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
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.