 Welcome to the 31st meeting of the Health and Sport Committee of 2018. We have apologies this morning from Alex Cole-Hamilton. Brian Whittle will be joining us in the course of the meeting. Can I ask everyone in the room to ensure that mobile phones are either off or on silent, and please ask that the proceedings should not be filmed or recorded as we do that ourselves? The first item on our agenda is the final evidence session on the Human Tissue Authorisation Scotland Bill, which proposes to introduce a system of deemed authorization. Our first panel will focus on evidence relating to law and medical ethics, and we will then take evidence from the Minister for Public Health, Sport and Well-being. Allow me to welcome to the committee Dr Emily Poston, early career fellow in bioethics and deputy director of the Mason Institute for Medicine, Life Sciences and the Law at the University of Edinburgh, Professor Alison Britton, convener of the Health and Medical Law Committee of the Law Society of Scotland, and Dr Colin McHillar, director of research at the Scottish Council on Human Bioethics. I thank you very much for coming this morning, and welcome. I will ask Emma Harper to begin her question. Thank you, convener. Good morning, panel. I just need to declare an interest as a former liver transplant nurse when I worked in Los Angeles, and I am still a nurse able to practice. I am interested in issues related to the rights of a person who is deceased. The committee has explored opinions about what the role of a family should have in the decision to donate a deceased person's organs, and much of the discussion that we have had is centred around who's wishes should have priority, should the wishes of the patient have priority or the wishes of the family. I am interested in your thoughts about whether deceased people have rights and who owns the body of a person who is deceased. Who would like to start? That is a big topic. Good morning, Emma. First of all, going back to the question of rights, taken from a sort of European and convention point of view, once a person has died, they probably do not have rights, but what they have expressed in life, whether it has been through the parameters of legislation or the system that we have just now with an opt-in system, the question probably is more around this issue of respect. If they register their wishes on some form of register to have all their organs donated or none whatsoever, they may not necessarily get that wish. That wish may not be possible to be respected. A couple of reasons, for example. Firstly, their organs may not be compatible for transplant. Even though they wished this, they requested it, they have written it down, they have expressed these wishes that they cannot be adhered to. Secondly, there may be other reasons. For example, the matter that you raised in relation to the weight of the preferences, the values and the views of the family there. In some ways, it is one of the many anomalies that if somebody refuses to give their permission for their organs to be taken, that is almost easier to deal with because it is clear and less questions arising than almost somebody saying that I do wish to have my organs donated. I think that I probably want to pass over at that point in terms of answering I guess from an ethical perspective to complement that. I would say that from an ethical perspective a deceased person doesn't have interest, but the person they were before they died certainly does have interests, and it is the respect for those interests that are essential concern alongside family interests, of course. Those interests extend, perhaps using the language of ownership is really commonplace. It is a language that we all fall into and use appropriately in many contexts, but it may be more helpful because ownership implies also thinking about property and remuneration and so forth, to think about self-determination. I would say that one of the key interests of the person before they are deceased is an interest in determining what happens to their body, which needn't be construed in ownership terms but is still a powerful interest. From a philosophical perspective, a deceased person no longer exists. A deceased person does not exist and therefore has no rights, but I agree with my colleagues that there is still an element of respect for the memory of the person, and that is why sometimes even statues of different famous persons in Edinburgh are protected to protect their memory. With respect to ownership, nobody really owns a body. People have responsibilities towards a body, but there is no ownership. In the past Soviet Union, before the Iron Curtain fell, the Government did own the bodies of deceased persons. It was usually in places like Moscow and other places that tramps who had died in the streets, from cold or whatever, who were used for transplantation because they were owned by the state and the state could do whatever they liked with those bodies. I will ask a little bit about realistic medicine and participatory care planning. If we know the wishes of people ahead of their death, it is easier to make decisions for opting in, opting out or organs but it is as well tissue. When I worked in Los Angeles, I was aware of a case where a family disagreed about o'r unrhyw, oedd niferion i gyflaeniaid iddynt. Gweithio'r cyffredinol yn fwy o'r anolfoedd middiao gyda y cwrwm. The parent overcrowded the decision that this man wanted to donate his brain for research. Felly, y bydd o'r byl a'r ddweud o'r ddweud o'r ddweud o'r ddweud o'r ddweud, yn ddylch yn cyffredinol ar gyfer y cyfaintfeydd, gan y gallwn gwneud, ac yn ddweud, yn gweithio'r ddweud, mae'r ffamil yn ei wneud. Emily Poston. Felly, rydyn ni'n ddweud ei cerddus i'r newid i'n gweithio'r ddweud. The only grounds in which they could challenge anything that was in an anticipatory care plan or on the register, either whether that was an opt-in or an opt-out or the deemed authorisation, is if they could bring pretty persuasive evidence that that decision was contrary to the most contemporary competent wishes of the person concerned. I suppose that everything hangs on what counts as the kind of evidence that a reasonable person would be persuaded by and whether the transplant coordination professionals will have the time to dedicate to understanding and investigating whether there are reasonable grounds, but that is my understanding that is the only time that a family's wish could ever alter the course from what the person themselves had wished. I think also, in addition to what has just been said, the realities of the situation do also have to be looked at. Again, taking a broader human rights perspective, very often the law has said in previous cases that the application of this is not theoretical or illusory sitting perhaps round this table and in buildings such as this writing legislation, it's much more at the cold face. I suppose that that brings us to one of the biggest anomalies of the current position just now, that whilst there is nothing in the current provision that we have in Scotland to say that the relatives wishes are taken cognise and so on, they are on a routine basis. That is more the reality and the effectiveness of how we behave. What we are moving to is a situation in theory and perhaps illusory. We are no longer going to take any cognisance of those wishes, but even among that there are some riders on that. For example, if it is a more unusual donation that is being made, for example reproductive organs or limbs, is that going to be passed without any comment there? Secondly, if the family member comes forward with evidence to say that this is not actually the wishes of the deceased, how do we evaluate that? What is going to be the consistent approach? Again, the idea in law has to be clarity. It is one thing to say that relatives no longer have any say, but we are going to apply that all the time. How are we going to apply it? It is not only having legislation, it is the quality of that legislation and how it is interpreted as well. We have also heard on 13 November Professor Turner saying that the clinicians will always ask the family. No matter what the law says, the clinicians will always ask the family and if the family refuse to co-operate, they cannot go ahead because of medical safety reasons for the recipient of the organ. When a person has not registered their wishes on a register, at the moment sometimes they would have talked to their relatives and said, I want this. Normally, the relatives should respect these wishes. If I had some relatives who overrode my own wishes, I would be quite upset. However, about 30 per cent of people have never told anyone, they have never registered their wishes, they have never told anyone what they wanted. We see in the SPICE report from the Scottish Parliament that about 65 per cent of these people who have told no one their last wishes, 65 per cent are opposed to the organ removal for transplantation. At the moment, the needless relatives will have no legal right to oppose the removal of organs in these cases where nobody knows their wishes. That is a form of hard opt out system. This is something that I think not many people have realised in reading these documents that we are also legalising a form of hard opt out when nobody knows the wishes of the person who has died. That creates quite a lot of concerns for me, because so far in our discussion in Scotland we have been told that it is soft opt out, it is a soft opt out, it is a soft opt out, but in certain cases it is also a hard opt out. That should be made clear to the Scottish public, the media and everybody else. David Stewart Thank you, convener. I can also point particularly to Professor Britten. I was vouched in your evidence for you looked at the convention of human rights. You quoted one case, Elbert v Latvian 2015, very briefly, because my colleagues, I am sure, were very familiar with that case, but Mrs Elbert's husband died in a car accident. There was nothing in the passport to indicate that he was donating his organs. She only found out later that organs and tissue were donated, and she took a case under article 8 and was successful. Even though we passed this legislation, we still have to look at the wider issues of the European convention of human rights. It seems to me that there are at least two recent test cases that would argue that, where there are no rights expressed by the deceased, that the living relatives still have some cases that they could make. Is this case consistent with the legislation that we are hearing today? One of the differences in the legislation provided in Latvia was that there was an expectation that relatives or next of kin were consulted. As you described, they looked at the passport and could find no indication that the family member objected, but they did not take active steps to check that was indeed the case. It was almost a passive exception, if that makes sense. Once it was two years later that the gentleman's wife found out about this because the organisation that took their organs was being investigated under criminal procedures. Her objection was the fact that they had not made positive steps to find out what she would have wanted at that time. Any interpretation on that law needs three things. The whole idea here is that there is a public agency, for example, the NHS, which is potentially invading an individual's private right captured under article 8. She also successfully won under article 3, as well, in humane treatment. To be able, as a public authority, to invade those rights, the law has to have three things. It has to be proportionate, it has to be legitimate and it has to be in accordance with the law. In the case that you describe, it is that last element there. Was it in accordance with the law? On the one hand, although she did not make an obvious objection, the court said nor did anybody actively find out what she did want, and that is what she won on. She did not win on the fact that she was an ex-Defkin. She won on the fact that, within the legal provision, she had not been consulted at that time, so it was a personal right to her. Before I pass on, we also have to be very careful that anything and law is always about terminology and the rights of the family and the role of the family. Hopefully, if the legislation goes forward, it needs to be very clear, because there are quite different things. In the Council of Europe, which is a lot bigger than the European Union, there is an additional protocol on transplantation. In paragraph 102 of the explanatory report, it says that it says that express wishes of the potential donor which are paramount. I