Legislative process
On July 19, 2022, the European Commission introduced a proposal for a regulation...
An important change to the new regime governing transfer of value to HCPs, students and associations will enter into force on 1 October 2020. This change involves the submission procedure to the authorities, which will now differ depending on the value of the advantage in question:
– a declaration procedure for advantages under the ceilings set by a regulatory text (arrêté),
– an authorization procedure for advantages above said ceilings.
For further information on the new legal regime, see our previous post – here – analysing the “anti-gift decree” published last June.
The regulatory provisions (“arrêté”) specifying said ceilings have been published on 14 August.
The applicable ceilings are as follows:
A. Remuneration, compensation and disbursements for activities corresponding to research, research valuation, scientific evaluation, consultancy, services or commercial promotion
| Amount above which an authorization is required: | |||
| HCPs | Hourly rate : 200€ | Remuneration for half a day : 800€ | Total remuneration per contract: 2 000€ |
| Students training to become HCPs | Hourly rate: 80€ | Remuneration for half a day: 320€ | Total remuneration: 800€ |
| Associations regrouping healthcare professionals or students | Hourly rate: 200€ | Remuneration for half a day: 800€ | Total remuneration per contract: 2000€ |
B. Hospitality in the framework of a professional, scientific or promotional event
| Amount above which an authorization is required: | |||||
| HCPs | Meal: 50€ | Break: 15€ | Hotel night: 150€ | Total hospitality per invitation – including the meals, breaks, hotel nights and transportation: 2 000€ | Registration fees – in addition to hospitality: €1,000. |
C. Donations and gifts intended exclusively to finance activities corresponding to research, research valuation or scientific evaluation
| Grants and donations intended exclusively to finance research, research valuation or scientific evaluation activities. | Grants and donations intended for another health-related purpose | Grants and donations to associations recognized as having a public interest, including those intended exclusively to finance research, research valuation or scientific evaluation activities | |
| Amount above which an authorization is required: | |||
| HCPs | 5 000€ | ||
| Students training to become HCPs | 1 000€ | ||
| Associations regrouping HCPs or students | 8 000€ | 1 000€ | 10 000€ |
D. Financing or participation in the financing of vocational training or continuous professional development actions.
| Amount above which an authorization is required:
|
|
| HCPs | 1000€
|
Another “arrêté” has been published on the same day. This one specifies the ceilings under which some categories of advantages in kind or in cash are considered to be of negligible value, and thus fall out of the scope of the “anti-gift” regime. It sets both the maximum amounts for such benefits and the maximum frequency per calendar year. Otherwise, such benefits are prohibited.
