Regulatory Watch: Further Updates Regarding French Transparency

05.03.17 | By Benoit Racault

The French Ministry of Health released two new ministerial decrees in the past month as a follow-up to two previous announcements on December 30, 2016 [1] and on January 28, 2017 [2]. The first decree, released on March 26th, introduces a new reporting form [3] that requires companies to collect and report more granular data. Consequently, companies must evaluate their transparency reporting system to ensure it has the capability to gather and report this more granular data.

The form is described in the appendix of the decree and contains the below changes:

  • Deletion of the recipient qualification
  • Adding of the official contract purpose drop down list
  • Adding of the total contract amount
  • Adding of the fees for services amount
  • Adding of the fees payment date
  • Adding of the contract identifier (i.e., contract number, contract name or other manner to identify the specific contract) for the fees for services

It should be noted that some labels of the form headings have been updated as well, even for existing fields. This decree is important as companies must now ensure that their transparency reporting system is configured to capture (1) the fees for services payment dates and (2) the contract purpose from their contract system. Companies must also update their transparency system to comply with the form’s new output format which is now implemented by the French central platform.

This new reporting form is another milestone moving towards the implementation of the December 2016 decree, which significantly expanded the scope of transparency reporting in France. As Polaris reported in a prior article, the December 2016 decree requires the disclosure of all benefits and fees to HCP/Os – both “cash” and “in kind.” Thus, the French Transparency report is now closer to the EFPIA definition of “Transfer of Value”, which also includes fees for services.

For example, if an HCP is hired to serve on an advisory board the company would previously disclose only the value of travel, meals and/or accommodations provided to the HCP if they were 10€ or more. However, under the new December 2016 law, life science companies must also disclose the fee the HCP received for participating in the advisory board.

The second Ministerial Decree [4], which was released on April 20th 2017, broadened the scope of the professions having the French national identifier: RPPS. Previously, only Physicians, Pharmacists, Dentists, Physiotherapist and Mid-wives had a RPPS identifier. However, under the new decree all covered recipients under Loi Bertrand (aka the French Sunshine Act) will now have a RPPS identifier. This decree is significant as it will streamline transparency filing for companies by reducing the types of identification numbers, and it will also ensure more accurate recipient identification in general.

Polaris is updating its STAR (Spend, Tracking, Analytics and Reporting) Solution reports to address these new requirements. The Polaris consulting team also helps our clients to define, collect and manage the requisite data feeds in a timely manner to comply with global reporting requirements.

For information on Polaris’ solutions and how they can help you stay compliant with this and all global regulations, contact us.

 

[1] http://polarismanagement.com/regulatory-update-french-transparency-report-template-revisions/
[2] http://polarismanagement.com/french-transparency-update-regarding-makers-marketers-veterinary-medicinal-products/
[3] https://www.legifrance.gouv.fr/eli/arrete/2017/3/22/AFSP1709245A/jo/texte
[4] https://www.legifrance.gouv.fr/eli/arrete/2017/4/18/AFSZ1711814A/jo/texte