Examination of Witnesses (Questions 520
WEDNESDAY 21 JULY 2004
Q520 Mr McWalter: You have issued
150 licences. How many of those have been withdrawn? You have
a licence. Now you are inspected and this inspector is looking
at all sorts of things, presumably quite a lot of the time including
perhaps training but that does not seem to be very clear, and
now you have arrived at the situation where you think these guys
are not hacking it. How many times does that happen?
Dr O'Toole: To my knowledge, it
has not happened very often. I think there have been about two.
However, I can supply the Committee with the exact figures where
a licence may not have been renewed because the work was not progressing
as it should have been or something like that.
Ms Davies: Are you talking about
licences in general or just research licences?
Q521 Mr McWalter: If I had 150 students
and only two failures and both of those had withdrawn voluntarily,
they might view my assessment techniques as perhaps rather less
than harsh. If this general feeling in the community is that on
the whole once you have the licence you are unlikely to be subject
to really intensive scrutiny, including for instance it would
appear that since patient safety is rather entirely dependent
upon the actual things that laboratory technicians do, we do not
seem to have an agreed training protocol for that so it becomes
a bit easier for people, once they have a licence, to keep it.
The sharpness of the evaluation seems to be a bit of an issue.
Ms Davies: I agree with you that
the sharpness of the evaluation is very important. The Authority
has a range of powers it can use before it goes to the extent
of revoking a licence and refusing renewal. It can impose conditions
and it does and has done. It can suspend activities. There is
a range of ways in which it can limit the functioning of a centre.
It can refuse to agree to a new person responsible and not accept
them as being suitable for that role. There is a variety of ways
in which it can impose sanctions on a centre without going to
the step of revoking a licence, but it has revoked licences in
the past on several occasions.
Q522 Mr McWalter: Are you qualified
to judge whether research in human embryonic stem cells is justified
Dr O'Toole: Parliament extended
the purpose for which we could issue a research licence that included
the use of embryos for detecting and treatment of serious disease.
Q523 Mr McWalter: I asked whether
you were qualified. If you go into a lab and this guy says, "This
might help with Parkinson's disease", are you qualified to
say, "Hang on. These cells are being taken for too long a
Dr O'Toole: We have expert scientific
inspectors and that is one of the reasons we go out for peer review.
Depending on the application, we can extend our peer reviews or
approach different peer reviewers to tailor for each application.
If it was for a particular disease, we might go out for a clinical
opinion for that.
Q524 Mr McWalter: The Newcastle Fertility
Centre has argued that there should be a clear, biological distinction
between a nucleus and a pronucleus in the law. That is one of
the potential changes because they are worried about mitochondrial
disease for unborn children from nuclear systems. Do you recognise
that as a problem? Do you think that something should be done
Dr O'Toole: With the review of
the Act, it was one of the issues that was raised by the House
of Lords Select Committee, the treatment of mitochondrial disorders.
Q525 Mr McWalter: They did not raise
the issue about the distinction between nuclear and pronuclear.
Dr O'Toole: No. If we think that
any research that involves pronuclear rather than nuclear is outside
the Act, we would alert the Secretary of State for Health, as
is our duty to do so. It is then up to Parliament to make that
decision whether they want it brought into the remit of the Act.
Ms Davies: We are currently taking
legal advice on this.
Q526 Mr McWalter: You do recognise
Ms Davies: Yes.
Q527 Dr Turner: In your decision
making process, how do you weigh social and clinical research
in making your decisions? How do you incorporate social and clinical
Ms McNab: Are you talking about
Q528 Dr Turner: Yes.
Ms Davies: The Licence Committees
have a mixture of members. In terms of research, there is always
a lay majority and a lay chair. They will have an ethicist, a
scientist and lay people on the Research Licensing committee and
they will take a view. Watching Licence Committees operateand
they meet every fortnight so I have a good opportunity to do thatthe
committees take their responsibilities extremely seriously. They
consider the applications in front of them very carefully indeed
and they also have very careful legal advice as to the issues
that the Act requires them to take account of. They do that systematically.
Q529 Dr Turner: Can you say what
in practice drives the decisions? How much weight do clinical
members who are essentially regulating their fellow clinicians
have, or public opinion? Which holds the balance?
Ms Davies: I do not think either
holds the balance. The committees when they operate take account
of public opinion and clinical advice, but they also look at other
issues that may be before them and they form a view on the evidence
before them. I do not get any sense at all that they are making
their decisions based on external pressures.
Q530 Dr Turner: How do you evaluate
the ethics of a decision?
Ms Davies: Fortunately, I do not
have to do that. That is what the licence committees have to do
but it is a very difficult job. It is a very weighty job which
Parliament has given the Authority members to do.
Dr O'Toole: With research, we
ask for local research ethics approval before it comes to the
Authority because they are the ones who will have looked at the
information etc., for local patients. Therefore, they are the
best placed to say whether they think the research or the patient
information etc., is adequate for their patients. That is why
we insist on having that before we even consider a licence application
Q531 Dr Turner: I was going to ask
you about how you interact with local research ethics committees,
but coming back to the role of public opinion, do you not think
it is particularly important in making the ethical distinctions
in the decision making, especially given that as an Authority
you are essentially a servant of the public?
