Examination of Witnesses (Questions 20
- 39)
THURSDAY 22 NOVEMBER 2007
Dr Eduardo Fernandez-Zincke
Q20 Lord Kirkwood of Kirkhope:
That is very kind. Thank you.
Dr Fernandez-Zincke: What I wanted to say is
that regional cooperations have importance in a number of issues;
for example, if you are in a very small Member State, with a very
small donor pool, and you have a potential donor but you do not
have a recipient on the waiting list, this donor will never be
used. The second thing is that if you have an urgent patient—in
many cases you have a hepatitis fulminating that requires a liver
in three days—obtaining this organ on time could happen
in Spain, it could happen in France, it could happen in Eurotransplant
but it will be very difficult in Malta or in Cyprus or the other
smaller Member States. For those cases it would be advantageous
to organise a more extensive donor pool. Other examples could
be, for example, a paediatric patient who requires a specific
type of organs or those patients who are known as hypersensitised
patients, patients who need organs that really match completely,
again, extending the donor pool in this situation could help,
let us say, the performance of the system. It does not mean that
it has to be a European system. That is not the intention of the
Commission. The idea is that probably regional cooperations will
be really a very good idea in order to increase the performance
of the transplantation system and efficiency.
Lord Kirkwood of Kirkhope: So it is a
bigger pool. Thank you very much.
Q21 Chairman: You have said
quite a lot on quality and safety already. Is there anything else
you would like to add that has not been already said on quality
and safety? Because you said a lot in your introduction. It is
clearly a key area, is it not?
Dr Fernandez-Zincke: I think it is a key area.
I think that probably you could find in the communication the
key principles that we would like to introduce and include into
the legal framework. I probably can underline again that there
are elements of quality and safety that probably will go into
the action plan but not into the legal framework. That is the
idea behind the Commission, after consulting some experts. For
example, one element that we are not considering to introduce
into the legal framework but on which we are trying to build a
consensus between Member States, is the evaluation of post-transplant
results, that is a measure of the quality of the transplantation.
That never will or should go, in our opinion, into a legal, binding
requirement but will be a collaborative action between Member
States.
Chairman: That is clearly an area we
need to look at. Could we move on to Lady Gale, who is going to
deal with another area.
Q22 Baroness Gale: My question
is on organ trafficking. Do you perceive there is a problem of
organ trafficking across the EU? To what extent do you think there
is a potential for this to become an even greater problem in the
future? What role could there be at an EU level to monitor and
combat any growth in the problem of organ trafficking?
Dr Fernandez-Zincke: Thank you, Lady Gale, for
your question. I think the problem of organ trafficking in the
European Union is not a major problem. I think it is very scarce,
the cases that have been denounced of organ trafficking happening
in the European Union Member States. The first role of the Commission
probably in this area is always to have investigated and contacted
with competent authorities in the Member States, in case of any
suspicion of possible organ trafficking in the EU. Also, we have
extended the mandate of Europol in order to be combating the existence
of these kinds of cases, but, as I said, I do not think this is
a major problem in the European Union. I think the type of organ
trafficking that is a problem and which is happening—we
have data—is when citizens, also European citizens, are
going abroad to third countries to have an organ from the local
populations in these countries. The Commission is working together
with the World Health Organisation and with the Council of Europe
in order to monitor also this situation in third countries. As
far as our competence makes us competent to do something, we will
try to avoid the situation, as has been mentioned also in the
communication, but I think that, in this case, mainly it remains
the competence of Member States. Probably where we can play a
role is to try to agree with Member States common national positions
regarding this problem.
Q23 Lord Lea of Crondall:
Could I ask where organ trafficking becomes legal trafficking?
I am very sorry, I have come in halfway through the discussion
but presumably there is some subconscious worry that my organ
might go somewhere I did not want it to go. Have you come across
such a concept? Do you think people perhaps do not realise that
they can get a better match if they do go to a wider area? Presumably
people do pay money, do they, in the official arena?
Dr Fernandez-Zincke: Thank you for your question.
There is not any Member State in the European Union which allows
the paying for human organs. This is obviously a debate that is
probably happening in other parts of the world, mainly, probably,
in the US, but even in the US this is not allowed. I think that
basic ethical principles which are enforced in all Member States
prohibits the payment for human organs for transplantation.
Chairman: Thank you very much indeed.
