Following the press articles published today concerning a new case of quota exceedance involving a foreign gamete donor, as well as the publication of the relevant information on its website, the Federal Agency for Medicines and Health Products (FAMHP) wishes to clarify the situation. The FAMHP emphasises that the identification and publication of new quota exceedances form part of the Agency’s ongoing work and reflect its commitment to transparency towards citizens.
As the FAMHP has previously indicated, several factors explain the increase in the number of quota exceedances recorded since 2025. For instance, more detailed information is now available thanks to the launch of a dedicated application for biovigilance notifications. In addition to this, there are spontaneous reports from fertility centres regarding exceedances identified within their own centres, as well as new findings resulting from increased inspections.
These various measures have logically led to the detection of new quota exceedances.
Furthermore, the FAMHP has already emphasised that the quota exceedances recorded to date, which are regularly updated on its website, do not yet reflect the full picture. However, the publication of information on these exceedances enables the agency to fulfil its duty of transparency towards citizens, pending the consolidation of the data through the implementation of the new central donor register, which will incorporate retrospective data.
Recent press articles show that such exceedances are occurring in several countries, which once again highlights the need for a European approach. The establishment of a central European donor register and the harmonisation of the quotas applied in the various member states are essential tools for preventing quotas from being exceeded, improving the traceability of cross-border donations and ensuring confidence in, and the quality of, medically assisted reproduction. The agency will continue to actively advocate for these developments with other European authorities and institutions.
Finally, the FAMHP is continuing the implementation of its ‘Recovery plan for the supervision of fertility centres’ in order to guarantee the safety, quality and efficacy of gamete donations in Belgium, to improve the transparency of the system and to sustainably strengthen the protection of families and children born through donation.
Excerpt from the official page. The original is authoritative.