 Calwm yr unrhyws gwyrd amserau cael gyda'r E episodes welcome to the 13th meeting of the Health and Sport Committee of 2019 Can I ask everyone in the room to ensure that mobile phones are off or on silent and not to use mobile devices for photography or recording? Items 1 and 2 of our agenda tomorrow is consideration of an instrument related to the European Union with drawl act 2018. The instrument is the Public Health and Tobacco EU exit Scotland amendment regulations 2019. The purpose of these regulations is to make minor technical changes that are required to correct legislative deficiencies that will arise as a consequence of the UK leaving the EU. We will first of all consider the categorisation of the instrument under agenda item 1. Colleagues will be familiar with the protocol agreed between the Scottish Government and the Scottish Parliament on categorisation of SSIs laid under the European Union Withdrawal Act, which sets out an approach for that categorisation and gives a role particularly to the Delegated Powers and Law Reform Committee in highlighting to the lead committee where there is an issue around categorisation. The SSI in this case has been categorised as medium and the Scottish Government has identified the negative procedure as appropriate for this instrument. The DPLR committee considered the SSI at its meeting on 30 April and agreed that it was laid under the appropriate procedure and given the appropriate categorisation and had no matters to draw to the attention of this committee on that matter. Members are therefore invited to agree if we are content that the procedure and categorisation given to the instrument by the Scottish Government is appropriate. Agenda item 2 is to consider the negative instrument on our agenda. The Delegated Powers and Law Reform Committee determined that it did not need to draw the attention of the Parliament to this instrument on any grounds within its remit when it considered it on 30 April. Are there any comments that any members may have on this instrument? If not, the committee agreed to make no more recommendations. We therefore move on to agenda item 3, which is continued consideration or consideration at stage 2 of the Human Tissue Authorisation Scotland bill. I welcome the Minister for Public Health, Sport and Well-Being, Joe Fitzpatrick. Good morning. He is accompanied variously by Sharon Grant from the bill team, Jackie Pantoni and Claremont Gummary from the legal directorate and Max McGill from the Parliamentary Council Office. I understand that members of the team will come and go according to the particular items in front of us. I also welcome Jerry McBalfour, who is joining us this morning and has amendments in his name. I believe that Gordon Lindhurst will join us for the same purpose later this morning. I will explain the procedure briefly once again because, as is the first consideration of this bill, there will be one debate on each group of amendments. I will call the member who lodged the first amendment in that group to speak to and move that amendment and to speak to all the other amendments in the group. I will then call any other members who have lodged amendments in that group. Other members may, of course, catch my eye and indicate their intention to speak on the group. I will then, if he has not already moved an amendment, call on the minister to contribute just before asking the member who has moved the amendment to wind up. I will then conclude that debate by inviting the member who moved the first amendment in the group to wind up. I will then ask whether that member wishes to press the amendment to a vote or to withdraw it. If he or she wishes to press ahead, I will put the question on that amendment. Clearly, if a member wishes to withdraw an amendment after it has been moved, that member must seek the agreement of other members to do so and any member present may object and therefore require a vote on that. As I say, if no one moves an amendment, if any other member wishes may move an amendment failing that, I will move on to the next amendment. Vote is by members of the committee only, and voting in any division is by show of hands. If there are divisions again, I would ask members to indicate their intention clearly and for long enough for their vote to be recorded. We will move directly to stage 2. If we are successful in completing it today, that would be clearly a good thing. If we are not successful in completing stage 2 today, the bill will be reprinted tomorrow morning and further amendments can then be lodged. However, let's press on. We start because there are no amendments in section 1. The first question for the committee is that section 1 of the bill be agreed. Are we all agreed? Thank you very much. I therefore move on to the first group of amendments on the bill, which is covering the area of information and awareness. I will call amendment 4 in the name of Jeremy Balfour, which is grouped with amendments 56, 57, 7, 8 and 63. Before Jeremy Balfour moves his first amendment, members should note that amendments 7 and 8 are direct alternatives to each other, which means that both can be decided upon. If both were to be agreed, then it was the last one agreed that would apply, but clearly that is a matter for members to consider when they come to these matters. Can I ask Jeremy Balfour to move amendment 4 and speak to all amendments in this group? Thank you, convener. Good morning, committee and minister. At the start, I think that this is a really helpful bill and one bill that I think has got all-party support. The amendments that I am seeking to bring forward this morning in my name seek to strengthen this bill and hopefully make it work better. Amendment 4, for me, is the key amendment that I am putting forward this morning. That is in regard to the whole issue of informed consent. I think that one of the real positives of this bill is that it will hopefully kickstart a debate in Scotland around organ donation so that families, individuals will be able to have better conversations so that when someone gets the situation that they are dead and they can donate those organs, then the family is better informed. The evidence in Wales has been quite positive in that, before the bill was introduced and became an act, the public awareness was fairly small and that has increased quite highly since the act has become and I think that that is a very positive thing. I am also aware that the Scottish Government has committed to putting quite a lot of resource when this becomes an act so that there will be advertising, TV, et cetera. I suppose that the question for me