Transparency requirements under the French Sunshine Act: life sciences companies in the dark?

The implementing decree giving full effect to the French ‘Sunshine Act’ requires life sciences companies to disclose specifically listed information regarding agreements with, and benefits as of €10 to, a wide range of healthcare actors. Awaiting the establishment of a single public website to be created for that purpose, the information must be published on the companies’ websites (or a website of a group of companies) and — when concerning healthcare professionals or students — the website of the relevant healthcare professionals’ order. The information must remain available for a period of five years.

Immediate action is required, in particular with regard to information on agreements and benefits involving healthcare professionals or students (or their respective associations). Such information, for the year of 2012, had to be submitted to the National Council of the respective orders by 1 June 2013; information related to the first calendar half of 2013 is due by 1 August 2013. Companies have a little more time to adjust their websites for purposes of the required disclosure as the publication deadline for the information on agreements and benefits entered into, or granted between, 1 January 2012 and 30 June 2013 is set at 1 October of this year.

Non-compliance with these transparency requirements may subject life sciences companies to a criminal fine of up to €225,000. The decree also contains further specifications related to the anti-gift statute, as implemented in Article L. 4113-6 of the Public Health Code (PHC), which are not further discussed in this e-alert…

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