France: New approach for reimbursement of health products

One of the key changes introduced by the decree is that the costs of contraceptives for insured minors are no longer covered by health insurance. It also removes the obligation for the prescriber to write the claim "non substituable" in handwriting on the medicines prescription to exclude the substitution of originator medicines by generic alternatives (see our previous blog post, France clarifies situations in which physicians and pharmacists can exclude generic substitution).

In addition, the decree complements and simplifies various procedures for the reimbursement of medical devices by:

• Extending the validity of certifications for software that assists medical prescriptions by of a period of four months from the publication of the new French High Health Authority's standards and until 1 October 2021 at the latest.
• Making registration on the list of reimbursable products and services of medical devices incorporating the processing or hosting of personal data subject to compliance with the provisions of the EU General Data Protection Regulation ((EU) 2016/679) and the French Data Protection Act.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, October 2020 Issue (Thomson Reuters).

This post was originally co-authored by Jeanne Fabre & Eveline Van Keymeulen.