Examination of Witnesses (Questions 500
WEDNESDAY 21 JULY 2004
Q500 Dr Harris: The implication of
your earlier answer was that the Whitakers were turned down on
the basis of factors that now may have changed, which were public
opinion and two years of data on safety.
Ms McNab: Any policy which is
set or reviewed is based on those principles that I have outlined.
They include the legal principles, the medical, the scientific
and ethical evidence and any information that is available about
public opinion. That is the evidence that would have been considered
when a new, controversial technique such as PGD with or without
HLA was first considered by the Authority and that is the information
that will be considered today in a review.
Q501 Dr Harris: My understanding
was the Whitakers were turned down on legal grounds; it was outside
the powers of the HFEA under the HFE Act to license that activity.
Has the law changed?
Ms McNab: My understanding is
that when this technique was first considered and an application
was first received, there was a limited amount of evidence regarding
the long term safety and the outcomes from this particular procedure.
The balanced view at that time was that, in the case of the Whitakers
where there was no potential benefit to the embryo being created,
it was considered not to be for the welfare of the child to allow
this procedure to go ahead.
Q502 Dr Harris: You have had a legal
opinion to that effect?
Ms McNab: The weight of the evidence
at that time was a lack of information about the safety of this
procedure. Clearly, it is an invasive technique one is carrying
out when you are carrying out a PGD or an HLA on an embryo. There
is a biopsy involved. Therefore, one needs to consider what is
the evidence about long term safety to the embryo being created.
What are the potential psychological implications of a child being
created in order to save the life of another, a whole range of
information about the wellbeing of the embryo that is being created.
My understanding is that at that stage, at this very early time
when this new technique became available, there was very little
evidence and therefore a precautionary approach. It was the view
of the Authority at that time that, from the point of view of
the welfare of the child, because in the Whitakers' case there
was not a benefit to the embryo being selected, this could not
Q503 Dr Harris: What you are saying
is that there is not some legal opinion there in the files that
has not been published by the HFEA that says you cannot do this.
I do not disagree with your analysis. I understand where you are
coming from in respect of the lack of benefit and potential risk
to the embryo but you are saying that all this is in the public
domain and there is no secret legal opinion.
Ms McNab: As I have said, the
evidence that will be presented to the Authority this afternoon
will be presented on the web, along with the minutes. That will
not be a secret at all.
Q504 Chairman: Safety is one of the
issues. Would you say that there is new data on safety?
Ms McNab: We have two years' experience
that we did not have when the first applications of this kind
were received by the Authority. This is a situation which is bound
to happen again and again. A new technique becomes available,
something novel, something that looks as if it has huge benefits
potentially. An application is made to the Authority. There will
be two decisions to be made. One will be about the overall policy
regarding such a new technique and one will be about granting
a licence to an individual clinic to carry out that process or
not for the individual couple. I have to draw that distinction
because it is important that you know that even in an overall
policy about a particular application you still need to have an
application from a clinic to carry that out for a particular couple.
This is always going to be a dilemma when a new technique comes
to us and there is limited data. We have to be very aware of the
risks as well as the benefits and we may at times have to be precautionary.
That is why it is right that we are flexible when we review these
Q505 Dr Harris: When you made your
decision on the Hashmi case, it was different for reasons we understand.
You were criticised by this Committee in the report for potentially
exceeding your powers. Was that a factor underlying your decision
in the Whitaker case and, if not, in the view of this Parliamentary
Select Committee, why not?
Ms McNab: I am very happy to look
at the information from the committees and from the Authority
at the time in order to clarify this, if I in any way do not give
you the factually correct position. My recollection is that the
difference between the two cases was fundamentally based on the
welfare of the child and a concern for the ethical principles
underpinning selecting an embryo where there is no benefit to
the embryo itself. That is my understanding of the fundamental
principle that separated the two decisions. You are absolutely
right to draw attention to the fact that questions were asked
about the legal powers and whether this was a treatment that fell
within the jurisdiction of the Authority. That was a challenge
from outside. If you recall, we were challenged by an outside
organisation. That did go through the courts and our powers were
fundamentally confirmed in this area, so to that extent in the
intervening period those court cases have taken place. I am quite
sure that, as part of the context that is presented to the Authority
today, they will be reminded of that. My own recollection of the
initial decision between the Hashmis and the Whitakers is that
it was based on ethical and welfare of the child issues regarding
the benefit to the embryo and the risks and benefits of the procedure
itself, given that there might be no benefit to the embryo in
one case and there would be in another case. It was not a legal
Q506 Chairman: If there is new safety
data for the implementation of this now, how will that input into
your guidelines on serious disease? There would have to be implications
for that too, would there not, in terms of your guidelines? They
would have to change too. Will that be examined today?
