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France: Presentation of 2021 measures for innovative medicines

13 October 2020

On 30 September 2020, the French government published a press release announcing the draft of the French Social Security Financing Bill (PLFSS) for 2021, which it presented as “one of the most singular exercises since the creation of the PLFSS in 1996”.

One of the main points of the PLFSS for 2021 is a specific focus on the improvement of access to innovative medicines. The PLFSS is implementing a flagship measure designed to simplify and speed up the provision of innovative medicines to patients.

The text provides for a total overhaul of the current system of access and treatment of medicines subject to Temporary Authorisation for Use or a Recommendation for Temporary Use in order to allow faster access to innovative medicines for patients and to give greater visibility to the players involved.

It proposes to set up a simpler, clearer, more unified and more predictable system based on two pillars:

  • Early access for innovative medicines in development and intended to be placed on the market.
  • Compassionate access for medicines that are not necessarily innovative and not initially intended to obtain marketing authorisation, but which respond satisfactorily to a therapeutic need.

The two pillars will guarantee even faster access to medicines for patients, by granting immediate and automatic treatment once access authorisation has been obtained.

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