Examination of Witnesses (Questions 1
- 19)
THURSDAY 22 NOVEMBER 2007
Dr Eduardo Fernandez-Zincke
Q1 Chairman: Welcome. We are
really grateful to you for taking the time to come and see us.
This is an extraordinarily important inquiry that we have undertaken.
We have had a lot of interest in the inquiry, from all sorts of
groups, and we are hoping that the report that we make when we
have heard the evidence will be of some value in the wider debate
going on across the EU. Any help you can give us in starting us
on this direction, as you are at the beginning of our inquiry,
would be useful. Our specialist advisor, Professor Bobbie Farsides,
is with us. She has been extremely helpful at the beginning in
helping the Committee to understand what the issues are in relation
to European donations. We have an hour for the session, which
is open to the public. A transcript will be taken, a copy of which
you will receive in a few days. Would you advise us, please, as
quickly as you can, if there are any corrections to that transcript.
Could you begin by stating for the record your name and your official
title. You are then welcome to make a statement or to go straight
into the questions. Perhaps you would tell us how you want to
begin.
Dr Fernandez-Zincke: My name is Eduardo Fernandez-Zincke.
I am a medical doctor. I work as a medical officer in the Directorate
of Public Health and Risk Assessment, the Directorate-General
of Public Health and Consumer Protection of the European Commission.
My Lord Chairman, I would like to thank this group and this Committee
for giving the opportunity to the European Commission to be here,
to explain to you the future proposals on the area of organ donation
and transplantation that we are working on. I would prefer to
go straight to questions, to try to make it as interactive as
possible.
Q2 Chairman: Thank you very
much indeed. You have had some advance notice of where we are,
but could you begin by explaining the steps you propose to take
in establishing a European Union level role in the field of organ
donation and transplantation, including which future documents
would be likely to be published and whether proposals for a new
Directive or regulation are planned. Could you set out the likely
timetable for this, so that, if you like, we have some legal and
structural picture in order to begin inquiring.
Dr Fernandez-Zincke: Thank you, my Lord Chairman.
I would like to start, if I may, with a short briefing of why
the European Union is working in this area and what is the background
of this communications that the Commission has adopted in May
this year. I have to say that there are some milestones in the
work of the policy on organ donation and transplantation of the
European Union and I would like to go through these milestones
as I think that could be useful to understand why we published
this communication in May. The first milestone was the conference
of Porto held in 2000 by the Portuguese Presidency which established
the basis of the Community line, let us say, on organ donation
and transplantation. At the very same, it was incorporated in
the Treaty of the European Union, what is now known as Article
152, which gives competence to the Union on establishing the highest
standards of quality and safety for human organs, blood and blood
components, and substances of human origin. The second milestone,
which was linked with the conclusions of the Porto conference,
was a second conference organised by the Spanish Presidency in
Malaga in 2001, which established the basis, the technical basis,
for what is now known as the Tissues and Cells Directive. One
of the priorities that came out from the Porto conference was
the need to work on quality and safety rules for tissues and cells.
When the Commission was through the process of composition of
the Tissues and Cells Directive, there was a lot of pressure already
to introduce organs into the scope of the Tissues and Cells Directive
and, at that time, the Commission took the approach that organs
needed a completely different approach from the one having been
taken for blood and for tissues and cells. There was a very helpful
further milestone that I am going to mention, the conference in
Venice, organised by the Italian Presidency, which established,
with the conclusions, the main key elements in the area of organ
donation and transplantation. With these conclusions, the Commission
published a statement, together with the Tissues and Cells Directive,
saying that organs are different from tissues and cells or blood,
we have to consider that they are lifesaving treatments in most
of the cases, we have to consider that there are enormous organ
shortages in all European Member States and the quality and safety
principles which are basic and which are important should always
take into account this context in the area of organ transplantation.
So that is why, in this statement, the Commission also committed
to present an evaluation of the situation and a number of possible
actions to carry out in the area of organ donation and transplantation,
and the communication that we have adopted in May is the result
of this evaluation that the Commission has carried out during
these years and it is proposing a number of possible actions to
be taken at Community level. I will now make a very brief statement
of the content of the communication, in order that you have a
complete context, and then I will go into the future steps, if
that is correct for you. In the communication we identify three
main challenges or three main areas where we have to work at Community
level. The first one is what we call "transplant risks".
