Belgium strengthens oversight after sperm donor family limits breached

New regulations in sperm donation are being implemented by Belgium's Federal Agency for Medicines and Health Products (FAMHP), following revelations regarding the use of sperm carrying a cancer-causing mutation, and widespread breaches of donor limits.

In 2025, it came to light that a genetic mutation predisposing carriers to cancer had been present in sperm provided by a donor in Denmark, which was subsequently used in clinics across Europe. At the time, 23 children conceived from the donor were found to carry the mutation, ten of whom had been diagnosed with cancer (see BioNews 1319).

Professor Dirk Ramaekers, chair of the Belgian Federal Public Health Service, told the Brussels Times that the case highlighted 'structural shortcomings throughout the entire medically assisted reproduction chain.'

In Belgium, the donor was found to have fathered 53 children across 38 families; it has since been revealed that at least 93 other donors had also exceeded legal usage limits.

Belgium law on medically assisted reproduction, introduced in 2007 for ethical reasons, stipulates that no single donor may be used to treat more than six women. Similar limits exist in many countries, but officials have stressed that enforcement, rather than policy design, has been the central issue.

Professor Ramaekers told the Brussels Times: 'In hindsight, it is easy to point the finger at one specific thing or one specific person, but finding a scapegoat does not solve the problem. Instead, the system needs to be changed so that it cannot happen again.'

Appointed by health minister Frank Vandenbroucke, Professor Ramaekers has led a recovery plan following an internal audit by the FAMHP. The reforms aim to address systemic weaknesses in monitoring and enforcement across fertility clinics (see BioNews 1308).

One aspect of the reforms is improved donor transparency. This includes the removal of compulsory donor anonymity going forward, and the creation of an Institute for Donor Data to handle requests from future donor-conceived people about the identity of their donor (see BioNews 1330).

In addition, the existing 'Fertidata' donor register will be expanded to include records from 2007 to 2024, enabling better monitoring of donation breaches by clinics and governmental agencies.

The reforms also include strengthened oversight of the fertility industry, including increased inspections of clinics until 2027, and the establishment of a dedicated FAMHP unit to coordinate the activities of fertility centres.

'This is already happening for oncology and cardiovascular diseases, but not for fertility treatments in Belgium. We know that the results differ largely between the centres. Making these reports publicly available provides an incredible preventive incentive,' said Professor Ramaekers.

Finally, the reforms will introduce improved data sharing and faster, more structured reporting of quota breaches and other incidents between clinics and regulators.

'The aim is not only to offer concrete solutions to the shortcomings that came to light during the crisis,' Professor Ramaekers said, 'but above all to create a more transparent and safer framework for fertility care in Belgium, primarily for the benefit of families and donor children.'