Examination of Witnesses (Questions 466
- 479)
THURSDAY 3 APRIL 2008
Ann Keen, Ms Triona Norman, Mr Peter Jones and Mrs
Elisabeth Buggins
Q466 Chairman: Good
morning, Minister and colleagues. We are delighted you could come.
We know how busy everyone's schedule is that this time, but we
also feel that the work we have been doing is important in relation
to many of the things in which you are all involved at this time.
They have come together in an interesting way and we have found
it interesting. We have also had some useful evidence from the
Department and from the Taskforce and from other colleagues which,
again, has been helpful. Today is a time for us to draw threads
together and to flesh out and for you to tell us anything you
think we should know at this point, so if they are not contained
in the questions, just make sure we know what we should know at
this moment in time because we will be trying to pull the whole
of this complex inquiry together into some sort of form and order.
Perhaps you would start by stating for the record your name and
official title, because we have to have it from you. Then, if
you want to make a short opening statement that would be useful,
or we could go straight ahead with the questions.
Ann Keen: Thank you. I am Ann Keen, Parliamentary
Under-Secretary of State for Health Services. I have a short statement
which might help—it would help me anyway to bring me into
the situation. I have been a minister since the beginning of July
last year and the Minister responsible for organ donation and
transplants. Of course the whole area of my job is of particular
interest because I am a former nurse (for over 25 years) and I
have been in situations where relatives have been asked if they
would donate and I have been in situations where I have cared
for people who have required transplants. To be part of this inquiry
here with you today is a great privilege. I have learned masses
by looking at the evidence and in many different ways, but I feel
a particular privilege to have been on the service side and directly
sitting with you today, and I really welcome what you are doing.
It is so, so important. I know you are eager to start and that
we have a short period of time, so I will not go on any further
but I felt I needed to state that. To have Elisabeth Buggins with
us today, who is doing such great work with the Taskforce, is
very important as well. Prior to coming into the room, one of
the members of the public was pleased to be able to see me and
to say he had had a heart and lung transplant and we are going
to meet afterwards. I feel it is a very, very special hour and
that I am going to learn some more at the end of it by meeting
a very good man who obviously is doing good work outside of this
Place.
Q467 Chairman: You know that
our particular focus is the position in Europe. In order to understand
what added value or not Europe might bring to this area, we have
had to get some grasp, and that is why we have found it so useful
to have the Taskforce Report. We have heard about some of the
baselines and the difficulties in the UK because we had to understand
that in order to get into the European dimension, but that added
bit is what we are really about in terms of our scrutiny. We have
heard about standards in a number of countries. Particularly I
wanted to begin by asking for your view on the need for a European
Directive relating to the safety and quality of organs for transplant;
that being, if you like, the area of the EU, although we have
heard from some witnesses of their worries that they may stray
into other areas. I think those are concerns. To what extent do
you agree with the evidence we have heard that this would be of
value only as a means of raising standards in some of the newer
EU Member States? Really we want to ask you: do you think it would
be valuable to this country?
Ann Keen: Thank you. I would suspect that all
Member States would agree that there is a need for a common high
quality standard in organ donation. More safe, high-quality donor
organs available for transplant across Europe will benefit all
Member States. Clinicians, from my understanding, need the assurance
that organs received from other countries are retrieved appropriately,
in line with agreed consent provisions, and that appropriate procedures
are followed to optimise graft survival. All countries could have
the potential to benefit in some respects. We would learn. It
would be a good way of improving the system. I do not know, my
Lord Chairman, if you would allow Elizabeth to add to that. Is
that all right with the Committee?
Q468 Chairman: Yes.
Mrs Buggins: I am Elisabeth Buggins, Chair of
the Organ Donation Taskforce. I am also Chair of the Strategic
Health Authority in the West Midlands and a non-executive director
of the Blood and Transplant Authority, which is really what brought
me into organ donation work. There are three things in relation
to which I think we may be able to benefit from some European
collaboration. One is about learning, as the Minister has said;
the second is about the traceability of organs in the rare cases
currently where organs are transplanted across country boundaries;
and the third is that the quality of retrieval elsewhere is sufficiently
high for clinicians to be able to have confidence in implanting
those organs into their own patients.
Chairman: We may come back to some of
that, but I want to come on to Lord Wade, who is going to follow
up some of the potential problems with an EU Directive and will
also go on to talk with you about the action plan. Other members
might want to follow up on some of the detail of that.
