Examination of Witnesses (Questions 42
- 59)
THURSDAY 6 DECEMBER 2007
Sir Liam Donaldson and Ms Triona Norman
Q42 Chairman: Welcome.
We are very grateful that you have taken the time to come and
answer questions this morning. We see this as an extraordinarily
important. We hope to see the minister responsible towards the
end of the inquiry but it is because your 2006 Annual Report Organ
transplants: The Waiting Game was published and of interest
that we wanted to have your views early in this inquiry. It is
going to attract a lot of public interest. We really want to try
to get as close to an evidential base of thinking through it as
we can but we know there are a lot of feelings and emotional responses
in relation to this topic. We are assisted by our Specialist Adviser
Professor Bobby Farsides who is with us today. We have scheduled
this session until 11 o'clock this morning, and it is open to
the public and recorded for possible broadcasting or webcasting.
A transcript will be taken and put on the public record in printed
form and on the parliamentary website and your office will be
sent a copy of the transcript to check for accuracy. Would you
advise us as soon as possible of any corrections. You may give
us supplementary evidence to clarify or amplify any points which
you have given today, and there may be questions we do not reach
today, in which case we would be grateful for written evidence.
Could you start by stating your name and official title for the
record and then you may wish to make an opening statement or move
straight into questions.
Sir Liam Donaldson: Thank you. I am Liam Donaldson.
I am the Chief Medical officer for England and the UK Government
Chief Medical Adviser.
Ms Norman: I am Triona Norman. I am the Department
of Health Policy Leader on Transplantation.
Q43 Chairman: Would you like
to make an introductory statement?
Sir Liam Donaldson: I am not intending to make
an introductory statement because I think the questions you have
suggested cover the ground very well. I am not an expert on European
legislation and so I may be drawing on Triona Norman's expertise
a little bit in that area in answer to some of the questions.
Q44 Chairman: We have all
had an opportunity to look at your documents. We were interested,
particularly, in the gap between those people who say they will
be donors and actual donations, and also to read that 148 heart
transplants and nearly 2,000 kidney transplants were carried out.
We would like you to describe, if you would, the overall assessment
of the present and potential future significance of organ transplantation
as medical therapy. How would you characterise the relative importance
of organ transplantation in relation to other NHS priorities?
Sir Liam Donaldson: My view would be that it
is an important area of healthcare and medical practice and likely
to become increasingly important as the population ages and develops
more chronic diseases which precipitate the failure of organs.
An obvious example would be the increase in the incidence of diabetes,
which is a relatively common cause of kidney failure. Many patients
with kidney failure have the choice of going on dialysis, which
is inconvenient, unpleasant and often leads to poor quality of
life, versus transplantation, which removes many of those difficulties,
so it is an important area of medicine. The disappointment is
that it has not been able to fulfil its full potential because
of the shortage of donors, and 1,000 people a year, at least,
are dying for lack of a transplant. That figure represents only
those we know have been put on the waiting list and do not make
it through to transplant before they die; there are others, I
am sure, who are not put on transplant waiting lists because doctors
know there is no hope of them getting treatment, and they are
dying silently, as it were. Transplantation involves the straight
taking of an organ from one person and putting it into another.
