 Welcome to the 28th meeting of the Health and Sport Committee in 2018. I would ask everyone in the room to ensure that their mobile phones are on silent, and while it is possible to use mobile devices for social media purposes, I would ask members of the public please not to take photographs or the court proceedings. The first item of the agenda is for the committee to decide whether to take item 6 in private and all future considerations of evidence received on proposals by the Scottish Government to consent to the UK Government legislating using the powers under the European Union Withdrawal Act 2018 in relation to UK statutory instrument proposals. Our member so agreed. Thank you very much. Agenda item 2 is consideration of a proposal by the Scottish Government to consent to the UK Government using the powers under the act in relation to the following UK statutory instrument proposals. The human tissue quality and safety for human application, amendment EU exit regulations, the quality and safety of organs intended for transplantation, amendment EU exit regulations and the blood safety and quality amendment EU exit regulations. At our meeting on the 23rd of October, we agreed that we would write to the UK Government to request confirmation that the Scottish Government would receive final versions of each of the statutory instruments and when they would be issued. We have received a response from Jackie Doyle Price, the parliamentary undersecretary of state for mental health and inequalities in the UK Government. She has indicated that the Scottish Government received copies of the updated draft instruments for organs and tissues and cells on 22 October. Her letter details that final checks are currently being undertaken and that there may be further technical modifications to draft but that no policy changes are expected. The letter advises that the latest version of the statutory instruments would be sent to the Scottish Government by 2 November. We have since received a response from Joe Fitzpatrick, Minister for Public Health, copies of which members should have access to. That states that while the drafts of all three regulations are still being finalised by the Department of Health and Social Care in advance of being laid, the Scottish Government has now seen final drafts of all three SIs. We are therefore satisfied, that is the Scottish Government, that we have sufficient information at this stage. That is the view of the Scottish Government in relation to these particular items. We may wish to agree to write to the Scottish Government and to indicate that we are content for a UK statutory instrument to be given. However, Keith Brown indicated that he would want to make that condition and, in some way, tie that to an evidence session with the minister on agenda item 3. I can also say that, if this is the chance to speak on it, I think that it is far less than satisfactory that it would be nasty consent to this, which in certain circumstances will become the law of the land without seeing final versions, even with the assurance that the Scottish Government has seen them. This committee and this Parliament is not the Scottish Government. The committee and the Parliament are an obligation to satisfy itself as to the provisions of a legal requirement. If we agree with that, the difficulty will be that, in future consideration of future items—and we are told that there are lots of those to come—we will not have that. In addition to that, it would be useful to have an assurance from the UK Government—and I don't know who the appropriate minister would be—that we are not going to be put in this position again, that we will get to see final versions of proposed laws before we are asked to consent to them. I raised concerns particularly about the blood safety. I must concur with my colleague Keith Brown on that. We have not in this committee seen the final version—it may be with the Scottish Government as a draft, even—but we have not seen that, and I am quite concerned that this committee will be passing something that we have not actually seen at all. If it is a wish of the committee, the Scottish Government says that it is okay. I am happy to go along with the committee, but I do have concerns that particularly the blood safety aspect of it has happened in the past. We do not want to get caught up in this committee on something that has passed, and we have not actually seen the wording of it yet. I absolutely appreciate the point that has been made. Unless there are other views expressed—I know that we have discussed those matters previously—we should make a determination just now about whether we accept the timing subject to the minister's reply to a question in the forthcoming session. In any case, in addition, we should act on Keith Brown's suggestion that we write to the UK Government again and seek confirmation that in future such legislation, that final drafts will be available in line with our timetable. After all, it is the purpose of having an agreed timetable. However, as long as the minister is able to assure us that he will revert to us if there is any change in the policy substance of those particular regulations, then if we have that assurance this morning, we should agree to the Scottish Government giving consent in line with the timetable, if that is agreeable. Thank you very much, colleagues. The fourth item of the agenda is a negative instrument, which is the National Health Service general dental services, miscellaneous amendment Scotland regulations 2018. Those are simply delayed by a year of the date of implementation of electronic payments for orthodontic treatment. Can I ask if members have any questions or any points they wish to make? If not, are we agreed that we should make no recommendations on this instrument? Thank you very much, colleagues. The next item on our agenda—my apologies. We have skipped agenda item 3, so we will revert to agenda item 3 and deal with further EU legislation. I am delighted to welcome the minister, Joe Fitzpatrick, Minister for Public Health, Sport and Well-Beam. Neil Mojie, who is a solicitor from the legal directorate, Elsbeth MacDonald, from Food Standards Scotland, the head of strategy and policy there. To address questions that the committee will have in relation to, again, a number of statutory instrument proposals from the UK Government. Those are the general food law, the general foodstuffs hygiene, the specific foodstuffs hygiene, the contaminants in food and the quick-frozen food in each case, EU exit regulations. Can I invite the minister to kick off with an opening statement? Good morning and thanks for providing this opportunity to give further clarification as to why I am recommending that the committee should consent to the UK-wide statutory instruments that are applying in Scotland. As you know, the Cabinet Secretary for Government, Business and Constitutional Relations wrote to the conveners of the Finance and Constitution and Delegated Powers and Legislative Reform Committee on 11 September, setting out the Scottish Government's views on EU withdrawal. That letter also said that we must respond to the UK Government's preparation for a no-deal scenario as best we can, despite the inevitable widespread damage and disruption that that would cause. It is our unwelcome responsibility to ensure that devolved law continues to function on and after EU withdrawal. The rationale for the proposed changes that those instruments will make is to ensure the continuation of important consumer protections provided by the current EU food and feed regulatory regime. That will maintain the high standard of food and feed safety and hygiene that we currently benefit from as a member of the European Union. It is clear that the committee understands the importance of the legislation and, given its complexity, has understandably asked for additional information and clarification that I have provided to you in writing. In essence, the additional information related to firstly why the committee had originally only received eight days for scrutiny. That was due to the timing of the notification of the proposals from Westminster and that coinciding with the Scottish parliamentary recess. I am pleased to advise, as I did in writing yesterday, that officials have worked with their counterparts to negotiate revised laying dates at Westminster, which now gives the committee its full 28 days from the original notification being made. That is obviously very welcome. Secondly, the committee asked why the instruments had been categorised as category A as opposed to category B, as described in the protocol agreed between the Scottish Government and the Parliament, and I provided more information in response to your questions. However, it is fair to say that the intention of the categorisation is to be a guide to the committee and to help assist with overall prioritisation, but the committee itself is, of course, entitled to ask for evidence, hence we are happy to attend your meeting today. Thirdly, you asked for clarification in relation to any possible implications arising from the recent BSE case in Aberdeenshire and any impact on those proposed regulations. I have written to confirm that those regulations are not directly related to BSE controls, and there are no impacts in relation to those proposed regulations. Those instruments do not modify the principles or technical standards in the EU law, which has served us so well, but are about ensuring its continued operatability, should there be a no deal between the UK and the EU by the end of March next year, which is a situation that I am sure you all agree we want to avoid. The EU laws, which are covered by those fixing instruments, are concerned with general principles of food law, technical food hygiene standards and limits and levels of contamination in food. The instruments provide the mechanism by which the retained EU law in those areas might be modified in the future, and when it is considered to be required. As you fully expect, we have ensured that the provisions within the regulations provide that any such modifications in the future with regard to Scotland respect the devolution settlement. None of us want to find ourselves on 29 March 2019 leaving the EU against our will and with no deal, but we must ensure that, should that happen, as a consequence of the actions of the UK Government, there is a sound legal basis to the regulatory system for food safety to ensure that we can continue to protect public health. I hope that that is helpful, and I hope that any responses were helpful as well. Indeed it is. Thank you very much, minister, and it is clearly a success in encouraging the UK Government to abide by the agreed timetables and to acknowledge the importance of the Scottish Parliament having a different timetable in terms of our own proceedings from the UK Parliament, so that is very welcome. Are you content, minister, that having established that precedent, having won that or got the right result in that discussion, are you content that that establishes a positive precedent for further items of legislation of this type? I think that we have to recognise that, to some extent, in terms of those orders, we are, to some extent, subject to the timetabling of Westminster, so I think that this may be a challenge going forward, but I think that it is very important that we continue to press the rights of this Parliament to scrutinise these instruments, and I hope that the message has got through to some extent in Westminster. Thank you very much. Alex Cole-Hamilton Thank you very much, convener. Good morning, minister. Thank you for coming to see us today. I just wanted to ask about accountability in this, and how confident you are, minister, that Food Standard Scotland has the requisite skills, competency and preparedness to take on the functions designated by those SSIs? The functions that are transferring to the FSS are actually quite limited and they are in line with the role of FSS, as defined in the Food Standards Scotland Act 2015, which set up Food Standards Scotland. Accountability of Food Standards Scotland remains unchanged, and its accountability is directly to this Parliament. On that basis, the future accountability for the functions described here we will still have the whip hand in that regard. Yes, absolutely. There is no change to the accountability of Food Standards Scotland in that it is an unusual body, because other similar bodies are countered directly to ministers. Food Standards Scotland is directly accountable to this Parliament. Thanks, convener, and thanks, minister, for coming along today. Can I say that I probably do not agree with the idea that this has been a success in getting UK Government to change the deadlines? It seems to me utterly pointless to change the deadlines if we do not actually get the detail of what is being proposed. On the briefing note that we have received, the process asks us to make a particular decision on legislation without actually having seen the detail of that, which I think is a difficult position for this committee to put itself in. I would hope that the Scottish Government would support the idea that it is not just that important that Westminster complies with the timescales, but that it takes into account the fact that we have a recess just in saying what they do, apart from anything else, but that they actually give us the detail and we do not have the detail. We have not to rely on what the Government says it is seen from the UK Government, and that is not enough for the Parliament or the committee to go on. More particularly, can I ask about the issue of, as is raised in our briefing note, the potential for policy divergence here? In particular, if we have policy divergence as a result, and I appreciate that it is only applied in relation to a no-deal scenario, does that policy divergence open up the possibility, for example, that either the UK Government acting on its own can prescribe for different parts of the UK, say, for example, the acceptance of chlorinated chicken in relation to hygiene and foodstuffs, and that would then undermine any position that the Scottish Government or any other devolved administration would take in relation to, for example, not wanting to have chlorinated chicken? First of all, to the fact that it is highly unsatisfactory the whole process, but that was what we knew that was going to be the case, and that is why the protocol between the Scottish Government and the Scottish Parliament was formulated in the way that it was, because we did expect to be in this position where we were having to take evidence without seeing the final draft, and Neil will maybe talk about that process in terms of timescales. That is exactly why the protocol was established, to make sure that there was the opportunity to have scrutiny. Clearly, if the final order instruments that are laid are not in line with what we have been told and what we have told you as the committee, then we would have to take a view and we would either come back saying that those orders are as we expected, and that is great. We recommend that we continue, or that those orders are slightly different, but we still think that we should continue as before. Alternatively, if there is a significant change, we might come back and say that those orders that have been laid are not what we were expecting and we therefore do not recommend that they are approved, and we would then have to look at what other mechanisms we would take. In terms of future divergence, you can rest assured that I would not be in the position of recommending those to the committee if they effectively gave powers to the UK minister to make future divergence against the wishes of this Parliament and the Scottish Government. The orders that we expect them to be laid would respect the devolution settlement, so even in the future, the UK Government decides to go down the route of potentially wanting to be able to have chlorinated chicken in order to have a deal with the United States. As those orders are on the face, we would be able to diverge from that and ensure that we maintain to the higher standards of the European Union. One of the big risks here that is not directly related to those orders is the loss of our access to the European food standards agency, which is internationally a gold standard, not related to those specific instruments, but clearly it is something that it would be of concern if, in the case of a no-deal Brexit, we lost that wealth of expertise. I think that you are quite right in relation to the rapid alert system for food and feed. I think that it is also very worrying that we will no longer be involved in that. I am not going to ask a question with that. I just mentioned the fact that I have been thrown from some European norms. Going back to the point about what information that we have before