Ms McNab: The evidence that will
be presented to the Authority today will cover all of those areas.
It will not only look at outcomes and any information that there
is on safety, but obviously that will be a key bit of the information
that is presented. The principles that we need to apply within
this policy are one of the areas that the Authority will be considering.
Chairman: I can see sparks flying when
it is all decided.
Q507 Mr McWalter: In the evidence
we had in July 2002, some people of distinction told us that the
HFEA were inefficient, lacking specialist knowledge; you were
a slow and reactive body. This is to do with licensing. Were those
the bad old days and has it all changed?
Ms Davies: Of course. Since I
joined the Authority, I have certainly been made aware of a lot
of improvements that have been put in place, but the pace of change
is, if anything, even more rapid at the moment. If you look at
any recent cases we have been dealing with, you will find the
correspondence is dealt with a lot more efficiently. We have certainly
been streamlining the licensing process. We have made a lot of
improvements in terms of legal support. We have three teams of
committee members in place so that we have no problem now setting
up committees which I think has been a problem in the past. We
have just appointed a committee secretary to service those licences
which has not been the case in the past. We will be able to turn
around the correspondence. We are streamlining the whole process
of generating licences electronically and there are some fairly
complex conditions that have to be attached to licences. All of
that adds up to a much more efficient and effective licensing
process. That is what is going on in terms of managing the Authority
end of it. In terms of the inspection end of it, we are booking
our renewal licences well in advance now and centres have a lot
of notice. We are piloting some new inspection protocols to make
sure that the evidence we are looking at and gathering is much
more standardised than it has been in the past. We have modernised
our inspection process. We have changed our inspection reports.
We have given them the plain English once over. We want to make
them much more accessible to the public. We are turning them round
now within our performance indicator of four weeks after the inspection
and we are doing that regularly. I think all those add up to quite
a lot of improvements, but there is still more to do and we are
still looking at ways in which we can improve even on those figures.
Q508 Mr McWalter: I know you have
not been there very long but does it not surprise you that you
have had to make so many improvements? How the heck did it reach
the stage that the HFEA was falling down on the job in the first
Ms Davies: I did not get the impression
when I joined the organisation that it was falling down on the
job at all. What is refreshing is that the organisation is very
much prepared to look at the way it is operating and continuously
make improvements. I do not say for one moment that the things
we are looking at now and the improvements we are putting in place
will be the end of it. We will go back and talk to clinics and
centres and get information from them. One of the most pleasing
things for me about our recent improvements is the fact that we
have just put on line, on our website, a patient feedback questionnaire.
We want to improve our engagement of patients on inspections.
I am sure that has been an issue for some time and fortunately
we have the resources now to put that into practice. Not only
are we using paper copies being given out on the inspections themselves;
we have direct access for patients to feed back to us on line
which will help us gather together and focus the inspections that
we are going to be carrying out.
Q509 Mr McWalter: You must understand
that it would be a slight source of worry to us that the organisation
reached a stage where it had extensive evidence that there were
many problems. The previous chief executive was dismissed and
yet we are talking to somebody who says, "Well, no, it was
not too bad really". If that is the judgment of someone who
is now in post, namely you, and you feel pretty untroubled by
what has happened in the past, I am worried that if there are
major defects still now you might not be the person to spot them
and correct them.
Ms Davies: I am not sureand
I apologise if I didthat I did say I was untroubled about
what happened in the past.
Q510 Mr McWalter: You said it was
not falling down on the job.
Ms Davies: From the review five
years ago and certainly from prior to Professor Toft's report,
there were clearly a lot of issues that needed attention in the
Authority. Over the last year or so, a lot of improvements have
been put in place and we are building on those and capitalising
on the extra resources that we have to do so.
Q511 Mr McWalter: We have some evidence
that there are continuing problems post the Toft report. Would
that surprise you?
Ms Davies: I am happy to take
any criticism that you might have received in front of this Committee
and to act on it. Clinics are usually inspected once a year so
there is obviously a time lag between instituting improvements
and a centre being on the receiving end of those improvements.
Some of these will take several months to work through into the
next round of inspections for some centres.
Q512 Mr McWalter: Some of the problems
we have relate to the quality and professionalism of inspectors
and the question of accreditation. I would be interested in your
views on whether you feel there is a lot of work still ongoing
on that and indeed, for instance, whether you have thought of
having full time inspectors and whether there are any other matters
that relate to those expressions of concern that we have had.
