COPYRIGHT©2013 STRADLING YOCCA CARLSON & RAUTH, P.C.
Kathleen MarcusChair, Compliance Practice
Jason de Bretteville
(949) 725-4095 email@example.com
May 29, 2013 sycr.com
French Sunshine Act Requires Immediate Action
On May 21, 2013 France issued a decree implementing French Law No. 2011-2012 on theStrengthening of Health Protection for Medicinal and Health Products, known as the LoiBertrand or the French Sunshine Act (“the Decree”). The Decree imposes a generaldisclosure obligation on any company manufacturing or marketing pharmaceuticals,medical devices, and cosmetics in France.The Decree includes
disclosure obligations that apply to all benefits granted and agreements signed since
January 1, 2012
. Companies must transmit the information for 2012 to the National Council of the relevant health profession, such as the National MedicalAssociation, before
June 1, 2013
. The information must be published on companywebsites before
October 1, 2013
. The Decree includes the imposition of severe penaltiesfor failing to timely disclose the relevant data.
TO WHOM DO THE REPORTING REQUIREMENTS APPLY?
The Decree affects a broad range of health care companies, including any companymanufacturing or distributing any of the categories of products listed in Article L 5311-1 of the French Code of Public Health
(“Covered Companies”). These include companiesmanufacturing or distributing medicines, medical devices, cosmetic products, contact lensesand tattoo products. A Covered Company is subject to the Decree even if its products arenot eligible for social security reimbursement.Covered Companies must report and publish both benefits granted and agreement details, inFrench, with covered recipients. The Decree covers a broad range of recipients, includinghealthcare professionals (“HCPs”), associations of HCPs, medical students, patientassociations, hospitals, nonprofit associations, providers of medical software, consultingcompanies which advise on health products, companies running a press, radio, television or online public communication service or legal entities providing or participating in thetraining of healthcare professionals (“Covered Recipients”).
Article L 5311-1 covers: Drugs including insecticides, acaricides, pest control human products,compound, hospital and pharmaceutical preparations, narcotic substances, psychotropic or poisonous substances, essential oils, medicinal plants, raw materials
Contraceptive or contragestive products
Biomaterials and medical devices
In vitro diagnostics medical devices
Labile blood products
Human or animal organ tissue or cell
Therapeutic cells products
Contacts lenses products
Products for disinfecting sanitary rooms and vehicles
Ancillary therapeutic products
Non-corrective contact lenses
Micro-organism and toxin products
Devices that are not medicallynecessary but are used in medical biology laboratories to perform medical biology tests.