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On 5 December 2024, the French Government was forced to resign following the vote of non-confidence by the French National Assembly towards the Social Security Financing Bill (“PLFSS”). A new Government was then appointed on 23 December 2024. As a result, 2024 ended without a PLFSS for 2025, leaving the Pharma and MedTech industries in uncertainty, particularly regarding the safeguard clause mechanism.   A Special Law To Prevent From Any Shutdown The PLFSS is debated…

26 December 2023 marked the enactment of the annual French Social Security Financing Bill for 2024 (LFSS). As every year, the LFSS introduces a number of changes which could have a significant impact on companies in the life sciences sector. This year’s LFSS includes amongst other, new measures to fight shortages, a reduction of the maximum contribution payable under the safeguard clause for certain medicines and a new clawback mechanism for manufacturers of medical devices…

On June 13, the French Government released a list of 450 medicines considered “essential” to meet patient priority needs and which require specific measures to ensure their availability. Medicines were selected according to shortage criticality combining frequency of use and severity in case of shortage. The current list is available here but is not set in stone. It is intended to be enriched and updated according to changes in the French population’s needs and the…