Examination of Witnesses (Questions 760-775)|
FILKIN, CBE, MS
WINTERTON, MP AND
22 OCTOBER 2003
Q760 Baroness McIntosh of Hudnall:
Can I just pick up one issue? You talked about research being
in the best interests of a patient before it can be legitimate.
It was put to us by the witnesses that have already been referred
to that the definition of "best interests" could be
extended to include the wider interests of that patient, such
that, for instance, with research leading to treatment improvements
that would not benefit the patient directly but would benefit,
say, that patient's family, let us say, the discovery of genetic
defects that could be corrected, the use of "best interests"
in that context might be suitably extended to allow that kind
of research. I am choosing my words rather carefully because what
this seems to me to indicate is the extraordinary plasticity of
the notion of "best interests" which has come up a number
of times in the evidence we have heard. First, can you comment
on this question about research and it not being directly in the
interests of the individual patient and, secondly, does it give
rise in your mind to any thoughts about best interests and whether
or not it needs to be tied down as a concept rather more firmly
than it presently is within the draft Bill?
Ms Winterton: Let us take an example.
I am trying to think it through. If there was something which
meant, for example, that the person's carer would perhaps otherwise
not be able to care for them any more and they might die, and
there was research which on the one hand did not harm the person
but might in the overall sense allow them to maintain the lifestyle
where they were happy where they were being cared for, is that
the kind of area that you would define as in the person's best
interests? That might well be the case. If it was that the medical
research might allow the carer's children, say, to have a benefit
in the future for their own children, then you are getting further
away, I would have thought, from the person's best interests.
There is a whole series of ways that I would suspect it is quite
difficult to tie down to individual circumstances and would perhaps
be something that would be looked at in codes of practice as opposed
to trying to define something on the face of the Bill. Those are
the kinds of areas that you would start to take into account when
you were looking at trying to define best interests.
Q761 Baroness McIntosh of Hudnall:
The Scottish Bill does not talk about best interests. It talks
about actions which are directly beneficial or of benefit to the
person about whom the decision is being taken. In this particular
area of research, if the Bill stated that decisions had to be
directly of benefit to the person it would be pretty clear that
something that was not directly to their benefit would not be
acceptable. That is why I ask you whether this particular issue
does allow reflection on whether "best interests" is
sufficiently robust as a definition or whether it should be qualified
in some way, as has been suggested by other witnesses.
Ms Winterton: I suppose you could
interpret "direct benefit" in the same way too. I would
have thought that in the instance that I have given back you could
see that one situation was a direct benefit; the other was not
necessarily a direct benefit at all, and therefore I am not sure
that "best interests" does not cover it adequately.
As I say, if it is felt that there is a need for greater safeguards
we would certainly look at that and hear what the Committee had
Q762 Baroness Knight of Collingtree:
Is it not the case and ought not it always to be borne in mind
that the whole business of using incapable or possibly sub-standard
people to do research on is something which strikes a chill in
many a person's hearts? I think one of the difficulties here is
that to try and assess the words that you used, Ms Winterton,
"harm" and "best interests", is capable of
all sorts of different constructions. What might be the best interests
in the mind of a doctor with regard to a patient might well not
be that patient's idea of what are in his own best interests.
I think that the whole business of embarking upon using incapable
people to do research on is fraught with danger and I would suggest
that that is one of the reasons why this Bill has been criticised.
Ms Winterton: I would slightly
take issue with the use of the word "sub-standard" because
what we obviously have to do is make sure that in these circumstances
we are treating people with the dignity and respect that they
deserve as human beings. I think we need perhaps also to remember
that in some of these circumstances, as people do when they are
making a decision, for example, in drug trials, and certainly
if there was consent from the person who had lasting power of
attorney with knowledge that the person had perhaps previously
expressed a desire to be or had previously been involved in such
a situation, that might be an occasion where it was felt to be
appropriate. In all those circumstances one would have to look
very carefully at the expressions made by family members or somebody
with lasting power of attorney, but if that had been something
that had been stipulated previously or undertaken previously that
might be an area where it was considered to be acceptable.
Q763 Baroness Knight of Collingtree:
I am only suggesting that it is a slippery slope if we embark
upon the concept of doing research on people who are thought to
be incapable; that is all. I think that there are certain dangerous
corners in this legislation that we ought to try and avoid because
they will spark off trouble.
Ms Winterton: Could I also mention
that, for example, research into new medicines for the treatment
of, for example, Alzheimer's Disease, will have to comply from
May of next year with the EU Clinical Trials Directive. That says
that people who are incapable of giving legal consent to clinical
trials should be given special protection and there should be
some form of individual representation of the individual's interests.
That is obviously in addition to the requirements for a positive
opinion about the protocol of any such trial from an ethics committee.
I think if we put those things together we do have that kind of
protection there. As I said, we will, of course, listen to what
the Committee says about this area.
