Examination of Witnesses (Questions 99
- 119)
THURSDAY 13 DECEMBER 2007
Mr Chris Rudge, Mr Gareth Jones and Ms Triona Norman
Chairman: Good morning. We are very grateful
to you all, particularly Ms Norman who has been with us for two
sessions, one after the other, for taking the time and trouble
to come and talk about what we see as a very important inquiry
and I am sure that is true from where you stand particularly.
The issues that arise from the Commission's proposals arouse quite
a lot of public interest and we recognise that not only is it
of interest but also of public sensitivity. Again, working where
you are, that will come as no surprise. We are taking evidence
on a number of aspects of existing and developing UK policy on
organ donation. Today's evidence from you on the work of the organisation
UK Transplant and of the Department of Health's Organ Donation
Taskforce is of particular importance in all of that. We have
our Special Adviser with us, Professor Bobbie Farsides, who I
understand you will know. Perhaps I should state now that she
is a member of the Organ Donation Taskforce that will be discussed
this morning. We have another declaration too.
Baroness Neuberger: My brother-in-law
James Neuberger is deeply involved in transplantation. I see you
all nodding, so you obviously realise that.
Q99 Chairman: We have a scheduled
hour until 11 o'clock for the session. I should remind you that
the session is open to the public and will be recorded for possible
broadcasting and webcasting. A transcript is taken of the evidence
and put on public record in printed form and on the parliamentary
website. A few days after this session, your office will be sent
a copy of the transcript to check for accuracy. Please advise
us of any corrections as quickly as possible. You may submit supplementary
evidence after the session to clarify or amplify any points made
during your evidence or to answer any questions that may not be
reached today. Please could you start by stating for the record
your names and official titles. After that you are very welcome
to make an opening statement; otherwise you can move straight
into the questions.
Mr Rudge: My name is Chris Rudge. I am the Managing
and Transplant Director of UK Transplant, which is part of NHS
Blood and Transplant. I was a transplant surgeon myself for 30
years before doing the job I now hold. I would like to make an
opening statement.
Mr Jones: Good morning. I am Gareth Jones from
the Department of Health. I am the Director of Scientific Development
and Bioethics and organ transplantation is one of the areas that
falls within my remit.
Ms Norman: Good morning. I am Triona Norman.
I am the Department of Health Transplantation Policy Lead.
Q100 Chairman: Mr Rudge.
Mr Rudge: I would like to make three very simple
points very quickly that will come as no surprise to this Committee,
I am sure. The organ donor rate and therefore the transplant rate
in the United Kingdom is poor and it is static: it has not really
changed for ten years or more. The waiting lists of those people
waiting for an organ transplant is rising and the gap between
the number of people waiting for a transplant and the number of
organs that become available is increasing. That results in at
least 1,000 patients a year who are on the waiting list for a
transplant dying before a suitable organ becomes available. The
third point is slightly more complex. The number of people who
we can demonstrate are on the waiting list for a transplant is
a very poor reflection of the number of people who would benefit
from a transplant. Most transplant units limit the number of people
who are put on the waiting list to an approximation of the likely
number of organs that are going to be available. That is particularly
true of the heart transplant and the liver transplant programmes.
There are probably thousands more patients a year—it is
unquantified, but it is in the thousands and probably the tens
of thousands—who would benefit from a transplant but are
never placed on the waiting list. As you said in your introduction,
My Lord Chairman, this is a very, very important question to us
and I am grateful to you for taking the time to listen to us.
Q101 Chairman: We will start
by looking at the role of the Organ Donation Taskforce. We need
to learn more about this. Although we are going to have oral evidence
later on from the Chair of the Organ Donation Taskforce, could
you begin by describing for us the composition of the membership
of the Taskforce and how it goes about its business? In relation
to the initial remit of the Taskforce to make recommendations
about how to increase donor and transplant rates in the UK, would
you please outline the key issues that the Taskforce has considered?
While we understand that the precise nature of the conclusions
and recommendations in the first report of the Taskforce will
be confidential until it has been published, can you describe
for us in general terms the main thrust of the report and the
principal ideas it puts forward for improving organ donor and
transplant rates in the UK?
