Danish clinics lost disease warnings as oversight failed for years

Several Danish fertility clinics and gynaecologists failed for years to warn donor-conceived children about hereditary diseases, according to a review by the Danish Patient Safety Authority, DR reports.

The conditions may include heart defects, chromosomal abnormalities or other diseases hidden in a sperm donor’s genes. In such cases, the mother and child must be warned immediately and offered genetic counselling.

Several clinics and gynaecologists did not notify women because they believed the responsibility belonged to the sperm bank, said Birgitte Drewes, deputy director of the Danish Patient Safety Authority.

“It is now very clear to them what the rules say and what their obligations are,” Drewes said.

Asked whether the authority had sanctioned the clinics, she said it operated under the Tissue Act, which provides relatively few administrative sanctions. The authority can report cases to the police, but limitation rules also apply, she said.

The review identified several other weaknesses. Some warnings were sent to old email addresses, while clinics are not required to ensure that the warning has been received. Under Danish law, the obligation is fulfilled when the woman has been notified; she does not have to confirm receipt.

In other cases, patient records and traceability data had been lost because clinics had closed, gone bankrupt or changed IT systems. Fertility clinics are required to retain traceability data for 30 years, but the authority said it did not know how many women may still be unaware of a serious genetic risk affecting their child.

Private clinics also lack access to the digital mailbox system E-boks and depend on outdated contact information. The authority said some lost data made it impossible to determine which women had been included in the affected datasets.

The problems went undetected by the authority for more than 10 years. Drewes said there had been no indications that would have prompted it to investigate the reliability of the notification chains more closely.

“It was only in connection with the review that we became aware of this vulnerability,” she said, adding that the authority would have acted if warning signs had appeared earlier.

Drewes expressed sympathy for families who are now wondering whether they were affected and whether the system should have worked differently. She said the authority would work to make the system more robust.

She advised families to ensure that their contact details are up to date with their fertility clinic. Anyone who is uncertain should contact the clinic directly, she said.

The review has been under way since the end of last year, after DR reported on a sperm donor with a hidden cancer mutation. According to DR’s investigation, the donor is the biological father of more than 200 children worldwide.

About 40 per cent of women treated with the donor’s sperm in Denmark were not definitively warned in time about the potentially fatal genetic defect.

Health Minister Ida Auken of the Social Democrats said after the review that she wanted stronger oversight of Danish fertility clinics and sperm banks. She plans to invite health policy spokespeople to negotiations within the next month, with the aim of putting forward a bill.