us, I understand the point that has been made that the protocol allows for that, but I would ask that, first of all, the reason for this is not to do with anything that the Government of the Parliament has done. It is because it has been so late in the day coming forward with those proposals. That is why we are now in this position. Would you not accept that it cannot be right for a legislature to agree potential new laws or legislation without having sight of the detail of that, first of all? That is highly unsatisfactory. The whole thing is highly unsatisfactory, the whole process. Neil, do you want to talk a little bit about the timings in terms of what you have seen in terms of the draft orders, in terms of giving me advice that I have then clearly passed on to the committee? Yes. I would say that, in most cases and certainly in the cases of the instruments before this committee, the Scottish Government has not seen the final draft at the point that we present the notifications. The SIs are still being finalised ahead of their laying at Westminster, so we are trying to provide as much detail as we can in the notifications, taking account of the fact that the SIs are not final and are not yet in the public domain. However, at the official and legal level of the FSS, we are seeing drafts from the FSA at every iteration. My team is working closely with its counterparts in the UK Government, the Food Standards Agency, in this example. We have regular sight of the way that these draft instruments are developing. We are obviously working closely with our legal advisers in SG. The information that we are able to provide to you is on the basis of having been very closely involved in this process. As Neil said, they are not at the stage of being completely final text yet, but we are able to provide the assurance that we have been working closely with our counterparts. We have been our focus clearly around ensuring that we have got our ongoing continued protection of public health and ensuring that we can protect the interests of this Parliament and of Scottish ministers to make determinations in relation to Scotland. I think that you are confirming that, both in relation to these items and other items, should there be changes in substance after this stage, you will revert to the committee and not proceed? Absolutely, we will revert to you and say why we were suggesting whatever. Okay, thank you very much. David Stewart. Thank you, convener. Thank you, minister and officials, for coming along today. Clearly, there is a lot of vagueness in the Brexit negotiations, as we speak. What we do know from today's discussion is that we have put through the general food law EU exit regulations, we are going to revoke EU regulations 16-2001, which sets up the rapid alert system for food and feed. Now, the commission, as you know, minister, has made it clear that, thanks to this alert system, that we have averted food safety problems across the whole of the EU and the Eftah countries as well. This will disappear, so we know that categorically. What recent discussions have you had with the UK Government to set up a UK-wide system to stop problems happening before it can have major food safety problems in the future? You are right. Those are really significant matters which have to be resolved. Clearly, the best way of resolving them would be for us to be able to remain within the EU if not then a Norway-style deal that would allow us to have access to all those protections. There is still hope that we do not end up with that no-deal Brexit, but we have to plan for that worst-case scenario. If there is a deal, there would be legislation around that deal that would withdraw those instruments and put us back on to a better footing. There is work on going now between the FSS and the Food Standards Agency to look at what frameworks we need to put in place for March next year in the event of a no-deal Brexit. Clearly, we have been working very closely with our counterparts in terms of no-deal contingency planning. The instruments that we have in front of you today and lots of others are part of that. There is a huge amount of operational readiness contingency planning that is also required. We recognise that, in the event of there being no deal, loss of access to EU systems is something that we would clearly need to address. We have been working with our counterparts in Food Standards Agency in terms of how we could develop replacement systems or replacement arrangements, whereby we would continue to get information about food safety risks in other parts of Europe and other member states and countries that are still in the EU. There are other ways by which we can try to ensure that we continue to have access to that set of information so that we can act quickly to protect the food chain, but we completely recognise that loss of access to these systems will bring significant changes to how we have to operate, but there is a lot of planning going on behind the scenes to address those points. It would seem to me that there is obviously lots of complexity here, but it is not rocket science just to replicate the European wide model with the UK. How far down the track are we? Is it very likely that this is going to happen? Is there a plan B to have a draft UK rapid alert system for food and feed and is something recently happened about this? What we will still have is that there are different layers of access to the rapid alert system for food and feed. As a member state, you have obviously the most detailed level of access, but there is still a public level of access that we would still be able to have as the UK outwith the EU. However, there are other systems. For example, there is a system called InfoSan, which is a more international system that draws information from RASF. That will allow us to have timely and up-to-date information about food safety risks. In terms of within the UK, we already have very close working relationships across the four countries. We are pretty efficient already at working collaboratively across the four countries in terms of dealing with any food incidents, being able to ensure that we exchange information, and that operates pretty well at official level, and I do not see that being affected as a consequence of this. It is more about the access to the EU and the international information. I have just one final question. I am not disagreeing with the point that you are making, but clearly what we have in the rapid alert system is a gold standard across the 28 plus the four countries in the EU. What you are suggesting is a system lower than that. Are you able to replicate what currently happens with the other nations in the UK very quickly on the basis that we withdraw with no deal from the EU? I think that that is certainly the intention, but obviously until the final details of that contingency planning is determined, I cannot provide that assurance that it would be every bit as good. But we are withdrawing. So this instrument withdraws us from the scheme? In a no deal situation, the UK would not be able to remain within the rapid alert system for food and feed, whether to be a negotiated settlement and a deal between the EU and the UK. That situation might be different. Thank you very much. The area where the Scottish Government has responsibility in these areas is in relation to the categorisation of instruments and that falls to yourselves. In this case, in relation to the general food hygiene regulations and others, those appear to confer powers on ministers. Therefore, the question that I think was raised with you was why the categorisation of those was as category of a technical nature rather than category B of greater substance. I wonder if you would like to respond to that. I think that if members look at the protocol that was agreed with the Parliament, the category A is effectively technical but also when there is not a policy change. And so, while there are powers moving, these instruments don't change anything on the ground in effect, so one minute before Brexit, one minute after Brexit, the technical application of these regulations would be the same. So there's no policy choices within these. However, it is a call and clearly this is simply guidance. Government makes our call. It's about helping prioritisation and it's absolutely appropriate for the committee. If you decide that you want to be more robust in your scrutiny, then absolutely respect the committee's right and that was written into the protocol as well, that the committee can make a different and take a different view on that. That doesn't affect your view. It's effectively aimed at helping you to prioritise. I understood. Good morning. I just wanted to follow up on Dave Stewart's point. David Stewart mentioned that the European Food Standards Agency is the gold standard. Given that the UK has been part of developing that gold standard, in fact probably one of the key driving forces in developing that level of standard, why is it that we're considering the potential then for it to be—even in terms of a no deal—that we would have a lower standard than that when it was us that drove those standards in the first place? What we have to recognise is that in the event of a no deal scenario we may not have access to the European Food Standards Agency in the way we do just now. To be clear, it is not just EU nations that have access to the agency, so it is possible that if there's anything better than a no deal Brexit that we might manage to have access to that, that is the gold standard. Clearly it is our job to make sure that the law works as it should, which is what these instruments are doing, but going forward, if we don't have access to the European Food Standards Agency, we need to make sure that we have something else in place to maintain those standards at the same level. Our view in the Scottish Government is that we would want to remain the standards as closely aligned to those that our European neighbours have as possible. There's obviously the on-going discussions between FSS and FSA in order to try to make sure that we have that backstop of something. If we can't be part of the European Food Standards Agency, we need to do something else, so that's why those discussions are on-going. One of the things that I should point out is that all this work is going for the worst case scenario. Clearly, I think that everyone in the room here is hoping that that's not what we would get to. A huge amount of effort being spent to deal with this scenario, which should have been ruled out by now, and I think that that's the most frustrating thing, is the huge amount of this Parliament's time and the Scottish Government's time, the Food Standards Scotland's time being used to prepare for a worst case scenario that we all hope won't happen. I'm asking a very specific question. What I'm saying to you is that the UK has been the driving force in developing the gold standard in the European Union. Why do you think that, in no deal, we would reduce our standards? I don't think that that. I think that we are going to have to work to make sure that we can set something up to maintain those standards, whatever they are, and that's why that work is on-going between the FSA and the FSS to make sure that we can maintain those standards. That has to be our aim. The idea of chlorinated chicken just horrifies me. I think that that point is understood, and finally Miles Briggs. I think that it's just important to get on record to follow David Stewart and Brian Whittle's questions, that what we're achieving is that post, and I'd like to hear from the panel, post Brexit, that, with regard to food standard legislation, it will be just as strong as it is currently today. I think that kind of scaremongering doesn't help with that debate. Also, in terms of a specific point, I take it that you accept that this is best to do those regulations on a UK-wide basis going forward. I'm recommending that those specific instruments are recommended to be accepted on a UK-wide basis. It is important that those regulations respect the Scottish Parliament's place and that those matters are devolved. Any future arrangement between the FSA and the FSS on those matters is important that Scottish interests are protected in there. I'm sure that you'd imagine that the Scottish Government will make sure that that is the case. However, I agree that it is important that we look at what we're looking at through clear glasses rather than through roast tinted or some other more opaque glasses. What those instruments are about is about making sure that the law, the day before Brexit withdrawal, is maintained the day after. Thank you very much Minister. I think that that meets the questions that committee members had. I'm grateful to you for your time and we will no doubt be in touch regarding many of these instruments again in the very near future. Thank you very much. Suspend briefly just while the panel changes. We will now resume the next item on our agenda is the first of our public evidence sessions on the Human Tissue Authorisation Scotland Bill. The bill, as everyone in the room, I think will know, proposes to introduce a system of authorised consent or deemed authorisation for organ donation in Scotland. We have two sessions today to hear from patient and public representative groups. Can I welcome to the committee David Maculgan, the Senior Policy and Public Affairs Manager for Devolved Nations with the British Heart Foundation, Harpreet Brang, the Information and Research Hub Manager with the Children's Liver Disease Foundation and Julian Hollis, who is attending in a personal capacity as a lung transplant recipient. Can I welcome you all to the committee and thank you very much for offering to give evidence today and indeed further written evidence that colleagues have seen and I know found very informative indeed. I simply start by asking members of the panel what is the need for legislative change in this area and do you think that the deemed authorisation under the bill will result in a marked difference in practice? Who would like to start? David? First of all, thanks for inviting us to the committee. It's great to see this bill coming back to the Scottish Parliament. The British Heart Foundation has been pretty clear in our support for opt-out over the past several years. Our biggest concern is the gap between the need for organs and the number of organs that actually do become available. I think that the biggest challenge for anybody looking at organ donation is the gap between those who are willing to donate after death and those who actually get around to donating. A number of polls have shown that in the UK around about 80 per cent of the population would be willing to donate their organs. However, in Scotland, only 51 per cent of people actually get around to registering their wishes. That gap is a challenge. One of the other big challenges is those who register are willing to donate but actually follow through to donation. I'm sure that the committee are aware that family consent rates in Scotland are the lowest in the UK. That's been since 2014. One of the challenges around that is how do we increase family consent. I think that the Wales experience has been really crucial. In Wales, since 2015, when opt-out was put into operation, there has been a 50 per cent increase in family consent rates up to about 72 per cent. There has been a lot of myth around Wales, around follow-through to donation, but we are really interested in that family consent. I think that opt-out, certainly soft opt-out, is a really good way and the evidence is there to show that it does increase family consent rates. I completely agree with all those points. I think that, also with this legislation, it's trying to encourage people to make a choice. Some members of the public might think that they're being forced into donating the organs of that family member. It's encouraging people to make a choice about it. I think that that is another opportunity in terms of this bill. Thank you very much. In terms of the families that we work with, a lot of the families of the children with a liver condition say that until their child was going through the treatment and needed a transplant, it didn't always come into their minds to consider organ donation. As soon as their child needed a transplant, they were registering as soon as possible. Often, it's a fact that people don't think about it beforehand and that it doesn't lead to them taking action to sign up. They sort of put them to make a decision either way. Thank you very much. Gillian, I know that you're here in a personal capacity rather than as a member of the Scottish donation and transplant group, so feel free and we're certainly interested to hear your views too. I suppose, like everyone else around this table, I'm very pro any means to increase the number of organ transplants that take place each year. I've seen the benefits myself, there have been 15 fantastic years. Over these 15 years, the Scottish Government, the NHSBT and the NHS have done a lot of things to increase the number of transplants that take place. First of all, I think we should be celebrating that and the achievements of the last decade, 15 years, because they've been real inroads made. Opt out to me immediately after my transplant. I was completely in favour of it. I thought it was a no-brainer. Why would you not? I think I've been working on committees and groups associated with transplantation for the last six years in particular. I've found that my view has changed a bit. I'm not convinced that moving to a noctite system is the right means of doing it. I think it's far more nuanced, and I can see from the briefing note and the discussions that have come in, the comments from people that some of those nuances are things that we'll be talking about in this session. Yes, indeed. One particular aspect of the current law 2006 act and also of the bill is that neither of them formally provides for family objection, but they both are designed, I think it's fair to say, in the expectation that if a family are not content, then a transplant will not proceed. Do witnesses feel that, once again, not explicitly referring to that in the bill as appropriate, or should there be an explicit reference in the bill to that point? There might be a lot of backlash from not making it clear to people what that family's role is. I noticed in the briefing notes that there was discussion about families can provide information in regard to Dean's authorisation to say whether that family member would have changed their mind or not agreed with the decision to take their organs, but it might not be overly clear to that family member what that information is that they need to provide and how to provide it. I think that, as long as that's made clear enough, then it's clear that they still have a say and they're still involved in that process, then the opt-out approach could still work. It's about changing people's perceptions of what it actually is. It's a hard thing, and certainly the idea of the 2006 legislation was to try to take away that right of veto of the relatives. However, my experience of speaking to medical professionals on this issue is that, if you've got a situation where the relatives think, I don't want that to go ahead, it's the front page of the newspaper scenario. None of these doctors are going to go ahead against vehement reluctance or prohibition from the relatives. My own experience in this was coloured somewhat by taking part in a Radio 4 discussion a few years back, and it was all opt-out. I went in very naïve, I suppose, and very positive, and was actually quite taken aback. It was a phone-in. There were a lot of very strong views on this, and relatives felt very strongly that they should play a part as well. Thank you very much. A very brief supplementary article. Gillian, it's remarkable to hear your story. My interest in this area comes from personal experience as well. My close childhood friend Anders needed a transplant for the 30 years of his short life and got that, but it died sadly very shortly after because of complications, and he sort of drove my interest in favour of an opt-out. I'm just really interested to hear about your unpacked journey as to why you were very in favour and now you're less so, and what's caused that? I think it's one of these things where I'm in reading the transcripts of the commons where the English bill was discussed last week. I was very struck by, it's a really feel-good bill and thing to do, that it feels like doing the right thing to move to an opt-out system. I think it was only when I started looking at some of the implications and talking to some of the specialist nurses about the discussions that they have, and hearing some views of other members of public that got quite upset about the idea of the state having some issue over their body, control over the body in a way, that I just realised that it was so nuanced and not as straightforward. I mean my background, I did a law degree and ironically, this was before I was ill, medical jurisprudence, medical ethics was one of my subjects, so this is the kind of thing that I'd studied as a student and then came back and actually seeing it. I'm intellectually interested in it, but I've just found, I'm less enthusiastic about the move to opt-out than I was, say, 10 years ago. It's not because I don't believe in increasing organ donation, I would do anything if I thought, I just feel that there's a potential for a bit of a backlash. Thank you very much. David Stewart. What assessment have you made of the element of gift in the cadence system? Can we start with Gillian Hall's, because your submission was very interesting in that particular point? I think that the gift is something that is very important. I owe my life to my donor and their family and the fact that it was an active decision to give organs a long-to-me, a heart to the girl who was transplanted the same night as me in the same hospital who received the heart and who I've kept in close contact with. I mean we really appreciate that gift and it's a very important part of the process for both sides and I think it's something, you know, should this bill go through, I think it's very important that that element of gift is retained as much as possible, because it is people helping other people and that is a true gift, a donation is a true gift. I think that the point of gift is really, really important. I think that Gillian raised that in our evidence as pointed out. I mean, from a British Heart Foundation point of view, we don't see moving to a soft opt-out system as removing that choice of a gift. All we see it as a change in the initial conversation, so people will still perfectly be within the right to opt out. People will actually be able to register their objections much more strongly and legally than they currently can. There's a reason why British Heart Foundation don't support a hard opt-out that doesn't involve the family compared to a soft opt-out. I think that the big part of that is maintaining that positive choice to donate rather than a state-sanctioned donation, which soft opt-out absolutely isn't. We don't see the concept of gift being removed through soft opt-out. We just see it changing the initial conversation at the start. In a conversation that I recently had with one of our Scottish families, the idea of a gift was something that she explicitly said. The mother was completely in support of a soft opt-out approach, but she said that when her daughter received a split liver transplant, she said that they were ecstatic because if they hadn't received it at that time, then their daughter wouldn't be alive right now, but then she remembered that for her daughter to get that liver transplant, someone else has passed away, and they did see it as a gift, the fact that someone chose to donate that liver. She said that she would feel slightly more uncomfortable about it if she knew that it wasn't a choice that they made actively, but looking at the soft opt-out approach, people are still given a choice, but it is the idea of a gift that still needs to be retained, as Gillianne said from both sites. How important is the simplicity of message in the bill to quote from Gillianne Haas's submission? She said that it is quite a complicated language. Tell us if you want to donate, tell us if you don't want to donate, and if you don't tell us anything, we're presuming that you've got authorized donation. That, as a layman, seems complicated to me. Gillianne Haas? That's something that I do feel, just from talking to people as there's work going on about the opt-out bill, and people say, oh, I thought that had gone through already. People are not aware generally of what's happening. I do think that it's a complicated message. Some of the terminology doesn't help. Deemed authorisation is quite obscure. Opt-out, opt-in, as I said in the submission, there's lots of double negatives possible there. I think that it's going to be challenging, but it's very important that the message is clear, because we're all of us wanting to do a good thing, and we need to make sure that we convey that message as positively as possible, but as simply as possible so that we get it across, especially when you're moving to default position where we're saying that the organs would go to donation anyway. I think that it has to be simple. The interesting thing about the opt-in and opt-out, and we had this debate when Anne McTarget brought our members' bill forward, but we kind of defaulted to Wales, where there was actually quite a movement during the Government legislation to retain the opt-in. The original Welsh Government legislation was going to get rid of the opportunity to opt-in, but many people still want to make that positive choice while they're alive. Many people are quite proud of carrying an organ donor card, and that was one of the reasons why we've retained opt-in. I don't dispute Gillian's point around confusion around that, but we've got to look at organ donation campaigns that have happened up until now. None of them have spoke about opt-out. None of them have spoke about any of the messages that were here. If we learn from the Welsh experience, where they had an 18-month campaign, the vast majority—it was over 80 per cent of the population—understood the legislation, there's not much legislation that comes out of the Scottish Parliament that has that level of understanding. One of the reasons why BHF really likes this bill is that compared to the English bill, for example, there is a duty on ministers to communicate the legislation. That will be very important in the run-up to that. While the legislation may be confusing right now, and that can be said for any piece of legislation, it will be about how the communication from the Scottish Government comes out, following if the bill was successfully passed. That's just a quick supplementary. We're unusual in Scotland in having the money devoted to organ donation campaigns that we've had over the past few years. I think that all of us really appreciate that. I think that's made a huge difference in getting the number of people on the organ donor register higher in Scotland than anywhere else in the UK. It's against that background of getting money for campaigns and having good campaigns. I really appreciate that. Harper, do you want to add anything? In terms of the bill being made very simple, this is an opportunity to shift people's attitudes as well, and perceptions and the culture surrounding organ donation. The more simple you can make it, the more efforts and investment you put in raising awareness. It needs to be very simple. The more effective it will be in increasing the number of organ donations. My final point, convener, is a very general point. What is your assessment of the issue of deemed authorisation? Will that increase donation rates and subsequently save lives? Just to reiterate my introduction, nine out of ten countries across the world or the top ten countries across the world in terms of donation rates, nine of them use an opt-out system. The only one that doesn't is the United States. When we did this bill a few years ago, many people wanted to see what happened in Wales because it's a similar healthcare system and a similar culture. The evidence here has shown that there has been a significant increase in family consent rates. One of the points that Gillian touched on earlier was the specialist nurses. In Young et al's analysis of the Welsh experience, he said that specialist nurses found conversations to be much easier and families to be much more informed. One of the things at Wales has been a bit of a smoke and mirrors. Organ donation rates haven't increased massively, so they estimated 20 per cent. In Madden's analysis of the legislation, they put that down to eligibility of donors. We can't predict how eligible certain people will be for donors, but what we can try and shift is that family consent rate, which is countries that have high donation rates, has high family consent rates. Scotland has the highest percentage of the population that is opted in already, but we are the lowest in terms of family consent rates. That is where we are really to move the culture. We believe from international experience and the Welsh example that family consent rates can shift using an opt-out. Emma Harper I will pick up again about the number of donation rates increasing. First, I need to remind everybody that I am a former member of the liver transplant team when I worked in Los Angeles. I am interested in the increase in donation rates. It is about a cultural change and you have alluded to that because there is no single measure that will increase the number of donors that we have. You have already said that in the bill the Government has a duty to communicate to people, so how would you expect that communication to be delivered? As I said earlier, the lead-up to the implementation of the legislation in Wales was an 18-month communication campaign, which was highly effective. One of the other things that is interesting in Wales is the increase in people who have decided to opt-in since they brought out the opt-out legislation, so more people have got round to doing it. I think that communication is key. The Welsh Government used a whole multi-channel approach, so it did a great radio campaign. There was a whole raft of literature that was used by the NHS and organisations such as the Beatsheff in Wales. We live in a multicultural, multilingual Scotland and we need to make sure that any legislation or campaign is targeted to all communities in Scotland. The seven words to save seven lives campaign that the Scottish Government ran recently were really good. The Scottish Government has clearly got something that is working for it in terms of getting people to opt-in. What we now need to look at is how we move the family consent. Any sustained campaign or organisation is going to be effective, given the experience that the Scottish Government has had historically. I think that the dean's authorisation on its own does not necessarily mean that organisation rates are going to increase. It is all about taking a holistic approach to it and that could be in terms of starting with the communications to the public as soon as possible. For example, like I mentioned earlier, many of our families don't actually join the organisation register until they're actually affected by it or understand what it's there for. It might be surrounding promoting and showing people the lives that it affects and how it affects them and how it can save lives. A lot of people, especially in certain cultures, don't like to talk about death and they don't like to think about that stage of their life. I think that trying to start that communication as early as possible with certain groups and older generations don't like to talk about that stage because of the fear of it. It's about being able to talk about it more openly and the language used and the routes, for example, in not always being through online portals, through different routes of communication. I think that it is a continuation of what's going on at the moment, which has been an increasing acceptance of talking about organ donation publicly. In hospitals, there's a whole hospital approach where all the staff, whatever their department, are encouraged to think about it rather than just the areas that are dealing with intensive care or accident emergency. There's also been a bit of a shift to trying to get discussions about organ donation as part of the usual part of end-of-life care as well, which has been quite important. There are smaller cultural changes that will make a difference. The more regular campaign that's on-going with educating and starting at school age and up is very positive and helpful. Can I just come in on Emma Harper's question? I noticed from the evidence that countries who already have soft op-types such as Israel, Belgium, Norway, Spain and Sweden have higher rates, and specifically with regard to Spain, they introduced their system in 1979. I just wondered if there's any evidence of what they've done differently, or has that been a cultural shift over time as well? I suspect that you'll have a bit more information on Spain because it is very much held up as the model of organ donation, how to get organ donation rates up. Again, if you look more closely at the figures, they brought in optat, but it was only 10 years after bringing in optat that they really saw a big difference, a big increase, and that was due to infrastructure changes, so bringing in the way that their teams were organised, the availability of retrieval teams, operating theatres, public awareness. There were a lot