Examination of Witnesses (Questions 220
- 239)
THURSDAY 21 FEBRUARY 2008
Dr Anthony Warrens and Mr Keith Rigg
Q220 Chairman: Would you like
to come in?
Mr Rigg: Yes, I do. To come back from what Anthony
was saying, I think we recognise that for the majority of people,
within an organ sharing scheme within one country such as the
UK, there are enough people waiting to actually match those organs.
One of the concerns, if you start to share between more countries,
is the actual time that is involved, the so-called ischemic time.
There is only a finite storage time for organs and, therefore,
if you increase the transport times, that then means that the
organs can become unusable, and so I think we would recognise
that the outcomes are far better when we are able to transplant
organs a lot quicker. For kidneys, for example, there is good
evidence to show that, if we are able to transplant them within
20 hours, then they are more likely to work both in the short-term
and in the long-term. Once you start to talk about sharing those
within a wider geographical area, there is therefore the risk
that those organs may not work as well. What Anthony was referring
is that there is a group of patients who are far more difficult
to find a suitable organ for, whether that be a deceased donor
organ or a living donor organ, and for that small group of patients,
therefore, it may be advantageous to dispel the geographical reasons:
because you then have the choice of either not getting a transplant
at all or getting one from elsewhere, accepting that the outcomes
may not be quite as good because of the longer transport times.
Coming on to the specific incidence of paired donation, this is
something that has been allowed into the Human Tissue Act which
we had not been able to do in the UK prior to that. In the living
donor context, say, there is donor A and recipient A who would
like to be able to donate to each other but they are biologically
incompatible and, therefore, at the moment could not go ahead
with live donation, and then another couple, donor B and recipient
B who, again, are in a very similar situation. What the paired
donation scheme allows is for the donor in pair A to donate to
the recipient in pair B, and vice versa. When we talk about pooled
donation, it is where there is more than two in the chain. It
does get very complex, and logistically it is quite difficult
to put into practice. This has been allowed in the UK since September
2006, but up to now only two of these transplants have gone ahead.
That is partly because the British are always slightly more reticent
about new things and it takes a little while for new schemes to
come on board and there are always those at the vanguard who would
like to be first and others who would like to see how it goes
first. I think what Anthony was saying was that within a wider
European pool, for example, and you could argue this in France
and Belgium which are quite accessible, if there was a larger
pool, then there would be the possibility of matching more people
in this way. This would still be a very small proportion of the
overall number of living donors. Last year the number of living
donors in the UK was nearly 700, and so we are talking about a
very small proportion of that.
Chairman: Lord Lea, you may want to come
back, but can I pursue this bit with Lady Gale bringing her question
in, because she wants, I know, to ask about quality and safety
and one of the issues, of course, is whether there should be a
framework of safety. Do you want to come in here, Lady Gale?
Q221 Baroness Gale: I wonder,
could you describe the views of the British Transplantation Society
regarding the seriousness of the risks of transmitting disease
if the number of organ donations is increased and organ sharing
across EU borders becomes more frequent? What form of EU regulation
in this area would you find the most helpful and what, if any,
inappropriately onerous restrictions do you think should or could
be avoided?
Mr Rigg: I think there are two things to say,
just to put it into context. First of all, the risks of transmitting
disease, either an infection or a malignancy, are actually very
low because of the systems that are in place within this country.
There are very strict regulations in terms of donor assessment
to be sure that the donor has not had previous diseases. There
are also strict regulations on what infectious diseases a donor
may have had. There are various tests we do to ascertain whether
somebody has had exposure to HIV or hepatitis, for example, before
and then there is a traceability process so that there is a very
clear system in place. Therefore, the risk of transmission is
actually very low, but we can never say that it is not there,
because sometimes you do not know, even on blood testing, even
on close questioning. So, there is a very small risk, and we would
always have to explain that to the patient. The second thing to
say, as we have already hinted at, is that the number of organs
that we receive in this country from Europe is actually very low
in the grand scheme of things. There is the occasional kidney
that cannot be placed within Europe and there may be perhaps a
slightly higher proportion of livers and hearts where the actual
recipient pool is lower. So it is very important (and I think
this is one of the things that is important in the European proposals)
that there should be minimum standards that all countries should
stick to so that at least one can gain some assurance that an
organ that you are receiving from another country meets the same
standards as you would expect from our own country. One of the
concerns from the transplant community is that the baseline or
the precautions that are already in place are pretty robust, and
I am not sure that we would see the need for that to be increased.
