Agreements between life sciences companies and healthcare actors subject to stricter transparency requirements
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On 30 December 2016, Decree 2016-1939 concerning the transparency of benefits granted by companies manufacturing or commercialising products for health or cosmetic purposes intended for humans was published (2016 Decree). The decree follows the February 2015 Supreme Administrative Court’s partial annulment of a prior decree.
The 2016 Decree implements the transparency requirements set out in the French Sunshine Act and the Healthcare Act. It requires life sciences companies to disclose certain information regarding their agreements with, and remuneration and benefits that are worth EUR 10 or more that are granted to, a wide range of players in the healthcare industry, including their values. Furthermore, the 2016 Decree requires companies to provide information on their identity (such as legal denomination, purpose, and address of headquarters), as well as on the identity of beneficiaries. Companies remain responsible for the accuracy of the information, which is made available on a public website, for five years.
In addition, the 2016 Decree confirms the obligation for persons collaborating with or serving in public health and safety authorities to publically disclose the exact remuneration and financial contributions received from life sciences companies. It also requires those persons to verify the information, which will be included on a public website, once a year.
The 2016 Decree will enter into force no later than 1 July 2017. Non-compliance with its requirements is subject to criminal fines.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, January 2017 Issue (Thomson Reuters).
This post was originally co-authored by Patricia Carmona Botana.