Examination of Witnesses (Questions 80-99)
MS SHIRLEY
HARRISON, ANGELA
MCNAB
AND PROFESSOR
NEVA HAITES
31 JANUARY 2007
Q80 Chairman: Why is there any doubt?
Ms Harrison: There does seem to
be a spectrum of opinion. As you know from the history of this,
and I am new to the job as you know, the Horizon Scanning Group
of the HFEA identified this as a possible issue some time ago.
We have had our Scientific Group look at it and give their views
and we have had our Legal and Ethical Committee look at it and
give their views. In general the view is that it probably falls
within our remit. Now is the point to go out and broaden that
consultation just to check out exactly where you started from,
the point of the broad spectrum of entities we might be talking
about. We do have two specific licence applications in front of
us but we want to have our policy to be able to cover possible
future applications that may come to us. We want to have some
broad guidelines. Our view is we will certainly feel it is important
that such work should be regulatable, licensable and not go on
in an unlicensed way. We need to be clear that is what the general
view is.
Q81 Chairman: I want to be clear.
Certainly from the press notice which you issued following your
last meeting, when you decided that you would go out to public
consultation, the clear steer which HFEA are giving is that you
believe this is within your remit?
Ms Harrison: We think it is probably
within our remit and we want to be sure. If we make a decision
based on shaky ground, then we would be open to challenge and
we would not want to do that.
Q82 Chairman: Since 1990 you have
been under shaky ground. That was the reason you were set up,
to actually give that lead. That is why we have been so successful,
because there has been a body which has been able to actually
make a clear decision on licences. What we are seeing now is significantly
different from what we were having in 1990. I put to you that
under the 1990 Act the use of human embryos for research was permissible
only where it was necessary—I think that was the definition—and
it cannot be carried out using animal embryos. Should a similar
restriction apply to the creation and use of these hybrid or cybrids,
if we want to use that terminology, and, if so, is the use necessary
because human embryos are in short supply? The argument that both
Kings and Newcastle are making is we are not getting enough human
eggs coming forward and unless we actually go down this line we
are not going to be able to develop the techniques to enable us
to go forward. This is about necessity, is it not?
Angela McNab: I think there are
two points but can I can go back, first of all, to the scope.
Q83 Chairman: You will not forget
this point.
Angela McNab: No. Let me take
the points in turn. The first point is in relation to do we believe
this potentially falls within our remit. There was, from those
scientists we consulted, a view that the entity or the embryo
that would be produced would be likely to have the full human
genome within it. However, there was not a consensus, from those
experts we consulted, about the viability, whether or not it would
be able potentially to implant and be viable. That is the second
test in order for it to be within our scope. I am not a scientist
so if there are further questions about the scientific view on
that I will defer to my colleague.
Q84 Chairman: They are not asking
them to be implanted but grown in a dish for up to 14 days.
Angela McNab: Indeed, but the
test of whether this falls within our remit has to be whether
or not it has the full human genome and whether or not it would
be viable. The second part of that question was not clear from
those scientists we consulted. It was for that reason that the
legal advice we had was, in order to be certain that we got as
much evidence as possible to base our policy on and to be sure
we did have the responsibility for this area of research, we should
explore that further with the scientific community. The second
issue you raised was about necessity. Again, there have been mixed
views about this expressed to us from the scientific sector. It
is very important, in putting together a policy, we are seen to
be acting in a fair-minded way. We have to now have an opportunity
to explore those views in more detail and gather as much evidence
as we can from the full scope of views on that matter.
Q85 Chairman: Are you actually saying
that every time there is going to be a difficult decision it is
now going to go out to public consultation?
Angela McNab: I am certainly not
saying that. In fact, I think it is because this is such a novel
area, such a large step, and because the issues are not black
and white, that in this unusual circumstance we have taken the
step of saying we will hold off from considering those applications.
That is something extremely unusual for us to do. It is not just
public consultation, although it is absolutely right and proper
in putting together a policy that we take public views into account,
but it is also, I must stress, an opportunity to hear the wider
views of the scientific community. That is very important both
in terms of the legal position but also in terms of the necessary
question that you rightly raise.
Q86 Adam Afriyie: Did HFEA make the
decision to go out to public consultation and, if so, were there
any discussions or pressure from Ministers to do so?
Ms Harrison: No, it was our decision
entirely. We made it at our last meeting on the 10 January.
Q87 Adam Afriyie: Government Ministers
were not involved.
Ms Harrison: No.
Q88 Adam Afriyie: There were no discussions
or debate about it?
Ms Harrison: We have a representative
from the Department of Health who attends our meetings, quite
rightly, and they were quite happy for us to go ahead with this
consultation. To be quite honest, everybody thinks it is a good
idea to gather as much information as possible from the wide spectrum
of views. Going back to the public element of this, clearly, as
Angela has said, the science is quite difficult to understand
but in some ways it is actually quite easy. I was speaking earlier
to a colleague about a little graphic that was in one of the newspapers
not very long ago which made it very clear that what we were talking
about in terms of hollowing out an egg, putting a stem cell in,
exciting it and growing some cells that you can experiment on
and then discard is really quite straight forward to understand.
The public is a wide spectrum of people including those who suffer
from horrible degenerative diseases for which there is no cure.
One of the first things on my desk when I started my job on the
2 January was a letter from somebody who suffers from motor neurone
disease. This is clearly an issue of huge public interest to a
very wide range of people.
Q89 Chairman: With respect, it was
of huge public interest nine months ago when this issue first
arose. You did not, at that time, say we must go out to public
consultation.
Ms Harrison: At that time we had
not the research applications for licences and so we were not
in any hurry, if you like, to make a policy.
Q90 Chairman: With respect, you have
not even examined those applications for licences.