That is extremely helpful. It would be helpful for the Committee
if we could move on, out of order, to Lord Trefgarne, who is going
to ask about the ethical issues, because he has to leave very
promptly. With the Committee's indulgence perhaps it would be
possible for us to move on to the ethical issues next.
Q24 Lord Trefgarne: Thank
you very much, my Lord Chairman. What have your investigations
revealed as to the ethical concerns which presumably arise between
different Member States in relation to this matter? How do you
think these issues can be handled most sensitively to ensure that
they do not interrupt the orderly flow of donation services while
at the same time having regard to the sensitivities? The related
issue is whether you are going to have to define more carefully
the so-called point after death at which organs may be taken from
donors. Is this when breathing ceases or when the heartbeat ceases
or when brain-stem death is assumed to have occurred?
Dr Fernandez-Zincke: Thank you for your question.
I would like to start stating that it is not the intention of
the European Commission to harmonise ethical issues. I think we
have a wide variability of social talk around religious values
in Europe which does not make it possible, and it is not within
our competence, to harmonise, let us say, the ethical issues.
Saying that, I think I have elaborated a list of the main ethical
issues linked with organ transplantation because this is a field
which has a number of elements which are very important on ethical
grounds. The first one is the need for consent. This is something
that has to be very clearly stated in all Member States. It is
not the intention of the Commission to say how consent should
be organised the different Member States but, as we have done
with the Tissue and Cells Directive, it is important to stress
the need of consent, however the Member States organise this consent.
Q25 Lord Trefgarne: It is
not going to be assumed consent.
Dr Fernandez-Zincke: No.
Q26 Lord Trefgarne: It will
be positive consent.
Dr Fernandez-Zincke: It will be a need for consent
and then I think Member States should choose the preferable options
that they consider are more appropriate for their own societies,
let us say. It is not something that will be coming from the European
Union. The second element is the question of commercialisation
of human organs. It is the question of ensuring voluntary and
unpaid donations for organs, which I think is kept in the chapter
from the fundamental rights of the European Union which says that
there should not be financial gain from the parts of the human
body, as such. I think that is, again, something that is already
endorsed or promoted in the Blood Directive and in the Tissue
and Cells Directive and I think it is something that is a basic
principle where we are working on it. The third element is probably
data protection and confidentiality of the organ donors. I think
that is a principle that has been already announced before in
the previous pieces of work. The other aspect that is important
in the organ field is of course the allocation criteria of organs.
Q27 Lord Trefgarne: Before
you move away from the area, have you take into account the various
religious concerns? We have been seeking guidance from various
people and we have not had very much. Have you had any representations
of that kind? Have you taken them into account?
Dr Fernandez-Zincke: I think that taking into
account the religious groups is very important in trying to make
a policy on organ transplantation. In fact, last week, I was in
a meeting at the Vatican and we had a discussion on organ donation
and transplantation. We have asked, also Member States' national
experts what are their experiences regarding different ethnic
and religious groups for organ donation and transplantation. But,
again these are questions that—and I want to insist on this—are
the subject of subsidiarity. It is something on which we could
cooperate and put on the table.
Q28 Lord Trefgarne: What did
they tell you in the Vatican?
Dr Fernandez-Zincke: I think the Catholic Church
is one of the churches which is more active in the area of organ
donation and transplantation and they are considering—and
take this as non-official information—to organise some initiatives
next year on organ donation and transplantation, which I think
could be a very good idea.
Q29 Chairman: What about the
Muslim states? Are there more problems and less donation in Eastern
Europe because of some of the issues around cultural and religious
beliefs?
Dr Fernandez-Zincke: We have tried to record
some experiences of some Member States regarding Muslim populations.
For example, I think in Spain and also in the Netherlands they
have some experiences on how to promote donations in these populations.
As far as I know, there is nothing in Islam against organ donation.
Q30 Chairman: It is knowledge.
Dr Fernandez-Zincke: In most of the practice
I think there is not any official statement of the church, let
us say, promoting this situation, as it is in the Catholic Church.
I think that this kind of campaign or initiative focused on these
ethnic groups or on these religious groups should be promoted.
It is one of the ideas that we are thinking to incorporate in
this action plan, trying to find best practice in different Member
States and previous experience, and trying to share it then with
other Member States.
Q31 Lord Lea of Crondall:
Have you ever heard it advanced within any faith group that there
may be some preference for stipulating that an organ can only
go to somebody else in the faith group?