To look at the scope for alternatives, over the years there has
been research into other ways of creating transplant tissue or
organs. The idea of using animal organs, modified genetically
or otherwise, is one alternative. Also, in some fields of transplantation
the idea of using mechanical organs has been researched and is
still being researched, particularly a mechanical heart. Then,
thirdly, there is the prospect of stem cells being produced in
the future which, in the first instance, could yield tissue for
transplantation and then the challenges of turning that tissue
into the architecture of an organ would be a scale even above
that. There are other fields of research of relevance. Although
in the early days of transplantation stopping the organ from being
rejected by the immune system was a big problem, things have improved
there, with the benefit of new immune suppression drugs, but still
there is a risk of rejection and there is also a greater incidence
of cancer because a person's immune system is suppressed and the
immune system does not remove cancer cells as easily as in somebody
with a fully competent immune system. Then there are other more
diagnostic areas. For example, more sophisticated scanning techniques
are being researched which will allow doctors to assess whether
the early stages of rejection are starting. At the moment that
is a rather crude science but, with sophisticated scanning and
marking of tissues, it is possible that early warning could be
given to that. In the mainstream transplantation field, the key
issue is just the straight shortage of organs. There are some
other fields of research to provide alternatives to the straight
replacement of organs which offer some promise but none that offers
the opportunity to replace the conventional form of transplantation
and then there are other fields of research which are targeted
mainly at reducing the risks of rejection and being more selective
about the suppression of the immune system that does not bring
other side effects.
Q45 Chairman: In answering
that question I think you have given us the answer to some of
the trends too. Perhaps I could pursue a little bit the issue
about the relationship with other NHS priorities. We heard in
previous evidence that contrary to what one might anecdotally
believe, because these sound expensive operations, they in fact
save money in the long run because people get better and are not
living on drugs or dialysis or whatever for the long term. Could
you comment on that economic?
Sir Liam Donaldson: Certainly in the case of
kidney transplants—which are the commonest form of transplant,
as you know—there is a straightforward economic comparison,
because the costs of dialysis can be easily quantified and they
are more expensive than a transplant because they are ongoing.
In the other fields, it really depends on how long people survive
if they are not going to get a transplant and they are in need
of one, and their costs are variable according to the organ that
is diseased. Most of them will be on drugs of one sort or another,
many will require periods of hospital admission whenever they
become acutely ill. For the people who do have transplants, we
need to set against the cost of the transplant the costs of immune
suppression drugs—which people do need for life really—and
any complications they develop from their immune system being
suppressed. It is possible to do a full cost-benefit analysis
of the options and I am sure that if you want further information
on that we can send it.
Q46 Chairman: I want to move
on but we are really interested in where it fits in the priorities,
if you like, in the NHS.
Sir Liam Donaldson: The subject of priorities
in the NHS is a difficult one because the NHS, by its nature,
has to run with multiple priorities. If you asked me for a rank
order of priorities I could give you one but it would be drawn
from just one perspective. For example, in the annual NHS priority
document certain targets are picked out, but that does not mean
that the rest of the service is ignored or the needs of patients
are ignored. It really is a highly subjective opinion when you
ask me: Where does this stand in the pecking order? I would say
it has a relatively high priority because people's lives can be
saved and you would not willingly deny them treatment if that
treatment was available.
Q47 Lord Lea of Crondall:
I am new to this and I was astonished, as is brought out in your
document The Waiting Game—and I do not know about
a game but it looks like a dance of death to me—that there
is an astonishing gap between supply and demand. In connection
with the reasoning which laid the formulation of the conclusions,
do you happen to know whether the gaps are as big in other countries?
What do you think about any European role? Some people might think
that anything to do with Europe is bureaucracy gone mad but would
you comment on that in relation to your own document The Waiting
Game?
Sir Liam Donaldson: Looking at the statistics
of organ transplantation across Europe, in general countries which
have an opt-out system of consent have higher rates of donation
of organs. Some argue that that is not solely due to the fact
that the consent approach differs. They say that in those countries,
for example, Spain—which has done very, very well in recent
years in increasing its organ donor rate and did introduce an
opt-out consent mechanism—it is not purely due to that;
it is due to the infrastructure of services for retrieving and
coordinating the availability of organs. I suppose at the simplest
level, without getting into any question of European Directives
or European legislation, there is a theme of sharing good practice
and learning from the countries which do it differently from us.
Going to the other end of the spectrum—would there be any
scope for a European Directive which prescribed that all countries
should work in exactly the same way?—I probably am not the
best person to judge that because some measures are popular and
easily accepted by countries and others are not and I do not know
where different European Member States would stand on that one.
