Examination of Witnesses (Questions 40
- 59)
MONDAY 14 JUNE 2004
MR RICHARD
KENNEDY, PROFESSOR
NEIL MCCLURE,
DR SIMON
THORNTON, MRS
LIZ CORRIGAN
AND DR
SUE AVERY
Q40 Mr Key: Fifteen years ago when
the Bill was being discussed before it became an Act, people were
then saying that technology is going to move on so swiftly in
this area that you will be back. I said you would be back in 10
years and in fact it was a little longer (it is probably a pity
that it was not 10). What challenges do you think the Act is facing
from the new technologies? After all, we are moving into an era
where, in effect, we are going to have fertilisation without fathers,
are we not? This is how the tabloids see it and this is your problem
and our problem. If you have fertilisation without fathers where
on earth are we going? Slippery slopes are coming out everywhere
you turn and this is what we are trying to address. What do you
see as the challenges to the Act from new technologies? Do you
think the HFEA is equipped to deal with those challenges?
Dr Avery: I do not think it is
and again, for the same reason, I do not think it was designed
to do so. If you look at the explosion of work relating to stem
cells and the issues there, we have two sets of issues: we have
the social and ethical issues in terms of using human embryos
to go into this research for proper information for patients and
proper ethical scrutiny of what goes on; then you also have the
science and the possible applications and the positive applications.
How is a body, set up as it is, that has a struggle to inspect
clinics and give them a four hour inspection, and a struggle to
deal with research licences in a timely manner, going to deal
with this kind of expansion? I cannot see how it can possibly
deal with it.
Mr Kennedy: Undoubtedly there
has to be a forum for determining policy in the future, for coping
with the new challenges, for coping with scope for research or
treatment which is going to expand, and dealing with that and
determining policy. That is where an element of the Authority
or the Human Genetics Commission—or a combination of both
or whatever—can deal with that in a way which develops policy.
What we are trying to do here is distinguish what is a policy
creating body or committee or commission as distinct from the
practicalities of administering of the day to day practice and
ensuring it is in compliance with whatever legal framework there
happens to be and whatever clinical standards we agree are appropriate.
Q41 Mr Key: So we might go down the
road of saying there should be more specific regulation for cell
nuclear replacement and therapeutic cloning and research on embryos
created by parthenogenesis but in fact, as we try to be more specific
with our regulation, someone will come along and say that parthenogenesis
is going to overtake all this anyway and it will all be irrelevant.
Dr Thornton: I think there is
a great danger in being very prescriptive about lists of things
that are covered. I think if anything it needs to be the other
way to keep the framework open to deal with the new technologies
rather than close it into a check-list of things that will be
regulated.
Dr Avery: The definition of an
embryo, as we know, did not foresee current developments and that
in itself has caused some problems.
Q42 Mr Key: In that case could I
ask you to think outside the box here. What is wrong with reproductive
cloning? Have we really got it wrong here to be worried about
this? Of course, safety is a thing which always comes up now as
the reason why we should not even think about it and it is not
going to happen because the risks are too great. However, if you
were to take the safety equation out of it, if it became safe,
would it be acceptable? Should it be acceptable? Should the Human
Reproductive Cloning Act 2001 be repealed?
Mr Kennedy: That is for society
to decide. It is not for individual clinicians, doctors, MPs or
nurses to decide; it is for society to decide on key issues such
as that. Cloning is a tiny, tiny, tiny area; it may become bigger
and certainly therapeutic cloning is important, but in terms of
the generality of the practice that we are faced with and that
our patients are faced with, we want a simple, easy, unbureaucratic
system to deal with that. By all means have a policy making group
which can engender public debate and move forward the issues such
as you are alluding to.
Q43 Chairman: Would you like to add
to that, Dr Avery? The answer so far is that society is going
to decide this. I am boggled by that. Could I have another solution,
please?
