Examination of Witnesses (Questions 299
- 319)
THURSDAY 28 FEBRUARY 2008
Dr Rafael Matesanz
Q299 Chairman: Good
morning, Dr Matesanz. We are very grateful indeed to you for coming
all this way. I need to apologise that the Committee, many of
whom were really looking forward to your visit and to meeting
with you, were actually unable to be here this morning because
we have a debate on women's issues in the House today and it runs
into this, and it is one of our major starred debates. But people
did ask me to say that they were very grateful to you for coming,
as a whole; so thank you very much indeed. I have to do the housekeeping;
it is very boring but I have to say a number of things to you,
apart from saying welcome and we hope you had a good journey.
We have to tell you that the session is open to the public but,
as you can see, we have masses of public! Do not be deterred by
that, however, because it will be recorded and can be used for
future broadcasting or webcasting. As you know, a verbatim transcript
is taken of the evidence. This is put on the public record in
printed form and on the Parliamentary website, so it will be there
on the website. A few days after the session the office will send
you a copy and we would like you to check that, if you would,
for accuracy, and to tell us if there are any corrections. We
do turn this around rather rapidly so I apologise for asking you
to do it as rapidly as you possibly can. If at the end you think
that we have not covered anything or if when you get away you
think that there are other things we should know, please let us
have any supplementary evidence. You are an extraordinarily important
witness to us and we want to know anything you think that we should
know, apart from the things that we have managed to gather. This
room, although it looks as if we have amplification, is not good.
If you could project your voice rather as I have. We also need
you to start, again for the record, to state your name and official
title, and then when you have done that I will go on to where
we are going to take the questions.
Dr Matesanz: Thank you, my Lord Chairman. My
name is Rafael Matesanz; I am a medical nephrologist; I am the
Director of the Spanish National Transplant Organisation, which
is the official agency in Spain in charge of donations and transplantations
of organs, tissues and cells.
Q300 Chairman: Thank you very
much indeed. You have seen the questions and you know that the
Committee might ask you others apart from those that you have
had in advance. If you wish to you could make an introductory
statement, but you may think that the introductory questions cover
quite a lot of the issues. But it is over to you; if you want
to begin by making a statement to the Committee?
Dr Matesanz: A short introduction, just to explain
that we started in Spain with what has been called the "Spanish
Model" in 1989. We started because the situation in the Spain
was not really satisfactory—the organ donation was 14 donors
per million population and there has been a decrease in organ
donation during the recent years, during the late 1980s because
of a medical strike. So we started this model, we created the
Spanish National Transplant Organisation, the ONT, and it started
with a model which in fact is a management system for organ donation.
We can discuss during the next few minutes how it is managed but
practically I can say that the ONT was the first agency in Europe
which was entirely dependent of the Ministry of Health—because
until then all of the organisations in Europe—I mean France-Transplant
or Eurotransplant—were non-governmental organisations—which
is a not for profit organisation, which was mainly in charge of
sharing organs. But what we did is to put the essential efforts
of the Spanish government in organ donation because we realised
that if we have no donors, if we have no organs there is nothing
to share. So we put all our efforts in this point and we established,
let us say, an official system with national coordination—I
mean the ONT—, a regional coordination, because you know
that at this moment Spain is a very decentralised country—,
and then the hospital coordinator, which is quite different from
the hospital coordinator from other European countries. So I can
say that the main figure of the system is the hospital coordinator,
which is a medical doctor that makes a big difference with what
is happening in Central Europe, the UK and in the USA and in many
other countries. We looked for, let us say, a clinical champion,
a medical doctor with clinical authority inside the hospital,
just to look for the potential donor and just to have an exchange
of ideas and an interface with people in the intensive care units
or with transplant teams or with many other actors that are involved
in organ donation and transplantation. These doctors are working
part-time and that also makes a big difference with other coordinators
who are working full-time; and we decided it this way because
we think that this job is very complicated and it is very difficult
to have the same person for many years approaching the families,
and after the family has lost the father, the mother or the children,
approaching the families is really a very disappointing job. So
we realised that after two, three or several years this professional
became "burned out" and you had to change this professional.