But there is a clear area where Europe already does have legislation
in similar fields and that is the field of safety and protecting
people. There are European Directives and rules in relation to
blood and tissue safety. There are risks associated with not taking
the necessary medical precautions in the transplant of organs
which put people at risk of catching diseases like HIV and hepatitis
and so on. There is another area, which is to do with the trafficking
in organs, particularly the purchasing of organs from people in
developing countries and then making them available to people
in developed countries, and then there is a so-called transplant
tourism strand. In the areas of safety and trafficking and exploitation,
I think the European Commission would have an important role.
In relation to facilitating Member States getting together and
sharing good practice I think it would have an important role.
I am probably not the best judge in knowing whether any standardised
form of procedure would be acceptable or desirable.
Q48 Lord Wade of Chorlton:
I would like to explore with you the legal implications of introducing
presumed consent in the UK. What amendments to the Human Tissue
Act 2004 do you envisage would be needed to introduce a system
of presumed consent for organ donation in the UK? What rights,
if any, do you think such amended legislation should give to a
qualifying relative to refuse consent for the removal of an organ
from a deceased person who had not opted out of the system?
Sir Liam Donaldson: Let me start with a general
philosophy of the legislation and then I might ask my colleague
to chip in on some of the detail. I had a big part in the action
that led to the current legislation because I reviewed the situation
following the so-called scandal in Alder Hey and Bristol, where,
after children had died, usually following heart operations, their
organs were retained without the consent or even the knowledge
of the family. I spent a lot of time with the families from Liverpool
and Bristol and I made recommendations about amendments to the
law which basically involved much more explicit consent. That
was somewhat controversial because the research and scientific
community felt that we were going too far overboard in taking
account of the views of relatives and thus restricting good scientific
research, sensible scientific research, from going forward. It
was quite a controversial set of proposals but, given some of
the abuses that took place, I felt it was necessary. At that time,
because we were amending the more than 30-year old Human Tissue
Act, the opportunity was taken also to look at the transplant
area. There were some changes made there but they did not go so
far as introducing presumed consent—although I understand
that was debated at the time in both Houses. Since my Annual Report
was published, I have had some letters from parents in Alder Hey
and Bristol saying that they are very disappointed in this proposal
because they see it as backsliding on the measures that we put
in to get explicit consent on the donation of organs and tissues
after post-mortem examination, but I do think there is a clear
distinction between that field of donation and the transplant
field. There will always be controversy about a proposal to introduce
opt-out, but if it were introduced it would mean a change to primary
legislation. Perhaps I could ask Triona Norman to say what that
change would be.
Ms Norman: The Human Tissue Act 2004, as you
probably know, is the relevant legislation and it would be necessary
to change part 1 of that Act. At the moment consent is required.
If the deceased has made his or her wishes known, that consent
in law is the consent that is followed. If he or she has not made
that consent known, then obviously they turn to the relatives,
and there is a hierarchy of whom they approach first to seek consent.
In practice we obviously need the support of the relatives because
we have to take a social and medical history before donation would
go ahead, but, in law, as I understand the advice we have had
from our lawyers, if we wanted to move to a system of presumed
consent we would have to amend that part of the legislation.
Q49 Lord Wade of Chorlton:
Clearly you have had a lot of experience discussing with the public
the issue of consent and presumed consent.
Sir Liam Donaldson: Yes.
Q50 Lord Wade of Chorlton:
From that experience you have had with them—and I come from
near Merseyside, so I am aware of the enormous emotional tension
caused by the Alder Hey issue—what do you think would be
the likely response of the public if we were to suggest presumed
consent of organ donation should be accepted?
