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In 2018 the so-called 'implant files' journalistic investigation concerning the certification and control of medical devices put on the market made media headlines. Now, the implant files have again become the centre of media attention due to a recent Paris Lower Administrative Court ruling, which highlights the inherent difficulty which lies in balancing various contradictory – but nonetheless important – rights.
In June 2020 the Cergy-Pontoise Lower Administrative Court ordered the suspension of the marketing authorisation for Baclocur (a Baclofene-based drug) on request of the Collectif Baclohelp patient association. In a recent ruling, the French Administrative Supreme Court found that the conditions necessary for the suspension of an administrative decision (urgency and serious doubt as to the decision's legality) had not been met. As Baclocur's suspension has been lifted, it can once again be commercialised.
Over the past two years, the French administrative courts have witnessed several proceedings concerning the use of Baclofen for alcohol-related disorders. The Baclofen saga highlights the difficulty for a health authority to make decisions lacking a purely scientific basis which aim, at least partially, to satisfy third parties.
Physicians, nursing trade unions and constituents recently petitioned the French Administrative Supreme Court with interim measure requests for the protection of fundamental rights during the COVID-19 crisis, resulting in eight rulings. Such interim measures (ie, injunctions or suspension of regulations) can be ordered for urgent matters when it is necessary to safeguard a fundamental freedom.
The French Administrative Supreme Court recently cancelled the Ministry of Health's decision to refuse to include Adcetris's extension of indication on the list enabling healthcare establishments to invoice drugs directly to the French health insurance system, which was based on a National Authority for Health opinion. The court notably ruled that assessments of public health interests concerning drug indications cannot be limited solely to the appreciation of prevalence.