CNOM declaration: the main reasons for refusal!

September 19, 2024 — published by Pyramidale Communication,
medical communications agency

Déclaration CNOM : les principaux motifs de refus

Collaboration between manufacturers and healthcare professionals: keys to anticipate, plan, and successfully submit your CNOM declarations!

Are you a product manager or regional scientific manager looking to fully understand the ethical rules governing collaboration with healthcare professionals?

Pyramidale Communication, a medical communications agency, offers this series of exclusive articles to help you plan and ensure the success of your collaborative events!

CNOM declaration: the main reasons for refusal! the essentials:^1-2

The latest CNOM evaluation report identifies 8 main reasons for refusal under the “Encadrement des avantages” system.
When a declaration is refused, manufacturers may revise the submitted agreement and request a second CNOM review.

CNOM declaration: what are the main reasons for refusal?¹

The latest evaluation report from the CNOM, published in March 2023, highlights eight key reasons for refusal:

Outside the procedure – submission deadlines not met.
Excessive hospitality, including accommodation, meals, and transportation,
Excessive fees,
The amount of free time is not justified by the length of the scientific program,
Lack of authorization from hospital and/or university superiors,
Difference between the content of the authorization from superiors and that of the agreement,
Lack of scientific interest in the doctor’s participation in an event abroad,
Hospitality is prohibited for students: interns, junior doctors, acting as interns (FFI) and practitioners qualified outside the European Union (PADHUE).

DID YOU KNOW?
Companies have the option to revise the agreement and request a reevaluation, considering the reasons for refusal. In this case, they should consult the relevant healthcare professional or association to discuss any modifications before resubmitting the file to the Medical Council. If the refusal is final, the operation must be canceled completely, and the manufacturer will notify the relevant healthcare professional or association.²

Illegal benefits: what are the penalties?^2-3

Any benefits granted to healthcare professionals who do not comply with the exceptions or exemptions set out in the benefits framework or the prior review procedure are considered illegal.
Consequently, failure to comply with the regulations constitutes an offense that may result in:

Up to two years’ imprisonment and a fine of €150,000 for individuals who have granted a benefit,
Up to one year’s imprisonment and a fine of €75,000 for those who have received an undue benefit, in addition to other penalties.

Healthcare professionals who are members of a professional association and students may face criminal prosecution and disciplinary proceedings by the competent authorities for failure to comply with the regulations.

Find out more in our next article:

Declaration errors to avoid: recommendations from the CNOM.

References:

Conseil National de l‘Ordre des Médecins – Rapport d’évaluation 2020-2022.
Leem – Le nouveau dispositif « encadrement des avantages » : https://www.leem.org/sites/default/files/2021-06/Brochure_encadrement_avantages.pdf
Ministère du travail de la santé et des solidarités – Encadrement des avantages : tout comprendre du dispositif.

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