was given evidence to the health committee in 2005 on this very topic again on transplantation, and I was trying to explain that there may be areas where it would be possible to bring a case to the European Court of Human Rights, because people hadn't been asked about what would happen to their organs. A response from one of the MSPs said that they can't do that because they're dead and they don't exist. In the spirit of the law, it's not just because they can't bring a case to the European Court of Human Rights that what happened is okay. It can still be wrong from an ethical perspective, even though they would never be able to bring a case to the European Court of Human Rights, because they died. For me, that stronger ethics is, in a way, more important than just the possibility or not the possibility to bring things to court. Thank you very much. Keith Brown. Thank the panel for coming along this morning. I'm just interested in the point that Dr McKellar made about the Soviet Union being ownership of dead bodies. He also had ownership of children, I think, was under the Soviet law when it first came in. I'm really interested in a particular case where somebody has expressed a definitive preference, either to opt in or to opt out, where that's then overturned. I'm just interested in some of the evidence that's been led, so it mentions, I think, some of Dr Britton's evidence. We are placing the rights of the relative far above the integrity of the deceased and the need of a possible recipient. The last autonomous wish of the donor is potentially being thwarted simply because he or she is in no position to object. Suppose my point is that is it not the case that the potential donor, in full possession of their faculties and taking a conscious decision to say, I want to opt in or I want to opt out? I suppose that I'm trying to get an idea of where, if that's reduced to a wish that should be respected rather than a right, is whose rights then come in? The point that Dr Britton made was that if it's going to be the family that has the arbiters on this, surely that should be written into the law. But is that the view that it is the rights of the family or, as it seems at present, the rights of clinicians to say that they feel a bit uncomfortable about the donor's wishes and they'll go along with the discomfort felt by the family even if that changes? I'm just trying to get an idea of the hierarchy of rights that apply here, I suppose. Who would like to start? Collin McEller. There was a case in Singapore in 2007 where they had an opt-out system. So we don't really know whether, I can't remember if it was hard opt-out or soft opt-out, I think it was a hard opt-out in Singapore. They were taking away the body of a young man and the family were pleading with the clinicians not to take away this body. They wanted to be with this person a few more hours. Actually the mother was crying on her knees asking the clinicians not to take the body out. Eventually nine police officers had to come and it was a scandal in Singapore and eventually the family was compensated by five years of reduced healthcare costs. There is no NHS in Singapore. So it is a difficult one. But personally I would feel that if the views are clear either opt-in and opt-out, those should be respected by the family. It's a bit like a will. Some of us have a will and that is respected in law. The problem arises for me is when nobody knows what the wishes were and I believe that the family should certainly have the possibility of having the last word in those cases when nobody knows the wishes. Alison Brook. Once again you're almost going back to terminologies because we talk a lot about deemed authorisation or presumed consent. Particularly consent is a very special meaning in law and increasingly as the years go on it implies an understanding, an opportunity to weigh up the pros and cons of any decision being made and recent case law post 2000. It's very personal to the individual so consent for me might be quite different for you and indeed for others. I don't believe that it's possible for the families to be able to replicate that and what you're then looking at is perhaps to give a permission, which is very different from a consent because they may not be in a position to understand fully the values, the things that actually made the individual make the decision that they actually did. You're not really asking the family in some ways to replicate the views of the individual, you're asking them to make a decision on whether they're willing to give permission if that person's values and wishes and consents are not known. Emily Poston I think that there's an important point to notice that if genuinely no one knows the wishes of the deceased person that then saying that the wishes of the family would then somehow be better access to that, that that should be somehow the preferred option, is sort of misleading because it's in genuine equipoise whatever the family decides could be contrary to the genuinely unknown wishes of the deceased person. So exactly as Professor Britton says, we would then be moving to a whole different paradigm which is about looking at the interests of the family and respecting their distress or their wishes to give a gift or whatever it is in terms of permission, but then moving away from the language of consent entirely. I'd like to add my voice as well to the excellent point that Professor Britton raised, if despite what is written in the legislation it is hard for healthcare professionals to move away from a paradigm where people have acquiesce to the wishes of the family more often than respecting the wishes of the deceased person, if it's going to be hard to make that change then that's a real problem for the success of this law because it will be saying one thing and something else will be happening and that will serve to undermine precisely what Professor Britton has just spoken about in the importance of anything that's like consent or authorisation which is full information and full understanding of the undertaking that you are signing up for when you're opting in or opting out. So if the law cannot function in the way it's written because the culture is due to change that strikes me as a real problem. There is no formal role for the family in the current legislation but there was before 2006, so if you were to formalise permission or some other formal legal role for the family would that reverse the change made 12 years ago? At the moment it's the family that authorises what happens in the case, so they always have the final say at the moment. They authorise what happens whether the organs are used or whether the organs are not used. In the legal sense, yes, it is an authorisation at the moment. The family always has the last say and so even at the moment and to come back to what was said just before, even though somebody has registered their wish to donate organs on the register, members of the family can still veto that at the moment because it's them that do the authorisation. It's an authorisation again, it's not consent. We don't use the concept of presumed consent or deemed consent in medical ethics. We use the system of opt-out and opt-in. Deemed consent is a sort of contradiction in terms in bioethics. To consent, and this is what Professor Britton was saying, it is a native decision that you make. It is a decision that you make for yourself. You cannot consent really on behalf of somebody else, especially if you don't know what their wishes were. I would qualify that in terms of my understanding of the role of the family in the current position that the anomaly to me is that there is no legal provision for the role of the family as the law currently stands, but there is a general recognition that the specialist nurses will enter into dialogue with the family to gain their views at that time and they will not go against the views of the family at that time. It's more custom in practice rather than provided for in any statute. Providing a statutory basis for that would reverse to the position pre-2006 would not be your understanding. If it were done efficiently, it would, but I still would go back to what I said earlier that this role cannot be arbitrary. If you have, for example, an exception on the nature of a particular organ to be removed and the family members have a role, that might lead to, if that is one circumstance, are there others? That might lead to a presumption that it is indeed arbitrary. The idea of consistency and clarity within the provisions of the law, and if that clarity isn't there—I'll just revert back to the current position just now because it's easier to give the example—but hypothetically, if that clarity within the law isn't there, then very often the courts may look to what's custom in practice because you're back on this idea of effectiveness, the reality of the situation, not some ideology, the practicalities of what happens. Without a doubt, the practicality in custom and practice of what happens at the moment is the wishes and values of the family's take predominance. The last point that concerns me, and I suppose I'm really just concerned on the narrower point where somebody has expressed their wishes and they've been specific about either opting in or opting out. I realise that, practically, it might not be possible to fulfil that wish, and I realise, of course, in the situation where no wish is expressed in all sorts of other considerations or plans. It's not those points that I'm trying to make. I'm trying to just—I think the need for clarity in the law about whose rights are being followed is quite important. I have the feeling that the donor is really going to be—it's essentially a charade. It doesn't really matter if they consent—if they say that they want to opt in or opt out because something else supersedes it subsequently. If that is the case—and I have issues with that—then surely we should be explicit about that. We should say that you don't have—I'm not sure I get the idea that authorisation doesn't clash with consent. I think that the two things I think are very much sitting in conflict, but surely we should be clear about the fact that you might think—and it's important as well for the take-up, the real-life situation of people taking this up—that they're not going to be giving consent if they think that it means nothing in any event because it can be overturned by somebody else. That's why it's really important to be clear on whose rights, whose wishes are being followed—again, that introduces a confusion. It's just that point of clarity. If it's the case that some people think that the wishes of the family should take precedence, I think that there are four countries identified with that. It's not the case where it's simply what the donor wants. It's possible to do that. There's also the point that some of the donor's families don't want to be involved in this decision at all and they agonise with it. Is it not possible to have a straightforward situation where the donor, where they express their wish, and only in that situation, either to opt in or opt out, that is what's respected? They made that decision as adults and in full possession of their faculties. They made that decision, so shouldn't that just be followed? Emily Poston. My understanding of that is how the law is drafted at the moment. The concern is if there is a culture where there are expectations or it just doesn't happen in practice because that's not how it's been done. For the bill to work as it's written, that culture change needs to be supported in the healthcare setting. It needs to be supported in changing of social norms and public awareness and publicity of the significant change that the bill has drafted. The wishes of the deceased person cannot be overturned by the wishes of their family, only by what their family can bring to bear in terms of evidence that their wishes have changed. That comes back to the question of what guidance will be given to the transplant coordination team in terms of what counts as good evidence of a changed wish. We said in our written evidence that, to some extent, that is going to be opaque because we can't look into people's souls and tell if they're being absolutely straightforward. Maybe there's a consideration about whether guidance could have indicative forms of evidential support and so forth, so that people weren't at least working in the dark about working out what counts as my relative's wishes change. I know they did, I can show you, and here is me trying to enact my own wishes by sleight of hand. As drafted, it would work as you suggest, but there are so many ways that it could not