is how do we keep this conversation going over the next five, ten years? I think that there is a danger that there is a high take-up initially. People understand what it is going on, but as other things come on to our agenda, as other things move on, it becomes less well known. I think that if we are generally going to have informed consent, it has to be informed. Obviously, people who are 16 plus now will be part of that campaign, but there will be people coming behind that in years who may not be aware of what is going on. Amendment 4 simply puts a commitment on to the Scottish Government to say that every two years there should be some kind of communication with the people in Scotland. I am not suggesting that that has to be an individual letter to each person. What could work quite well would be if there was other communication going out, your council tax, other forms, but on a second-year basis that information would go out and people would be aware. The advantage of that, from my perspective, is that it simply allows the debate to continue over the next four, five, ten years. It also means that those who are turning 16 will also be aware of it, because, again, those who are, say, in their 8, 10, 11 at the moment will be a number of years before they reach that time and will be informed about the decisions that they are asking to make. I would be interested to know what the Scottish Government's view and the committee's view is on that, but one of the keys of the bill is informed consent, and we need to make sure that informed consent is not just for now, but for the future. That leads me on to amendment 7 and 8, as the convener said, it gives two options, a two-year or a three-year. That relates to those who are coming not from the UK but from other parts of the world, whether it is Europe or other parts of the world. At the moment, you have one year before you would enter into the system if you come from a different jurisdiction. I suppose, again, that my question is around informed consent. If I pitch up from Australia into Scotland and I get myself part of a country, is there something that's going to come on to my radar within the first 12 months? I'm not convinced that it is. I accept that the Welsh has gone for a 12-month, and at the moment, the legislation for England is also the same. I don't think that that necessarily means that we have to follow suit. We have to be comfortable in ourselves that there is deemed authority, and that authority comes from an informed situation for the individual. I suggest that a slightly longer period than one year is required for that individual to know what's going on and to have appropriate conversations with his relatives or her relatives in other parts of the world. I will leave it there, convener. Thank you very much, Mr Balfour. I have tabled two amendments in the group, the following discussions that I had, particularly with the Law Society around what might be the most appropriate format for addressing some of the issues. Some of the issues include those that Jeremy Balfour has raised. In particular, amendment 56 ensures that the duty to promote information and awareness is continuous and that the minister should promote awareness on at least an annual basis once every calendar year. Amendment 63 amends the bill in order to allow a two-year information and awareness period before commencement of the act. Those are joined together, but they need not go through together, but they are both intended to achieve the same objective of allowing an adequate level of information and awareness in advance of the implementation of the bill. I invite David Stewart to speak to amendment 57 and to other amendments. Thank you, convener, and I thank the minister for the meeting that we had to discuss the generality of the amendments. The wider issue that Jeremy Balfour has said is that I am and Labour are very supportive about the general principles of the bill, but I think that there are opportunities to strengthen the bill through some amendments. I am speaking to and moving amendment 57 in my name. Amendment 57 is in addition to section 3 of the bill, which concerns the maintenance of the register. Stage 1 was clear to the committee that the success of the bill in achieving an increase in organ donations would rest on individuals making clear that their wishes were explicit. Amendment 57 therefore seeks to make the process easier and more commonplace. It places an obligation on the Scottish ministers in the maintenance of the register to consider and promote regular opportunities for individuals to make clear their intentions for their organs or to alter their stated wishes regarding the donation of their organs. In particular, section 2 requires Scottish ministers to consider how such opportunities can be made available through ready existing interactions that individuals have with the NHS and health services. Such interactions could include, but would not be exclusive to the times that individual registers with a GP or attends clinic appointments. The purpose being that when individuals are asked to confirm their deals by an NHS service, that should include confirmation of their wishes regarding organ donation. Within the group, although I am sympathetic to the intention behind amendment 4 and the need to inform the public of changes that the bill makes, I believe it to be too resource intensive. I am also concerned that linking to the electoral register would allow those who are not registered to fall through the gaps. There are also possible practical problems relating to those who do not wish their dress to be used for purposes other than voter registration. I consider amendment 56 to be a better alternative, which satisfies the tension behind amendment 4 but does not limit the potential audience who may be reached and could be delivered more efficiently. Before I invite the minister, I invite other members who may have come. Alex Cole-Hamilton, followed by Emma Harper. Welcome, Jeremy Balfour, to the committee. Thank you for moving your amendments. I will not be supporting them today, but I support the intent of amendment 4. I agree with David Stewart that it would be resource intensive and there would be potential to miss certain very key and vulnerable people in our society out altogether. I think that there is something counterproductive in attaching something as positive as information about organ donation to a council tax demand or something like that, whereas the amendment in the convener's name around an annual publicity of media buy-in from the Scottish Government might lend an error of celebration to what