Dr Avery: If you take some of
the issues that have been consulted on, things like sex selection,
it is very interesting. The consultations have come back again
and said, "We don't want this". You could argue that
that is society's decision and you could also argue it that it
is the decision of those active members who are keen to get involved
in this debate. I am trying to remember what issue it was, but
there was certainly an issue on which the authority made a decision
where there was a strong argument that this was something that
should have gone to Parliament instead of being made within this
group.
Q44 Bob Spink: It was PGD.
Dr Avery: Yes, it was. I think
it is very easy to say that society should decide, but if you
are going to say that you have to decide through what mechanism,
is Parliament the body to represent society in this case?
Q45 Chairman: Is it?
Dr Avery: I would guess that if
you are going to make legislation on an issue like this or you
are going to make regulations and rules on an issue like this,
then I would not put it to a committee in a room, a committee
that is formulated by something other than a rigourous selection
of the relevant experts or the relevant people.
Q46 Mr Key: Government by experts;
we have been there before, have we not?
Dr Avery: I do not think that
that is the way an issue like this should be decided anyway. If
you are going to let society decide, let it be through Parliament
rather than a consultation that we know is not going to get a
representative view.
Q47 Mr Key: It has to be Parliament,
does it not?
Dr Avery: I would say major policy
issues such as cloning, sex selection are not issues to be decided
by a committee; they are issues for Parliament.
Q48 Mr Key: In order to guide Parliament
here, should perhaps the HFEA have a research budget? Should it
be doing the social as well as the clinical research?
Mr Kennedy: You give the scientists
the research budget; you give the MRC the research budget. You
let the scientists do the research, you produce the evidence and
once you have the evidence before you then you can judge whether
it is safe or not safe; what more research do you need to establish
whether it is safe or not safe? There are ethical bodies to determine
whether something is ethically appropriate or not ethically appropriate.
Q49 Dr Harris: Just following on
that last question, an argument against allowing human reproductive
cloning is that it is not safe, that there would be too many embryos
lost and so forth. You are all people who know about this field
and you have opinions. I am not asking you to speak on anything
but your personal opinion. Clearly there are arguments for and
against allowing human reproductive cloning. In your view, assuming
it was found to be safe—which I know may be years away—do
you see any ethical objection against human reproductive cloning
for fertility purposes, for treating fertility, in that for example
we do not ban identical twins who are effectively clones? If you
do, what are those ethical objections beyond the safety ones?
Mr Kennedy: I think it is a completely
irrelevant question in the sense that we all have opinions. My
personal opinion is that I would not do reproductive cloning.
Q50 Dr Harris: Why?
Mr Kennedy: Because I think it
takes us a step beyond where we should reasonably be going in
terms of utilisation of egg, sperm and treatment.
Q51 Mr Key: Why?
Mr Kennedy: We have enough problems
in perfecting and dealing with straightforward treatment, let
alone moving forward towards reproductive cloning.
Q52 Dr Harris: I understand that;
that is an argument against moving forward in other fields as
well. What is it specifically about human reproductive cloning,
other than the safety issues, that lead you to that view, which
I am sure is a common view? We want to go beyond the "yuk
factor" if we are having a proper review to find out what
the objection is?
Mr Kennedy: My objection might
be religious; it might be personal; it might be through life experience.
It could be any number of different things. I think the social
objection is a personal and an individual objection.
Q53 Chairman: Are you happy to happy
to leave it there with a Parliamentary process with the kind of
people who end up as MPs and members of the Lords to make these
decisions?
Mr Kennedy: Generally speaking
the Parliamentary process has been successful in steering a very
sensible pathway over the years. That is what democracy is and
I would not feel that that was an unreasonable route to take.
Dr Avery: We do not want to leave
it to the doctors and scientists to make those decisions.
Ms Corrigan: But all those years
ago we would not have had IVF if it had not been for a small group
of people who forged the frontiers.
Professor McClure: The situation
here really is parallel with IVF. Any new technique the public
does not have a view on it except we are scared of it. Fear is
often lack of knowledge, lack of understanding, lack of society
discussing around the issues and acceptance or rejection gradually
evolving. Therefore if we are going to have a Parliamentary process
through committees like this which feed back information and advice,
then that seems to me to be the ideal way to move this forward.