We know, and it is noted, that organ transplants pose a risk of
transmission of disease from the donor to the recipient. This
is not only a theoretical risk but we have had cases in the last
years at the European level where we have seen transmission of
HIV, HTLV, malaria, rabies or malignant neoplasm from the donor
to the recipient. And it is not only this, but many times an organ
donor is also a tissues and cells donor, so there is a connection
between the donation of organs and the risk and the donation of
tissues and cells and the risks that that imposes. Also, in some
cases, the transmission of diseases has affected more than one
Member State. This is something that we could probably address
later on in your following questions. The second challenge, which
for the Commission is the main challenge that we have to address,
is the organ shortage. We have more than 50,000 patients on the
waiting list. There is a common problem that is facing all Member
States and we think that this is the main problem that we will
have to try to resolve. The third problem, which is probably a
consequence of the second, is that of organ trafficking. There
is the possibility that, given the situation of the scarcity of
organs, there are some criminal organisations who are taking the
possibility of exploiting vulnerable populations in order to take
organs for patients in need. Taking these three challenges in
mind, the communication is proposing three areas of action. The
first one is to ensure quality and safety and responding to the
core of the competence of the Treaty; the second is to increase
organ availability or increase organ donation rates; and the third
one is to make transplantation systems more efficient and more
accessible. Because these are three different problems, the Commission
thinks that all these problems cannot be solved with the same
instrument, so we are proposing two different instruments. The
first one is an action plan on the strength of cooperation between
Member States. The second instrument, which complements this one,
is the new legal framework that will establish the basic levels
of quality and safety at Community level. After adopting the communication
in May, the Commission have started working with national experts.
Because we do want that this process should be as consultative
and transparent as possible, we have already had three meetings
with national experts, one in July, the second one in October
and the third one last week, on 20 November. The Commission is
willing to introduce and has already introduced in the agenda
of the legislative programme of the Commission of 2008 the possibility
of presenting by then, 2008, a package of proposals on organ donation
and transplantation which will be composed of the first instrument,
an action plan on the strength of cooperation, where a Member
State will have to identify which are the main priorities, and
the second instrument, a new legal framework that should be flexible
enough on one side to cover or to ensure the basic quality and
safety rules and on the other side to respect and not to undermine
donation rates in Europe.
Chairman: That is extremely helpful and
clear, sorting out the issues and the timetable. Lady Neuberger,
would you like to move on from that.
Q3 Baroness Neuberger: I think
you have answered quite a lot of my second question in what you
have already said. The bit of the question that, in a sense, you
have not dealt with, is that there are members of the medical
profession—and as a doctor yourself you will be only too
well aware of this—who are worried that the EU package,
when it emerges, may well over-bureaucratise what is already happening
and not allow individual doctors or, indeed, transplantation programmes—to
declare an interest, my brother-in-law is involved in one of those—to
use their clinical expertise and judgment. You have said that
you are bringing in the experts. To what extent can you give us
reassurance that the experts feel thoroughly consulted and, indeed,
are really contributing?
Dr Fernandez-Zincke: Thank you, Lady Neuberger.
I think that is also our concern.
Q4 Baroness Neuberger: I should
think so.
Dr Fernandez-Zincke: If you read the impact
assessment which is attached to the communication, it is very
clear that we are working in this line. In fact the approach that
we are presenting to national experts differs from the blood and
the tissue cell approach, in the sense that what we want to construct
is a system where you have to collect the needed information from
the donor or from the organs and transmit this information to
the transplant team, but we do not want to interfere in the clinical
decision of the team. That is the main difference between the
legal frameworks that we have in place and the future legal framework.
I can say that we are trying to make an extraordinary effort to
communicate this aim to the medical community. From the very beginning,
they are invited in the discussion of the content, let us say,
of the legal framework, and they are contributing—at least
the national experts that are nominated by Members States. But
we are not happy enough with this, so we are planning to create
a group of medical professional, patients and other relevant stakeholders
who will have the opportunity to comment on the content of both
documents, the action plan and the legal framework. After all
these consultations, we will anyway proceed in the normal way
that the Commission does regarding these kind of documents, and
an open consultation on our web page will be launched in order
that everyone who wants to give their input into the content of
the documents has the opportunity to do so.
Q5 Lord Trefgarne: I am very
concerned to be assured, as I think Lady Neuberger is, that the
Commission are not going to involve themselves in what are clinical
matters. They are not going to be interfering in the clinical
judgment of the consultant or for that matter in the various professional
organisations within the Member States which, in many cases, are
so distinguished. Can you give me that assurance?
Dr Fernandez-Zincke: I can give the assurance
that that is the intention of the Commission. The intention of
the Commission is not to interfere in the clinical decision. It
is not to interfere in the healthcare system of Member States.
That is why we are proposing a combination of two mechanisms.
Even in the action plan there will be a number of measures intended
to ensure quality and safety but we want to analyse which of the
mechanisms of quality and safety should be in the legal mechanism
and which should be in a national plan on a more voluntary basis.
