First and foremost, Polaris would like to provide reassuring clarification that there have been no changes to the French Sunshine rules. There have been many mentions of French Sunshine reporting requirements by the media and our competitors over the past few months, and in light of growing concerns, Polaris would like to provide reassurance that there are no modifications to the requirements. In addition to our own in-house point of view on this subject, Polaris has confirmed with French legal resources. The Sunshine Act à la Française requirements remain the same:
- Public disclosure is done twice a year: First, on Feb. 1st for data from July to December, and second, on Aug. 1st for the period of January to June.
- Both expenses greater than 10€ VAT and a list of agreements without amounts must fit the central platform format
- Specific mapping of recipients to the designated code for each specialty is mandatory
- Up until now, there is no EFPIA transposition. France is considered as an exception as a pre-disclosure transparency law.
The buzz created earlier this summer, concerned a letter from the Directeur General de la santé (The Ministry of Health) that was sent to the unions for both pharmaceutical (LEEM) and medical (SNITEM) industries. This letter was to inform them about the Conseil d’état decision that reports for agreements should report the contract amount. The letter stated that this will apply retroactively starting from 2012. However, both LEEM and SNITEM replied that this is not applicable as it violates intellectual property (contract update) and currently the French Sunshine text does not require this retroactive reporting. The decision of the council status is final but it has not been validated by any law. The law is still pending.
To prepare for potential regulation changes, Polaris recommends life sciences companies take proactive action. Polaris wants clients to be ready if this change does eventually get adopted into law. Life sciences companies should begin capturing the amounts associated with agreements in their data for reporting immediately.
For more information, please contact:
- Stephan Vincze
- Boston Managing Partner
- Tel: +1 617 444 8762