The Federal Agency for Medicines and Health Products (FAMHP) has presented a recovery plan to the House Health Committee after it emerged that sperm from multiple donors had been used in Belgium beyond the legal limit of six families per donor.
The issue first came to light in May last year, when a Danish donor was found to have fathered 53 children across 38 families in Belgium. More recently, it was discovered that at least 93 donors had been used more frequently than allowed.
Following the revelations, an internal audit was carried out at the FAMHP. Public health minister Frank Vandenbroucke appointed Dirk Ramaekers, head of the FPS Ministry of Public Health, as crisis manager. He presented the recovery plan on Wednesday.
The plan builds on a government decision to abolish donor anonymity and proposes the creation of an Institute for Donor Data, where donor-conceived individuals will be able to access information about their donor. The FAMHP also intends to complete the central Fertidata database with data from before 2024.
Stronger oversight and capacity
A key pillar of the plan is tighter supervision of fertility centres. All centres will be inspected this year and next, with visits beginning this month, according to Vandenbroucke. Six additional inspectors are being recruited, and a dedicated unit will be set up within the agency to strengthen its capacity.
Fertility centres will also face stricter reporting requirements. Inspection reports will be made public, including the names of the centres concerned, and specific quality indicators will be introduced from next year. Additionally, the FAMHP is seeking the power to impose administrative fines to act more quickly in case of violations.
The plan further calls for more efficient data sharing, both within the agency and with the minister and other stakeholders.
Restoring confidence
Vandenbroucke commented on the gravity of the findings. The shortcomings were “very serious,” he said. “We will not let this pass as an isolated incident.” The measures are intended to restore confidence in both the authorities and fertility centres.
Vandenbroucke also warned that further irregularities are likely to come to light. These will be published systematically on the FAMHP website. From mid-2027, families will be able to consult the data themselves via a central register. In the meantime, fertility centres will inform those affected.
A second comprehensive audit by the FAMHP is due to be completed before the summer.
© PHOTO YUICHI YAMAZAKI / AFP
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