We believe there are some initiatives that should remain in a
legal mechanism, because they should be established in all transplant
systems, because no transplant system could work without these
guarantees, but also we think that some measures intending to
improve the quality of transplant should go into the other mechanism,
which should be created on a more voluntary basis and taking into
account the participation of the professionals.
Q6 Lord Trefgarne: There is
likely to be a Directive resulting from all of this.
Dr Fernandez-Zincke: I think that the intention
of the Commission is to have a Directive for one side plus an
action plan on the other side. But of course you have to establish
an impact assessment and try to analyse the different impacts.
Q7 Lord Trefgarne: Which article
of the Treaty will that Directive come under?
Dr Fernandez-Zincke: 152.
Chairman: This leads in very well to
Lord Wade's questions, I think.
Q8 Lord Wade of Chorlton:
Thank you. I have a couple of questions that cover the current
position and then some on what the longer-term objectives are.
How would you characterise the present quantity and quality of
organ donation and transplantation services across the EU? What
do you see are the realistic aims for the short- and longer-term
future in improving the quantity and quality of organ donation
and transplantation services across the EU? In other words, how
do you see they are now and how do you think they will improve
as a result of these Directives?
Dr Fernandez-Zincke: I will start probably with
the quantity and then we can go to the quality. I have to say
that we have in mind two mechanisms, not only a Directive but
also an action plan in order to strengthen cooperation between
Member States. I have to say that, in general, organ shortage
is a problem that is facing all Member States, so it is a common
problem in Europe and in the world. The average donation rate
of the European Union is 18.8 per million of population. If you
compare this average with, for example, the average of the US,
the US have achieved an average donation rate of 25.5 per million
of population, so we are below. But what is more important, I
think, is that the situation at the European level is not homogeneous.
There is a wide variability of organ donation rates between Member
States, which runs from 35.1 per million of population in some
Member States to less than one per million of population in other
Member States.
Q9 Lord Kirkwood of Kirkhope:
To less than one?
Dr Fernandez-Zincke: Yes, it is 0.8 in some
Member States, so practically non-existent. That is also transferred
to a wide variability on transplantation activities. It is not
only the donation part but also the transplantation activities,
which rise from 1.6 to 57.6 per million population, depending
on the Member State, in the case of kidney transplantation, or
from 0.8 to 24 per million population in the case of liver transplantation.
So, again, there is a wide variability between Member States.
In Europe there were approximately 58,000 persons on the waiting
list in 2006. I have mentioned some figures now regarding deceased
donations and transplantation from deceased donors, but, if we
look to living donations, the activity of living donations also
varies completely in different Member States. In some Member States,
100% of the activity of kidney transplantations is coming from
living donors; in other Member States, no living donation programmes
are open. So, again, there are different experiences and different
situations that vary widely. This situation of not being homogeneous
also applies if you see the situation of waiting lists: how waiting
lists are managed in different Member States; the sizes of waiting
lists in different Member States; the conditions to include patients
in the waiting lists in different Member States. That is also
interesting: if you look to public awareness and if you look to
the willingness to donate in the different Member States, that
also varies widely from one to the other, and if you look to some
indications like family refusals, the refusal of a family at the
moment of the donation, that varies from 15-20% in some Member
States to more than 40% in some Member States. If you combine
these two indicators and you analyse for one side the willingness
to donate of the population and the actual donation rates, you
can see that these two figures are not always correlated. That
means that in some Member States they have not enough success
in transferring the willingness to donate into actual donation
rates or, saying this in another way, some Member States have
more success than others in doing so.
Q10 Chairman: We are almost
halfway through our time and we have a long way to go. Your answers
are superb and we are certainly going to want to have everything
you have to give us, but I want to give some other members of
the Committee the opportunity.
Dr Fernandez-Zincke: Thank you, my Lord Chairman.
May I just mention one feature on quality and safety because there
was a second part to your question. I think we have made a survey
in 2003 on the situation of quality and safety systems in Europe
and I also want to add that, again, there is a wide variability.
There are some Member States who have all the systems in place
and there are some Member States who do not have.
Q11 Lord Wade of Chorlton:
To sum that up, you are saying that one of the objectives and
one of the things we ought to see happen is much more equalisation
of these services throughout Europe. The main method has to be
in the areas that are weak rather than the areas that are strong.
Dr Fernandez-Zincke: I think that you have expressed
it very well. I think we have to use the best practice and the
experience of some Member States in trying to help other national
systems in increasing their level of performance.
Q12 Lord Wade of Chorlton:
The other question is what views do you have on the need for the
EU to coordinate the policies relating to organ donation and transplantation
with the health policies designed to reduce the prevalence of
lifestyle-related diseases?