should be a very positive development in public policy. I will not be supporting Jeremy's amendments, but I will support the convener. Thank you, convener. Good morning to everyone and again thank you, Jeremy Balfour, for bringing your amendments forward. As a former liver transplant nurse who has performed kidneys and pancreas transplants, I also have an input that might be different than normal members into the process. I absolutely support the idea that we need to provide informed consent for everybody and raise awareness of the process and the presumed consent and opt-in opt-out as the bill moves forward. I am keen to make sure that we raise awareness with schools and encourage families and conversations to occur. I agree with Alex Cole-Hamilton and Dave Stewart that it would be resource intensive to implement a process such as the amendments by Jeremy Balfour, but I would be interested to hear from the minister how we would monitor engagement and uptake and people adding their names to the organ donation register. I am aware that in Spain they do not even have an organ donation register, because through this whole process it has become the norm for people to donate their organs and tissues, so they do not even have an organ donation register. I am keen to support the amendments with the Government in this issue. Good morning to the panel and welcome my colleague Jeremy Balfour. I suppose that there is more a question for the minister as well, because in terms of the guidance that will be attached to the actual bill, I was wondering where the direction of travel was going in terms of public information around the bill. I completely accept what my colleague Jeremy Balfour has tried to bring forward with amendment 4, but I think that it is limiting in terms of a letter. I was wondering in terms of a future of the bill where that public information campaigns would be as we move towards far more digitalisation of health information. I thank Jeremy Balfour for moving his amendments, but I agree with David Stewart and Alex Cole-Hamilton that the convener's one for me is much better worded and one year is much better in that respect. I just have some concerns over seven and eight, which Jeremy Balfour has put forward. I am concerned that moving it from 12 months to two years, then 12 months to three years before consent can be given, is a bit concerning, not just for organ transplants, but perhaps for the person involved also. I have a concern in that respect. In David Stewart's particular one, I wonder if that would cause extra work or whatever it may be. People have registered and I presume that people can say whether they wish to be ordered or taken off it. Maybe it is a bit of duplication, so that is just my thoughts on it. Perhaps the minister could clarify that point, or Jeremy Balfour on the seven and eight. Thank you very much. If there are no other members' questions to contribute at this stage, can I invite the minister, please? Thank you, convener. Amendment 56 would mean that, as part of their duties in respect to transplantation and donation, the Scottish Minister should have a campaign of awareness and information at least once every calendar year. Amendment 57 sets out a duty on Scottish ministers to promote regular opportunities for persons to make a review, make or review their decision to donate or not to donate and to consider how such opportunities can be provided when a person is receiving healthcare services. Under the 2006 act, the Scottish ministers have a duty to promote information and awareness about donation for transplantation. New section 1D of the act set out in section 2 of the bill will add to that by also requiring Scottish ministers to promote information and awareness about how authorisation for transplantation may be given, including deemed authorisation. Awareness-raising carried out in accordance with the duty will make clear to people that their choices are and what their choices are and what the implications of the new system will be. One of the strengths of the 2006 act has been the duty on Scottish ministers to promote awareness and information about donation. As a result of the importance placed on that by successive Administrations and the evidence-based approach to awareness-raising, efforts to fulfil the duty have resulted in high public awareness of donations in Scotland. That has been demonstrated by year-on-year increases in people recording a decision on the organ donor register. The duty is fulfilled in a range of ways from specific targeted initiatives with different groups of the population to high-profile media campaigns. Awareness-raising is on-going, for example from promotion at public sporting or entertainment events, to information provided in GP surgeries, pharmacies and other public areas, similar to the request that David Stewart was making for his amendment. In addition, information is given through different media and social media activities, which happen regularly throughout the year. We will build on that as we raise awareness specifically about the opt-out system. As well as the broad awareness-raising, it is crucial that we undertake work to reach specific groups. We have committed to working with different groups, including disability groups and faith groups, to research, develop and test clear and accessible information, which will also be available in a range of languages. I know that the committee has made a number of helpful suggestions in that area. We have also committed to learning from Wales about its engagement strategy, particularly regarding reaching minority groups, and officials are in regular dialogue with English counterparts and developments there. We will continue to work with Kidney Research UK, who will provide updated training for peer educators in order to raise awareness of donation among South Asian communities. There will also be specific work to target young people. A point that was made by Mr Balfa will be updating the secondary schools education pack, and, as previously, we will work with Education Scotland to do so. We are also looking at ways to identify ways in which we can inform young people of the law shortly before they reach their 16th birthday and continue to keep them informed on an on-going basis. The financial memorandum of the bill takes that into account. Our intention, backed up by the new duty in section 2 of the bill, is that regular awareness raising about the opt-out system will be a priority and opportunities will continue to be taken to promote information and understanding of the opt-out system and the choices under it. That will also be supported