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Print articleAmendment of the Rules on Affiliation and Financial Support for Healthcare Professionals
March, 2021 - Mikkel Vittrup, Michala Kragmann
In connection with the adoption of a new law on the ethical treatment of clinical trials of medical devices, the Folketing has made a number of changes to the rules on the affiliation and financial support of pharmaceutical and medical companies to healthcare professionals. The amendments will enter into force on 26 May 2021. Companies should be aware of these changes, including those mentioned below, as they involve a change in the circle of covered companies and in the obligation to notify or apply for a permit.
Wider circle of companies subject to the rules
Until now, a pharmaceutical company has been covered by the affiliation rules and the rules on financial support if the company was the holder of a marketing or business license. With the changes, the group of covered pharmaceutical companies will be expanded to also include Danish representatives of foreign pharmaceutical companies. It is expected that the expansion in practice will mean that another 100 Danish companies will be covered by the rules.The circle of covered companies is further extended to include a limited group of companies that manufacture, import or distribute equipment without a medical purpose - that is, so-called aesthetic products such as contact lenses without corrective function, equipment for liposuction and implants for cosmetic purposes. This extension is a consequence of the new EU rules on medical devices, which means that selected products without a medical purpose will in future be regulated as medical devices.
Obligation to report financial support
According to the current rules, pharmaceutical and medico companies established in Denmark are obliged to inform the Danish Medicines Agency once a year which healthcare professionals are affiliated with the company. Under the new rules, companies must also notify the Danish Medicines Agency once a year if they provide financial support for healthcare professionals' (and certain professionals from the purchasing and sales stages for medical devices) participation in profession-relevant activities abroad or international and professional congresses and international conferences. which is held in Denmark.Certain professionals from the buying and selling stages are understood to be medical technicians and other persons who professionally advise on and purchase medical equipment, including persons from the hospital sector, as well as owners and senior employees in stores that sell medical equipment.
The requirement to report applies in parallel with the requirement that pharmaceutical and medicinal companies must inform healthcare professionals of their independent duty to i) notify certain forms of financial support and ii) to notify or apply for a license to be associated with pharmaceutical and medicinal companies.
Change in the affiliation rules' requirements for permission or notification
According to the current rules, affiliation in the form of healthcare professionals' assistance with the preparation of professional information requires prior permission from the Danish Medicines Agency. With the changes in the law, this type of affiliation - in line with teaching and research - will only require prior notification. Assistance with the preparation of professional information may, among other things, consist of contributions to press coverage and questionnaire surveys. The Danish Medicines Agency will also have access to take a position on which tasks constitute "teaching, professional information and research", as well as authority to, by executive order, include several types of tasks in the notification scheme.The changed rules also mean that healthcare professionals with full-time employment in a company covered by the rules for affiliation and financial support must apply for a permit from the Danish Medicines Agency if they wish to carry out clinical work outside the company.
In addition, the rules for doctors' affiliation with specialist shops with medical equipment will be changed from constituting a pure notification scheme, as is the case today, to a stricter scheme with a permit requirement in the future. The rules will thus be the same as for doctors' affiliation with pharmaceutical and medical companies.
Our comments
The amended rules implement a number of recommendations made in connection with the Danish Medicines Agency's evaluation of the rules on the competence of healthcare professionals in collaboration with the Life Science industry.The changes contribute to increased transparency in relation to the co-operation, including a more accurate picture of affiliation, as companies that act as representatives of foreign companies are covered by the rules. It should be noted, however, that the rules do not cover all companies with activities aimed at Denmark, which is why transparency will not be perfect.
As mentioned, the law enters into force on 26 May 2021. However, a transitional arrangement has been laid down in relation to the changed rules for doctors' affiliation to specialist shops with medical equipment.
The changes can be read in their entirety here .
