“Depakine fathers” demand the same compensation as mothers – study strengthens call for recognition of paternal exposure

Paris – 10.07.2026: In France, fathers who took medicines containing valproate, such as Dépakine, before conception and whose children have severe neurodevelopmental disorders are seeking access to the state compensation mechanism. Until now, the rules have primarily addressed cases of maternal exposure. The request is being driven by a pharmacoepidemiological study by the Epi-Phare research consortium, which describes a statistically increased association between paternal use and developmental disorders in children during the three months before conception.

The publication of the analysis has already had regulatory consequences: the ANSM medicines agency has strengthened warnings in product information, reiterated contraception and counseling obligations, and drawn attention to alternatives depending on the indication. At the same time, it clarified that treating physicians must address risks when patients wish to have children. Sanofi, as the manufacturer, refers to risk minimization and information measures implemented since 2024/2025.

Political pressure is growing. Family representatives and the victims’ association APESAC are calling for fathers and cases caused by paternal exposure to be explicitly included in the out-of-court compensation procedure through the Office national d’indemnisation des accidents médicaux (ONIAM). A motion submitted in Parliament calls on the government to provide legal clarification. Members of parliament and senators argue that the historical focus on maternal exposure was due to the knowledge available at the time; more recent evidence now requires an adjustment of the scope of beneficiaries.

The government refers to ongoing reviews. Legally, the issues concern defining the relevant time window before conception, the burden of proof between exposure and established harm, and coordination with existing liability regimes. In practical terms, ONIAM procedures, expert assessment practice, and funding requirements are the focus. Experts emphasize that the administrative framework must be clearly defined to enable consistent decisions and avoid duplicate structures.

For the families concerned, equal treatment is the priority. They demand that children with comparable harm be compensated regardless of whether exposure was maternal or paternal. According to the associations, those affected held talks with ministries and parliamentary groups in recent days. Observers expect the specialist committees of the Assemblée nationale to organize hearings shortly in order to jointly assess the medical, legal, and budgetary aspects.

How quickly a legislative solution will be found depends on the outcome of these reviews and agreement between the government and the parliamentary majority. What is certain is that the Epi-Phare data have given new momentum to the debate, health authorities have adapted their recommendations, and the issue of including paternal exposure in the compensation system is now firmly at the center of the health policy agenda.