by monitoring changes in public attitudes—a point raised by the deputy convener—and awareness as part of the planned evaluation of the opt-out system, which means that we can be responsive if there is a need to adapt that approach. I support the principles of amendment 56 to have a campaign of awareness and information at least once every calendar year, and I am happy to recommend it to be accepted today. However, I do think that it would be preferable, given the crossover between the provisions already in the bill and the amendments and the duties that are already in the bill, so that we should probably refine some of that text at stage 3. I would be happy to work with the member before stage 3 to achieve that. I thank David Stewart for bringing forward amendment 57. I hope that I have been able to provide reassurance on our continuing commitment to use every opportunity to raise awareness and, in particular, about the new system. Consider the duties in the bill and, on-going practice, meet the intentions of the amendment. David Stewart will therefore withdraw amendment 57. In the light of the discussions that I will have with the convener in relation to his amendment, I would be happy to meet David Stewart to make sure that any refinement of the convener's amendment would take into account the points that he is raising. If there are any that he considers are still missing by not passing that amendment, so I would ask him to consider not moving his amendment. Turn now to amendment 4, which requires Scottish ministers to send information at least once in every two-year period to persons registered on electoral roll. In light of the intended awareness raising and the general approach that I have outlined, while I appreciate the aim, I consider that amendment may be limiting, even if the law allowed access to electoral register for this purpose and I understand that it does not. It would not reach those who had decided not to include their details on electoral roll, as has already been mentioned. In addition, the proposal would have a high cost, which is estimated at around £2.5 million every two years at the current rates. That would have an effect on reducing the ability of Scottish ministers to raise awareness in other ways. As I have said, the awareness raising work that we undertake is based on evidence of what works best. I do not want to inadvertently limit ourselves to being required to use specific awareness raising methods when they may not be the most effective. As well as the awareness raising methods that I have outlined, I would like to reassure Mr Balfour that within the 12-month period there will be a direct mailing to all households, which means that, even if someone was not on the electoral roll, they would have access to the information. Again, that is accounted for in the financial memorandum. On that basis, I ask Jeremy Balfour to consider withdrawing amendment 4. I turn to amendments 7 and 8, which provide direct alternatives to increasing the length of time that a person needs to be ordinarily resident in Scotland before deemed authorisation for transplantation applies to either two or three years. I appreciate that Mr Balfour is concerned that people who are newly resident in Scotland may be subject to deemed authorisation when they may not be aware of the system. When developing the bill, the need for protection of certain groups of people who might not be aware of or understand deemed authorisation was a key consideration. The ordinarily resident requirement is part of those protections and the required duration of 12 months is in line with the legislation in Wales and England, as Mr Balfour said. Establishing what is a sufficient length of time to live in Scotland before deemed authorisation applies is, of course, a balance, and Mr Balfour's amendment seeks to lengthen that period to either two or three years. The proposal in the Transplantation Authorisation of Removal of Organs, etc. Scotland Bill, introduced by Anne McTaggart in the last bill, was for a period of six months, and this committee considered that to be an insufficient period and recommended that it be increased to 12 months. I do appreciate that there will be a difference of views on what is appropriate, and we should all accept that. However, I am not persuaded that the duration should be increased. A 12-month residency requirement, which has been in place in Wales since 2015, and we are not aware of any difficulties arising from the approach there. Additionally, the bill contains safeguards that aim to ensure that donation does not proceed where it would be against the wishes of the potential donor. That includes awareness-raising duties that seek to ensure that this is a public awareness about the implications of the new system and the duty to inquire, which applies in all cases and seeks to ensure that the views of the potential donor will establish whether or not donation is authorised. I hope that information that I have already outlined about awareness-raising provides assurances on this point. Specifically, in terms of people newly resident, we are looking at what was undertaken in Wales. That includes utilising various channels of awareness-raising, including through new GP registrations, universities, state agents and major employers. That type of activity would supplement the broader, on-going awareness-raising campaign. I hope that that provides reassurance that the system includes sufficient safeguards alongside the awareness-raising work and, therefore, the residency requirement duration of 12 months in the bill as introduced should be retained. On that basis, I ask Mr Balfour not to move amendments 7 and 8, and if moved, we would urge members to resist. Finally, turning to amendment 63, which would prevent the optic system from being implemented before a two-year awareness-raising period has been carried out, beginning from royal assent. We have always been clear that there needs to be a high-profile public information campaign over at least 12 months before commencement of the system. I was pleased to see that the committee recommended that we are welcome to this commitment at stage 1 in its report. That approach was also proposed in the Scottish Government's consultation and attracted significant support. I understand that there was a similar requirement to that proposed in this amendment in the Welsh legislation, but there is already a greater deal of exposure about opt-out since then. There have been many conversations in Scotland over the past few years about introducing opt-out, including in this Parliament, and most recently England has