Examination of Witnesses (Questions 360
- 379)
THURSDAY 13 MARCH 2008
Mr Peter Lemmey
Q360 Baroness Neuberger: Presumably
you can do it more quickly if necessary?
Mr Lemmey: Indeed.
Q361 Baroness Neuberger: And
have done sometimes.
Mr Lemmey: Yes indeed, and also for unstraightforward
cases, where the local assessor has picked up some particularly
complex issue, or in novel cases—and I think the Committee
have already heard about the way in which the Human Tissue Act
has brought in altruistic donation and also the paired donation
between two couples. Those are approved by a panel of Authority
members. For altruistic donations, since the Act came into force
we have approved eight cases altogether. For paired, there have
been two sets of pairs approved. We think there will never be
enormous numbers of altruistic donations to add to the total number
of transplants but we do think that there is a lot of scope, particularly
working with our colleagues in UK Transplant, to expand the number
of paired donations, perhaps up to about 50 a year. Last year,
in 2006-07, the Authority approved 690 recommendations for live
organ donation and in the current year, 2007-08, we think by the
end of March we should have approved between 1,000 and 1,010.
There is, of course, a slight discrepancy between the number of
approvals and the number of operations. In a few cases perhaps,
donor or recipient may for medical reasons not be able to proceed
with the transplantation. There is also a six-month period after
the Human Tissue Authority has approved a particular transplant
in which it can take place, so some transplants may take place
slightly after the counting period.
Q362 Baroness Neuberger: I
just want to pursue the other bit of the question. You have given
us the basis, the core principles, on which the work is based
when it is live donors. What we have not had from you are the
core principles underlying the Human Tissue Authority rather more
generally, and we do actually want you to try and link some of
that, if you can, with the Commission's own Communication.
Mr Lemmey: Certainly. Just a quick word about
Scotland?
Baroness Neuberger: Yes, and Scotland.
You mentioned Northern Ireland, so, particularly given Lord Eames'
presence here, we ought to take that on board to.
Q363 Lord Trefgarne: Could
I ask also one factual point? You have recited at length how many
approvals there have been. How many refusals have there been?
Mr Lemmey: There have been, I think, two cases
in which the Authority has not approved. It is a very small number,
and the reason for that is that the training and accreditation
process for the independent assessors, the people working locally
to assess the cases in the hospitals with transplant units, involves
quite a lot of work with the Authority in working on the provisions
of the Act. There is also a fair amount of telephone discussion
between us in the Authority and assessors during the assessment
process. All that serves to ensure that in almost all cases the
independent assessor is able to ensure that cases do not come
to the Authority if there are any doubts. Those doubts will be
shared with the staff of the transplant unit and, of course, the
donor coordinators who run much of the process locally, as you
know.
Q364 Chairman: Can I pursue
that, before you move on to the second part of the question. Would
there be any way of knowing when cases are almost turned down
informally at the earliest stage? If the assessors are making
the assessment, and having a discussion, there must be a point
when they decide not to bring the case forward. Would there be
any picture of that at all?
Mr Lemmey: I think it certainly happens in the
way I described. I will perhaps give two examples of where this
might happen, and again, as I say, the independent assessor, while
making an independent assessment, is part of the process in the
hospital involving the transplant team and the donor coordinators.
So far as consent is concerned, there have been occasions, I think,
when a family has presented and it may be that the father, who
may be a pater familias figure, has got kidney disease
and needs a transplant. There are a number of children, and perhaps
the youngest child, who is perhaps a rather quiet young man, is
the one who apparently is going to be the donor, and the issues
there about consent are clearly quite interesting. It is not just
an issue for the independent assessor but, of course, particularly
the donor coordinators will have been working to see whether there
is in fact a possibility of taking this case forward under the
Human Tissue Act, and it may be that at an early stage the donor
coordinator will decide that the consent issues are not clear
and the transplant team will not proceed.
