In October 2018, Decree No. 2018-864 on the presentation, information and promotion of health products and related services entered into force, which was adopted pursuant to Article 58 of the Social Security Financing Bill. The decree introduces measures that aim to provide quality information to assist healthcare professionals in their therapeutic choices for health products, such as medical devices. In particular, the decree amends the Social Security Code in that it determines:
- The conditions under which the presentation, information and promotion of health products and related services should take place (such as during medical visits). The High Health Authority (HAS) is competent to set up the certification procedure framework for such activities, which will apply as of 1 January 2019.
- The procedure to set up a quality charter regarding information and promotion of medical devices and other health products (other than medicines), as well as the conditions for approval or renewal of the charter, which is originally valid for a two-year period.
- The procedure to report infringement of the charter by companies, as well as for the Economic Committee for Health Products (CEPS) to impose financial penalties as a result of such infringement.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, October 2018 Issue (Thomson Reuters).