embarked on an awareness-raising campaign that will run over 12 months. I also want to reassure members that, while we have committed to a specific awareness-raising campaign of at least 12 months before the introduction of opt-out, that is not limiting. I am grateful for Mr Macdonald for taking the time to discuss his amendment with me. I am happy to give the assurance that, in addition to the 12-month campaign, we also intend to provide information about the move to a new system in a variety of ways, starting as soon as the bill receives royal assent. As I have said, I am pleased to see the committee welcome as a Government commitment to have a high-profile awareness-raising campaign. I am satisfied that the awareness-raising duties in the bill, along with the commitment made by the Scottish Government, including awareness-raising over at least 12 months, support the aims of the bill and will ensure that people are aware of the new system and its choices within it. While I agree that there needs to be awareness-raising, I hope that members will agree and the additional assurances that I have given today that, on balance, we have the balance right, I would ask Lewis Macdonald not to move amendment 63. If the amendment is moved, I would invite members to reject it. Thank you very much, minister, and I can now go to Jeremy Balfour to wind up and press or withdraw his amendment. Thank you, convener. I think that the debate that we have had has been very helpful, and I think that the comments by the minister have been particularly helpful. I think that I would slightly caveat the minister's views that I am not sure that the public are as aware, as perhaps you said in your opening statement, and I think that there needs to be work in regard to the amendments. I think that amendment 56 achieves more than I would be looking to achieve, so I am willing to withdraw amendment 4, and I would personally ask the committee to support amendment 56 and make that commitment. I will withdraw amendment 7 and 8 at this stage, but I may ask the minister if we could just look at what information is particularly given to somebody who arrives in this country from abroad. When we visit their GP, most people will probably be at their GP within a year to register, and at that point, if they were given an appropriate letter of information, I think that that would be some comfort. I would also just maybe ask the minister to reflect before we get to stage 3 again on whether—and I appreciate the cost going out for two years—but whether a letter could go to every 16-year-old child who would be at school, which would be part of the pack that we might get when we are leaving school, so it would not add any extra cost. It would simply be something that a child would get. I might start the debate with him at school, as well as beyond that. With your permission, convener, I will withdraw amendment 4, 7 and 8. We will come back to amendment 7 and 8 in due course, but the proposal at this point is that amendment 4 be withdrawn is our member's content, and that amendment 4 be withdrawn. We will now come to amendment 56. In my name, I have already debated with amendment 4. I note the ministers and acknowledge the ministers offered to discuss this further in advance of stage 3. On that basis, I move amendment 56. The question is that amendment 56 be agreed, or are we all agreed? Thank you very much. The question then is that section 2 be agreed. Are we all agreed? Thank you very much. We then move to the next grouping, which relates to accepted body parts. This is, again, an amendment in the name of Jeremy Balfour, amendment 5. It is grouped with amendment 6, amendments 9 to 17, inclusive, and amendments 19 to 23 inclusive. Can I ask Jeremy Balfour to move amendment 5 and speak to all the amendments in the group? I suppose that the amendment in regard to making sure that tissue is not used to create reproductive cells in research is again just to highlight that I think when we are talking about this bill, everyone is talking about organ transfers, which obviously is something that we are already keen to see. Beyond that, there is the issue around tissue and how tissue could be used. My understanding, and I am open to the minister to comment on this, is that at the moment within the bill, tissue could be taken and used for research such as reproductive cells, artificial sperm or eggs. I will use different tissues from my body to create human embryos for research. I think that that goes beyond what is understood by most people to be within this bill. I think that there is an ethical difference between creating that type of tissue compared to a kidney or a heart transplant. I am just seeking the minister's understanding of whether that is right and whether the Government and the committee believe that that is something that we want to move down effortfully. The other amendments all deal with the difference between non-exempt body parts and exempt body parts. From my understanding, this is a terminology that is not found in any other part of the act, either in Wales or in the rest of the world. Again, I am open to correction of that. For me, there should be no difference between accepted and non-exempt body parts. I think that we should be encouraging people to use all parts of their body for transplantation. Again, I think that I just want to understand where the Government is coming from from drawing up the two types of different lists. From my understanding, that does not happen in Wales, and I am interested in knowing why we think that that should happen in Scotland. Thank you, convener. I am interested in that because we have had discussions about this. It is not just about organ transplantation—solid organ—it is about tissue as well. Tendons and heart valves are quite common as tissues that are transplanted, but there are people who freak out when they talk about face transplants and other as well. That does not really happen in this country, but there is continued research and development. I am aware that there are other organ transplantations that are in trial, such as uterus in Wales. For me, there are issues around pancreatic transplants and the obtaining of islet cells. We need to allow people time to engage in the understanding of what it is that we are talking about when we mean organ and tissue. Most folk understand the common solid organ transplants of heart, lung, liver and kidney. The distinction is warranted to show that we do not want to restrict the transplantation of other tissue, but we do not want people to not opt in because they might be subject to being afraid of what might be tissue