Joint Committee on the Draft Mental Incapacity Bill Minutes of Evidence


Examination of Witnesses (Questions 760-775)

THE LORD FILKIN, CBE, MS CLAIRE JOHNSTON, MS ROSIE WINTERTON, MP AND MR ADRIAN SIEFF

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 to say.

  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 of practice.

  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 be undertaken?

  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 unsound.

  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 medical side?

  Q768  Baroness Barker: No, in terms of the decision-making and consultation.

  Lord Filkin: I do not think we know.

  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 decision-making.

  Baroness McIntosh of Hudnall: Whose family perhaps?

  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 immoral.

  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 research.

  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 Bill.

  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 resources.

  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.





 
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