Examination of Witnesses (Questions 1159
- 1179)
WEDNESDAY 8 DECEMBER 2004
DR RICHARD
KENNEDY, PROFESSOR
ALLAN TEMPLETON
AND PROFESSOR
LESLEY REGAN
Q1159 Chairman: Thank you very much
for being patient; we are slightly late and we hope to finish
by half-past eleven, so the Committee will be short, sharp and
as ugly as ever, I guess, in the questioning. If you could be
the same in your answers it would help us get through more material,
which would be very useful because we do recognise your importance
in our inquiry. You will have seen the evidence that we have taken
and seen what we have been doing. The Committee has been to the
Vatican, been to Sweden and is very knowledgeable, I guess, about
the whole issue now, across the board, and you are going to add
to that, I hope. Would you like to start up, Allan?
Professor Templeton: Yes, thank
you very much. Thanks for the invitation. If I could start just
by giving an RCOG perspective, which I think is one of the main
reasons I am here—
Q1160 Chairman: Do not be long because
we have some questions. Okay?
Professor Templeton: Do you want
two minutes?
Q1161 Chairman: One-and-a-half. I
am timing now.
Professor Templeton: By and large,
we think the Act has worked—by and large. There are rough
edges and the rough edges include the database, the need for confidentiality,
the welfare of the child, particularly, and then the accreditation
process. If there is an opportunity to revisit some of these things
within a revised Act then I think that Act should reflect the
difficulties with the current Act. So, broadly, we think it has
worked, we think there are various issues that could be put right,
if the opportunity arose. Another issue, of course, which I understand
that you re not considering but is tied up with the HFE Act of
course, is the aspect of the upper gestational limit for abortion,
and I think we would probably advise that that was taken out of
any revision of the future—
Q1162 Chairman: You would like abortion
to be considered separately from this?
Professor Templeton: Separately.
I think that appears to be the gathering feeling, although of
course there are many issues, as you well know, to do with abortion
at the present time, and not just the upper gestational—
Q1163 Chairman: I would like to question
you on why, but that is not within our remit at the minute. You
could argue it might be or should be but the Committee has decided
to concentrate on one particular area. I will ask you the first
question about the proposal to merge the HFEA with the Human Tissue
authority. This will be a new regulatory authority, in a sense.
What do you think about that proposal? Hare-brained, or do you
think it is sensible?
Professor Templeton: Neither of
those. I think it is something we need to think through a lot
more. It is not a completely daft idea in that much of the activity
to do with the HFEA—
Q1164 Chairman: Had you considered
it at all as a possibility?
Professor Templeton: We had not
considered it until the proposal came up with the review of the
arm's length bodies, in fact. If it is going to be a reality then,
of course, someone needs to sit down and work their way through
how that would work in practice. I do not think any of us have
really done that thoroughly enough to give informed answers. It
is going to have to work, I guess, and we are going to have to
do that in due course, but I am not convinced it is necessarily
a good approach in the sense that I think there is public concern,
particularly, about reproductive technology and reproductive matters.
I think there should be a focus on that, from the public reassurance
point of view. I should say that the one thing the HFE Act has
achieved is it has allowed the progress of clinical practice and
science within this country within a framework that has been broadly
reassuring to the public. Of course, that was one of the major—
Q1165 Chairman: Another area within
this issue is animal experiments. You would not guess it by the
publicity, of course, but in terms of the Home Office issuing
licences and so on, that is closer to Parliament and Government
and so on. Would not a model like that be satisfactory to you?
Professor Templeton: I think it
might well work. The analogy in the medical field might be the
inspection and regulation of the abortion clinics, for example,
which is the other area of our practice that is covered by legislation.
It may well be that that approach—a sort of hands-off, professional
inspectorate and a much more focused approach, informed by a more
professional input into the accreditation system standards—
Q1166 Chairman: Allan, do you not
think you are catching the wrong wave? It is all happening around
you now, and it is going to be decided. People are blinking and
deciding on these things and you are still thinking about it.
What does that say about you and your pro-activity levels?