Mr Jones: I would like to thank the Committee
too for inviting us and giving us the opportunity to talk to you
and help you with your inquiry. As Chris Rudge has outlined, there
is a recognisable problem here in the UK with donor and transplantation
rates. Health ministers were sufficiently concerned to get up
this Taskforce in 2006 with the remit of taking stock of progress
in terms of our success in these areas, trying to identify the
specific barriers to the donation of transplantation and, of course,
making recommendations on how we can improve the situation. They
asked Elisabeth Buggins to set up a Taskforce with the relevant
expertise. The Taskforce had its first meeting at the end of 2006
and they have met nine times, up until September this year. The
composition of the group ensured that all of the key areas of
expertise and interest were represented: transplant surgeons,
intensive care specialists, patient representation, NHS management,
donor liaison, nurse interests, people with an ability to bring
to the discussion the issues around diversity and also media interest.
We are very grateful for the time, energy, knowledge and expertise
that the members have brought to this task. They have done a lot
of very, very good work and the report, as you know, is currently
with health ministers. They did not just rely on the expertise
around the table. They recognised very early on that other countries
have better success rates than the UK—we do not do well
against other Western European countries—and so they took
evidence and advice from a number of people: Rafael Matesanz from
Spain who led for 15 years the development of the Spanish model;
Frank Delmonico from the USA, another example of a successful
model; and Jeremy Chapman from Australia who is chair of an Australian
taskforce looking at similar issues. They were enormously helpful
to the group in being able to bring to the discussion areas where
certain steps they had taken in their countries had been found
to significantly improve the rates of donation and transplantation.
In broad terms, the Taskforce recognised very early on that they
needed to address the systemic issues: the capacity and capability
within the system; what they could do to improve the way that
things were done. They looked at structures, roles and responsibilities
and how the thing works in practice at each stage. They also recognised
a number of fundamental things: first of all, that, although it
is a local activity, in essence it is a UK-wide service. Also,
they were asked specifically to look at all of these issues within
the current legal framework. They were not asked, for example,
to look at presumed consent or opt-out or other issues which might
not be possible within the current legal framework. They looked
at funding: Is the funding appropriate? Is it in the right place?
They looked at what makes people want to donate? There is, seemingly,
a very high degree of public support for donation—90% of
the population, we are told, support the principle—but in
practice only 25% of the population are on the Organ Donor Register.
There is the issue around black and minority ethnic populations,
which are significantly under-represented on the Organ Donor Register
and yet are disproportionately more likely to require a transplant.
They were looking at all of these factors—the legal issues,
the ethical issues—and the practical issues: What could
they recommend that they felt would make a significant difference?
The report, as I say, is with ministers at the moment and we are
looking forward to publication and a government response early
in the New Year. I think they have done a terrific job: I was
at many of the meetings and I think what they have produced will
be an extremely worthwhile report and a real contribution to this
area.
Chairman: Thank you very much.
Q102 Baroness Neuberger: You
have answered part of what I wanted to ask. In September the Secretary
of State asked the Taskforce very specifically to consider the
opt-out question. I do not know if that has all been included
in the report which is going to come out early in 2008 or whether
that is going to be an additional piece of work but, either way,
it would be very interesting for this Committee to know what the
precise issues are that have been considered over that question.
If it is not coming out with the report in early 2008, can you
tell us when that is going to be ready?
Mr Jones: It was not included in the original
remit. The Chief Medical Officer, who gave evidence to you recently
explained that his annual report this year had within it this
proposition for presumed consent or opt-out scheme. The Secretary
of State and health ministers recognised that although the Taskforce
had the right people to look at presumed consent—because
they have amassed this expertise and looked at the detail of the
issues—the nature of the question of opt out is different.
It is not looking at what we can do within the existing framework;
it is a separate issue, there are sensitivities around it which
we all recognise, and therefore the Secretary of State in September
asked the Taskforce to take it on board as a separate task. They
are now looking at what additional expertise they will need to
draw on in order to answer questions. There are a lot of issues
to consider: What do we mean by consent? And there are practical
issues: How would it work in practice? Would it make a difference?
