Pharmaceutical and device manufacturers operating in France must brace for more extensive reporting requirements under the French Sunshine Act, or “Loi Bertrand.” Last week, the Conseil d’Etat, the French Government’s “advisor in matters concerning the preparation of draft legislation, ordinances and certain decrees,” announced that the scope of the country’s disclosure law should be expanded.
The French law requires that companies make available on a public website any “benefit” in cash or in kind granted to covered recipients exceeding €10 (about $13.70 US dollars) and the existence of any contract with a covered recipient. Before the announcement, companies needed only report the existence of a contract, not the amount paid.
“In a May 29, 2013 Circular…the Ministry of Social Affairs and Heath announced that “benefits” would not include remuneration for services rendered (i.e. fees for service),” states Polaris, a company specializing in consulting and technology solutions for life sciences healthcare law compliance. “Last week’s decisions reverses this policy, arguing that by excluding fees for service, the Ministry exceeded its regulatory authority and failed to fulfil the purpose and parameters of the Loi Bertrand.”
Polaris raises a number of pertinent questions regarding the effect of this seemingly unforeseen announcement:
Firstly, when will changes be implemented? Considering the past tendency of the French government to impose rules and changes retroactively, companies should prepare for the need to report these fees for service for as far back as January 1, 2015; it is unlikely (though not impossible) that retroactive reporting will go further back than that. The current reporting period, which began on January 1, ends on June 30, with reporting due on August 1.
Second, how will these fee for service payments to be reported. Will they need to be reported in the same way as any other benefit? Or will companies be required to report agreed-to fees as part of contract reporting. While the former is most likely, either is possible.
We will continue to follow the French developments regarding Loi Bertrand, as well as other international transparency initiatives.