It comes back to the bureaucratisation: actually if it came to
a place where transplant units needed to be licensed, where there
needed to be more paper work, I think this would add unnecessarily
to what is already a pretty safe scheme where there have actually
been very few adverse events. We have a system that is working
very well, and I think we would want to see those best practices
incorporated into a European framework but without making it overly
bureaucratic.
Baroness Gale: My Lord Chairman, before
I ask another question, could I ask you, should I have declared
an interest before I asked my question?
Chairman: You probably should have done.
Perhaps you could declare it now.
Q222 Baroness Gale: My interest
is I am a patron of Kidney (Wales) Foundation. Could I ask you,
are there any cases of infections after a transplant, and are
you saying that, even if we got all this regulation, there would
not be many organs coming from EU countries? Would we be able
to manage in the main?
Mr Rigg: On the whole, I think all countries
within the European Union have more people waiting for a transplant
than there are organs available. I think even in Spain, where
they have the highest donation rate, they still have people on
their waiting list. I think in the main we would, I am sure, within
any allocation system, allocate to those within that local geographical
area. We obviously have UK Transplant in this country. In Europe
there is Scandia Transplant and Euro Transplant, which may cover
a few of the adjacent countries, but I think there is a lot to
be said for those smaller regional allocation sharing schemes,
partly to come back to what I said before about minimising the
transport times. I think even if there were to be a combined European
view on this, I think there would still be only a small proportion
of organs that were shared. That might be different in perhaps
some of the newer Member States, who have very low donation rates
and very low transplant rates, perhaps some of the Eastern European
countries; I suspect that we would not necessarily be able to
help those because we are quite far geographically from them and,
therefore, any sharing is likely to be within those countries
nearby, such as Spain, France, Belgium or even Germany.
Chairman: We are still trying to pursue
what value the EU could add. I think, Lady Perry, you are going
to pursue this. Lord Lea started this one and we are still pursuing
what value it can add.
Q223 Baroness Perry of Southwark:
Yes, indeed. In your submission you did point to at least one
omission, as you saw it, in the Directive, which is the quality
of the retrieval. I was amazed to learn that apparently sometimes
you waste an organ because the retrieval has not been efficiently
or safely carried out. Do say something about that, and are there
other areas where you feel that the Directive could be expanded
to include more than is currently there?
Dr Warrens: With respect to safety, I would
say that is the major issue that we felt was missing. The other
area that I think would be very important to promote on a European-wide
basis is research. I feel I also ought to declare an interest
here in that I am research active. I am interested in mechanisms
of increasing organ donation, and so I would say that, would I
not? But, I do believe that there is a lot that we can learn from
our sister countries throughout Europe, because the factors that
make people less enthusiastic to donate, I am sure, cross national
boundaries, but by increasing the number of people from whom we
glean information, we will learn what those factors are and put
in place the most appropriate way of trying to respond to them.
I would like to say from the start, I do not think that the results
of that research always has to be that everyone will agree to
donation. It may be that, for entirely appropriate, personal,
religious, cultural, ethical issues somebody is disinclined to
support donation. I think our responsibility is to make sure that
the decision they are making is an informed one, and by understanding
what their concerns are, I think we are in a better position to
help that process of informing them and the step before understanding
what those concerns are is research, and so I am very keen to
see at a national and, indeed, supranational level, the promotion
of research into the issue of what inhibits people from participating
in organ donation.
Q224 Baroness Perry of Southwark:
This would be social science research and not medical research?
Dr Warrens: Yes.
Chairman: We are going to come back to
research again, but could I take you back again to the EU Directive
and really pursue it again. I know Lord Eames wants to ask some
questions about practitioners in this, but what do you think the
Directive could bring? From the documentation we have had from
the EU, in their view, what value could they add in terms of safety
or sharing?
Q225 Baroness Perry of Southwark:
I think we would like you to be specific about what you would
like the Directive to say about safety and retrieval, for example,
standards in retrieval, and also, now you have mentioned this
kind of research, what could the EU do or say in their Directive
that would help that?