Sir Liam Donaldson: There have not been any
scientifically conducted surveys of public opinion. All we have
to rely on are the sorts of surveys which the media carry out
and the hits on websites and that sort of thing. However, after
I made the recommendation in the Annual Report those sorts of
surveys did show a majority of people in favour. Indeed, in so
far as it is relevant, the BBC Radio 4 Today programme
has an annual poll for listeners to say what they think, and the
second most popular request for legislation was this. It could
be that these were just supporters of the idea phoning in but
I think it is fair to say that there was a considerable public
sympathy. I think the objections of the parents from Liverpool
and Bristol are based on a misunderstanding and I think some will
be reassured if that misunderstanding would be cleared up. Others,
I think, would probably stick firmly to the view. Then there is
obviously another school of philosophical thought which describes
this, in rather colourful terms, as the nationalising of people's
bodies and it is not the Government's business to do this. It
is not something for which you would ever get unanimous or even
virtually unanimous acceptance. The other thing to say which provides
you with a final bit of context is that some of those European
countries which have an opt-out legislation in place refer to
their system as so-called "soft opt-out". Whilst they
have an opt-out clause, they still go to the relatives and rely
very heavily on what the relatives want and if the relatives show
any objection then they would not take the organ. The distinction
between that and what we have at the moment is quite difficult
to draw and it really, I suppose, depends on the nature of that
discussion with the relatives and how much time you put into saying,
"Well, in the area of the country you lived there was a lot
of information. He surely would have taken the opportunity to
opt out had he wanted it." I think the modern approach to
doing this is to try, as far as possible if you did go for opt-out,
to publicise it very well and encourage people to have a discussion
with their families while they are alive to make their intentions
well known. But I think cutting the relatives out of it completely
at the end, even with an opt-out, would be unacceptable. I think
there would need to be an engagement with the relatives so that
they were involved. If somebody registered a really strong objection,
then I do not think you could go ahead.
Q51 Lord Trefgarne: Sir Liam,
is there not a difference or should there not be a difference
between consent given for organs to be taken for research and
consent given for organs to be taken for transplant? Most of us
have no problem with allowing the organs of ourselves or maybe
even our child to save the life of somebody else but to be used
for research is different. If one recalls the Alder Hey case,
where thousands of organs had annually been taken, they were not
used for anything.
Sir Liam Donaldson: It is a good point. The
new Human Tissue Act has made the recurrence of such a situation
in the future very, very unlikely and I do not think anyone would
suggest taking away the forms of consent which are now required
for post-mortem tissue in order to be taken. I absolutely agree
with you that the situation in Alder Hey was deplorable and the
organs were not used, but, on the other hand, the majority of
parents I spoke to from Liverpool who were involved said that
they would have been very willing to allow their child's organs
or tissues to be used for research "had they been asked"—and
that was the key thing. It is probably fair to argue, as well,
that good research on post-mortem tissue could indeed save lives—perhaps
not in the immediate sense of the transplant but over time. The
adding to medical knowledge, the discovery of the cause of diseases
like breast cancer and so on, could lead to the saving of lives
if it is properly conducted and regulated.
Chairman: Lady Gale, you are going to
pursue this issue about consent.
Q52 Baroness Gale: Yes. I
have three questions and they are all related to presumed consent.
What do you see as the key issues that the Organ Donation Taskforce
study of presumed consent should address? To what extent would
you see it as sensible for the Government to move ahead to implement
the findings of the Taskforce first report which related to the
organisation of organ donation and transplantation services in
the UK within the present legal framework—in advance of
the findings of a second report relating to the issue of presumed
consent?
