Newsroom & Alerts

France-2020 CNOM/LEEM/SNITEM Conventions

In France, the use of the 2020 CNOM/LEEM/SNITEM Conventions facilitates declarations of recurring interactions between marketers or manufacturers of pharmaceutical products or medical devices and Health Care Professionals.

Please see our alert from Aug. 16th for more information on previous legislation regarding declaration/authorization thresholds for HCP’s: www.cabanel-law.com/newsroom–alerts/two-ministerial-orders-of-august-7th-2020-complete-french-anti-gift-law-in-the-healthcare-sector.

TWO MINISTERIAL ORDERS OF AUGUST 7th 2020 COMPLETE FRENCH ANTI-GIFT LAW IN THE HEALTHCARE SECTOR

KEY POINTS

Two Ministerial Orders that define the thresholds (i) for authorization or declaration of agreements with HCPs or HCOs covering permitted benefits, and (ii) for benefits to be considered of negligible value, were published on August 14th 2020.

Pursuant to the Decree of June 15th 2020, benefits that fall above or belowthresholds now defined in the first Ministerial Order will require either a declarationor an authorization by e-procedure to the relevant professional order or competent authority.
While declarations must be filed at the latest 8 days before the benefit is granted, the process for authorization could now take up to 4 months.
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In addition, the second Ministerial Order defines the amount of authorized in-kind or cash benefits which are considered of “Negligible value”.
The abovementioned Decree and Ministerial Orders will enter into force on October 1st, 2020.

To get ready, anticipate these changes by:

• reviewing template agreements, policies and processes
• developing internal communication and training  

New Decree strengthens french Anti-gift law as of Oct. 1st 2020

KEY POINTS

New Decree n° 2020-730 of June 15th, 2020 that strengthens anti-gift restrictions was recently published.

Starting October 1st, 2020 individuals and companies in the life sciences and healthcare industry will have to comply with the new Decree.

Above or below certain thresholds, grant of benefits will require either a declarationor an authorization by e-procedure to the competent authority or relevant professional order.

Such thresholds, based on the amount, nature and/or the duration of the benefit are yet to be defined by Ministerial Orders soon expected to be published.

While declarations must be filed at the latest 8 days before the benefit is granted, the process for authorization could now take up to 4 months.
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To get ready, anticipate those changes by:

• reviewing templates, policies and processes
• developing internal communication and training