Earlier this year, we published a blog highlighting the French Decree on ‘anti-gifts’ that was published on June 17, 2020.[1] Additional ‘orders’ related to the French ‘anti-gift’ provisions were issued on August 7, 2020.

The French “anti-gift” provisions strictly frame the conditions under which companies in the health sector are allowed to provide advantages, “in cash or in kind”, to healthcare professionals (HCPs), healthcare organizations (HCOs) and students.[2]

Two relevant ‘orders’ of August 7, 2020 further define:

  1. The amounts that are considered to be of ‘negligible value’ in application of 4 ° of Article L. 1453-6 of the Public Health Code.[3]
  2. The amounts from which an agreement provided for in Article L. 1453-8 of the Public Health Code is subject to authorization.[4]

Benefits of negligible value

Pursuant to 4 ° of Article L. 1453-6 of the Public Health Code, applicable entities are not allowed to offer advantages or benefits to HCPs, unless – amongst others – such benefits are of negligible value.

Examples of benefits that are considered to be of negligible value are meals and snacks of €30 within the limit of two per calendar year, €30 for a book or magazine (up to a total limit of €150 per calendar year) and office supplies of €20 in total per calendar year.

Other requirements include, for instance, that the benefit should relate to the HCPs profession. Details and other limits can be found here.

Subject to authorization 

Furthermore, pursuant to Article L. 1453-8 of the Public Health Code, applicable entities must request pre-approval via an online portal before being able to give certain advantages (transfers of value) to HCPs, HCOs, or students.

The thresholds (including taxes) that need to be applied in this respect include, for example, when companies plan to pay remuneration for services to an HCP, pre-approval should be asked when paying more than €200 per hour (within the limit of €800 per half-day and €2,000 for the entire contract).

Another example is €5,000 for donations intended to finance research activities for HCPs (compared to €8,000 for HCOs). Details and other thresholds can be found here.

[1] Décret n° 2020-730 du 15 juin 2020 relatif aux avantages offerts par les personnes fabriquant ou commercialisant des produits ou des prestations de santé, NOR : SSAH1933329D, web: https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000041999448/

[2] Refer to the law for the detailed definitions: ‘natural persons mentioned in article L. 1453-4 of the public health code and natural and legal persons providing health services or producing or marketing health products mentioned in article L. 1453-5’.

[3] Order of August 7, 2020 setting the amounts below which benefits in kind or in cash are considered to be of negligible value in application of 4 ° of Article L. 1453-6 of the Public Health Code, NOR: ECOC2019446A, web: https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000042234007/

[4] Order of August 7, 2020 setting the amounts from which an agreement provided for in Article L. 1453-8 of the Public Health Code and stipulating the granting of benefits is subject to authorization, NOR: ECOC2019449A, web: https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000042234024/

 

Frederique Reijntjes
Senior Legal Consultant

November 19, 2020