Examination of Witnesses (Questions 440
- 459)
THURSDAY 27 MARCH 2008
Dr Adamos Adamou and Ms Anna Pavlou
Q440 Lord Kirkwood of Kirkhope:
Will your report reflect that?
Dr Adamou: Yes, it already voted on this issue
yesterday.
Chairman: It may well be reflected and
reinforced by another report, as you can hear.
Q441 Lord Lea of Crondall:
You have no particular problems with the process, given the nature
of the European treaties, between the Parliament and the Commission;
you are doing your job and your procedure. When it comes to action
plans for cooperation with Member States, can you just say how
you relate as a Parliament to Member States during the development
stage of the directive. Under co-decision you are feeding in Parliament
views to the Commission and yet there is a very critical relationship
with the work that is going to be done by Member States. Can you
just say a bit more about the Member States part of the triangle
because you have two separate procedures here, have you not?
Dr Adamou: Let me clarify something here. This
person here is the Director of my office and she can answer that
question.
Ms Pavlou: As you mentioned there are two mechanisms,
the directive and the action plan. In respect of the action plan
the Parliament does not really have any powers. It is the Commission
that coordinates the activities of the Member States. Of course
in the current communication that you are examining they mention
both the possible directive and the action plan so we are commenting
on both, we are welcoming both instruments. In the future when
the action plan is issued it will mostly be the Member States
that will have the responsibility of implementing what the action
plan proposes. Obviously, since it is the Member States, it is
the country indirectly that gives the direction to the action
plan; it is the government of the Member States and their willingness
to implement the action plan of the Commission. In respect of
coordinating activities of the Member States, for the time being
unfortunately the Parliament does not have great powers.
Q442 Lord Lea of Crondall:
Do you happen to know that the Member States, through the Council
Working Party, is happy—as you, I think, are happy—about
the proposed line of demarcation and the proposed dichotomy between
the two procedures?
Ms Pavlou: They are happy but they are afraid
and even more afraid in the Parliament about what you just mentioned
about the administrative burden. Most Member States are not in
favour of an EU donor card although the Parliament voted for it
yesterday. Most Member States are afraid, as Mr Adamou said, that
we will have fluctuating standards. For instance, the French are
very afraid that their levels will be minimised; the Germans are
very afraid about how this directive will be implemented because,
as Mr Adamou said, they have problems with implementation of the
Tissue and Cell Directive. The reactions of the Member States
fluctuate. They are very happy with the current state of things
but they still need a lot of reassurance from the Commission as
far as we have understood from the meetings and the negotiations
we have had so far.
Chairman: That is very clear. We have
been looking for an answer like that; that is very helpful.
Q443 Lord Eames: I want to
raise a practical issue with you and that is the question of the
difficulties of transportation across Europe. Why should there
be more transportation problems within the European states than
bringing a donation from the north of Britain to the south of
Britain? It is a practical issue and I wonder how you react to
that.
Dr Adamou: As you very well know organs are
vulnerable. It is not only their flight time from one country
to the other. It starts from the time the surgeon has removed
the kidney or heart or liver or lungs, which are then taken to
be prepared in certain boxes. There is then travel from the hospital
to the airport, from the airport to the other airport and so on.
There is a time limit. It does not make any sense to transport
one organ from Cyprus to London or to Sweden. What we are looking
for is for neighbouring countries to cooperate. We know this very
well because we have examples like Eurotransplant or Scandiatransplant
where countries have built up an alliance among them. They exchange
best practices and they exchange organs. If you say from London
to Scotland then this is very practical. And I want to mention
something else. How many organs will be needed to be transported
to another country a big country like the UK or France or Germany?
In my country we only transplant kidneys so all the other organs—liver,
lungs, et cetera—travel to neighbouring countries: Israel,
Greece, Austria and sometimes Turkey. There is cooperation between
the Turkish Cypriots and the Greek Cypriots; this is not an issue
with political problems. We exchange organs with them. I want
to say here that in Cyprus we have the biggest bone marrow donor
trust in the world. One in three Cypriots are members of this,
and this includes the Turkish Cypriot people. We give bone marrow
to Turkish Cypriot people; they give to the Greek Cypriots. When
we come to health and humanitarian issues we are together. Cyprus
is number one in Europe in living donors and this is because of
the very tight family ties. The mother gives to the son; the sister
to the brother and even our new president has been transplanted
with a kidney from his sister nine years ago. This is not a secret;
it is published.
Q444 Lord Eames: You mentioned
local countries agreeing, therefore cutting the journey time of
the whole process. What happens if a particular organ is required
and it is at the extremities of the European Community? Are we
talking about real live difficulties in that case or do you foresee
that as purely exceptional?
