Denmark’s sperm bank inspections have failed to meet legal requirements, the country’s patient safety regulator has admitted, adding a new dimension to the growing scandal over sperm donation and hereditary cancer risks.
The Danish Patient Safety Authority (Styrelsen for Patientsikkerhed) acknowledged in an official letter dated October 7 that it had failed to carry out mandatory on-site inspections following reports of serious adverse reactions or incidents at sperm banks.
Health Minister Ida Auken has now ordered a new investigation, with external legal assistance, to determine the extent of the failures and whether they had consequences for patient safety.
Mandatory sperm bank inspections were not carried out
Under Danish regulations, the authority must inspect sperm banks when serious incidents are reported, including cases where children conceived through donor sperm are diagnosed with severe hereditary diseases.
However, following questions from public broadcaster DR, the regulator acknowledged that these mandatory inspections had not taken place.
The agency said it had conducted other forms of oversight, such as reviewing reports and requesting additional information from fertility providers. Nevertheless, these measures did not fulfil the specific inspection requirements established by Danish law.
The authority has acknowledged that its procedures did not comply with the regulations and said it is changing its practices.
A scandal that began with a sperm donor carrying a genetic mutation
The admission follows months of investigations into Denmark’s fertility industry, particularly the case of a sperm donor known as Kjeld, whose donations were distributed by Copenhagen-based European Sperm Bank.
The donor unknowingly carried a rare mutation in the TP53 gene, which substantially increases the risk of developing cancer in children who inherit it.
An international investigation coordinated by the European Broadcasting Union initially identified 197 children conceived using his sperm. Further reporting by DR in June 2026 raised the figure to at least 211 children across 14 countries.
Although the mutation was discovered in 2023, many affected families were not informed of the potential health risks until the case became public in 2025.
The scandal subsequently raised questions about how sperm banks were supervised and whether national limits on the use of individual donors were being respected.
A September review by the patient safety authority revealed that, among 373 sperm bank inspection reports dating back to 2013, only three explicitly documented spot checks of compliance with donor limits.
The same review found that European Sperm Bank had reported 81 instances of donors exceeding Denmark’s limit of 12 families per donor.
The latest revelations therefore shift attention beyond the practices of individual fertility providers to the performance of the public authority responsible for supervising them.
Health minister demands a new investigation
Auken expressed serious concern about the latest findings, which emerged after the authority had already submitted two reports examining the fertility sector.
In an October 8 statement, the minister said:
I find this deeply unsatisfactory.
She has requested a comprehensive new report, prepared with external legal assistance, to establish whether the missing inspections affected patient safety and whether the authority’s wider oversight practices complied with Danish legislation.
The investigation must be completed by the end of January 2027. Auken has also summoned parliamentary health spokespersons for a briefing on Friday, October 9.
The controversy has implications beyond Denmark, given the international distribution of sperm from Danish donors.
The authority has also identified gaps in notification requirements for some facilities offering simple insemination. These providers are expected to fall under broader European Union rules on substances of human origin from August 2027.
For now, the central question remains whether the failures in Denmark’s oversight system delayed the identification of risks or prevented families from receiving information essential to their children’s health.
