Rules governing doctors’ association with the industry are loosening up

Life Science og Health Care  Written on 12.01.2017

As of 1 January 2017, changes to the rules regulating HCPs’ association with the pharmaceutical and medical device industry entered into force. The changes are to be seen as relaxations of the previous rules – but it is not a revolution.

The much discussed rules on HCPs’ association with the pharmaceutical and medical device industry have been amended on the following points:

  1. It is no longer required that pharmaceutical and medical device companies collect and report to the Medicines Agency the social security number (CPR number) of the HCPs associated with the companies. Now, HCPs’ authorization IDs suffice.

  2. In scientific work, HCPs’ reporting obligation is limited to the HCPs having the overall responsibility of the given scientific project. For example, this entails that subinvestigators in clinical trials are no longer required to report to the Medicines Agency their association to the industry in connection with the given scientific project (clinical trial), provided that the subinvestigators in question are not remunerated by the pharmaceutical or medical device company for the work performed.

  3. Writing of articles for the industry is as a starting point an association covered by HCPs’ obligation to apply for permission from the Medicines Agency. However, HCPs’ writing of articles closely connected to the participation in a clinical study is exempted from this starting point and instead covered by the reporting obligation connected to the scientific work.

  4. HCPs’ participation in public panel debates are no longer covered by the HCPs’ obligation to apply the Medicines Agency’s prior permission, provided that the panel debate regards subjects of a general health related nature. Instead, such activities are covered by the HCPs’ obligation to report such association. This relaxation applies inter alia to HCPs’ participation in public debate panels organized by pharmaceutical and medical device companies (potentially in collaboration with patient organizations, news media or via an agency).

Particularly no. 4 has been the object of significant public debate as a number of doctors refrained from taking an active part in the public debate at such meetings due to the strict rules. All of the changes reflect relaxations of the rules. It is worth noticing that only the 1st change is implemented directly in the legislation (namely the executive order on healthcare professionals association with pharmaceutical and medical device companies and specialist shops for medical devices), whereas the 2nd, 3rd and 4th changes are reflected only in the codified practice of the Danish Medicines Agency.

The changes have been part of an enquiry process that ended by the end of 2016 during which selected industry associations and public bodies were provided with the opportunity to comment on the contemplated and now approved changes.

DELACOUR’s life science team is specialized in providing advice to pharmaceutical and medical device companies’ collaboration with HCPs. Contact DELACOUR, if you require further information on the changes described above and/or is in need of legal assistance with e.g. updating your firm’s contracts with HCPs.