Decision of the French “Conseil d’Etat” (Highest Administrative Court) dated 24 February 2015

Proceedings were initiated before the Conseil d’Etat with a view to challenging the legality of a number of provisions of Decree n° 2013-414 of 21 May 2013 and its interpretative circular before the French Conseil d’Etat.
In its decision of 24 February 2015 (No. 369074):

  • The Conseil d’Etat notably confirmed that the agreements pursuant to which HCPs purchase from pharmaceutical or other concerned life science companies fall outside the scope of the publication obligation. Thus, for example, discounts awarded in these agreements should not be considered an advantage to be disclosed under the French Sunshine Act. The same exemption would also appear to apply to advertising agreements with TV, radio and internet companies.
  • Furthermore the Conseil d’Etat invalidated the distinction between incomes paid to HCPs in compensation of professional services and other amounts awarded to HCPs.

Prior to this decision income given to HCPs in compensation of professional services provided to companies fell outside the scope of the advantages to be declared except if the remuneration was obviously disproportionate.

 

Loi Touraine ( « Loi de Modernisation de notre système de santé » or Law modernising our health system)

The text adopted by the French National Assembly on 17 December 2015 was promulgated on 26 January 2016.This new law is aimed at modernising the French Health system but it also did touch upon the French Sunshine Act.

This text was much debated and around the summer of 2015 the French government introduced by way of amendment a new article to the draft Bill the purpose of which was to enable the French government to take fresh measures (within one year of the promulgation of the new law) in relation to the French Sunshine Act and notably in relation to article L 4113-6 of the French Public Health Code.

In summary the “Loi Touraine” reinforced the transparency framework and notably introduced:

  • A specific disclosure regime for remuneration has been put in place (disclosure threshold could be 30 Euros- to be confirmed)
  • As far as agreements are concerned it would now be compulsory to disclose the specific object of the agreement and the direct and final beneficiary of the agreement

All these new obligations will need to be clarified by way of a decree and despite 2 drafts it is yet to be formally published (initially summer of 2016 but now likely to be 2017).