Examination of Witnesses (Questions 1280
- 1298)
WEDNESDAY 19 JANUARY 2005
MS SUZI
LEATHER, PROFESSOR
NEVA HAITES
AND PROFESSOR
EMILY JACKSON
Q1280 Mr Key: What assessment have
you made of the impact of the Freedom of Information Act upon
your work at the HFEA?
Ms Leather: The Freedom of Information
Act has already had a very profound effect on the organisation,
both in terms of how open it is but also in terms of our management
of information—so a very profound impact. However, we have
been moving to openness in a very big way for the last two and
a half years. We meet in public; we put the research applications
on the website; the comments made on those research applications
by people are passed to licence committees; we have an embryo
research conference which is open; we invite people, including
people who fundamentally oppose the activities we regulate, to
our meetings and to that research conference; and all our inspection
reports are available. So we have moved a very long way; but,
like other public organisations, yes, there will be big demands
on us.
Q1281 Dr Iddon: Pursuing a question
that Dr Turner was asking a moment ago, it seems to me—and
this is a personal opinion—that some of the decisions you
have been asked to make would have been better made in a wider
forum. I know that you have been asked to make these decisions
by Parliament, but do you think that the time has come when we
should reconsider whether Parliament should debate some of the
more difficult applications, which set up general principles for
your work, rather than your body discussing them?
Ms Leather: I certainly think
that some of the decisions we have made must have seemed rather
confusing for many people, with seeming contradictions. The significant
area here is pre-implantation genetic diagnosis and tissue-typing.
These decisions certainly are not easy. In my own professional
life, I cannot think of an issue over which I have lost more sleep
than the issue of saviour siblings. I think that probably all
Authority members share my view that it would have been nice to
have had this chalice taken away from us, in a sense. We face
considerable scientific uncertainty. There is ethical unease about
this area of work. Ethics committees throughout the world have
been divided over this issue. It is therefore not easy. Above
all, however, we struggle because of the law. The original decision
that we made, the Hashmi decision—based on our policy,
which followed public consultation we conducted with the Human
Genetics Commission—was overturned, as you know, by the
High Court. The licence committee which was then faced with the
Whitaker decision was legally advised that we should not grant
the licence. The Hashmi decision was then reinstated by
the Court of Appeal, which confirmed our very wide discretion
in this area. The story has not ended there, however, because
the Hashmi decision will go before the House of Lords in
March. This is obviously difficult for us but, more importantly,
it is very difficult for the families concerned. In August 2002,
I publicly said that I hoped Parliament would go back and look
at this. Now we are saying please set out the purposes for which
you think embryo selection is acceptable, in the same way as you
have done for embryo research.
Q1282 Dr Iddon: One of the criticisms—and
I put it bluntly—is that, at some of your meetings, people
who might have had the competence to help you make some of your
decisions just have not been there, for personal reasons. The
decisions you make are in proportion to who turns up to the meetings
on the day. Obviously you have fewer people in your organisation
than the 659 parliamentarians in this place. It seems to me that
some of the decisions you are making are far too important to
be made by a body like yours, rather than referring them back
into Parliament where there might be the competence and, in any
case, if there is not the competence we could take advice from
people who are competent.
Professor Jackson: I think that
what Suzi is asking for is precisely that: for Parliament to take
a view on these matters. What we are faced with, however, are
licence committee applications. Parliament cannot make decisions
on individual patients. That would be completely impossible for
Parliament. We have to make those licence decisions; but we are
saying that we would welcome Parliament debating these issues
and coming to a view.
Ms Leather: In drawing up your
list, of course, be aware that there will always be a new technique
over the horizon. In addition to a positive list of situations
for which you think embryo selection might be acceptable—like
tissue-typing, like pre-implantation genetic diagnosis, like sex
selection to avoid a serious medical risk—it would be very
helpful to set out the principles by which whoever the regulator
will be can decide these new things which come along; because,
sure as fire, they will come along.
Professor Haites: We have set
up a horizon-scanning group which is international, with the aim
of trying to look ahead at the things that are going to hit us.
That may well then be able to feed into that loop, so that more
open discussion could be held.
Q1283 Dr Iddon: That is a good idea.
Could I turn to another concern that we have picked up, during
what is now a very long investigation? We have picked up a feeling
that there is a high turnover of staff, particularly in your regulation
department. Is there any reason for that?
Ms Leather: We do not have a high
turnover of staff. The national average turnover of staff is 16%
per annum, and it is of course higher in smaller organisations.
The turnover of our staff in the last 12 months annualises at
17.3%. So I do not think that we are out of the average here.
We are certainly, as part of our modernisation process, making
changes to regulation which will strengthen regulation and which
will make us more proportionate and more targeted. That sometimes
has some human resource implications.
Q1284 Chairman: There is no truth
then in the rumour or the assertion that there were ten people
there and they are going to go down to three? That is not true?
Ms Leather: Absolutely not. Some
people who were in regulation have moved across to another, important
part of the organisation, which is the historic audit project.