Dr Warrens: I will talk about research and I
shall let Keith talk about retrieval, since he does retrieval
as a surgeon and I do not as a physician. I think social science
research is exactly the right phrase. We need to understand the
structures of the communities, and I mean the smaller communities
to which people identify, within which their opinions are formed.
What are the processes that allow the formation of those opinions,
what are we succeeding in communicating and what are we failing
in communicating? What are the anxieties that people have about
going ahead with donation or permitting one of the members of
their family who has died to become a donor?
Q226 Baroness Perry of Southwark:
That would not, however, be in the content of the Directive, would
it? It would be the EU in another of its personas in its sponsoring
of research topics and programme?
Dr Warrens: Sure. The development of the criteria
for sponsoring research follows on from policy directives and,
in the context of the conversation we are having today, I would
like to see in a document such as this that discusses policy actions
at EU level a comment that says: it is very important for the
EU to recognise the need to increase our knowledge in this area
and it would be an appropriate place for EU funding to be given
to research. I know that would then have a knock-on effect on
the criteria that the funders of research use to decide how to
disburse their moneys.
Q227 Baroness Perry of Southwark:
And retrieval?
Mr Rigg: So far as retrieval is concerned, the
retrieval of organs from deceased people tends to be an out-of-hours
activity and, therefore, is often unpopular, it has often been
done by perhaps the junior members of the team and, I think, as
the European Working Time Directive increasingly bites, it then
becomes increasingly difficult to deliver that in the context
of also trying to deliver the rest of the services. Perhaps I
can talk about what we are trying to do in the UK first, because
that then has a context to what is happening European-wide. I
think we have recognised within the UK that there has been a problem.
I chaired a UK Transplant working group five or six years ago,
which has subsequently been taken on by the British Transplantation
Society, to look at what the problems were and what some of solutions
might be. I think some of the solutions are actually highlighted
in the recommendations from the taskforce, but it is trying to
have dedicated multi-organ retrieval teams, maybe ten to cover
the UK. That would be their job for that period of time. So, they
were not involved with routine elective work, their commitment
was to the team, they were properly trained, they were properly
resourced, the teams were dependent on no one from the donor hospitals,
they would take the surgeons, the nurses the anaesthetists with
them and, therefore, they would be able to respond in a timely
way. We believe in this country that, by implementing that, that
will provide a much safer way of providing organ retrieval, both
in terms of the quality of the organs that are removed but also
in causing least disruption to the donor hospitals: because intensive
care units are under increasing pressure for their beds as well.
The last study that looked at organ damage was about seven or
eight years ago now, and that showed that about 14% of organs
were damaged during retrieval, although I should say that most
of those items of damage could be repaired and only a very small
proportion were actually discarded and not used; but I think it
does show that it is a stressful operation, it is done out of
hours often with inadequate assistance for the operating surgeon,
and it can be a difficult procedure and, therefore, to have dedicated
teams who are trained is very important. I think there are steps
to put this in place, and we hope that that part of the taskforce,
we hope that all parts of the taskforce recommendations, will
be implemented, but from a surgical point of view, I have great
hope that that will take place. As far Europe is concerned, I
think there can be standards of training and standards of competency
in delivering these services. I think retrieval services are delivered
differently in different countries and I think some of the recommendations
that have been put forward in this country have been implemented
in other countries, I think, but in the majority of countries
they have not and, therefore, to have a European-wide Directive
that says: these are the standards for training, these are the
standards for competency, and there is already a European transplant
exam which has donation and retrieval as a module, is perhaps
one way forward, but, again, to have something from the EU Directive
that actually applies to all states means that there is a good
standard, not just for the country in which the organs are removed
and most likely will be used. There is also that assurance that
if the organ is coming from another country it will be of a quality
that you will be ready to use. For some of those organs, the livers
or the hearts, that come from Europe, often if it is retrieved
in mainland Europe, then one of the surgeons from this country
will go out, and vice versa, if a liver or heart is being retrieved
in this country to go elsewhere in Europe, then the European surgeon
will come, because surgeons at the moment do not necessarily trust
other surgeons to do things in just the way that they would like.
Therefore, I think that some standardisation and some trust and
acceptability is very important and I think this is something
that the Directive, or at least the action plan, could address.