Dr Adamou: Distance is a problem. The organs
are vulnerable. There are other scientific and clinical issues
which are not dealt with in the report; it does not deal with
clinical aspects or interfere with scientific decisions. However,
as a doctor let me explain to you that organs are very vulnerable.
Not only this, it is the recipient as well, who is not able sometimes
to receive an organ despite the recipient being identical, because
there are other co-morbidities on the recipient like other organ
failures or systems that even if we transplanted here we might
have a high percentage of rejection. Distance plays a major role.
We need to be accurate on this and be on time. That is why in
my country when we remove the organs you see police everywhere:
it is as if the prime minister is moving.
Q445 Lord Wade of Chorlton:
Following on from that very interesting answer, do you believe
that if cross-border movement of donors' organs were to develop
as a result of these proposals that there are any particular issues
that either the donor countries or the EU particularly ought to
set up to make it easier and to make it more likely to happen?
Dr Adamou: As I explained just before, organ
donation between Member States has many disadvantages. On the
one hand there are the long distances that exist between Member
States and on the other the vulnerability of the organs. It is
far more likely for countries that have common borders to exchange
organs and to be even more precise it is far more likely for cross-border
regions to exchange organs. Evidence exists that countries will
firstly accommodate their own needs and then provide their so-called
surplus of organs to another country. As I said to Lord Eames,
the UK is a big country therefore, how many organs will not have
a recipient? I do not think that happens, but in my country we
have this; we take only the kidneys and all the others we transfer
to neighbouring countries. I think there are more efficient ways
to promote cross-border organ donation to increase the pool of
organs. If we look at the Spanish model in giving incentives to
Member States to have within the majority of hospitals in-house
transplant coordinators. The establishment of an efficient system
to identify persons that could become organ donors after their
death, once all mandatory consent requirements of Member States
have been met, is a key element in fighting organ shortage. The
process of organ suitability evaluation is multi-facetted. Focus
on the definition of acceptance and acceptable risk, of transmission
of infectious disease, the establishment of practical steps of
the risk evaluation process, considering in a single case the
transmittable disease, the specific conditions of the recipient
with respect to the transmittability of disease, are means for
the prevention and treatment of the disease. Another important
option in expanding the donor pool is to consider the promotion
of tourist donation from living donors. That is what is happening
in my country. Another is to use another term for expanded donors,
allowing transplants from an HIV positive person to another HIV
positive person. This includes the term expanded donor. Doctors
are concerned with the increased likelihood of rejection of the
organs and here comes the issue of biotechnology or the advances
in biotechnology we have today, so we eliminate the rejection
process. Let me move ahead and tell you that maybe in the next
decade we will not be discussing organ donation; we will be able
to create an organ from our own cells. From just a skin cell,
if we drive it correctly, we will create the organ we need. This
research in biotechnology is going on now and of course, as you
know, research in medicine takes some time to produce a result.
When I mentioned this at a meeting with the NGOs in Brussels they
looked at me as if I was talking about science fiction. I told
them that this was not science fiction; it is something that is
coming. Maybe in the next ten to 20 years there will be no need
to do organ donor cards or all of these things we are doing now.
Chairman: Meanwhile we are ploughing
on with what we can do now and one of the issues is this next
one about the European donor card. Lady Gale is going to follow
up this issue.
Q446 Baroness Gale: Before
I put my question I ought to declare an interest in that I am
a patron of the Kidney Wales Foundation. My question is about
donor cards which you have already touched upon. How effective
do you think that the introduction of an EU donor card would be
in increasing the willingness of EU citizens to identify themselves
as a potential donor after their death? In which Member States
might such a card be likely to have a beneficial effect?
Dr Adamou: The vast majority of the Council,
including the UK if I am not mistaken, oppose the introduction
of an EU donor card. Many Member States argue that such a donor
card might create an administrative burden for those Member States
that do not already have it. The creation of an EU organ donor
card will not per se increase the number of donors. In many Member
States where they have introduced the donor card it is legally
possible that family members of a brain-dead patient who is a
donor card holder refuse to donate the organs. So that makes one
wonder what is the need of donor cards if the family has the right
to refuse the wish of the dying or dead person? I will give you
some statistics here. I think it is important to cultivate a culture
of donation across Europe as it happens in Spain. It seems that
European citizens want to donate. When asked, 56% of Europeans
declared themselves ready to donate their organs whereas family
refusals to donate the organs of their deceased relatives ranged
from 6-42%. There is an important gap that needs to be filled
here. European people should be encouraged to speak about organ
donation and communicate their wishes within the family. This,
for me, is the most important thing. We are talking about public
awareness; no, discuss the issue and express your desire within
the family. All the post mortem donations in Cyprus occur because
they have been discussed within the family and donors have expressed
their desire. If you do not express your desire the family can
refuse to give the organs. Less than half of those asked have
discussed organ donation within their family and yet it is the
family members that have the last word when it comes to donation.
