Two additional children reported in the TP53 gene mutation dossier

date: 07/06/2025

After a fertility centre contacted the Federal Agency for Medicines and Health Products, it emerged that its dossier on the sperm donor carrying the TP53 gene mutation was incomplete, as two additional children were reported. FAMHP inspectors immediately visited the centre for an inspection. The procedure is still underway. The FAMHP considers that the fact that the centre is communicating these elements only now, despite previous information and questions, is very serious.

On Friday 6 June 2025, a fertility centre informed the Federal Agency for Medicines and Health Products (FAMHP) that the information it had provided regarding the dossier of the donor carrying the TP53 gene mutation was incomplete. FAMHP inspectors immediately visited the centre to clarify the situation.

Timeline

  • On 28 May 2025, in response to the news, Minister Vandenbroucke instructed the FAMHP to contact the fertility centres involved again, asking them to provide additional information on the children involved in an anonymised way.
    The fertility centre in question confirmed to the FAMHP that two women were involved, resulting in the birth of three children.
  • On 3 June 2025, this information was reconfirmed by the fertility centre.
  • On 6 June 2025, the same fertility centre notified the FAMHP that its dossier was incomplete.

According to information currently available to the FAMHP, it appears that at this fertility centre, two additional women, each having given birth to one child from the donor in question, are also involved. In the meantime, these two newly identified women have been warned of the medical risk associated with this sperm donation.

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

We are currently preparing a hearing before the Committee on Health and Equal Opportunities of the Belgian House of Representatives, at which we will try to explain all the elements as clearly as possible.

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