Q469 Lord Wade of Chorlton:
Some people have suggested that the Directive could cause problems
within the UK. What is the scope that you would view as acceptable
for a European Directive on organ safety and quality? What elements
would you resist being included in such a Directive because of
the damage they could cause to existing UK arrangements. What
can you tell us about the views of other EU Member States about
the proposal for a Directive?
Ann Keen: I think it is important that we say
straight away that UK transplant clinicians already work to high
quality standards in organ procurement and transplantation. It
is almost a gold-plated service. What problems could we have if
we were to work to a real Directive? I think clinicians must ultimately
make that judgment for themselves and not necessarily follow the
Directive. That is the evidence I have had from clinicians, that
they want still to be able to make their own judgments. They may
wish any Directive to recognize that the risk-benefit for donated
organs is different for organ transplantation than, say, for tissue
and cell transplantation. Clinicians worry that a Directive will
introduce additional regulation and that that might put people
off, for want of a better way of saying it; that if it got too
regulated, how would a particular area of expertise follow such
a strict regulation and it could have the potential to put off
organisations, particular hospitals/Trusts which would have to
follow such strict guidance, because the framework of support
would not be in place for them to achieve that. That is the general
feeling in relation to the first part of your question.
Q470 Lord Wade of Chorlton:
That supports other evidence we have received, that if the Directive
is too specific it might end up restricting some of the work that
we already do. You are saying the same thing.
Ann Keen: But, again, an action plan is very
different.
Q471 Lord Wade of Chorlton:
I am coming on to a question about the action plan, which, as
you say, might take us to a different area. What is your view
of the Commission's idea that it is necessary for the EU to develop
an action plan relating to organ donation and transplantation?
What benefits do you think that the UK and other Member States
will be able to gain from this that would not have been available
anyway through the existing exchange of information between medical
professionals across national boundaries? What is the action plan
going to add, in your view, to what is happening now?
Ann Keen: I believe that we can learn from each
other. In most walks of life, we can learn from looking and listening
to other people. In particular in this area I think there is the
potential for this to improve the quality and safety. Common definitions
to help evaluate transplant results and monitor outcomes: there
is bound to be so much learning and so much benefit that could
come from that. Promote the best organisation of donation and
transplant services: looking at best practice and promoting that
is also something that I believe we are very keen to follow and
to do. Training of professionals: that is very important. I know
myself how I was put in positions of asking relatives without
appropriate training—but this was some years ago. Nevertheless,
it is like being given the opportunity to do your job well when
you have had the help and advice as to how to do that, when you
work in a culture where you know everyone has had a standard training
of how to approach what, of course, is a very difficult area at
a time when people are at their most vulnerable, when families
are at their most vulnerable. You need to have, I think, a standard
training, because it is a community. The professionals in this
community do need a lot of support. I think that would help us
do that too.
Q472 Lord Wade of Chorlton:
How do you see the UK is in relation to other countries in the
respect of quality of care in these areas? Do you see that an
action plan that did these things would add value to the UK? Or
is the UK going to be the one that is going to pass information
to others?
Ann Keen: I think it is both. I think we would
learn, but we could also benefit other countries with how we manage
ourselves as well—because we do have a very high quality,
a very high standard, of which we are very proud, but there is
always scope, I am sure, in particular for the training of professionals,
and how other cultures might look at it is something we should
be open to.
Q473 Chairman: Could I ask
two supplementaries on that, because they link into questions
we have had before. I have to declare an interest. I am a trustee
of Little Hearts Matter, which deals with children with hypoplastic
left heart syndrome and similar heart conditions and they will
at some point find themselves in competition for heart transplants
with the general population. With so many people dying on the
waiting lists, one of the bits of evidence we have heard is about
how the assessment on quality is made and whether it has to be
perfect or good enough. Some of the early evidence we had was
that people were concerned that if their clinical judgment was
to be interfered with then some of organs that might be good enough
and save someone's life might be rejected because of some of the
marginal quality issues. I know that is a clinical judgment and
I think the clinicians want to be very much assured they could
make that judgment. From what you have just said, it sounds as
though the Government take that view as well.
Ann Keen: Most definitely. We would support
that.
Q474 Chairman: It is the gold-plating
question.
Ann Keen: In what is already a high quality
service, would it reduce transplant rates? I think at all times
clinicians have to be free to make that decision.