of things that went on there. I think that we've all, in our submissions, talked about the raft of different proposals and different infrastructure things that have to come in at the same time to make a difference in the organ donation rate. In international evidence, there's a whole range of different opt-out systems, if you would. Every country that runs opt-out has brought the legislation in, which is one of the three pillars that we look at as the BHF. Pillar number one is legislation, opt-out legislation, number two is continued infrastructure investment. If you look at some of the countries that run opt-out, some of the highest availability of ICU beds in the country, which is really important, and then also staff training as pillar three, so that continued investment. Spain is a really good example. They brought in legislation 79. They didn't create a national co-ordinating body to wait to nine. They then ran a really big media campaign in the early 90s, and that's when you really started to see the climb. I think that it's that kind of, I think that it was her previous said, that it's not the silver bullet in this legislation, but it's actually a part of a whole package. We need to continue investment, we need to continue training staff and then start that cultural change within Scotland. I thank the panel for the evidence and for coming along today. In particular to Julian Hollis, I thought that your evidence was great in terms of its clarity and its brevity, and I also very much agree with your point about it being complicated, the message that we're trying to put forward, but also your other point about how well things we've done over the last 15 years and the fact that we're doing the dedicated resource that you talked about. My particular interest though is in relation again to something that you mentioned about the rights of the individual. If somebody, an adult, takes a decision that they want to donate, what rights do you think that other family members have to override that? I suppose a related issue is, in presumed consent or deemed consent, what right does the state have to say that we will take control of your body to that extent unless you've expressed a wish otherwise. And I suppose a little bit added to that is, is there a danger if we continue to allow family overrides that that's more likely to happen in a situation where they're trying to override a deemed consent than it is an explicit consent? I think that's actually the nub of the really difficult issue, and it's something where you're not going to get consensus on these points, because under our existing system, and when we first talked about the 2006 legislation that did allow, in theory, doctors to override the relatives consent, there were still a lot of people who were saying, you know, we don't want that. There's very strong views on both sides, both from, you know, if I make a decision I want that decision to be carried out, I don't want my relative to be able to do that versus the relative on the day at this bedside saying you're not going to take the organs away from my loved one. It's very personal, and I'd probably sit on the fence a bit with both. I'm not sure what the correct answer there is. It's a difficult situation, as Gillian said, because family members are, if they have a very strong opinion, that they might see this as a bit of a state taking control in a way, but again, I think that comes back to educating them. It's a difficult one to, it's a matter of opinion on how people perceive it, and I think it's also about the staff that they're dealing with, the medical professionals that they're dealing with at that time as well. I think that the training that they have should be a sort of cohesive, collaborative approach with the family members, and I think that that might ease this sort of tension up a little bit in some way, but I think that it will always be there. Yeah, I think that I'm re-attaining what Gillian said. Our experience of working with clinicians on this is that no clinician is ever going to go against a family's wishes. We might have been speaking to the same person, but the front page of the newspaper analogy was given to me that if a family said no and said, well, the law says we can do it, and that's just never going to happen, but I think that the interesting part of this for me around Dean Consent State ownership right of the individual is that the family's decision and the family's role in the whole process is made significantly easier when the wishes of the individual is known, so we know that families are less likely to object to the nation if they know their loved one wanted to donate, and I think that the same would be the flip if they knew their family member adopted out. I think that the family role becomes much easier just to confirm that their family's wishes. I've met through the consultation on Anne McTaggart's bill. We met families where the children were all for organ donation, but the parents said that they wouldn't do it, and that's a really challenging conversation to have as a family, but I think that what we want to do through opt-out is to make that conversation easier, to make those conversations more likely, and I think that it really does start to take out that legalese challenge of state ownership because the family really understands their role within it, and I'm not sure that's in the current system, as I quite understood how often the family are involved. For my reading the bill, this doesn't make the family's role any clearer what's proposed. There's nothing explicit in the bill that I can see but the role of the family. I'm really interested in what you think allows the rights of the views of the family to supersede the expressed wish of the potential donor, either not to donate or to donate. I understand the point that you make about medical professionals. Perhaps that would be easier if it was in law what the position was, but what is your understanding of what gives the family that right? Obviously, there's the family nature, but if that person has made a decision, another point that I try to make is if this goes ahead as planned, is it not likely to be the case that families, if they get this continued, non-legally acknowledged right? Are they not more likely to challenge it when it's a deemed consent than they would do if somebody explicitly consented to it? He or she never agreed to this. It's just because it's a law and I'm going to object it for that reason. Where do the family's rights derive from? Is this not going to be counterproductive in terms of family veto? In the point about deemed consent, if someone hadn't opted in or opted out, the legislation is very clear that they are in to donate, so they have not made the explicit statement of, I don't want to donate, unless they'd said to their family members, look, I don't want to donate but I've never got round to opting out. Those cases are written in. I completely shared the challenge around where does the family have a right to overrule, so if someone has opted out, we would see it as that person is out and the family shouldn't be overriding their decisions. It's the same as if someone has opted in, but we do know that already happens. There are a number of reasons for that. I would never want to find myself in a position where I would have to make that decision to donate someone's organs even if they had opted in or out, because it's a high stress situation. I would come back to Gillian's point around effectively training staff to have those conversations. I think that there will always be cases where family members will feel they want to go against the wish of their loved one. Now, whether the Parliament wants to decide whether to make that not possible to do or not, BHF doesn't really have a view on that. I think that you'll probably find that there are views on both sides of the aisle there when you're going through the evidence sessions or publicly as well. Okay. Anybody else want to comment? Brian Whittle. I just wanted to pick up on something that you said there, David, around a healthcare professional who will never go against the will of the family. I think that it's a dangerous statement to say, because I don't agree with it. I also don't think that we should be putting those kinds of decisions on to healthcare professionals, and I think probably to Keith Brown's point, do you not agree that if we could bring this bill forward, it must have absolute clarity so that there's no wriggle room there, so we're not putting those kinds of decisions on healthcare professionals, because I'm not convinced of your argument there. The point on healthcare professionals is purely anecdotal, so I've not polled all healthcare professionals, but it's a very common message that's given to us, and it's a message that we wrangol with when we're looking at this legislation and topic. On the point about the clarity of the bill, the clearer a bill the better for me and for everyone I think, and I think that the panels said that. I think that the less complicated it is, the better, the easier it is to communicate the better, and I think that it's important to bring that through. We do have instances at the minute where I don't have the figures to hand, but there are only in the five, six, seven, eight cases where families have objected to their loved one donating even though they've opted in, so I think what's interesting is to go back and look at, understand what those conversations were like and why under the current legislation the clinicians didn't say, well, we have the right to do this because your loved one's opted in under the current legislation, so I think that it's interesting to go back and look at why that's happening right now, why it still happens and what percentage of donations are where clinicians say we're going to do it. I mean, I think you find it be very, very small. Again, I don't have any evidence to back that. And we do have our Welsh colleagues who have been running a system for two years now, and I think I'm not sure if the committee is going to be hearing from anyone, but I think that they will have a wealth of experience already in two years about how those conversations have gone and what it's like. I mean, I think that that's where what the bill is proposing is a very big change in the default position, the deemed authorisation if you've not recorded a yes opt-in or yes or no opt-out. And that has to be made clear to people before you can then enforce the fact that it will be deemed and that's what's going to happen and relatives should not be able to override that. So again, it's something in the bill that is a very big change and will need to be communicated, and if it's communicated properly then it will be all right to be able to not to accept relative overrides. I think it comes back to again where it talks about the relatives need to provide evidence or information. I think being very clear about what that is will make not easier, but a little bit more clarification for the professionals involved in that process, because I think at the moment that that might not necessarily be clear, it will be just interpretation. Thank you very much, convener. I would like to ask about the family override again, and it struck me that when we took our informal evidence session with the specialist nurses who were talking us through the process by which that conversation happens currently, that they were revealed to us that there are literally hundreds of questions that are asked to families at the most difficult time when they are just coming to terms with sometimes very sudden loss of a loved one, and that it was a demonstrable deterrent to families from allowing consent, because they would sometimes or often bail on that process because it just became too long and too drawn out and they needed to collect themselves. Can we do something with this bill to reduce that bureaucratic pressure, or are we going to, by necessity, create further bureaucracy in this process? You are absolutely right that my understanding from the specialist nurses is that, and from reading papers on why donations did not go ahead, the length of time in the process and the amount of questions and bureaucracy that had to be answered was one of the very big factors behind that. I know my husband's cousin's husband died in a motorcycle accident, and she went through the donation process with her husband. This is now 15 years ago. She was horrified at the number of questions she had to go through, and she said, quite frankly, I got halfway down the first page and I can't do any more of this because, as you point out, the circumstances are so difficult. I am not sure the extent to which this bureaucracy is us having a better understanding of what can and can't be transplanted, and we now can do more and can transplant more organs. I am not sure if the extra bureaucracy is an essential thing, but I would certainly welcome anything that reduced that. Interestingly, from a patient recipient point of view, the forms that we are not being asked to sign now are a lot more bureaucratic and longer than ever. I just signed a one-page thing so that I will accept any organ and the risks that come with it. Now people that go on the transplant list are being asked to sign pages of forms and the different types of donors and the different risks that might associate with each of them. It is a very difficult position. I do not know how much of that bureaucracy is necessary, but if it can be reduced, I would welcome that. Any other witnesses have a view on that question? From our point of view, it is anything that is clinically safe. I think that we need to, I mean, that BHF would not have an opinion on that, but I think that anything that makes a process easier for families and streamlined as long as it is still clinically and medically safe, and I think that it would be defernt to our specialist nurse colleagues who operate that. If I may with a just a brief supplementary community, because we were told by the specialist nurses that this very much mirrors the sort of questions that you answer when you are donating blood, and I understand that. There is a need for clinical charity about what is coming in, but obviously that has not done in isolation. With blood, as with organs, there are tests done to just check that it is clean, that there is nothing, no contaminants, no diseases, but also we are asking very vulnerable families very intimate questions, which they may not actually be able to tell you the accurate answer on. If it is about sexually transmitted disease or lifestyle factors, it may be that they do not want to reveal that that was a fact or something going on in their family member's life, or they may not know. I do not think that there is actually that much surety that you could derive at that time, and I just wonder if we can dispense with part of that to give them that comfort, to give them that respite from quite an arduous questioning, and just wonder what you thought about that, whether it was still clinically necessary to probe those areas. Wearing another hat, I sit on an advisory committee, SABTO, which advises the UK and devolved governments on matters to do with the safety of blood, tissues and organs for transplant. We are doing quite a lot of work in that group to increase organ donation by looking at organs from people who might have previously been considered too high risk, or the particular organs might have a particular risk attached to them. We have been doing a lot of work on categorising different risks and how these organs might be utilised safely. That is being very successful in increasing the number of organs that are becoming available and can be used for transplant and increasing the number of transplants. There is a balance there between making sure that we are getting the safety part right, but not doing things that mean that it is far more difficult for the relatives to say yes to organ donation in the first place. If this can be used as an opportunity to cut down on the bureaucracy and the number of questions that people have been asked at such a difficult and sensitive time, then that is fantastic. We cannot really comment on how clinically safe it is because we are not medical professionals at Children's Liver Disease Foundation, but if there is that opportunity with this bill, it might be the ideal time to consider it. I will just ask a small follow-up in Gillian about the answer to some of my questions. You are involved in that. What organisation or groups have any of them at all been asked about the questions? Have they been consulted? Do you think that part of the bill should be a consultation because Alex Cole-Hamilton is absolutely right? Some of the questions that were asked were so intimate at that particular time that the people did not know anything about it. Do you think that that should be part of the bill? Should