Q365 Baroness Gale: Before
I put my question, I need to declare an interest in that I am
a patron of Kidney Wales Foundation. You talk about paired donations.
We have had very few in this country so far, and we all know about
them because there was lots of publicity about it. I wondered,
would it work if you had paired couples from, say, Spain and Britain?
Would you see that as being extended across Europe? How would
you then determine giving permission or authority with people
in different countries?
Mr Lemmey: There are very few organs either
imported or exported for transplantation. I think I am right in
saying the figures for last year, for 2007, both in and out, barely
got into double figures. Even in this country paired donations,
paired transplants, are very difficult to arrange, partly because
of the time. It would, I suppose, be possible in theory if you
are carrying out a paired donation to have both pairs in the same
hospital, in the same transplant unit but, for all sorts of reasons,
that is not possible at the moment. Indeed, paired donations that
have taken place, as I think you know, have involved places as
far apart as Cambridge and Edinburgh and have involved the use
of an aeroplane. The timing of that is crucial. Also we are finding
that the set-up work, even within a single UK system overseen
by UK Transplant is very complex. I think we are some way away
from either an organisational synergy that would allow that to
happen, but also there is always going to be a problem about the
time taken to swap the organs between one unit and another.
Q366 Chairman: Can we come
back to the Scotland question?
Mr Lemmey: Very quickly: in practice, live organ
donation in Scotland operates under the same system as it does
in England, Wales and Northern Ireland, and consistency of approach
across the UK has been the watchword, and the Human Tissue Authority
acts on the Scottish Government's behalf in cases of organ donation
in Scotland. Having said that, Scotland has its own Act, the Human
Tissue (Scotland) Act 2006, and there are one or two detail differences.
For example, the concept of consent in the Human Tissue Act 2004
is known as "authorisation" in Scotland. The provisions
as regards children are slightly different because in Scotland
people over 16 are regarded as adult and it is over 18 in this
country. There are a number of other small differences which I
can provide information to the Committee about.
Q367 Baroness Neuberger: The
link-up to the Commission's Communication. Do you feel—I
think we need this for the record as this is particularly our
area of concern—that the principles that underpin what you
do in the Human Tissue Act, and, indeed, what there is in the
Scottish Act, link well with the Commission's Communication? Do
you feel that the same principles underpin both?
Mr Lemmey: Can I start to answer that by setting
out what I think the principles are?
Q368 Baroness Neuberger: Yes,
that would be very helpful.
Mr Lemmey: I think there are two sets of principles
which underpin the regulation of live donation and also by which
the Human Tissue Authority steers. The first of these I think
are the ethical principles set out in the 2004 Act, and they are
about ideas of a degree of individual autonomy, the primacy of
consent in the process, the importance of consent being properly
informed, people giving consent properly informed, and the importance
of there being, certainly in terms of organ transplantation, no
trafficking and no coercion. There is a second set of principles
which I think shape the regulatory activities of the Human Tissue
Authority, and those are ones derived from the work of the erstwhile
Better Regulation Commission, the Better Regulation Executive.
Those are about accountability, proportionality, being targeted
and transparent, and the Better Regulation principles are actually
written into the Human Tissue Act as something that the Human
Tissue Authority needs to bear in mind. I think there are those
ethical principles and Better Regulation as well. There is actually
I think a third, perhaps not a principle, but it is an important,
again, guide to the Authority. We are sponsored and partly funded
by the Department of Health and the Authority supports the Secretary
of State for Health's objectives on maximising transplantation
rates, to the extent it can without compromising its remit to
regulate the process. With those sets of principles in mind, we
look at the proposals in the Commission's Communication really
from two immediate standpoints. One is that it should allow subsidiarity,
so far as it can, to allow individual Member States to support
their own ethical principles and, secondly, that any regulation,
any proposal, any EU action, should be able to be implemented
in this country in terms of Better Regulation. Shall I go on?
Q369 Baroness Neuberger: If
you have a specific point, yes, although we are running short
of time. Have you any particular areas where you think there is
a conflict?