Otherwise what is happening in many countries can happen: that
the person who many years ago was the solution has become the
problem. So this is the main point of the Spanish Model—because
there are some other points that we can discuss later—this
is the cornerstone of the Spanish Model.
Q301 Chairman: That is very
helpful and you have described how a typical hospital might be.
If I can take you into evidence that we heard in our last session,
where we had a coordinator and a doctor talking to us about how
it worked. It was clear that not only the coordinator and the
champion were important, but the people who were prepared to identify
within their units were important, otherwise nothing happened.
How have you managed to make that work in Spain?
Dr Matesanz: Since the very beginning of this
system we dedicated a great effort to the training of medical
professionals and also of the nurses. You should realise that
we started only in 1991 and every year we train about 300 or 400
people in all aspects of organ donation—potential donor
identification, maintenance of the donor, how to approach the
family, how to distribute the organs.
Q302 Chairman: So this is
multi-disciplinary.
Dr Matesanz: Yes, really multi-disciplinary,
and we dedicated a great deal of effort and most of the budget
of the ONT is to medical training and to train nurses and all
kind of professionals. We started in the 1990s and at this moment
all our coordination network is formed by 200 doctors and 150
nurses. So you should realise that we have trained no less than
4,000 or 5,000 people. This means that we have a lot of people
who are really helping the whole process in the whole of the hospitals.
It is not just the coordinator; there are all the intensivists
who are working in the intensive care units, who are being trained
in the whole process. For instance, tomorrow I have a training
course in Madrid with 40 new doctors who will work in the intensive
care unit during the future, and we train every year more than
100 people—all the young doctors who will be the intensivists
in the future receive special training from the ONT about what
is brain dead and how to approach the family. What I mean is that
it is not just the coordinators but it is the coordinators and
practically the whole hospital because, as you said, organ donation,
transplantation, but specifically organ donation is a very new
disciplinary work. So we have a lot of people who are really helping
and collaborating with the project.
Q303 Lord Kirkwood of Kirkhope:
Can I ask you a very important question about that? Is anybody
trainable and are these numbers of people volunteers? Is everyone
required to undertake this kind of training or do you solicit
people who are really interested in doing the work?
Dr Matesanz: It is totally voluntary but, as
you know, at this moment in Spain we really have, after all this
work, the ONT as an institution with a great prestige in the medical
class, among the medical, among the nurses. So every year we get
the promotion of many courses, the specific courses; for instance,
every year we make three courses for young intensivists, three
general courses for coordinators in which courses we train new
coordinators but also coordinators, for example from Latin America
or from Italy or from any other countries, and specific courses
for brain dead, and we make the announcement to the whole network
of coordinators, to our people, and there are some people who
say, "I am interested; I am interested" But it is not
mandatory because we think that it is better to have the cooperation
of the whole people on the voluntary basis. What is important
from this scheme is that we can very easily change the coordinators.
When a coordinator becomes burned out after two, three, four years
or sometimes more, as we have a lot of people who have received
the basic training it is really very easy to change the coordinator,
because these people are working part-time as coordinators and
their basic job is intensive care doctors; more of them, about
80% are in intensive care—there are some nephrologists but
more of them are intensivists. So these people are working as
a coordinator for a period but then have the basic job of intensivist
and they can move into their other job without any problems, and
it makes a big difference what is happening in other countries
because if you have a person whose only job is to be a coordinator,
if you take them away from the job you really do not know what
to do with him or her.
Chairman: This also enhances their career
prospects generally.
Q304 Baroness Neuberger: It
is really interesting to hear you say that it is voluntary and
obviously then they can go back to being intensivists, or whatever.
Is the system in Spain the same as it is here—because I
think it is becoming EU-wide—that young doctors get a choice
of various options that they might choose to do as specialists—various
forms of specialist training. Is this one of the options and is
it something that you are not compelled to do it but it is very
much expected and it is, if you like, a fashionable thing to do?
