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A sunshine act "à la française "

January 1st, 2012 - (IFPMA) - Healthcare Regulatory update


The new article L 1453-1 of the French Public Health Code requires a general disclosure obligation on any company manufacturing or commercializing products with a medical or cosmetic purpose. The obligation concerns all agreements such companies may have with healthcare professionals, students of medicine and other healthcare related studies, clinics and hospitals, foundations, press and communication agencies/companies, software editors of drug prescription related softwares, as well as with educational companies in the healthcare area.


The obligation will require disclosure of any advantages in kind or in payment provided by the companies to such persons mentioned above (the threshold amount triggering this disclosure obligation is to be determined by decree).


The law provides for fines for infringing the obligation of up to 45,000 Euros in respect of physical persons and up to 225,000 Euros in respect of legal persons.


In addition, the law requires the disclosure by those holding regulatory powers devolved to them by the French Ministry of Health, cabinet members and members of the new ANSM of any conflicts of interests when taking on their functions.


Enforcement decrees will precise obligations.


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