Mr Lemmey: The Communication has three themes.
The first one is quality and safety. Despite what the Committee
has already heard, I do not think that is a major problem in this
country. Standards of quality and safety are derived from both
statutory and professional bodies, and there are mechanisms in
this country, the NPSA being one, for tackling those. I think
it is also correct to say that standards in this country are seen
as being pretty robust in other parts of Europe. So it is not
immediately obvious that European action—
Q370 Chairman: May I just
make a precise point that has come to us on a number of occasions?
We have had a number of witnesses who have been concerned that
an EU Directive might make it difficult to be flexible in relation
to certain organs where people are dying—we know that—because
there is a shortage of organs, and that there may be such a high
standard that a number of organs that might be usable, putting
it very simply, would be rejected if we had a Commission Directive
that was too tight. That is what Lady Neuberger is trying to see
whether or not you think that a Directive needs to be flexible
enough to ensure that what is commonly called, I suppose, "gold
plating" does not happen.
Mr Lemmey: I think flexibility is very important.
One of the lessons that the Human Tissue Authority has learned
from implementing the previous Directive, the Tissue and Cells
Directive, is that too much detail in Directives can sometimes
be a hazard. I think good European legislation works well, and
the Tissue and Cells Directive in many ways does work well, but
it is a very detailed document and detail tends to ossify over
time, and it is difficult to adapt and be flexible if the transposed
regulations from EU Directives are too detailed and prescriptive.
Baroness Neuberger: That is what we wanted.
Thank you very much indeed.
Q371 Baroness Gale: We have
been told that there is a conflict of interests between the Human
Tissue Act and the Coroners Act which leads to a lack of clarity
about the way in which the medical treatment of potential organ
donors—particularly non-heart beating donors—should
be determined so as to reconcile any conflict between the coroner's
forensic interests and the objective of retrieving organs of good
quality. Does the HTA recognise this problem and, if so, how would
you like to see clarification being provided?
Mr Lemmey: We do recognise this as a problem.
It is not a very widespread problem at the moment but it may be
that, if it is further addressed, it may enable a greater number
of transplants to take place. Cases coming in through accident
and emergency, through casualty, dead or dying, are in many cases
potentially coroner's cases but also may potentially be transplant
donors. So far as possible donation for transplantation of organs
is concerned, the transplant unit, the hospital, will need to
check on the consent status, and that can take a little time.
Part 3 of the Human Tissue Act 2004 allows what are called "minimum
steps" for preservation for transplantation to take place
while that consent is sought, while the donor register status
is sought or contact is made with the relatives, with the family.
Those minimum steps could include a process called cold perfusion,
which is passing cooling preserving fluid through the body to
keep the organs cool until the question of consent can be resolved.
This only happens in a limited number of hospitals. I think currently
actually it is only at Newcastle, although there have been programmes
run elsewhere. It is quite resource-intensive but, at the same
time, while that process might go on the coroners will be concerned
that their criminal justice investigations, for example, blood
tests or toxicology tests, might be impeded or jeopardised if
that process takes place, although certainly, if it is done in
a planned way, there are ways in which both the cooling process
can take place and the forensic examination can also take place.
Until the 2004 Act the lawfulness or not of these immediate steps
was not clear, but the Act goes out of its way to explain that
those processes are lawful and, interestingly, the provisions
of the Act that cover minimum steps and cold perfusion are actually
in Part 3 of the Act, which is the part of the Act which does
not contain the exemption for coroners' purposes. The Human Tissue
Authority interprets this as recognising the importance and validity
both of the coroners and criminal justice interest on the one
hand and the transplantation team and the potential for donation
on the other. Where cold perfusion has taken place across the
country, there have been different arrangements, I think, locally
with coroners and with hospitals. As I say, I think now in fact
only one programme is running. There needs to be a practical way
to balance both those interests. What the Human Tissue Authority
has done is, we are in the process at the moment of writing a
generic protocol to enable hospitals and coroners on this issue
to work through the issues and come to an agreement which allows
both sets of interests to be recognised and to be worked through.
