« back to LEGISLATIVE WATCH

Denmark
hcp engagement rules

Latest update: 9 February 2021 | Important Notes

Pharmaceutical Companies

Authority

Laegemiddelindustriforeningen / The Danish Association of the Pharmaceutical Industry (LIF): “Members of the Danish Association of the Pharmaceutical Industry (Lif), the Danish Generic and Biosimilars Medicines Industry Association (IGL), the Danish Association for Parallel Importers of Medicines are automatically subject to the jurisdiction of the Ethical Committee for the Pharmaceutical Industry in Denmark (ENLI).”

https://www.enli.dk/en/about-enli/affiliation/

Medical Device Companies

Authority

  1. Medicoindustrien: “Medicoindustrien is the industry association for companies in Denmark which develop, manufacture, sell or otherwise take an interest in medical devices.”
    https://medicoindustrien.dk/content/about-medicoindustrien
  2. DiaLab: “DiaLab is a branch company for companies involved in the supply and / or production of laboratory products.” (Translated by Google.)
    https://www.dialab.dk/https://www.dialab.dk/om-dialab/

Resources

The Pharmaceutical Industry’s Code of Practice on Promotion etc., of Medicinal Products aimed at Healthcare Professionals:

“The scope of these ethical rules is to create a framework for the necessary and professionally responsible collaboration between the pharmaceutical industry and healthcare professionals, in such a manner that professional standards and ethics are paramount, and pressure opportunities and dependency between the parties are excluded. The ethical rules state a number of minimum standards, which must be complied with, in addition to the applicable laws and regulations.”

https://www.enli.dk/en/rules/

Important Notes and Disclaimer:

  • This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
  • Kindly check with your legal department and do not solely depend on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information provided reflects the most recent changes and is still applicable.
  • Including a jurisdiction in the Legislative Watch does not guarantee that jurisdiction is available for reporting via the MediSpend Transparency Reporting Solution.
  • Transparency Reporting: Reporting dates are related to the transparency obligation. regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding – in most cases – suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. In case it is based on codes of conduct, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of the association that follows that code.
  • Transparency Reporting: Reporting date normally means the date the transfers of value need to be published. The deadline for e.g. submission/sending the complete information to the authority could be before that date, for example to give HCPs and/or HCOs and/or the authority/association who publishes the information, the possibility to check the data the pharmaceutical companies/medical device companies are going to disclose.
  • Transparency Reporting: The information does not take into consideration (unless explicitly mentioned):
    • Transparency reporting related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency reporting related to patient organizations (unless the patient organization is considered an HCO)
  • HCP Engagement: This page provides links to useful information for life science companies who are interacting with healthcare professionals (HCPs) and healthcare organizations (HCOs).
  • HCP Engagement: The rules mentioned are only applicable to members of the mentioned industry/trade association.
  • HCP Engagement: We selected links to codes of conduct of industry/trade association that are leading/much followed in the respective jurisdiction and contain (in most jurisdictions), compared to e.g. the law, more detailed guidance on compliant interactions with HCPs and HCOs.
  • The information contained in this website is for general information purposes only. The information is provided and/or referred to by MediSpend and, while we endeavor to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the website for any purpose. Any reliance you place on such information is, therefore, strictly at your own risk.
  • In no event will MediSpend be liable for any loss or damage including, without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of this website.
  • Through this website you may be able to link to other websites which are not under the control of MediSpend. We have no control over the nature, content and availability of those sites. The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.
  • Every effort is made to keep the website up and running smoothly. However, MediSpend takes no responsibility for, and will not be liable for, the website being temporarily unavailable due to technical issues beyond our control.