Professor Templeton: It may be
the direction of the wave but I think it does, in honesty, require
a little more thought. I have not heard very clear indications
of how the whole thing would work. We are putting our view, which
is carefully thought through in the sense that we have 15 years
or so of experience of regulation, but we also have very considerable
experience of visiting and accreditation in other circumstances,
so it is from that kind of perspective that I would advise this
sense of direction in relation to the regulatory aspects.
Chairman: The canny Scot approach, I
guess.
Q1167 Dr Turner: We are interested
in exploring the ethical boundaries, for instance, of what is
possible and what is legislated against. So if it comes to a position
such as whether you permit a couple the freedom to choose the
sex of their child, who do you think should be making that decision?
Should it be Parliament, should it be a regulator or should we
leave it to the couple or the clinician? Who do you think should
take that decision?
Professor Templeton: There has
to be some sort of legislative framework which allows the decisions
to be taken in an appropriate environment. If it is new technology,
if it is a new treatment that might threaten public anxiety or
that might have safety and efficacy issues, there first of all
has to be a system backed up, in my view, by legislation, that
allows you to take these decisions. Having settled that then,
I think that in the approach that the HFEA have adopted—leave
aside the composition of the actual 21 good members and true for
the moment—there has been insufficient clinical and scientific
input into those discussions (and we can touch on that if you
wish). I think these individuals reflecting, to some extent, science
practice, the public and society, should be in a position to provide
some guidance. That guidance can be translated into the regulations
or accreditation systems, however we decide it is to be done,
in due course. I think Parliament for the framework and then these
decisions, such as sperm selection. I personally have no problem
with sperm selection (I ask myself "Why not?" and I
do not come up with a good reason why not), but I do have a problem
with sex selection where it would require either abortion or even
PGD. I just have reservations for that particular reason, but
that is a personal position. One would have to look collectively
at what would be permissible within society. You need, I think,
a responsible body that can move and reflect on these issues.
Q1168 Dr Turner: At the moment, we
have, effectively, a body that is responsible both for policy
and for regulation of that policy.
Professor Templeton: Yes.
Q1169 Dr Turner: What is your feeling
about it? Do you think it right it should be the same body or
do you think the functions should be separated? What do you think
would be the effect on public confidence if we did that?
Professor Templeton: I think probably
they should be separated. However, that is changing. I think the
HFEA themselves have recognised that the regulatory processes
rather than the structures have been less than satisfactory—in
fact, have been quite inefficient in many respects, and we have
seen examples of that. So I think the two should be separated,
essentially. Coming back to the model the Chairman was indicating,
of an animal inspectorate kind of separate inspectorate, following
standards and guidelines produced mainly by the relevant professional
societies and so on, it may be that policy down to that regulatory
body—should sperm selection be in or out, for example—could
be fed into it, but I do not think the policy-making body, if
you like, should be very much involved in the regulatory process.
I do not think that is a model that I have seen working satisfactorily.
Q1170 Chairman: If your fellow witnesses
want to jump in, please indicate.
Professor Templeton: I know that
Richard has had a go in the past.
Q1171 Dr Turner: Given that Parliament
sets out in legislation the boundaries, do you think you actually
need a separate policing-making body? Can we not leave it to clinicians
to make decisions in the light of the particular circumstances
of the given patient?
Professor Templeton: You could
but I think, probably, in many instances the clinicians would
welcome a view that they felt reflected the views of, in the broader
sense, society on what would be acceptable because it gives them
some protection as well in what they can offer as a treatment
and what they can reasonably turn down, if you like, as a treatment.
Something just one step removed clinicians also find helpful.
Q1172 Dr Turner: Dr Kennedy, you
have told us previously that if they were to set up a human genetics
commission that they could take on the role of policy making.
Would you want its decisions to be binding? Would Parliament have
to accept its advice? What is your view of the actual constitutional
role of a human genetics commission?
Dr Kennedy: I am not so sure I
am expert enough to answer that question. I agree with Allan that
policy should be determined by a body such as that we have previously
referred to. Parliament's duty and role is to provide the overall
overarching regulatory framework within which that policy is constructed.