Baroness Perry of Southwark: Very quickly
to follow up, the conditions you have described, the after hours
work and not a sufficient team to back-up, is that true for living
donors or simply for the—
Chairman: Can I hold you there, Lady
Perry, because we are moving into some areas that we are going
to come to.
Q228 Baroness Perry of Southwark:
I wanted to confirm what he said about the—
Mr Rigg: It is deceased donors only. Living
donors are done during the day by experienced consultants.
Chairman: Thank you I can see Lady Perry's
anxiety there! Lord Eames, this touches on the question you wanted
to ask. I would like to come to research immediately after, because
it fits in.
Q229 Lord Eames: It touches
very much on what I have been thinking about. Can I say, first
of all, how helpful your presentation has been? We have had many
presentations, but I have found this one particularly helpful,
just as a personal aside. Gentlemen, with the avalanche of EU
directives, there is one that perhaps impinges very much on what
you have already said this morning, and that is the one which
concerns working times. It brings me to ask the rather pointed
question whether or not, in the light of all that, you feel that
there is sufficient experience within the transplant units on
the part of practitioners to face up to these pressures that are
coming elsewhere in other directives. In other words, it is linking
together a lot that you have said already, your reference to after
hours and junior members of the team and all that sort of thing.
On the safety, on the expertise point of view, experience, what
do you think?
Dr Warrens: Perhaps I could start and I am sure
Keith will contribute. I would seek to reassure you that this
is something that the profession is very aware of and over the
course of the past 15 years you will have seen a contraction in
the number of units that actually do perform transplants largely
for that reason: because we recognise that, in order to maintain
skills, you need to be doing a certain minimum number of procedures.
The pressure to conform to directives limiting the number of hours
any individual can work only increases the pressure to have a
large number of transplants in one centre so that any one individual
can maintain his or her skill-set. There was an important and
influential report published by Sir Peter Morris, at the time
he was President of the Royal College of Surgeons, about exactly
this issue, rationalising the number of transplants units, and
we moved in that direction. It may be that, if the situation arises
that we are required to conform to a number of other directives,
we may move further in that direction. However, we have had a
major problem with training junior transplant surgeons. Again,
Keith is better placed to answer that than me, but I know that
we have got over many of those problems and the problem is not
as great an issue as it was perhaps three or four years ago, but
I will pass over to Keith, as a surgeon.
Mr Rigg: One of the concerns for those of us
who practise in one of the craft specialities, such as surgery,
is that you obviously do need the experience and you can train
someone to do an operation but that is the easy bit. The more
difficult aspects are making the decision whether to operate or
not and being able to recognise the complications afterwards.
Those are the sorts of things that often do happen out of hours.
One of the concerns is whether you can actually provide that training
and that experience within a 48 hour working week. The thing is,
we do not quite know that yet, and we do recognise that, as the
training times have come down, we have obviously had to change
the way in which we train our junior surgeons, but I think there
is no doubt that the experience they come out with at the end
is perhaps not as comprehensive as it once was. Whether this will
be adequate or not I think remains to be seen. When we do get
down to the 48 hour requirement in eighteen months time, whether
the eight years of training will be sufficient, we do not know,
but I think there are concerns and, therefore, when someone is
appointed as a consultant they will need to be mentored very carefully
for perhaps a couple of years before they are fully up to speed.
Certainly within the area of organ retrieval, where it is out
of hours, I think that comes back to the fact that we do need
dedicated teams who are able to do that.
Q230 Lord Eames: From the
point of few of the European Union, which is our particular concern—I
referred in my question to directives on working hours and times,
and so on—do you see a conflict emerging in your expert
field on this?
Mr Rigg: Very much so. I think there are great
concerns about actually going down to 48 hours, there are actually
great concerns at being down to 56 hours at the moment and people
have calculated as to how many fewer hours of training people
now have. I think surgeons will often put in extra hours to gain
that extra training and experience, which obviously they should
not be doing but from an educational point of view they do. I
think that is what I am saying, that when we do go down to 48
hours to meet with the Directive, there will be even greater concerns.
Although we say that in surgery, I am sure it is the same in other
specialties as well.
Lord Eames: For the record, I was going
to say that when my two sons, who are consultant surgeons, hear
that this was the question I asked you, they will be horrified,
but I will pass back.