Q1285 Dr Iddon: As we have gone round,
we have picked up from the professionals in the field, both in
the public and private sectors, a feeling that your organisation
operates in a very inconsistent way, and that the outcome depends
on who is doing the inspection. It is a bit like the fire brigade.
Our Labour clubs are always complaining that another inspector
comes in, wanting another piece of work done that the other inspector
did not want done. We have had that kind of inconsistency argument
presented to us. We do know that one of your employees resigned
because he felt that there were unfair and inconsistent judgments
being made by your licence committees. Is this a concern of yours?
Have you picked this up and have you done anything about it?
Ms Leather: I think that historically
that is a fair accusation. We have done a great deal in the last
two and a half years to improve consistency, both within inspections
and within licence committee decision-making. For instance, we
train all our inspectors and accredit all of our inspectors. We
have introduced standard protocols for inspection. So I am confident
that, within inspection, that has introduced much more consistency.
The feedback we are getting from clinics indeed says that. The
clinics are telling us that we are much more focused and targeted
and they feel that it is much better. Within licence committee
decisions we have also moved to improve consistency. All licence
committees have legal advice and we monitor the decisions that
different licence committees make, so that we understand what
the precedents have been. However, under the legislation, a licence
committee cannot be fettered—either by another licence committee
or by HFEA policy. That is part of the structure of the legislation.
Professor Jackson: As Suzi has
said, each licence committee has legal advice, and it is important
that it is the same legal adviser. We have an in-house legal adviser
who has been appointed in the last two years. Because of that,
because she sits on every single licence committee, she is able
to ensure that they are making decisions which are consistent.
I therefore think that there have been some significant recent
improvements on this point.
Q1286 Dr Turner: It is probably true
to say that, under the current system, IVF treatment in the UK
is regulated as intensely as anywhere in the world. So how do
you account for the fact that, if you look at the international
comparisons of performance indicators, as it were, of success
rates per cycle and so on, the UK is at the bottom or low down
most of these league tables of international comparisons? Why
is it that in many respects IVF treatment in the UK does not seem
to have the success rates that, in particular, Scandinavian countries
have?
Ms Leather: But it has better
success rates than some other countries. I would have thought
that we were probably about halfway, but your scientific advisers
will tell you that. I do not think that you can read across straightforwardly
from that to the regulatory framework. However, all of Europe
is moving through the Tissue Directive into the regulatory environment,
so that all European countries will have a regulator. In fact,
our clinics which are currently licensed will benefit from the
fact that the HFEA has been in existence. They get another 12
months before the EU directive bites in this country, because
we have already had good regulation. In addition to that, we are
becoming more targeted and proportionate about our regulation.
So there will be an increasingly level playing field. I personally,
and I think the Authority as well, would like to see the clinics
themselves taking more responsibility for quality standards in
clinics; and then the regulator can check that. That, again, would
be a lighter touch. However, whereas perhaps 13 or 15 years ago
we were regulating very firmly and nobody else had regulators,
that is not true any more.
Professor Jackson: May I come
in on this success rate point? There is also the very important
factor that data are collected differently in different countries.
It is hard to read across, therefore, because what counts as,
say, an abandoned cycle in one country, might not be the same
in another. There are difficulties therefore about cross-national
data. The other thing is that the existence or not of a regulator
is not the only variable. There are other significant variables,
such as the extent to which there is public provision of IVF or
the extent to which it is done in the private sector. So I think
that it is difficult to highlight the existence of a regulator
as the only variable.
Q1287 Paul Farrelly: Touching on
the international context—and we have been abroad to see
how other regulators work and have been set up—if there
was one recommendation that we could make as a Committee that
you feel would improve the way regulation works in this country,
perhaps adopting some of the best practice from other countries
around the world, what would that be?
Ms Leather: In whatever model
the future regulatory organisation is to have precisely—and
I personally support the merger of the HFEA with the Human Tissue
Authority, I think that is a sensible move—I do think that
keeping together the regulatory roles that we currently have is
very sensible. There are other changes which are nothing to do
with the HFEA and nothing to do with regulation in a sense, but
which would have a beneficial impact on regulation. If you look
at the Scandinavian countries who have been able to move more
quickly, for instance, to single embryo transfer, it is very clear
that some of the factors to do with that are not just that the
neonatologists in Sweden have been talking to the IVF professionals
in a way which perhaps they have not here—partly because
there is so much private IVF practice here—but the availability
of publicly provided treatment has given patients confidence,
so that they feel they are not having to expend so much of their
personal money, and therefore that sometimes puts people off moving
to single or double embryo transfer.
Professor Jackson: One of the
most important things that Suzi has highlighted already is the
removal of the overly stringent confidentiality provision in the
1990 legislation, which I think has had a damaging effect on patient
safety and has hampered the possibility of doing effective research
into the longer-term outcomes of treatments. I think that would
be a really important point.