go that way. I agree with you. From an ethical perspective, to go against the last wishes of a person is wrong. From a practical perspective, we already heard from Professor Turner, they would never go against the wishes of the nearest relatives. At the moment, I was just checking the Human Tissue Scotland Act 2006, it is the nearest relatives who always have the last word through authorising or not authorising what happens to the organs of the deceased either for transplantation, they can also legally authorise for the use of these organs for research, for education and many other purposes. Sometimes this happens even though, again, the person hasn't said nothing, they can still authorise all these things happening. I don't know how to get around it because if you write down in law that the wishes of the deceased should always have a priority, it would create incredibly distressing situations in very rare cases. I don't think that the medical professionals will be prepared to there are ones who are going to have to deal with it all, and that is the problem on the ground, that is. As Dr Paustan said rightly, the legislation alone is not going to be enough, the idea of a cultural change in people's attitudes needs to accompany this. There has been quite a lot of studies done across the piece about legislation standing alone, and very few jurisdictions agree that that is sufficient. There has to be buy-in, there has to be an understanding, there has to be an education, and what you are doing is fundamentally changing an active process of opting in to an arguably more passive process if somebody does nothing of opting out there. To be able to get the support that that is going to be has to involve, the support of families has to be brought about by education understanding that we are putting forward a fundamental change in culture and approach here. Thank you convener, and good morning to the panel. I wanted to pursue a bit more a point which Professor Britton made around rights and role of family members. I think that that is important for what we are trying to look at, because when you look at the law as it stands in terms of convention and practice, it is very different. We know from the most recent data that around 10 per cent of potential donors who had recorded their wishes on the organ donor register had that overturned by family members. In terms of a potential bill, do you think that it would be beneficial to reflect convention and practice on the face of that bill to try to make sure that those who are tasked with working with families to achieve donation feel that they are protected as well and are not potentially exposed to any legal or regulatory challenges? I think that I would like to focus particularly on the latter part, because looking at the Alberta case and the idea of rights and roles, I think that you raised a very important point, but none of that will work unless there is clear guidance to those who are providing the information and support for family at that time. The specialist nurses that we have already do the most challenging job and the most sensitive of circumstances, and that is in the absence of what is being proposed. Then they are going to have to do the same job, but also with the knowledge that there is now a legislative provision to try and acquiesce to the wishes of the deceased. That brings with it much more challenge for them, a more difficult role, and their training and, again, the background and understanding is going to have to be much more acute than it has been previously. In all the past discussion, and I was reading the discussions in this committee in the last few weeks, there has always been a presumption that they are family members, or at least friends of long standing. However, we unfortunately live in a society where some people, more and more people, unfortunately, do not even have a friend of long standing. I have got a very good friend who is the Church of Scotland minister down in North Leith, and sometimes she's got to ask the congregation for some people to at least come to the funeral of this person, because the only person that would otherwise be there is the minister and the undertaker. We've got to also think about these cases where people don't have family, people don't have friends of long standing, they may have a few friends who come to their funeral, but they're not really close friends, nobody knows their wishes, and that's got to be taken into account as well, and I don't feel that it has been taken into account in some of the legislation and also in the discussions. Interesting aspects of this, and we've met with many families who have gone through the process and have always highlighted how good the nurses have been who have dealt with them, but what's been important is that often there's failures towards the end of that, even though they know that the family member has signed up to their wishes that the whole body, whatever is needed, could be used for transplantation and donation. Things like the eyes is what they said they decided themselves to veto, and it was whether or not we could create a situation where the wishes, as Keith Brown's outline, of the individual who are made at some point are absolutely paramount to that and not that you end up people then deciding themselves in the case of eyes, even though they're happy to support the donation going forward. Some aspects of that are then their personal wishes being applied. For a lot of nurses, they find that very difficult to then try to go back to individual families to try to see if they would fulfil the wishes of that individual. That's why it's very important to have clarity in exactly what the role of the specialist nurses is going to be, because if there isn't clarity from the outset that idea of a consistent and not arbitrary approach there, it's going to raise the issues that you have just suggested. Eventually that will then once again be custom in practice. It's custom in practice to acquiesce that the eyes are not removed or the heart is not taken, whatever it happens to be that is important at that time. Immediately you start to do that, you're into that role of perhaps medical judgment, ethical judgment, but you are moving it away from the provisions of what you have put before us today. There's a possible risk as well of there being a tension in the way that the intentions of the proposed legislation are drafted, for example, in the explanatory policy memorandum, in that there's a constant emphasis on that this is a soft opt-out system because the views of the family are critical, but then when it comes down to what the views of the family that are actually sought, they are fairly limited. They're the medical history of the person and any evidence of differing views, so if that tension between valorising the family and then limiting their actual input persists into practice, that could potentially undermine the aims of the legislation and the feeling of the family of being valued. Can I continue the theme of the rules of the family and deemed authorisation, and some of our points have been covered, at least in part, earlier? Can I raise one point that has been raised already, is that whatever the law might say, in practice, medical professionals will take into account the wishes of the family. So, if we accept that that is a given, that's a culture, and that's a good thing, in my view. Should that then not be reflected in the law? I believe that it should be reflected in the law. Again, I remember in 2005 the health committee discussing those issues, and it was made very clear to the MSPs in those days that the family will always be consulted because they need information of the person who's deceased for patient safety, and that gave reassurance to some of the MSPs at the time to go along with the present legislation. So, it was a sort of practical, they felt more comfortable supporting the present legislation because of that. Perhaps just a small point, but both my colleagues here have talked about the role of the family in giving medical evidence or support that there may have been underlying conditions, and I think that may be problematic. Many families, partly for the reasons that Dr McKellar has said, may not be able or here or alive to be able to have that specialist knowledge, but also matters of confidentiality. There may be underlying conditions that a potential donor may have that the family have no knowledge of or are not aware of. That's quite a responsibility to place on them, to ask them for any medical background that they may simply not have. They could say, well, there is no condition where that may not indeed be the case. I could ask another point that just occurred to me. In a scenario where surviving family members had power of attorney, under Scottish law, would that give them any more clout in terms of making decisions about their deceased relatives' possible organ transportation? Not really. Unless there were some matters of raising about incapacity when the person was alive, the rights that they now deceased will have are not transferable. The other point is that, as you know, all legislation has to be authorised to say that it is compatible with the European Convention of Human Rights, but, if I have learned anything on this job, it is that not all lawyers agree with each other. Is there anything in the legislation that we could do to strengthen the legislation to make sure that it is more compatible, particularly with the test case that I mentioned in 2015, albeit that you have given some information about that already, Professor Britt? I guess that if you are trying to strengthen it, the law is enhanced at the price of the medical judgment, the ethical judgment, in terms of the examples that your colleague just gave. Would you go ahead and remove someone's eyes? Well, if the law was absolutely clear and compliant and there was no room for any question or arbitrariness, then the question there would be if that was the wishes of the individual, and those eyes would be removed. If you were going to bring in ethical matters, moral judgment, then you may be always compromising a hard and unequifical take on the law. One of the pillars of medical ethics is informed consent about providing the right information in a clear way and then enabling people to make their own decisions. The more information you will be providing to the general public about this bill or the present act in a way that is clear, in a way where most people or nearly everyone knows that this is the system in place, what is involved, then it is a lot less likely that any case will go to the European Court of Human Rights or go against the European Convention on Human Rights. It is really important for this information side to be provided and consent, or when people are still alive and consenting about what they want to do, is a continual process. It is not just a one-off that people then forget 30 years later, it is something that has got to be reminded of doing again and again and they have got to also be able to withdraw their consent. All this should be explained to the general public in Scotland in a clear way and in a continuous way, not just a one-off. Alison Bruggan. I think that that is a very valid point and I think that it is something that Wales experienced and discussed as well. One of the initial iterations of the Welsh legislation I think allowed for something like a six-month lead-in time to be able to inform the public and provide that support. I think that at the end of the day that was changed to round about two years and a very important point that once that information is given and that education starts to feed through, you do not stop, you keep going because this idea of changing culture that you are not facing, these really difficult legal, ethical, moral decisions will come when people are more familiar. There is always a knee-jerk reaction when something new is brought in, but if people are educated get a chance to be able to understand the reasons, the benefits, but the education has to be on-going. I agree absolutely with what both the previous witnesses have said that not only is the education and ensuring that the citizens understand what is going to happen important for deemd authorisation to have any traction at all with the idea of our interests in having self-determination of our own bodies. If we do not have the information about what will happen in terms of deemd authorisation then that cannot even pretend to be anything to do with respect for the interest in self-determination, but furthermore from bad experiences in governance that have happened in the UK, for example something