Mrs Buggins: The waiting list, as you know,
my Lord Chairman, is far too high and one of the objectives of
the Taskforce was to reduce numbers on the waiting list, make
more organs available for transplant, but the clinician knows
the patient and the degree of risk that the patient is prepared
to take, which could never be known at a European level. The quality
of that relationship between the clinician and the patient is
very, very important in making that risk assessment.
Q475 Chairman: The other question—and
I do not know whether your colleagues might like to come in—is
that we have heard that the Directive on human tissue did make
life very difficult for people in that field. Would there be learning
from that area?
Ms Norman: I am Triona Norman, the Transplantation
Policy Lead in the Department of Health. There is learning that
we can learn from the implementation of the Tissue and Cells Directive.
You have taken evidence from Mr Lemmey, who is here from the Human
Tissue Authority, who I think has gone through that with you.
An Organ Directive is quite different from a Tissues and Cell
Directive, for the reasons that the Minister has laid out. The
risk:benefit ratio is completely different with an organ transplant
than it would be for a tissue transplant where there is much longer
to undertake a series of tests to look at the viability of that
particular piece of tissue.
Chairman: That is really helpful. We just wanted
a government view on some of those crucial issues
Q476 Lord Wade of Chorlton:
I do get the impression—and I want you to confirm this—that
you do feel it would be right for us to express concerns that
the Directive must not come to the level of interfering with what
the clinician or the person on the ground would want to do.
Ann Keen: That would be correct.
Q477 Lord Wade of Chorlton:
That would be your view.
Ann Keen: Yes.
Q478 Baroness Perry of Southwark:
Turning to a different topic now about trafficking of organs,
we were told by Dr Adamou that his view was that organ trafficking
was not a particular issue within the EU. My question is: what
is the UK government doing to fight organ trafficking across the
world? To what extent do you think this is an EU-related problem
and in what way could the Commission's involvement help to prevent
that practice? My second question is: what can the EU and/or Member
States do to stop the "organ tourism"; that is EU citizens
going abroad to buy organs in third world countries?
Ann Keen: First of all, may I make it very clear
that the Government's position on organ trafficking is that the
Human Tissue Act of 2004 prohibits commercial dealings in human
material for transplantation; to give or receive a reward; to
seek to find a person willing to supply; and to take part in the
management or control of a body or persons, corporate or incorporate,
is not acceptable to us at all. We are very aware of transplant
tourism. Some people from the UK do go abroad for transplants
from a live donor. On the figures I have here, there are 15 to
30 cases each year that we know of in the UK. It might be legitimate
if it is a friend or a relative, of course, but it is not a major
problem in EU states. However Member States always have to remain
very, very vigilant on this. Action has been taken against an
individual who contravened that Act, so we have acted on that
Act. That was new information for me to have which was good to
share with you today.
Chairman: Could we move on to Lady Gale.
Q479 Baroness Gale: Good morning,
Minister. Before I put my question to you, I wish to declare an
interest, in that I am a patron of Kidney Wales Foundation. My
question deals with the European donor card. How important is
the existing organ donor card in the UK and what suggestions do
you have, if any, for changing it? To what extent could the Commission's
idea of a European donor card be helpful? Could there be a place
in the UK for community-based donor cards along the lines of the
card developed in the USA for use by the Orthodox Jewish community?
Ann Keen: First of all, the debate is happening
now with the Taskforce in relation to how important the card is.
To explain it in my own words: if I have—as I have—a
card, does that mean that I would be willing to have my organs
donated in another European country? I had never had that debate
until knowing I was coming to sit in front of your Committee.
When I had that debate in my own mind, I personally decided I
would not mind. I personally would not mind that. However, that
debate is still to be had and I know Elisabeth with the Taskforce
is looking at that. Until we have completed that those are my
personal views, but I do not believe we have taken this debate
to within the country and it is obviously something we have to
have. Elisabeth at some stage may want to say that. It is consent,
is it not? That is the difference. It is complicated and it is
about the consent. If you put yourself on the register you are
more willing to have had that consent. Families will still of
course be asked. This is what makes it all so very complex, because
the relatives will still be asked regardless of my individual
or of our community's individual consent. I am not completely
clear what you mean by a community-based card. I am not sure how
to answer that, to be very honest with you. I am not clear on
what you mean.
Chairman: The European Union have made a suggestion
that there might be a European donor card and we have had very
mixed responses about it. Dr Adamou in Spain said, "Forget
donor cards altogether—just get on with your reorganisation."
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