We move on to item 3, which is the Human Tissue (Scotland) Bill. This is our fourth opportunity to take oral evidence on the bill. We will hear evidence from two witness panels. The first comprises a range of organisations that have an interest in the bill. I ask that panel to take their seats at the committee table.
I represent the British Medical Association—the professional association for doctors in the United Kingdom, which represents more than 133,000 doctors from all specialties. I am deputy head of ethics at the BMA and I led its work on the Human Tissue Act 2004. I have also been heavily involved with BMA Scotland in work on the Human Tissue (Scotland) Bill.
I am sorry; Duncan McNeil coughed so I suspect that we missed a key word.
The committee decided to recommend to the BMA that mature minors who are competent to make such a decision for themselves should be able to be living donors. There should be adequate safeguards to ensure that, for example, there is not pressure on them. We will retain our opposition to incapacitated adults and young children who are not able to give consent being living donors. That recommendation must go to the board of professional activities for formal approval, which will not happen until next month, but it is the recommendation from the Medical Ethics Committee. I will let the Health Committee know when the decision has been made.
I am director of research and development at the Parkinson's Disease Society. The society broadly welcomes the bill and its provisions although we have a number of concerns, most of which are mentioned in our written evidence, so I will not go through them.
I am director of the Mental Welfare Commission for Scotland. Our role is to safeguard the rights and welfare of adults who have mental disorders, which gives us roles under the Adults with Incapacity (Scotland) Act 2000. I am here to address whether the provisions in the Human Tissue (Scotland) Bill are consistent with the 2000 act, and to advise on what the commission sees as being appropriate safeguards. I think that the committee knows that the matter of benefit for the adult is a key principle of the 2000 act. We have not been asked to make a written submission, but when we were told about the committee's consideration of the issue in response to the further consultation we felt that it was important to be here to listen to the arguments and to give appropriate advice.
I will kick off on adults with incapacity, so that we can establish the views of the panel members. I know that the Executive is undertaking a separate mini-consultation on that aspect of the bill, which it felt did not have sufficient coverage in the original consultation. Panel members might answer some of my questions simply with a yes or no, but others might need elaboration. Should incapable adults be excluded completely from making living organ or tissue donations? Should there be a blanket exclusion of people who are deemed incapable?
The question comes down to benefit. Section 1 of the 2000 act says that no intervention shall take place in the affairs, welfare, finances and so on of an adult with incapacity unless that intervention will benefit the adult. We must be careful about how much the elastic of benefit can be stretched, which I say having read the consultation document. We see that an argument might exist for people with incapacity to donate regenerative tissue, but only in exceptional cases. We do not envisage how it could in any way be appropriate for people with incapacity to donate whole organs that do not regenerate when those people are not in a position to appreciate the possible risks. We would be extremely anxious about any such provision.
To paraphrase, you say no, but donation of regenerative tissue might be okay occasionally.
That is possible. The question is whether it would benefit the adult involved—the donor, not the recipient.
That dealt with the second question that I intended to ask. Does either of the other two witnesses want to respond?
I support what was said. We take a similar view. In exceptional circumstances, bone marrow donation might be acceptable, but organ donation would not be. The reasons for that relate to the level of risk and the improvements in immunosuppressive drugs. Those improvements mean that a less strict match of kidneys is needed, so a cadaveric organ could be used, for example, or perhaps that of another living donor.
I will deal with that later. Does Dr Breen have views on the initial question?
Dementia is one factor that is associated particularly with late term and long-term Parkinson's disease. People with incapacity should be considered to be in a position to donate their brains to a brain bank. Such people should not be excluded totally from the bill. Each case should be taken on its merits.
The issue is the point at which people are incapable of making decisions. You think that, even in the circumstances of incapacity, a person should still be allowed to donate.
Such people should not be excluded from donating.
That would be hard to legislate for.
We may be talking about two different issues. Dr Breen is talking about post-mortem donation, but we are discussing live donation. We have no difficulty with excluding live donation, but post-mortem donation is another issue.
You think that even if somebody has incapacity in other terms, they are capable of making a decision about post-mortem donation.
The question that we were asked was about live donors; it was about the donation of tissue by people while they live and when they will continue to live. We were not discussing donation after people die. Have I misunderstood the question?
Does Dr Breen think that people should be able to make a live donation?
It depends on their state of capacity or incapacity. We feel that, with consultation of relatives and appropriate bodies, they should be considered to have the potential to give post-mortem donations.
I am not sure that we are much further forward with that. If somebody authorises the use of their body and subsequently suffers incapacity, which means that they are not then capable of making a decision about withdrawing the original authorisation, should the original wishes be respected or should it be considered that a decision has not been made? That is a slightly complicated example, but severe head injury can result in incapacity where there was none previously.
