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Caroline Arrighi-Savoie

Caroline Arrighi-Savoie is an Associate in Baker McKenzie Paris office.

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.

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.

Health Technology Assessment is a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing health technologies. This multidisciplinary process evaluates the medical, social, economic and ethical issues related to the use of a health technology. Health technologies encompass medicines, medical devices, in vitro diagnostic medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.

According to a parliamentary report dated 14 October 2021, shortages of health products are on the rise. The number of medicines of major therapeutic interest declared out of supply has increased from 404 in 2013 to 1,499 in 2019. As for medical devices, the French Health Agency estimates that, as of 8 October 2021, one essential medical device is currently subject to supply difficulties and has been for more than a month, which jeopardizes the continuity of patients’ care.