Examination of Witnesses (Questions 460
WEDNESDAY 21 JULY 2004
Q460 Chairman: Do you record near
misses and incidents as a safety procedure which operates across
Ms McNab: Since the Alert process
came in, all clinics have to report every adverse incident that
occurs, including near misses, and they have to report them to
us within 24 hours.
Q461 Dr Harris: For the general public
whom you serve, do you, following suitable anonymisation, publish
Ms Davies: Indeed. We publish
a report every six months. We are just about to issue the first
onebecause this is a relatively new process that we have
put into place.
Q462 Chairman: Is it ever used in
evidence to de-licence a clinic? Or are you inhibited from getting
the data because you may have to de-licence a clinic for too many
near misses? Is that a factor: if there are six near misses, that
is as bad as an incident?
Ms McNab: There is not a recipe
or a calculation of that kind.
Q463 Chairman: Do you think there
Ms Davies: I do not think it would
be appropriate to classify all near misses as exactly the same,
or all incidents as exactly the same, actually. There are different
types of incident. They have different weights attached to them.
There is a big difference, for example, between nearly pressing
the wrong programme on a freezer and mis-labelling gametes. There
is a huge difference, so I think to lump them all in together
and say, "If you've got more than three strikes you are out,"
would be grossly unfair. But I think we have to remember here
that there is a real balance to be struck between encouraging
clinics to be open and to tell us when things go wrong, so that
we learn from those and we make sure we have proper systems in
place that prevent that happening somewhere else . . . . We are
never going to get rid of human error. We will never, ever, ever
get rid of human error.
Q464 Chairman: I would not want to
tell you because I might be de-licensed for a near miss.
Ms McNab: Exactly. That is the
Q465 Chairman: How do you get round
Ms McNab: When we talk about publishing
the reports, we have to balance the need to put information properly
and accurately into the wider domain so that we can learn from
it and so that people do not think things are being kept secret,
and on the other hand not having things all over the front page
of one of the newspapers every other week, dramatising things
so that clinics just think, "Okay, we will not tell you."
We have to get a balance between those two things. I feel passionately
that we have to work with the clinics and the professional bodies
to find a system that does encourage open reporting, without blaming
people for what might actually be a near miss, a minor system
problem, that by flagging it up we can do something about and
protect the wider world.
Q466 Dr Harris: Coming back to the
Toft report and continuing with the Toft report, it was highly
critical of the HFEA in various areas. Why do you think HEFA has
fallen into such disrepair that such a strong report was needed
to correct it?
Ms McNab: There were clearly a
number of difficulties with the inspection regimeand I
have to put my hands up to that. I think, largely, the authority
had served this area extremely well in the first ten years that
it had been running, but clearly there were some resource issues,
and Professor Toft himself draws attention to those. The number
of treatments had doubled in the first two years, the complexity
of the treatment systems we were working with had really significantly
increased, and the funding had not increased. In addition to that,
there had been difficulties with perhaps reviewing the way that
inspection was being carried out (standing back and thinking what
an appropriate safe system would be) and clearly there was a need
for more opennessand I put my hands up to that. So there
were some weaknesses in the system, some of which were down to
resources and some of which were needing to have a more modern
understanding of regulation. I am absolutely convinced we have
made the vast majority of changes that Professor Toft himself
recommended. We have gone further in some stages. I think the
system we have now is much stronger, much more robust, and considerably
Q467 Dr Turner: These nine adverse
incidents that happened in the past, were they each the subject
of independent investigation? Were the results of that investigation
published? How confident are you that those nine adverse incidents
were the only ones that actually happened?
Ms McNab: Let me take those points
in order. When Professor Toft approached me when I first came
into post, he asked me whether I could find information about
whether there had ever been incidents in the past of this nature,
of this particular type he was looking at around labelling and
identification, and, if so, how many. It was very difficult getting
hold of the information. The systems that were in place at the
time, for the first ten years or nine years of the Authority,
did not make it easy to retrieve that information, so it meant
going back through a number of records to find out whether such
events had occurred. By going through that exhaustive process,
I did identify a small number. I cannot recall whether it was
seven or nine, but I am happy to correct that later if the Committee
would like me to. It was certainly less than 10, a small number,
over a 10 year period. In each case they had been reported to
the Authority by the clinic concerned or identified upon inspection.
They had been investigated, therefore, by the regulatory staff
and the information presented to a Licence Committee; so there
had not been an external review, as there had been with the situation
Professor Toft was commissioned to look at. The report had been
made to a Licence Committee. They had clearly then followed up
with the clinic whether the appropriate changes had been made
to make sure that such things could not happen again, whether
they were satisfied about the safe running of the clinic, and
it was a private matter on the licensing history of the clinic.
That changed when we instituted the Alert system, when we said
that any event that was reported to us, once appropriately anonymised
to encourage open reporting, would be circulated right across
the whole of the UK, so that we did not have a situation where
a clinic has a problem, they realise there is a potential for
human error causing a problem, they tell us and we do not tell
anybody else: "Gosh there is this potential and let's all
do something to make sure it cannot happen again." Now, we
do have that system, so that we do not keep any of these events
localised and the learning therefore not shared.