Writing a protocol is one thing; getting it enacted is another.
This is where the Human Tissue Authority feels it is so important
that the recommendations of the Department of Health task force
on organ donation, the Organs for Transplants report, are
enacted. I think recommendation 14 of that report covers this
area and what that holds out the hope of is some centrally driven
work both by the Department of Health and the Ministry of Justice
on ensuring that these sort of agreements and protocols can be
taken forward, and we might then see this minimum steps cold perfusion
programme being adopted a little more widely, and that again would
add to the number of transplants, we would hope.
Chairman: That is really helpful.
Q372 Baroness Neuberger: Obviously,
from what you have said, in fact it has not been an easy process
if you are down to one centre doing it. In that remaining one
centre, is it handled through intensive care or is it also through
A&E?
Mr Lemmey: I think it is through both but I
do not know the detail. What I do know though is that they are
resource-intensive programmes because, of course, it is difficult
to predict when cases are going to actually appear.
Chairman: If you have any thoughts that might
clarify that, maybe you would let us know.
Q373 Lord Eames: In a sense,
what I want to draw attention to has been touched on in various
aspects in some of the evidence you have given this morning. It
is to do with the experience of the Authority in operating the
Tissues and Cells Directive within the UK. In addition to what
you have said about the experience of the Authority in these various
Directives, could you say something more to us about the relevance
you have seen, the problems you have come across when we have
to have a Directive such as this on a very sensitive issue operated
within the UK culture, legal system, and so on. Could you tell
us something about that?
Q374 Chairman: Have you anything
to add to what you have already said?
Mr Lemmey: Yes, certainly. I have explained
that the Human Tissue Authority is one of the Competent authorities.
I have explained that we are now regulating 200 or more establishments
that deal with tissues and cells. We are talking here about stem
cells, heart valves, corneas, skin, and so on. I have also said
a little bit about what we thought was in some parts an over-detailed
aspect of the Directive. Another aspect of implementing the Tissues
and Cells Directive has been that a dual licensing system has
had to be set up. It may have been helpful during the development
of the Directive if there had been a greater attempt perhaps to
map the proposals on to the individual legislation of Member States.
The Human Tissue Authority has to operate two licensing systems:
one under the Human Tissue Act and one under the Tissue and Cells
Directive covering similar areas involving human tissue, and indeed,
some establishments have to have a licence under both systems,
under both regimes. It really is, I think, stretching the boundaries
of the Better Regulation to suggest that is an optimal position.
That is really an issue, I think, about the way in which European
legislation and legislation in Member States is looked at.
Q375 Lord Eames: Before you
leave that, could I just ask this? Are you in fact saying that
there was perhaps a lack of pre-consultation, of wedding what
was going to come in the Directive with what was happening in
individual Member States, that is, before the Directive arrived
on the scene?
Mr Lemmey: I think that is broadly right. Before
the Tissue and Cells Directive was ratified something called an
RIA, a regulatory impact assessment, was carried out to try and
judge the impact but that was, I think, at the start of the process.
It took about two years, from Spring 2004 to Spring 2006, to complete
the Directive and its two detailed technical annexes and during
that time, of course, the proposals it contained had changed.
I think there is an argument for perhaps revisiting those impact
assessments at least annually during these long drawn-out developments
of European legislation.
Q376 Lord Lea of Crondall:
So there was not so much a lack of consultation as a fine-tuning
of the consultation according to the iterative process going on
at that time?
Mr Lemmey: That is right, and indeed, the Commission
is now having to fine-tune the Directive because, as I say, of
the way in which life has gone on since then.
Chairman: We are going to have to move on. If
there are other areas in this, would you write to us about it,
because that would be really helpful?
Q377 Baroness Perry of Southwark:
Mr Lemmey, I think you have probably answered quite a lot of my
question. You know that the British Transplant Society said to
us that they thought the Directive should cover just the issue
of minimum standards relating to organ retrieval, including the
training of staff. What we would like to hear from you is what
areas that are not currently mentioned in the Commission's document
you think the Directive should cover?
