Danish agency cannot document checks of sperm donor family limits

Denmark’s Patient Safety Authority cannot document the spot checks it says it carried out to ensure sperm banks complied with the limit of 12 families per donor, DR reports. The disclosure has intensified scrutiny of the authority’s oversight of European Sperm Bank.

Last week, DR reported that European Sperm Bank had been reported to police after selling sperm from 81 donors to more Danish families than permitted. Figures from the sperm bank show that the breaches have continued since 2013.

The Patient Safety Authority, which has supervised sperm banks for the past 10 years, previously told DR that it checked donor family numbers through spot checks during every inspection of European Sperm Bank.

But after DR repeatedly requested documentation, the authority said it could neither confirm nor deny that the checks had taken place.

“It is a huge problem,” said Sten Bønsing, a professor of administrative law at Aalborg University. He said the authority had either previously provided incorrect information or could no longer stand by its earlier statements.

Kent Kristensen, a lecturer in health law at Aalborg University, also concluded that there had been no formal supervision of whether European Sperm Bank complied with the family limit.

“If there had been, it would also have been possible to document it,” he said. He called the lack of supervision “really serious”, because it meant that the number of children fathered by donors had not been subject to public oversight.

Under Danish law, a sperm donor may be used to father children in no more than 12 families. For donors from before 2013, there is a recommendation of no more than 25 children per donor.

Kristensen said the limits are intended partly to prevent inbreeding and the widespread transmission of hereditary diseases if a donor is found to carry a hidden genetic defect.

He said spot checks of such an important issue should be recorded in the inspection report that authorities are required to prepare after a supervisory visit. In his view, the failure to do so represents a breach of the authority’s responsibilities.

The case directly affects about 10,000 people in Denmark, according to DR. They include women treated with sperm from donors who exceeded the limit and their donor-conceived children.

In an interview with DR on 5 December last year, Bente Møller, a unit manager at the Patient Safety Authority, said inspectors checked sperm banks’ systems and carried out spot checks during every inspection.

Asked how many checks were conducted during an inspection, Møller said the number varied but could be four, five or 10, depending on the circumstances.

Her comments followed DR’s report that a donor known as Kjeld from European Sperm Bank was the biological father of about 200 children worldwide. Without knowing it, he passed on a dangerous cancer gene to several of them.

European Sperm Bank told DR on 7 September that it was not aware of the Patient Safety Authority carrying out spot checks of the number of families or pregnancies linked to specific donors during the 10-year period.

The authority said that inspections at European Sperm Bank in 2016 and 2018 may have addressed family limits, but the inspection reports contain no mention of spot checks.