French Transparency Regulations: An Overview for the Life Science Industry Webinar
27 Feb 2014 - 27 Feb 2014 - WEBINAR
Thursday February 27, 2014 - 5:00 PM CET/11:00 AM EST to 6:30 PM CET/12:30 PM EST
After almost two years of drafts and debate, the so-called French Sunshine Act, was finally implemented by the French Ministry of Health by the Decree of May 21, 2013. Heavily motivated by both the US Sunshine Act, as well as local controversies such as the PIP breast implants and the case involving the drug Mediator, the French government has enacted the broad reporting requirements that entail disclosure from both pharmaceutical and medical device companies. However, the final Decree left many questions unanswered. Although interpretative guidelines have been published both by the health sector representative associations and French Ministry for Health and the process for disclosures on a single public website is taking form, compliance with the French Sunshine Act still remains a great challenge for many companies, since numerous issues remain to be clarified.