Agenda item 4 is consideration of the Human Tissue (Scotland) Bill at stage 1. Members are aware that the bill was referred to us before the summer recess and that the committee called for evidence on the bill during the recess. Copies of all the submissions that were received have been circulated. Today is our first opportunity to discuss the bill in detail.
I will be as brief as possible. The bill provides a new framework for transplantation and hospital post-mortem examinations and modernises the Anatomy Act 1984. It has its origins in the distress that was caused to families by revelations in the year 2000 about the way in which organs had been retained at post-mortem examination without the families' knowledge or permission. In response, the Executive set up the review group on the retention of organs, to investigate the problems in past practice and to suggest changes to the existing legislation—the Human Tissue Act 1961. As members have heard, Professor Sheila McLean chaired that group.
Thank you for the opportunity to speak briefly today. Will Scott has covered much of the ground but I would like to say a couple of things to reinforce what he said.
I am a transplant surgeon involved in liver, kidney and pancreas transplants and am also the chairman of the Scottish transplant group, which is a multi-disciplinary team looking after patients who require transplantation. The group also has lay transplant recipient and donor family representation. In 2002, we drew up an organ donation strategy for Scotland and have been interested in the bill as it has developed.
Part 5 of the bill proposes amendments to the Anatomy Act 1984. We are proposing those amendments because the Executive received representations about perceived shortcomings in the act. A difficulty with the 1984 act is that, although anatomical examinations are possible, surgical reconstruction is not, which means that students can dissect a corpse but cannot practice surgical procedures unless they fall within the scope of anatomical examination. In addition, in England and Wales the Department of Health has repealed the Anatomy Act 1984 and the Human Tissue Act 1961 and has replaced them with the Human Tissue Act 2004. Although the Anatomy Act 1984 will remain in place for Scotland, unless it is repealed by the Scottish Parliament, the action by the Department of Health will impact on the arrangements of Her Majesty's Inspector of Anatomy for Scotland.
Thank you. Before we open up the discussion to questions from committee members I ask the four witnesses what they think are the real issues of controversy in the bill.
As John Forsythe said, there have not been public concerns about transplantation but there are people who would like a complete change in the system on which transplantation is based. They would like it to be turned upside down and switched to a system of opting out, so that the assumption would be that unless someone had registered an objection to their organs or tissue being used after death, retrieval could take place. We have discussed that in the policy memorandum.
You think that that is the issue of most controversy.
I think so, in that part of the bill. In relation to the post-mortem provisions, the review group worked closely with all the key parties. The consultation suggests that there is a strong measure of support for what we are intending to do.
Professor McLean, from your perspective are there any areas in which we may find ourselves stumbling into controversy?
The only likely area is an historical one. Will Scott is right that we have worked with health care professionals and with most of the family groups, and they are all on board with this. In fact, practice has changed, very much in line with our broad recommendations. There may still be some historical concerns among certain individuals or groups, but the bill should be largely uncontroversial—if that is not a hostage to fortune.
I underline what Will Scott said about the transplant side and consent: opting in versus opting out, and authorisation. Those issues are debated across the world where transplantation has any impact. The bill also provides for preservation of the body or parts of the body for the purposes of transplantation. That is another advance, if you like, but that is the only other part that I would point to.
There are no real issues of controversy in the modernisation of the Anatomy Act 1984. There may be some concerns around the new licensing arrangements that are being introduced with respect to the public display of bodies. However, generally the response to the consultation that we carried out was supportive of the changes.
It is helpful to get a feel from the four of you about where you think the most likely areas of controversy lie.
The Human Tissue Act 2004 is a recent piece of Westminster legislation. Although the legislation here is slightly different, the Executive has made the point that it has actively sought to ensure consistency throughout the UK. I wonder why it is felt that we need different legislation here. Could you outline the reasons for that and say why our legislation will be different?
The parts of the bill that I have been dealing with address subjects that are devolved to the Scottish Parliament, so it was felt that it was appropriate to consider legislation in the Scottish Parliament. Part of the reason for that was that we had already been doing quite a lot of work to develop Scottish solutions to those problems, through the review group and through the important work that NHS Quality Improvement Scotland has done in developing standards for hospital post-mortem examinations. As you heard from John Forsythe, the Scottish transplant group was already examining those issues.
I understand the point that was made about the bill relying more on authorisation than on informed consent, which I think is in the 2004 act. Are you saying, in effect, that the Scottish bill will go further than the 2004 act?