Mr Lemmey: I am not sure whether this is so
much issues to be covered by the Directive as a Commission action
plan or indeed Commission action more generally. The Committee
has already heard today of the possibility of greater sharing
of information, particularly about incidents that have happened
in transplantation. I think the Human Tissue Authority would particularly
pick out the importance of sharing information about the organisation
and management of organ transplant systems in other countries.
All Member States would have something to learn from each other
there. I think also there are questions about access to transplant
services which it would be helpful to exchange information about.
I think those are two of the areas in which we would see benefits
from greater European action.
Q378 Baroness Young of Hornsey:
I have a couple of questions around presumed consent. What would
a move to presumed consent in the context of organ donation entail
in terms of changing the Human Tissue Act? Secondly, how would
such a change in the law affect the HTA's general working principles
and the way it organises its work? Thirdly, what, if any, significant
problems do you think could arise in implementing an Act which
allows for presumed consent?
Mr Lemmey: There is a lot here. I think at minimum
the Human Tissue Act 2004 would need a change to Part 1 of the
Act, because the appropriate consent provisions for deceased organ
donation provisions would need to change, and also there would
have to be a change in Part 2 of the Act to change the remit of
the Human Tissue Authority in that area. Having said that, I think
in reality it may be that Ministers might prefer a much more radical
legislative change, in the form perhaps of a Transplantation Bill,
but it is not for the Human Tissue Authority to make that choice.
I think it is important that I state that the Human Tissue Authority
has not come to any decision about presumed consent, although
it has debated the issue and it has identified in its meetings
some of the questions which it thinks it is important to address.
Also, I think the Authority has noted that if presumed consent
were brought in for deceased organ donation, it would actually
also have to pick up some other activities, investigative and
clinical, that are part of the transplant process as well and
that should perhaps be borne in mind. The Authority supports a
balanced and evidence-based approach to policy-making and, through
the Chair of the Authority, we are already involved in the work
of the reconstituted Department of Health task force that is looking
into presumed consent. That is gathering and assessing evidence,
as you know, about the impact of presumed consent on the transplantation
programme. Should the evidence point to presumed consent being
a major trigger for improved donation rates, I think the authority
would certainly bear that strongly in mind in any advice it wanted
to give to Ministers about that. Clearly, if the law changed,
the Authority would implement and regulate under the new arrangements.
Having said that, the Authority has highlighted a couple of points
at this stage. One is an ethical issue really, and it is about
informed consent. The current provisions in the Act require there
to be informed individual consent and, if that notion of information
as the context in which consent is given is to continue under
presumed consent, a soft opt-out arrangement, there are clearly
important issues about how a population of 60 million people can
be properly informed. That is certainly an area which the Human
Tissue Authority would hope the task force would address.
Q379 Chairman: We heard from
the Spanish senior coordinator last week that all of this does
not matter if the organisation is quite clearly set out, that
donor cards might be quite useful, information will be helpful,
but unless the structures are there in the hospitals where there
are coordinators who can work with families on the ground, the
numbers will not go up. What would your view be about that?
Mr Lemmey: I think that is the sort of area
that some further evidence on which will both be helpful to the
Human Tissue Authority and I think it is actually issues like
that which point towards the answer on this particular debate.
To go back to your question, there is a second issue that the
Authority has particularly identified, and that is about the integrity
of the Human Tissue Act across all its other uses and activities
affecting human tissue like research, like post-mortems, like
anatomical dissection by medical undergraduates, and even public
displays of bodies. Currently the notion of informed consent,
the requirement for informed consent, applies to all those activities
as well and the Authority is, I think, concerned that if one of
the activities within its remit, which is organ donation in death,
if presumed consent is brought in for that, then the informed
consent provisions, explicit consent provisions, across those
other activities should not be jeopardised.
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