance is at least equivalent to that of the common specifications. 

Read more about the initiative on the Commission's website here and read the Implementing Regulation here.

The European Commission launches public consultation for EU Global Health Strategy

On 4 July 2022, the European Commission launched a public consultation and call for evidence on the new EU Global Health Strategy. The strategy will address the gaps in global health society shown by the COVID-19 pandemic by strengthening pandemic preparedness and response across the world. Further, the new EU Global Health Strategy will contribute to reaching the Sustainable Development Goals and be better prepared through reinforced partnerships.

The consultation will remain open for 12 weeks from 4 July 2022. Read more here.