No. I think that informed consent and authorisation are different terms for trying to ensure that people's wishes are expressed and, having been expressed, are respected.
There is another underpinning set of reasons why Scotland should legislate on its own. First, as Will Scott said, it is important that we separate transplantation and organ retention and removal, which the initial English report did not do. Secondly, the review group on retention and removal had a much bigger remit than its equivalent for Bristol and Alder Hey. We were also invited to consider adults, so it was likely that there would be a different set of solutions.
We now live in a world of what we might call surgery tourism. We are talking about trying to achieve some similarities for the whole of the UK, so that we do not have a situation in which things are terribly different in Scotland. Does that go for the European Union as well? Is there a broad general agreement in EU countries? There might be some minor differences about the issue, but are we moving towards a general agreement? That is probably about as far as I can take the question, because there is not much that we can do about surgery any further away from us, but I wondered about that wider scope. We are now in a world in which people are signing up for package tours that involve surgery.
I will have a go at answering that, but John Forsythe, who is not only chair of the Scottish transplant group but president of the British Transplantation Society, will be more able to talk about the European dimension. Certainly, there are arrangements within Europe for the exchange of organs and tissue in accordance with the general rules governing health matters in the EU. John Forsythe will say something more about the specifics of that in the context of transplantation.
The laws across Europe are quite different from country to country, with some countries requiring people to opt in and others requiring people to opt out, which can be either a so-called soft opt-out or a hard opt-out. There is quite a bit of variation, but there is some capacity for the movement of organs in particular. Organs that will not be used within the local area or nation can be moved around. That is not very common but it happens, with close co-operation. For patients who require a transplant, it was felt after discussion that it is fair for such patients to be able to move around by opting to be on a waiting list in another area, but they can be on only one waiting list at a time. That is probably a fair compromise in the circumstances.
The Human Tissue Authority, which was established by Westminster under the Human Tissue Act 2004, has been the subject of a couple of comments already. It was mentioned that the authority will have a role in Scotland in monitoring transplants involving live donors and that the small number of such transplants was one reason why it was not felt necessary to have a separate body for Scotland. In that case, which authority will monitor and oversee the other aspects of the bill for matters other than live donation? How is that envisaged?
Do you mean which authority will monitor those aspects in Scotland?
Yes.
For post-mortem examinations, oversight will be by NHS Quality Improvement Scotland. NHS QIS has already had a go at assessing performance against the standards that it developed; indeed, it published the results of that assessment—the publication is mentioned in a cross-reference in the briefing from the Scottish Parliament information centre—back in February of this year. That report provides a good overview of the current state of Scotland's post-mortem services, which reflect many of the changes that, as Sheila McLean said, have taken place as a result of the work of the review group that she chaired, and public concern about past practice. In the context of post-mortems, NHS QIS will have a monitoring responsibility.
Transplantation is heavily audited and is subject to data collection perhaps more than any other type of health care in which I have been involved. Allocation policies and so on are overseen. If I may hark back to my previous point, I would say that transplantation has not been seen to get things wrong or to have anything other than good practice in the past. The task is simply to facilitate the continuation of good practice rather than to stop some previous difficult or bad practice.
We understand that, should one be required at a later date, the bill provides for a suitable body to be established for monitoring purposes. Is that the case?
It is more the case that we are leaving our options open. The bill contains a power for the Scottish ministers to ask any other public body anywhere in the UK to take on any of the bill's functions, which is one of the reasons why section 1 includes a statement of the functions of the Scottish ministers.
Given that oversight now applies not only to unrelated transplants but across all living donor transplants, our slight concern is that there could be a swamping of the mechanism. It is important that the mechanism responds in a timely fashion; we need to keep an eye on that.
I understand that organ donation has been in rapid decline in recent years. The bill should arrest that decline and make transplants easier. I have my old and rather battered NHS organ donor register card with me—some of my colleagues might like it to be used sooner rather than later.
We made a deliberate decision not to include in the bill reference to the NHS organ donor register. We cannot be sure what will happen in 20 or 30 years—the register might have served its purpose and some other mechanism have been put in its place. We thought it best to establish the general principle without expressing it in terms of a specific mechanism. The decision was made for no other reason.