That question is different to that which we were asked before. You asked previously whether somebody who is living can go on living and donate tissue.
You are saying that they cannot.
They cannot, other than in exceptional circumstances. We are now talking about whether—
No. Even if we are talking about living donors, somebody might have signed up to the organ donor register and agreed that their organs can be used in the event of whatever happening—although that would of course apply if they were dead. There is an issue about the withdrawal of consent, which we are trying to work through.
I return to what we said earlier. I agree totally with the BMA that there might be a situation in which a person has made an advance statement that if somebody in their family would benefit from a kidney while they are still alive, they would donate it. That is an unusual and not readily foreseeable situation, but I would be happy to discuss it; I see merit in that. We are now talking about people who have said "After my death I wish organs of mine to be used for transplantation or research", but who before their death become incapable.
Yes. Such people will have the right to withdraw their consent, but if they have incapacity, their capacity to make a decision about withdrawal will be gone.
When it comes to the crunch, the decision has to be made on the basis of the person's wishes and any evidence that they might have changed their mind. If there is no such evidence, the previous wishes should be stuck to. Discussions are going on around the code of practice and part 5 of the Adults with Incapacity (Scotland) Act 2000 as to whether we should obey somebody's previous or present wishes. Where somebody has made a capable decision, unless there is clear evidence that they have made statements that would significantly alter it, it should stand.
Should nearest relatives have the same power to authorise donation for adults with incapacity as for others?
We have found that people with Parkinson's and Alzheimer's who have decided that they wish to donate their brains for research have made that decision in consultation with their nearest family or friends. When a person has decided that he or she wishes their brain to be donated to a brain bank, for example, it is done with the prior knowledge that they might suffer dementia at some stage or might become incapacitated. The fact that a person has made that wish known beforehand should be respected.
We agree with that.
I move on to authorisation. The BMA has stated that a definition of authorisation is required in the bill. Will you summarise your reasons for saying that? Do the other panel members agree with that?
The main reason is that authorisation is a new concept. We have traditionally talked about consent, even though we agree that authorisation is a more appropriate term. A definition would help to ensure that people understand why it is being used. The framework of legislation is one thing, but we need to get the definition used in practice. Anything that helps to achieve that will be useful.
We agree that the term "authorisation" should be used. However, it should be explained either to the person concerned or to their nearest relatives, following death, what exactly is meant by it.
I agree. The word "consent" suggests an on-going process between doctor and patient. Here we are dealing not with an on-going process, but with something that is decided in advance. The term "authorisation" is better.
In its written evidence, the BMA says that it is concerned
It is important that our members are clear about what authorisation they require. Sometimes authorisation needs to be in writing, sometimes it can be verbal, sometimes one witness is needed and sometimes two are needed. That is incredibly confusing. We are worried that our members may inadvertently breach the law. They may think that they need only one witness when they need two. One standard form of authorisation would solve such problems because the situation would be clearer and people would know what the requirements were.
Would you standardise authorisation at the higher level of two witnesses, rather than one?
Not necessarily. We need to consider the practicalities, because authorisation includes registration on the organ donor register, for which two witnesses are not required. In evidence to the committee, Will Scott said that although the requirements look confusing in the bill, they will be clearer when they are properly set out on consent forms. There is some truth in that. However, our main concern is that our members will be confused. We need to find a way of getting over that problem. The issue is not just the number of witnesses. Authorisation of the part 1 activities can be given verbally by an adult, but must be withdrawn in writing. We are not clear about why it must be made more difficult for someone to withdraw authorisation than to give it. Authorisation for children must be in writing, but it is not clear why there should be a higher threshold for mature minors than for adults.
There are inconsistencies.
Absolutely.
I agree with what has been said.
I have nothing to add to that.
That was commendably brief.
I will focus on the BMA's written evidence—specifically, on the issue of presumed consent. You make it quite clear that you are very much in favour of presumed consent, but the bill moves away entirely from the notion of consent—presumed or otherwise—towards authorisation, which we have just discussed. You say that one reason why you are keen on presumed consent is that survey after survey shows that up to 90 per cent of the British people are in favour of donation. Are you concerned about the other 10 per cent or more of people who do not want to donate? In previous evidence, we have heard that people have been very careful when asking families about donation, so that there is no dissonance. If the state takes someone's body and becomes responsible for it, leaving that person's parents, children or other family members with no say in what happens to it, will not that cause trauma, upset and difficulty? That will not help us to achieve the aim of the bill, which is to increase the amount of organ donation.