Professor Haites: In terms of
research in this area, linking all of the registries across the
country with the historic registries and allowing that data to
be analysed for minor, but still very significant, risk variations
in different techniques would be extremely helpful.
Q1288 Dr Harris: Do you think it
is important to create and use the evidence base and research
the evidence, before making policy decisions or recommending policy
decisions to government?
Ms Leather: I certainly do. There
are certainly decisions that we make—perhaps one that you
are particularly interested in, the issue of donor anonymity—where
there is not a fantastically good evidence base. For us, the issues
there were more principles. However, if we look at the two-embryo
transfer policy, which we adopted in our code of practice in January
2004, that was very firmly—
Q1289 Dr Harris: Let us take the
first one, because you could commission research. Did you do that?
Did you produce a paper to say, "This is the risk of increased
non-disclosure" and "This is the potential risk to gametes
supply"?
Ms Leather: We certainly did take
into account the risk that there would be fewer people, particularly
in the short term, prepared to come forward. Yes, we did take
that into consideration.
Q1290 Dr Harris: What about the other
risk, of more non-disclosure? What you did not recommend is that
parents should tell their children or would have to tell their
children. So the risk was of greater secrecy. There is a study
showing that over two-thirds worry that the father might be rejected.
Ms Leather: No, the evidence on
it does not show that. The evidence in Sweden shows that there
is a greater move towards disclosure within families when you
move away from donor anonymity.
Q1291 Dr Harris: That is not what
the Swedish told us.
Ms Leather: I am absolutely sure
that the removal of donor anonymity is a very important thing,
and we fully support it.
Q1292 Dr Harris: I understand you
do that, but I just wanted to clarify it.
Ms Leather: In terms of embryo
transfer, we looked both at our data from the register and at
the American data. It very clearly showed us where to put the
cut-off period—at 40, for instance.
Q1293 Bob Spink: I want to turn to
consultation and transparency and to ask you questions on that.
We are pleased that you are now consulting the public more. We
thought that was necessary. What notice will you take of what
the public feel? For instance, if the public think that the welfare
of the child is best served by the child having a father, will
you change your policy and advice to the Government on that, or
will you simply ignore the public?
Ms Leather: No, we will of course
look at the feedback we get from the public consultation on welfare
of the child. We will share that with government, and that may
or may not influence the review of the Act. However, the purpose
of that consultation was not to do with changing the Act; it was
to do with ensuring that our current guidance under the existing
legislation is appropriate.
Q1294 Geraldine Smith: Do you think
that you have given sufficient emphasis to the risk factors associated
with egg donation? What position would you be in if someone who
had donated eggs were to die or suffer a permanent loss of fertility?
What would be the legal position regarding the HFEA? Do you think
that you have paid enough attention to that?
Ms Leather: We certainly require
clinics to inform all patients of the risks of any of the procedures
they are taking part in, and that is absolutely core to informed
consent.
Professor Jackson: Our position
is to try to ensure that patients are as well informed as possible
before they volunteer to become egg donors so consent and the
informed consent provisions that we enforce are much more stringent
than they are for other sorts of medical treatment. For example,
consent has to be in writing. Our Code of Practice fleshes out
factors that people must be told about, that they must understand
before they consent, so we do our very best to ensure that consent
is informed. Legally, the position is if somebody were to die
as a result of egg donation the responsibility would rest with
the treating clinician rather than the HFEA.
Ms Leather: I hope you have seen
this booklet [Patient Guide to Infertility] which is a
very good guide both to infertility and to all treatments. We
wrote it in consultation with patient organisations and it has
been very well responded to, so I will leave it for you.
Q1295 Geraldine Smith: Do you actively
encourage gamete donation? Do you actively try and drum up support?
Ms Leather: No, I do not think
it is the authority's position to do that, but I do think we have
to ensure that the regulation that impacts on sperm, eggs and
embryo donation is fair, is evidence-based and is not putting
unnecessary obstacles in people's ways but no, I do not think
we have a responsibility to what you call drum up support, no.
Q1296 Dr Iddon: We have collected
some evidence that the draconian powers you have been given are
inconsistent with good risk management in the clinic, yet you
have gone on record to say that you need stronger powers, especially
for misbehaving clinics. How do you reconcile those two different
positions?
Ms Leather: I think that we need
more bows in the quiver, or whatever the expression ought to be.
I think the sanctions we have are rather all or nothing at the
moment, and some more intermediate sanctions would be helpful.
If, for instance, you withdraw a licence from a clinic, which
we have done and we have suspended—
Q1297 Dr Iddon: How many?
Ms Leather: I will have to let
the Committee have that—and we have suspended particular
treatments in clinics, but in making that decision you have to
bear in mind, of course, that in doing that you are harming other
patients who are in the course of treatment, so that is a difficulty
and I would ask you to give the regulator some more intermediate
steps.
Q1298 Chairman: Thank you very much.
I am sorry to rush you towards the end. We have some more questions
and we will write to you.
Ms Leather: And we will let you
know how many clinics we have withdrawn licences from.
Chairman: Thank you very much.
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