we be looking at reducing the question? Should we go out to consultation or should organisations such as yourselves be asked exactly what? I think that that was a time like that. We are all about advocating patients' voice and speaking on behalf of the public and getting their opinions and views on things because of the dates affecting them. For example, if you speak to family members who might potentially be asked these questions, you can derive from them what the most sensitive questions are and then work alongside medical professionals who know which one is absolutely necessary. You have to involve a lot of different stakeholders in that to come to the right in-between and the right level of… I suppose that my question is back to you, Sandra. Is it that we need legislation for that, those questions to be written, or is it a recommendation that can be made to NHSBT to look at it? What we have to remember is that organ donation is not Scotland and England, Wales and Northern Ireland, it is a UK-wide framework. We would need to work with colleagues across the UK to understand what questions would be appropriate across the UK and understand that in the current setup. I could not speak from experience when it was last reviewed, but I think that it is something worth looking at. It is certainly something that the committee has identified. I know that it was identified a number of years ago when a former MSP spoke about his personal experience. I think that it would be something that would be worth doing. I think that it is absolutely right that patient involvement and families have went through the process. That kind of framework to bring the best answer would certainly be worthwhile doing. That recommendation would go to the NHSBT, who are the people who are dealing with that and doing the questions. As David says, it is doing it on a UK-wide basis. Clearly, it is not just in Scotland. I agree with David that it is not probably part of the legislation, but it is something that, if a strong recommendation was made at that point to review, having said that, I do believe that it is being reviewed in NHSBT because it is being seen as a hurdle to increasing donor numbers. David Tollans Good morning, panel. In Wales, deemed consent applies to people aged 18 and over. In Scotland, deemed offerisation applies to people aged 16 and over. Do you agree with 16 being the age at which deemed offerisation should apply? We are happy with 16. We looked at this when the previous bill was going through and we looked at the legal age of consent in Scotland. It differs from the rest of the UK, and that is why we are happy with 16. However, if the consensus was to move it to age, BHF would not have any major opposition to that. However, the previous age was set just to tie in with the age of legal consent. David Tollans A reason to ask that question is that 16 unders a very hard group sometimes to engage with. How can we provide sufficient opportunity for young people to express their wishes on advancing reaching age 16? I think that this is something that the education in schools can be part of. I have done quite a lot of talks in schools sometimes as part of the curriculum looking at the personal social responsibility. Some pupils are covering it, and hopefully a lot of them are. The first thing I stress when I go in is that I am not here to convince you all to sign up to the organ donor register. That is not what I am here for, but I am here. One of the things I do want you to do is go home tonight and discuss with your families and find out what each of you views are. I think that it can start early, and it probably does have a place in the school curriculum to discuss organ donation. I completely agree that that discussion can start within schools in the school environment. The earlier it starts, the better, almost, because, like Gillian said, a lot of school children will go home and discuss that with families. You are targeting family members as well as the children, and educating people at a very early stage so that that culture change can happen from that age range. Given the point that David Smith made about the UK operating as one in relation to this, if it was to be passed at the point that David Torrance made in Scotland when it was 16, does that introduce legal complications for where organs can then go in the UK? That is a good question to it, so there is no immediate answer. Completely stumped there. As somebody who lives in Scotland but had my transplant in England because the Freeman hospital in Newcastle was the nearest long transplant centre, I think that my lung came from another part of the UK, not England, not Scotland. I do not know the ins and outs of how that would work. My understanding of the Welsh system at the minute, so we have two systems that operate in the UK. We have a soft opt-out in Wales and then the opt-in across the rest of the UK. As someone who is a frequent traveller to Cardiff, I would like to keep an eye on this, but there is a residency period in the Welsh legislation. I believe in the Scottish legislation, which is a year as well, before it applies to you. If something was to happen to me in Wales, I would not be treated under the opt-out system or be treated under the opt-in system. I would imagine there is precedence there for an English family visiting Scotland and someone who was under 18, they would not default to the 16, it would be the 18, which would be operated across the rest of the UK unless they decided to lower it as well. I think that there is precedence there for us to have a look at how Wales operates in their system. It is more the case of, say, a 16-year-old in Scotland and was a donor. Is there a restriction then on where those organs can go within the UK given the presumption that it must be 18-year-olds old and over elsewhere? I have a feeling that that is maybe a question that we will have to put to the Government in due course. Sandra White I want to touch on an issue of the pre-death procedures. It is something that grows great concern when we were talking to individuals and we had the private session as well in regards to if you are deemed to be brain dead or your heart has failed. Basically, a number of issues were raised about whether it caused the patient pain, even though the brain had not stopped, etc. What do you feel about that, about people where they are not deemed to be dead and are deemed to do the PDP's procedure on these patients? Obviously, it might be set out as regulations. Do you have concerns in regards to that? Families and people certainly raise concerns in that area. Julia Whittle This is an area in which I have a better understanding, although not a perfect understanding. I was at one organisation conference where one of the doctors said that his whole talk was on when somebody is actually dead and just talking about the difficulties and different definitions of death. That was an eye-opener to me because I had just thought there was one state or the other. What you get into with these pre-death procedures is that, for a lay person, it is quite hard to understand that someone might be dead under some criteria, but there are things that they ought to or can do in order to make organ donation better in these circumstances. The final point on the briefing note, some people said that there was distaste about the name of the pre-death procedures. That is definitely something that is an awkward phrase. It just sounds quite nasty, but it is not just about calling something a different name. Some of these things, I think that you have got to be clear with the relatives about what is going to happen there so that people do understand what is happening and why. That might involve a discussion of the definition of what is death. I just wanted to follow that up. I am a lay person as well and I did not realise this type of thing. Obviously, if something happens, some organs will not survive if they are not transplanted. Apart from the fact that the name pre-death procedures is something that you would not want to ask anybody, it is the deemed consent, deemed authorisation, which worried a lot of people who thought that if deemed authorisation was there, then the pre-death procedure could go ahead just to get the organs. Is there anything that we can do in regard to the bill that would explain to people that this necessarily would not happen? I think that it needs to be made very clear to the public and to family members that pre-death procedures could take place because it might be that they are not even aware of what that is at the moment. If you have that initial organ donation conversation with people, the proc first thing they would say is, if you bought that, please, what is that? When you talk about organ donation, people think from the point that everything has switched off longer there. That is probably the starting point for it because there is a complete lack of understanding of what it is. It should not get in here because I want to clarify what pre-death procedures are. Are we talking about extra IV lines or arterial lines of central venous access or changing medication that would improve renal function because some meds might improve renal function but the compromised liver function? Is that what we are talking about when we are saying pre-death procedures? How do we optimise organs in preparation because we know that we are moving forward with a donation process but it is not just about doing things without consent, it is about preparing for donation in the most optimal way. Very good questions. Perhaps there will be other witnesses who will have a more medical perspective on that, but certainly Gillian. My understanding is that, as you have just said, it is understanding that the person is going to become an organ donor and, on that basis, there are some procedures that they will do to help make sure that the organs are working as efficiently as possible. They would not do those procedures if the person was not going to become an organ donor. That is a clinical judgement. Alex Cole-Hamden. Thank you, Yng Nghymru. This is about the financial memorandum and capacity. Obviously, if this bill is to be a success, it will lead to a greater number of organ transplants happening in this country and otherwise why we are here. To that end, I wonder if the panel can explore whether there is sufficient capacity within the bill, particularly in the financial memorandum, to recognise the increase in workforce that will require both specialist nurses and surgical capacity. Will we be ready for this if we pass the bill as it currently stands? I think that one of the points that was raised in the space briefing was that the Scottish Government has recognised that they are already funding to the 2020 capacity, which is a target that they set, which they are not meeting at the minute. There is funding there for extra impact at the positive impact that it will have. I suppose that the other part that came out in the member's bill previously was how much what pounds and pens to be put on a person's life. That is what we are talking about here as someone, certainly from a heart aspect, surviving or not surviving. Now, the UK transplant list has trebled in the past 10 years in terms of people waiting for a heart. It is 150 per cent higher in four years in Scotland, so there is a need for more transplants. It will come with a cost, but somebody later might have the exact figures for you, but I remember Kidney Research did an analysis of how much it was to keep someone on dialysis versus giving someone a transplant, and the costs were significantly less to give them a transplant and bring them off dialysis. That might be something that comes up later on, if not, I can send the figures into the committee. The Scottish Government has been clear that there is money there in the 2020 target, and we are talking about people who are waiting on a second chance for life here. That does not go wrong. I am not concerned that we will need to spend more money on this. I absolutely get the preventative agenda, as you described there. My only question is, I just want to be sure that we are ready, both in terms of workforce and finance, to absorb the additional demand that this bill will create. I learned a lesson at one of our commissioning meetings when we were looking at the finances of transplantation, and I certainly found out that as a long transplant recipient, I was effectively funded by all the kidney transplants. The kidney transplant programme is so successful in terms of the financial point of view versus the cost of dialysis that all our lucky heart and long transplantees benefit from that. Taking the finance aside, the practical implications that our local Lothian Organisation committee is having quite a big discussion at the moment on theatre capacity, because at the moment most transplants are done in the evenings. Obviously, they are unscheduled. They cannot be scheduled in a way that other operations elective surgery can be, so they usually happen at night for that reason. I am aware that locally there is a discussion about pressure on theatres for doing transplants. There are a number of resource issues that would follow through, probably best to speak to the witnesses in that area. However, if numbers increase past the 2020 levels, that is something that has got to be considered. I thank all of our witnesses this morning. It has been very helpful to the committee. Clearly, there have been one or two questions asked, which perhaps there were no immediate answers to, or on which you may reflect and feel that there is something else that you would not like to have said. Do feel free to make a post-appearance submission if there is anything that you would like to draw to our attention. I will now suspend the meeting for five minutes to allow the panel to change. Resume, thank you very much. I welcome to the committee Shabin Begum, the director of the Scottish Independent Advocacy Alliance. Fiona Loud, policy director with kidney care UK, and Dr Gordon MacDonald, parliamentary officer care for Scotland. I thank you for coming to join us this morning. I know that you are at least some of the witnesses sat in on at least some of the previous evidence sessions, so you will not then be surprised if I simply start with a general question. Do the witnesses believe that there is a need for the Human Tissue Authorisation Scotland Bill, and do you believe that it will result in a marked difference in practice? Thank you very much for the invitation to speak today. Kidney Care UK is a national kidney patient support charity and we really do welcome the opportunity to increase the number of transplants in Scotland and in fact across the whole country as a consequence of that. With people dying every single day waiting for a transplant, many of them waiting for a kidney, we know that there's more that can be done and so we absolutely believe that changing the rules so that it is presumed that you will be a donor unless you have said otherwise in life is the right thing to do, but we believe that it is not the only thing to do, it will only work if we take account of the views of the public and so we are very careful and very clear about the education and the promotion of the continuous and consistent message across the country about what this is aiming to do, what it means and what your rights are within this. We also believe that it must be supported by the right capacity within the health service to do that, but we certainly believe that it has the opportunity to transform lives and for many kidney patients to feel very strongly about this, this just gives them some hope for a far better future, for a life that is transformed through a transplant. Thank you very much. We support this bill but our main motivation for responding to the consultation was that we felt that the bill needs to be strengthened in considering the needs of people who might have limited capacity or limitations on their communication or other marginalised groups and so that is what we are interested in really. Thank you very much. I think that we would say no is the answer to the question what is needed is improvements in the administrative system around organ donation. Certainly the evidence from Spain suggests that it is not presumed consent, a legislative change introducing presumed consent that matters, but it is rather the administrative system, the improvements in the administrative system, particularly having specialist organ donation nurses and we would suggest that it would be better to invest the money in that. Certainly the Nuffield Council bioethics found that where specialist organ donation nurses exist that the donation rates increased from 27.5 to 68.6 per cent and that I think speaks for itself. We have already met in the committee with several of the organ donation specialist nurses. Is your point really