The Commission not only argues that the creation of a European
organ donor card will contribute to increased public awareness,
but also that 81% of Europeans support the use of an organ donor
card. I am not that optimistic about these figures given the fact
that only 12% of the European people have a card. Having said
that, as I said before, we voted yesterday for the donor card
to be complementary to the existing system of Member States because
this is the wish of a lot of MEPs. Of course we have to wait to
see if there will be any further amendments at the Plenary because
the rules of procedure in the Parliament say that if 35 MEPs sign
an amendment this should be voted on at the Plenary. I do not
think this is very easy to happen since all the political groups
agree on this compromise, but nothing is impossible for the European
Parliament.
Q447 Lord Lea of Crondall:
Is there a danger of two or three different issues being confused
here? It may be just me who is confusing them, but I would like
to ask you to comment if you would. First of all, there is the
question of hospitals around Europe recognising anybody's donor
card from a national donor card. Secondly, you then go onto the
question of the wishes of the donor card holder being overridden
by the family. I find that a bit strange, but can you say that
that is what you are saying, that these donor cards do not mean
what they seem to say, that they can be overridden by the family?
Thirdly, on the so-called shortage of organs it is by definition
not a shortage of organs but a shortage of technical capacity
if the organs are available but it is not an issue of technical
capacity if the organs are not available. You certainly need donor
cards as well as the technical capacity. Have I understood those
three separate issues?
Ms Pavlou: The Commission is actually proposing
an EU donor card in its Communication as far as we understand
from discussions we had with them. You have the Parliament where
most members seem not to be in favour of an EU donor card, although
we voted for it as being complementary to existing national systems.
The other half of your question was whether an EU national donor
card would be more suitable. From the evidence we have gathered
we think it would be more suited in smaller countries and in smaller
regions than on a pan-European level, but we do not really have
evidence on that because we are mostly using the evidence we have
taken from the Commission and from national expert meetings. For
the time being, the Commission is pushing for an EU donor card
whereas we would be more in favour of having it complementary
to existing national practices. Mr Adamou mentioned that with
a donor card the numbers will not raise per se. This is what we
gathered from information from Spain but, as you know, they have
one of the best systems in the world. They told us that although
it helps people identify themselves as donors it does not per
se raise the numbers of potential donors. It is in Spain where
they have very big problems with the family overriding the wishes
of donors. Even people who work, let us say, for the transplant
organisations and they want to be donors themselves when they
die, their families sometimes do refuse to give the organ. That
is why we want to promote donations so that you will raise awareness
and people will discuss it within their families so we will not
have such problems. Then you mentioned technical capacity and
shortage of organs. Potentially there is going to be technical
capacity if you have enough organs to donate, but for the time
being in Europe there is more a problem of shortage of organs
than the capacity. In Spain they have so many organs and they
have managed to accommodate the organs they have because they
have what they call the ONT which is a national transplantation
organisation, and then they tried to accommodate the organs and
to diffuse them across the country. I do not think we will have
the technical capacity to accommodate a large number of organs.
Q448 Lord Lea of Crondall:
The position in Spain is just not the same as the position in
Britain.
Ms Pavlou: The situation in Britain is that
you do not have enough hospitals to accommodate the organs.
Q449 Baroness Gale: Has presumed
consent been discussed by your Committee? If so, what are the
views?
Dr Adamou: Presumed consent was discussed by
the Committee to a large extent during the hearing we organised
in mid-November and to a great extent in the civil liberties and
legal affairs committees. Furthermore, some of my colleagues came
up with the idea of having a legal representative that would be
entrusted with the task of carrying out the wish of a person to
become a donor after his death. This legal representative would
be able to contravene family members in case they decided not
to donate the organs of their deceased relative. This was amendment
73 and it was rejected. It was a detail we learned yesterday.
The principle of presumed consent implies that a person is automatically
a donor unless he states otherwise. This in theory would be a
very good system and would probably drastically increase organ
donation rates. However, as you know, due to the principle of
subsidiarity health issues and also issues that are intrinsic
to the legal system of the Member States do not fall within the
competences of the EU. We should let Member States decide on their
own which systems would work better, whether this be an opt-in
or opt-out system, or one of presumed consent. What the EU can
do is provide Member States with information of which works better
and achieves optimal results. As with ethical issues I am of the
opinion that certain issues should be dealt with at Member States
level.