like care.data where notwithstanding how lawful the use of patient data in research or further uses was, there is just a failure to take off because the lack of information, the lack of understanding, the lack of sympathy for the aims of the perfectly lawful initiative just haven't been given social licence, they just haven't been deeply enough imbued in people's understanding and in the shift in culture. Is there any obvious gaps in the legislation that we are discussing here today that if we were starting from scratch you would change and so we could have much better legislation because we all want the same thing, concrete donation rates. Is there something that the legislation is getting in the way of that? Is there some obvious changes that we might be missing that we could as a committee change to make this better legislation? Feel free to think about that and come back to it if you want. I think the only initial observation I would make is the idea that the legislation should be tied in to the smaller detail of education, lead-in, change in culture and the opportunities for all members of our society from all backgrounds, faiths and cultures because some of those perspectives that may be part of their culture may be slightly different, so taking cognisance that one size does not fit all and making sure that a tie-in to this proposed legislation ensures that it reaches the widest possible audience. Emily Poston. In our evidence the Mason Institute suggested, I don't believe it's a current provision, the possibility that there would be a statutory requirement for reporting on any research and monitoring of the uptake effectiveness and impacts of the legislation to be reported to ministers to make sure that it happened on a timetable that was rigid and frequent and that certain standards were met. Collecting and reporting on the evidence, the effectiveness of this and remaining alert to whether further nuancing and changes are needed is going to be essential because, as we can see from the international evidence, it's just not clear how deemed authorisation systems work. The assessment on how effective legislation is? In qualitative terms as well as just quantitative, not just numbers of donors and donations, but the nature of the discussions that are happening in healthcare settings. As well, your legislation is scandal proof. At the moment, there is a lot of trust in the system and you only need one scandal for the whole trust to be undermined and people then will stop donating their organs. In a way, and this is what I used to do in my national ethics committee for the NHS, for research, we've always got to see, is there a situation where a scandal could take place and how do we make sure that it doesn't, so that this trust in the whole system doesn't be undermined? You just need one scandal and then it's too late anyway. Good morning. Just a quick supplementary. Professor Grant, you were discussing around this need for continual education. We know that there's roughly 40 per cent of the population who would give consent, who haven't yet given me consent. Given that I was one of them until last week, and I didn't find it that easy to be quite honest, to find a way to sign up, would it not just be simpler? In terms of continuing an education programme, giving, making sure that the opportunity to make a decision one way or the other was easier to make and then you wouldn't need to deem consent because then you would have an express wish. Would that not make the bill much clearer and make the role of the nurses easier? Sorry, I'm not quite clear about you. What would you expect in the individual to do in those circumstances? Make a decision. We would give everybody a much clearer opportunity to make a decision to opt in or opt out, negating the need for deem consent. A mandated choice model? There was a proposal for this two years ago when Mrs MacTaggart was bringing her bill to the Scottish Parliament. There was an MSP—I can't remember which party or her name—and that was her speech in the hemicycle that we bring in a mandated system where everybody has to make a decision. That would actually make things a lot easier. There would probably be more organs available and there would be a lot less ethical challenges, a lot less ethical problems because everybody would then know what the position is. There are situations like in Belgium, one canton in Switzerland and in some states in Australia where people are obliged to vote for elections. Would it be a possibility to have a mandated system where everybody has got to make a decision? Personally, I would not be opposed to that. I think that these arguments have been rehearsed before perhaps in front of this committee, but one of the problems is enforcing the mandated choice. The other is all the problems that we have been discussing today in terms of people changing their views or families believing genuinely or otherwise that they have evidence contrary to the mandated choice view. They all still subsist even in a mandated choice. You add an onerous layer of potential enforcement and penalty, but the dilemmas still persist. I was not suggesting that we force people to make a choice. What I am suggesting is that the opportunity to make a choice is more readily available. The one piece of evidence that came forward was that people were very happy to see it as a gift, so whether the mandated would come into that. However, that is not the question that I wanted to ask, but I wanted to get in on that one. Good morning and thank you very much for your evidence. I am interested in the pre-death procedures and the ethics and the law behind that. I am not an expert on it and I was really surprised at some of the evidence that we were given where people were suspicious that doctors would use it as an experiment or whatever it might be. I am trying to find the exact words to accelerate death in order to have their organs. Even people who were presumed to be in favour of donation and also not donation were a bit suspicious when it became deemed consent in that regard. I was interested in not just that but in how it affects the law of the hippocratic oath, if it is deemed consent and how it sits with the current medical law. Would it see it as a conflict of interest in the ethics and the hypocritical oath of doctors? How does it affect the ethics and the law? I know that I have an expert panel here, so I would be keen to hear your views on that. I might start on some of the ethics that might be bleeding into some of the law. On whether it is contrary to the hippocratic oath, it would not be, certainly if it was not contrary to the best interests of the person involved. It would not be necessary to promote their best interests, but if it was not contrary to their best interests, that would not necessarily raise ethical concerns. I would like to say probably with more force than that. When we think about the best interests of individuals, that is not solely deemed in terms of medical treatment or even physiological interests. It is also in someone's best interests that their wishes are fulfilled and that they can live out the life plans, projects and commitments that they value. If those life plans, projects and commitments involve donating their organs, a non-painful, a minimally inconveniencing—or how it is described in the policy memorandum—intervention is by no means necessarily contrary to the best interests of the individual. I want to interrupt you. You are talking about wither consent and not painful, as you might say, but what if it is deemed consent and it is not for the patient's benefit and it is intrusive and it could be painful? It is the opposite of what you are saying. Obviously, that is what patients are saying. There are separate things, but I guess the key part for this consideration is the if it is deemed consent as opposed to explicit consent, does that affect how you make that argument? If we are understanding deemed consent to be operating in a context of people being informed, so deemed consent is in line with people's wishes—steamed authorisation is in line with people's wishes—then, if we can have that caveat, a minimally invasive non-painful pre-death procedure is in line with their wishes and could be understood as being in their interests. I think that another ethical and perhaps cultural consideration, particularly for family next of kin, is the idea that if there has been an expression to donate organs, will those caring for them not go the extra mile to try and preserve life? I think that is what you were also maybe alluding to in terms of the hippocratic oath. There would be no reason to believe that that would be the case because the current physician there is usually some time, not often sometimes not a great deal of time, but there is some time to recognise that this could be a situation of potential donation. At this point, the specialist nurses are starting to have this communication with those who are perhaps with the person who is going to be the potential donor there. Those conversations already do take place, but it highlights the need for greater clarification because people are frightened of the different definitions of death. There are ethical definitions, there are legal definitions, and the ones that you tend to focus on in your current proposals are very much around the idea of brainstem death, but what it does not cover is perhaps somebody who has a longer death, maybe somebody who is terminally ill and may die in a longer time, so that could perhaps be broadened out. Once again, it is down to the skill of those having that communication, a cultural understanding that at the end of the day this person is going to die and they are trying to maximise the opportunity to be able to give those organs to someone else. I will come back to what I said previously. What is really important in medical ethics is informing people. If they are informed and they know what is going to happen to them even when they have just died, that is acceptable. The problem arises when things happen to people and they were unaware that this was going to happen to them or to their bodies or the families are unaware. That is why it is really important to support this information site of the person who is going to die. Of course, there is a lot of skill in the specialist nurses, but the specialist nurses can just do so much. If the persons were not informed at all and it all comes to a surprise to them, then the nearest relatives would be very upset no matter what the specialist nurses say. It is extremely important to inform people about what is going to happen. I do not think that there is a lot more work to be done in our society in this area of transplantation. We saw even in the SPICE report how confused everybody is on page 34. There is a lot of confusion in this area and that creates, for me, as an ethicist a lot of concern. I will follow up slightly. I will take on body exactly what you are saying. I think that, obviously, an awareness campaign is something that needs to be done so that people understand. However, when you mentioned the fact that if people have not filled in a donor card, obviously you have to ask the family and they can overrule any wishes or whatever it may be. You would ask about keeping the organs alive and you would have the pre-death procedures there. What you are saying is that even if consent is not given, no deemed consent, you still have to ask the family, that does not go against hypocritical oath and it does not go against the law or the ethics of doctors. That is what we are trying to pinpoint. The procedures that take place, even though it is deemed consent or not deemed consent, would not go against the law. Normally, what happens at the moment, usually in terms of clinical practice, is that there are two sets of teams, medical teams. There would be a medical team caring for that individual on the basis of whatever ill health that they have or whatever condition that they have and there would be a specialist transplant team as well. They do not interact. They are separate teams, so one is totally focused on the health and wellbeing as much as that can be achieved for the individual patient and it is a separate team that would be dealing with transplant. In medicine, there is always a bit of a balance. If the interventions are not very serious, if it is taking blood samples or if they are doing something more but there is no pain, that should normally be acceptable. If the interventions reduce the life of the patient, that would certainly not be acceptable in any way. There is a bit of a grey area here. Thank you very much. David Torrance Good