Some other countries have a presumed consent regime and some would
claim that it has made a difference. What is the public attitude
to some of these issues? I think they have quite a difficult complex
task and they recognise that they need to augment their membership
with people who can help them answer some of these questions.
They are looking at research that has already been done in some
of these areas and making sure they learn from that, and it is
very possible they will have to commission some new work where
there are gaps in that. I do not think they have a definitive
timetable at the moment. It will not be part of the main report
of the Taskforce when it comes out early in the New Year but I
think they are very much seized of the need to provide an answer
as quickly as possible.
Q103 Baroness Neuberger: I
think we knew it was not going to be in the original report but
I wanted to get that on the record. You say they are expanding
their membership or thinking about expanding their membership.
When is it likely that they will at least have their membership
established and be ready to start work on this question? If you
cannot tell us when it would finish, at least it would be quite
nice to know when it is going to start.
Mr Jones: They have already met to talk about
how they will handle it. The membership of the taskforce itself
will not significantly change because they now have a dynamic
as a group: they work well together and they have a shared understanding
of the issues. The likely approach is going to be that they will
set up a number of groups to look at each individual area for
example, if there are practical considerations, getting the right
sort of group of people together to thrash that out. The work
will begin shortly in the New Year. They have pencilled in a series
of dates for work to progress fairly quickly. I would not want
to predict on their behalf how much time they will need for the
work. Perhaps when Elisabeth Buggins speaks to you, she will have
a better idea.
Baroness Neuberger: We can press her
a little on that as well. Thank you very much.
Q104 Lord Trefgarne: If presumed
consent is eventually decided upon as the right policy, will that
mean legislation?
Mr Jones: My understanding from our legal advice
is that, if implemented in the way that we currently understand
it, we will need to revisit the Human Tissue Act. I think the
Taskforce will want to look at: What do we mean by consent? What
are the various models of presumed consent or opt-out that you
might look at?
Q105 Lord Trefgarne: To take
an organ today without consent is against the law.
Mr Jones: My understanding is it is. That is
correct.
Q106 Lord Trefgarne: You have
no idea which law, I suppose.
Mr Jones: The Human Tissue Act.
Chairman: We would like to talk a little
about the role of UK Transplant and Lady Morgan is going to lead
into this area.
Q107 Baroness Morgan of Huyton:
First of all, could you briefly outline the main functions of
UK Transplant so that we are all clear about those, but, probably
more importantly, could you describe for us what you think you
would need to change in order to move us nearer to the Spanish
success rate. What changes do you think would have to happen?
To what extent are you comfortable that the stakeholders in the
field would think that UK Transplant was the right organisation
to take on a larger role, a new role?
Mr Rudge: The current roles and responsibilities
of UK Transplant I can summarise very briefly. There are five
main responsibilities. It is a UK-wide NHS organisation responsible
for holding the lists of all the patients who are waiting for
a transplant. There are approximately 7,500 names of patients
actively waiting today for a transplant. We have a role in allocating
organs once they are donated. That falls into two parts: agreeing
what the rules should be as to how you decide who gets the organ
but then also implementing those rules. We work very closely with
the transplant community and with the Department of Health in
defining, if you like, the rules for allocating organs, and then
we have—24 hours a day, seven days a week—a duty office
managed by people who are notified of every organ donor in the
country, the whole process as it follows through and then the
allocation of the organs. The details differ a bit, depending
on whether it is a kidney, a heart, a liver or a lung, but, in
principle, we allocate the organs. The third thing we do is to
collect data. We collect data about every single organ donor and
every single organ recipient and we collect data about the recipients
for the rest of their lives whilst the transplant is working.
We are following up on people who have had transplants for 20
years or more. We get a report every year on them. We receive
about 100,000 forms of information each year on the total range
of things that we do. The fourth thing we do is to use that data.
