The Danish Ethics Committee for the Pharmaceutical Industry (ENLI) has revised four of its sets of ethical codes as well as its regulations on penalties and fees by adopting a number of changes and adjustments. Several changes are being made as a result of the Danish Medicines Agency’s recently published guidelines on drug advertising.
The ethical codes (with associated guidelines) concerned are the Code of practice for the pharmaceutical industry on the promotion, etc., of medicinal products intended for health professionals (the Promotional code), the Rules of ethics for donations and grants from the pharmaceutical industry (the Donation code), the ethical rules for collaboration between patient organisations, etc., and the pharmaceutical industry (the Patient organization code) and the Ethical rules for dialogue and negotiation with decision-makers (the Lobby Code).
The majority of changes to the four ethical codes and guidelines are either updates in the form of clarifications or structural and linguistic adjustments. A common structural change is to introduce and add “rule boxes” to each provision of the guidelines to allow the provision in question to be read in conjunction with the relevant guidance comments. A central focus of the changes has been to create more clarity and transparency, and the significant changes are summarized below.
So what’s up?
With regard to the promotion code, it should be noted that the monetary thresholds for meals (food and drinks) in Denmark at professional events referred to in Article 13(8) have been raised to: 450 DKK for lunch, DKK 850 for dinner and DKK 1,400 covering all meals at full day meetings/conferences etc. Danish healthcare professionals, in line with current practice, are also subject to the reporting obligation. In addition, exceptions to what constitutes advertising for medicinal products are now written directly into the code with the definitions of the terms “advertising”, “health professionals” and “the public” of the Executive Order on advertising for medicinal products. medications.
In the Lobbying Code, section 1 relating to the purpose of the code has been rewritten to bring it closer to the corresponding provision of the Promotions Code. In addition, a more recent decision of the Appeals Board of ENLI from December 2021 is referenced in the context of article 13 of the code on the prohibition of financial support to decision-makers. The ruling is important for understanding the limits of the Section 13 prohibition and what does not constitute prohibited financial support for decision makers. The decision is further explained and discussed in Accura’s previous newsletter from January 2022: Read it here.
With regard to the Donation Code and the Patient Associations Code, no substantial changes have been made and the same rules and practices therefore apply as before. Both codes have, however, been rewritten and structured in a more systematic way, and new provisions have been inserted while the content of others has been clarified and provided with new paragraph numbers.
Finally, the content of ENLI’s Penalties and Costs Regulations has been clarified by inserting “+VAT” in the provisions on fines and costs in accordance with current invoicing practices, and two examples on this issue, both based on appeal cases. Council in 2021, have been inserted in Article 6.
The above changes to the relevant codes of ethics and guidelines came into effect on July 15, 2022.