morning, panel. Previous witnesses have raised concerns about the bill in relation to adults with incapacity. Do you think that the bill is clear enough about a level of capacity that will be sufficient for deemed authorisation to go ahead? Should the bill be clearer about the length of time that incapacity has existed? David Torrance I was talking to a psychiatrist and they were saying that capacity is a holy grail and everybody is different. It is very difficult to legislate in these areas because every single case is different. Personally, I believe that my council believes that adults with incapacity who cannot make these decisions then it is appropriate for the persons in charge to make the decisions for them. However, they should be involved as much as possible if they can. It is a bit like with children who are between the age of 12 and 16. They should be involved as much as they can in the decision. The present legislation is quite good and the proposals in this bill are actually quite good, I believe, relating to how to address these situations. Emily Poston I did have a question about whether the way capacity was spoken about was to all or nothing. There was a lot of emphasis on the persons having capacity for sufficient time during which deemed authorisation was the law so that they appreciated that it was the context within which they function and would have had the opportunity if they wished to opt out. I assume that that is the reason why. The understanding in both law and ethics is that capacity is context specific and question specific. That did not strike me, maybe, as coming through sufficiently in what I had read, that potentially with fluctuating capacity that there should be efforts to help people and support people in working out whether they can make decisions about whether they wished to opt in, opt out, change their mind about previous decisions that they had made and just that nuance of the fact that things can be more context specific and more fluctuating. I completely agree with that. The legislation that we have in terms of mental health legislation and capacity is very good because it takes cognisance of the beliefs, the values, what the person is able to contribute to that discussion of what they understand at that time. I think that just as Dr Poston says, just to contextualise that a little bit more into the existing proposals. On incapacity with adults with incapacity Scotland act 2000, and would there be any benefit in linking them in some way? In some ways. Linking them, I do not think that it is probably required to link them, but I suppose that I have almost at least tried to answer that already. The provisions within the adults within capacity Scotland act provide that opportunity for context, for decision making and it provides that the individual is encouraged to make a decision to the best of their ability and the best of their capacity at that time. I think that those provisions in Scotland are already there, they are very good, they capture what we hope to be able to do in terms of respect for the individual and their contribution. For me, it is just to not link it, but even to refer that those tests are there and to make sure that the proposals before us take cognisance of those. All of our witnesses for their evidence on our range of questions this morning has been very helpful. We will suspend briefly to allow the panel to change. Thank you very much. Welcome to the committee. To the Minister for Public Health, Sport and Well-being, Jo FitzPatrick MSP. Good morning, minister. Accompanied today by Claire Tosh and Farron Morris from the bill team and Stephanie Verlaugeau from the legal directorate. Welcome to you all. I believe that the minister is going to give us a short opening statement before we proceed. Thank you, convener. I am grateful for this opportunity to speak to the committee about the human tissue authorisation Scotland Bill. The primary aim of the bill is to introduce a soft opt-out system of organ and tissue donation for deceased donors. The bill amends the existing Scottish legislation that supports the nation, the 2006 Human Tissue Scotland Act, by introducing a new additional form of authorisation called deemed authorisation. Deamed authorisation will apply to most adults from the age of 16 who have not otherwise explicitly opted in or opted out of donation. In practice, what that means is that where a person was not known to have any objection to donation, the assumption would be that the donation could proceed. The bill contains safeguards to ensure that donation won't proceed if that isn't what the person would have wanted. The bill is necessary to build further on the improvements that we have already seen in that area. Despite the real benefits of transplantation and advances made over recent years, there are still over 500 people in Scotland on the transplant waiting list at any one time. There is an absolute limit on the number of people who could ever become donors. Only about 1 per cent of people will die in circumstances where organ donation is possible, but if there are steps that we can take to allow more of that 1 per cent to donate, I am keen that we do that. Evidence suggests that there is no one answer to increasing organ and tissue donation. Opt-out systems clearly work better as part of a package of measures. There has been a lot of work done over the past 10 years in Scotland to improve infrastructure and our systems. Learning from other countries such as Spain and responding to major reviews such as the organ donation task force has seen associated increases in donation and transplant numbers. However, as support and awareness for organ donation has grown in recent years, so has interest in a move to opt-out. The member's bill, introduced by Anne McTaggart in the last session, began the conversation and although that bill was not supported, Parliament and Government recognised that there was an appetite to move towards a different form of authorisation. That bill is a product of a great deal of work over the last few years following from those previous committee discussions. We have worked with a lot of people, including NHS professionals and people affected by donation and transplantation, to consider how best to introduce a system of opt-out in a way that contains appropriate safeguards and in a way that will not compromise the already complex and lengthy donation pathway. I know that the committee has been interested in how long donations can take and we are concerned not to lengthen that. We have placed a particular importance on making those changes in a way that is transparent and open to the public. Organ donation enjoys and depends on a high degree of public support and we do not want to do anything that would put that at risk. The bill therefore builds on the requirements in the 2006 act for Scottish ministers to support and raise awareness of donation by also introducing a requirement to raise awareness around the changes that the bill introduces. I know that the committee has had some discussion about the previous provisions relating to pre-death procedures or anti-mortem interventions, as they are known to those working in donation and transplantation. That is a complex area, but I want to reassure the committee that those procedures are not new. They are already an important part of the donation and transplantation pathway. Those procedures help to ensure that donated organs are more likely to be transplanted successfully and that a donor's wishes can be fulfilled. However, we recognise that clinical procedures have and will continue to change, and we want to ensure that there is a clear framework in place that sets out how and when pre-death procedures can be used and what safeguards must be in place. We also feel that it is important that potential future donors understand that those procedures can form part of the donation process. The bill does this by ensuring that we are open about what is involved and by putting in place certain requirements around communication and awareness raising. As with provisions around opt-out, our approach is to be transparent and to maintain a high degree of trust in donation. I am grateful to the expertise, dedication and experience of the NHS clinicians, professionals and organisations that have helped to shape the bill. I want to particularly acknowledge the Scottish Donation and Transplant Group, which advised the Government on those matters. I also want to pay tribute to every person who has donated in the past and every family who has supported donation. Through such selfless acts, lives are saved and improved. I hope that the bill will lead to further increases in donation to further save lives, and I would want to offer any such progress as a tribute to all those who have donated in the past. I am keen to hear from the committee and I know that that will be an on-going conversation as the bill progresses. I will give careful consideration to any proposals that the committee brings forward to strengthen and improve the bill. Obviously, I am happy to take questions and hope that, along with my colleagues, we can provide further clarity to what I know has been a very thorough stage 1 process. Thank you very much, minister. I think that we would want to start by welcoming that commitment to pay attention to any proposals coming from the committee's consideration. Clearly, other evidence that we have heard this morning has reminded us of the debate around the 2006 act. You have said just now that the purpose of this bill is to increase the level of donations. The Scottish Government's own review of evidence found that, simply changing from one form of authorisation system to another, there was weak evidence that that in itself would make a difference to donation levels. I think that, therefore, you put it in a wider context. What can you say to the committee today to give us confidence that the bill in and of itself will result in an increase in donations and transplantations? We are aware of the view that, opt-out alone, we would not have a significant increase in donations, but it is opt-out as part of a package of measures that we have taken forward for a number of years. I think that there is evidence internationally that that is where it will make a difference, adding to the other measures that we are taking. Given that those other measures have been effective since 2006 and that they are on-going, what is it that the change in the opt-out system brings to the party? In other words, if awareness-raising and engagement is proving effective under the current law, what is it that this change in the law will additionally bring? There is no question about the changes that we have made. We have made a difference just looking very quickly at the numbers. There has been an 89 per cent increase in donor numbers in the past 10 years or so, so that is a lot. There is a 22 per cent decrease in the number of people who are on the waiting list, so in 2008 it was 689 and that went down in 2017-18 to 534. However, that is still a lot of people who are waiting for a donation. The evidence internationally is that if we do that correctly as part of a package of measures, it will lead to an increase in donations. Some might argue that the numbers show that progress is being made, and therefore that the effort should be dedicated to further progress along the same lines, for example, making it easier for people to express a wish or making it more likely for people to express a wish, and that that would make the difference. I don't think that those things are contradictory. We can do both things, and that would certainly be my view. As part of the process of the bill, going through Parliament and assuming that the bill passes the enactment of the bill will increase awareness of donations in general, and I hope to increase the number of people who are on the register as well. The two things go hand in hand. There is no conflict here. Can I thank the minister for public health, sport and wellbeing for his evidence and congratulate them on the daily mile that Murray fielded on Saturday? It was more interesting than the match, I have to say. One of the points that was made earlier on during the evidence was the idea of public support and the need for public to buy into this. Is it possible to say that if somebody, under the new system, as the bill proposes, decides to opt in or opt out, that those decisions will be respected in as far as that will happen? Notwithstanding, of course, there may be practical reasons why it can't, because the organs might not be suitable or because of any other evidence brought forward to say that a change of mind is