Sir Liam Donaldson: Let me deal with the second
two questions first. We have only relatively recently received
the report of the Taskforce and ministers are still considering
it, so I cannot go into the detail of it. It may be that when
you interview Elisabeth Buggins she will give you more information
on that. The report does not deal with presumed consent, as you
are well aware; it deals with other action that can be taken to
strengthen the opportunities to increase the organ donation rate,
including looking at methods of containing organs, co-ordination
of services across the country and so on. On the specifics, I
cannot say we would address every recommendation yet, but, in
general terms, I think those changes would be necessary anyway
because the experience of other European countries that have opt-out
is that you do need to give attention to the infrastructure and
the co-ordination and the organisation of proper service as well
as the method of consent. Coming to what we would like them to
look at, I think we would like them to do an analysis of the success
and the reasons for the success and any drawbacks of the use of
opt-out in other European countries or other countries in the
world. We would like them to try to draw an assessment of the
relative benefits of the pure change to the consent versus the
other factors to which I have referred, and then I think we would
like them to do some analysis of some of the underlying ethical
points and, where possible, draw attention to public opinion and
public attitudes.
Q53 Baroness Gale: Do you
think there is some sort of consensus on which is the best way
forward? Presumed consent or, as you say, the idea of the improvement
of organ donation and transplantation services? Would that increase
the supply better than just saying, "We'll have presumed
consent"?
Sir Liam Donaldson: There is not a firm evidence
base to give you an exact assessment of the relative contributions
of each because the research has not been done, and, indeed, it
would be difficult to do. As far as a consensus is concerned,
I do not think there is yet an overall consensus. Certainly I
am in favour of it, as I made clear in my report. I think quite
a lot of people in the transplant field—although not all—are
in favour. I think the majority of public opinion—but not
the wholesale majority of public opinion—is in favour.
Q54 Baroness Gale: For young
children who die it would be the parents' consent which would
be needed would it not? You would not presume consent the consent
of a child, would you?
Sir Liam Donaldson: No. A personal view would
be that children initially should be excluded from this. I think
there are too many difficulties and too much baggage with the
Alder Hey and Bristol cases. Although some of the other European
countries do include children in their presumed consent, my own
personal view would be that that would be too difficult for the
public to accept.
Baroness Gale: I would agree with that.
Q55 Chairman: What is the
alternative there? Parental consent?
Sir Liam Donaldson: Yes, it would be as it is
at the moment, which is parental consent. Once children reach
a certain age, then their opinion is taken into account and in
some cases they are regarded as autonomous.
Q56 Lord Trefgarne: What age
is that?
Sir Liam Donaldson: I think it is around 12.
Ms Norman: I think it would also depend on the
child to a certain extent.
Q57 Chairman: Age and understanding.
Sir Liam Donaldson: Yes.
Q58 Baroness Gale: What is
your view of the degree of acceptability that a system of presumed
consent would find across the medical profession? To what extent
do you think that the opposition which might exist could lead
to difficulties in implementing such a system?
Sir Liam Donaldson: As far as professional opinion
is concerned, the British Medical Association have come out some
time ago in favour of it. Many people in the transplant speciality
of medicine are in favour of it, but not all. As far as the acceptability
of it is concerned, I think there are things that could be done
to increase the acceptability. That would largely be about educating
and informing the public and making absolutely sure that every
opportunity was taken to make people aware of their right to opt
out. The opt-out rates vary between European countries. For example,
in Belgium it is only 2% who opt out and in other countries it
is slightly higher. I am not aware, from my limited contacts with
other European countries, that there have been major problems
of errors where there have been serious complaints.
Q59 Chairman: Could I clarify
one point before we move on: are you saying that you really need
the structural changes in which you can then place presumed consent?
Are you saying that those two things need to be together in order
to achieve what you are looking for?
Sir Liam Donaldson: Let us imagine you introduce
presumed consent and did very little to change the organisation
of services, then, at the very least—and it would be a serious
problem—you would suddenly have a flow of additional organs.
If the services were not equipped to receive them and deal with
them and allocate them to patients, there would be a serious problem.
You are more or less bound to look seriously at the way services
are organised and co-ordinated and the infrastructure—whether
there are enough staff and transplant surgeons and so on—before
you implement presumed consent.
Chairman: Yes, that is an important point
for us to hold on to.
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