We use the data to inform clinical practice, to inform what the
right allocation arrangements are, but we use it increasingly
as a monitoring and oversight organisation. In the last two or
three years we have developed some very sophisticated ways of
monitoring the results of individual transplant units, both in
terms of comparing one unit with all the other units but also
trying to identify as early as practical if an individual unit's
results are deteriorating. That is monitoring and oversight. The
fifth role—and this is a little limited—is that we
do have responsibility to promote organ donation. That falls into
two headings. The first is to the public. We have—and you
would expect me to say this—a limited budget to promote
organ donation, for publicity to promote the Organ Donor Register,
but we also have a certain amount of money that we use to invest,
to give to transplant units and others within the NHS to try to
increase organ donation. That has been in place now for about
five years. There are three strands of it. Two have been extremely
successful—the number of non heart-beating donors has risen,
the number of living donors has risen and continues to rise—but
the number of heart-beating donors—and they are really the
bedrock for many forms of transplantation—has been falling
slowly but steadily.
Q108 Baroness Morgan of Huyton:
Why has that fall happened?
Mr Rudge: That is really the essence of everything
the Taskforce has looked at. There is a wide range of things to
do with the explanation. It is primarily related to the practice
within intensive care units. One of the things I have not mentioned
which we have established at UK Transplant is the Potential Donor
Audit, so we have information on every single patient in the UK
who dies in intensive care. The starting point is: Could they
have donated their organs or not? At each possible stage of the
process we can identify whether the right things happened or did
not happen, so we can answer your question in quite a lot of detail.
My Lord Chairman, there is a UK Transplant Activity Report—and
I can very happily leave this copy and provide as many more copies
as you would like—in which you will find a breakdown of
the figures I have just described in the Potential Donor Audit.
It shows that potential donors are not subjected to the brain-stem
death tests on every occasion; they are not considered as an organ
donor: nobody thinks about it; they are not referred to the donor
co-ordinators every time; 40% of families, when they are approached,
do not give consent—and so it goes on. There is a lot of
detail in there.
Q109 Lord Lea of Crondall:
You might not have this figure at your fingertips but you did
mention, Mr Rudge, that you have had a modest budget for public
information and advocacy of people signing up. If you happen to
know what the size of that budget is off the top of your head,
it would be interesting to know. If you cannot today, could you
give us a note on that question, and maybe the related question,
if you have the information, as to what sort of budgets other
European countries throw at this.
Mr Rudge: All the information is available.
I could give you an approximate answer now but I would prefer
to give you an accurate answer, and I will certainly do that for
you. I do not know if that information is available elsewhere
in Europe but, if it is, I will try to find it for you.
Q110 Baroness Gale: This might
seem a strange question but it is one that intrigues me: you are
a UK-wide organisation but, as you know, health has been devolved,
for example, in Wales. Are there any implications in that? I have
not heard any calls for this to be devolved to Wales but, as you
know, there are lots of calls from the Welsh Assembly to have
further measures devolved to Wales. Is this all in harmony, so
that there are no problems with it? I do not think there should
be but I would be interested to hear from you.
Mr Rudge: I meet regularly with colleagues in
the Department of Health in London but I also meet regularly with
colleagues in Cardiff, in Edinburgh and in Northern Ireland. Part
of our funding comes through the devolved administrations and
I think it works very well. I think it has to work on a UK-wide
basis. If a patient were dying today in Plymouth, the only available
liver that could save that patient's life could be in Aberdeen
or Inverness or Caernarfon. Unless you have a UK-wide organisation,
it is not going to work, so we have to preserve that emphasis.
Mr Jones: The Organ Donation Taskforce including
representatives from each of the four countries and four sets
of health ministers are considering the recommendation collectively.
Q111 Baroness Morgan of Huyton:
Could we return to the question of where we go next.
Mr Rudge: Yes, I would love to answer your second
question: Where do we go next? Could I answer your final question
first: my view on whether stakeholders would support the idea
that UK Transplant or NHS Blood and Transplant (our parent authority)
was the equivalent body. I think there would be very wide support.
The Taskforce considered this and was unanimous in the view that
the promotion of organ donation is a UK-wide responsibility and
that NHS Blood and Transplant/UK Transplant should take a wide
role. I think that will not be a major problem. What would the
steps be? During the work of the Taskforce over the last six months
there has been a lot of work carried out within NHS BT to try
to anticipate the recommendations of the Taskforce and to try
to identify the likely steps that we would need to put in place.
