In its quick review of Arm's Length Bodies, published last week (1), the Government announced the Human Fertilisation and Embryology Authority (HFEA) would be disbanded (2). The news was welcomed by some (3), criticised by others (4) and the HFEA put out a fairly terse statement (5).
It's hard not to believe fertility treatment is overregulated compared to other treatments - and, indeed, to infertility treatments outside the HFEA's remit. It is a well-known and curious anomaly that doctors who treat infertility with drugs or surgery or fresh sperm (in some cases) are not subject to the extra regulation although the interests of the patients and the not yet existing child - to those who agree this is a relevant concern -apply just as much.
Doctors are already subject to criminal sanction, employer sanction, General Medical Council (GMC) sanction, tort actions, the regulatory body for health care (currently called the Care Quality Commission, the CQC), any clinical governance and ethics oversight and, where relevant, NHS structures.
The main argument for the additional regulation of fertility treatments - mainly which are routine clinical practice - is that new advances raise ethical concerns. These require an expert body to hold consultations, provide advice to legislators and apply pro tem restrictions through licensing. What this really means is successive Governments have wanted an expert body to prevent the use of controversial treatments that might cause a fuss in the newspapers.
This function would not be required if there was a fully mature system of clinical ethics oversight and governance by healthcare providers, given the CQC's and GMC's existing responsibilities. One key question is whether this clinical oversight mechanism will be mature and effective when the HFEA disappears.
During pre-legislative scrutiny of the Draft Human Tissue and Embryos Bill 2007 , the joint Committee recommended against merging the HFEA and Human Tissue Authority (HTA) into RATE (the Regulatory Authority for Tissue and Embryos). They believed a single body would lack the expertise needed to cover two complex, but separate, areas.
I was never convinced this was a critical problem, because I was not certain that experts in the existing authorities were prepared to challenge papers from the executive, anyway. But, in any event, specialist sub-committees could be created to retain the expertise required.
I suspect the real objection to merger may be that those opposed to embryo research on principle are currently effectively prevented from serving on the HFEA. The dubious reason given is the HFEA's purpose would be defeated by containing people who oppose it. In a merged regulator, it is possible that someone who opposes embryo research could be appointed to the board, on the basis of general or tissue interest.
In my view, it's far better to have someone upfront about a contrary - albeit minority - view than to allow a subterranean fear of adverse tabloid over-reaction to distort decision-making. Provided the person respects the usual requirements of confidentiality, of course.
The loss of the HFEA is, however, some way off. Merging regulators and stripping functions requires primary legislation to amend the HFE Act 1990 and Human Tissue Bill 2004. There would be an opportunity for amendments to these bills to give Parliament the opportunity to decide the state of the legal framework. This is entirely right and proper in a democracy, even in one with little scientific expertise in the house. But, because it would allow elected politicians to debate issues on votes not subject to the whips, it will be a low priority for the Government and may never happen.
Sources and References
3) Our fertility watchdog is a huge success. Scrap it right away