An urgent submission to the CNOM: exceptional but possible!

September 5, 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!

An urgent submission to the CNOM: exceptional but possible! key figures:^1-2

There are seven reasons why manufacturers can submit an agreement for Urgent authorization to the CNOM.
The CNOM’s response time is reduced to three weeks.

An urgent submission of agreements to the CNOM: what reasons are accepted?^1-2

Under certain conditions, manufacturers may submit agreements to the CNOM on an emergency basis. The Medical Council will issue a decision within three weeks. According to the latest CNOM assessment report, nearly 600 urgent cases were submitted in 2022, which is a 47% increase compared to 2021.

The situations in which the emergency procedure may be accepted are:

1. Fees:

Awaiting the decision of the National Management Center on the availability of a physician;
Expertise required to respond to a request from an administrative authority.

2. Hospitality:

Participation in an important conference by a doctor who has just been registered with the medical association;
Late change from a remote investigator meeting to a face-to-face meeting.

3. All files:

Submission error concerning the applicable regime (recommendation vs. authorization);
Change of speaker;
Summons to a Transparency Committee to accompany a contradictory phase or potential hearing.

PLEASE NOTE

Pursuant to Section 4 of Article L.1453-6 of the Public Health Code, provided that their market value, including all taxes, does not exceed the amounts below and within the limits specified for frequency:

1. Impromptu meals and snacks related to the beneficiary’s professional activity: €30, limited to two per calendar year;

2. Books, publications, or magazines, including subscriptions, related to the beneficiary’s profession: €30 per book, publication, or magazine, with a total limit of €150 per year (including subscriptions);

3. Samples or demonstration copies: €20 each, limited to three per calendar year.

By way of derogation, the following samples and demonstration copies are authorized without any limit on amount:

Medicinal samples governed by Articles L.5122-10 and R.5122-17 of the Public Health Code.
Samples and demonstration copies provided for educational or training purposes to healthcare professionals and that cannot be used in the context of patient care.
Samples and demonstration copies used by healthcare professionals for educational purposes with patients or given to patients exclusively for testing, adapting to the product or temporary use only.

4. Office supplies: €20 in total per calendar year.

5. Other products or services related to the beneficiary’s profession: €20 in total per calendar year.

Coming up in our next article:

CNOM declaration: the main reasons for refusal!

References:

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.
Légifrance – Arrêté du 7 août 2020 fixant les montants en deçà desquels les avantages en nature ou en espèces sont considérés comme d’une valeur négligeable en application du 4° de l’article L.1453-6 du code de la santé publique.

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