2022-09-29 22:00:00
The summary
Pursuant to Article 57 of the organic law of 1 August 2001 relating to finance laws, Christian Klinger, special rapporteur for the “Health” mission, carried out a budget control mission on the compensation system for victims of Depakine.
This system was put in place in 2017 to facilitate compensation for families whose children suffer damage following their mother’s taking Depakine during pregnancy. It is backed by the National Office for Compensation of Medical Accidents (ONIAM). The public health problem is major, since it is estimated that between 2,150 and 4,100 children suffer from malformations, and between 16,600 and 30,400 experience neurodevelopmental disorders.
The system was designed as an amicable compensation procedure, which would be simpler and faster than litigation. However, it suffers from a high rate of non-use in view of the epidemiological data available. There are many reasons for this: the compensation process is complex for the families, the compensation is less attractive than that decided by the civil courts, and the procedure is subject to significant delays. While the ONIAM college of experts is supposed to deliver an opinion in six months, the average time is 32 months.
However, this delay results from the initial unsuitable organization of the system, which led to the accumulation of a large stock of files. Since the 2019 reform, ONIAM’s college of experts has been examining files at a steady pace. For this reason, the Special Rapporteur does not recommend further reform. On the other hand, it is necessary to guarantee the stability and effectiveness of the compensation mechanism: the recent influx of litigation related to Dépakine must not destabilize ONIAM’s services, and the care of victims must be assessed for improvement.
It should be noted that ONIAM presents offers in substitution of the persons designated as responsible. SANOFI, which markets the drug, is the main laboratory concerned. So far, SANOFI has not acknowledged any liability in the Depakine case, and as such refuses to participate in the compensation scheme. No final court decision has yet been rendered on this issue, even though the first disputes started more than 10 years ago.
The complexity of the issue of liability in the Depakine case raises questions about the liability regime applicable to defective drugs. It comes under the common law regime for defective products, resulting from Directive 85/374/EEC, while medicinal products present inherent risks. The special rapporteur therefore proposes to initiate a reflection at European level on the liability regime applicable to medicinal products.
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