Dr Matesanz: The decision for anybody to be
a coordinator belongs to the director of the hospital because
this is a functional network, which starts with the ONT, which
belongs to the Ministry of Health; then the regional coordinator,
which belongs to the regional health service, which has the full
function for health assistants; then the hospital. The decision
to nominate a person or another person belongs to the director
of the hospital that on many occasions asks the ONT if this profile
of this person is adequate or not. But they ask me or they ask
the ONT because they are convinced that I am going to give good
advice—not because they have to, because they are 100% autonomous.
So what is happening in many regions is that the regional coordinator
is discussing with the directors of the hospital who are the more
adequate persons because they are in contact with all the coordinators.
What is very important is that there is a functional link between
the hospital, the regional and the national coordination. For
instance, all the decisions about the transplant policy in Spain
are taken by the regional councils in which they meet a national
coordinator—that is myself—and the 17 regional coordinators.
So you realise that this makes a big difference with what is happening
with our country because in other countries you know that the
real power belongs to the surgeons or the clinicians, and in Spain
it is not like this. What we used to say is that the national
coordinator and regional coordinator should be some kind of interface
between the political or the administrative level, which sometimes
are more or less the same, and the professional level—the
real work, which are the hospitals. So the key for the system
is to have this interface.
Q305 Chairman: So this gives
you compliance and consistency across the system and the capacity
to share good practice right across; that is what that gives you.
Dr Matesanz: Sure.
Q306 Chairman: The model has
obviously been commended to us from every quarter. If you were
to improve it in any way in your system, what would you be looking
for?
Dr Matesanz: Three months ago in Madrid we celebrated
a general conference in which clinicians, surgeons and coordinators
were involved. The point is that we have at this moment 34, 35
donors per million but in fact in Spain there are 17 regions and
there are seven regions which have over 40 donors per million.
The highest during the last year was a very small region, which
is La Rioja. La Rioja is very characteristic because of the wines!
It is very curious, and very interesting the case of La Rioja;
there are some 300,000 people—so very small, and it has
no neurosurgery. For a hospital the key point for having or not
having donors is to have neurosurgery because in the hospital
with neurosurgery, cranial trauma or people with cerebral bleeding
and so on are concentrated, so the possibility to have brain dead
is much higher in a hospital with neurosurgery than a hospital
without neurosurgery. So in La Rioja there was not neurosurgery
and for years there was one donor per year, two donors per year,
which means three donors per million, seven donors per million
and nothing more for many years. The explanation was that there
is no neurosurgery so the possibility to have donors is very small.
But four years ago there was a change of coordinator. The person
who was the coordinator before was an urologist and he did practically
nothing at all. But there was a new coordinator who was a very
young intensivist, who was right there, and in the first year
four donors, seven donors and this year 23 donors—23 donors
means 72 donors per million, without neurosurgery. And we detected
five more donors in neurosurgical, which were transferred to the
neighbouring regions. So in La Rioja during the last year the
organ donor rate could reach 94 per million. So that means that
we have not reached the top—the epidemiology of brain death
is much greater than we thought before if we have enough ICU beds—and
that is very important because the key point is to have enough
beds in the intensive care unit with mechanical ventilation (otherwise
there is competition between the person who is very ill and the
potential donor). So what we are trying to do now is what we call
the "Plan 40". I mean, all the regions should reach
the 40 donors per million, and in doing this we are trying to
develop some new action; specifically we are convinced that we
are not detecting 100% of potential donors, and the example of
La Rioja is very, very clear. We are trying to develop more the
non-heart beating donor's programme, which in Spain means only
5% of the donors, which is very, very low. We have to develop
reaching more of the nation, and that is important; we have to
reach more fluently to immigrants who come from Northern Africa
and Asia because we have real problems—
Q307 Chairman: Yes, we want
to come on to all of that if we can.
Dr Matesanz: We have no problems with Europeans,
we have no problems with Latin Americans, but we have real problems
with people from Africa, but that is another point. Especially
we have to reduce the family refusal rate, which is very low at
15%, but we have to reduce it a little bit. The aim is, the project
is that the 17 regions should reach at least 40 donors per million.
