Examination of Witnesses (Questions 480
WEDNESDAY 21 JULY 2004
Q480 Chairman: Animal/human hybrid
Ms McNab: Indeed.
Q481 Chairman: Do you have a view
on that in the HFEA?
Ms McNab: I do not particularly
have a view, because my job is to serve the Authority. My job
is to give them the advice and the evidence that they need in
order to form a view.
Q482 Mr Key: Would the view of the
HFEA be determined by the methods of the Authority coming to a
Ms McNab: Clearly that is where
the decision-making lies within the organisation.
Q483 Mr Key: What is the quorum of
the Authority? How many members must be present in order to make
a decision which is in effect a change of policy?
Ms McNab: I will have to check
that I have my facts right on this, but my understanding is that
it is two-thirds and that there has to be a lay majority.
Q484 Mr Key: How good are the members
of the authority at turning up? Because obviously a decision might
be quite different if the ethicist on the Authority is not there
Ms McNab: I think the first thing
to say about that is that we have an incredibly committed and
conscientious Authority and our attendance is extremely good.
The second thing to say is that, if there were a particular issue
that required specific expertise, we would defer that issue if
we were aware that members with that expertise, who would be particularly
wanting to contribute or if it was important to have their contribution,
were not going to be there. The Chair is particularly aware of
this situation. We would not allow a meeting to take place where
a crucial decision was taking place without the appropriate expertise.
Q485 Mr Key: Would you be willing
to send us a list of the attendances at the Authority's meetings.
Ms McNab: Absolutely.
Q486 Mr Key: Over the past year.
Ms McNab: Absolutely. I would
have no problem with that at all.
Q487 Mr Key: Thank you very much.
Each Code of Practice when it is coming out, the new edition,
has been longer than the last Code of Practice. In other words,
there is a regulatory burden which of course falls on clinics.
I wondered if you have any method of making an impact assessment
on the work of the clinics in order to comply with your regulations.
Ms McNab: I think, to some extent,
it is inevitable that, as the science becomes so much more complex,
the guidance or the detailed information that we provide to clinics
on how they can properly meet the standards also becomes more
detailed or more complex. As I said earlier, I think it is absolutely
right that we continue to look at the balance between proper safe
regulation and not being a burden. I am fully aware of the need
for us to stand back. In fact, I think it is very important in
the next couple of years, with the Tissue Directive, that we look
at what are the appropriate methodologies for regulation. I do
not make an apology for increased length if it means that we are
addressing some of the new complexities out of the developments
that are taking place. I think it would be much worse to say not
enough and for people to be left in a chasm of misunderstanding.
Regulatory impact assessments are carried out with every new bit
of guidance that we give. I can give you a really good example
here: Through our Alert system, we became aware that there were
a small number of problems arising with dewars, where gametes
are stored. We investigated therefore whether we should change
the standards, the guidance that we gave to clinics about this
issue, because it is clearly very important. If people have, for
example, had cancer and have stored gametes so that they can have
a family later on, the last thing they want to find is that those
have been made vulnerable because of a problem with the equipment.
We looked at this and we carried out a regulatory impact assessment,
as we do with any change of that kind: Looking across the board
at all the clinics, what will this mean for clinics if we impose
some greater standard to protect individuals' future potential
for a family? Then we put through a policy change. That is a really
good example of how the Alert system works well, how we can react
fairly quickly, but not impulsively, without consulting and looking
at the impact of what we do.
Q488 Mr Key: Have you discussed the
problem of regulatory and financial impact upon clinics and which
they dislike most: the regulations or the prospect of very substantial
Ms McNab: I have not given it
to them as a choice in that way: which do you like least, being
inspected or potentially having to pay more in fees, so I cannot
tell you which one they would choose. I have to say that we now
seek feedback from every clinic and after every inspection so
we certainly get comments about the quality of the inspections,
whether or not they were burdensome, whether or not they were
consistent and any comments that they want to make. We have also
done a survey of all clinics asking similar questions just recently.
Largely, clinics appreciate the inspection and regulation that
goes on because it is in their interests not to have rogue clinics
operating, not to have poor standards operating. They clearly
want the profession to be a quality profession that everybody
has confidence in and they support regulation very strongly. They
also see that through good regulation you can ensure that services
Q489 Mr Key: Why do you carry out
Ms McNab: In order to take account
of the public view on particular matters.
Q490 Mr Key: If your duty is to interpret
the statutes, is it really appropriate for you to do that?
Ms McNab: I think it is absolutely
appropriate and I was very pleased to see in the BMA's own response
that they agree that not necessarily purely relying on public
opinion but taking account of public views is very important indeed.
Q491 Mr Key: Do most of the views
come from one particular lobby group one way or the other or are
they generally representative of the public, do you think?
Ms McNab: I do not want to mislead
the Committee in any way. I suspect that it depends largely on
the topic that we are consulting upon. I suspect that there will
be some topics where there will be a lot of interest from a particular
community and maybe not so much interest from others. I suspect
that for other issues such as sex selection there will be a wide
ranging interest across a whole range of groups. If the Committee
would like me to look at the last few consultations that we have
had and give you a balance of the types of reply we have had from
different sectors, I would be very happy to do that. I do not
have those facts in my head, I am afraid. My apologies.
Mr Key: That would be very helpful.
Q492 Chairman: Is it your bet that
today the Authority will make a decision on the situation which
has been heavily trailed on the family in Northern Ireland?
Ms McNab: The policy regarding
PGD and HLA, as we have said, has been under review and the evidence
regarding that review is being presented to the Authority today.
Q493 Chairman: You are making a judgment
on a particular case that has been heavily trailed through the
Ms McNab: No, we are definitely
not doing that. We are reviewing the overall policy and information
is going to the Authority today.
Q494 Dr Harris: Will a decision be
made today? Is that your expectation? Is there a question to be
Ms McNab: The policy is being
reviewed and the Authority will wish to look at that policy as
it exists and consider the evidence put before it to see whether
it is now timely to change that policy. I cannot anticipate whether
or not the Authority will do that and I cannot absolutely guarantee
that that will happen today because the Authority must make its
own mind up when it sees the evidence presented before it.
Q495 Dr Harris: Is it scientific
evidence or has there been a legal development? What has changed
since the Whitakers were turned down?
Ms McNab: What has changed in
the area of PGD and HLA is that there is now two years' more data
across the world of carrying out these kind of techniques. Therefore,
there is information regarding outcomes, safety, and about the
data, not just in this country because a relatively small number
of these procedures are carried out worldwide, but there is collectively
two years' worth of experience and in addition any update on the
views of the public and on the wellbeing of the children.
Q496 Chairman: As members of the
public, will we see that evidence as presented to you?
Ms McNab: Absolutely.
Q497 Chairman: Will it be in The
Ms McNab: The minutes of all our
meetings go onto the web.
Q498 Chairman: Including the evidence?
Ms McNab: Including a summary
of the evidence, indeed.
Q499 Dr Harris: I am still confused.
I am not clear about this. You did not mention in your reasons
why the policy might change legal advice or legal changes. You
said public opinion, which you have already caveated as not being
critical, scientific work and the safety of the procedure.
Ms McNab: Forgive me if I misled
you. Whenever any policy review is carried out, it will look at
the legal, the ethical, the medical, the scientific evidence that
there is and it will take account of public opinion. Those are
the principles that underpin all policy, whether it is new policy
or policy review, and those are the areas of evidence that will
be presented this afternoon to the Authority.