that is applied to them and their families. Thank you very much. Any other members who wish to contribute? If not, can I invite the minister to respond to this group? Thank you. The effect of these amendments would be to remove a protection from the bill. The bill, as introduced, includes an exemption so that deemed authorisation does not apply to accepted body parts. The bill includes provision for regulations to specify what the category of accepted body parts includes, and those will be subject to the affirmative procedure and subject to consultation. The intention, as outlined in the Scottish Government's consultation, is that deemed authorisation will apply only to those organs and tissues that are commonly transplanted. Those are the organs and tissues that most people might commonly understand as being able to be donated, including kidney, heart, lungs and liver. The intention is that all body parts, aside from those commonly transplanted ones, the accepted body parts will be listed in regulations and will be exempt from deemed authorisation. That is the same approach as has been taken elsewhere, and it is a regulation in the Welsh legislation that lays down the list. As well as this exemption, deemed authorisation applies only in relation to transplantation, not to research—again, a point that Mr Balfour was making—and no body parts can be used for research purpose without explicit authorisation. Amendment 9 and 10 remove the category of accepted body parts and instead include a protection only in relation to parts of the body that contain reproductive cells or are to be used for reproductive purposes. The fact of this is that parts of the body that is intended would be excluded body parts would, under amendment 9, be able to be removed and transplanted under deemed authorisation. To get to Mr Balfour's point, I am very much a supporter of organeration and I have opted in to say that I am content for all of my body parts to be used after my death if I was to die in such circumstances that they could be used. However, the bill does not assume that that would be covered under deemed authorisation if it is not commonly expected as the commonly transplanted organ, so I guess that there is the slight difference. It makes the point about how the organ donor register remains very important within the legislation. I mentioned earlier that there is a list in Wales and the respective list in Wales includes such body parts as the face and hands. I do not think that it is common public understanding that these parts of the body would be denated and transplanted and I think that it is appropriate that we provide the safeguards so that it is clear to the public what the limitations of deemed authorisation are. I understand Mr Balfour's concerns in relation to reproductive cells and body parts not being part of deemed authorisation for transplantation. As I have said, the Government's intention is to ensure that only that material, which is publicly understood to be routinely denated, should be part of deemed authorisation. I do not think that the material that those amendments relate to would fall within that. The list in Wales includes the types of material that those amendments relate to, for example, ovary uterus penis testicle. Subject to consultation and this Parliament's view, it is expected that the list of accepted body parts here will be very similar. I propose that the accepted body parts regulations are the vehicle to limit the parameters of what can be donated under deemed authorisation and, on that basis, urge Jeremy Balfour to withdraw those amendments. Mr Balfour specifically asked some questions around reproductive cells and how that would be covered under the bill. The procurement, storage and use of gametes or reproductive cells is dealt with under the Human Fertilisation and Embryology Act and requires a human fertilisation and embryology authority licence. It is completely separate from the 2006 act and this bill. Thank you very much, minister. I now ask Jeremy Balfour to do two slightly different things, to wind up in the group as a whole and then to press or withdraw specifically amendment 5. I have nothing to add, convener, and I withdraw amendment 5. Thank you very much that amendment is withdrawn. The committee is so agreed. We therefore move on to the next group, which relates to the establishment and maintenance of the register. We call amendment 24 in the name of the minister a group with amendments 25 to 33. Minister, to move amendment 24 and speak to all amendments in the group. Convener, I am bringing forward amendments 24 to 33 following further consideration about how the provisions of section 3 of the bill about disclosure of information by the register organisation will work in practice. The amendments aim to more accurately reflect who information needs to be shared with, to clarify that the information disclosed must be about a particular potential donor and to refine the purposes for which information can be shared. New section 2C1A of the 2006 act, as inserted by amendment 25, restricts the powers of the register organisation to disclose information within Scotland to those carrying out functions under part 1 of the 2006 act. New section 2C1B, also set out in amendment 25, provides a power for the register organisation to disclose information to persons out with Scotland who are carrying out functions related to the removal and use of parts of the body for transplantation. The power to disclose information out with Scotland reflects the collaborative arrangements in which donation and transplantation services operate. New section 2C1A would allow information to be shared within Scotland by the register organisation with those listed under section 2C2 for particular purposes but no longer directly with relatives of donors. In practice, there is only a need for the register organisation to disclose information to specific persons who are engaged in functions related to the removal and use of a part of the body for transplantation. Therefore, amendment 27 reflects that by replacing the existing reference to health boards, etc., with a reference to those persons. Amendment 26 makes it clear that the register organisation's power to disclose information includes the power to disclose that there is no recorded information on the register. Within Scotland, that will support those undertaking the duty to inquire, allowing, for example, specialist nurses to have conversations with the family about the views of the donor. Amendments 28 and 29 have the effect that those listed in section 2C2 can disclose information that they receive