Q468 Mr Key: I would like to turn
to your powers under the Act. It has been put to us that you exceed
your remit, that, in the words of one witness, you are "altering
statutory boundaries". Do you think you are?
Ms McNab: No, I do not think we
are. I think we meet very well the principles that are set out
in the original Act. As I have said, and as the authority has
made public, we think that now is the time for a review of the
Act. We are very pleased about that. We think there are some areas
where debate in Parliament and further consideration is absolutely
appropriate. But, as confirmed by the courts, whenever decisions
that we have made have been taken to the courts, I believe we
have utilised those well and we have worked within those powers
Q469 Mr Key: Are you talking about
schedule 1, paragraph 2 of the Act, which gives you a general
power to perform certain functions, that bit which you use to
justify your campaigning, your comments on court rulings and so
on? That is the bit, is it, that you use?
Ms McNab: Yes.
Q470 Mr Key: Do you think you should
be a policy-making body? Because effectively you are trying to
change policy, are you not?
Ms McNab: I think there has to
be a balance between being able to respond fairly swiftly, through
an organisation such as the HFEA, to new advances that are made
in the field that we regulate, and particularly being able to
consider some of the individual situations that come to us where
we are very much at the boundaries of new science. I think the
balance is between having an organisation that can respond appropriately,
based on the legal, medical, scientific and ethical evidence,
and, on the other hand, absolutely appropriately standing back
and looking at some of the wide ethical issues and ensuring that
those are debated in Parliament and that those principles are
set by Parliament. I think we work very well within the statute
that we have and I think we make those decisions in a measured,
Q471 Mr Key: Under schedule 1, paragraph
2, which gives you the power to do anything which is calculated
to facilitate the discharge of its functions, it does not give
you any power to do anything new. It has been put to us that you
are in fact extending the powers which are given to you under
the act; for example, encouraging research, which is not in the
Ms McNab: I think it is appropriate
in our regulation of research that we are not obstructive. By
ensuring public confidence and ensuring the safety of research
and ensuring that research is carried out to the criteria within
the Act, that we facilitate good research, and therefore improving
patient safety and treatment services.
Q472 Mr Key: You have had a Legal
Adviser since 2003. What difference has that made?
Ms McNab: Our Legal Adviser is
now absolutely on hand to be able to advise every single Licence
Committee. I would say the greatest difference which that has
made is in the support to Licence Committees. Previously Licence
Committees clearly could access legal advice, but, because we
did not have our own in-house Legal Adviser, I think there were
sometimes delays in accessing advice. I think the on-going potential
for legal support was not as well put forward as it could have
Q473 Mr Key: Has your Legal Adviser
ever advised you that you are acting outside your statutory remit?
Ms McNab: The Legal Adviser, particularly
when we are looking at individual clinical issues, will remind
us of the boundaries of our statute regularly.
Q474 Mr Key: But that is not what
I asked. Has the Legal Adviser ever told you that you are acting
outside your remit?
Ms McNab: No. They have told me
what the remit is, what the boundaries are, and therefore we have
made sure that we have not overstepped them.
Q475 Mr Key: Has the Department of
Health ever had any discussions with you about your remit and
possibly exceeding it?
Ms McNab: We have regular ongoing
discussions with the Department of Health about our remit, but
I do not recall ever being told that I was overstepping my remit.
And when we have taken decisions that have been controversial
or where people may have been concerned about those areas, the
courts have confirmed that what we have done has been appropriate,
within our powers.
Q476 Mr Key: Do you think it is appropriate
that the HFEA should campaign for changes in the law on ethical
or, indeed, social grounds?
Ms McNab: I think it is appropriate
that the HFEA can draw to people's attention where there may be
inconsistencies or where there may be a need for society and Parliament
to review certain areas. I think that is appropriate.
Q477 Mr Key: We have been told by
a former member of the HFEA that you have on occasions acted ultra
vires. Do you reject that?
Ms McNab: It is not my recollection
whilst I have been at the Authority but I am happy to go back
and check any specific issues which you draw to my attention.
Q478 Mr Key: Would you please do
that and let us know. Thank you very much. Do you have staff,
senior staff, who have the same level of expertise in social justice
issues, for example, as in legal terms? I mean, do you have ethicists
and other staff who can advise you on that?
Ms McNab: The decision-making,
of course, rests with the Authority itself and not with the executive
staff. We have to remember the split between the executive and
the non-executive side of the organisation. We have staff who
certainly have good experience in working with ethics but we have
an ethicist on the Authority. The Ethics and Law Committee is
where the first consideration of ethical issues will take place
and advice will then be placed before the Authority. I am quite
content, particularly with the increase in resources that we have
been given, that we have been able to draw in the skills and the
expertise that we need.
Q479 Mr Key: Is it becoming increasingly
difficult to interpret the Act in the light of new technologies
Ms McNab: Yes, I think that is
true. That is one of the reasons why we have said that we welcome
your discussions in this area and your advice to government and
we welcome the possibility for a review. Science has moved on
enormously in 13 years and it is absolutely time to revisit some
of those areas, particularly around issues such as the selection
of characteristics and some of the areas that the new technologies
pose to us.