The European press has published information about a Danish sperm donor who carries a rare genetic mutation (TP53). Many European countries have been affected by this. In Belgium, this case has received extensive media coverage since May 2025, and several parliamentary hearings have taken place in which the FAGG responded to questions from federal parliamentarians.
Improving traceability and safety
To recap, these are the measures implemented in Belgium to prevent the recurrence of such incidents with tragic consequences for families and society:
- Since 1 January 2024, Belgium has had a central national donor register, called Fertidata. This system was established by the FAMHP to structurally improve compliance with the rule that limits the number of women who may be inseminated with the same donor to six. Every Belgian fertility centre is required to register the details of donors and recipients in this register before use, ensuring the quota is respected. Once the maximum of six women is reached, the donor’s sperm may no longer be used.
- Fertidata does not yet provide a complete overview of quota exceedances prior to 2024. Therefore, the FAMHP is currently working on a legal and technical solution to collect all historical data, aiming for full transparency for families and stakeholders.
- As part of its supervisory responsibility, the FAMHP conducts periodic inspections in fertility centres to check, among other things, whether they are using the Fertidata platform correctly, and takes action when violations are identified. In 2026, a new series of inspections is planned in all fertility centres, focusing on traceability systems and the follow-up of corrective and preventive action plans (CAPA). Centres that have not corrected past errors will be dealt with strictly.
- All inspection reports from fertility centres (except those that are part of ongoing judicial investigations) have been published on the FAMHP website. A reader’s guide has also been prepared to make the reports and their context more understandable.
- A legislative proposal is being prepared to lift donor anonymity and to establish a new institution - a contact point for donors, children born from donation, and families—with powers to report irregularities.
- The obligations of fertility centres are also being tightened.
Need for a European framework
As the competent authority, the FAGG takes the issue of responsibility for systemic shortcomings very seriously. Recent events have exposed vulnerabilities in the system and an organisational framework that was not robust enough to prevent certain risks.
Addressing these shortcomings requires a revision of the legal framework. In 2023, Belgium, together with the Netherlands, took the initiative for a central donor register with a European quota, as part of negotiations on the SOHO regulation. A European working group, led by Belgium, is now working on this dossier. The aim is to turn this crisis into a lever for systemic improvement, so that the protection of patients and children accompanies every step of the parenthood project.