to say that there should be more rather than a change in the laws that essentially the point you are making? Yes. Thank you very much. Clearly coming from different perspectives in all three cases, I guess, but one of the key questions that has arisen is the question of the wishes of family members and under the current legislation there is no formal place for the wishes of family members and within the bill there is no formal place for the wishes of family members. Would witnesses believe that that should change that the wishes of family members should in some way be written into the legislation? It is very difficult for a clinician to go against the wishes of the family at a particularly difficult and sensitive time. Whether the bill is written into the bill or not, I think that the practice will be, as it seems to be the case in Wales, that clinicians will not go against the wishes of the family. I think that there is a very dangerous precedent in allowing clinicians to override the family, particularly where there has been no opt-in on the part of the deceased. Clinicians, I am sure, are very conscious of that, although you would obviously have to speak to them in any case. The bill, I mean, we would not wish to see presumed consent introduced in any case, but we would certainly want families to have a strong say as to whether or not to be involved in the process. Indeed, that seems to be the evidence from Spain and other places that the key thing here is dialogue and communication with families rather than passing bits of legislation. I think that, in order—well, I think that the legislation needs to be really clear about rights, and I think that if it does not mention anything about the rights of family, then that is a potential barrier to the success of the legislation. I think that there needs to be that consideration. The bill needs to have safeguards in place for potential donors for family members and also for clinicians. The previous panel gave evidence around the lack of clarity for the clinicians and how it would be difficult for a clinician to go against the wishes of a family member. I agree that I do not think that we should be putting individual clinicians or teams in that position of having to be in dispute with family members, but also equally if I carry a donor card. I think that if something happened to me, my family would be in that situation of parts of my family wanting to support my wishes and then other parts of my family not wanting to support my wishes. I think that the good, robust legislation would need to take that kind of nuance into consideration to safeguard everyone and to protect my rights to make that kind of decision. We think that a soft opt-out is the right thing to do, so it does allow the family to present evidence as to why their loved one would not have wished to become a donor, but we also think, and we've heard it said earlier today as well, that really encouraging the conversation with family members all the time. If anyone takes the option to opt in, great, we would say to people, please do let your family members know what your wishes are, but even if you don't take that option, you're content to have your consent deemed. Still, we'd like to see people be encouraged to have that conversation because by having that conversation, by knowing what your loved one's wishes are, we'll continue to make it much easier. I think we should look at what's happened in Wales and the right to a soft opt-out remaining there, what is proposed in England as well, so that we can have some consistency as well and that, of course, the importance of training staff, so they can understand that. If I go back to Wales looking at what they learned about how they started to present what the new rules were and how they matured over time, I suppose, and being able to become more confident of saying, well, this is the rules, this is the rules, but we'd like to work with you as a family around the donation. I've actually heard family members from Wales speak about that and also very approvingly of the way in which it was introduced to them when this was a deemed authorisation. Thank you very much. David Stewart. Thank you, Gavina. Good morning to the panel. What assessment have you made of the strengths of the gift concept in the current legislation? If you're not. From the point of view of, if I speak from the recipients, first of all, so the kidney patients, there are, I think there's about 464 of them waiting for or hoping for a transplant in this country at the moment. Any kidney patient who ever receives a transplant has the greatest respect for their donors and they never ever forget them. They remember them, they speak of them with huge respect all the time, so I think from the point of view of recipients, most of them, they will see that as a gift and they will be forever grateful for the life transformation that that donor and their family have been able to grant to them. From the point of view of donor families, we have spoken with many donor families and they will see that as their gift, as that donation as well. The ones that we've spoken with are very proud to say that and the ones that we've spoken with and I appreciate this is only a selection, so I'm just telling it as a story rather than as factual evidence. We'll also say that provided that their wishes are still considered in the way we've just described in terms of a soft opt-out and that their donations continue to be respected and spoken of in the highest possible terms and accepted as, you know, vital part of what we're doing here that they are supportive of it and that they still see that as a gift, they don't see it taken away and I appreciate not everybody feels that way but those are the evidence that we've heard from the folk we work with. I think one of the strengths of the bill is that we've got this concept of it being a gift. I think that it would be dangerous to squander that and introduce any element of compulsion or that the state had certain rights over the body of an individual and kind of marginalised or sidelined the wishes of the family, so I think this bill being packaged as me being able to provide a gift to other people within society is a really, really powerful message and I think that the public would be open and amenable to that kind of message rather than that something happens to me and the state can do whatever it likes with my body. Gordon? I think the gift element is very important and certainly the organ donor task was, as I'm sure you're well aware, found out when they did their study in 2008 that the gift element was important not just to donors but also to the recipients. I think that there is a danger of moving away from the gift element, precisely the point that's just been made, that if the perception is that this is no longer a gift, that the state is claiming a right, then the danger is that people choose to opt out of the system, which is what seems to have happened in Wales, that the number of people opting out has gone up to 182,000, I think, or maybe 187,000, I can't remember the exact figure, which is about 6 per cent of the population whereas if you look in the other constituent parts of the UK it's less than 1 per cent of the population that have opted out. The effect of that is that rather than 99 per cent of the population being potential donors because of course the fact that I have opted into the donor register, but if I hadn't opted into the donor register and something happened to me, my wife could still donate my organs. Rather than 99 per cent being potential donors, you have 94 per cent in Wales being potential donors, so I think we do have to think about the potential negative consequences of moving away from the gift element towards a—even if it's not in practice—at least the perception and the formal informality in law, a compulsion approach. Related to then my first question, which you've just answered, how important is simplicity of language in the bill? Well, the bill and any associated documentation should be clear, I think, and should be honest. Part of the problem in Wales was that there was a fundamental misconception at the core of the debate, which was that the Spanish system was essentially a presumed consent system, whereas in practice it's an informed consent system because there's no opt-out register in Spain. Certainly a study in the BMJ by Professor Faber and others, including the leading Spanish clinician in this area, argued that that was the case that it wasn't, in fact, in practice a deemed authorisation or presumed consent system. It was, in fact, the system that we have in practice. I think that certainly the last time the health committee considered this issue—and I gave evidence on that occasion as well—some members of the health committee went over to Spain and spoke to the Spanish authorities, and I would certainly recommend that you do the same again. Yes, Fiona, please. Thank you. Indeed, there's been a great deal of debate about why Spain has been so successful in achieving world leader in organ donation and transplantation, and I think it's important to say that what Spain has done is all the things that we'd like to see happen, so it has really built its base in terms of capacity, in terms of training its staff, as well as having a default that you're considered to be a donor unless there's a conversation that goes along in Spain with every potential donor and their family. When the organ donation task force reported back in 2008, it recommended a number of things based on the Spanish experience, so it recommended the implementation of organ donation committees, of trained staff, clinical leads and so forth, and embedding specialness nurses in hospitals, and a whole range of public education things, but it didn't recommend, as we know, to go with the presumed consent approach. This is 10 years on. Many of those things have been put into place. There's still more to do on some of those things, but the one thing we haven't yet done is the thing that Spain has done, and other successful countries such as Croatia and so forth, which is to change the law as well, to go along with it, so it's that combination of all those things that we think is the right thing to do, and that we hope believe that the Scottish Government is planning to do. I'll just make a point about Croatia, if you don't mind, because Croatia is quite an interesting case study, because it now sits up at the same rates that Spain is sitting at, but what happened in Croatia was, of course, that they introduced presumed consent first in legislation, and it didn't make any difference to the rates, and it was only after they did all the other things that the rates started to increase, which suggests that there isn't a direct link between introducing the legislation and the system and increasing the rates, it's actually the other things that make the difference. Unless, I suppose, the change in the legislation changed the context, unless the review has taken that the change in legislation changed the context and made these other changes easier to deliver? Yes, but it was some years later, I think, and I think, I mean, we can send you further evidence on that. OK, that's appreciated. Just to add to that, by changing the context and by changing the national conversation alongside all those things, that's the thing that will make the difference, and that's why I was quoting that particular country. It's all of those things together, so you're changing the default, but you're changing the support system alongside it. Thank you very much. Just a wee quick in our additional evidence, or when we first started this, about over 80 per cent of Scots said that they would donate their organs, so I've had conversations with people that think that the deemed authorisation is a way to allow folk that just haven't got round to putting their names on the organ donor register, so what would be your comments around or your response to that? I made earlier, which is that we're talking about over 99 per cent potential donors in Scotland who haven't opted out, and so, whilst I take your point that we're sitting at 50 per cent, which is actually very good compared to the rest of the UK, in terms of people who've opted in, there is that sort of 49 per cent or so, and the figure that you're quoting there is 80 per cent, you know, there is a good 30 per cent of people there who are realistically potential donors. The key thing in relation to that is going to be the conversations that are had with the family around the time of the death, and that's where we would come back to our point that, you know, the best thing to do and to use the resource well is to invest in organ donation nurses, and certainly the UK Government's figures are 45 million start-up costs and then 2 million a year to run the system, and then another 5 million or so every five years to run a publicity campaign. Well, I don't know what the figures are for Scotland, but that money could certainly be better spent in our view investing in staff and in family communication. So, could I just comment on the 8 out of 10 being in support of organ donation, but only about, as we know, about half the population for which Scotland is to be absolutely congratulated are actually on the organ donor register. So, we've still, what we have is a group of people up to 80% who say that they would support and would be willing to donate, who would be, captured perhaps isn't the right word, but who would be covered by the deemed authorisation bill, and that would be where we would think would be the absolute, would be the gains, because there would always be people, of course, who will choose not to donate, who will not wish to donate, and having that right to opt out, of course, is incredibly important as part of the democratic work with this bill. Will the bill itself increase donation rates? If not, yes or no, that's good, but if not, what would the areas that would need to be invested in, and you've mentioned some already, to increase donation of people on the organ donor register? So, can I just say that I think that the way that we need to, to your point earlier on, was a really good illustration of the lack of awareness and lack of understanding around this complicated area, and also, I think, because it's so emotive and people think that, you know, if I'm carrying a donor card that that's the end of the story, and my wishes will be safeguarded, I think that we need to have a bigger conversation within society. We don't talk about mortality, lots of us don't have wills, we don't, lots of people don't have advanced statements, which is something that the mental health act allows for. So, I think that there's all sorts of things that need to happen in terms of infrastructure and finances, but also we need to have a conversation within society on a bigger level about what happens when we die and what we would like to see happen. I think that the key issue is going to be, you know, to look at what has happened in Wales over the last four years or so, and the evidence from Wales—and everybody acknowledges this, including the Welsh Government—is inconclusive at the moment. However, I'm certainly from looking at the stats that I included in our submission, there's no clear link, I think, in terms of improving the figures, and, in fact, what really struck me when I looked at the NHS BT figures was that the deceased donor rate is increasing in all the other three due restrictions in the UK, but in Wales it was not on a regular trajectory of increasing, shall we say. It goes up and down each year, and that's why it's quite difficult to just take a few years and make an assessment. I do think that there needs to be more time given to see what happens in Wales before the Scottish Government and Scottish Parliament should legislate in this area. So this is a national conversation, and it's almost a once-in-a-lifetime opportunity for us across the whole country to be able to raise our game and raise the conversation and have that open national conversation that should have been just spoke so clearly about. What we're seeing, I believe, is the raising in numbers of deceased donations is probably because we're having this national conversation in most of our countries now about what's going to happen next and where it will go, but we do have to be careful, as one of the earlier witnesses said, because many people think the bill's already gone through. We've heard about that on the news, it's already happened, and actually it's still going through all of this, and there's a simple response back to original comment there about, do we think the numbers will go up over time? Yes, we do think the numbers will go up over time, and I think what we should be looking at is the consent rate in Wales. It's now something like 72-73%, which is about 40-something percent when this started. So it's