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HFEA must address its 'misconceived interventions'

21 February 2011
By James Lawford Davies
Partner at Lawford Davies Denoon
Appeared in BioNews 596
On the morning of 15 January 2007, I attended a meeting about hybrid embryo research in the UK Parliament. Halfway through, I received a message from a journalist that fertility regulator the Human Fertilisation and Embryology Authority (HFEA) had announced there would be a press conference that lunchtime about a London IVF clinic, the Assisted Reproduction and Gynaecology Centre (ARGC) run by IVF specialist Mohamed Taranissi.

As I left the meeting, I was called and asked to go to the ARGC urgently. The scene upon my arrival was extraordinary. The first thing I noticed was that the clinic was full of patients, some of whom were in tears. At the top of the stairs, a number of police officers sat waiting while inspectors from the HFEA examined documents and interviewed staff about their involvement in alleged criminal offences - but without offering them the opportunity to have any legal advice or representation.

This raid was conducted pursuant to a warrant obtained that morning by the HFEA, relying upon evidence from the HFEA's Chief Executive, Angela McNab. The warrant was executed within hours and, while her team were at the ARGC, Ms McNab gave a press conference at the HFEA offices in Bloomsbury. Footage of both the press conference and the raid of the clinic were included in a BBC Panorama programme about the ARGC, broadcast that evening.

Although extraordinary in itself, the HFEA's raid of the ARGC was not the most remarkable aspect of their conduct towards the clinic. It subsequently emerged that the HFEA had colluded with the BBC in the making of the Panorama programme for many months before its broadcast. They divulged extensive information and provided regular - often daily - assistance to the BBC, going to remarkable lengths to facilitate the production of a programme which targeted one of the clinics the HFEA was obliged to regulate with impartiality and objectivity.

Beyond Panorama, they referred matters to the police, seeking to recruit former patients to provide evidence against the clinic, and they referred the ARGC's Medical Director to the UK's General Medical Council (GMC), which regulates doctors. Throughout this period, they also sought repeatedly to revoke the clinic's licence on the basis that the statutory Person Responsible was not suitable to operate a clinic.

Each of these interventions failed once put to the test. The warrant obtained by the HFEA on 15 January 2007 was quashed by the High Court, and Ms McNab was held to have given evidence under oath which was 'seriously misleading' and 'unfair and highly misleading'. The HFEA settled a libel case brought by the ARGC, making a statement in open court that they had no criticism of the clinic's medical practice.

After being withheld for several months, the clinic's data was reinstated with no substantive change, but only after the threat of judicial review. The GMC threw out the two cases brought against the Medical Director halfway through and the police dropped their investigation, indicating there had been flaws in the evidence submitted by the HFEA. Finally, after protracted licensing hearings, the ARGC was granted a new and unconditional treatment licence.

Many commentators observed this episode reflected poorly on the HFEA. Writing in the Times, Alice Miles said of the HFEA's involvement with Panorama that 'the HFEA was pandering to the cameras; sick behaviour from an unelected regulatory authority that appears to be out of its depth'. The British Fertility Society suggested that 'it would have been wise for the HFEA to have disassociated itself from the Panorama programme and conducted its own inquiries in isolation … To see the fertility regulator engaged in such a sensationalist TV programme causes considerable concern for professionals working in this sensitive area of medical practice'.

Phil Willis, now Baron Willis of Knaresborough, was quoted in the Sunday Times as saying 'Angela McNab must go.... She should not return to the HFEA'. Indeed, Ms McNab's successor as Chief Executive, Mr Alan Doran, wrote in an internal memorandum in April 2009 that this was a 'disastrous and dysfunctional period of time' for the HFEA.

He further wrote: 'The major attention, effort and resource of the Authority has gone into a series of interventions in respect of one [Person Responsible]. Not a single one of them has been shown to be well-founded; not a single member of staff has been asked to explain themselves let alone be rebuked not can we point to any explicit acknowledgment of the need to learn'.

For these and other reasons, Mr Doran concluded that there should be an inquiry into the HFEA's conduct in two particular areas: their involvement with the BBC in the making of the Panorama programme and their referral of matters to the police. It was proposed that this inquiry be led by an outsider with 'the requisite experience and seniority to ask difficult questions'. This also echoed an earlier call for an inquiry from the British Fertility Society, and indeed repeated calls from the ARGC itself.

After further discussion, the plan for an externally led inquiry evolved into an internally run 'governance review'. It was initially intended that this be presented to a HFEA meeting in Autumn 2009. This was then put back to Spring 2010 and its release has been repeatedly postponed since then. It follows that, at the time of writing this article, there has been no published review of the HFEA's conduct in 2007, no accountability, and no apology for the catalogue of 'misconceived interventions' (Mr Doran's term) against the ARGC. Likewise, there has been no scrutiny of the HFEA's use of huge amounts of public money to pursue these actions.

Why the need for this review of the events of 2007 in 2011? Much has been said and written in recent weeks about the future of the HFEA, and the possibility of a comprehensive review of its functions and operation. In principle, I would support such a review, which could prove to be an important contribution to reforming the regulatory and policy landscape for IVF and embryo research. However, such a review is only likely to be meaningful if it asks the 'difficult questions', and addresses the all-important issue of the accountability of the HFEA.

There are, of course, good reasons why we need regulators like the HFEA to have a degree of independence from government, hence their designation as an 'Arm's Length Body'. Such independence, however, makes accountability and transparency vital attributes for the HFEA and other bodies like it. Perhaps they will offer cogent explanations for their conduct in 2007 if the report of their internal review is ever published. However, in the absence of any public confrontation of the ghosts of their past, numerous and serious questions remain unanswered about their actions, which bodes ill for the prospects of real reform.

19 September 2011 - by Sandy Starr 
The UK's fertility regulator, the Human Fertilisation and Embryology Authority (HFEA), has published a long-awaited review of its conduct in relation to IVF specialist Mohamed Taranissi and related legal proceedings....
7 March 2011 - by Professor Anne Kerr 
Past and present members of the Human Fertilisation and Embryology Authority (HFEA) have challenged the UK Government's plans to abolish it. They say it's led to improvements in access to information and choice for patients, and to better treatment and research through careful regulation and inspection. Recently, the HFEA's record of preventing errors has been given as another reason to retain its special role regulating fertility clinics. But what is the evidence...
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