It is not easy but in fact it is a process of benchmarking; we
try to identify the bench, the better practice in the specific
region and try to transfer to the other regions. It is very curious
because when we started with this process there was a very interesting
experience in Madrid, in Catalonia and even in the country of
Basque, but now the highest region, the high donation rate is
not in any of these regions. In fact the situation changes all
the time.
Q308 Baroness Morgan of Huyton:
You have touched on the edge of the question I wanted to ask,
but maybe you can give us a bit more detail. How do you handle
the differences between the possibility of donation from non-heart
beating donors and brain stem dead donors?
Dr Matesanz: That is an interesting question
because in Spain non-heart beating donation is concentrated in
three programmes—two in Madrid and one in Barcelona. But
non-heart beating donation does not mean the same as in the UK
because, as you know, there are four types of non-heart beating
donors according to the Maastricht classification. In Spain we
use types 1 and 2, while the UK, Holland and other European countries
use type 3.
Q309 Baroness Morgan of Huyton:
Could you explain that?
Dr Matesanz: That makes a real difference, but
there are different situations.
Q310 Chairman: Tell us that
again because I do not think we have quite caught the point.
Dr Matesanz: Types 1 and 2 from the Maastricht
classification means dead on arrival—a person who arrives
at the hospital and has a cardiac death and on the very rapid
action of the coordinator they do everything. Or unsuccessful
resuscitation; unsuccessful resuscitation means a cardiac arrest
in the street, so the emergency service tries to make resuscitation
and after one hour or so of trying resuscitation and there is
no possibility to recover there is a strict protocol for sending
this patient to a specific hospital where there is such a kind
of programme. Then we have a very short time to contact the family,
to contact the judge, which in Spain is necessary, and to do everything
and then if everything is positive we procure the kidneys, the
lungs—we have a specific programme for lungs—and on
some occasions also the liver. That is what is happening in Spain,
but Spain, as far as I know, is the only country in Europe with
such a programme because they are very, very complicated. They
are very complicated because you need a team for 24 hours with
a surgeon, a coordinator, a lot of people, on which you should
concentrate the efforts for the specific programme. In Madrid
we have one hospital in the north, which has about 45 to 50 donors
a year, which are really very much, and another in the south;
and in Barcelona there is one group of perhaps 20 or 30 per year
and nothing more. Because to have a programme like this you need
a big city with at least one million people. We are trying to
develop such a kind of programme in Valencia, Bilbao, Seville,
which are also big cities. But what you are doing in the UK and
what is done in Holland and also in the States is what is called
non-heart beating type 3. Type 3 means those patients who are
in a no hope situation; so they are very close to being declared
dead but they are not brain dead because there is still some function
in the brain stem, and in this situation you take out the mechanical
ventilation and you wait for some minutes for the person to be
declared dead and you can take out the organs. So that is a different
situation. In Spain this is not illegal but when we discuss to
do or not to do such a thing we prefer not to do because that
is complicated. For instance, if you look at the New York Times
about a week ago there was a very complicated case about one of
these non-heart beating donors in California and there has been
a big discussion about it. We can do it but it is complicated.
Chairman: We are absolutely fascinated
by this and I am going to come back to the other part of my question
because time is moving on. I am going to ask Lord Lea to come
in.
Q311 Lord Lea of Crondall:
I am hugely better educated by what you have said in the last
15 minutes and thank you very much for that. I am very glad to
see that you have the yellow batch of documents. I am coming on
to question five but can I associate that with Annex A, which
is our attempt to I hope accurately summarise what the two major
areas of EU proposals actually are—there are three actually,
as the third one is fighting organ trafficking. But if we take
the directive on quality and safety, that is one, and the framework;
and the second one is the action plan for strengthened cooperation.
Can you first of all just tell us, is that programme one that
you support; you think there are good things about it or bad things
about it, some things which are a waste of space because they
are bureaucratic? Could you comment and then perhaps answer the
question five as specifically as you find it useful to do so?