taking place. However, if those are the expressed wishes of the individual, and if we are trying to get public support, will those wishes be followed through? The bill is very clear in that, and it follows on with the same principle that was in the 2006 act, that the right to authorisation is the donor's right. Clearly, and the law is not changing in that respect, there are discussions that have to happen with families that might determine whether donation does proceed or not proceed, but there is no family veto as such in most cases, and that is consistent with the law as it stands right now from the 2006 act. That is not changing, so it is just a continuation of the law as it was. I suppose that that is my concern. As you rightly say, that is the current situation, and it is not written into the current legislation that there will be a family override, but I think that what you are saying, minister, is that there will be a family override. My point is that if there is a family override, then somebody looking at this new legislation and being subject to the education that we intend that they should have about their rights deciding to do this could quite easily say to themselves that there is no point, because the family themselves, my family, are interested in what happens when there is no family. They will be the ones that will decide, along with the medical professionals. Really, my decision is not relevant here, because all that will be taken as an express wish, rather than my right to do it, and that might limit the take-up or the involvement of people in the process. The legislation as it stands and the legislation that we are proposing is very clear that the right to authorisation rests with the potential donor. Clearly, the decision to proceed with a donation is a clinical decision, and that is a different aspect. The legislation adds in to the current provisions that the duty to inquire, so that places the duty to try to find out what the last wishes of the donor is. So, when we are not asking the family about what their views are, we are asking the family what they believe the deceased or the relative, the potential donor's views are. That is the kind of role in terms of authorisation. Obviously, a different role is a process in relation to donation. There has to be a clinical decision to proceed with donation. It would be difficult for the clinicians to make a decision to proceed with the donation if they had not managed to go through all the safety questions. They have to make that choice. In practice, I do not think that there is anything that we could put in law that would change that ability for a family to say, I am not going to co-operate, and that puts the clinician in a very difficult position, because they have to make a choice about safety. There are two big things that the clinician has to respect, first of all, the rights of the donor in terms of their donation wishes, but also the safety of any recipient. However, the right to authorisation, the legislation, as it stands from the 2006 act and as it would stand in this act, is very clear that that is a right of the person who would be donating. My very clear impression from previous evidence referred is that that would still leave substantial doubt in the minds of somebody considering whether to opt in or to opt out, but leaving that aside, the point that you make, Minister, about the information that is required from the family being pretty necessary to a decision to donate or a transplantation to replace, is an example given an immediate session that we just had of somebody who has nobody, no family, nobody else to consult with. It is just really a point of information that your officials might have. In that circumstance, is it possible that the tests that can be done are sufficient to allow donation to a place? If you cannot get any of the dozens and dozens of questions that you normally ask the family or somebody else, is it still possible that transplantation can take place? Before I pass over to Clare on that point, maybe just to go back to the other point in terms of I think that the point that was and I was kind of heard this session before, the point that you were trying to make, I think emphasises the need for us to have a strong publicity campaign to encourage people not just to get on the donor register, but to make sure that they have that conversation with their family before I am, because that's what will make it much easier for these conversations to happen, is if that conversation happens before anyone gets that unexpected circumstances. What maybe, Clare, do you want to answer? In terms of the bill, as introduced, there is a duty to inquire. It would actually be quite difficult to fulfil that duty to inquire if there wasn't anybody to seek those inquiries from. The bill that is currently drafted puts the duty to actually find out what those wishes were, and if somebody didn't have somebody who you wouldn't be able to find out that information. As mentioned earlier, there is also the question about the medical history as well that needs to be gone into, so that would be unlikely. What we would say is in development of the bill, we obviously spoke to people about some of these issues around not just publicity in terms of big campaigns, but also how to try and reach different groups of people. That would be part of implementation as well, and we have spoken particularly to some faith groups about how to reach lots of different groups of people, but that will also be part of implementation. We are also trying to ensure that the publicity is as widespread as possible, so that it could be assumed that we are a person who hasn't registered a decision to opt in or opt out that they should be aware and that they may be deemed, but there is also the additional duty to inquire that would be difficult to fulfil if somebody didn't have anybody. If it is not about consent, I can do that. If somebody has nobody that the clinicians can speak to about the medical history of the person involved, is it possible, based on the test that can be done for transplantations still to happen? That would be a matter for the clinician to decide if they are comfortable. I think that that would probably be a matter for the clinicians and NHS BT, but, certainly, in a broader understanding, it would be quite difficult for them to proceed in those circumstances. Thank you very much. The point that Keith Brown explored about authorisation came up in the previous evidence session this morning, as you probably heard, and the suggestion was made that, ultimately, under the 2006 act, despite the sense that it puts the donor at the centre that, in fact, final authorisation may still lie with the family, and, indeed, the NHS blood and trans blood leaf that is currently in circulation says that, when a person dies, an organ donation is a possibility. We rely on their family to agree to donation going ahead. I wonder if I could ask, rather than necessarily a detailed answer at the moment, if your officials could reduce to a flowchart or some similar form an indication of how the wishes of family members are currently taken into account under the 2006 act, and how, if at all, that would change under the bill? I have asked for that flowchart, so I have seen it, so yes. Excellent. I am glad that we think in the same way on these matters. That is very helpful. Miles Briggs. Thank you and good morning to the panel. I wanted to ask around the Welsh system, because we last week had officials from Wales up. I wondered what you learned from the Welsh Bill and the progress in some areas that they have made, and anything that we could learn in Scotland. Specifically, I know that it is not contained in the bill, but some concerns have been raised with us with regard to infrastructure in Scotland and the potential moving forward around that. I wonder if you have any comments on that. Obviously, in drafting our bill, we spent a lot of time learning lessons from Wales in terms of how the bill has been implemented in practice and the impacts that it has had. There are some positive figures coming out of Wales just now, particularly in terms of the increasing rates of consents, as they call them, in Wales's authorisations, as we call them. I think that Wales now has the highest level of consents across the UK. However, we have certainly looked at their experience. The financial memorandum covers a number of areas in which there is significant investment going forward in terms of the nation pathways. Does somebody else want to add? In terms of specific learnings, the Welsh, as you are aware, undertook an evaluation and some things came out of that. We looked at clarity about the role of the family to begin with. There was uncertainty about what the family's role was. As the minister set out, it is clear in the bill what the expectation is. It is the individual's choice that decides whether their authorisation or consent is in place or not. The family's role is about giving evidence to that. It is also about the need for on-going awareness raising, so that awareness is maintained over time. One of the things that I have taken with me is that future cultural change will need. However, how you achieve that on a very positive note, and sometimes Government advertising does not achieve the outcomes that we hope they would and the amount of money that we spend on public information, for example, does not necessarily drive the change that we want to see. In terms of future publicity and how we make this a national conversation, if the bill does end up being passed by Parliament, what sort of work have you undertaken around that already to make sure that this is something outside of a bubble that people will understand and want to engage with? Obviously, I do not think that it would necessarily be Government. It would be the main organisation that is fronting the education. It is more likely to be NHSBT and SNBTS that would be fronting that. However, we need to work with all of our partners to make sure that the messages reach the widest possible group of people. We have already heard that we have agreed to work with religious groups to make sure that if there are particular issues there that we can make sure that people understand what the legislation means. If I can just maybe add to what the minister said, there is obviously the duty on ministers regarding information and awareness. That is Scottish Government-led. It follows the general marketing principles. We work under way to develop the right messaging, as the minister said, about what the changes are and how to reach different groups of people. Learning from Wales about that and taking into account the work that has already been undertaken by the Scottish Government in terms of marketing is already a consideration to think about how that work may be taken forward. That is also included in the financial memorandum and the prospective costs around that. It is also mentioned, potentially, of the schools pack that has been developed and how that can potentially be developed further in the future. Just one very brief question in terms of the age difference that we have discussed in terms of 16-year-olds being included—16 and 17-year-olds in Scotland—you have mentioned discussions around school packs to make sure that that is maybe age-specific as well. That is welcome. However, what work have you undertook around the potential of parents not 16 or 17-year-olds living at home? Parents wanting to be part of that discussion as well? As I said earlier, it is always best if decisions are made after discussion with families. That is a good practice and that is something that we should be encouraging. However, in Scotland, the age of legal capacity is 16 and 16 is the age that the current 2006 act says that a young adult is able to make that decision. We are not changing that. We are just keeping the age at 16 as it is just now. That is appropriate, but it is important that we recognise that we want to make sure that young people understand the legislation prior to their 16th birthday. That is why having the packs going to schools and the proposal for a direct mailing to all young people as they approach their 16th birthday so that they can make that decision. We would still encourage people to, once they have made their decision, register on the organisation bill, register one way or the other and let their family know what their decision is. That would make it a lot easier for families if those unfortunate circumstances ever come to pass. Start with a straightforward one. I have heard from the specialist nurses that their conversation is made easier and the reduction in family