New rules on HCP relationships with companies and economic support to HCPs
When adopting a new act on the scientific ethical processing of clinical testing of medical devices, the Danish Parliament has made a number of changes to the rules on pharmaceutical and medico companies' relationships with and economic support to HCPs. The amendments will come into force on 26 May 2021. The companies in question should be aware of the changes, including the ones mentioned below, as these changes entail an extension of the group of companies comprised and an amendment to the obligation to make notifications or seek permission.
A wider group of companies to be comprised by these rules
Until now, a pharmaceutical company has been comprised by the rules on HCP relationships and economic support if said company held a marketing or company authorisation. With these changes, the group of comprised companies will be extended to also comprise Danish representatives of foreign pharmaceutical companies holding such authorisations. This extension will presumably entail that in practice, an additional 100 Danish companies will be comprised by the rules.
The group of companies comprised will also be extended to comprise a limited group of companies that manufacture, import or distribute equipment without an intended medical purpose - meaning so-called aesthetic products such as non-corrective contact lenses, liposuction equipment, and implants for cosmetic purposes. This extension follows from the new EU rules on medical devices, entailing that selected products without an intended medical purpose are to be regulated as medical devices in the future.
Obligation to report economic support
According to the current rules, pharmaceutical and medico companies established in Denmark are obligated to notify the Danish Medicines Agency once a year about the HCPs with whom the company has a relationship. According to the new rules, the companies now also have to notify the Danish Medicines Agency once a year if they provide economic support to HCPs (and certain professionals buying and selling medical devices) participating in professional activities in other countries, or international and professional congresses and international conferences held in Denmark. The duty to notify will also apply to the Danish representatives of foreign pharmaceutical companies holding marketing and/or company authorisations.
Certain professionals buying and selling medical devices mean medico technicians and other people offering professional advice on and purchasing medical devices, including people from the hospital sector, as well as owners of and management in shops selling medical devices.
The notification requirement applies parallel to the requirement that pharmaceutical and medico companies must inform HCPs about their individual obligation to i) report certain forms of economic support, and ii) to report or seek permission for a relationship with pharmaceutical and medico companies.
Changes to authorisation or notification requirements in the relationship rules
According to the current rules, a relationship where the HCP assists with the preparation of professional information, requires prior authorisation from the Danish Medicines Agency. With the amendments to the act, this kind of relationship - in line with teaching and research - will only require prior notification. Assisting with the preparation of professional information could consist of contributing to a press release and a questionnaire, among other things. Further, the Danish Medicines Agency will now be able to assess which assignments constitute "teaching, professional information and research", and will have the capacity to order that other assignment types are to be included in the notification requirement.
The amended rules also entail that HCPs working full time for a company comprised by the relationship and economic support rules shall seek authorisation from the Danish Medicines Agency if such an HCP wants to do clinical work outside the company.
Also, the rules on doctors' relationships with specialist shops selling medical devices are amended, so that there is no longer just a notification requirement, as the current rules prescribe, as it will require an authorisation in the future. This means that the rules will be the same as for doctors' relationships with pharmaceutical and medico companies.
The amended rules implement a number of recommendations following from the Danish Medicines Agency's assessment of the rules on HCPs' independence when working together with the Life Science industry.
The changes contribute to more transparency in these cooperations, and they provide a more accurate view of a relationship, as companies representing foreign companies will now be comprised by the rules. We note, however, that the rules do not comprise all companies with activities directed towards Denmark, and this means that we will not have full transparency.
The act enters into force on 26 May 2021, as mentioned. However, there will be an interim arrangement regarding the amended rules on doctors' relationships with specialist shops selling medical devices.
You can read about all the amendments here (in Danish)