Ms Davies: One of the recommendations
of Professor Toft that we are still putting in place is the whole
business of appraising our inspectors and retraining them. We
did a big recruitment drive at the end of last year and we put
the inspectors that we recruited then through a two day training
process and selection process, at the end of which we had a lot
of confidence in their ability to handle inspections in a consistent
way and in accordance with our protocols. We are commissioning
another piece of work with existing inspectors to put them through
that same process so that we can ensure consistency. The fact
that we have introduced new protocols will help in that respect.
We will expect them to fill in the details of the questions we
are asking in a standardised way. You can never eliminate some
kind of human variation and variability, but we are putting in
as many measures as possible to do that. With regard to your question
about full time inspectors, we have tried to recruit so far a
clinical inspector without success but we are looking at that
again. We are about to advertise for a full time scientific inspector.
I think it is healthy to have a mixture of full time inspectors
with expertise and the ability to call on expertise from the field
when we need it. It is a very specialised field and I think we
will always be in a situation where we need a certain amount of
expertise that we cannot necessarily maintain in house.
Q513 Mr McWalter: It is worrying
though, is it not? If you are looking for people in very senior
posts to hopefully give you specialist expertise that currently
you lack and yet you are still appointing inspectors, it looks
as if the claim about lack of specialist knowledge may still have
a certain amount of sting to it and it might mean, for instance,
that people offer themselves as inspectors to you and they may
not be assessed as adequately as they would be had you more senior
people in post.
Ms Davies: We have about 80 inspectors
on our books and between them they have an enormous range of expertise
which gives us the ability to draw in the teams we want for each
inspection. Within my own staff, there is a lot of expertise in
terms of scientific background and those staff are full time.
They chair the inspections. Their job is to ensure that the team
operates with a degree of consistency and to pull together and
write up a report. We have the mechanisms in place at the moment.
I go back to my earlier point about always wanting to improve.
Q514 Mr McWalter: You have awarded
150 research licences since 1991. How many of those have been
for staff training?
Ms Davies: I am not aware that
we license for staff training.
Q515 Mr McWalter: You license for
staff training in connection with the other eight functions for
which you will need licensing and training has to be part of that,
does it not?
Ms Davies: In terms of the competence
of the centre to carry out their research?
Q516 Mr McWalter: Yes. If you are
enabling knowledge to be developed in terms of serious disease
or something, will not training play a role in your evaluation?
Ms Davies: In our evaluation of
the applications, yes. We do carry out extremely thorough evaluations.
Dr O'Toole: The fundamental part
of giving a research licence is that the use of a human embryo
has to be absolutely necessary for one of the purposes set down
in the Act. 16 of our current projects are towards improving fertility,
looking at for example non-invasive biochemical marker to evaluate
embryos so that we can move towards putting back a single, good
quality embryo that has the best chance of implanting, which hopefully
will reduce the multiple birth rate. Prior to a licence being
granted, it has to have external ethics approval. We send it out
to peer review and part of that is to ask whether the use of human
embryos is necessary, whether it meets the criteria of the purposes
set down in the Act. We also insist on seeing patient information
and consent forms because fundamentally it is the patient that
has to consent to the use of their embryos in research and they
have to do so in an informed way that will not impact on their
own treatments. We look at all of this as part of the inspection
of research and the information that we ask for before it is submitted
to a research licence committee to make the ultimate decision
on whether the licence should be granted.
Q517 Mr McWalter: Obviously if you
go along to a research institute and you are looking to evaluate
whether they should be licensed or not, you are in part going
to be looking at the extent to which they are or are not competent
to train the people who work there to be able to carry out the
tasks within the purview of the Act. I would have thought that
should be a very clear indicator.
Dr O'Toole: Absolutely. Some of
our projects for looking at pre-implantation genetic diagnosis
is to look to see if they can improve the texts or extend the
text to look for more genes as detection for other serious diseases.
Obviously part of it as well is to improve the technique of removing
the single cell from the embryo, which is done under a research
licence to begin with before we allow that person to perform an
embryo biopsy as part and parcel of clinical practice. Obviously
staff have to be competent before we allow them to use these quite
invasive techniques in clinical practice.
Q518 Mr McWalter: You have a training
protocol, standard operating procedures and technicians and so
on and that is all part of your inspection regime, is it?
Dr O'Toole: In terms of the research
inspections, we have in house staff that chair the inspections
and we will take along with us an appropriate scientific inspector.
Q519 Mr McWalter: That is sharp to
me. Would you be surprised to hear that some people have told
us that on the whole clinics do not have much to worry about really
when an inspection happens and, on the whole, it is pretty easy
to meet the requirements of the HFEA?
Dr O'Toole: Say a centre wants
to carry out research either for the first time or in another
project. We are in constant dialogue with that clinic. We will
go and see them or invite them to meet with us. There is an awful
lot of dialogue before we get to the full application coming in
and before the inspection so hopefully the inspection has been
met before we get there.