I think that that would cause "trauma, upset and difficulty", but it is not what we are proposing. We are proposing a system of presumed consent with safeguards. I will explain briefly how we envisage the system working. A shift to the presumed-consent system would need to be preceded by a great deal of high-profile publicity, which would have to make it clear to people exactly what that shift would mean. It should be made easy for people to sign up to opt out of organ donation—they should be given many opportunities to do so. The fact that people who did not want to donate would be able to record their wishes represents an improvement on the present system, under which there is no way for someone who opposes donation to record those wishes formally. The proposed system would enable such people to express their wishes more clearly and would provide them with assurance that their wishes would be respected.
Do you not see that that is not the case, because even if there was a system for people to register their objection to donation, many people would not do so because people do not do such things? It is a fact that many people who do not register would be quite willing to have their organs donated.
That is why we are not proposing a strict opt-out, such as the one that operates in Austria. In Austria, if someone has not signed up to the opt-out register, their organs will be available for donation. That is not what we are suggesting. We are talking about a system in which the relatives will still have a role to play.
We have responsibility for scrutinising the bill. If an amendment that sought to incorporate a system such as you propose was lodged, we would have to examine the issue. Basically, you are asking us to legislate for a situation in which the state would have control over people's bodies. Is that correct?
No. Our proposal is about the individual's wishes. There would be the opportunity to opt out of donation and the relatives would be talked to.
Let me put my question in a different way. You are saying that there would be an opportunity to register an objection. When there was a potential donor, the register would be checked automatically. If no objection was recorded in the register, consent would be presumed and the body could be used for transplant or organ donation. In other words, in practice the family would have no legal basis on which to object.
That is not correct. Under our proposal, the involvement of the relatives would be written into the legislation. That would be an important part of the presumed consent that we support.
Are you saying that the relatives would have a veto?
They would be able to say that the individual had an unregistered objection, so there would be additional scope not to proceed. The legislation would give authorisation to proceed; it would not require that donation be proceeded with. In any circumstance, if it was clear that to proceed would cause severe distress to the relatives—
Would the relatives have a veto?
No, but they could say that the individual had suggested that they did not wish to donate.
You are saying that, at the end of the day, even if the relatives did not want donation to go ahead, it could happen anyway.
That is what the current proposal is—the bill will not give relatives a right of veto. It says that the individual's wishes should take precedence.
That is correct, but what you are proposing is quite different to what is in the bill.
It is. Our proposal turns the situation round the other way. We are saying that we know that the majority of people—90 per cent—support donation, but that not everyone gets round to making those wishes known. Under our proposal, we would presume that consent had been given. Unless there was evidence that someone did not support donation, that would be a reasonable presumption because we know that 90 per cent of people are willing to donate. There would still be scope not to proceed with donation.
You just said that we should "presume consent". How can that be fair and equitable? You would be making a huge presumption. The bill focuses entirely on authorisation. In effect, what you are saying is, "We know best."
No, because we base the presumption on knowing that 90 per cent of the population want to donate.
But 10 per cent do not.
When you say that 90 per cent of people do not mind, what you mean is 90 per cent of people who were asked in a survey.
Repeated surveys.
Yes, but let us be clear about this. Those people have not signed the register.
That is right. There are three different groups of people: those who strongly want to donate their organs and who will go out of their way to ensure that their views are known; those who strongly do not want to donate their organs, who will also go out of their way to make their views known; and the majority of people, who are quite happy to donate but who never get round to doing anything about it or registering their wishes. For a person in the third group, the relatives have to make a best guess of what the person's wishes were. Often, relatives will go for the default position, which is not to donate.
My day job used to involve looking after people with advanced dementia, so I often dealt with the relatives of people who were dying. I want to make some comments on that basis, rather than on behalf of the Mental Welfare Commission.
The evidence from countries that have operated this type of system is that many relatives find it easier because they are not being asked to make a decision when they have recently been bereaved.
The Parkinson's Disease Society deals specifically with a tissue bank. We have found that education and information are key factors, and we can tell members of the society—from whom, of course, the message then spreads out—that people are very willing to donate their brains after death. I agree with what was said about 90 per cent of people being willing to donate, but I would still say that it should not be assumed that a person should donate unless they have said otherwise. Educating people properly beforehand would get over some of the difficulties that have been mentioned.
May I—
I really want to move on, because we are already—
I wanted to raise a point that was made in evidence by the British Heart Foundation, which is not represented here today. The BHF has put forward a different argument.
Well, there will be very different arguments.
The bill already contains presumed consent of a certain type. The British Heart Foundation's point is that any system should be based on trust and that going as far as the BMA suggests would undermine public trust. I wondered whether the BMA agrees with that.