overrides is greater if we have consent, if we have people who have opted into the programme. Under the proposal bill, we will have three different options here, one opt-in, opt-out and a deemed consent. Do you not think that it would be better if we maximised—we looked at the number of opt-ins possible—to maximise that and remove the ambiguity of deemed consent? I think that having deemed consent will make the conversations easier, because the conversation then is about what the person's name is and what he thinks about donations. That is the starting point—what do they think. The families are rather thinking about their own views on donations and about the person that they have lost or expected to lose. I am clear that there is a two-track approach here. We have the new system, but we continue to try and encourage people to register and, more important, to have those conversations. The conversations are more important than whether someone is registered. Someone being registered but not speaking to their family—it is better that they have that conversation—is the most important thing. However, the bill does not swap us wanting to continue to try and encourage people to sign up on the register to tick the box. I am struggling with here is for deemed consent to be effective. We then have to make sure that everybody has an easy opportunity to opt out. For me, that is the only way that you can make deemed consent particularly effective. We know that 40 per cent of people would opt in that have not opted in. As I said in the previous one, I have said many times during this that I was one of the 40 per cent. I managed to opt in last week, but that was only because I changed the address and went away from a driving licence to be changed. That is one of the ways in which we can do it. If we agree to strengthen deemed consent and make deemed consent strength, we have to make sure that everybody has a really good and on-going opportunity to opt out. Surely, then, by education and by publicity, we can increase people's opportunity to opt in. That would be a much stronger statement than a deemed consent. I think that your evidence that is going through this process is encouraging people to start thinking about these things and making these decisions so that that is good. Welcome to the organ donation club, register club. I think that as part of the process, we want to make it easier for people to record their preference and record what their decision is. That goes either way, whether someone is wanting to express their view that that should they find themselves in the circumstances of their organs can be used for donation. Either they want them to be used or they do not want to be used. We want to encourage people to make that decision and record it on the register, but it is equally important to make sure that their family is aware of what their decision is in one way or the other. David Stewart. Good morning, minister, and welcome to your officials. What assessment have you made of the Spanish system of organ donation? So, clearly, in Spain, there are very high levels of donation have come. That looks like it's in part. Any country that has an opt-out system, we've, as a Government, looked to that in drafting this bill. It looks like in Spain, the opt-out system there is part of why they've got such a high level, but there are other cultural changes as well, which explain why Spain is particularly so high. Clearly, we've looked at all international examples. Thank you, minister. Obviously, I feel free if the officials want to contribute as well. You'll know that we've had considerable evidence on this and one of the articles appeared in the British Medical Journal in 2010. Some of the evidence suggests that, in fact, the consent system itself is not the real factor. What they argue is that the real effective system has been transplant coordinators, donor detection programmes and the group provision of intensive care beds. If I can just give you the complete for completeness, if you compare UK with Spain and we tend to operate in a UK system, even if you adjust the family refusal rates from 40 to 15, the donation rate in the UK is only half of that of Spain. Clearly, Spain is best practice. Other evidence, of course, has said that you can't always compare apples and oranges, and I appreciate that there's also the cultural thing, particularly the role of the Catholic Church, which has supported this, and that's obviously very welcome. If you place to one side the consent system, there is an argument in terms of opportunity cost that, in the financial memorandum, instead of looking primarily at consent, you can invest money in the financial memorandum on to increase the number of intensive care beds, because clearly that's very important in the Spanish example. Clearly, we need to look at other examples. The financial memorandum makes significant provision for extra resources for staff in terms of registration, training, development and recruitment, so that there's a large amount of extra resources already in the financial memorandum. Even if we manage to increase the donation to the levels that we're hoping, it's unlikely that that would lead to the number of transplant units exceeding the forecast in the current strategy, the commissioning transplantation strategy 2020, which runs until 2020. In that short period of time, I don't think that there's any expectation that levels would go above that and there's still capacity within that system. I was struck by your opening comment when you said that you're very willing to listen and look at amendments legislation. I think that I can speak for my colleagues to say that this is not a partisan issue. I think that every member here wants to see more organ donation, and we want to do this right. As someone said, what is right is what works, and whilst I do accept that there may be some different cultural issues with being clearly on top of the league in terms of the European examples, could you have a look at the issue of intensive care beds? I know that I appreciate that this can't be turned around overnight, but that seems to be a much more valuable factor than looking around the consent issues. I think that obviously we need to look at all circumstances around donation. I don't think that if that was a direction of travel, it wouldn't be something that would find itself into this bill, because I don't think that it would be relevant to this bill. It's more of an organisational factor, but I hear your points and we'll feed that in and look at what you're... I'm supposed to ask my question another way. Have you looked at cost alternatives to the financial memorandum? In other words, are there things that you could do better with the funding that you're very allocated to this bill? The financial memorandum is about how we fund what we're trying to do with this bill, so that's what the financial memorandum is around. I think that the financial memorandum was prepared as well as a business regulatory impact assessment as well, and it was prepared with input from NHSBT, SNBTS and other partners. It takes account of the on-going work in the package of measures that's currently in place, including the high-profile awareness raising that is currently on-going. Looking forward with the bill, it is intended to work with those partners going forward to see what measures can be put in place if necessary to further support the implementation around that. As the minister said, the work with the National Services Division around taking transplantation to 2020 will be a further commissioning strategy around those transplantation costs that is currently under way. There are opportunities beyond the specific legislation. I'm sorry if I'm stressing this too much, minister. I do believe that the consent system has a place. All I am saying is that it does appear from the Spanish example where we may be missing a trick on looking at the best practice that they have when their donation rate is double ours. Even adjusting for cultural differences, I think that stressing the importance of intensive care beds, the transplant coordinators and donor detection programmes that they have, might not appear in the legislation, but I do believe that that would make a big difference from the Spanish example. I mean, the reason that we're bringing forward this legislation is because we want to increase the number of donors and increase the number of transplantations ultimately to help that list of about just over 500 people. That's the ultimate aim. We've never said that this legislation on its own will get us to where we would want to be, so I'm obviously happy to look again at the specifics. It might be helpful if I add—I think it was Lizzie Logan from NHSBT who highlighted some of the differences with Spain about higher discadrates and organs being retrieved without recipients being identified, which is very different to the system that we have here in the UK. If the objective is to increase the number of transplants, which clearly is a shared objective, we heard from Dr Robertson of the BMA his description of transplant surgeons as a bunch of tired people working very hard. How confident is the Government that the transplant infrastructure that we currently have can cope if you are successful in increasing significantly the number of donations? I think that, as I said, the expectation is that, certainly in the short term, we wouldn't expect that to lead to the numbers of transplants above the 2020 target, so that's what the infrastructure is in place for. Going forward, if it looks like this is more successful than we might have expected, then I guess that would be something that we would have to look at for the future strategy going beyond 2020. Thank you very much. Can you say a little about opting in? We understand from the bill and accompanying document that that remains a focus of Government effort. How significant is that as part of the overall picture that you have painted this morning? I mean, people to record their views to opt in or to opt out is, I think, very important. If we can encourage people to do that, then that will make the conversations with families easier. Importantly, we would ask them to record their decision and then have that conversation, because it's part of it, but the conversation is so important. And so, when you are investing in awareness around this bill, that will include the opting in, the existing register, as well as making people aware of how to opt out. We will obviously engage with stakeholders to make sure that our messaging works in terms of people understanding what this bill does and what their options are. Can the minister clarify by options for opting in? Do you not match those that are available for opting in, i.e. driving licence, passport, things like that? Perhaps, if any, I can say that the opting out is available, the register itself is operated by NHSBT in a UK-wide level, the organ donor register, and there's the organ donation Scotland website as well, and the specific opt-out box was placed, I think, on the website after the introduction of the Welsh legislation, so that is where also publicity would be directed around this is the option to opt out as well. I think perhaps that is where people will be given the opportunity to opt out as well, I don't know if there's any. So it is already there on the register, so which Brian would be able to tell us going into the deal last week. I'm sure you're alluding to the DVLA, I think at the moment you can only opt in via the DVLA and those other routes, because there's a delay in those being processed in the central NHSBT ODR, so that's why there's not an option to opt out through those routes. You touched not earlier about working with religious groups, but can you expand on how you're going to communicate with minority groups and far-to-reach groups, and I'm talking about non-English-speaking or adults who have difficulty in reading the right groups like that? I think that that's a very important point that we make sure that we have the widest possible understanding, so there's already been engagement with some of the religious groups and some of the other stakeholder groups, do you want to add any more about that? Because there's been a lot of work to try and understand what we need to do. Yeah, I think that there will be more work undertaken to understand what is needed around that, but also that it's public information, I think that the plans are potentially to target different groups, but also there's updated training for peer educators who are currently important. That's part of the on-going work under the Scottish Donation Transplant