But looking at Annex A, more generally what do you think about
these proposals?
Dr Matesanz: Thank you very much for the question,
which is very interesting. When I was reading that question I
started to think about it because the question is very well done—to
what extent have you benefited from the activity at EU level in
the past around organ donation? I have to say that it is not specifically
the European Union which has supported organ donation in a more
effective way, but the Council of Europe. I have to say that there
has been an institution, the Transplant Committee of the Council
of Europe, which was started in 1988, so it is an old institution,
and I had the honour to be the President of this Committee for
seven years; and there was also someone from the UK who was President
also (Dr. Peter Doyle). Before the European Union was involved
in organ donation or in tissue and cell donation that was the
only official institution, let us say, who coordinated—it
was not a mandatory institution because the only thing that we
could do for years was just recommendation, but in fact all the
EU action had been based on the recommendations which were agreed
by all the countries at the Council of Europe level. I have to
say that in Spain we learn a lot from other countries in the Council
of Europe because we share very good experiences; we define what
to do and what not to do—and probably it is most important
not what to do than what to do in organ donation. So we learned
a lot in fact in the new situation when the European Union became
involved with organ donation, so our philosophy as being responsible
for the Spanish programme or organ donation has been that you
will learn a lot in the field of transplantation in the field
of donation from other countries and it is probably our duty at
that time to share our experiences, specifically with the new
emerging countries of the European Union. You ask me what are
the benefits for the UK from this directive and I would say that
probably not many, but I would say just the same for France, for
Germany, for the biggest western countries. But we should realise
that at the moment the Union is formed by 27 countries with many,
many differences. We have 34, 35 donors but there are some countries
with less than one donor per million. The situation in Greece
is that there are five or six per million, but Cyprus, Malta,
Romania or Bulgaria it is practically nothing. So I think that
what the European Union can support to the Union is probably some
specific recommendation. For instance, one which is very important
is that you should put in place in every country an official organ
donation and transplantation organisation. This is very important
because there are many countries which have nothing at all, and
at that time for any aspect in this field where you want to find
a solution, even for trafficking, even for ethical, for quality
or for possibility of the organs you need to contact country to
country; you cannot have a contact from hospital to hospital or
to call to the surgeon because "he is a very good friend
of mine" or something like this. So in my opinion in respect
of quality and safety it will not mean any significant change
for the UK, for Spain, for France, for Germany at all because
we have now very high standards.
Q312 Lord Lea of Crondall:
Could I just say that that body you are now talking about, you
would like it obligatory, mandatory to have a national body of
the type that you have described. Is that different from the body
that is referred to in Annex A in the first bullet point: "The
directive would establish a basic quality and safety framework,
including: the establishment of a national oversight authority
or authorities responsible for implementing the requirements of
the directive." Is that another body or is it the same body
that you are talking about?
Dr Matesanz: I think that is the same body because
you need an official authority—you can say official body,
official organisation or whatever—on every country that
should be responsible for these quality and safety requirements
for organ donation. The main reluctance from many people, from
many professionals for this directive is to have a very bureaucratic
and very closed practice which can be contrary to the useful practice,
but I do not think it is the case, at least as far as I know,
that we have been discussing in Brussels with the experts of other
countries. It is, let us say, a very light directive with very
basic requirements; in fact, I do not think it can be higher than
we are using now in western countries.
Q313 Chairman: Dr Matesanz,
can I just ask you, you have made an important distinction between
the Council of Europe and the EU—
Dr Matesanz: No, I am talking about the EU now.
Q314 Chairman: Yes, I know
but you earlier made that important distinction about the influence
and where the influence came in terms of the development. Could
you just tease out for us, so that we are clear, what it is in
each of those bits of the organisation that is pressing forward
the transplant issues?
Dr Matesanz: The Council of Europe Transplant
Committee was formed in 1988 when in fact there was nothing in
the European Union—the European Union became involved in
this field—
Q315 Chairman: So they responded
to the Transplant Committee.
