In 2020, the French government amended the regulatory framework governing the interactions between industry and health care professionals (HCPs) in France. This “anti-benefits regulation” prohibits any entity (French or foreign) manufacturing or marketing health care products or providing health services from granting or offering direct or indirect payments and other transfers of value to French HCPs and other categories of stakeholders. The regulation also prohibits stakeholders from receiving such benefits.
However, the regulation provides for some permitted exceptions, as we previously described here. For these types of authorized benefits, an agreement between the parties must be entered into and include, according to a “thematic typology”, the precise subject matter of the agreement and the entitled benefits.
More particularly, the thematic typology of benefits and agreements lists the categories of benefits and the purposes of agreements entered into by companies subject to the benefits framework granted to health professionals, students, or associations of health professionals. The agreements covered by this framework must include certain information, set out in Article R1453-14 of the French Public Health Code, including the precise purpose of the agreement and the nature of the benefits granted, as originally described in ministerial order of 24 September 2020.
However, in response to criticisms from practice, a ministerial order dated 20 January 2023 has amended some of the “thematic typology” of the prior order.
Modifications to the typology of the agreements
Article 1 of the ministerial order proposes a non-exhaustive list of thematic typology, now called “typology of purposes”, for the agreement’s subject matter. The typology of purposes has been modified as follows (modifications are in bold) :
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Types of agreement
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Specific purpose to be mentioned in the agreement provided for in Article L1453-8
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Agreements in the context of research, research valorization, scientific assessment, consulting, service provision or trade promotion activities
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- the typology “contract for the purchase or rental of space in the context of scientific events”
is replaced by
“contract for the purchase or rental of space in the context of scientific manifestations”;
- in the typology “scientific research contract (expert, consultant)” ,
the words “(expert/consultant)” have been deleted;
- the typology “consulting or expertise contract other than scientific (survey, study, market study)”
is replaced by
“consulting/expertise contract other than scientific” ;
- the typologies “scientific expert contract” and “survey, study, market study (excluding research)” have been added.
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Agreements within the framework of events of an exclusively professional or scientific nature, events promoting health products or services
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- the typology “consulting or expertise contract other than scientific (survey, study, market study)”
is replaced by
“consulting/expertise contract other than scientific” ;
- in the typology “scientific research contract (expert, consultant)” ,
the words “(expert/consultant)” have been deleted;
- the typology “contract for congress registration”
is replaced by
“contract for the participation to an event”;
- the typologies “survey, study, market study (excluding research)” have been added.
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Agreements for the financing or participation in the financing of professional training or continuing professional development
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- the typology “training” has been added.
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Modifications to the typology of benefits
Article 2 of the ministerial order proposes a non-exhaustive list of categories of benefits in kind or in cash. This typology of benefits has been modified as follows (modifications are in bold):
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Categories of benefits
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Type of benefits to be mentioned in the agreement provided for in Article L1453-8
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Benefits in the context of research activities, research promotion, and scientific assessment
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- the benefit typology “donations (research, training) or loans”
has been replaced by the following two typologies:
“donation or loan for research” and “donation or loan for training” ;
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Benefits in the context of events of an exclusively professional or scientific nature, events promoting health products or services
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- it is specified that “registration fee”
means
“registration fee within the framework of an event”;
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Benefits for financing or participating in the financing of vocational training or continuing professional development actions
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- the typology “donation (training)”
has been replaced by the following two typologies:
“donation for training” and “grant for training” ;
- the typology “meeting/organization costs”
is replaced by the following two typologies:
“"meeting costs” and “organization costs” .
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This new thematic typology thus appears to be more consistent with the reality of the practice, the operations implemented by the health actors and the nature of the advantages granted. The new ministerial order has thus :
- reworded some of some agreements subject matters and categories of benefits in order to provide the necessary clarifications to remove the doubts left by the previous designation (distinction between research contracts and expert/consultant contracts other than scientific); and
- completed the categories to fill some gaps (mention of surveys and market studies, creation of categories relating to training).
As a reminder, when the purpose of the agreement or the benefit granted does not fall within the typologies , it can be freely specified in the agreement and on the platforms dedicated to tele procedures.
Publications linked
You can find our previous articles following the publication of the Decree No. 2020-730 of 15 June 2020 and of the ministerial orders of 7 August 2020, which entered into force 1 October 2020 [by clicking here and here], and on the ministerial order of 24 January 2020 establishing the thematic typology of benefits and agreements provided for in Article R1453-14 of the French Public Health Code was then published on 30 September 2020 [by clicking here].
Next steps
We routinely advise entities involved in manufacturing or marketing health care products, as well as entities involved in providing health services on how to comply with governing regulatory frameworks. Please contact the authors or the Hogan Lovells attorneys with whom your regularly work for questions regarding your specific benefits and agreement needs.
Authored by Mikael Salmela, Joséphine Pour, and Letizia Nieddu.
