Sperm donation - TP53 gene mutation and exceeding the limit of six women per donor: information and internal crisis unit

date: 06/06/2025

Context
At the end of 2023, following a biovigilance alert, the FAMHP asked Belgian fertility centres to inform the parents of children born from a specific sperm donation that their child(ren) had potentially inherited a mutation in the TP53 gene, which is potentially carcinogenic. In line with its responsibilities, the FAMHP had also asked them to provide the necessary follow-up.
It has recently been confirmed that 51 children from inseminations carried out in Belgian fertility centres are concerned by this sperm donation. This represents 37 families living in Belgium and abroad.

Limit of six women per donor
The Belgian law of 2007 on medically assisted reproduction and the disposition of supernumerary embryos and gametes states that no more than six different women can have children from one and the same donor. However, the FAMHP has noted that this provision has been broken in recent years, which raises questions.

The FAMHP has also referred two fertility centres to the public prosecutor. 

Information
On the initiative of Belgian Health Minister Vandenbroucke, a joint press conference was held with the FAMHP to present the chronology of events and discuss the roles and responsibilities of the actors involved.

At the same time, the FAMHP is in contact with Belgian fertility centres to gather all available information. The dossier will be presented to the Belgian House of Representatives at a hearing scheduled for 17 June 2025.

Audits
In view of the extent of the dossier, a compliance audit will be carried out by the Federal Internal Audit Service (FAI) at the request of Minister Vandenbroucke. It will cover internal processes, enforcement, inspection and external communication.
The FAI will also be asked to carry out an audit of the entire organisation.

Internal crisis unit
In order to respond to the situation in a rigorous, transparent and responsible manner, the FAMHP has set up an internal crisis unit dedicated to managing this dossier.

Contact
All questions (from press, politicians, citizens, associations ...) and information related to this dossier should be sent to icm@fagg-afmps.be.

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