from the register organisation to another person carrying out transplantation functions under part 1 of the 2006 act, as well as to relatives of the donor. For example, in practice, that would allow a specialist nurse for organ donation to share information with a retrieval surgeon that an authorisation for donation is in place, so that, among other things, the retrieval surgeon can be satisfied that the requirements in section 11 of the 2006 act are fulfilled before retrieval takes place. Amendments 30 to 33 are consequential. I move amendment 24. Thank you very much, minister. Can I invite other members who wish to speak on this group of amendments to do so? Are there other members who wish to make comment? Therefore, if not, minister, anything else you wish to add? I think that I'm content. Question then is that amendment 24 be agreed to. Are we all agreed? I now call amendments 26, 27, 28, 29, 30, 31, 32 and 33. All of the name of the minister are all debated a moment ago with amendment 24. Can I invite the minister to move these amendments on block? Thank you very much. Does any member object to a single question being put on these amendments? If no member objects, the question is that amendments 25 to 33 are agreed to. Are we all agreed? Thank you very much. Therefore, I call amendment 57 in the name of David Stewart. Already debated with amendment 4, David Stewart to move or not. The question is that amendment 57 be agreed to. Are we all agreed? We're not all agreed that it's there for be a division. Can I see those in favour of amendment 57 and can I see those against? That amendment is carried by five votes to four. Thank you very much. The question is that section 3 be agreed to. Are we all agreed? The question is that section 4 be agreed to. Are we all agreed? Thank you very much. We now move on to the next group, which is in relation to how authorisation, declaration or withdrawal is to be made. Can I call amendment 34 in the name of the minister? Which is grouped with amendments 36, 40 and 42. Thank you, convener. I'll speak to all the amendments in this group, which seek to enable a person to orderly withdraw a decision that they have given to the registered organisation. At present, in Scotland, a person can withdraw their donation decision in writing only. Currently, when contacting the organ donor register helpline to withdraw a donation decision, individuals in Scotland are advised that this can only be done in writing, such as by changing their decision online on the organ donation register or writing to the organ donor register requesting the change. Those amendments will provide flexibility as to how a person can have a previously recorded decision withdrawn from the register and will bring Scotland in line with practice in the rest of the UK. NHSBT has welcomed the fact that through those amendments, callers to the organ donor register helpline from Scotland will not be required to be directed away from the call centre to withdraw decisions online or separately in writing. As a matter of good practice, any withdrawal of a recorded decision is followed up by the organ donor register in writing as confirmation. This is more a point for clarity to be quite frank. In terms of how an oral withdrawal will actually be logged or recorded, can you provide more information on how the actual procedure for someone to withdraw orally from consent? Either the minister may intervene or he may respond once we have heard from other members. Are there any other members or members attending the committee who wish to comment on this group? Sandra White Cymru. This was one of the issues that I raised under 57, which I thought was duplication of this. I think that it is important that people get the opportunity to say if they wish to continue or not. I think that amendment 34 fills that gap, so it is very supportive of it. Thank you very much. Are there other comments? I would concur that there seems to be a useful improvement in the bill, but I am very interested in the minister's comments. Can I ask the minister to wind up, please? Just to respond to Mr Briggs's point, this would bring us into line with practice in the rest of the UK. I understand that the procedure there would be that a person would telephone the ODR. The ODR would then verify their ID, and that would then be followed up in writing. It would have one system for the whole of the UK. Obviously, the ODR holds register for the whole of the UK, but currently they have to have these two different systems where they have a system for the rest of the UK. For people from Scotland, they have to be diverted away to do it differently, so that would bring us into line with the rest of the UK. As a matter of information, Minister, if I may intervene on you, have there been issues around the different methods in these regards under the current legislation, or is this a precaution against a possible issue arising in the future? I am told that NHSBT would be very pleased if this amendment is passed because, currently, if someone has taken the decision to change their registered view either to opt in or to opt out, they get turned away and, often, members of the public are not very happy when they are told that they cannot do what everybody else can do. Indeed. Thank you very much. There are no other comments, so I will put the question. The question is that amendment 34 be agreed to. Are we all agreed? Thank you very much. We now move on to the next group in relation to the standard of evidence, and this includes amendment 35 in the name of the minister, grouped with other amendments as shown in the groupings. Can I ask the minister to move amendment 35 and speak to all amendments in the groupings? In speaking to the Government amendments in this group, I wish to note Mr Rumble's interest in this aspect of the bill. We met to discuss the amendments that he lodged on this point and shared the same aim to ensure that authorisation for transplantation is not deemed where it would be against the potential donor's wishes, and that has been the aim of safeguards included in the bill. We agreed to look further at the issue to see whether we could amend the test in the bill to meet the concerns raised by Mr Rumble's. Amendment 38 seeks to do that, and I am pleased that we have been able to find agreement. I am grateful to Mr Rumble's for withdrawing his amendments on that basis. Amendment 38 relates to the test to displace deemed authorisation for transplantation. As provided for the amendment to do this, a person must provide evidence to a health worker that would lead a reasonable person to conclude that the