The ins and outs of regulatory reforms in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.
1. Are there proposals for reform or significant change to the healthcare system?
Clinical Trial Regulation
The aim of the Clinical Trial Regulation is to ensure greater harmonisation of the rules on clinical trials throughout the EU. To this end, it will introduce, i.a.:
- A more efficient application procedure for all clinical trials conducted in the EU via a single Clinical Trials Information System/database,
- A single authorization procedure for all clinical trials, to allow a more expedient assessment by all concerned EU member states,
- The extension of the silent agreement principle to the authorization process giving more legal certainty to sponsors and researchers, in particular SMEs and academics, and
- Strengthened transparency requirements for clinical trials data.
Medical Device Regulations
The European Commission has adopted and published two new EU regulations on medical devices:
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (“MDR”); and
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (“IVDR”).
The MDR will become applicable on 26 May 2021, and the IVDR will become applicable in May 2022. The purpose of the regulations is to bring EU legislation into line with technical advances, changes in medical science, and progress in law making. The regulations share largely the same basic regulatory requirements as the existing medical device directives, and no existing requirements have been removed. However, the regulations add new requirements and more stringent requirements, e.g. with respect to notified bodies, control and monitoring by national authorities, a wider scope of devices (e.g. reprocessed single-use medical devices and certain devices with no intended medical purpose), a new Unique Device Identification system, increased transparency, and the new European Database for Medical Devices (“EUDAMED”). Furthermore, the MDR also includes more clear obligations of the different actors (manufacturers, importers and distributors) and their relations.
In December 2020, the Danish Parliament passed a new act on Research Ethics Review of Clinical Investigations of Medical Devices, etc. (the “Act”), which includes new rules and amendments of existing rules on medical devices to ensure that Danish legislation is conform with Regulation (EU) 2017/745 (“MDR”).
The main new elements and consequences of the Act are:
- Pursuant to existing Danish legislation, clinical investigations of medical devices require approval from the Danish Medicines Agency and the competent regional research ethics committee. However, with introduction of the Act, two new state research medical ethics committees have been established, and the approval of clinical investigations of medical devices must in the future be conducted by these committees and not by the regional research ethics committees;
- The MDR entails that certain products without a medical purpose must be subject to the rules on medical devices. However, the existing Danish rules concerning medical products do not apply to products without a medical purpose. Therefore, the Act implies that several amendments to the existing Danish legislation on medical devices will be made with respect to devices without a medical purpose, e.g. with respect to registration of importers and distributors, manufacturers and EU-representatives, reporting on relationships between Danish companies and HCPs, advertising and marketing, clinical investigations, reporting of adverse events, etc.;
- Pursuant to existing Danish legislation, importers and distributors of medical devices are required to archive copies of all invoices related to medical devices marketed/delivered on the Danish market for 5 years (and for 15 years with respect to implantable medical devices). The copies must be made available to the Danish Medicines Agency upon request. As a result of the new requirements in the MDR on traceability in the supply chain of medical devices, the Danish requirements as to archiving of invoices will be abolished;
- Pursuant to existing Danish rules on medical devices, manufacturers (or their representatives) and importers and distributors of medical devices must report any malfunctioning, failures or deteriorations of medical devices and any inaccuracies in labelling or instructions for use (which may cause or may have caused a death of a patient or user or a serious deterioration of the health of such person) to the Danish Medicines Agency. With the implementation of the MDR (and once the new database EUDAMED is operational), manufacturers must report directly through the EUDAMED;
- The Act also amends the current rules concerning pharmaceutical companies’ and medical device companies’ affiliation/relationships with HCPs, as the group of companies that are subject to the affiliation rules will be expanded to include Danish representatives of non-Danish pharmaceutical and medical device companies. Further, the group of companies will be expanded to include manufacturers, importers and distributors of devices without an intended medical purpose;
- The Act also amends the current Danish rules on pharmaceutical companies’ and medical device companies’ financial benefits to HCPs and certain other individuals. The current rules stipulate that a recipient of financial benefits from a pharmaceutical company or a medical device company must report the financial benefits to the Danish Medicines Agency, and the provider of the financial benefit is subject to an obligation to inform the HCPs of their duty to report to the Danish Medicines Agency. The Act introduces a new requirement on the pharmaceutical companies and medical device companies to report to the Danish Medicines Agency when they offer and/or provide financial benefits to HCPs (and certain specialists engaging in the purchase and sale of medicinal products and medical devices) for participation in professional activities abroad and international congresses and conferences held in Denmark.
Several other legislative initiatives have been taken to ensure the Danish legislation on medical devices is adjusted to accommodate/conform to the MDR. A large number of executive orders related to medical devices have been sent for public hearing in March 2021 in light of the MDR, e.g. generally on medical devices and devices without a medical purpose; on importers and distributors of medical devices and devices without a medical purpose; on advertising of devices without a medical purpose; on affiliation between pharmaceutical and medical device companies and HCPs; and executive orders amending the existing executive orders on advertising of medicinal products and medical devices. Further, the Danish Medicines Agency’s guidelines related to medical devices, e.g. the guidelines for manufacturers, importers and distributors of medical devices, and the guidelines on labelling and instructions for use, have been sent for public consultation in March 2021.
2. When are they likely to come into force?
While the Clinical Trial Regulation entered into force in 2014, it has not yet become applicable. The delay is mainly due to the technical difficulties involved in the development of the single entry point database.
However, when the Clinical Trial Regulation becomes applicable, it will replace the existing EU Clinical Trial Directive (EC) No. 2001/20/EC and national legislation that was put in place to implement the Directive.
In Denmark, the parliament has already adopted a new act on clinical trials of medicinal products based on the Clinical Trial Regulation. The Danish act is intended to enter into force when the new EU Clinical Trial Regulation becomes effective. According to the EMA, the new regulation will most likely become applicable in 2020.
As mentioned above, the MDR will become applicable on 26 May 2021, and the IVDR will become applicable in May 2022. The new Act (on Research Ethics Review of Clinical Investigations of Medical Devices, etc.) will also become applicable on 26 May 2021.