Q450 Baroness Gale: So from
what you are saying you do not see any likelihood of a European
directive on this and it would not work anyway, and it would have
to be decided in each nation state.
Dr Adamou: Yes, issues of ethics are usually
left to the Member States. If you bring it up with the Parliament
there are a lot of disagreements so there was the concept of advanced
therapies to make the amendments so we leave the ethical issues
to the Member States to decide. Otherwise the rapporteur was strongly
against this but we managed in three major political groups to
agree and so we passed this legislation, first reading, and it
was a great success.
Q451 Baroness Neuberger: I
need to declare an interest because I have a brother-in-law, James
Neuberger, who is deeply involved in organ transplantation, particularly
livers. Dr Adamou, before I ask my question I want to ask you
about a discrepancy that some of us have picked up in the question
of shortage of organs and organ trafficking. If you look in the
draft report it says that there are 40,000 people waiting for
kidney transplants in Western Europe, but if you look in the Commission
Communication: Policy Actions at EU level it says simply that
there are 40,000 people waiting for transplants in Europe. We
do not know which figure is the correct one. I would be interested
in that before I move onto the question about trafficking.
Dr Adamou: It is more than 40,000.
Q452 Baroness Neuberger: In
general, across Europe.
Dr Adamou: More. More than 50,000. These people
are on the waiting list and every day ten of them die. It is more
than 50,000; it is 53,000 or 56,000; something like that.
Ms Pavlou: Currently there is no data on Eastern
Europe but out of political correctness we wanted to do the whole
of Europe. There seems not to be a lot of data on the new Member
States.
Q453 Chairman: Would it be
fair to say that we really do not know? We have some ideas of
waiting lists but not a lot of idea of how many people would be
on waiting lists and indeed would receive an organ in a perfect
world. Your answer is saying that we do not know but it is a lot
more than 40,000.
Dr Adamou: We do not have the numbers; we presume
that there are more. We are talking about 40,000 people without
Eastern Europe.
Q454 Baroness Neuberger: Can
I just pick up one little bit about what we were just discussing?
In one it says "kidney transplants" and in the other
it just says "transplants" so presumably, although it
is a relatively small number for liver and heart and so on there
is a further discrepancy.
Dr Adamou: I think the 40,000 refers to all
the transplants, not only kidney.
Q455 Baroness Neuberger: In
the draft report it says kidneys. I just wanted to pick that up.
Dr Adamou: The vast majority of transplant patients
are for kidneys.
Q456 Baroness Neuberger: Moving
on to question ten, how serious a problem do you think organ trafficking
and transplant tourism are across the EU? What measures, beyond
what is already in place, do you think are necessary at either
EU level and Member State level to combat what is going on?
Dr Adamou: Of course the issue of trafficking
is important. However, the Committee, according to the rules of
procedure, does not have the competence to extensively deal with
issues of trafficking. That is why the Committee of Civil Liberties
as well as the Committee of Legal Affairs, were charged with the
task of producing subpoenas to my report. Many of their suggestions,
including those related to trafficking, were incorporated in the
text of the report and were voted on yesterday. To get back to
your question, despite what I mentioned, I should stress that
on the face of available data of the trafficking of human organs
and evidence of rapidly developing commercialism in transplant
tourism, it is pertinent not to underestimate organ trafficking
as a secondary area of concern. Scientific studies have shown
that organ trafficking is caused by poverty, homelessness, the
desire to work and make a living, corruption, criminals, globalisation
of the economy and exploitation of human beings. On many occasions
people in the east become the spare parts inventory for the sick
of the west. Although the problems of trafficking concern countries
outside the European Union more than they concern Member States,
a link between organ shortage and organ trafficking has been established.
Therefore, the best way to fight organ trafficking is by increasing
organ availability through appropriate action at both Member States
and EU level and to subsequently fight and block the import of
organs from outside the EU. In order to do this a mechanism of
traceability should be put in place so as to prevent these organs
entering the European Union. During the discussion with the Committee
one colleague mentioned that he asked Europol if it knows that
there is any organ trafficking in the European Union and the answer
was no. Of course it is no, but European citizens are going to
developing, poor countries and they pay and they receive an organ.
