The long-awaited implementation in statutory law of the fight against medical devices and in vitro diagnosis medical devices shortages mechanism is currently being discussed in the French Parliament, in a bill containing various provisions adapting French law to European Union law on diverse topics and particularly in the field of public health.
On 24 November 2022, the French Agency for the Safety of Medicines and Health Products issued three sentences against pharma companies that have failed to meet their reporting obligation regarding the risk of a medicinal products supply shortage or a supply shortage.
In August 2022, the French Agency for the Safety of Health Products published an updated version of its guidelines for determining financial penalties, which will come into effect on 1 October 2022.
The French Authorization for Temporary Use and Recommendation for Temporary mechanisms enabling a derogation for coverage of medicines were substantially amended by the Social Security Financing Bill for 2021.
With the aim of speeding up market access for innovative medicines and allowing exceptional access for medicines that meet a therapeutic need on an ad hoc basis, the new mechanisms of early access authorization and compassionate use were implemented as from 1 July 2021.
Almost a year after the implementation of such new early access mechanisms, the French High Health Authority and the French National Agency for the Safety of Medicines and Health Products gave a very positive first report on EEA.
On 20 April 2022, the French government adopted an ordinance adapting French law to EU Regulation 2017/745 on medical devices (MDR). Although the MDR is directly applicable since its entry into force on 26 May 2021, adaptations of the provisions of the French Public Health Code were necessary and much awaited by the medical device industry.