The Danish Patient Safety Authority says it cannot document the spot checks it previously claimed to have made on sperm donors’ family limits at European Sperm Bank.
DR reports that Styrelsen for Patientsikkerhed, the Danish Patient Safety Authority, was asked repeatedly for documentation of the checks. In a written answer, the authority states it is unable to confirm or deny that any spot checks were carried out.
The authority has supervised Danish sperm banks for the past ten years. It had told DR earlier that it monitored compliance with the family limit through spot checks, and that it did so at every inspection of European Sperm Bank.
Last week DR revealed that the company had been reported to the police. The Danish sperm bank sold sperm from 81 of its donors to more Danish families than the law allows. Figures from the bank itself show the breaches have continued since 2013.
Experts point to a supervision failure
Sten Bønsing, professor of administrative law at Aalborg University, calls it a huge problem that the authority earlier stated something it can no longer stand behind. He considers it doubtful that the spot checks were ever performed.
Kent Kristensen, associate professor of health law at Aalborg University, concludes there has been no formalized supervision of the family limit. As he told DR, documentation would exist if such supervision had taken place, and the child numbers have therefore not been under public oversight.
Under Danish law, each sperm donor may be used for children in a maximum of 12 families. For donors from before 2013, a recommendation of no more than 25 children per donor applies. Kristensen notes the limit exists partly to prevent inbreeding and the spread of hereditary disease.
He adds that spot checks on something this significant must appear in the inspection report that authorities are obliged to produce after a control visit.
Shifting explanations
In an interview with DR on December 5 last year, unit head Bente Møller said the authority made spot checks at all inspections. She estimated four, five or ten checks per visit, depending on the situation.
European Sperm Bank wrote to DR on September 7 that it is not aware of any such checks during the ten-year period. The authority’s latest answer says two inspections, in 2016 and 2018, may have touched on family limits. The inspection reports contain nothing about spot checks.
According to the authority, the inspections were carried out by staff who are no longer employed there. Bønsing says public bodies have a considerable duty to file and store material, and cannot depend on what employees remember.
DR has previously reported that the case directly affects 10,000 Danes. The group includes women treated with sperm from the donors where the limit was exceeded, and their donor children.
