In August last year, we wrote about the extent to which the French “sunshine rules” apply to the medical devices industry (see our post), alongside the pharmaceutical and cosmetic industry, and other health-related industries.
A number of developments have occurred since then.
First, we highlighted in our previous post the uncertainty regarding the territorial scope of the French sunshine rules, which apply to companies engaged in manufacturing, distribution, or other services related to products covered by those rules. An official from the Ministry of Health has confirmed that the reporting requirements apply to all such companies that interact with healthcare professionals or other persons in the healthcare sectors covered by the French sunshine rules (e.g., healthcare students, HCP associations, healthcare institutions, patient associations etc.), i.e., those conducting their activities in France. It is irrelevant, in that respect, whether the company is established or has its registered office in France or whether its products are actually marketed in France. This interpretation is in line with the applicable legislation and the interpretative Guideline published by the Ministry of Health in May last year.
Second, a Decree on the operating conditions of the centralised public website was published last December. The publication of this Decree put an end to the transitional regime for transparency reporting, which required disclosure on the companies’ websites as well as on the professional councils’ websites, when applicable. Companies must now register with a centralised website managed by the Ministry of Health. All reporting for benefits and agreements covered by the sunshine rules must be done through this unique website. At the moment, the website is only accessible to declaring companies. It should become accessible to the public on 1 April 2014 at the latest.
The entry into force of this Decree also put an end to the transitional deadlines applicable for declaring relevant agreements and benefits (i.e., twice a year; by 1 August for benefits granted and agreements concluded between 1 January and 30 June; and by 1 February for benefits granted and agreements concluded between 1 July and 31 December of the previous year). While this timeframe still applies for the reporting of benefits, agreements must now be reported within 15 days of their signature.
Third, a draft Decree is under discussion, the aim of which is to simplify the reporting requirements under the French sunshine rules. It is proposed that agreements be declared on a bi-annual basis, according to the same timelines as for benefits. It is also proposed that the qualifications and title of healthcare professionals no longer be reported and that the programmes of scientific events no longer be submitted (but be replaced by the name of the organiser, the name, date, and location of the event, as suggested by the Annex to the December Decree on the operating conditions of the centralised public website). Finally, it is proposed that the deadline for re-submitting the transparency information for the year 2012 and the first 6 months of 2013 (initially published on the companies’ and the professional councils’ websites) on the centralised website be postponed to August 2015.