However, there needs to be a step below this sort of committee
which is a regulatory body which is aware of the advances, the
changes, the societal implications, the personal implications,
the dangers and which can make a recommendation about when that
magical point is where a process changes from being something
which is a fairytale through to something which is everyday clinical
practice. The process is very nebulous, how you move from one
to the other? It has to be through a chain of command but ultimately
it does need to be through Parliament.
Q54 Bob Spink: Can I just challenge
Professor McClure on that because I thought he just said that
society really takes no view on this.
Professor McClure: No, I did not
say that at all. Society's view is not obvious to those of us
who are trying to identify what society's view is; society's view
will change and it will change as issues become apparent and as
they are talked through.
Q55 Bob Spink: So basically you are
saying that society does not have a basis to take a rational view
on it and therefore society takes a view that is based on fear
et cetera.
Professor McClure: That is human
nature.
Q56 Bob Spink: I challenge that totally.
Society takes a view based on the danger to the individual that
he has created and based on the danger to society as a whole from
creating individuals when we do not have knowledge about the process
and where it is leading. It is perfectly rational for society
to be sceptical.
Professor McClure: And I do not
think we are saying different things. What I am saying is that
society's views will change as the issues are aired and people
become more conversant with the issues. The automatic response
of the person on the Clapham omnibus tends to be "no"
to something which they know nothing about which they are scared
of. As they discuss the issues, as they are absorbed by some process
of osmosis and society moves forward in this nebulous way then
views change. That is where we need a panel to identify that change
which can then feed back to this body or a similar body in Parliament
and into legislation.
Q57 Bob Spink: Yet the instinct of
society is to be fearful of these new technologies and perhaps
that instinct is extremely well based.
Professor McClure: Fears are often
foolishly founded and also often wisely founded, but I do not
know how you tell the difference to start off with.
Q58 Mr Key: Could I just return to
the question of the HFEA consultation on fees? This document was
published on 31 March as a consultation on Human Embryo Research
Licence Fees and a lot of people throw up their hands in horror
because the fee is generally now about £200 for the licence
and could rise to £6,000. I made representations to the authority
on behalf of the fertility unit at my own district hospital and
this morning I had a letter back from Suzie Leather in which it
is very clear as she says here that the £200 is a sum which
only meets a very small percentage of the actual cost of research
licensing and regulation and she is not going to get any more
money from any department—either the Department of Health
or the Department of Trade and Industry—so they have no
option if they are going to continue. What would be the impact
of raising the fee from £200 to £6,000?
Mr Kennedy: You would destroy
research in the area.
Professor McClure: Most research
is funded by charities. We are already facing major problems over
research governance; who is going to be responsible and so forth,
who carries what legal responsibility and financial responsibility?
If, on top of this, the very limited resources which we have are
going to be spent on £6,000 a year regulation for a project
which could perfectly well be regulated on a local basis by research
governance and ethics committees, this makes a complete nonsense—with
all respect—of what Suzie is saying. However, she does not
need to be doing this; it is a tier of bureaucracy which is left
over from the dinosaur age before the whole system of regulation
changed to where we are today. They do not need to be involved
in basic projects. Where that arbitrary line is needs to be defined
and it would take me some time to work through that in discussion;
the line is in the wrong place at the moment.
Q59 Mr Key: The chairman has said
to me that the authority has a statutory responsibility to ensure
that human embryo research is carried out within the framework
set out by Parliament but we will work hard to ensure that regulation
does not impede research. Would anyone like to add anything to
this problem of the £6,000 proposal?
Dr Avery: I just wonder to what
extent in making that costing the authorities looked at the efficiency
and the cost effectiveness of the procedures, particularly given
there is an example where you might have an inspection of your
unit for your licence one week and a team may come back the next
week and physically inspect you all over again for your research
licence but nothing is likely to have changed. Perhaps that is
an area they might want to look at and perhaps in an open way
in order to demonstrate that this is really necessary.
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