We would not want to make changes without public support, but we believe that there is growing public support for what we propose. I admit that not everyone has been surveyed, but surveys over the past five years have shown increasing support. The most recent survey, in May this year, showed 60 per cent support—and that is before we have had a sustained debate and educational campaign. Public opinion is crucial and we believe that there is growing support for our proposal.
I think that we should move on.
I have a question on withdrawal of authorisation, which is an issue that we have discussed at the past two committee meetings. Although the subject seemed not to challenge some of the witnesses, it certainly challenged committee members.
I agree that there comes a point at which it is no longer practicable to withdraw authorisation, which would be in the type of circumstances that you described. I am not in a position to say whether the cut-off point should be at a particular stage. I would want to talk to transplant surgeons about how the procedures work and about the point at which the cut-off should be set.
No other member has a comment on that subject, so we move on to the issue of living donations.
My questions are on definitions, the first of which relates to the Parkinson's Disease Society submission and ties in with the British Medical Association's suggestion that it would be a better idea to have a separate authorisation for research and education. I also note the point that the BMA made on post mortems. I think that it would like the general public to be clearer about what a post-mortem examination is.
Obviously, it is difficult to define the brain as a tissue or an organ, as our knowledge of the brain, how it functions and what exactly can be done with it after death is evolving all the time. Our main concern was in relation to taking tissue for research, particularly for stem cell research, in which we are very interested. When people think of stem cells, they tend to think of embryonic stem cells, but an increasing amount of evidence suggests that one can take stem cells from the brain that could subsequently be used for transplantation. We think that the position in relation to research needs to be clarified.
You would like that to be made clearer on a form so that people could agree to it?
Yes.
That might also be what is in the mind of the BMA.
There are two parts to your question about having a separate authorisation for research. From our reading of the bill, it appears that the authorisation for a post-mortem examination will be an all-or-nothing authorisation that includes authorisation for use in education, training, audit and research. A good argument can be made for seeing education, audit and training as integral parts of the post-mortem procedure. That is explained to people when they give authorisation.
Could that be dealt with on the form that people will sign?
It could be. You would want to have a consistent approach across Scotland; you would not want different places to have different forms.
Should something about stem cells be written on the form, along with an explanation, because not everyone will know what they are?
I do not know whether one would use the term "stem cells" because, as you say, many people would not know what it means. If one said that research could include subsequent use of the tissue for regenerative purposes, for example, I would be happy with that. The form should define exactly what is meant by research rather than leaving it open to an individual's interpretation.
I want to ask about authorisation for live donation. I would like Veronica English to respond. I understand that the BMA agrees with the proposals in the bill but that the General Medical Council has a different view in relation to live donation for under-16s. Earlier, I think you said that the GMC is in favour of mature minors being able to consent to living donation if adequate safeguards are put in place. However, I do not think that there are safeguards adequate to stop a child feeling that they are under pressure, particularly if their donation would save the life of a sibling, and I definitely do not think that safeguards can be put in place to protect a child from the pressure that they would put themselves under if a sibling died because they had not agreed to a live donation. Would keeping the bill as it is rather than amending it be better in terms of safeguarding a mature minor?
A number of issues came up when the medical ethics committee discussed this issue last week. One is that setting the age at 16 would exclude someone who was 15 years and 11 months of age. People mature at various ages and the important aspect is maturity rather than chronological age.
I am not as concerned about coercion as I am about the repercussions for a mature minor who decides not to go ahead with a live donation. I am thinking about the kind of pressure that a mature minor might be put under if they decided not to donate a kidney and their sibling died. I feel that the state should protect mature minors against having to make such a decision. If the state made the decision for them, they would not have to deal with coercion or the repercussions.
That is a good point. However, we need to view those people as being sufficiently mature to make a decision, although the question of where to place the chronological age limit remains.
We have probably exhausted our questions. I thank the three witnesses for coming in. If anything occurs to you that you want to follow up, please contact the clerk directly and it will be included in our deliberations.
SORRO welcomes the opportunity to appear before the committee in support of the Human Tissue (Scotland) Bill. Our particular focus is the retention of organs at post-mortem stage. As I am sure members know, families have waited a long time for the bill and they have worked closely with the independent review group and the Scottish Executive to ensure that the initial questions that we posed to the then Minister for Health and Community Care, Susan Deacon, were answered to our satisfaction. Our concerns were that no other family should find that their baby's organs had been removed without their knowledge or consent and that a change in the law was essential. We will always support research and education as long as they are based on appropriate authorisation and in the expectation that the cause of our babies' deaths will be discovered.
