10 Human Fertilisation and Embryology
Authority and Human Tissue Authority
337. Clause
75 of the draft Bill, innocuously entitled "Amendments to
the Public Bodies Act 2011", would in fact result in the
abolition of the Human Fertilisation and Embryology Authority
(HFEA) and Human Tissue Authority (HTA).
338. Section
1 of the Public Bodies Act 2011 gives ministers the power by order
to abolish any of a large number of public bodies listed in Schedule
1 to the Act and to transfer their functions to another body.
Section 5 allows ministers to modify the functions of the bodies
listed in Schedule 5, or to transfer those functions, or some
of them, to another body. Orders under section 1 or section 5
are subject to the super-affirmative procedure, which allows either
House to refer the draft Order to a Committee of that House, and
requires the Minister to have regard to any recommendations the
Committee may make.[268]
339. Currently
both the HFEA and the HTA are listed in Schedule 5 to the Act,
so that the minister may modify or transfer their functions, but
may not abolish them. Clause 75 of the draft Bill would transfer
both bodies from Schedule 5 to Schedule 1, so that the minister
could abolish either or both of them and transfer their functions
to other bodies (in which case he would of course have no need
to modify their functions).
340. On
28 June 2012 the Department of Health issued a consultation paper
entitled "Consultation on proposals to transfer functions
from the Human Fertilisation and Embryology Authority and the
Human Tissue Authority". The paper noted that there was considerable
overlap between the functions of both bodies and the Care Quality
Commission (CQC). This point was repeated in oral evidence by
Ted Webb, the Department's Deputy Director for Health and Bioethics,
who told us that "There is an apparent overlap of their role
and that of the Care Quality Commission. Something like 300 places
that the Care Quality Commission goes to are also regulated by
the HFEA or the HTA, and something like 90% of the places that
the HFEA regulates in England are also regulated by the CQC or
are situated in places that the CQC already regulates."[269]
341. The
Department's preferred option was to abolish both bodies and transfer
their functions to the CQC, with the exception of the HFEA research
functions which would be transferred to the HRA. A second option
was to abolish both bodies but with different provisions for the
transfer of their functions. Option 3 was for both bodies to retain
their functions but to deliver further efficiencies. Responses
to the consultation were invited by 28 September 2012. 109 responses
were received. They were placed on the Department's website at
the end of January 2013. The overwhelming majority of them favoured
Option 3. Consultees were particularly afraid of losing the expertise
which both bodies had built up.
342. In
our Call for Evidence we also asked for views on these proposals.
Those we received were from the major research organisations and
their funders, and they unanimously opposed the abolition of either
body or the transfer of their functions. The Academy of Medical
Sciences replied: "There is a great deal of support among
our community for the HFEA and the HTA; both are perceived as
having developed the experience to respond in a balanced, practical
way to the changing landscape that reflects the evolving risks
and benefits of research. The relatively small savings to be made
through disbanding the HFEA and the HTA need to be balanced against
the inevitable period of disruption and uncertainty, and any potential
risk of loss of expertise, efficiency, effectiveness and coherence
that could hinder research and practice and result in the loss
of public and professional confidence…. We therefore support
retaining both the HFEA and the HTA, providing they work closely
with the HRA and other regulators to further streamline the regulation,
inspection and governance process for patient and public benefit."
343. The
Wellcome Trust reiterated much of the response they had given
to the Department: "Transferring functions away from the
HFEA and HTA would present a significant risk for loss of specialised
expertise and specialist function within the HFEA and HTA, and
potential corresponding impacts on researcher and public confidence
in the regulatory system. Furthermore, we considered the proposal
to split the HFEA's functions by transferring its research functions
to HRA, and the rest of its functions to the CQC, carried a risk
of losing cohesion between the HFEA's clinical and research functions
and diminishing its ability to keep pace with emerging treatments
and techniques. … In light of these concerns, we broadly
supported Option 3 in which the HFEA and HTA would retain existing
functions but deliver further efficiencies."
344. Cancer
Research UK supported the option of retaining the HTA and HFEA
while streamlining their functions, but did believe that "the
Department's preferred model could potentially be an acceptable
means to restructure the functions of the HTA and HFEA in the
future once it has been established that the CQC is able to perform
the functions to a standard that will support researchers in gaining
approvals and also public confidence in the handling of human
tissue and embryos." But the Royal College of Surgeons did
not believe that the CQC would be able to perform these functions:
"The College is concerned that the safe and ethical use of
human tissue is complicated and requires specialist expertise
and appropriate regulation which is sufficiently different from
the general regulation of health and social care currently undertaken
by the Care Quality Commission (CQC)."
345. Dame
Jo Williams, the outgoing Chair of the CQC, had said that the
preference of the CQC was that the functions of the HFEA and the
HTA should not be transferred to the CQC. At his pre-appointment
hearing with the House of Commons Health Select Committee on 5
December 2012 David Prior, the newly appointed Chair of the CQC,
was asked whether he agreed. He replied: "I think I probably
do, without knowing enough about it to give you a considered answer.
My basis of probably agreeing is simply that we have enough to
do, I think, in CQC to get our existing shop in order without
taking on a new responsibility. But I would have to take more
advice on that. That would be my gut feeling."[270]
346. On
25 January, four months after the consultation had closed, the
Department published their response to the consultation. They
said: "In the light of the above, we have decided, on balance,
that we will not pursue a transfer of functions at the present
time. However, retaining the HFEA and the HTA with further efficiencies
must take account of the support for a review of the way in which
the two bodies undertake their functions, with a view to reducing
the regulatory burden. It must also include a programme of work
on achieving efficiencies to deliver streamlining of their non-specialist
functions." Anna Soubry MP, the Parliamentary Under-Secretary
of State, said in the course of a statement: "Taking all
views into consideration, the department has decided, on balance,
that it will not pursue a transfer of functions at this time."
347. The
words "at this time" caused us some anxiety, and when
Dr Poulter gave oral evidence we asked him to confirm that it
was his intention not to include the current clause 75. He replied:
"… the clause as it stands will not be part of the Bill."[271]
348. Deletion
of the whole of clause 75 would ensure that ministers could not
now abolish either the HFEA or the HTA. It would however retain
the current entry of both bodies in Schedule 5 to the Public Bodies
Act 2011, allowing ministers to modify or transfer their functions,
if not now, at some future date. We believe that ministers should
retain this flexibility, which will in particular allow any changes
to be made which are needed as the work of the HRA develops. We
believe that ministers should not have the power to abolish the
HFEA or the HTA, and we recommend that clause 75 should be deleted.
268 Section 11 of the Act. Back
269
Q 33. Back
270
House of Commons Health Select Committee, 5th report, session
2012-2013, Evidence, Q 36. Back
271
Q 356. Back
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