an enormous increase in consent, and looking at family consent rates to donate is probably the best thing to look at because, of course, as we've just heard, numbers will vary from year to year when you have perhaps a relatively small number of donors where one or two additional donors can make all the difference to the numbers of actual transplants, and I think that's incredibly encouraging. Thank you very much. Thank you, convener, and more on the panel. If you only have answered some of the question that I was going to ask there, but it was around that issue that we've heard in evidence many times, that family consent is probably one of the major issues that have to be tackled within organ donation, and I suppose it's specifically to the Dr MacDonald that, on the few acknowledge that Wales is a success in raising that family consent rate, and one of that is probably more of a more important indicator of success rather than the number of people who have opted out. I think that we don't know what the reasons are. That's the key thing. Is it to do with passing legislation on presumed consent, or is it to do with, as has been commented on, all the discussion around it that has been taking place in terms of the media and including the information campaigns that have been funded, or is it to do with investment in specialist staff and improving communication with families? That's the issue that's not clear. I think that that's where there needs to be some sort of bottoming out, really, as to what has caused that rather than just assuming that it's to do with passing the legislation. You can certainly have a national conversation without passing this legislation. You can certainly invest in publicity campaigns without passing this legislation, and we would certainly support both of those things. Would you then agree with me then that the very fact that we're having this discussion around legislation and in itself is having an impact in the country? It may be having an impact. The danger is that it has a negative impact, as has been seen in Wales, in relation to a significant percentage of the population who say, well, I wouldn't have minded in the past or donating my organs, but if the Government is going to claim it, then we can get lost. That's the real danger. I think that you focus very much on the opt-out here. Surely, the outcome should be the number of donations, organ donations that actually come to the fore rather than who's opting out. Indeed, but that's the point. The number of deceased donor donations, the deceased organ donations has increased in other parts of the UK but doesn't seem to be increasing in a steady trajectory in Wales. The reason for that needs to be got to the bottom of, because the Welsh Government made all sorts of claims, based on an academic study, that there would be an increase of 25 to 30 per cent. The evidence to date—as I say, you have to give it a bit longer to see how things develop—the evidence to date suggests that that isn't happening on a regular basis. That being the case, the danger is that you have an adverse impact rather than the positive impact that you were hoping to have. Whereas, if you did other things, you can have that positive impact. To be fair to the Scottish Government, that's what the Scottish Government has been doing. The Scottish Government has been putting a lot of effort into improving communication and putting extra resources into organ donation, which is why we have seen the rates going up in Scotland on a steady basis and the number of donors going up in Scotland and the people who are opting in going up in Scotland. I would go back to what we can learn from Wales. I have no doubt that the committee will be taking evidence from folk in Wales to say that, if we turn it around the other way, it's that startling increase in family consent, which I think is very strong in terms of the impact of the work that they've done there, but also to learn from what they learned, which was around the importance of training staff, which I guess they knew about, but actually seeing that in action, and also on keeping families and family members continually targeted on what the new rules are and what the law means. Actually, as we turn it around that way, we now have a situation in Wales where there are far more members of the public who will know about organ donation and families who, as a consequence, have agreed to donate through whichever route they've gone. We would far rather have that 80 per cent of the population be willing to donate with, of course, the option for those who don't wish to donate for whatever reasons they are. I'm not sure we know enough about why people will have taken the option to opt out already, but that might be something to look at in the future. Actually, that is their right, and there's no way that any of this is about a compulsion, but it's about changing the default so that, as a nation, Scotland is a country that accepts organ donation as the natural thing to do with all the safeguards that I know we're discussing. Thank you very much, Keith Brown. By the evidence so far, I think that Fiona mentioned—I think that one phrase that you used was that the person would have been content to have given their deemed consent, for which, of course, the bill makes no provision. I think that she's been mentioned in a scenario quite rightly where family members might have different views. I think that Gordon mentioned the fact that clinicians will have an obligation to listen to the families. Although I would have thought that clinicians would have an obligation to the person that might be a patient as well, it might not be a patient, it could be deceased. I don't know what the legal standing is of that person. It just strikes me that, in that scenario, the individual whose body is comes potentially third or fourth after the state, after the families, and potentially after the interests of the clinicians. Surely, there must be some recognition, which we've heard very little of so far, of the rights of the individual, especially if the individual has expressed a wish either to donate or not to donate. Rather than asking a direct question, I'm interested in the views of the panel on the rights of the individual whose body it is. I think that it's the individual's rights that are paramount in this situation. The issue that I touched on earlier on is that we can't have a situation where there's even a perception of compulsion in this legislation. I think that it's interesting that you mentioned the state as having rights, first of all. I think that this could be a potentially tricky situation of balancing the rights of different groups. That's always tricky. The rights of the individual need to be paramount. I think that we can't have a situation where clinicians know that there are other patients waiting for organs, for a kidney or whatever. That is their motivation for carrying out a procedure. It should be the wishes of the individual that are of the highest consideration. Is that the heart of this debate? The individual who is the donor, their view should be respected if it has been expressed. There's no question about that. Clearly, in some situations, families have overruled that. That is a difficult scenario for clinical staff. There needs to be more work done with families in order to reduce that from happening. The problem is that that's about respecting people, respecting the autonomy of people who are mentally competent and have made a decision. The issue here is about the people who haven't expressed a view one way or the other. Although probably the majority of those people would be content to donate, there will be some of them who would not be content to donate. In those situations, the state is claiming a right that overrules that individual's right. Under the present system, the family make the decision. The family say that they haven't made a decision, but we think that it would have been. It might be that they are reflecting the deceased's view or that they are reflecting their own view, but that's the best thing that we can do in terms of trying to get to what the deceased or trying to get consent to. It's important philosophically that we understand that the state doesn't have rights over us. It has responsibilities to respect our rights. That's the way human rights work. The duty is on the state to respect our rights, and the rights are not given to us by the state. The rights are inherent. We have inherent human rights. The human rights legislation is about recognising the fact that we have inherent human rights. When we get into a discussion—I'm sure that this wasn't what you intended—which implies that the state somehow or other has rights over our bodies or other parts of our person, that's quite a dangerous philosophical step to make as a society. We need to be very careful not to be so focused on the pragmatism of trying to get numbers of donations up and doing anything to do that, so that we end up crossing over a red line in relation to the relationship between the state and the individual. I think that it's absolutely right that the individual right of an individual has expressed a view to opt in and opt out. Of course, that should be honoured, and many patients we've worked with have said, I want to donate, and I don't want anyone to be able to override that. In practice, we know that, occasionally, somebody who has currently opted in their rules, their views are currently overridden because the family has to make the final decision nowadays, and so if the rules are to change, then we do have to have a very careful and nuanced conversation about where that goes and what that actually means, so to provide the opportunity for the patient's family to be able to say, well, that person has changed their mind, and we know that person has changed their mind, because people may change their mind. We heard earlier from Jenny, who said she'd changed her mind about how these things will work, and others may do that, so as long as we provide that opportunity and that safeguard in there, but we honour the right of the individual when they've expressed a right to do that, that's very important. Now, for those people who haven't expressed a view, but where no other view is known, that's what the communication, the discussion, and all those other things should be addressing, and that's why it's very important that we are as clear as we possibly can with what the new rules are should they change. Miles Briggs. Thank you, convener. I wanted to come back to the rights of families in a soft uptake, because I think that that's really where the committee has been really focusing some attention. I wondered probably more, I think, for Dr MacDonald. You, obviously, were involved in the past bill when that came forward. I think that this is the third bill, actually, the Parliament's scene around this. Where do you think the current bill has addressed some of those concerns, and are there some positive steps forward that you've seen? I mean, I'll need to try and rack my brains as to what the details were in the past bill, but I think that there were concerns the last time round about the practical procedures, I think, as I recall, which was one of the main reasons why the committee rejected it. I was interested in reading the SPICE briefing that the committee, the majority of the committee, also rejected it because they weren't convinced that it was going to make any difference, actually, in terms of the numbers, which have been quite interesting. But certainly the evidence that I gave was part of one of these private informal consultations where we have two MSPs and a whole bunch of people sitting around the table. It was very noticeable that everybody from a variety of faith perspectives had reservations, and I don't know whether that impacted the committee or not, because it was only two MSPs that were there, but it was very noticeable that this was something that people had real reservations about. There was more unanimity than there is in many issues between people from different faith traditions on this point. My own comment would be that I understood that it was to do with the practicalities and perhaps being a little bit over complex, and that therefore, and I would suggest that this bill is more straightforward and perhaps there's more things we can discuss about keeping it and making it as straightforward as possible. I know some of the previous witnesses discussed that. Shaleen, did you have anything to add? Well, my point would be that legislation quite often isn't that accessible, and so that's a challenge for this time round to make it as accessible as possible, but also to engage the public in the consultation. I think that the idea that this legislation goes through all of a sudden will make this huge impact on the numbers who donate is where I want to put the question. Would you accept that there's a period of time that will be required for this to cascade down, if you like, when it takes in perhaps an increase in family consent that somewhere down the line it may lead to an increase in donation? I wonder if there are other examples around the world that have over a period of time shown that increase. Is there a period of time that we should expect, or should we be at least willing to work towards, that would help that conversation? If absolutely, it's not a magic wand that we can just wave, and suddenly everything's marvellous, because if it was, we would have probably done it an awful long time ago. If we look at Wales, that was in December 2015, so that's three years ago, that's still learning, there's still work going on in there, and I believe the Welsh Government's looking probably up to 10 years, I think, before it does a final evaluation on that. If we look at other countries, we've quoted Spain and Croatia and so forth, we've quoted again periods of a number of years before the really big changes have started to come into play, and I notice also the financial briefing for this Bill was something about not expecting to have to increase capacity for transplantation to something like year four, I believe that's right, I could correct me if I'm wrong, but something like that, so in other words you're already looking at realising that there's going to be a period of time before we get the uptake, so probably it's going to be five to ten years I should think, because it's a whole lifetime change isn't it, and also for that message which will come through, and perhaps you're taken up by many of the younger generation, who we know tend to sign up and opt in quite willingly and of course in the education system as well, for that to come through those people to mature in their own lives as well, so that would be my suggestion based on that evidence. I think the figures from Wales are interesting because 2014-15 there was 128 deceased donor transplants, 2015-16 as we heard it came in, then it was 168, but in 2016-17 it was 135, and in 2017-18 it's 139, so we don't have a long period of data there in Wales, but certainly the limited data that we do have doesn't suggest that the new bill has made this a spectacular difference, in fact potentially it might have reduced the numbers compared to the 2015-16 period, but that's speculation as I said, because ultimately what the biggest impact on the numbers is the number of people who are dying in the appropriate circumstances, and this is where again there's perhaps sometimes a misconception that there will be a huge increase in the numbers of organs available because there's only 1 per cent of deaths that are in the appropriate circumstances where a donation can take place, so that is the key factor I think in terms of the rates. Thank you very much. Good morning to the panel. I was very struck, I know Gordon MacDonald that you're not in favour of this bill, but I was struck by what we could do in your estimation to improve organ donations, and that was about dealing with administration, and I think my question is particularly to yourself and Chavine in terms of what we do when we're consulting families at the moment, and what we might do in the context of this bill, because we met with specialist nurses who took us through the process, which revealed that there are something like 300 questions that are asked to grieving families at their most vulnerable time, which actually leads to many families overriding into sickness, and I don't want to be part of this any more. I think that first Chavine, obviously advocacy is really important, getting people's views are important, but can we use this bill to simplify that process, to make it easier so that people couldn't express their views without having to go into intimate minutiae of detail around their partner or their son or daughter's lifestyle and their suitability for transport? That was a little bit taken aback by the fact that there's 300 questions, so I