Ms Harrison: They have arrived
so we know what they are.
Q91 Chairman: You knew what they
were nine months ago and nothing has changed significantly in
that time. It was quite clear that both Kings and Newcastle were
developing this line of research and would be coming to you with
licences.
Ms Harrison: Yes. As I mentioned
earlier, our Ethics and Law Committee discussed the whole issue
in May last year and the Scientific Group in April last year.
The discussions and gathering of evidence has been going on for
some time. It was only when it comes to the point where we have
to make a decision that we then had the basis on which a decision
had to be made.
Angela McNab: I just wanted to
add a little to that. You are absolutely right that nine months
ago, or even before that, we started considering, as part of our
horizon scanning, some of the issues that may well be coming to
us. We did not receive applications, I can confirm, until November,
much later in the year. It is also important to say that we ourselves
did state before receiving the applications, way back when we
were doing the early work on this, we thought this would be an
issue best dealt with in Parliament. However, as you will be very
well aware, we have a responsibility to respond and deal with
applications that come to us, and so we must do that. It is important
to say that ideally we would see this as best dealt with in Parliament.
Q92 Dr Iddon: I do not see the point,
with the greatest respect to the three of you, of having an horizon
scanning organisation and then waiting for an application to come
in before you do the consultation. Surely the idea of having an
horizon scanning department is to start the consultations prior
to the applications coming in so that you do not hold up vital
research. The way you are operating now is the research is being
held up.
Angela McNab: If I could answer
that because it is very much related to an operational issue.
I agree with you that in an ideal world the horizon scanning would
be showing you a variety of areas where, at some time in the future,
one might expect that there possibly could be applications, and
one would be developing a well formulated, well evidenced policy
in advance of that happening. However, you will, I am sure, appreciate
that our resources are limited and we have to make a judgment
call about which of those horizon scanning issues we are going
to be able to pursue, in terms of opening the full policy, and
at what stage. We have to make those judgment calls. Sometimes
we will not have something on our agenda or, in terms of well
resourced, being able to do it. Then we find that, in fact, the
science is advancing so quickly we realise that has come to the
forefront and we are going to have to do something about it. As
I say, we are in a difficult position. There is a review of the
Act that is under way. I think we made our views clear about feeling
this was an issue that would be best placed to be dealt with in
Parliament, nevertheless the advance of the science, and the scientists
wishing to proceed, obviously makes this an issue we have a responsibility
to deal with now. Had we known that a year ago we would have made
different decisions.
Q93 Dr Turner: A lot of the time
the scientific community would be of the view that the current
legislation, the current framework of regulation, comfortably
embraces the work proposed in both of these applications so that
there is actually no need either for further change in the law
or for public consultation on this issue and that it is, in fact,
an issue which the HFEA is perfectly legally entitled to pass
judgment on and to license. Can you please explain why you feel
unable to license this?
Ms Harrison: The discussion we
have had about it within the Authority is really to do with being
fair to everybody. Part of our legal advice was, in order to make
a decision which fairly gave everybody the opportunity, both proponents
and opponents of something which is after all extremely novel
and where there has been quite a lot of misinformation, and so
on, in the media. It was important to air those issues and give
everyone the opportunity, in a fair and transparent way, to input
into the evidence.
Q94 Dr Turner: That is not a legal
consideration. What were the legal considerations?
Ms Harrison: There is a legal
consideration about fairness.
Q95 Chairman: Will you publish your
legal opinion? Will you let this Committee have it?
Ms Harrison: We have given you
the gist and we have provided you with our draft minutes in which
the legal views were discussed that we were given.
Q96 Chairman: Why can we not have
the legal opinion?
Ms Harrison: As far as providing
that opinion, I think legal privilege requires that we retain
it ourselves. We may be the subject of legal proceedings at some
point in the future so it is important that we keep that.
Q97 Chairman: I thought you were
having a public consultation but we cannot have the legal basis
on which you have decided there is some question over whether
you could grant these licences under the 1990 Act?
Ms Harrison: We have tried to
give you as much as we possibly can and tried to be as helpful
to you as we can in this respect but our advice is we should retain
the legal advice to ourselves.
Angela McNab: I am sorry to say
the lawyers have made their position clear about this. I hope
what we have given you is a very good summary of the advice we
have received. To go back to the previous question, the real issue
for us is to ensure this does fall within our scope, and the viability
issue is key. That is one of the key things we will be testing
out in the consultation with scientists.
Q98 Chairman: This perhaps is unfair,
in which case say so. Are you conscious of the fact that procrastination
may well set back Britain's scientific development in this area
by a significant period of time?
Angela McNab: I certainly would
not want to see the Authority setting back scientific development
because I think the progress of science in this area has been
very much encouraged by good solid regulation and it is not our
intention to hold things back. However, what we are talking about
here is a need to be absolutely sure that we have been fair in
considering the issues and we are legally absolutely certain we
have the best evidence we can about the statutory responsibility
for the organisation of the Authority. It is, after all, a few
months. We have made an absolute commitment that we will get on
with this and those applications will, therefore, be able to be
considered before the end of this calendar year. In terms of holding
back, I would hope very much it is a few months.
Q99 Chairman: I am sorry, I cannot
let you get away with that. I agree your consultation is only
a few months and then some decision will be made in October, but
you have said earlier, and the Chairman has emphasised this, you
would like Parliament to actually make decisions in these areas.
Angela McNab: Let me clarify that.
I raised the point that ideally we did think, and continue to
think, that would have been the best position but we have a very
clear responsibility to act under the current law and once we
have carried out this consultation we have made a commitment that
we will consider this application. That is our responsibility
and we will do it. That is the position we are placed within.
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