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Greater than the sum of its parts - comment from the HFEA

17 September 2012
By Peter Thompson
Chief Executive, Human Fertilisation and Embryology Authority
Appeared in BioNews 673

It's a busy week for the Human Fertilisation and Embryology Authority (HFEA). As we launch our government-commissioned public consultation on mitochondria replacement, we are in the midst of a public debate about who should regulate IVF and embryo research. We will publish our response to the Government's consultation on the HFEA's future later this week. This comment piece gives a taste of what we will be saying.

One of the key points we will be making in our response to the consultation is that the existence of a specialist, dedicated body for overseeing assisted reproduction and embryo research delivers effective regulation and targeted information which responds to the needs of patients, donors and donor-conceived people. Breaking that up would be a risky move.

At the heart of our regulation are the embryo, the patient and the donor-conceived person. We track the embryo, in both treatment and research. We provide the patient with essential safeguards and accurate information to enable them to make informed choices about their treatment. And we provide a means by which donor-conceived adults can access information about their genetic origins - information that we hold in trust, for all time. The integrated nature of our functions enables us to do these things in a joined-up, consistent way.

Our public consultation on mitochondria replacement, Medical Frontiers, is a case in point. Close working between our staff in different departments has enabled us to present the science in a clear way, to explore the ethical and social issues in depth and to tease out how - if it were made legal - we would regulate such a treatment and follow up the children born as a result. The Authority's thinking about what advice to give the Secretary of State for Health, in the light of this consultation, will be done in public by a well-balanced group of board members who bring different perspectives and expertise to the table.

It might be argued that this integrated approach could be maintained if the HFEA was transferred wholesale to the Care Quality Commission (CQC). Whilst such a transfer would keep our functions together, we think it would gain little in terms of cost savings. And it would do a lot to undermine the transparency and visibility of the IVF regulation.

The consultation estimates an annual saving - after transition costs - of £500,000. We take seriously the need to make savings across the public sector. Indeed, we have already saved £2 million (25 percent of our costs and a third of our government grant) since the abolition of the HFEA was first proposed in July 2010. But let's get this into perspective. Even on the Government's estimate, which we think is over-stated, the annual savings to the public purse from the transfer of the HFEA's functions to the CQC is equivalent to the cost of running the NHS for three minutes.

So, the cost savings would be tiny, but the risks of such a transfer would be much greater. If IVF regulation was part of the CQC, policy-making would be made by a small board with expertise in other areas or a bigger sub-committee in a non-transparent way. With a loss of visibility, the thousands of patients contacting us each year would be confused about where to go for information or advice and unlikely to receive the kind of attentive service that they receive now. The HFEA's reputation - and the public confidence in regulation that accompanies it - could be significantly undermined. It could take years to get this back.

On the face of it, transferring one regulator that inspects a small number of healthcare providers into another larger regulator that inspects a large number of healthcare providers must bring efficiencies of scale. But this misses the point about what they are inspecting and how they do it. The modest regulatory overlap which exists between the HFEA and the CQC can be resolved without a transfer of functions - that work is already underway and we set out in our response a proposal to make assisted reproduction clinics subject only to one regulatory regime.

So, when we respond to the consultation, we will be recommending the retention of the HFEA as a separate organisation. It might seem that by arguing for this option, we are driven by self-preservation. Not true. We don't think the HFEA is perfect: we can - and will - save more money and improve our service for patients and clinics alike. Work is already underway to address recommendations from IVF professionals about data collection and inspection. However, we genuinely feel that retaining a specialist, dedicated regulator which patients, donors and donor-conceived people know and trust is the best way of ensuring that IVF regulation maintains the public confidence that we have all worked hard to build.

SOURCES & REFERENCES
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