A new rule, adopted on 29 December 2011 and published on 30 December 2011 after an unusually expedited procedure due to strong government pressure, will heavily modify the regulatory framework in which healthcare companies, but also to some extent cosmetics companies, operate in France.
Besides replacing (next August, but the law has immediately been enforced) the current government healthcare agency (AFSSAPS) with a new ‘National Agency for the Security of Drugs’ / ‘Agence Nationale de Sécurité des Médicaments’ (ANSM) which will have more control powers and will be able to fine non compliant actors, the new law sets out transparency requirements for healthcare and cosmetics companies that are comparable to those provided by the US ‘Sunshine Act’.
The new article L 1453-1 of the French Public Health Code imposes 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 fixed 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.
The new law also sets forth new pharmacovigilance requirements and provides more stringent rules concerning the advertisement of drugs as well as – this is new – medical and diagnostics devices.
More details will be provided in follow-up decrees to be made in the coming weeks. In many cases, this new regulation sets very stringent standards which will require all healthcare companies, but also to some extent (in particular in terms of the transparency requirements) all cosmetics companies, to restructure their businesses in France.
For more information, please read the issued Client Alert here.