Q231 Lord Lea of Crondall:
Maybe Lord Eames' sons would be horrified because they would know
perhaps, would they not, that there is an averaging rule in the
48 hours. There was a time when junior hospital doctors, we all
know, worked all the hours that God sends, and that was itself
not a very bright idea from the health and safety point of view,
and so there has been a general acceptance now that that this
is the position. Of course you need to have more staff if you
are going to have any hours limit, but when you say 48 hours,
how exactly do you mean 48 hours is binding on this? It is not
48 hours in any particularly short period of time, is it? You
are just talking about the amount of labour input that is needed
extra because of the general average of 48 hours?
Mr Rigg: Yes and no. The European Working Time
Directive, as far as I understand, averages out at 48 hours work
per week, which by the time you have got to a night on call, for
example, takes out 16 hours, which leaves you 32 hours for the
rest of the week. Actually you have not got people there very
often by the time you have covered the weekend, so we need to
consider other ways of providing the service as well as the training.
There are various ways, but if you increase the number of trainees,
then you dilute the experience and you then have not got the consultant
posts at the end of it for them to go into, so you then end up
producing a large number of trainees with nowhere to go. There
are other options of providing this service by people who are
not trainees. There are no simple answers, and I think it is something
that we are wrestling with, and I am sure we are not alone in
the medical profession.
Q232 Chairman: We want to
move on, but do we have any knowledge from Spain and Belgium as
to how they have tackled the point? The issue is continuity, is
it not, in this field?
Mr Rigg: Yes
Q233 Chairman: You have got
to have someone seeing the thing through. Do we know whether they
have cracked the Working Time Directive in relation to this?
Mr Rigg: I know in some countries the individuals
choose to disregard it actually. They pay lip service and then
just carry on doing what they have always done.
Chairman: Thank you. Because we have
got into research, it seemed that it would be worth pursuing and
battling this one out before we move on to the other complicated
questions about what is life and what is death, you know!
Q234 Lord Kirkwood of Kirkhope:
I will deal with the easy questions first! My Lord Chairman, I
concur with Lord Eames: I think this is a splendid four-page submission.
It is concise, it is lucid and it is persuasive. I nearly spoilt
it all by saying "for something that is written by a doctor",
but I am being facetious. I did really both enjoy and learn a
lot from the submission, but I wonder if you could clarify a sentence
for me. I am interested in public awareness, because it is an
important part of this whole inquiry and there is a sentence under
organ shortage, research potential, where you say, "Indeed,
we believe there is an under emphasised level beyond awareness,
namely public perception and information to support organ donation."
Could you expand a little on that? That is the first time that
has been suggested. I thought awareness was the target that we
were aiming for, but you seem to be suggesting that actually we
need to try and aim for something slightly higher than that.
Dr Warrens: I certainly do believe that. If
I can refer to some of my own research here, I am currently undergoing
a project, funded by the Big Lottery Fund through Kidney Research
UK, in which we are doing some social science research with various
communities in London. There are a number of ethnic and religious
issues that appear to have an impact on the level of knowledge,
but, over and above that, there is a recurring theme of alienation
amongst certain communities from the medical establishment. This
was something that seriously distressed both myself and my fellow
researchers: that people feel that the process of organ donation
is not something in which everybody is dealt with in an equitable
fashion. Members of some communities fear that they would not
be accorded the same level of care in order to preserve their
personal health if they were seen as a potential donor. Clearly,
I would want to put it on the record that, of course, we bend
over backwards to pursue absolute equity of care for everybody,
but it is clear that is not how it is perceived. There is perceived
to be, and I think I cannot use an alternative phrase, a white
medical establishment that discriminates with respect to organ
donation against other communities and. horrified though I was,
I think what we need to do is address that perception of how we
behave.
Q235 Lord Kirkwood of Kirkhope:
I think trying to explain to politicians that there is a disturbingly
high level of mistrust in the medical establishment, which I think
we know about, we know about disturbingly high levels of mistrust
in this building—that is very interesting—but the
key question going on from that is: you were saying in relation
to social science research that is necessary to do it across border,
and that is something that the European Union can do and that
is important to the consideration of our report, but explain to
me what you can gain from comparing social scientific surveys
between Athens and Edinburgh? I can understand that drilling down
into the reasons why people are resistant and getting awareness,
if not perceptions, is what we are trying to do, but is Eastern
Europe the same as the Southern Mediterranean countries? Would
a cross-border piece of research be useful comparing north, south,
east, west across a really wide continental spectrum of opinion?
