Anti-benefits regulations: the last piece of the regulatory puzzle published

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Decree no. 2020-730 of 15 June 2020 and the ministerial orders of 7 August 2020 have completed and specified the new anti-benefits regulations which will come into force on 1 October 2020 [find our detailed analyses of the decree and the orders in the related materials column]. All that was missing was the ministerial order setting out the thematic typology of benefits and agreements provided for in Article R1453-14 of the Public Health Code. This last piece of the regulatory puzzle was published on 30 September 2020 in the Official Journal.

Reminder of the exceptions permitted under the anti-benefits scheme

The anti-benefits regulations prohibit any entity manufacturing or marketing health care products or providing health services from granting or offering direct or indirect benefits of any kind to numerous categories of stakeholders. These regulations also prohibit such stakeholders from receiving said benefits.

Article L1453-7 of the Public Health Code allows for exceptions to this prohibition on offering benefits.

The following benefits, in kind or in cash, can be granted:

  • remuneration, indemnification and defrayal of expenses for research activities, research valorisation, scientific evaluation, consultancy, provision of services or trade promotion activities. Such benefits are permitted provided that the remuneration is proportionate to the services rendered and that the compensation and expenses do not exceed the costs actually incurred by the persons concerned;
  • hospitality offered, directly or indirectly, during professional, scientific or promotional events. This hospitality must be reasonable, strictly limited to the main purpose of the event and must not benefit persons other than those directly concerned by the event;
  • educational grants (e.g., in the context of continued medical education) and research grants;
  • donations to associations of health professionals and/or students intended to pursue health professions, provided that the purpose of the association is related to their professional activity.

For these authorised benefits, an agreement must be concluded between the beneficiary and the entity providing the benefit, in accordance with Article L1453-8 of the Public Health Code.

The requirements relating to the content of this agreement were specified by the decree of 15 June 2020, which introduced Article R1453-14. In particular, the agreement must include, according to "a thematic typology", the precise subject matter of the said agreement and the benefits in kind or in cash. The order of 24 September 2020 sets out the typology of agreements and the typology of benefits.

Typology of agreements and typology of benefits mentioned in Article R1453-14 of the Public Health Code

Article 1 of the order proposes a thematic and non-exhaustive typology for the subject matter of the agreements, reproduced in the table below:

Types of agreements Specific subject matter to be mentioned in the agreement provided for in Article L1453-8 and on the teleprocedure portal
Agreements in the context of research, research promotion, scientific evaluation, consulting, service provision or trade promotion activities - Contract for the purchase or rental of advertising spaces
- Contract for the purchase or rental of space in the context of scientific events
- Scientific evaluation contract
- Contract as speaker at an event
- Scientific research contract (expert, consultant)
- Consulting or expertise contract other than scientific (survey, study, market research)
- Contract for the award of a research grant
- Award contract
- Patronage
- Sponsorship
- Partnership
Agreements within the framework of events of an exclusively professional or scientific nature, events promoting health products or services - Consulting or expertise contract other than scientific (survey, study, market research)
- Contract as speaker at an event
- Scientific research contract (expert, consultant)
- Contract for congress registration
- Patronage
- Sponsorship
- Partnership
Agreements for the financing or participation in the financing of vocational training or continuing professional development actions - Patronage
- Sponsorship
- Partnership
Where the subject matter of the agreement does not fall within the above-mentioned typology, it must be freely specified in the agreement and on the teleprocedure portal.

 

Article 2 of the order proposes a thematic and non-exhaustive typology of benefits in kind or in cash, reproduced in the table below:

Categories of benefits Type of benefits to be mentioned in the agreement provided for in Article L1453-8 and on the teleprocedure portal
Benefits in the context of research, research promotion, scientific evaluation activities - Remuneration
- Compensation
- Expenses
- Donations (research, training) or loans
- Research grant
- Research prize
Benefits in the context of consulting, service provision or trade promotion activities - Remuneration
- Compensation
- Defrayal
Benefits in the context of events of an exclusively professional or scientific nature, events promoting health products or services - Registration fees
- Transport costs
- Hospitality - catering
- Hospitality - snacks
- Hospitality - accommodation
Benefits for financing or participating in the financing of vocational training or continuing professional development actions - Donations (training)
- Meeting/organisation costs
Where the benefit granted does not fall within the above-mentioned typology, it must be freely specified in the agreement and on the teleprocedure portal.

 

Amount of benefits in kind

Finally, for each of the exceptions listed above, the order of 24 September 2020 specifies the method for calculating the amount, all taxes included, of benefits in kind that must be mentioned in the agreement referred to in Article L1453-8 of the Public Health Code.

The "average market value of the good or service in question" or the "cost (before tax) to the company providing the benefit" should be used. This notion of cost to the company has not been specified for the evaluation of benefits in kind considered to be of negligible value, but it would seem logical to apply it to these cases as well.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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