Dr Fernandez-Zincke: I have to say that this
has not only happened on the specific ethnic group. Some persons
come to the transplantation services saying, "Okay, I want
my organ for this specific population, this specific country"
et cetera. What it is important in the allocation rules in Member
States is that you are not able to select to whom you are going
to donate your organs because it is a gift, and it is a gift given
to society. This element of equity should be maintained.
Q32 Lord Lea of Crondall:
Other religious groups, as far as you know, go along with that.
Dr Fernandez-Zincke: I would not be able to
give you this information.
Q33 Baroness Neuberger: When
you said it is a question of education and particularly encouragement
in particular groups, the issue that worries certainly relatively
orthodox Muslims and Jews and which I think has been an issue
for some Catholics as well is the definition of death. It is brain-stem
death versus the cessation of breathing, and the definition of
death being when somebody has stopped breathing for eight minutes
which is often too late for taking some of the organs. I think
there is a real issue and I wondered how much the EU is really
taking that on and looking at the question about how you encourage
ethnic groups and religious groups across the EU to make it as
easy as possible to give organs, given the restraints.
Dr Fernandez-Zincke: I think that is a key element.
Taking into account, for example, the data we have from Spain,
9% of the donors that they had last year were non-Spanish citizens,
so were foreign citizens, and 50% of this 9% were European citizens,
so we could think that in the future more and more of our donor
populations will probably come from donors coming from third countries
and coming from different Member States. That is why this has
triggered the need to go into these populations and explain it
and try to promote donation. It was very useful when the Catholic
Church made a clear statement about brain death. Then doubts disappeared,
and I think that that has been pretty useful. If that could happen
in other religions, that would also be very useful.
Q34 Lord Trefgarne: Brain-stem
death will be the definition that is used.
Dr Fernandez-Zincke: Yes.
Q35 Lord Wade of Chorlton:
What evidence can you describe to us, based on the experience
of countries both inside and outside the EU, which sheds light
on the benefits for the treatment of patients needing organs for
transplantation that could potentially be achieved by improving
the organ donation and transplantation services?
Dr Fernandez-Zincke: I would probably want to
start with a sentence that I have heard sometime ago and I think
it is very clear: I think that transplants are victims of their
own success. If you go through the data, for example, we have
already: a renal transplant recipient who has been living with
their kidney for 43 years, and it is 33 years for a liver transplant
recipient; 27 years for a heart transplant recipient; 24 years
for a pancreatic transplant recipient. You can see that the long-term
survival of the transplants have really increased in the last
decade. Also, if you go through all the data of survival rates—and
I am not going to bombard you with all the data I have here—the
survival and quality of life of these recipients who have received
a transplant has improved a lot in the last decade and that has
provoked that more and more patients and more and more clinical
indications are considered now for being on the waiting list for
being the subject of transplant. That is probably one of the reasons
why waiting lists have been increasing, but, even increasing the
donation rate in some Member States, we cannot cope with the demand
for transplants. There is another element here that it is probably
not the most important—the most important is this improvement
of quality of life and survival—and that is the cost-effectiveness.
The studies that I have revised during the last years show that
really organ transplants are a very cost-effective treatment.
If you compare a kidney transplant, for example, with dialysis,
dialysis costs six times more than a kidney transplant, so all
the studies show that investment in organ procurement, in increasing
organ donation rates, is, at the end of the day, a saving for
the health system. Knowing that we have very good treatment and
knowing that in terms of public health it is a very cost-effective
treatment, I think that it is another reason to try to promote
this type of medical treatment.
Q36 Lord Wade of Chorlton:
Thank you. What is your view of the problems posed by the European
Working Time Directive for medical practitioners who need to work
sufficient continuous hours in order to see through, from the
beginning to the end, an episode of organ transplantation?
Dr Fernandez-Zincke: I can probably only give
a partial answer to this question because it is not my direct
competence. It is my colleagues in DG-Employment who are dealing
actually with the Working Time Directive. I can say that the Commission
has already incorporated a number of measures to this Directive
in order to make more flexible this Directive in the field of
health. Discussions are currently taking place in the Council
and we will have a solution by December this year. So far, that
is all I can say.
Chairman: You may be interested to know
that this Committee produced a report on the Working Time Directive
which would be very supportive of making it more sensible. Our
country has tried to press that, along with, I know, a number
of other Member States. It is an important issue.