You heard the exchange with the previous panel about adults with incapacity who, for whatever reason, are not capable of making the kind of informed decision that you or I would make. Have you been consulted on that aspect?
No.
Do you have any views on the position of adults with incapacity? I appreciate that your focus is children rather than adults.
I do not think so. Our expertise does not lend itself to that area.
That is fair enough. You mentioned concerns about your relationship with the Procurator Fiscal Service. How can its process in relation to post mortems be improved? Has the bill got it right?
The bill covers hospital post mortems; it does not really cover the Procurator Fiscal Service, which is where our big concern lies.
Could specific practices be done better than at present or are you aware that things are already changing for the better?
Things are changing for the better. We do not want to go back to what happened in the past; we are looking to the future. As you know, we have campaigned for five years to ensure that what happened never happens again, and I have faith that it will not. I hope that the Lord Advocate takes that on board and supports the bill.
Shona Robison has questions about authorisation.
You listened to the previous exchange about authorisation. Does SORRO have concerns about the various processes? Some require verbal and some written authorisation; some require two witnesses; some require one witness; and some processes are different for different ages. Will you comment on that?
Authorisation should require two witnesses. I do not care which way it goes, as long as the authorisation is written down and is witnessed by two witnesses, so that there is clarity throughout.
A couple of issues might be of particular interest to you. For example, should medical staff be allowed to be witnesses for hospital post-mortem authorisations? Do you have a view on that?
No. I do not think that it makes any difference. I assume that a medical person would take the authorisation. However, when we did peer-review visits with NHS Quality Improvement Scotland, we talked to pathologists and all the medical staff, who said that it would be helpful if they had bereavement officers in post. That would alleviate any problems, whether medical staff or the bereavement officers took the authorisation. Obviously, the big concern is money.
So you would not have particular concerns about medical staff giving out post-mortem authorisations.
No.
How should we deal with disputes between parents or with authorisation where there are no parents? Those are difficult issues.
The families that we have discussed that with feel that, to avoid any confusion, if there is a dispute, the post mortem should not go ahead. There may be disagreement in a split family. The situation is difficult. If the husband and wife are confused and disagree, the post mortem should not go ahead.
Should weight be given to the parent who has had most to do with the child's upbringing, rather than to the more distant parent?
How long is a piece of string? There could be disagreement for many reasons. One parent might say, "I don't like the way you're bringing up my child." A judgment cannot be made. To keep everybody right, if there is a disagreement, the post mortem should not go ahead.
How involved were you in the lead-up to the introduction of the bill? Did you find the process useful and helpful?
In what respect?
Were you consulted? You talked about visits and so on. Were your views taken into account in the lead-up to the bill?
Yes, they were. The McLean report was published two or three years ago. Since then, consultation has been on-going. We have had information from the Scottish Executive. We went to the publication of the post-mortem standards earlier this year. We were consulted all along and we responded in turn.
Short of hanging, drawing and quartering, which is probably your immediate idea of an appropriate penalty, are the penalty proposals in the bill satisfactory? Looking at them objectively, do you feel that they are appropriate?
Families initially said to Susan Deacon that the bill should include provision for penalties for anybody who retains organs from a post mortem without anybody knowing about it. I think that the bill's penalties are fair. However, I am sure that the issue will never arise, because there is no chance of pathologists getting into penalties. We whole-heartedly support pathologists, who have had a raw deal. We now understand where they are coming from.
Are there any further, brief questions?
Did the witnesses hear the discussion with the previous panel on a separate authorisation form for research? Would the witnesses like a form to make it clearer that they might be signing up for a separate request after a post mortem?
I have something to say on that. My baby Amanda Jane died a long time ago—42 years ago—and members will know that, at that time, we were not told anything at all about what was happening. I did not find out what had happened to my baby until five or six years ago, when I got her hospital papers and saw what they had done to her in the post mortem. I suppose I was naive, because she died of a heart condition and I thought that they would just examine her heart. That was the normal procedure that I would have expected. However, they took out her brain, liver, kidneys—you name it, they took it out. That really upset me when I read about it.
Obviously, it is important that we all know what we are talking about—definitions matter.
Yes. Doing research is different from doing a normal post mortem. I was shocked when I found out what they had done to her.
The new authorisation forms were supposed to be published last year, but they are still being made up. However, the sample form that we received and discussed had separate parts for authorising research and retention, and we were happy with that.
Thank you. You are free to go. You can sit in and listen to the rest of the meeting, but I am not sure that you would find it interesting, because we are moving on to budget matters. Thank you for taking the time to come in.
Thank you.
Previous
Subordinate Legislation