Group to raise awareness of organ donation among South Asian communities. Also looking at presenting information in different ways, because we understood from some of the focus groups that were carried out with people's learning difficulties around presenting information, enabling people to make a choice and how that information is provided. So there will be consideration of how best to communicate, and then there is obviously the duty and the bill that ministers will raise awareness and promote information about that. Emma Harper I'm interested in the medical questionnaire and aspects around that. In our evidence sessions we've heard about the questionnaire and learned that there could be up to 350 questions asked of a family or the next of kin in order to obtain the medical history to enable clinicians to make the informed decisions whether organs or tissue can be donated and then transplanted. I'm sure that you're aware of the news yesterday of Pauline Hunt, who's from Kilmarnock, she's 49, in my South Scotland region, and she received a donated kidney and now has developed cancer. That might be an opportunity to talk about the process of assessment for donors and organs and tissue for transplant to assure people that the current process is robust and it's safe and supports optimal practice. What review is intended or is taking place following the news yesterday is the room for a review of the current process or medical questionnaire. First of all, to separate those two things, to some extent, this is an absolute tragic case, and my sympathy goes out to Pauline Hunt and her family. I can't imagine what she's going through right now. Clearly, it's important that, if there are any lessons to be learned from that particular case, that they are learned and understood across the whole of our donation and transplantation family. That has to happen, and the cabinet secretary has been clear that she wants to make sure that, if there are any lessons, they are learned. I'm just absolutely tragic and sympathise with Pauline Hunt and her family. In terms of the medical and social history questions, I know that the committee was concerned that perhaps it seemed like there were an awful lot of questions and, in some cases, it is a lot of questions, but it's about safety and the level of questions that the clinicians say they need. I think that there are around 40 questions and then some other questions underneath. If you add them all together, it gets to a much bigger number, but we shared with the committee, and I looked at how that has done elsewhere. It's a similar level of questions. Obviously, our specialist nurses ask those questions in a very sensitive way, and that's what they're trained to do as sensitively as possible. However, I think that we need to take the lead from the clinicians to make sure that we've got the balance right in terms of making sure the safety of the donation process. The question is not the only approach to determine whether organs can be or tissues, because we keep talking about solid organs this morning when actually it's tissues as well. There are case notes connecting with GP and other information that we elicit to make sure that organs can be used optimally. All of that comes together to do what we can in the relatively short time that a donation can proceed or not to make that as safe as possible and in a sensitive way as possible. I want to continue the theme that I had raised with the previous evidence session on the pre-death procedures. I thank the minister for his opening remarks, particularly in the fact that it is a very sensitive area. More information will be given out to people. Obviously, you're aware of the concerns that folk have raised, even those who are very supportive of organ donations and not about the procedure as it goes through. Obviously, from myself and others, the lack of knowledge that has actually took place at all. I welcome your comments regarding an awareness campaign. There are two specific questions that I want to ask, if I may. Could PDS be carried out under deemed authorisation before any conversation about donation has taken place with the family? The second question is probably the opposite of that. What are the minister's thoughts on requiring express consent for PDPs, either from the patient or the family? I'll just leave those two questions. In terms of the first question, no, because there is a duty to inquire. That is within the legislation's duty to inquire, so that could not happen, whether the deemed procedures were type A or type B and that that duty exists. Can you say your second question again? Sorry. The second question is probably the opposite to the deemed consent. What are the minister's thoughts on requiring express consent for this to go ahead either from the patient or the family? Would that be the best way to go forward? For some of the procedures, you would speak to the family or the patient themselves. There is a range of different procedures. Some of the procedures are a urine test of a blood sample, so there are a range of procedures. What we are trying to do in this bill is to bring a bit of transparency to a process that has been in place and carried out across the UK since pre-2000s for four years. It's important that we have a framework that can be adapted to changes, which is why it's appropriate that we have the list, the two lists that have come to Parliament in regulations. I think that it's also important that people understand what the processes are. As I said, I thank you for your opening remarks in regards to, hopefully, an awareness campaign. In previous sessions, I've asked why people aren't aware of those tests and the answers that I got back were basically, if they're going to do those tests, then they speak to the family. They're the ones that are informed, not necessarily people who are going through organ donation or opting in or opting out. In your awareness campaign, I'm assuming that's what it would be, the information. You will be letting people know that, when they opt in and your organs are there for donation, they may be subjected to whatever language you use. Is that the type of awareness? That's a duty on ministers within the bill. That's a new duty. The existing legislation places a duty on ministers to inform people about the organ donation register, and the bill places a duty to make sure that we raise awareness about the opt-out system and the pre-death procedures. That's a good thing, because we can build trust in the system where people understand it more than we can build trust. There's more transparency. That's great. We had some discussion earlier about circumstances that would arise where there are no family members to whom questions can be put. Clearly, for organ donation in general, that may well be from what we've discussed, be a showstopper in the sense of being unable to access the vital medical and social information. In terms of Emma Harper rightly drew her attention to the fact that the bill covers tissue as well as organs. Can you clarify, minister, whether in those circumstances where there is no family to consult and no access to medical and social records, are there still some possibilities for the use of tissues either for research or for other purposes that could take place and would have to be addressed before the donor died? Deemed offerisation is really referring to the main categories of donation in terms of the specifics of somebody with no family. I think that for tissue it's actually a higher threshold because it's life enhancing rather than life saving in most cases, so they'll accept a lower level of risk than an organ recipient would. So they'd seek more assurances, more information about the safety of that tissue before a transplant. They would require more information, so in fact it would be more difficult in certain instances if there are no immediate family members able to answer the questions that are put to them. That's very helpful. On the point about the main organs, unusual transplantations such as face for instance, then the deemed does not apply and then we go back. It wouldn't apply simply because a greater level of risk or a greater protection against it. No, because it's not what people understand about donation. I think that it's similar to the Welsh model where there would be accepted categories that will be set out in regulations for Parliament to consider after consultation around what might not be expected to be organs or tissue that could be subject to deemed authorisation, and that would be quite clear as well. So that's a slightly different question around the authorisation and what deemed would apply to and not apply to, but that's what we've called, or what is understood to be accepted categories, and that's how the— That's acknowledged in the bill but would be laid out in regulations. Thank you. It's just a quicks up, pre-death procedures. Is there not an argument to call it pre-donation procedure because we're talking about cardiopulmonary or cardiac death or neurological, but now there's the issues around it, anticipatory care planning, where somebody knows they're going to die but maybe chooses to donate a kidney or both kidneys or whatever. So pre-donation procedures might be an argument to look at instead of that finality of the word death. I think it's difficult, but I think if we're trying to be transparent, then I think we probably want to stick to the language that is accurate. The medical term might be preferred anti-mortem interventions, but I'm not sure that might be understood. If we want to have to put trust in the system, then I think we need to be careful not to be using language that might not be as clear. I suspect that this might be a matter that we'll come back to, but the final line of questioning for this morning is from David Torrance. Thank you again, convener. In relation to incapacity, does the minister agree that these provisions need strengthening in the bill and would it be better to link the bill with adults within Capacity Scotland Act 2000? We need to understand people's ability to understand the legislation, so in terms of deemed consent, people need to be able to understand the legislation for a period of time. We specifically make the point that there needs to be a period of time that people would have been able to make that judgment. I think that that is probably pretty clear in the legislation. Do you want to add anything on that? In terms of the definition that has been used about an adult who has over a period of time been incapable of understanding deemed authorisation, that has been left intentionally flexible so that it can be applied in the different circumstances that can apply to individual potential donors before their death. A more rigid definition could lead to unintended consequences and difficulties in fulfilling the wishes of people who wished to become donors. Thank you very much. I thank the minister and his officials for their attendance this morning, and I look forward to our further engagement on the bill as it goes forward. Thank you very much. We will move swiftly to agenda item 2, which is the other item that we are taking in public session, and then we will have a brief suspension after that before we go into private session. Agenda item 2 is in relation to petition 1477, which in summary calls on the Scottish Parliament towards the Scottish Government to extend the current human papillomavaris HPV immunisation programme in Scotland to include boys. The committee is simply invited to consider our next steps in relation to this public petition. Committee members will be aware that the Government has acted to change the law in this area in the way that has been described. Are members content to proceed to close this petition? I congratulate the movers of the petition. David Torrance and I were both on petitions committee when this came out so many years ago. I have forgotten, but the key point is that having a gender neutral vaccination is very important. Obviously, it has had UK-wide authorisation. I think that it is a very positive move, and it is obviously evidence-led, but it shows the strength of the petitions committee, so I am delighted that we are seeing a final end in sight. I agree with that committee. I also say that I may or may not know the petition, and I do not know whether that is relevant or not. I just don't know somebody called Jamie Rayne. I do not know if it is the same person, which is to put it on the record. That was on. Okay, thank you very much. If we are agreed, we will then close this petition and we will now move into private session. I will suspend for a couple of minutes just to allow it.