Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals, pharmaceutical and medical device manufacturers, and government officials, among others. As Reed Smith partner Daniel Kadar points out in “The French Sunshine Act Continues to Be a Challenge,” an article published in the April 2015 edition of eHealth Law & Policy, the law is viewed by many as a work-in-progress that requires frequent clarification. Daniel attributes this to the “erratic” evolution of the law, which he also chronicles in the December 2014 eHealth Law & Policy article “Implementation of the French Sunshine Act – One Year On.”
While the French Sunshine Act – which requires manufacturers of medical products such as drugs and medical devices to disclose any financial agreements or benefits with health care providers – formally came into law on January 1, 2012, its rules of implementation only came about in a decree adopted in May 2013 (which was applied retroactively to January 2012). June 2014 saw the introduction of a unique transparency portal to capture the disclosure information. And in late 2014, the French Directorate General of Health offered its own interpretation of the French Sunshine Act by deciding that the disclosure requirements should be extended to pharmaceutical and medical device manufacturers headquartered outside of France that have financial relationships with French health care providers.
Most recently, on February 24, 2015, the French Council of State expanded the scope of the French Sunshine Act even further. Under these new regulations, manufacturers of non-corrective contact lenses, cosmetic products and tattooing products are now required to disclose any financial relationships they may have with health care providers in France. The French Council of State also called for the disclosure of salaries given by companies to health care professionals such as physicians. This newest expansion to the law’s scope was covered in an article published in the March 2015 edition of eHealth Law & Policy in which Daniel is quoted. It is evident that the French Sunshine Act has gone through several transformations since its enactment, and the string of changes may very well continue into the near future.