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Focus on Regulation

New French Sunshine Regulations About To Kick In

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. These regulations also govern the declarations of interests that experts must file in relation with their interactions with the industry.

Sunshine regulations were amended in January 2016 to increase transparency. Some specifics of these changes have been partly established by an implementing decree dated 28 December 2016. These changes, along with forthcoming additional details, will enter into force through the publication of a ministerial order, at the latest on 1 July 2017.

A revised framework will apply to the reporting of fees paid by the industry

The decree provides that the companies have to disclose fees paid to stakeholders amounting to 10 euros or above. This is not completely new. The French Administrative Supreme Court had already ruled in 2015 that sunshine regulations required the disclosure of such fees. This was debated, since the regulations did not expressly state that. The industry had expressed some reservation regarding the practical implementation of such disclosure, but authorities insisted that such fees need to be reported. Part of the industry had hoped that the decree would dispense reporting of fees under the legal regime prevailing before the changes brought by the 2016 regulations. But the decree does not include such dispense, hence reporting of fees being legally deemed required since 2012 (albeit under different rules). This has created practical issues for companies that have not traced the payment of fees from the outset of the regulations in 2012. The implementing decree dated 28 December 2016 clarifies the situation for future disclosures.

Other notable changes

The industry must report:

  • 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 a classification to be set forth in a forthcoming ministerial order.

As a reminder, the identification of indirect and final beneficiary of the benefits and fees granted will need to be disclosed. The decree provides that stakeholders contracting with the industry will have to provide the information allowing the identification of such indirect and final beneficiaries, if any.

The decree provides some practical relief for companies, since reporting the information in relation with agreements entered into with stakeholders will no longer be within 2 weeks of their signature. In practice, companies will have to disclose the above information, including those in relation with such agreements, at the latest:

  • on 1 September, for the agreements entered into, the fees paid and the other benefits granted in the course of the first semester of the current year;
  • on 1 March of the following year, for the agreements entered into, the fees paid and the other benefits granted in the course of the second semester of the previous year.

How to get ready for what is next

Companies should:

  • continue making sure they trace and report fees paid to stakeholders. The reporting that needs to be carried out currently must be made in application of the 2015 French Supreme Court decision. As soon as the ministerial order enters into force, the fees will need to be reported under the new regime resulting from the 2016 regulations;
  • anticipate the adaptation of their tools (where needed) so that they will be able to classify and report the purposes of the agreements in accordance with the ministerial order;
  • 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.