Flash Pharma - Anti-gift provisions - July 2018

By Alexandre Vuchot, Anne-Charlotte Le-Bihan, Dora Talvard

07-2018

Transfer of value: new French legal framework effective as of July 1st but implementing texts are still missing.

The French so-called “anti-gift” provisions strictly frame the conditions under which companies active in the health sector are allowed to grant advantages, in cash or in kind, to healthcare professionals, as well as to some students, associations and public servants, the principle remaining the prohibition of such advantages.

The “anti-gift” provisions were amended by an order of 19 January 2017 aimed to enter into force on a date provided by decree or, at the latest, on the 1st of July 2018.

The new provisions (articles L1453-3 to L1453-12 of the French public health code (CSP)) entered into force on July 1st. However, the implementing texts are still missing, which leaves the companies concerned in a “grey zone”.

What do the new provisions change?

Extension of the legal and physical persons subject to the prohibition

  • Extension of the prohibition to grant advantages to any person manufacturing or marketing health products or providing health services (formeprovisions onlyapplied to companies providing services, manufacturing or marketing products that could be funded under the social security scheme)
  • Extension of the prohibition to receive advantages to all HCPs as well as to osteopaths, chiropractors and psychotherapists (former provisions applied to only some categories of HCPs)

Clarification of the scope of the operations excluded from the prohibition and those authorized under some conditions:

  • Exclusions: notably revenues deriving from the exploitation or transfer of IP rights relating to a health product
  • Specification of the authorized advantages, involving as previously a contract with the beneficiary

New rules for the submission to HCPs’ professional bodies:

  • All submissions have to be made online
  • Binding prior opinion of the professional body is required when the transfer of value will exceed a defined threshold (the former provisions only provided for a non-binding prior opinion)

Increase of the criminal sanctions

Some provisions can be directly applied while others remain inapplicable pending the implementing decrees.

For instance the extension of the scope of the concerned persons can be directly applicable, but the terms “person […] providing health services” remain unclear without further regulation. The new submission process requires further specification as well.

In the meantime, since the former regulatory provisions (article R. 4113-104 and seq. CSP) relating to the legal provisions in force have not been abrogated, they should remain applicable to the extent that they remain accurate and not in contradiction with the new enacted rules.