ENLI increases fees & fine levels and launches a new notification system
Fees & Fines
ENLI has announced upcoming changes to its Sanction and Fee regulations, entering into force on 1 January 2025.
The fee for notification of an activity will increase from DKK 475 to DKK 525 excluding VAT per notification. In this connection, we note that the activities subject to notification pursuant to section 21 of the Promotion Code are:
- Events organized or co-organized by a pharmaceutical company targeting Danish healthcare professionals (e.g., meetings, congresses, conferences, symposia, courses, etc.).
- Financial support from a pharmaceutical company for third-party events, including sponsorships for events targeting Danish healthcare professionals or for their participation in such events.
- A pharmaceutical company's purchase of exhibition stands at congresses in Denmark.
- Promotional materials from a pharmaceutical company directed at healthcare professionals, including printed materials (e.g., ads, brochures, handouts) and restricted-access electronic content.
The fee for pre-assessment requests for advertising materials will increase from DKK 8,000 to DKK 9,000 excluding VAT, while the fee for other activities, including events and other matters, will increase from DKK 6,000 to DKK 7,000 excluding VAT.
Additionally, the minimum fine for code violations will increase from DKK 30,000 to DKK 60,000, with a maximum fine of DKK 250,000. In cases of repeat offenses, the maximum fine will be raised from DKK 300,000 to DKK 500,000.
The new notification system
ENLI introduces a new case management and notification system, "ENLIsag", to replace the current ESS system by February 2025.
The new case management and notification system introduces enhanced features for pharmaceutical companies, including the option of having one or more administrators in the company, draft functions, expanded file upload options and simplified user registration for employees as well as consultants. All existing users will automatically be transferred to the new platform.
The system will be tested in late 2024 with the involvement of eight companies to ensure functionality and to gather feedback for ENLI. By February 2025, all affiliated companies are meant to switch to ENLIsag, which will be accessible via ENLI's website.
To support the transition, ENLI will provide user guides, and its secretariat will offer assistance via phone and email.