Lord Lea of Crondall: Could I add a supplementary
and declare an interest. I had something to do with the creation
of the Working Time Directive years ago and the junior hospital
doctors in this country had to fight for years to get some prejudices
within the profession addressed. They had to work ridiculously
long hours and the idea—and I am putting it to you to comment
on that—that there are no downsides to doctors working until
they are exhausted and almost fainting on the job is ridiculous.
We have to see some balance in this and I am sure that that is
in your mind. Would you like to comment on the problems of balance
within Working Time and genuine worries?
Chairman: Lord Lea, I think this witness
just said this is not his area of expertise and we may have an
opportunity to ask someone else. The question is that these procedures
do take this length of time, and, in order to get these operations
seen through, that is what we are looking for in the balance.
I think that is the point you were making, was it?
Lord Lea of Crondall: But does it have
to be the same person hands-on all the time? That is a non
sequitur, I would have thought.
Chairman: Sometimes cases have to be
seen through.
Baroness Neuberger: One person has to
be in charge.
Chairman: That is the evidence that has
been given.
Lord Wade of Chorlton: I do not know
the answer, not being a medical person, but how long might one
of these operations take? How long does it take to do a heart
transplant?
Chairman: Our specialist adviser informs
me that it varies. Especially with a non heart-beating donor,
from the identification of the donor, from the withdrawal of the
treatment to the donor dying, it can go over days.
Baroness Neuberger: The view would be,
from most of the doctors I know in this country who are involved
with it, that they may not have to be there absolutely all the
time but they need to be on call all the time because there is
a time when you have to get up and do it. That is the problem.
Q37 Chairman: That is the
problem about Directive, about the continuation. That is what
we looked at when we did the inquiry. I have one last question
about research and information, which I am sure you think is an
absolutely crucial area. We are interested in knowing what proposals
the Commission have for promoting and funding new research and
improvements of information, in order to provide a sounder basis
for organ donation and transplantation activities.
Dr Fernandez-Zincke: Thank you, my Lord Chairman.
The European Union is already supporting collaborative research
in a number of areas. I have a list of areas that very kindly
our colleagues of the EU research have provided to me: immune
tolerance to avoid/reduce the need for immune suppressive drugs;
regenerative medicine approach, notably cell transplantation to
regenerate diseased or injured organs; artificial organs; xenotransplantation;
and identification of best practice, organisation of services,
et cetera, at the level of the Health Service system. I also want
to mention that the Research Directorate-General, in the sixth
framework programme, has financed a project called ALLIANCE-O.
ALLIANCE-O is a project that was looking into different research
programmes on transplantation in the different Member States,
for example, UK transplant was present in partnership, and trying
to, let us say, approximate and coordinate these transplant programmes.
The project has issued a number of conclusions that I can provide
to you if that could be of any use.
Q38 Chairman: Also, what might
be useful is where you think the gaps might be, where we need
more information and research.
Dr Fernandez-Zincke: One of the gaps of transplantation
research at Community level is that it is very fragmented. There
are different research groups working in different Member States
and there is not always effective coordination. One of the conclusions
of this project shows that it is very important to try to have
coordination of the research programmes at a national level. At
the moment, few Member States have this kind of organism doing
this job, to organise and coordinate the different efforts of
different transplant groups. From the Community perspective, we
have already funded a number of important projects in the last
years. I want to mention the project of DOPKI, which is looking
into methodologies to increase organ donation and mainly to see
how the level of risk in the use of what we call "expanded
donors" or donors who are not, in principle, ideal candidates.
Also, the project RISET is a project that consists of researching
into reprogramming the immune system in order to avoid as far
as possible the rejection of the organ. The DG Information Society
has also funded a project on Eurodonor and EUROCET, which is a
platform in order to inform the public about issues relating to
organ transplantation and also trying to make a register of activities
of organ transplantation and tissues and cells transplantation
at the European level. Just to finalise: our Public Health Directorate
is funding two other projects. The first one is on the training
of professionals and the training of donor coordinators, and the
second one is on living donation, trying to see what the different
practices of living donations are around the European Union in
order to try to establish guidelines for living donation programmes.
Q39 Lord Lea of Crondall:
Chairman, I would like to add something to what was said earlier,
a bit of supplementary information. It was news to me, but I think
the speaker said that Spain was a net importer of organs, that
Spain had more organs coming into Spain than went out. Did you
say that?
Dr Fernandez-Zincke: No, no.
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