Q764 Mrs Humble: I was going to come
in after Baroness McIntosh's earlier comments but in fact they
also follow on from the debate that we have just had. In answer
to Baroness McIntosh you said that you were going to look at the
different elements of best interests and perhaps introduce something
in a code of practice to look specifically at areas of medical
research. When you are looking at these codes of practice will
you also then look at the possibility of giving different weight
to the elements in clause 4 of the Bill where "best interests"
is outlined, because it does list quite a few different things
and it lists the individual's past and present wishes and then
goes on to say that it would be practical to consult a variety
of other people. Which is likely to be more important, especially
in this very delicate area of medical research, if somebody is
incapable of making their own decision and perhaps has not expressed
any wishes prior to it, and then the only best interest test would
be the views of their carers, their family, and is that sufficient?
It is these two issues. In general terms is this list in a priority
order and, if it is, then tell us? Secondly, would you be looking
at according different priorities to these different elements
in codes of practice that you would issue?
Ms Winterton: Obviously, I have
already given some of the safeguards that will be there and particularly
in the wider sense with the EU directive. I also think that in
terms of looking at the whole issue of best interests it could
in a sense distort the priorities if there was a ranking order.
What we really need to be looking at is how we promote a partnership
approach to decision making that, to the extent that the individual
can be involved, should be and remains at the heart of the Bill
and that should be something that is paramount in so far as it
is possible. In addition, there will be the need to take into
account the views of, for example, whether it was relatives or
a person with lasting power of attorney. Again, that would be
something that we would look at, but I know that this is an area
where there is a high degree of sensitivity and I think that it
is absolutely right that we do give consideration to how we can
make sure that there are safeguards, and particularly when considering
the issue of best interests in that area. I think it is something
that we do need to look at very carefully in terms of the code
Q765 Baroness Fookes: I hope I am
right in thinking that a patient with capacity can take part in
research which may be of no direct or indirect benefit to that
patient but they are willing to participate because of the advantages
for the future. That is not possible if someone lacks capacity
because they cannot give consent, but it does mean, does it not,
shall we take Alzheimer's, for example, that it makes research
into that which affects thousands upon thousands of people that
much more difficult? Is there no way of finding a way round this
for those who do lack capacity? It clearly cannot be in their
best interests but is it not possible to introduce some arrangement
whereby, subject to very strict safeguards, such research might
Ms Winterton: That is exactly
what we are looking at. If we could go to an example, were there
to be a drug that had been proven not to be harmful but that there
was uncertainty as to whether it could improve the situation but
it was only possible to test that in the situation where somebody
had, for example, Alzheimer's, then that might be subject to all
the safeguards that I have laid out already. Would that be an
area that it could be said may be in the person's best interests
because we know that no harm is going to be done but that there
could be an improvement, so that might be an area where it was
felt to be in the patient's best interests but at the same time
I do think it is important that we look at what would happen as
a result of the EU directive where an individual's point of view
will be represented to make absolutely sure that there is going
t be no detriment to that person.
Q766 Lord Rix: Would not a simple
start be to drop the word "research"? That in itself
is indicative of things that we have heard from Baroness Knight,
thoughts of Hitler, experimentation, research, that conjure up
rather unpleasant memories? I would have thought that if you used
a different phrase like "new treatment" or "untried
treatment", at least you are talking about treatment. With
"research" people have horrible thoughts and I would
have thought it might be a good idea to change the word.
Ms Winterton: As I understand
it I am not sure the word "research" is actually used
in the Bill. In terms of talking about what flows from the Bill
in terms of the words that are used, we would not be able to distinguish
in terms of what we were doing with one group of people who are
perhaps incapacitated and use one word for them and another word
for other people, because that might be considered to be rather
Q767 Baroness Barker: There is one
wider point. This process is going on in parallel to the consultation
on civil partnerships. Would it be agreed that there would be
a read-across from any civil partnership legislation, if it were
to be passed, to this Bill?
Ms Winterton: In terms of the
Q768 Baroness Barker: No, in terms
of the decision-making and consultation.
Lord Filkin: I do not think we
Q769 Baroness Barker: Can I leave
that question with you?
Lord Filkin: I cannot immediately
think there is a read-across..
Ms Winterton: In terms of consultation,
are you talking about?
Q770 Baroness Barker: And things
like power of attorney and who is going to be consulted about
Baroness McIntosh of Hudnall: Whose family
Q771 Baroness Barker: Yes.
Ms Winterton: I think that is
probably something which is particularly applicable in the health
care setting where there are a lot of issues about who should
be consulted and, for example, if the Court of Protection was
making somebody a deputy or giving a lasting power of attorney,
if one had not previously been made, then I would imagine that
there would be quite strong emphasis, if there was civil partnership
legislation, on that being somebody who would be considered.
Lord Filkin: I think we should
reflect on it and see if there is anything further in regard to
that and provide it by a note.