The major difference between the legal regime in the bill and the previous one is that a relative will not be able to veto a donor's wishes. One of the problems with the Human Tissue Act 1961 is that it appears—either from the face of the act or in practice—that relatives are allowed to veto. The review group's recommendations on the locality of the authority were taken into the transplantation arena as well, which means that, if someone has registered their wishes, the card that they carry will have more weight in the future than it ever did in the past. The obligation under the bill is to discover only whether the person has changed their mind; there is no obligation to ask spouses and distant relatives whether they agree.
Is it necessary to have section 8—"Existing written request: adult"—and section 6, "Authorisation: adult"? Surely, when the bill comes into effect, section 6 will cover people like me who carry a donor card and have registered their wishes. What is the need for section 8?
Section 8 makes it absolutely clear that people who carry a card or who have joined the register do not need to do anything more. When the act comes into operation, all those authorisations will be automatically sorted out—people will not need to go through the process again.
My question is for Professor McLean, who commented on the age of 12 for a competent minor and why that age was decided on, which many submissions discussed. Your submission says:
I am happy to do so. I do not know why the age of 12 was selected except that, historically, a girl reached the age of minority at 12—boys did so two years later. At that age, increased legal status was recognised; a child stopped being a pupil and became a minor. That might have permeated the drafters' consciousness.
The subject is difficult and everyone is trying to get it right. It seems to be right that a competent minor should be able to decide, for example, to give a portion of his or her body to help a sibling to survive or have a better quality of life. We would all be comfortable with that if a piece of skin was being transplanted, but we might be a little less comfortable if a kidney was being transplanted—a procedure to which significant morbidity and mortality rates are attached. We might be talking about a person who was only 13 or 14, which would mean that they would live with only one kidney for a long time. Would that be right for them? Beyond that, would it be right to remove a portion of liver from a live donor of that age, so that it could be given to someone else?
Surely that would come down to the individual child. The same concerns apply whether the child is 12, 13 or 14. Surely it is important to ensure that the system and procedures that are put in place prevent such coercion as much as possible. I hear what you say, but I am just not sure that the provision that the child should be aged 12 or more would stop coercion.
That is right. The difficulty is that people's views mature as the years go by, so there is always a worry that it is easier to coerce a younger person, even if one does not mean to, than it is to coerce an older person. That may be wrong, but we probably all feel that innately.
The problem is that a person who is 16 can do anything they like with their body, but can be coerced just as easily as someone who is 15 years and 11 months old or even someone who is 14. The real question is about what we think we mean when we talk about legal competence. If we are saying that a person is competent to make health care decisions, it seems to be inappropriate to second-guess them. If there was evidence of physical harm or it was likely that there would be physical harm in the long term, we would have a different set of reasons for questioning a young person's decision but, in the absence of such evidence, if we genuinely mean that we as a legal community regard certain young people as being legally competent, it is difficult to justify second-guessing their decisions.
I want to return to the issue of witnesses. One of the submissions spoke about avoiding having medical people as witnesses. I think that it stated that, in relation to children, the two people who would be required to act as witnesses must not be medical people. I assume that that means nurses or doctors. Would anyone like to comment on that?
As Sheila McLean has not been directly involved in drafting the bill, I should have a stab at dealing with that.
I want to return to the previous exchange about the age of 12. I am a little confused. Section 9 of the bill, which is entitled "Authorisation: child 12 years of age or over", and sections 10 and 11, which refer to that age, come under the heading,
Two different sets of provisions apply to children. The provisions on mature children who are aged from 12 to 16 relate to children who have died and for whom the question of donation arises. Those provisions are in section 9 of the bill, which relates to children who are 12 years or over. Section 15, which deals with transplants involving live donors, will make it an offence to remove
So, am I right in saying that transplants are not allowed for people under 16 and that the age is 16 and not 12?
The age is 16 for live transplants.
Yes. We erred on the side of caution for living children because of the risks and pressures that John Forsythe has talked about. Removal of regenerative tissue, such as bone marrow, is the sole exception—that should still be possible with safeguards.
So the age of 16 relates to live transplants.
Yes.
We are basically saying that people who are aged 12 and over can make a decision about what will happen if they die, but people must be 16 or over before they can make a decision about live transplants.
Yes—that is right.
That is clear enough. A slight air of confusion was rippling around the committee.
I want to return to the issue of ages, particularly with regard to post mortems. The independent review group gave a lot of consideration to disputes between parents. The bill proposes that only one parent would be allowed to give authorisation—both parents do not need to do so. There will potentially be contentions if a parent who is not looking after the child objects. How can we deal with such situations?
