The ministerial orders setting the thresholds for the determination of the notion of negligible value of benefits provided in kind or in cash, as well as the thresholds for the agreements triggering the authorization procedure has finally been published on 14 August.
These orders follow the adoption of the decree n°2020-730 of 15 June 2020, bringing further details on how the new anti-benefits regulation will apply. See a more detailed analysis of this decree by clicking here.
These two orders will enter into force on 1 October 2020, as per the decree of 15 June 2020. The targeted stakeholders will therefore have some time to adapt their internal procedures and to train their teams.
The thresholds provided in these orders are almost identical to the latest version of the draft orders that were circulated by the Ministry of Health (Direction Générale de la Santé). The tables below summarize the applicable amounts.
| Thresholds triggering the authorization procedure for agreements |
| |
Members of the professions targeted by the regulations |
Students targeted by the regulations |
Associations targeted by the regulations |
| Net remuneration, compensation and payment for research activities, research promotion, scientific evaluation, advice, provision of services or trade promotion |
200 € per hour, within the limit of 800 € per half-day and 2 000 € for the entire agreement |
80 € per hour, within the limit of 320 € per half-day and 800 € for the entire agreement
|
200 € per hour, within the limit of 800 € per half-day and 2 000 € for the entire agreement |
| Donations and supports intended exclusively to finance research, research valorisation or scientific evaluation activities |
5 000 € |
1 000 € |
8 000 € |
| Hospitality offered during professional, scientific or promotional events |
150 € per night,
50 € per meal and
15 € per snack, and
2 000 € for the entire agreement including travel costs; and
1 000 € for the event registration fees that can be paid in addition to other hospitality expenses
|
N/A |
N/A |
| Educational grants for the financing of professional trainings or continued medical education |
1 000 € |
N/A |
N/A |
| Donations and grants intended for other health-related purposes |
N/A |
N/A |
1 000 € |
| Donations and grants to associations of public utility, including those intended exclusively to finance research activities, research promotion or scientific evaluation. |
N/A |
N/A |
10 000 €
|
These amounts cover the entire duration of the agreement.
There is uncertainty as to whether the above amounts are provided tax included or tax excluded, except for hospitality amounts, which are expressly provided tax included.
The regulations also:
- exclude the threshold for the payment of initial or continuing education of students, which were initially provided in the last draft order circulated by the Ministry of Health (Direction Générale de la Santé); and
- create a threshold for the remuneration of associations, as requested by the industry.
| Amounts below which benefits in kind or in cash are considered of negligible value |
| Unexpected meals and snacks related to the beneficiary's activity |
30 € within the limit of two per year |
| Educational material (books, magazines), including subscription, relating to the beneficiary's activity |
30 € per educational material including subscriptions within the limit of 150 € per year |
Samples of health products for health purposes or demonstration samples, except the following samples and demonstration samples which may be provided with no limit on the amount
- samples of medicinal products ;
- samples and demonstration samples provided for educational or training purposes for the healthcare professional and which cannot be used as part of the ‘patient's care pathway’ ;
- samples and demonstration samples used by the healthcare professional for educational purposes with the patient or given to the patient exclusively for the purpose of testing or adapting the product and for a temporary use
|
20 € within the limit of three per year |
| Office Supplies |
20 € in total per year |
| Other product or service which relates to the exercise of the beneficiary's profession, except products whose supply to professionals is requested by a public authority, which may be supplied without amount limit. |
20 € in total per year |
The thresholds for the benefits considered as of negligible value, are explicitly provided tax included. The regulations also specify that the amounts and frequencies provided for must be comprised as per beneficiary and per company (or other stakeholder targeted by the anti-benefits regulation).
The thresholds for benefits of negligible value are identical to the amounts previously provided in the last draft order that was circulated by the Ministry of Health (Direction Générale de la Santé).
What is still pending?
Following the publication of these orders, we are still awaiting the order providing the typology of agreements, as indicated in article R1453-14 2° of the French Public Health Code. We expect the order to be published in September.
[View source.]
