Examination of Witnesses (Questions 540
WEDNESDAY 21 JULY 2004
Q540 Dr Iddon: Some people have said
to us that you are regulating things that are now routine medical
procedures. Do you think those could be transferred to the General
Medical Council for controlling and inspectionIVF, for
example, and infertility treatment?
Ms Davies: I am not sure that
the creation of life is a routine medical procedure. I think that
is a bit different from any other medical procedure. As the Act
stands, Parliament has thought this is a very special area and
needs regulating separately. One of the ways in which we are trying
to streamline our licensing and inspection process is, where say
new techniques have come in and we have been looking at them very
closely, like ICSI, and we have required centres to give us a
lot of information, we have gone out and inspected how competent
their staff are. Now that that has become much more of a routine
procedure, the Authority has now agreed that we do not have to
do that any more. We can put the responsibility back to the clinic
to ensure that their staff are competent and just give us the
data so that we can periodically check that that is the case.
Q541 Dr Iddon: Can I make sure that
you are giving us the view of the HFEA, your committee, rather
than the executive opinion on what I have just said about routine
medical procedures being transferred out of your control into
GMC control? Is this something you have discussed as medical procedures
become much more routine that are now under your control? Has
that been discussed, the transfer to the General Medical Council?
Ms McNab: I do not think it would
be appropriate for it to transfer to the GMC whose focus of interest
would be slightly different. We have a memorandum of understanding
with them so we are very clear about what our areas of responsibility
are. We have to remember that, when you look back at the alerts
that we have had and the incidents that have occurred, they have
largely occurred during the course of routine, day to day, ordinary
activities, not the new technologies. Therefore, I think that
demonstrates that continued, strong regulation in this area is
what is required.
Q542 Dr Iddon: You have told us you
are in the process of appointing a full time scientific inspector.
Ms Davies: Recruiting.
Q543 Dr Iddon: You plan to employ
a clinical inspector to carry out a proportion of inspections
consistently to monitor the performance of external inspectors.
Is that person in post now?
Ms Davies: No. We have not been
successful in our first couple of attempts to recruit a clinician
so we are having another go at it.
Q544 Dr Iddon: Is that going to be
a continuing trend towards more in house inspectors to bring about
the consistency we discussed with Professor Toft earlier, which
would diminish the number of external instructors?
Ms Davies: What we will want to
do is evaluate the impact of having in house inspectors. Clearly,
if we feel that that is beneficial and the most effective way
to proceed, we can expand on that and divert resources from one
set of staff to another.
Q545 Dr Iddon: Do you think there
are conflicts of interest when clinicians are responsible for
making judgments about their competitors?
Ms Davies: The whole issue of
conflict of interest is dealt with extremely scrupulously both
by Licence Committees and by inspection teams. For example, I
am aware of one team which got to an inspectionand we do
screen for conflicts of interest before we put the teams togetherand
the clinician recognised that he had trained with one of the clinicians
on site. It was agreed that he should depart and we got somebody
else in at very short notice to carry on the work. We are very
careful about that.
Q546 Dr Iddon: Are inspectors expected
to declare interests of that kind as part of your procedures?
Ms Davies: Yes.
Q547 Chairman: Will the EU Tissue
Directive cause more work for inspectors?
Ms Davies: We understand that
we are likely to be the Competent Authority in terms of the gametes
and embryos that we regulate. It will be more work for us. In
terms of the centres, I think there will be particularly challenging
standards for them to meet. That will involve them in a certain
amount of extra work but the whole idea behind the Tissue Directive
of having mandatory quality assurance systems is a really good
one and it is something that we want to move towards having a
much stronger focus on.
Q548 Dr Iddon: What is it about assisted
conception that requires it to be regulated in the same way today
as it was in 1990?
Ms Davies: What we have said and
what the Authority feels is that there is scope for some changes
in the legislation. Your review and the review of the Act are
welcome. Assisted conception does need regulating but it may need
some changes in the way it is regulated.
Q549 Dr Harris: I want to ask a policy
question around the welfare of the child. It is a difficult area.
You have now recommended that this be looked atindeed,
in particular, the need for a father provision within that being
looked at again by Parliamentand that was a recent suggestion
by your chairman. Do you think that is timely or overdue, given
that we have had the Human Rights Act protecting the rights of
people not to be discriminated against somewhat longer than we
have had the recommendation from the chair of the HFEA that this
needs to be looked at?
Mr Lister: It is very timely and,
as well as the Human Rights Act, we also have the civil partnership
legislation as well.
