11 April 2017 - Authored by:Eveline Van Keymeulen
On 27 March 2017, with the publication of the new Order on the practical functioning of the transparency website www.transparence.sante.gouv.fr (the Order), the revised French transparency regime entered into force. The revised regime strengthens the transparency in relationships between Life Sciences companies and healthcare professionals. It was established by the 2016 French Healthcare Act and its implementing Decree – which the Order supplements – after the prior regime was partly annulled by a 2015 French Administrative Supreme Court decision.
The revised regime reinforces the disclosure obligations for Life Sciences companies, in particular requiring them to also disclose the value/amount of agreements (from EUR 10 onwards) with a wide range of healthcare actors. In contrast, it somewhat decreases the administrative burden for companies by requiring that such information be communicated twice per year instead of within 15 days of the entry into force of each agreement.
To effectively allow publication of the additional information required under the revised regime, the Order amends the 2013 Order establishing the original operating terms of the transparency website. The new Order introduces, in particular:
- A list of categories to describe the precise subject matter of the agreement (for example, purchase of scientific documentation, hospitality, donation, partnership, scientific research, sponsorship, market study, scientific expert/research/consultancy contract, training course, equipment loan, assessment of cosmetic products, conference registration fee, etc.).
- Different sections to include the value/amount of the agreement, information related to the remuneration under such an agreement (such as the payment date and the amount paid), and the identification of the organiser of an event (which replaces the requirement to submit the programme of the event).
The first publications in accordance with the reinforced transparency regime will appear on the dedicated website www.transparence.sante.gouv.fr on 1 October 2017. A revised government circular shedding further light on some of the revised provisions is expected to be published shortly.
This post was originally co-authored by Patricia Carmona Botana.