Fertility Journal

Can Assisted Conception be over-regulated by the HFEA?

In 1991 when The Human Fertilisation and Embryology Act [HFE(Act)1990] came into force, clinics were regulated by what appeared to them to be a fearsome body. It was very much “them” and “us”. There was poor rapport between the Authority and the clinics.

With the huge advances in assisted conception over the last 20 years there were first modifications of the original 1990 Act and then the new HFE(Act) 2008. Many areas have been clarified and the regulation of clinics has increased dramatically.

In the early 1990s many clinics felt that they were victims of a new authority flexing its muscles. In the culture of blame and the aura of witch-hunt that existed then, clinics undoubtedly covered up errors.

It is to the credit of the HFEA that the rapport between themselves and clinics is now excellent. Clinics are required and encouraged to report all incidents so that the causes can be corrected and lessons can be learned. The HFEA’s response even to a serious incident is to be supportive and constructive.

In spite of all the regulation, incidents are still occurring. The most recent figures show that reported incidents have almost doubled from 2007-8 to 2008-9. Although disturbing, incidents are below one per cent of more than 50,000 treatment cycles carried out in 2008-9. Many incidents are relatively straightforward, such as the admission to hospital of a woman with ovarian hyperstimulation syndrome (OHSS). Although potentially serious, the vast majority of OHSS cases resolve. In contrast the transfer of an embryo to the wrong woman is not inherently hazardous to the life of the woman, but can have devastating effects on both the recipient and the rightful “owners” of the embryo.

Assisted conception today is far removed from the early days of regulation. It is a complex science moving with astonishing speed. Strong enforceable regulation is essential. The potential for error by clinics is huge and it is to their credit that the majority of clinics have developed safe and largely foolproof working practices. The HFEA have provided clinics with an impressive Code of Practice which provides clear guidance on the mandatory requirements of the HFE Acts. The HFEA is transparent in its activities and consults widely with both the profession and the general public.

I had the privilege of being a clinical member of the HFEA between 2006-2009. I have never before worked with such a remarkable group of people. The skills and dedication of the Executive are extraordinary. The reports produced for Authority meetings are clear and precise and show a depth of understanding of the issues that is rare even in clinics.

Regulation must continue to be vigorous and sensible without immobilising clinic activities. Good regulation gives clear delineation of what can and cannot be done. It does in fact remove doubt and sets clinics free.

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