The Netherlands
As previously announced, the Foundation for the Code for Pharmaceutical Advertising (“the CGR”) and the Foundation for the Code of Conduct for Medical Devices (“the GMH”) have decided to further tighten their rules as of January 1st, 2024.
We now have a better view on what those changes will be. The chapter on transparency has been revised in both Codes of Conduct.
Here below a summary of the main changes:
GMH (medical devices)
- Internal approval board sponsorship and service agreements
Entering into a sponsorship or service agreement requires the demonstrable prior approval of the executive board is required. This consent must be evidenced by the signature of or on behalf of the board of board. In practice, it may occur that a healthcare professional is associated with more than one institution associated with more than one institution. In that case consent must be obtained from the board of the institution for which the relevant agreement is most relevant. The board of directors of the other institution(s) where the healthcare professional is also partly employed must be informed.
- Internal reporting obligation reimbursement of costs of participation in meetings
If a healthcare professional enters into an agreement regarding reimbursement/sponsoring of costs for participation in a meeting, this must be reported by the healthcare professional to report this to the board of directors.
The obligation to report does not apply to participation of an individual healthcare professional to a meeting organized
- By a third party and sponsored by one or more medical device companies.
- By a medical device company, and does not fall within the definition of a product related meeting or an accredited meeting
- As satellite meetings
The hospitality must be reported by the healthcare professional to the institution where he/she is predominantly employed.
Institutions must ensure that there is a process in place regarding reporting to the board of directors, including any delegated powers in this regard.
- Reporting obligation extended to include new professional groups
As of 2024 (disclosure in 2025), nurses, nursing specialists and physician assistants, as well as the partnerships and institutions in which they work will be included.
- Reporting obligation extended to Patient organization sponsorship
- In addition to the fee for service, the reimbursement of expenses are also in scope
CGR (medicines)
- Recognisability
Professionals should, prior to a meeting, be able to take note of the fact that a meeting is (partly) established with the financial support of one or more pharmaceutical companies. Pharmaceutical companies should therefore check that sponsorship agreements with the congress organiser include agreements on transparency prior to the meeting. Patient organisations should also be transparent about the sponsorships received.
- Internal approval board sponsorship and service agreements
Entering into a sponsorship or service agreement requires the demonstrable prior approval of the executive board is required.
- Internal reporting obligation reimbursement of costs of participation in meetings
If a healthcare professional enters into an agreement regarding reimbursement/sponsoring of costs for participation in a meeting, this must be reported by the healthcare professional to report this to the board of directors.
The obligation to report does not apply to participation of an individual healthcare professional to a meeting organized by a third party and sponsored by one or more pharmaceutical companies.
It is important to note that, insofar as the professional is affiliated to a hospital, a service or sponsorship agreement can only be given effect to if it is co-signed by or on behalf of the hospital’s board. Before execution may be given to the agreement in question, pharmaceutical companies shall verify that it has been countersigned by or on behalf of the board.
2024 will be seen as a transitional year for pharmaceutical companies to adapt their internal procedures.
Source (in Dutch) GMH (Medical Devices): GMH_Nieuwsbrief_2023_nr._5_november_2023-02.pdf
Source (in Dutch) CGR (Medicinal Products): *CGR-nieuwsbrief-4-2023-Transparantie.pdf.aspx