The Danish Parliament has passed a new Act which changes the rules governing pharmaceutical and medical device companies' collaboration with and financial benefits to healthcare professionals and certain other individuals. The changes will apply as from 26 May 2021.
Danish Act no. 1853 of 9 December 2020 on research ethics treatment of clinical trials of medical devices, etc. changes the rules governing pharmaceutical and medical device companies' collaboration with and financial benefits to healthcare professionals and certain other individuals (HCPs). This article outlines the changes from the companies' perspective.
Companies to report to the Danish Medicines Agency when providing financial benefits going forward
At present, Danish pharmaceutical and medical device companies established in Denmark have a duty to report to the Danish Medicines Agency (DKMA) about certain HCPs with whom the company are affiliated, for instance in the form of a collaboration agreement on the delivery of consultancy services.
In the future, companies will also have a duty to report to the DKMA when they offer or provide financial benefits to HCPs' (including certain specialists engaging in the buying and selling of medicinal products and medical devices) participation in professional activities abroad or international congresses and international conferences held in Denmark. Until now, only the recipient of the payment has had a duty to report to the DKMA about the financial benefit; whereas the company has been under an obligation to inform the HCP of his or her duty to report to the DKMA.
Certain specialists engaging in the buying and selling of medicinal products and medical devices include medico technicians and other professionals who offer commercial advice on and buy medicinal products outside pharmacies, including persons in the hospital sector, as well as owners of and senior staff of stores authorised to sell medical devices.
More companies are made subject to the affiliation rules
Going forward, the group of companies subject to the affiliation rules will also include representatives of non-Danish pharmaceutical and medical device companies. This is expected to extend the rules to an additional 100 Danish companies or so that are currently not subject to the rules because they do not have an independent marketing or company authorisation in Denmark.
Moreover, the regulated group of companies will also come to include a new category which manufactures, imports or distributes devices without an intended medical purpose, such as dermal fillers and implants intended for injection or placement in cheeks, chins, breasts or for other cosmetic purposes. The increased list of regulated companies is the result of Regulation (EU) 2017/745 of 5 April 2017 on medical devices (MDR). Current applicable law holds no rules on HCPs' affiliation with companies that deal in devices without an intended medical purpose. MDR implies that selected equipment without an intended medical purpose will become subject to medical device legislation and, accordingly, companies will become subject to the rules on affiliation and financial benefits, hospitality etc.
Adjustment of the requirement to apply for permission or notify about affiliations
The existing notification duty covers educational and research activities. These can by exemption be established without prior permission from the DKMA. The new rules extend the list of activities eligible for the notification exemption to include professional information. Furthermore, the DKMA is granted authority to add more activities to notification exemption as it sees fit. However, HCPs are only subject to the notification duty if they do not have a full-time employment at the company.
The rules governing stores specialised in the sale of medical devices will be amended to the effect that the stores will no longer be subject to a mere notification duty but will have to observe stricter rules and, in general, apply for permission and authorisation. Hence, the stores will be covered by the same rules as those applicable to pharmaceutical and medical device companies.
As stated above, the amendments take effect on 26 May 2021, but the Act stipulates a transitional arrangement for HCPs' duties.
The amendments provide increased transparency with regard to the industry's collaboration with HCPs and others. At the same time, by expanding the scope of the notification duty, the Act ensures that the administrative burden does not constitute an unnecessary obstacle which could deter HCPs from contributing to press coverage or professional training.
Parts of the industry would have wanted the rules on affiliation to include all companies with activities targeted at Denmark. However, only companies established in Denmark or with a permission from the DKMA are covered by the rules. One reason may probably be that the DKMA could face difficulties in monitoring for compliance and enforcing the rules against companies with no formal, regulatory connections to Denmark.
For more details on the legal amendments, click here.