What would you learn that would not be better than spending a
lot of money in Edinburgh for Edinburgh and a lot of money in
Athens for Athens?
Dr Warrens: There may well be very great differences
between Edinburgh and Athens, but poverty may bring with it shared
perceptions or shared feelings of alienation and that is exactly
the same in different parts of Europe. Immigrant status, be it
to Germany or Spain, may bring with it the same feeling of alienation.
Let me take one step back. I did a lot of work with the Muslim
community and discovered that there are some strands within Islam
which have a negative view of donation, but by no means universal,
and we found this amongst some of the black community in London.
So I asked the question, was this specific to black Muslims? We
then started a small study in black Christians, and the fact is
that there is a shared common cultural heritage from Africa that
owes, we think, more to the experience in West Africa than it
does to the Christian or Islamic traditions; and so we have already
demonstrated, by looking at different groups that you would not
think shared things in common, that it is possible to learn things
from groups that appear to be rather disparate. That is one answer.
The other answer is by getting larger numbers, by studying larger
numbers of people, you get more information, and so that would
be our principal argument in support of research across boundaries.
Q236 Lord Kirkwood of Kirkhope:
The fairy godmother question about cross-border research: if you
were only allowed one wish and you could have anything you liked
in terms of European-wide cross-border research, what would it
be?
Dr Warrens: I think I need to understand what
it is that means that donation rates in the UK are so low but
those in Spain are so high—having taken out the organisational
factors (the Taskforce report has dealt with that very well indeed).
We are hopefully going to move forward and build on that, but
there are still going to be common factors. Even if, as Keith
has said, we were to reproduce the figures that they have in Spain,
we would still have a significant shortfall; so there is a gap
there that we need to fill.
Q237 Baroness Neuberger: I
have to declare an interest, which is that I have a brother-in-law
who may be known to you, who is a physician specialising in transplants.
It always seems a rather odd interest to have to declare, but
there we are. Can I just proceed quickly on the research area,
because I think we all feel we wish we had heard about this earlier
on in this work, and pick up also what you have said about your
work with the Muslim community? I completely accept your wish
to conduct more cross-border research, but in the research that
you have been doing with the Muslim community in this country,
do you believe that the reluctance to be organ donors—this
feeling that they are facing the white medical establishment—also
exacerbated by something we do keep hearing about, which is the
desire to target the South Asian community in order to get them
to be organ donors because of the shortage? Is there another further
exacerbating issue that we need to drill down into?
Dr Warrens: I am not quite sure I fully understand
your question. Are you asking that the community is feeling that
it in receipt of an unreasonable level of attention because of
that?
Q238 Baroness Neuberger: Yes,
because people want those organs?
Dr Warrens: No, I do not think that, because
the information that we keep on getting is that, if organ donation
so is important, why are we not hearing more about it? My GP tells
me, or has leaflets about heart disease and making sure my cholesterol
is all right and stopping smoking. Why is he not continuing to
say, "Are you on the organ donor register?" (Again,
on the subject of declaring interests, this is the subject of
the grant proposal I have currently under consideration with the
National Institute of Health Research.) No, I do not believe there
is a feeling of victimisation at all. In fact, quite a lot of
people, when they hear that there is an issue, when they hear
that their community is particularly susceptible to diseases that
will result in renal failure, are actually more thoughtful about
it and are more prepared to consider it. That has been our experience.
Q239 Baroness Neuberger: That
is very useful. Can I move on to what I am supposed to be asking
you, which is about organ donation after cardiac death, and that
is really important because in your submission one of the strong
recommendations you are making to us is that we should press for
more detailed consideration of organ donation after cardiac death
in what the Commission itself does. What would be very useful
to us, I think, is if you could set out your views on the potential
ways of increasing the practice of organ donation after cardiac
death and say to us what else you think we should be asking, because
I think that is key if we want to really go and follow your suggestion.
Can I add into that something that is not on the script, which
is the question within Europe of the large prevalence of Catholics
and the extent to which that has been a difficulty in some of
the Commission's own consideration, because that is where a lot
of the negativity has come from? I can say that as a Rabbi!
Dr Warrens: The principal issue with donation
after cardiac death is organisational, because it is extremely
labour intensive.
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