Dr Matesanz: ... in transplantation. They became
involved in 2002 and the European Union started with tissue and
cells with the present directive on tissue and cells. So the Council
of Europe in fact was involved with not just the countries belonging
to the Union but all the European countries—even Russia,
Norway, Switzerland, and the countries which do not belong to
the European Union. So the Council of Europe has made a lot of
recommendations; they are not mandatory, the only mandatory document
was the Bioethics Committee of the Convention of Oviedo, and nothing
more. But with respect to transplantation it was just recommendations.
So, the Council of Europe has been replaced by the European Union
in this field with the exception of non EU countries. Of course
the action of the European Union should be mandatory with a directive
or something. So what we are discussing now is if it is really
necessary for the organs, such a kind of directive or not. What
the European Comission has said is we are trying to do an action
plan, which I think nobody is against because an action plan means
a kind of cooperation between the different countries in order
to improve organ donation. So we can discuss how this action plan
should be developed, but I have never heard anything against the
action plan. But the point is the directive, the directive of
quality and safety and there are two main positions. We did one
directive for tissue and cells and everybody agreed it was necessary
because of traceability, because of assurance of quality and safety
and because it is more or less the same in the United States with
FDA—no discussion about tissue and cells. But the point
is that it is really necessary that there is a directive for organs?.
So there are some points that I stressed before. I do not think
that such a kind of directive makes a big difference for western
stronger countries. I think what makes a real difference is with
what is happening with eastern, with emerging countries, with
countries where in fact there is practically nothing at the moment
in organ donation and transplantation; but the European citizen
can go from country to country in fact and they should receive
at least the same basic level of quality in this directive.
Chairman: I am going to come back to
Lord Lea to pursue organ sharing a little but I am going to ask
Lord Kirkwood if there are other issues on the quality question,
and as we have gone into it, Lord Kirkwood, would you like to
pursue this now?
Q316 Lord Kirkwood of Kirkhope:
It is interesting just listening to you. If it was left to you
would you have this EU directive? I think you have just explained
that it is necessary for the emerging nations and therefore you
are prepared to put up with it, but you are only in favour of
it if it has a light touch in terms of the bureaucratic input
for safety and quality. It is an EU core responsibility, they
feel that quality and safety is their real locus in this argument,
if you like. You seem to be saying that you accept that but that
it could go horribly wrong—I am putting words in your mouth
now so stop me if I am doing that—if it became too overwhelming
and too heavy handed. Is that your personal position?
Dr Matesanz: I fully agree with you. I am in
favour of the directive which makes a basic standard for quality
and safety; I am not in favour, for instance, of a pan-European
system of sharing organs—not at all, I do not think it is
necessary—or with very tight, mandatory statements about
what to do and not what to do. I am not in favour of that and
I think nobody is in favour of this. But probably the establishment
of some kind of international body which can not make a mandatory
law but some kind of coordination between the different countries
in this field I think would be very necessary.
Q317 Lord Kirkwood of Kirkhope:
And you could not do that just with voluntary cooperation and
best practice like the Council of Europe in earlier times?
Dr Matesanz: Yes, I think that has been a very
good way to work for years, but I do not think that at this moment
this is possible because the EU is becoming very big. I remember
the first meeting I went to at the Council of Europe was in Paris
in 1989 and we were six countries—UK, Germany, France, Spain,
Italy—Europe was very, very small; but at this time it is
not so small and we have real problems—real problems—with
the emerging countries where we do not really know what is happening
in many fields, and I am afraid that the field of transplantation
is one of these.
Chairman: Thank you very much, that is very
helpful. Lord Lea, do you want to pursue the question of organ
sharing between Members?
Q318 Lord Lea of Crondall:
If there is anything that have not had the chance to say, because
we keep interrupting you, in the area of questions five, six and
seven, now is your chance. As I understand it you are agreeing
substantially with the EU programme but—
Dr Matesanz: More or less; not all but I agree
with most of it.
Q319 Lord Lea of Crondall:
You are disagreeing with things that would go beyond it?
Dr Matesanz: Yes.
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