Reporting errors to avoid: CNOM recommendations

July 11, 2024 — published by Pyramidale Communication,
medical communications agency

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: which option to choose, declaration or authorization? the essentials:

Collaborations between healthcare professionals and pharmaceutical companies must be transparent and comply with a strict legal framework.
The anti-gift law, governed by The CNOM (Conseil National de l’Ordre des Médecins) No. 2017-49 of January 19, 2017, prohibits the receipt of benefits in kind or in cash, except when an agreement is made between healthcare professionals and the manufacturer and submitted to the CNOM in advance.
The CNOM ensures that agreements signed between the pharmaceutical industry and doctors comply with ethical standards.
There are two possible CNOM submission regimes, depending on the value of the benefits granted to healthcare professionals: recommendation or authorization based on applicable benefit amount thresholds.

What is the benefits framework?^1-3

Collaboration between pharmaceutical companies and healthcare professionals and/or associations of healthcare professionals is essential to therapeutic progress and the improvement of patient care pathways. However, such collaboration must be conducted within a clearly defined regulatory framework.

The LAC (anti-gift law), governed by Ordinance No. 2017-49 of January 19, 2017, relating to benefits offered by persons manufacturing or marketing health products or services, has established a regulatory framework to avoid any conflict of interest between healthcare professionals and pharmaceutical manufacturers.

The LAC prohibits:

healthcare professionals and students from receiving illegal benefits from manufacturers in the healthcare sector,
manufacturers from offering or providing illegal benefits to healthcare professionals.

Since October 1, 2020, new regulations on benefits granted by manufacturers to certain healthcare professionals have taken effect, imposing strict conditions and procedures.

The law allows for three types of exemptions:

Remuneration, compensation, and reimbursement for activities relating to research, research promotion, scientific evaluation, consulting, service provision, or promotion, provided that the remuneration is proportionate to the service rendered and that the compensation or reimbursement does not exceed the professionals’ actual costs
Benefits received by medical students for research activities carried out as part of degree preparation;
Hospitality offered to physicians at exclusively professional and scientific events, provided that it is reasonable and limited to the event’s main professional and scientific purpose, and not extended to individuals other than the directly involved professionals.

Please note! The term “benefit” includes payment for meals, accommodations, transportation, equipment, etc. Granting these benefits requires an agreement between the beneficiary and the manufacturer. The manufacturer must submit this agreement to the CNOM for approval.

who is affected by this measure?^1-2

Healthcare professionals, as well as chiropractors, osteopaths, psychotherapists, and students training for these professions.
Associations or similar entities in which healthcare professionals are involved in its governance and participate in its missions.
Public officials and certain administrative bodies are also affected, given their influence in the field of health. This includes officials from the HAS, ANSM, etc.
Members of certain commissions, councils, and bodies given their role in health expertise.
Healthcare professionals and military students.

For a detailed list of those affected, please refer to the September 11, 2020 information note

What is the role of the CNOM in the application of this system?^3-4

The CNOM has been entrusted with a public service mission in connection with the “Encadrement des Avantages” (Benefits Framework) system. The CNOM monitors the benefits provided to healthcare professionals by pharmaceutical and medical device companies.

Manufacturers must submit their applications to the CNOM online in accordance with the provisions of Decree No. 2020-730 of June 15, 2020, and Articles L.1453-12 and L.1453-10 of the Public Health Code. All applications must be submitted via the IDAHE V2 application.

Agreements relating to research involving human subjects are also submitted to the professional association’s commission on doctor-industry relations for informational purposes and decision-making.

Important! Companies must also declare information relating to agreements entered into and benefits granted to healthcare professionals on the Transparence Santé, a public website managed by the Ministry of Health and Solidarity.

CNOM declaration: which regime to choose, declaration or authorization?^3-4

1. Main Thresholds for Determining the Submission option

Beyond the benefits considered to be of “negligible value,” threshold amounts are established according to the categories of persons (health professionals, students, and associations of health professionals) and the types of benefits concerned (professional training, exclusive funding of research activities, fees, and hospitality). These amounts are set by the August 7, 2020 decree: https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000042234024/

2. Depending on the value of benefits offered to healthcare professionals, the legislation provides for two CNOM submission regimes:

“Recommendation” regime (agreements not exceeding the established thresholds): the CNOM reviews the application and may comment on the agreement. The manufacturer have to take these comments into account when submitting new applications. Applications under the recommendation regime must be received by the CNOM eight days before the benefit is granted. Following its review, the CNOM may indicate that the application is incomplete and suggest changes

“Authorization” regime (agreements exceeding the established thresholds): the CNOM either authorizes or refuses the agreement between a manufacturer and a healthcare professional. The agreement may not be implemented until a formal decision has been issued by the CNOM.
The authorization application file is sumitted to the CNOM, which makes a decision within two months of receiving the file. If the CNOM considers the file incomplete, it will notify the applicant; once it is complete, the two-month review period begins.
The CNOM sends electronically its reasoned decision to the applicant, who is responsible for informing the individuals or legal entities benefiting from the agreement. If the CNOM refuses the application, the applicant may submit a modified agreement within 15 days. A new decision will then be made within 15 days.

For information: in 2022, 153,239 agreements were submitted to the CNOM for declaration, including 28,818 authorization requests.

Useful information!
Documents to be included in the file in addition to the agreement:

The event program,
Authorization to hold multiple positions issued by the competent authority: For a hospital practitioners, it is granted by the hospital director. For university hospital practitioners, it is granted by the university president (or the Dean of the Faculty (UFR)).
The list of doctors approached to participate in an event (event, expertise, consulting, etc.),
A summary, written in French, of the research or scientific evaluation protocol,
The draft observation log or data collection document.

Coming up in our next article:

An urgent submission to the CNOM: exceptional but possible!
Learn how to master best practices to ensure the safety and effectiveness of your promotional campaigns.

References :

Ministère du travail de la santé et des solidarités – Encadrement des avantages : tout comprendre du dispositif : https://sante.gouv.fr/professionnels/article/encadrement-des-avantages-tout-comprendre-du-dispositif
Brochure Leem, Le nouveau dispositif « ENCADREMENT DES AVANTAGES » Quelles obligations, quelles modalités de contrôle, quels impacts concrets pour les entreprises et leurs partenaires ?
Conseil National de l‘Ordre des Médecins – Les relations avec l’industrie pharmaceutique : https://www.conseil-national.medecin.fr/lordre-medecins/conseil-national-lordre/relations-lindustrie-pharmaceutique
Conseil National de l‘Ordre des Médecins – Rapport d’évaluation 2020-2022.
Arrêté du 7 août 2020 fixant les montants à partir desquels une convention prévue à l’article L. 1453-8 du code de la santé publique et stipulant l’octroi d’avantages est soumise à autorisation. https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000042234024/

SHARE THIS ARTICLE:

Contactez-nous