As you know, the review group's recommendation was that a post mortem should not go ahead if there was such a dispute. The bill has not taken that recommendation on board. Will Scott may be able to explain why. We certainly thought that there was scope for considerable contention if parents were in dispute.
Following the review group's work, we consulted on the matter because it raises all sorts of tricky issues. As you say, the bill makes it possible for one parent to give authorisation, but that does not preclude the other parent from agreeing to give authorisation, too. That will be reflected in the authorisation form.
If clinical opinion was that a post mortem was necessary, perhaps for diagnosis, but one parent objected while the other felt strongly that a post mortem should go ahead, how would that be dealt with?
We have tried very hard not to skew the legislation either way. You will have seen from one of the submissions that there are concerns even now that hospital staff may put parents under undue pressure to agree to post-mortem examinations. The review group's thinking, as embodied in the legislation, was that this had to be a process of discussion and agreement; there is no place for any kind of coercion.
I suppose that I ought to declare an interest as the mother of a transplant recipient, which was successful, I may say.
I am probably not the right person to answer that question. We had developed a carefully calibrated system of authorisation to take account of different circumstances, whether transplantation or post mortem, adult or child.
Some clarification comes from other sections in the bill; for example, there will be a list of who is entitled to authorise if the deceased has not made authorisation. The common law would cover people who had made their own declarations and the list of next of kin will explain who else is given the power of authorisation.
I have read through the submissions and it seems to me that there is some confusion and uncertainty.
You are absolutely right. It is important that from the words in the bill are drawn forms that are relatively easy to use in practice in the specific situation that you are talking about. UK Transplant is well organised and it is likely that the forms will be produced relatively quickly. Teams from England and Wales visit Scotland—rarely, but it happens. Likewise, my team from the Scottish liver transplant unit sometimes makes visits. It is, therefore, important that we are aware of legislation in other parts of the UK. That requires good forms and proper training.
Do you think that what is in the bill is sufficient to ensure that that will happen?
Yes. The text is fine, but we need to ensure that any codes that accompany it and any forms that follow from it are clear. Generally, it is felt that "authorisation" is the correct term to use in trying to establish the primacy of the deceased person's views.
I have one or two other questions on whether it is ethical for a person to give authorisation if the individual who has died has not left any indication of their wishes. Is it ethical for someone else to assume that authority?
The position that has been adopted in the bill is much more in accordance with ethics than was the previous position. The principal purpose of these provisions is to make inquiries into what the deceased would have wanted.
That would cover a friend of long standing and that sort of thing as well.
Yes. We specifically included either a spouse or a partner as the first person who would be approached in the expectation that they would know better than anyone else what the person would have wanted, as they would be more likely to have had a discussion with them about it. A friend of long standing is included at the bottom of the list in section 45; nonetheless, it is there.
Shona Robison has questions about part 3 of the bill.
Yes—my questions are about the procurator fiscal. It is probably pretty obvious why you have decided that there cannot be authorisation for a post mortem to go ahead, as the procurator fiscal has that responsibility in the event of sudden, unexplained or suspicious deaths. However, what happens to the organs and tissue after the fiscal has finished the post mortem seems to be an area of contention. Perhaps you could say something about that. For example, why has it been decided to include
The hierarchy of nearest relatives for part 3 includes a person who had a long-standing professional relationship with the deceased on the basis of the advice that we got from the Crown Office and Procurator Fiscal Service, which deals with these cases. In quite a large number of cases, the deaths that the service investigates are of people who had no known relatives and no friends. The provision is included to take account of that and to open up the possibility that somebody such as a social worker or general practitioner with whom the person had had a long-standing professional relationship could be approached to give authorisation. That was the thinking behind the provision, which was introduced subsequent to the review group's discussions—the thought emerged during the process of developing part 3.
As Shona Robison may know, I raised that issue in my submission, as well as an issue that goes hand in hand with it: the question whether local authorities should be allowed to give authorisation. The intention to maximise the potential of post-mortem examinations to provide quality education and research opportunities is good. However, I am slightly uncomfortable about the extent to which the drive in that direction might be at the expense of the requirement for intimate knowledge of what the person wanted, on which we founded our recommendations. A general practitioner may be well aware of what a person would have wanted in respect of post-mortem examinations. However, there is a balancing act between the individual's right to make certain disposals and the extent to which the requirement for a certain quality of information about their wishes is met. My concern is that those two agencies—the GP or the local authority—may not have the level of knowledge that I would want.
So in a case in which there are no known relatives, what would the alternative be?
