The ‘Commission Santé et Égalité des Chances/Commissie voor Gezondheid en Gelijke Kansen’ once again addressed donor matters at its meeting on 4 November 2025, including a presentation and explanation of the Federal Internal Audit report and the reading guide for the FAMHP inspection reports.
On Tuesday, 4 November 2025, the donor issue was discussed again in the ‘Commission Santé et Égalité des Chances/Commissie voor Gezondheid en Gelijke Kansen’. During this meeting, the Federal Internal Audit report and the reading guide for the inspection reports of the Federal Agency for Medicines and Health Products (FAMHP) were explained.
The commission paid particular attention to the status of the case involving the sperm donor with a TP53 gene mutation and the breach of the six-women rule.
Recent events in the fertility sector, findings from inspection reports, and the FIA audit report have revealed serious shortcomings in supervision and quality control. It is our shared responsibility to now restore trust among families, donors, and society.
Background
- In the summer, it emerged that a single donor was involved in 53 children across 38 families, in violation of the legal limit of six families per donor.
- Inspection reports and notifications have revealed serious incidents and structural shortcomings in the quality management of fertility centres.
- The FIA audit confirms that FAMHP inspectors and other staff deliver quality work, but highlights organisational weaknesses within the FAMHP: insufficient risk-based inspections, unclear follow-up of breaches, poor internal information exchange, and a lack of clear escalation procedures.
Why is this important?
The shortcomings identified, both at the level of the fertility centres and the FAMHP, have affected not only families but also trust in fertility care in Belgium and in our organisation.
Our country is known for high-quality care, but that reputation can only be maintained through transparency, strict compliance with regulations, and a robust control system.
What actions are now planned?
- Publication of inspection reports: all inspection reports of fertility centres (except those involved in ongoing legal proceedings) will be made publicly available on the FAMHP website.
- Legislative proposals in preparation: minister Vandenbroucke is currently preparing a legislative proposal to abolish donor anonymity. In this context, Fertidata will also be expanded to include registered donor data from before 2024. The obligations for fertility centres will also be tightened.
Three-part recovery plan
- Minister Vandenbroucke has appointed Dirk Ramaekers, Chair of the FPS Public Health, Food Chain Safety and Environment, as crisis manager at the FAMHP. In collaboration with the Director-General and the executive committee of the FAMHP, he is tasked with:
- developing a concrete and feasible recovery plan based on the FIA audit;
- coordinating and monitoring the implementation of that recovery plan;
- regularly reporting progress to both Minister Vandenbroucke and Parliament.
- Secondly, the FIA will conduct a second audit to map the entire operation of the FAMHP and help strengthen the organisation for the future. The results of this audit are expected by summer 2026.
- Thirdly, the FAMHP is planning an inspection round at all fertility centres, focusing on tracing systems and the follow-up of corrective and preventive action plans (CAPAs). Centres that have not rectified their past errors will face strict action.
Hugues Malonne, on behalf of the entire FAMHP, once again expressed condolences to all affected families. He emphasised that the agency and its staff are committed to greater efficiency and transparency in the future.
Together with Dirk Ramaekers, the executive committee, and all staff, he aims to restore confidence in the FAMHP through existing expertise and a targeted approach. The planned actions – publication of reports, legislative changes, adjustment of Fertidata, FIA audit, and inspections – mark the beginning of a structural reform of our organisation. Our goal: a transparent, high-performing, and reliable system that protects all our stakeholders.
In the interest of transparency, the agency has decided to publish the inspection reports of fertility centres (since 2020) on its website (FR/NL), accompanied by a reading guide (FR/NL). The recording of the session is available on the website of the Chamber of Representatives.
Contact and further information
For any further questions, please send an e-mail to icm@fagg.be.