Q1173 Dr Turner: So you would not
favour a model whereby the commission advised Parliament on what
is reasonable at a given time and then Parliament actually did
the regulation because Parliament was reflecting, if you like,
the will of the populace?
Dr Kennedy: That would then infer
that the legislation would have to be altered from time to time
and the legislation should have sufficient latitude and flexibility
to allow a policy-making body to work within an overarching framework
and to adapt policy according to particular needs and particular
issues that come forward. Research will make new findings that
will determine whether particular procedures are safe or not safe
and the policy would then adapt accordingly. Then the inspector
and licenser would police that policy.
Dr Turner: That is a useful view.
Q1174 Tony McWalter: That latitude
that you want in the law potentially might allow such a body to
end up taking decisions that depart very widely indeed to what
the public would assent to and we might get into a rather disparate
conflict situation between that body and the sort of general view
of the public as expressed through the people they elect to Parliament.
So, clearly, whatever latitude you want, I am suggesting, needs
to be, in fact, itself quite closely articulated if those taking
these decisions are not to start removing themselves quite markedly
from public opinion, which, as you indicated, is a source of consolation
to them when they are trying to take difficult decisions.
Dr Kennedy: The current legislation
does provide some very strong reassurances to the public and it
provides some boundaries within which policy can be determined.
I would not envisage there being great alterations in those boundaries,
particularly as referenced to the embryo and care of the embryo.
In answer to your question, that would depend on the construct
of the policy-making body and its representation. Presumably that
would require due care and attention to ensure that that policy-making
body properly reflected the wide opinions in society and wide
medical opinion—scientific advice.
Q1175 Dr Iddon: I have a table here
showing pregnancy rates per embryo transfer—otherwise known
as parameters of excellence—expressed in terms of IVF treatment
and ICSI. It shows that the UK is more than halfway down the table.
Why is the quality of assisted reproduction that low in the UK?
Dr Kennedy: I have not seen that
particular data and I suspect that that data needs to be examined
closely in respect of the epidemiological background to the material
that is entered into the data and aspects of treatment such as
the number of embryos that are replaced. (Copy handed) Thank you.
So I think, looking at that data baldly and saying that "in
comparison with . . . we are such-and-such" you have to look
inside the data and determine whether or not there are aspects
of care that we are providing which are different and whether
clinical practices differ from country to country.
Q1176 Dr Iddon: Assuming there is
a problem (I accept that is a big assumption) do you think there
is any way that Parliament could regulate to improve that?
Dr Kennedy: I do not think Parliament
could regulate, but I think it is up to the professional bodies,
such as the Royal Colleges and other professional organisations,
to ensure that the clinical standards and laboratory standards
of practice are such that they strive to produce the highest standards
of care and the best possible results of practice.
Q1177 Dr Iddon: Would restricting
single embryo transplant to the NHS help, for example? Would it
bring more care in the transplant procedure and bring better results?
Dr Kennedy: One of the important
adverse consequences of assisted reproduction in the United Kingdom
is multiple pregnancy, and this is clearly an issue that we have
to address—urgently, in my opinion. There is increasing
data to suggest that single embryo transfer produces pregnancy
rates in selected groups which is similar to the pregnancy rates
produced with higher numbers of embryo transfer. I think that
requires very careful examination and, indeed, there are proposals
currently to conduct within the United Kingdom a clinical trial
to look specifically at that issue.
Q1178 Dr Iddon: Are there any other
improvements in practice similar to that which we could recommend
in our report?
Dr Kennedy: I think the European
Directive which is on our imminent horizon is going to require
standards of laboratory practice to be reached across the European
Union. I actually believe that the standards of laboratory practice
in the United Kingdom are very high but, clearly, there are areas
within which we can look at improving techniques and improving
quality management. The EU Directive will add momentum to standardising
quality management across United Kingdom laboratories.
Q1179 Dr Iddon: Do you think there
is any sense in striking off clinics that have rather bad rates
of success?
Dr Kennedy: I think the inspectorate
and licensing process has to have the teeth to be able to challenge
under-performing clinics, in the same way as CHI would challenge
an under-performing trust and exert the same teeth. Yes, I do
believe that bad results should be challenged.
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