After we finished the session one of my colleagues discussed face
to face and said, "Why not? If I am sick, I need a kidney
I will pay to take it because it is my living, I will live with
this". If the other person gives it to you altruistically
like what happened two days ago in Cyprus, a Canadian lady came
to Cyprus because she found a 29 year old resident in Australia
on the internet and their kidneys are identical. Because the lady
needed a kidney they both came to Cyprus, the boy gave the kidney
to the lady without any financial interest in this; it was an
altruistic action. However, nobody should ignore that transplant
tourism exists in Europe. I will give you another example I have.
Insurance companies in neighbouring to Cyprus countries pay you
for this. If you find a donor in a third country or a developing
country you go and receive a kidney and they pay the expenses.
This is incredible. They are saying, "Okay, you are transplanted,
where have you been? You've been in India." Everybody remembers
the publication in the newspaper some months ago about finding
European citizens in a clinic in India where they were receiving
kidneys for 10,000 dollar a kidney. When they discovered this
the doctor who was going to be arrested disappeared. So trafficking
exists, maybe not within the European Union but it happens to
European citizens who go to third countries to receive an organ.
Ms Pavlou: Can I comment on something you said
before? On page four of the impact assessment in the fourth paragraph,
they mention the fact about Western Europe. It is not mentioned
in the Communication that the data comes from Western European
countries.
Baroness Neuberger: Thank you for that
clarification.
Q457 Baroness Young of Hornsey:
On a number of occasions we have talked about information and
evidence and so on and obviously it is absolutely key to understanding
the issues we are trying to address. Can you say something about
your Committee's view about the need for better quality information,
particularly around different communities and the extent to which
they are willing to donate organs, looking at perhaps demographic
and socio-economic factors that influence people's organ donation
rates?
Dr Adamou: Our Committee dealt with this issue
extensively. It was a part of the compromise amendments which
we unanimously adopted in our vote yesterday. We understand that
there are important differences in respect to the source of organs,
deceased or living donors, within the EU. There are large differences
between Member States in their success in increasing their donor
pool; there are large discrepancies when it comes to quality and
safety of organs. There are also different organisational approaches
to organ donation and transplantation. We consider that the discrepancies
can be partly explained by a combination of economic, structural,
administrative, ethical, religious, historical, social and legal
factors. The critical factor seems to be how the whole process
leading to donation and transplantation is organised. That is
why better quality information is needed. If we want to increase
the rates of organ donation we should try to explain these large
differences and discrepancies that exist. Our Committee underlines
the importance of increasing public awareness across Europe on
organ donation and transplantation since it can facilitate the
identification of organ donors and thus increase organ availability.
The Commission's role on the issue should be strengthened. They
should try to take a more active role in collecting such data
and information. I am in favour of promoting and funding cross-border
research designed to improve this information and to make its
results widely accessible. That is why now in the Commission we
stress that the establishment of a well-structured operational
system and the promotion of successful models between Member States
and, where appropriate, at an international level, are of the
utmost importance. The Commission acknowledged that the different
organisational systems are the results of culture and ethnic differences
but should further promote the collection of such information.
Q458 Baroness Young of Hornsey:
One of the issues that we have come up against in this country
is that people from some communities within this country have
lower organ donation rates than others. One of the questions we
have been asking some of our witnesses is the extent to which
there is any knowledge and research that exists about whether,
within other nation states, there are these discrepancies between
communities within those countries.
Dr Adamou: Let me refer to other examples. I
am an oncologist and I am deeply involved in the screening tests
of cancer—breast cancer, colon cancer, cervical cancer—and
I was part of a team that initiated this screening programme in
my country. We succeeded by going down directly to the people,
even in the schools, to talk to them about their health. We gave
health lessons. There are organisations in the UK, the NGOs, that
are interested in public awareness so that should be the target.
You have studies in the UK that show you where you are weak on
this, so you have to go down to that level and explain to the
people. They are not scientists; they are not aware of many things.
They are aware of things only when they get sick from a certain
disease, either needing an organ or having a type of cancer, and
then some of them become very strong advocates in your effort
to promote the system. That is what I did in my country and we
have been successful in this, especially the mammogram screening
test for women. We took mobile units of mammogram equipment and
we went to the villages, we gathered them together, we talked
to them and the next day they came to have a mammogram. This is
the power of communication. You go there you educate them and
then you see that your numbers are raised.
Q459 Baroness Young of Hornsey:
I think it would be interesting and useful to share practice on
those kinds of issues. Could you say what measures you think should
be taken at EU level and at Member State level to promote and
fund cross-border research which is designed to improve the kind
of information that is available and to make the results widely
accessible?
Dr Adamou: I think I have answered this.
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