The French sunshine regulations require industry to report certain agreements along with the fees and other benefits provided to various stakeholders in the healthcare sector.
Sunshine regulations were amended in January 2016 to increase transparency. Some specifics of these changes were partly established by an implementing decree dated 28 December 2016. Through the publication of a ministerial order dated 22 March 2017, these changes, along with additional expected details, have now entered into force.
For the agreements entered into, the fees paid and the other benefits granted in the course of the first semester 2017, companies will have to disclose on 1 September 2017, at the latest (and on 1 March 2018, at the latest, for the agreements entered into, the fees paid and the other benefits granted in the course of the second semester, and so on):
- the fees paid to stakeholders amounting to 10 euros or above;
- the identification of indirect and final beneficiary of the benefits and fees granted (if any);
- the total amount of agreements entered into with stakeholders;
- the date of signature of the agreement, and its end date, if set when the agreement is signed by the parties;
- the precise purpose of the agreement, according to the following classification set forth in the ministerial order:
- purchase of scientific documentation;
- purchase/rental of stands during scientific events;
- purchase/rental of advertising space;
- prize awarding;
- scientific research;
- investigation/study/market study (except research);
- scientific expert agreement, agreement in the framework of a research, consulting agreement;
- advice/expertise (other than scientific);
- other services;
- loan of equipment;
- assignment of rights/operating license;
- speaker agreement;
- interview agreement;
- conference registration;
- cosmetic product evaluation;
- cosmetic product vigilance;
- other (in this case, precisions must be added).
Companies should, from now on:
- trace and report fees paid to stakeholders in compliance with the new set of regulations;
- accordingly, adapt their tools (where needed) to comply with the new requirements and notably to classify and report the purpose of the agreement in accordance with the above;
- update agreements to be compliant with the new requirements, notably to manage the provision of the information allowing the identification of indirect and final beneficiary of the benefits and fees granted, when applicable.