The President of the Family Division, Sir James Munby, has spoken of 'widespread incompetence' in the fertility sector and has questioned the adequacy of the regulatory framework overseen by the Human Fertilisation and Embryology Authority (HFEA).
The comments came in a High Court ruling concerning seven cases that involved administrative errors or anomalies in the taking of consent. The errors meant that the legal parental status of the parents affected was put in question, with legal and emotional consequences that followed. Each of the applicants sought a declaration that they were the legal parent of their children.
Following a court case in 2013 in which problems were first brought to light, the HFEA required fertility clinics to carry out an audit of their records (see BioNews 792). Of 109 licensed clinics, 51 subsequently reported anomalies in their records, including an absence of consent forms, forms signed after the treatment commenced or forms that were incomplete. The HFEA has since indicated there may be a further 75 cases.
'The picture revealed is one of what I do not shrink from describing as widespread incompetence across the sector on a scale which must raise questions as to the adequacy if not of the HFEA's regulation then of the extent of its regulatory powers,' said Lord Justice Munby.
'That the incompetence to which I refer is, as I have already indicated, administrative rather than medical is only slight consolation, given the profound implications of the parenthood which in far too many cases has been thrown into doubt.'
Unmarried parents undertaking fertility treatment using donated sperm or embryos are required to provide written consent to the partners' legal parenthood. The HFEA requires clinics to comply with certain formalities for a partner of a woman receiving treatment to be treated as a legal parent, including consent given in writing before treatment commences, and also the provision of adequate information and the offer of counselling.
In making a declaration of parentage in each of the cases, Lord Justice Munby said there was sufficient evidence that even where forms had been lost, consent had been given in its proper form in accordance with the statutory framework. He emphasised that this did not involve a 'reading down' of the statutory provisions, ruling also that errors made when completing the forms could be rectified by the court.
He then emphasised that all clinics should 'meticulously and all times' comply with HFEA guidance and
'I cannot help thinking that it might be better if this FUNDAMENTALLY IMPORTANT requirement, and the potentially DIRE LEGAL CONSEQUENCES of non-compliance, were expressed in more emphatic, indeed stark, language and, in addition, highlighted by appropriate typography. By appropriate typography I mean the use of bold or italic type, CAPITAL letters, or a COMBINATION of all three,' he said.
Commenting on the decision, the HFEA said: 'We are working with the clinics involved to make sure affected patients are contacted and offered the support and advice that they need. We have also changed our approach on inspection to make sure that consent processes in clinics are tightened up and that staff are properly trained.'
It is likely there are more couples whose parental legal status may now be in doubt because of administrative errors. 'The cases I have before me are, there is every reason to fear, only the small tip of a much larger problem,' said Lord Justice Munby.