Q772 Mrs Browning: I just want to
flag up my concern about this medical research. When one looks
at the medical research it goes from everything from experimentation
in its early stages through to experimentation which has been
advanced to the point where no human trials have yet been done.
We can all understand a situation where there was not a developed
drug or procedure that had yet been tested on human beings and
a last resort situation, and I am thinking of the recent CJD case,
for example, where the opportunity to submit somebody to that
is very clearly a last resort, and this general medical research
experimentation which I think should surely be something which
people with capacity should consent to. The idea that you would
need people without capacity to consent to this seems to me quite
Ms Winterton: As I have said,
I am sure that there will be those who say there are certain circumstances
where an improvement could only be seen if somebody actually had
the particular condition which is obviously what happens in certain
cancer trials and others. That is certainly something that happens.
What I am saying is that I understand that it is a very sensitive
area. I understand that with all the safeguards from the EU directive
there is still a very real need to make sure that it is monitored
extremely carefully. We are more than willing to hear views on
whether there are further safeguards that need to be built in,
at the same time balancing that with the points that are made
by people who feel that they have made a very strong contribution
in this area, that need to in some instances be able to work in
certain ways with people who are suffering from a particular condition.
It may be that you could overcome some of those problems in terms
of people expressing when they felt that it would be appropriate
for them. In some of the areas there will be fluctuating conditions
and what we must make sure that we do is take into account individual
people's wishes when they may have capacity in anything that they
may wish to participate in when they do not have capacity.
Q773 Mrs Browning: But that is part
of a different matter. When somebody is deemed to have capacity,
and bearing in mind that most conditions, including Alzheimer's,
are degenerative, it is not just something that happens overnight,
somebody who has capacity and who says, "If X happens to
me ...", in the same way as if you left your body to medical
research after you died and you take that decision while you have
capacity, that is a different matter. What really concerns me
is that someone who is deemed to have lost capacity is then presented
by some other party as being a suitable candidate for medical
Ms Winterton: Supposing you came
at it from the other direction when, as you say, somebody has
capacity and perhaps a clinician said, "Were you to lose
capacity and were we to feel that there may be something which
could be of benefit but we are not sure; we cannot guarantee that
it is; we might be able to guarantee that it will not do you any
harm but we need to see whether it could improve your position".
Supposing in that position somebody said that they would like
to give their consent for that, then that might be something that
would be considered. Against, just to emphasise this, the Bill
does not allow research to take place if it is not considered
to be in the patient's best interests.
Mrs Browning: I just think, Minister,
that if the person has capacity when they take a decision about
future benefit which may affect them, particularly if they have
a particular condition which is going to follow a pretty well
rehearsed pattern, that is a different matter. They are entirely
entitled to take that decision while they have capacity. What
would worry me is someone who loses capacity and then is considered
as a candidate for medical research under those terms. Those are
two quite separate things and I worry that this Bill would entrap
those sorts of people.
Baroness McIntosh of Hudnall: Minister,
could I say that Mrs Browning has raised a case which is of recent
date which does bear quite interestingly on this. I do not think
we have discussed it at all. This is the case of the patient who
was recently treated with a new drug intended to reverse the effects
of CJD. The situation there, as I understand it just from newspaper
reports, is precisely the one that is being described, that that
person has lost capacity to a very significant extent as a result
of the disease and was treated, presumably with the consent of
those who have responsibility for him. Perhaps you would like
to reflect on what impact, if any, that case and many others like
it might have on the way that research is dealt with. At the moment
research is not dealt with within the Bill at all but it has been
put to us that it should be and it is included in the Scottish
Q774 Mrs Browning: If I may just
say, that was a last resort type of intervention which could quite
clearly, if it worked, be seen to have benefited that particular
individual when all else looked as though it had failed. There
is a difference between that and in someone's interests which
might be of use in ten or 20 years' time to somebody else.
Ms Winterton: Obviously, what
we are seeing here are the very real fears that are around this
issue, which is exactly why it is not in the Bill, but of course
we will take back the views that you have put forward.
Chairman: I think we have reached the
point now where we should finish. I am extremely grateful, Lord
Filkin, Minister. You have been very patient with all the interruptions
and divisions. Although we have touched on "best interests",
general authority and resources throughout the whole of the session,
it would be helpful if you could write to us with specific answers
on the questions which have been given. They are number 7 on best
interests and number 8 on general authority, and at the end on
Baroness Barker: Could I ask, when you
respond to question 8 about general authority, would you say more
about your plans for appointeeships and particularly you might
like to include colleagues from the DWP in that respect.
Q775 Chairman: We are extremely grateful
to you both. We were given a very tight timetable by Parliament,
as you know. We intend to meet the timetable and we will be producing
the report by the end of November.
Lord Filkin: Could I thank you
for the expertise that you have brought to this. We will be pleased
to respond as fully as we can to those questions and any others
that, upon reflection, come to you in the next few days.