The French anti-kickback decree published on 17 June 2020

The decree n°2020-730 of 15 June 2020, which implements the Order of 19 January 2017 amending the French anti-kickback regulation, was published this morning in the French Official Journal.

This decree defines:

1. the persons providing health services, which are subject to the French anti-kickback regulation, in the same way as companies manufacturing or marketing health products;

2. the information which should be mentioned within the agreement governing the relationship between the company and the professional - in particular, whatever the type of the prior control, the authorisation of cumulative activities for the civil servants concerned (such as hospital practitioners, for example) should be attached to the agreement;

3. the modalities of the applicable prior control - as a reminder, the Order replaced the prior opinion issued by the professional Board by a control whose nature depends on the amount of the benefits mentioned within the agreement:

   • in the event the amount is lower than the thresholds set by a ministerial order - the signed agreement should be notified to the relevant authority no later than 8 working days before the date on which the benefit is granted;

   • in the event the amount exceeds the thresholds set by a ministerial order - the draft agreement (and, where appropriate, its attachments, including the authorisation for cumulative activities) should be submitted to the relevant authority for its prior authorisation, which will issue its decision within 2 months from the receipt of the authorisation request file.  In the case the file is incomplete, the two-month period shall run from the date of receipt of the missing documents.

   In case of refusal of authorisation, the company can submit an amended convention within 15 days from the notification of the refusal - the relevant authority will have 15 days to issue a new decision.

   The notification or the authorisation request should be made:

   • to the National Professional Board concerned when the beneficiary is a professional, a legal entity or a student intending to join a profession covered by a Professional Board,

   • to the Local Health Agency (ARS) within whose jurisdiction the agreement was signed, when the beneficiary is a professional, a legal entity or a student other than those mentioned above.

This decree comes into force on 1 October 2020.

We are now waiting for the publication of two ministerial orders defining :

• for the first, the amounts from which an agreement is subject to an authorisation and,

• for the second, the amounts below which benefits in kind or in cash are considered to be of negligible value.