The alternative would be that the organs or tissue that had been retained could not be used. That is the balance. Is it in the interests of society to proceed to use organs or tissue in those circumstances, or should we stick to one coherent ethical position?
Helen Eadie is interested in that issue, but that discussion probably answers her questions on it.
Yes, it does.
She also has a question about part 5, which will be for Joe Logan.
My question is about the definition of anatomical examination—I was worried in case I might not get my tongue round that. Will the proposed definition satisfy the expectation that a broadening of it will facilitate training opportunities in the procedures for all the relevant professionals, not just for surgeons?
Yes. We took into account the responses to the consultation exercise that asked us to consider that, for example, technicians are involved in retrieving organs from bodies for transplantation and that they should be allowed to practise the procedure. Our definition will widen the scope and will allow other professionals to use the facility for training.
Jean Turner has a question about verbal authorisations in relation to part 5.
The provision on verbal authorisation for the donation of one's body for anatomical examination seems to be different from the provision on authorisation for organ donation and hospital post mortems. A person will not be able to state verbally that they want their body to be used for the purposes of anatomical examination. However, at present, people can authorise the donation of their body in front of two witnesses. Will you explain the reason for that difference?
Again, in the response to the consultation, there was support for tightening that part of the 1984 act so that witnessed written authorisation is required. However, we will seek to standardise the authorisation forms. At present, the authorisation forms that the various anatomy schools use differ. We feel that the measure is justified, as there may be a desire to retain body parts, which could be used in the interests of education and information and could be put on public display. For example, that could be done to show healthy lungs and to demonstrate the effects on lungs of long-term smoking. It seemed appropriate to concentrate on written authorisation and clarity around that written authorisation in establishing what individuals were prepared to have their body used for after their death.
That exhausts our previously intimated questions, but do any committee members wish to pursue anything else arising from what they have heard?
I have a general point that goes right back to the start and the debate around the opt-in and opt-out possibilities. I would like to get more of a flavour of that debate. John Forsythe might be able to tell us what the balance is in the EU between countries that have an opt-in system and those that have an opt-out system of organ donation.
I am trying to do a quick calculation. I think that more countries in Europe have an opt-out policy, rather than an opt-in policy, although I cannot be absolutely certain. It is interesting that Spain is always cited as being the country with the best practice, with a donor per million rate of more than 30, in comparison with a rate of 13 for the UK. There is opt-out legislation in Spain.
Have there been any projections of what we can hope for by way of an increase in the level of donations, should the bill be passed?
It is difficult to know. There is no really good evidence to say that changing legislation in itself produces a major change in the level of donations. We hope that it will produce such a result and that the refusal rate among relatives, which a few years ago used to be about 30 per cent in the UK as a whole, but which is now about 46 per cent, might change. We can only guess why the refusal rate has risen but, following the events at Alder Hey children's hospital and Bristol royal infirmary, there has been a slight loss of trust between those who deliver care and those who receive care. It is important that what we put in place does not damage that trust any further.
There are systems known as required request systems. I think that there was some research carried out in Flanders, where one hospital adopted such a policy and another one did not. The rate of donation went up significantly where a soft required request system was in place, under which the clinicians in charge of the deceased person had an obligation to raise the question of transplantation with relatives. It seems from the research that I have seen that such a system can make a difference to the donation rate.
I might have missed something—Nanette Milne may have touched on this point—but I wish to refer to the General Medical Council's submission on live donation. The submission states:
Was that from the GMC or from the BMA?
That was from GMC Scotland.
This subject would have been covered by our earlier discussion about age limits.
Yes.
I was not sure whether the point that I have just highlighted came under that discussion.
That is indeed where some confusion arose, and I was hoping to get the opportunity to come back to this subject. We were discussing live donations by 12 to 16-year-olds because the bill does not permit such donations at all. However, consider the provisions on post-mortem examinations for 12 to 16-year-olds. I know that the BMA also feels that there should be some way of overseeing decisions in this area for those between the ages of 12 and 16. To have an outright ban not only precludes domino transplantations but rejects the notion of competence.
My reading of the BMA's submission was that it does not want living children to be involved at all in donation, other than when it comes to regenerative tissue.
I must have seen an earlier draft of that submission.
I am sure that we will be able to take evidence directly from the BMA. I thank all the witnesses for coming. I hope that you did not find the experience too painful. No doubt you will be watching the committee's progress on the bill with interest.
Meeting suspended.
On resuming—
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