The French supreme administrative court (the "Conseil d'Etat") issued a significant decision (the "Decision") impacting the transparency obligations set out under the so-called French Sunshine Act (Law No. 2011-2012 of 29 December 2011).
The Decision annulled certain provisions of the French Sunshine Act implementing decree of May 21, 2013 (the "Decree") and its interpretative circular of May 29, 2013 (the "Circular") and thus expanded the scope of the transparency obligations.
The two main changes resulting therefrom and impacting health sector companies are the following:
1. The remuneration paid to healthcare professionals ("HCPs") and other targeted health sector actors, (with the exception of the remuneration paid to HCPs working as employees of the targeted companies), qualifies as a benefit in cash under the French Sunshine Act and must therefore be disclosed pursuant to the French Sunshine Act. The Decision has therefore annulled the Circular provisions that specified that remuneration was excluded from the disclosures.
Under the current structure, this Decision means that agreements and the related remuneration need to be disclosed under two separate headings:
- first, under the heading "agreement", the targeted company disclosing the existence of the agreements (without remuneration); and
- second, under the heading "benefit", the targeted company disclosing the remuneration provided under such agreements.
The next date for disclosing benefits is August 1st, 2015. The targeted companies should therefore get ready to disclose the remuneration paid during the on-going disclosure period (first semester of 2015) on August 1st, 2015.
Guidelines should shortly be disclosed by the French government regarding the implementation of the Decision and notably regarding the possible retroactive effect of this Decision back to data of 2012 (relating to past disclosure periods).
The evolution of the situation should therefore be closely followed considering the important quantity of information that could be required to be published within a short period of time.
2. Companies manufacturing or distributing non-corrective contact lenses, cosmetic or tattoo products shall disclose all agreements they enter into with HCPs, and not only agreements related to the conduct of safety assessments, monitoring and biomedical studies on such products. The Decision has therefore annulled the Decree provisions that had introduced such limitations.
The Decision also confirmed that the exclusion of certain commercial agreements from the French Sunshine Act disclosure obligations should be interpreted narrowly, so that only agreements under which the targeted health sector companies sell goods or services to HCPs and other targeted health sector actors shall not be disclosed.