Examination of Witnesses (Questions 428
- 439)
THURSDAY 27 MARCH 2008
Dr Adamos Adamou and Ms Anna Pavlou
Q428 Chairman:
Good morning and welcome. Dr Adamou, we are absolutely delighted
that you have come to talk with us and immensely grateful that
you and Ms Pavlou have taken the trouble to join us. We think
this is an incredibly important inquiry. We have heard from a
large number of witnesses and we have been able to read your report.
Before I start I have to do some housekeeping points. I always
feel slightly silly about this but we just have to make sure that
you know all of this. The first is to tell you that the session
is open to the public. Also a webcast will be made of the session
and that will go on the web as well as there being an audio submission.
This will go wider even though there are not masses of public
here now. As you know, a verbatim transcript will be taken which
will be put on the public record and in a printed form on the
parliamentary website. A few days after you receive that—we
do need it back in a few days—could you make sure it is
accurate and return it to us. We do have rather swift turn round
times here. If you do not think we have covered everything in
this session you can send supplementary evidence in afterwards,
but we ware already very impressed by where you are in relation
to where we are and what we have received, so thank you for that.
This room is not good acoustically. Although we are fairly intimate
you can see I am public speaking and that is because the sound
goes up and the acoustic equipment is not brilliant. What you
have to say is so important that we want to be able to hear you.
When you start can we ask you to state your name for the record
because we have to have you tell us that you are who you are.
If you want to make a short opening statement please do so; if
you prefer to move into questions just let me know. I am sorry
about all that, but now we can begin properly.
Dr Adamou: My name is Adamos Adamou. I am a
physician by profession; I am a member of the European Parliament.
My speciality is medical oncology, dealing with cancer. I am a
member of the Environment, Public Health and Food Safety Committee
of the European Parliament. I do not want to make any statement
but I would just like to mention that my report was voted yesterday
afternoon unanimously by the Committee. The report you have in
front of you is not the final one; it is the one we voted yesterday
which now has some changes and will be voted in the Plenary Session
in Strasbourg next month. We will send it to you for your Committee
here.
Q429 Chairman: Do you think
you could tell us a little about how the European Parliament came
to be interested in this particular issue? How would you describe
the MEPs' reaction to your work generally, apart from your Committee?
Dr Adamou: The issue of organ donation and transplantation
is primarily a medical one. The three main themes covered by the
Commission's Communication and taken on board by my report are
organ safety, organ availability and trafficking; they are in
a sense life and death issues. The particularity of organ donation
lies with the fact that it encompasses a wide range of social
issues as well; that may be even more pertinent. I knew from the
start that the issue would draw a lot of attention. The public
hearing we organised with DG internal policies was very successful.
The majority of stakeholders were present—patient groups,
NGOs, representatives from the Commission and the Council of Europe—from
the biotechnology industry. Since I was appointed Rapporteur I
have also bilaterally met with most of the above mentioned interested
parties, heard their concerns and included many of their comments
in the report. I have also had meetings with the Federation of
German Hospitals, with the umbrella association of European hospitals,
with the Commission health attachés from various Member
States and many more. It is thus obvious that the topic has attracted
a lot of attention. An additional factor that demonstrates that
the topic has attracted a lot of political intention within the
European Parliament is the fact that I received nearly 160 amendments
and the report is not even a legislative one. Another important
factor that contributes to the increased political attention given
to this report across the European Parliament is that most of
my colleagues or, at least, members of my Committee, know that
the directive will also publish on the quality and safety aspects
of organ donation. As you know, health issues predominantly remain
within the confidence of the Member States. There is another directive
in preparation as you probably know and this is cross-border healthcare,
which for me is one of the most important things of the mandate
of this parliament now, 2004-09. I think that your Committee in
the future might want to deal with this; it is a very important
issue.
Q430 Chairman: You said there
were many amendments. Could you tell us what kind of reaction
you are getting? What kind of things are people talking about?
Dr Adamou: Referring to the over-reactions of
the Committee to the Commission Report. I should, first of all,
stress the general satisfaction with the time the communication
was issued since it follows a series of initiatives between 2003
and 2007. Overall Meps work out the communication and acknowledge
the positive direction in which it is moving. More precisely,
there has been a consensus on the need for a pan-European initiative
on organ donation and transplantation, although there is disagreement
within the Committee on what form this should take. Most MEPs
argue for coordination and reinforcement of best practices without
any harmonising measures which deprive Member States of their
autonomy to decide and put in place their own rules. Only some
were in favour of harmonising measures which involved measures
like a European donor card or a common organisational structure.
Nonetheless most Meps seem to acknowledge the need for increased
interstate cooperation in their attempt to deal with the issue
of organ shortage and in order to accommodate the needs of travellers
and people who reside away from their home country. The general
provision of the Commission's Communication was also thought to
be in line with a general consensus of the need to increase public
awareness among the European people. I have to say here that since
my report was voted yesterday we have to sit down again and see
how the report looks now after these 159 amendments. I managed
with my office and with the help of the shadow rapporteurs to
make 12 compromise amendments, but they include all the 159 ones.
The pan-European initiative of organ donation was not voted; they
voted for coordination, for exchange of best practices, for public
awareness and also for the donor card as being complementary to
what the Member States have now.
Q431 Lord Trefgarne: May I
take it from what you have been saying that you see a European
directive as to organ quality and safety as an entirely good thing
and one that is to be supported and encouraged?
Dr Adamou: The Commission is proposing a combination
of two mechanisms, a directive on organ quality and safety and
an EU action plan to coordinate the activities of the Member States.
