The Federal Agency for Medicines and Health Products (FAMHP) has informed the Public Prosecutor's Office about the violation of the six-women rule in two fertility centres, announced Federal Health Minister Frank Vandenbroucke (Vooruit) on Wednesday.
The move to involve the Public Prosecutor's Office follows the scandal involving the sperm donor that made headlines last week: 53 children were conceived using sperm from a Danish donor who ultimately turned out to be a carrier of a cancer-causing genetic abnormality.
Two of those pregnancies ended in miscarriage, so ultimately there were 51 children. The fertility centres violated the six-woman rule, which stipulates that a maximum of six women may be inseminated with material from the same donor.
The FAMHP has now referred the facts that took place at two centres to the Public Prosecutor's Office. Vandenbroucke did not disclose which centres were involved.
Six-women rule
In one centre, the facts initially related to 2010, which may have been time-barred, but a recent inspection revealed that a woman was still being inseminated with the same sperm in 2014. At the second centre, Vandenbroucke was informed by the FAMHP that an investigation is underway and the Public Prosecutor's Office had been notified.
At a third centre, an inspection recently found that seven women had been inseminated with the same donor – five of them Belgian. The centre had incorrectly interpreted that the six-women rule only applied to women living in Belgium, it said.
The FAMHP did not refer the matter to the Public Prosecutor's Office, but issued a warning and a statement of shortcomings. Additionally, the agency stated that it has its own legislation that allows its officials to deal with a case administratively or to refer it to the Public Prosecutor's Office.
Vandenbroucke did not want to comment on this, but it is one of the issues that the Federal Internal Audit must evaluate. As is well known, Vandenbroucke has asked that body to investigate the whole matter, but also to review the functioning of the FAMHP.