Dr Fernandez-Zincke: Absolutely, I think, this
is a key question. Health prevention and health promotion policies
have always been in the core, let us say, of the objectives of
the European Union and, also, in the core of the public health
problem of the European Commission. I think the Commission has
adopted recently what is called the Health Strategy, a strategy
that tries to be a comprehensive framework that brings together
many new policies to work towards health goals, and I think that
both the prevention and the promotion policies and the transplantation
policies are included in the Health Strategy. I do not think we
have to see this as a kind of competition between them but as
a kind of complementary approach to a number of diseases.
Lord Wade of Chorlton: Thank you very
much.
Chairman: Can we move on to Lady Young.
Q13 Baroness Young of Hornsey:
My question concerns ways for improving the supply of organs for
transplantation. Particularly with regard to the much higher organ
donation rate in Spain, than is in the UK, what do you think is
the relative importance for improving the supply of organs for
transplantation, between, let us say, improving organ donation
and transplantation services and, on the other hand, switching
possibly from a system of opting in, which is what we do here
to identify potential donors, to a system of opting out or this
idea of presumed consent?
Dr Fernandez-Zincke: Thank you, Lady Young for
your question. I can try to answer from my personal experience
and my opinion. I think the key elements of the success of Spain
in having the highest donation rate in the world is mainly because
of the organisational system and the model of organisation that
they do have. I think the Spanish model could be summarised in
six elements: (i) a transplant coordinating network with a key
person in all the hospitals who is in charge of the donation in
that hospital and who belongs to the staff of this hospital; (ii)
quality programmes which are evaluating continuously the performance
of donations in the different hospitals; (iii) a competent authority
of central office which is supporting all the system; (iv) a great
effort in training professionals how to detect a donor, how to
talk with the family, how to maintain the donor and how to follow
up all those procedures; (v) hospital reimbursement. It is very
important for the Spanish model to incentivise the hospital of
donation: if a hospital sees that donation is a burden more than
an incentive, then the donation rates will probably vary a lot.
I think we have to incentivise hospitals to, let us say, promote
organ donation; and (vi) a close attention to the media. I think
that during these two decades the system in Spain has constructed
a very important trust in the population. It has been built by
establishing permanent contact with the media and by improving
the media skills of professionals, mainly health professionals,
who are part of the system. There is an important debate—and
it is not only in the UK—about presumed consent and informed
consent. I have to say, after reading a number of papers, that
there is not a conclusive result of this, mainly because many
of the presumed consent systems, like the Spanish system, do not
apply the presumed consent law in a very restrictive way. In Spain,
all families are asked before performing the donation. It is a
presumed consent law which is applied in practice giving a lot
of importance to the opinion of the next of kin.
Q14 Baroness Young of Hornsey:
Are you saying that, because of the systems you have evolved in
Spain, there is much more confidence in the system and that is
the important factor rather than this strict adherence to a notion
of presumed consent?
Dr Fernandez-Zincke: I think that the presumed
content law in Spain gives, in a way, a guarantee to the professionals,
but I think that the main element of the success of Spain is the
organisational model.
Q15 Chairman: It is more structural
than cultural, if you like.
Dr Fernandez-Zincke: Yes. Absolutely.
Chairman: That is an interesting point.
Q16 Lord Trefgarne: Are you
Spanish?
Dr Fernandez-Zincke: Yes, I have to say that
I am Spanish.
Chairman: This structural/cultural issue
will come into Lord Kirkwood's point too, which is about cross-border
donations.
Q17 Lord Kirkwood of Kirkhope:
Thank you. Good morning. I have a very simple and apparently naïve
question to ask: what would be the principal two or three benefits
to widening the number of nations that are involved in a scheme
within Europe? At the moment there are six or seven, they are
functioning well, and you have given us some interesting statistics,
but what would be the two or three key things that would be different
if we made this Europe-wide?
Dr Fernandez-Zincke: Thank you for your question,
Lord Kirkwood. I think you are mentioning the example of Eurotransplant
as a kind of regional structure of cooperation. I think the example
of Eurotransplant shows that, once a common organisation and common
rules are in place, the number of organs has since increased and
contributes to maximise the opportunity for patients to obtain
the best possible organs.
Q18 Lord Kirkwood of Kirkhope:
Have you done any risk analysis of that. You are asserting that,
and I guess it is true, it would seem to be logical, but have
you done any modelling, any analysis or assessment?
Dr Fernandez-Zincke: I have to say that I personally
have not done any risk analysis on this and it probably should
be done. I think the Eurotransplant area has some studies on showing
these results.
Q19 Lord Kirkwood of Kirkhope:
If they exist, could we have access to them?
Dr Fernandez-Zincke: I will try my best.
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