A future directive on the issue would be based on Article 152
of the Treaty which enables the European Parliament and the Council,
after a proposal by the Commission, to adopt harmonising health
measures by setting high standards of quality and safety of human
organs. Patients across the EU can be confident they will benefit
from a directive setting broad quality and safety requirements
for organs. To start with, actions for quality and safety could
have an effect in increasing organ availability. Common safety
standards could potentially give additional expertise to doctors
and scientists, fill gaps that might exist in certain Member States;
urgent, difficult and special situations and precisions involving,
for instance, expanded donors could be dealt with more efficiently
if guidelines exist. Member States would be able to promote cross-border
organ donations where geographical limitations permit it. On the
other hand now such a directive raises potential questions of
implementation. How will Member States implement such a directive?
Will it create an excessive administrative and economic burden
on the health systems of Member States? Should Member States fear
that a directive setting safety and quality standards for organs
will diminish their current and in some cases already high levels
of protection? These are some questions we should pose ourselves
and consider as potential drawbacks but not disadvantages of such
a directive. Of course these are the questions we have not yet
seen because Parliament has to co-decide on this, on the safety
and quality of organs. We do not know how the report is going
to look, how the directive is going to look. I do not have any
information on it but when they have prepared the draft we are
going to discuss it with them and we have to agree so the directive
can be a directive which is different from a regulation. A directive
is indeed different. It leaves an open window to the Member States
to choose how they want to implement it; a regulation is a regulation;
you cannot do anything.
Q432 Lord Trefgarne: I conclude
from what you are saying that standards among different Member
States are not all good, or at least not as good as the best in
all Member States, and that therefore there is a need for such
a directive to bring the less good standards up to the better
ones.
Dr Adamou: I could not say with certainty whether
some Member States need such a directive more than others. Unfortunately
neither do I have studies on the topic, nor am I aware of the
existence of such studies. In any case, I think it is a bit unfair
to pinpoint certain Member States and blame their health systems
but praise others.
Q433 Lord Trefgarne: That
is a very diplomatic answer. I am not in the business of slating
one country or the other, but it stands to reason, does it not,
that standards are not necessarily the same across the whole of
the 27 Member States and to bring them all up to the best standard
would be a good thing.
Dr Adamou: Yes, I agree.
Chairman: We do not think we are doing
that well in this country. We are not at a very good level and
we do not feel complacent here. Lord Kirkwood?
Q434 Lord Kirkwood of Kirkhope:
May I ask you to clarify the process for us? Your evidence is
very welcome and it is very timely; your Committee has just been
completing its work. Did I understand you to say that there were
159 amendments tabled but that you managed to reconcile these
down to a dozen, twelve that you were comfortable with? Would
it therefore be safe to assume that the 12 amendments are all
amendments with which you are comfortable?
Dr Adamou: Yes. We worked very hard on these.
There was a paragraph and on this same paragraph there were ten
amendments. When discussing with my colleagues and the shadow
rapporteurs of the other political groups we found common ways.
Sometimes we noticed they were only linguistic amendments, a difference
in what they want to express.
Q435 Lord Kirkwood of Kirkhope:
So you are still comfortable with the general direction of travel.
Nothing has changed that causes you concern?
Dr Adamou: No.
Q436 Lord Kirkwood of Kirkhope:
We will see the final fruits of the plenary session after the
Strasbourg Plenary has taken place.
Dr Adamou: Yes.
Q437 Lord Kirkwood of Kirkhope:
Could you tell me whether you believe that the Commission will
then take real note and take proper concern and pay attention
to the work of that Committee? To what extent do you think the
Commission will accept Parliament's view as expressed in the Strasbourg
Plenary?
Dr Adamou: You know very well that the Commission—and
only the Commission—is the initiator of any legislative
proposal. I would like to make a personal comment here. I am an
elected member of the European Parliament by European people;
do I have the right to be the legislator? So the Commission decides
and is the initiator of any legislative proposal. The Parliament,
as co-legislator, can of course influence the procedure together
with the Council once the proposal is issued by the Commission,
in other words not during the drafting stage. One could argue
that in theory the Commission might not at all take into account
the Parliament's suggestions and concerns, but I want to be fair
on this. I should say that in the field of public health they
do to a great extent take into account our suggestions. It is
also to their best benefit to issue a directive that has the approval
of the elected representatives of the European people. The Commission
is aware of the many implementation problems that occur with the
Tissue and Cell Directive and in my opinion they do not want that
to happen again with a potential directive on quality and safety
aspects. Moreover, it seems that the Commission is trying really
hard to gather as much information on the topic as possible in
order to achieve the widest possible consensus. It issued a consultation
document, a communication and is organising regular national expert
meetings on organ donation and transplantation at EU level. I
am quite positive and I believe that the Commission will take
into account our suggestions, not only concerning a possible administrative
burden but on all -relevant issues.
Q438 Lord Kirkwood of Kirkhope:
That is quite an optimistic answer. You are optimistic that you
committee's views will prevail.
Dr Adamou: I am optimistic that they are going
to accept our opinion because at the end of the day it is the
opinion of the European people.
Q439 Lord Kirkwood of Kirkhope:
We have identified a vein of concern about what we call in the
United Kingdom "gold plating", overdoing the bureaucracy
and having heavy layers of extra work and practical difficulties.
Can you give us any assurances that your Committee is alive to
the dangers of stifling best practice and good work by over zealous
administrative conditions and burdens?
Dr Adamou: This is a problem not just for the
UK but for all the Member States. They are afraid of this burden
if we adopt measures that are going to change their current practice.
There are countries today which have very good organisational
systems and if we change that we might help some countries which
have low or medium standards, but what about the others that already
have high standards? How are we going to do this? Are they going
to diminish their standards to come to a common level? I do not
think this is the issue here; we are trying to help, we do not
want to add bureaucracy for the Member States. This is very clear
and it is made very clear to the Commission that the Member States
will not accept such a burden.
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