This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
The French so-called “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”).
The “anti-gift” regime was significantly amended in 2017 but the application of the new provisions remained subject to implementing texts whose publication has been awaited since then.
The decree relating to the advantages granted by persons manufacturing or marketing health products or services was finally published on 17 June 2020.
It will enter into force on 1 October 2020. This leaves about 3 months for companies to implement new compliance procedures.
An important change as compared to the current regime is that the submission procedure will depend on the value of the advantage in question:
- a declaration procedure for advantages under the ceilings set by an arrêté – yet to be published:
- the submission will have to be filed with the competent authority (the CNOM for physicians) 8 days before the grant of the advantage
- the competent authority will have the possibility to make recommendations
- an authorization procedure for advantages above said ceilings:
- the whole procedure may take up to 4 months, meaning that to be on the safe side companies would have to file their submissions at least 4 months before the contemplated event or service,
- the competent authority (the CNOM for physicians) will have 2 months to give a decision, or longer in cases where the authority notifies the applicant that the submitted file was incomplete; in case of refusal, the applicant can submit an amended submission within 15 days and the competent authority will issue a new decision in 15 days,
- the decision issued by the competent authority will be binding, meaning that the transfer of value cannot take place in the absence of an implicit (ie. no reply within the set time frame) or explicit approval.
Although the texts setting the ceilings under which the declaration procedure will apply have not yet been published, said ceilings are likely to be lower than the currently accepted one for hospitality and payment for services.
The decree also specifies the mandatory contents of the submission including the contract framing the transfer of value. It should be noted that in cases where the beneficiary HCP is a public agent (employed by a public hospital or university), an authorization by his hierarchy will have to be included in the submission.