So work has been done, and when the Taskforce is published I think
we will be in a reasonable position. Could we carry on and change
things? The key is in the assumption that appropriate funding
will be made available. If that were satisfied, yes I do believe
UK Transplant/NHS BT has the potential to expand its role. I think
we need to focus on the gaps that identify partly what I have
told you about and partly other evidence that has been sent into
the Taskforce. We need to make sure that every potential donor
is identified; that every donor is referred to the co-ordinator
network; that the right co-ordinators are there with the right
training and in the right number and with the right amount of
time—it is all to do with the Spanish model really—and
that the organ retrieval process, the surgical retrieval of organs
is optimised. There is a whole series of steps. Each step can
be improved. Do I think it can all be done? Yes, I do.
Chairman: We are fascinated by all this
but our real remit is to look at how the Commission's interest
affects a lot of what you are doing and what our view is on that.
Lord Lea is going to move into the European area.
Q112 Lord Lea of Crondall:
Would you be able to give us a broad view, to begin with, on the
description of the issues relating to organ donation and transplantation
which is given in the European Commission's Communication and
its accompanying impact assessment? Do you agree with the Commission
that there is a need for an EU-level role in this area in addition
to the activities of Member States and, if so, why do you take
this view? What re-assurance can you offer to those members of
the medical profession who feel that such an EU role might bureaucratise
procedures to too great an extent and inhibit the full application
of clinical experience and judgment?
Ms Norman: I am aware that you took evidence
from Eduardo Fernandez-Zincke a couple of weeks ago. I have read
the transcript and Eduardo obviously set out his stall, so to
speak—very well and in a foreign language, which is amazing.
Perhaps I could give the UK view on that Communication. I have
been working with Eduardo now for about five/nearly six years
and in answering this question I can draw on my experience of
taking through the Tissues and Cells Directive, which was published
in 2002, which we have recently transposed into UK legislation
and implemented. The Communication identifies three broad areas.
Obviously we need to address the shortage of donor organs across
Europe. Some countries obviously have higher donor rates than
the UK but we are all agreed that nobody has a surfeit. We all
need to improve our donor rates. We also need to look at the quality
and the safety of organs procured and transplanted, to ensure
that we have a harmonised approach and common standards across
the EU, so obviously the Communication addresses that. The third
point is addressing the trafficking of organs. Eduardo said in
his evidence that he did not see this as a big issue in Europe
but obviously we are aware—and Chris may again call upon
his greater knowledge on the ground, so to speak—that people
from the EU go outside the EU to procure organs. That is something
that the EU is aware of, but obviously we need to make sure that
trafficking does not happen in the EU. We need to make sure that
we keep an eye on it. I think it is true to say that every EU
country has laws in place to make it illegal in their own country
to traffic organs—and here, the Human Tissue Act is very
clear on that. Broadly speaking, the EU Government supports the
Commission Communication. It is very much in line with what Europe
wants to do: we obviously want to increase the number of organs
procured and we want to ensure the quality and safety of the organs
we procure and we transplant. We do have some reservations about
an organ Directive, which we have shared with the Commission over
a period of time, because we know that an implementation of the
Directive does not come without some cost and it could draw resources
away from what we see as the prime focus, which is tackling or
increasing the numbers of donors/the organs donated. We need to
ensure that any Directive is at a minimum, that it does not gold
plate what we are trying to do. We need to ensure that it achieves
its purpose, that it sets minimum standards. Obviously Member
States can implement to higher standards but we want the minimum
within a Directive, we do not want to gold plate. Obviously we
must continue to respect subsidiarity: Member States must be left
to make their own decisions around how they organise their health
services, and they are very clear about that. We do understand
that there are clinical concerns around over-bureaucracy. If we
look at the model of the Tissues and Cells Directive, every tissue
establishment has to be licensed—indeed, the Human Tissue
Authority representatives are sitting behind me today—and
it costs in the region of £8,000 to do that, so there are
costs. Obviously they have to make sure they meet the requirements
of the EU Directive, so that could have some costs, and I do understand
that. Also, clinicians want to be able to use their own judgment
about a particular donated organ and how they use it and the recipient
who receives it. They would want that respected within the Directive,
so obviously that is something we are negotiating with other Member
States. In summary, I would like to say of the five years I have
been working in Europe that I have found it a very positive experience.