Q550 Dr Harris: The fact that there
may be hundreds of people who have been discriminated against
since the Human Rights Actand of course those rights existed
with the European Convention of Human Rightsand clinics
you regulate have been saying, "Go away, you are gay"
you think has been acceptable until very recently?
Mr Lister: I am not aware of how
many such cases there have been.
Dr O'Toole: There are probably
very few. Most clinics that have a criterion that restricts who
they will treat and say they do not treat single women etc., would
normally refer them on to a clinic that will treat them.
Q551 Dr Harris: Do you know how many
clinics discriminate in a way that is questionable in law? Do
you know how many people have been humiliated in that way by being
told, "We are not going to treat you"?
Ms McNab: I cannot give you that
number but I am very happy to come back to you with the number.
I do not have the absolute number of those clinics that say they
are uncomfortable about treating single women or single sex couples.
There is a small number of clinics who say they are not comfortable
about doing that and they do not offer that therefore as a service.
Q552 Dr Harris: It is not just that
they are not comfortable; they are not going to do it.
Ms McNab: They have taken the
decision that they do not feel comfortable with it. I can give
you the numbers. There is also a large number of clinics that
treat single women and that make it very clear that they treat
single women and lesbian couples. The fundamental issues here
around the welfare of the child are twofold. One is that it seems
absolutely right that reproductive freedom on the one hand should
be balanced with the welfare of children being created on the
other hand, and it is right that clinics absolutely according
to the Act consider the welfare of children to be born. The more
important issue that you are alluding to here is: is it still
right that there are specific questions asked about the child's
need for a father when that appears to be perhaps inconsistent
with other areas of legislation such as the civil partnership
scheme and human rights.
Q553 Dr Harris: And inconsistentyou
have raised this yourselfwith the evidence from social
research suggesting that there is no detrimental effect on the
welfare of the child, which is the only context for this need
for a father provision.
Ms McNab: We would welcome your
advice to government and we would welcome this area being discussed
again in Parliament.
Q554 Dr Harris: Do you think you
should have proactively sought to question in law, through a judicial
review of the decision of a clinic, to help clarify the situation
whether that was lawful; or do you think it is okay to be relatively
laid back and say, "The law may be being broken, but we will
wait for someone to have the courage and the ability to parade
themselves publicly and take a judicial review themselves"?
Ms McNab: I am happy to be corrected
on this one but I absolutely believe that that would be outwith
my powers. I absolutely believe that the Authority is there to
implement the Act as it stands and to ensure that clinics meet
the requirements of the Act. It is not for us to judicially review
what is essentially in the Act. I think that the earlier question
about do I believe I exceeded my powers would apply if we had
tried to do that, but we are very grateful for your advice on
this particular issue to government.
Q555 Chairman: For long term issues
you will end up just regulating the market, will you not? You
will be looking at clinics, looking at their books and making
sure that they do not cheat and so on. Is that not how this whole
thing will end up for you as an organisation?
Ms McNab: That is absolutely not
my expectation. My expectation is that the fundamental improvements
that we have put in place to ensure that patient safety is guaranteed
and that patients are at the heart of regulation will continue.
I am sorry we have not had time this morning, for example, to
talk about our patient feedback process and the fact that patients'
own views and experiences are incorporated into inspections and
the judgments that we make. That is the direction that I would
very much see regulation continuing in. We will have more of a
patient voice and more methodology around the way that we carry
out our inspections, to ensure that we get this balance between
the burden or the bureaucracy, if you like, but also the absolutely
strong, fundamental assurance about standards. We have more to
do on that. I am sure we will improve on that.
Q556 Chairman: Tell me how patient
safety is compromised with the current processes. You are saying
you need to do more. How are they compromised?
Ms McNab: I do not believe that
they are compromised but with the Tissue Directive and new technologies
constantly appearing we have to continue to look at the standards
that are set and the way that we regulate. Another year's worth
of data from our alert system will, for example, give us a lot
more information about where are the real risk areas; how can
the technologies such as bar coding or electronic tagging and
those kinds of developments play a part in ensuring patient safety.
I do not pretend for a minute that we have all the answers to
that, as we do not have in other areas of medical care, but I
do think we will gather a lot more information now that we have
those systems correctly in place and we will be able to act upon
Q557 Chairman: Thank you very much
indeed for coming along and subjecting us to your knowledge and
enthusiasm. We wish you well and we look forward to a full investigation,
a full report and the government reacting.
Ms McNab: Thank you. We will come
back to you wish the issues that we promised.