14 March 2011
Ann Furedi is writing in a personal capacityAppeared in BioNews 599
At the time, the organisation was a shambles. A new chair and relatively new CEO were trying to make everything better before it became clear how bad things were. Determining responsibility for the mess was hard because the entire outfit was so utterly dysfunctional. It was trying to improvise how to do a colossal, but poorly-defined, job while maintaining public and professional confidence in its infallibility.
The HFEA was trying to survive on a capped budget that had not increased since the HFEA was set up, despite a vast increase in the number of clinics and laboratories it was charged to regulate, the complexity of treatments and scope of research. Additionally, the world of healthcare regulation was undergoing a sea change, which meant the traditional inspections conducted by appointed HFEA members seemed amateur and unaccountable. Furthermore, the boundaries between HFEA members (half clinicians, half 'the great and the good') and the executive were ill defined, resulting in misunderstanding and strife.
In principle, at the start of its life, the HFEA seemed a great, innovative and far-sighted way of providing oversight to the ethics and practice of services and research involving embryos and donated gametes. It seemed the sensible home for a register of children born following donation. It had the potential to provide excellent arm's-length support for officials needing to brief ministers on complex, controversial and complicated matters. It was respected as an international beacon of good practice.
In practice, it was shambolic. Inspections were inconsistent and there were insufficient staff to produce timely reports. The necessary IT framework necessary for the HFEA Register of UK fertility treatments was not up to the job and staff would joke that the organisation's Ethics Committee meetings had the sophistication of a Radio 5 Live phone in (only with no one as smart as Nicky Campbell).
Things changed after several internal crises. A new budget was agreed, which opened the door for professionalisation, and sufficient good-quality staff to run a decent executive function. The external culture of inspection and accountability, with a Care Standards Act and its 'enforcer', the National Care Standards Commission (which became the Healthcare Commission, which became the Care Quality Commission) provided a context for better regulation. It was a new world and the HFEA was tasked to fit into it.
Now another decade on, we've seen the bedding in of independent healthcare regulation and a differently structured healthcare, where independent clinics are subject to inspection against clinical care standards - whatever their functions. We've also seen many complex ethical issues, utterly unconnected with human fertilisation, demand attention.
Looking at the HFEA in this new world, it is no wonder legitimate questions have been asked about its future. Do clinics providing fertility treatment require a different regulatory regime than those providing other care? It is accepted that abortion clinics (which I now run) work in a complex and, some would say, controversial environment and yet the Care Quality Commission regulates them and other specialist clinics.
Abortion clinics are inspected against standards that apply to the care they provide. Couldn't fertility clinics be regulated in the way? The same logic applies to research institutions. And, as regards to the HFEA's role advising Government, we should ask - why does the Government need specific ethical advice about the use of fertilised eggs and donated gametes? And, should it require such advice, is a body like the HFEA best placed to provide it?
The question we need to ask while the HFEA's future is being considered is, what would we want the HFEA to do if we were setting it up now? And why would we want this body, and not another, to do it? I am open to being convinced that the HFEA has a role, but I'm equally open to being convinced it does not. The fact that it exists is not an argument for its continuance, any more that its uneven track record is an argument against it.