I am not sure whether that is because of the field or whether
we have been very lucky with the people who come to it, but I
have made some very good friends across Europe, some good alliances,
and certainly have used the knowledge and expertise in other countries
to help me take forward work in the country. I do not know if
Chris wants to add anything to that, because obviously he is very
involved in the European side as well.
Q113 Chairman: That was extremely
helpful but it would be useful to know exactly what you see as
gold plating and what you see as value added in relation to what
would be in a Directive. If you cannot answer that now, that would
be really a very useful thing for us to have later because that
is what we are trying to look at.
Ms Norman: It is difficult for me to answer
that perhaps on the organ Directive because we do not have the
text of one yet and we are still in that sort of pre-publication
phase where we are looking to see what could go in the minimum
standards. Perhaps I can draw on my experience of the Tissues
and Cells Directive to give you an example where there was creeping
gold plating—which we tried to bat out—to try to get
every single detail included within the Directive, rather than
perhaps looking at, for instance, a risk-based approach, allowing
clinicians to make their own judgment perhaps about some of the
clinical standards.
Q114 Chairman: We are familiar
with that kind of creeping.
Ms Norman: I think that is something we will
need to look at very closely with this negotiation. As negotiations
unfold, I might be able to give you some more evidence of that
but at the moment it is still at a fairly early stage.
Q115 Lord Lea of Crondall:
One of the ideas put forward in the Communication is that it might
be helpful to introduce a European organ donation card. How effective
do you think this might be in increasing the willingness of the
general public in the UK to identify themselves as a potential
donor of organs after their death? Before we hear from Mr Rudge,
perhaps I could say what an impressive piece of evidence you have
given us. It is very clear. Thank you for it.
Mr Rudge: As far as the European donor card
is concerned, all I am going to do probably is to repeat my written
evidence to you. The key question is: What would be/could be the
status of a European donor card? As a simple publicity gesture,
I think it is possibly harmless. I am not even certain about that,
because I think it would confuse people between our donor cards
and our Organ Donor Register, but, at best, it is harmless. If
it were to carry any form of legal authority about donation, I
think that would be a recipe for chaos and confusion because all
the European states have different legislation. We have just discussed
that we have in this country an absolute requirement for clear
and explicit consent before organs are removed. Austria has a
rule which is absolutely hard: organs will be taken unless you
have opted out.
Q116 Lord Lea of Crondall:
This is the problem we are confronting, I suspect. If I go to
Spain and I am on the register here, I assume if the donor card
is in my wallet that they say, "This chap's okay, just to
whip out his kidneys." Is that not the position at the moment?
Mr Rudge: No, because in law the donor card
in this country is an expression of your wishes and it is legally
valid consent. You have consented by carrying a donor card. It
is different in different legislations. I think it would be confusing.
I think it would confuse people. I do not think they would know
whether they were living in their legislation or somebody else's
legislation. Would they carry a donor card if it was meant to
be an opting-out donor card, or if opting in? I am sorry, I just
feel it would be confusing.
Q117 Lord Lea of Crondall:
This is probably going to the heart of our inquiry. Is it not
also possible to tell that narrative totally the other way around?
A lot of people travel—I think 20 million a year or something
around Europe—at least once a year and so on, and would
they not presume, if they were killed in a car accident in Spain,
that this was a blockage in them being able to help somebody?
Prima facie there is a need to make some progress in making
that less difficult. Why do you just put all the emphasis on causing
confusion?
Mr Rudge: I do not think there is a problem
there that needs to be solved.
Q118 Lord Lea of Crondall:
My kidneys could be whipped out just because I have a UK donor
card. I thought you said that was not true.
Mr Rudge: No, I am saying that what happens
in practice is that your family would be approached because you
were dead.
Q119 Lord Lea of Crondall:
I do not have a family—but that is another story.
Mr Rudge: Somebody would be approached on your
behalf and asked to establish your wishes and your wishes would
be carried out. I just think that a donor card is too explicit
a statement of what could be completely different legislative
frameworks.
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