think that that's going to be a barrier if somebody, if family members are in an emotional situation and aren't able to really think that clearly, and then especially when there's a dispute, I think that if the scenario that I gave of my family would be in that situation, and I think that it's, so I would completely support the reduction of those questions and the significance of those questions and the intrusive nature. Earlier on, the panel were talking about some of the intrusive nature of those questions. I think that advocacy would work really, really well in those situations where people could plan ahead and help people to think about what it meant to opt into a situation, but also it would give, I think, the individual, it would give them the strength and courage to have those conversations with their own family members, and advocacy might help specifically for those people who've got capacity issues or communication difficulties, but I think that non-instructed advocacy would work well in those situations where somebody is, we talked earlier on, about the pre-death situation that, so, you know, I'm not able to speak up for myself, but a non-instructed advocate might be able to safeguard my wishes in that situation, so I think the point earlier on was about will this bill make a difference straight away. I think that this bill is an example of a cultural shift that we need to have, and it isn't going to, it's not a panacea, it's not going to sort everything out immediately, but it's about changing our culture around these kind of issues, so I would say that advocacy would play a key role in different situations for different people. If the problem is the administrative system, then passing legislation is unlikely to make a difference. The key thing that will make a difference is reviewing the administrative system, and certainly I was surprised to hear the figure of 300 just at the end of the last discussion there, and I thought that that was quite astonishing, quite honestly, that that's the case. My comment would be that if we're talking about 300 questions at the moment where people have opted in, then to put people in a situation where of presumed consent and then put relatives through such an onerous process is likely to cause great angst, I would have thought, if the relatives themselves are not convinced that this was the person's wishes, so I think that that needs to be thought about, that clearly they should review the system and see if we can reduce the number of questions you need to talk to clinicians about that, I think, and see how that could be done. But I think that I would caution if the system is so burdensome of creating a situation where relatives are at a very difficult time put in the position of having to answer 300 questions when they're not convinced in the first place that the deceased or the dying person would have wanted it. Before I ask Fiona, just for a little bit of clarification, there are up to 350 questions in actual fact that might be asked, but that assumes that some of those are down particular lines of questioning in response to an earlier answer, so by no means everyone is answering 300 questions, and there's potentially that larger question. A couple of things, at the moment the specialist nurses will be asking a whole range of questions right now, some of which will be, as you've heard from, so those questions will be necessary, I can't comment on the questions themselves because they'll be to do with safeguarding and that side of things. I believe that in England the plan is for those, rather than writing the questions or the need to ask those questions in law, that's covered by the codes of practice instead, so therefore it can be taken, consulted on separately through the Human Tissue Authority and I would perhaps suggest that in order to keep the bill as simple as possible that that side of things could go into the code of practice where it would still be absolutely incorrectly dealt with, but maybe not come up as a potential barrier to this law coming through, so that might be one suggestion alongside the fact that, so already there are a range of questions which will be asked very sensitively by obviously very well trained specialist nurses, we have heard from families who do find those questions distressing, but the families that we've heard from have also said that they appreciate why those questions are being asked because they are in favour of donation and they want it to go through and so keeping it simple and maybe removing it from the law but having it in the codes of practice is a different way of doing it would be our suggestion. If there are good clinical safety reasons why questions need to be asked, then those questions will presumably still need to be asked even under presumed consent and so that's the key point I'm trying to make here. David Torrance. Thank you. In Wales, deemed consent is for 18 and above for people and individuals. In Scotland, deemed authorisation will be 16 and above. Do you agree that deemed authorisation should be 16? We agree in principle anyway, but the point that you were making is a valid point that needs to be looked into because otherwise there is a danger that there could be some sort of judicial review of the legislation if it was different in Wales or in Scotland or a judicial review of a particular in case legislation was different both sides of the border. To make a point on that, I think that the messaging would have to be very careful because it is different here than other countries and I also think that it should be looked into probably a little more just to understand whether there would be any implications of that and whether it would be better to be harmonious with the rest of the country or content to stay as is the age here in Scotland. We support 16 but I'd just like to point out that actually there's lots of anomalies between different pieces of legislation which consider a child at different ages so 16 is usually the age of consent but then young people are considered to be adults at different ages and different pieces of legislation so this would be a continuation of some of those anomalies. Thank you for that. As you were saying I was 16 and under sometimes a difficult age group to engage with and especially to get them to engage with for parents. How can we provide sufficient opportunity for young people to express their wishes? Prior to the age of 16. I'm going to say education education education so as part of the schools curriculum I know there are some some excellent tools already out there which are aimed at secondary secondary schools and at people 15 and 16 as well so not just the slightly older young people that makes sense so I think education encouraging but very much encouraging people to have those conversations with their families because children they often say are the change makers but by giving children that level of education in school not in terms of you must do this or you mustn't do this but as part of your your own health education and being part of society so they can receive unbiased information about what that might mean and be encouraged to take that back and talk it through with their their families as well and that would be our point there. I suppose some of the dealings that I have personally and professionally with young people are that some of them are much more enlightened and much more open-minded than lots of older people or adults anyway so I'm not I think I completely support Fiona's point about education and awareness raising but actually I think that there would be there would be examples of young people changing the minds of their family members and parents as well so I think that's right that's why I've made the comment about children's change makers. I signed up to the organ donor register when I was renewing my car insurance tax basically and it came up with a things in do you want and I thought well okay something and so it would seem to me that you know when people are sitting their driving test for example or applying for a driving licence you know there are opportunities or even possibly maybe not the young Scott card because it's a younger age but you know there will be opportunities in the system to engage young people and these opportunities should be taken particularly even even to express a view without necessarily making a commitment if they're younger than 16 possibly. So just another comment would be about social media because that's incredibly obviously incredibly important to young people and most of them will be world experts before they ever get anywhere near 16 but using that as an approach of course Thank you very much. Sandra White. Thank you very much. Good morning. Good afternoon nearly now basically you did mention and should be new mentioned about advocacy the question I asked the previous panel I'll ask yourself as well about the pre-death procedures which is you know the name of it is bad enough anyway we had concerns raised with us with the other witnesses as well and basically they're looking at procedures to go ahead in legislation would be put forward for that for donation to be deemed but the details are not actually there in regard of the pre-death procedures and others people actually raised concerns in regard to the deemed authorisation that this would go ahead. What are your thoughts on the pre-death procedures you did speak about you know basically advocacy should be and perhaps that should be included before someone gets to that stage I just wonder what your thoughts are on the pre-death procedures well I suppose for advocacy to be effective and the constituency that we're interested in in this context would be those people who have limited capacity or limitations on communication but also those people who are covered by the Mental Health Act because I wouldn't want to see this legislation kind of discriminating against a group of people and saying well you know you can't donate your organs so capacity isn't a black and white issue so people can make decisions about certain aspects of their life but deemed not to have enough capacity to so I might not be able to make decisions about my finances but I might be able to make decisions about other aspects of my life and I think that so we've got we've got safeguards such as guardianship and power of attorney and those are the places where I think that there needs to be consideration about organ donation and this would be obviously part of a national conversation around donation I think that so in that particular situation of pre-death so the earlier panel we're talking about this you know this isn't something that's scheduled you can't plan for it in the way that other situations might be planned and I think that if so in those situations the non-instructed advocacy might play a really really crucial role to to make sure that the the rights and wishes of the person because that's the issue that we raised earlier on about the balancing the rights of the family the state and the individual and I think that advocacy plays a really really crucial role in kind of a re-addressing the inherent inherent imbalances of power and dynamics within relationships and this would be a prime example of that so there needs to be somebody who is there who's independent who doesn't have any kind of agenda within the situation but is only there to to safeguard my wishes and reinforce my rights and make sure that my rights and wishes are being listened to appropriately and the you know other people within that dynamic and within that situation will have their own agendas and their own wishes but especially when that person doesn't have a physical voice themselves I think it's really really important that there's some sort of mechanism for making sure that that isn't lost. I mean I think the one one can understand why pre-death procedures would take place in order as we heard earlier to maximise the likelihood of success of a donation where I think there might be a concern might be if if there was any impact upon the care of a person who would otherwise not be dying for example and I think we sort of cited the UK Supreme Court's recent judgment in relation to people with severe neurological conditions etc so I think that you know that there could be concerns around that you also raised in the earlier session the issue of people whose heart has stopped beating and their brain might still be functioning and I certainly I have heard people express concerns about organ donation on that basis in the past and so I do think that these issues need to be carefully considered. I think the concept of an advocate could be helpful in in in some situations as should been said I think that in terms of being clear and transparent that is important and we we should look to do that whilst being very sensitive to the fact that not everybody wants to know not all families want to know all the details by by any means they they want to know what's going to happen how long it's going to take but they don't necessarily want to know everything and but they have the right to through with the support of a well-trained member of staff to support them as as they go through the donation process. Thank you very much. I briefly am a heart rate. Yeah just a week. Sandra brought up the question about pre-death procedures but you mentioned incapacity and so the basic question is does the bill adequately cover people who might have communication difficulties or incapacity difficulties and should there be more widening of any language in the bill to cover that? Our feeling was that it doesn't really adequately cover those those groups of people and it needs to be strengthened. Yes just finishing off with a question about capacity and the financial memorandum now I'm conscious that none of you are clinicians but you may have a view and that's why they're from your experience working in the transplant world and particularly Fiona in this. Is there going to be sufficient capacity built in after the bill to meet any increased demand and are we making enough money available to that end in terms of workforce planning? I welcome the fact that in the financial memorandum there is an estimate made of that which talks about I believe it is year four when numbers of staff need to go up to support the anticipated increase in transplantation so I think that is the right thing to do but I think we need to watch very carefully and evaluate as we go along how this is working because what we don't want to have is families who wish to donate and who are put off by any delays into the system. I asked the question in Wales recently following some work they've done there and actually they didn't feel that that had been an issue there but they were aware of that as a potential issue so with a different hat on I'm a chair of an organ donation committee at my local hospital so I am quite aware of the need to be able to make theatre space available in order to to go forward with a donation from a family and that is something that from my experience there in other hospitals chief executives of trust are very very supportive of and understand but we do need to we do need to be cognisant of the fact that this is something that as we said earlier is you know it's not what we planned at all and those donations will take place often in the in the middle of the night so making surgical staff who are appropriately trained and and an adequate space available is really really important and I think that we just have to recognise that you put some plans in place and to watch that very carefully to make sure we can continue to do the right thing here. I would just like to to point out that actually that there needs to be proper training in addition to the points that Fiona's made around the issues around capacity because I think that the danger is that we think about the capacity of the person who who is going to be the organ donor and that there needs to be consideration proper consideration of the the capacity of the family who might be making a decision who all disagreeing etc or supporting this that that there needs to be proper training for for staff around that as well. I just come back to my earlier point I can't really comment on whether the the Governments planning in relation to the financial aspects of this is accurate or not but or sufficient or not but we would come back to the point that it would be better to use the resource which has been committed to this in other ways basically. Thank you very much can I say thank you to all of our witnesses once again today that's been very helpful to us all as I said to the last panel if there are questions to which you feel a further further information would be helpful to the committee feel free to let us have that after the event and I will now briefly suspend the meeting and when we resume we'll be in private session thank you very much