Ms McNab: It is very important
that we distinguish between the different sorts of decisions that
the Authority makes. There are licensing decisions about whether
or not a centre should have a treatment licence, is fit to do
so and meets the requirements; and likewise whether a centre can
carry out research, whether it meets the requirements. That decision
making is based absolutely upon what is in the Act. The clear
criteria set out in the Act are the criteria that the licence
committees are assessing a centre against. Clearly, when it is
a treatment centre, they are looking at the standards that are
set out in the code of practice and guidance. The ethical principles
have been determined by Parliament. There is much more weighing
up of social research, the different public viewpoints, the different
values, alongside other evidence such as legal, medical and scientific
evidence when you come to the policy decisions. That is a completely
different section of the decision making. There is a danger that
we may be blurring the two types of decision making. Charles,
who heads up the policy division, will be able to talk to you
much more about the policy decision making and how research is
Q532 Dr Turner: Your licensing decisions
follow from your policy decisions so you cannot tease them apart?
Ms McNab: I categorically can
say that the licensing of research projects decisions is fundamentally
made against the Act and, yes, ethics committees of course to
make sure that the ethical considerations are taken into account
around how the research is being conducted, how the information
is presented and how consent is gained. Of course, that is absolutely
fundamental. The criteria about the research project itself and
whether or not it should be permitted are fundamentally against
what is in the Act. Chris and Trish sit on far more of these committees
than I do so they are the ones to tell the stories of those but
those are the distinctions that are absolutely extricated, pulled
apart and examined in minute detail.
Q533 Dr Turner: You had a working
group with the MRC on research in assisted reproduction two years
ago. Has the MRC funded any research as a result? When do you
expect the working group to report?
Ms McNab: I believe what you are
talking about is the concern that we have around follow-up studies
of a whole range of assisted reproduction technologies. There
has been a working group with the MRC. We very much sought the
MRC's view, particularly around what the priorities for research
might be. Obviously there is a whole range of different technologies
and techniques used in assisted reproduction and we felt it was
very important that there was some joint consideration of where
the priorities would be for long term follow-up studies to take
place. We are not a research institution, as the Committee will
be aware. We do not have research funding. We are not set up in
that way to commission our own research. That working party has
been meeting and they have looked at a whole range of issues.
We expect a report fairly shortly.
Q534 Dr Turner: One of your duties
is to keep a register. Has any work on the contents of this register
been undertaken? Has there been any analysis of the register and
does it have a useful research function? You must have a vast
accumulation of data, no doubt.
Ms McNab: The work that has been
undertaken has been limited because, as you may well be aware,
there have been some difficulties with the IT system or the register
system itself, the technology, if you like, where all the information
is kept. When I joined the Authority, there had been a difficulty
that had been identified and one of the major tasks for the Authority
in the last couple of years has been to put in place a new register
of information on screening and the treatments that are provided.
That work, I am glad to say, is absolutely on target. We now have
a new register up and running. We are going through a task of
going back and validating all the old information that was held
in the previous register where there was a problem. That is going
to take us still a little more time but we are on target to do
that. So far, the analysis that we have managed to do is very
much providing information for the European data set which we
give every year and also the information that goes into our patient
guide which gives, for example, some indication about what the
average outcomes are and the types of treatment provided, the
age groups that are focused on. In terms of follow-up, particularly
to answer your question about that, this is an area where we would
very much welcome your advice to government for a review of the
Act. The legal advice that we have is that the confidentiality
requirements in the Act prevent us from, for example, linking
our register with other disease based registers so that, for long
term follow-up investigations, say if we wanted to link with the
cancer register, we cannot do that. We are bound by the confidentiality
requirements within the Act and that is frustrating to us and
obviously to researchers.
Q535 Dr Turner: That is a problem
we have encountered with the cancer register in the past. Both
of these need to relate to the normal NHS medical records. Are
you satisfied with that relationship? Does any data fall down
the cracks? Do you get patients who will be treated by other doctors
who are unaware of things which could be important to them had
they access to your original records and register?
Ms McNab: I will go back and check
on this and it may be I have misunderstood your question, but
I am not aware that there is a problem with information getting
lost. What I am aware of is that, because of the confidentiality
which is so strict, the sharing of information and aggregating
so that you can see whether there is a greater incidence of something
or another and being able to do that through the electronic records
in the NHS, would be terribly valuable. At the moment, the restrictions
in the Act prevent us doing that and this is something that we
would very much like to see change when the review of the Act
takes place. We think that would be terribly helpful.
Q536 Chairman: It says here, "We
are keen to work collaboratively with other regulators to avoid
over and under regulation." Tell me quickly, please, what
that means. What have you done about it?
Ms Davies: We have had two meetings
with the Healthcare Commission which as you know only came into
existence at the beginning of April. We have begun to map out
the kind of information gathering that they are doing as opposed
to what we are doing and we are beginning to look at where the
overlaps might be and how we can begin to streamline that so that
one or other of us collects it.
Q537 Chairman: Why not just shovel
it on to them? CHAI, for example, is another organisation that
looks at your clinics.
Ms Davies: Our powers are very
different from CHAI. We cannot at the moment delegate our inspection
powers. They can delegate their inspection powers to us. We are
looking at whether we can, at least as a preliminary, do some
joint inspections to begin to see how well it would work for one
or other of us to start taking on some of their functions.
Q538 Chairman: Are you going to merge
with the Human Tissue Authority?
Ms Davies: That is for Parliament
Q539 Chairman: Have you had talks
with them or will you have talks with them when they are set up?
Is that the plan?
Ms Davies: The Human Tissue Authority,
I understand, has not yet been brought into existence so it is
currently still in draft legislation.