potential donor would have been unwilling to donate. That evidence would be about the potential donor's most recent view. The revised test also applies to establish whether a potential donor would have been unwilling in the circumstances to donate, perhaps because donation in that particular circumstance of death would be incompatible with their faith. The lead a reasonable person to conclude formulation would apply instead of the existing threshold in the bill that requires evidence that would convince a reasonable person. I know the word convince was a specific concern that Mr Rumble has raised when we met and I am glad to be able to address that concern. The change to conclude rather than convince is also in line with the wording in legislation in England and Wales. As a consequence of amendment 38, amendment 35 and 41 and amendments 37 and 43 seek to replicate the lead a reasonable person to conclude test where an adult or child aged 12 or over has expressed authority or opted out of donation. The effect of that will be again to change the test in the bill with regard to the evidence required to show that the potential donor has changed their previous decision or to show that in the circumstances they would have changed their mind if they were capable of doing so. The test is being replicated in these contexts in order to reflect the intention that deemed authorisation should have equal status to other decisions and to avoid operational confusion about the application of different tests in different scenarios. I would like to reassure the committee that the new test, as with the previous test, is designed to enable in all circumstances evidence about a potential donor's views to be brought forward and for their views to be determined whether or not donation is authorised. The test is robust enough to ensure that donation can only proceed where it would not have been against the potential donor's wishes and has been designed with the kind of decisions that take place with families by the bedside in mind. Operationally, evidence will most frequently be the family telling the specialist nurse for organ donation or tissue donor co-ordinator about the conversations that they have had about donation and what views their loved ones had expressed, but it is flexible enough to enable any kind of evidence to be produced. In addition to the test to establish views on donation, the revised test has also been applied with regards to incapacity. Amendment 39 amends the example of when an adult is considered to be incapable of understanding the nature and consequences of deemed authorisation in new section 64 of the 2006 act. The effect of the new section 62B is that deemed authorisation does not apply in relation to someone who is so incapable. In practice, a specialist nurse or tissue donor co-ordinator will seek to establish whether a potential donor had the capacity to understand deemed authorisation. Staff who have been caring for the patient are likely to be aware that the patient had a lack of capacity, but a potential donor's family member would also be able to provide evidence of incapacity. Although evidence is not required to establish incapacity, the example in the bill makes clear that where it is presented it should lead a reasonable person to conclude that the potential donor was incapable of understanding the nature and consequences of authorisation. A great deal of consideration has been given to the tests in the bill to ensure that information can be brought forward in order to respect a potential donor's wishes and to ensure that there are sufficient safeguards for those who are incapable of understanding the nature and consequences of deemed authorisation. I confirm that NHSBT and SNBTS were consulted and they are content with the approach in the bill on those issues and the associated amendments and I ask members to support them on that basis. Turning to amendments 58, 59, 60 and 61, I am unable to support those amendments as they undermine the very principle of an opt-out system. Authorisation for donation for transplantation is able to be deemed in the context of the duties of Scottish ministers to raise awareness about the new system. If a person is made aware of how the system operates and that system operates on the basis of deemed authorisation, then we think that it is reasonable to assume that an adult is willing to donate unless they opt out. We recognise that this assumption may be displaced in ways other than by an opt-out declaration. If a person's most recent view is that they are unwilling to donate, then that should be given effect to as well. That is the reason for the safeguards in the bill and to ensure that the evidence about the adult's latest views can be brought forward. Importantly, the bill provides that evidence of an adult's unwillingness to donate can be brought forward by a wide range of people to ensure that relevant information is not excluded from consideration. Amendment 59 restricts the provisions of evidence to only the nearest relative, reducing the possibility that relevant information could be produced. The amendments that are taken together would mean that deemed authorisation only applies if evidence is provided by the nearest relative that a person is willing to donate. It destroys the basis on which deemed authorisation operates as there is no assumption of willingness. It has to be demonstrated and by the nearest relative. Crucially, those amendments could risk the progress that we have seen under the 2006 act. Currently, under section 7 of the 2006 act, which is to be repealed by this bill, if an adult has not authorised donation, the nearest relative may authorise donation upon their death unless they have actual knowledge that the adult was unwilling to donate. The opposite test to what those amendments propose. Part of the reason for the introduction of an optite system is because we know that many more people support donation than register their willingness to donate. That is why we want to move to a system of deemed authorisation that makes donation the default position. We hope that provisions relating to deemed authorisation together with the awareness raising about the new system will contribute towards the on-going improvements that we have seen in donation rates. Those amendments, however, would damage that progress and undermine the efforts of those who are working in the system to increase donation, and I urge members to resist them. I move amendment 35. I welcome Gordon Lindhurst to the committee and I invite Gordon Lindhurst to speak to amendment 58 and other amendments in this group. Thank you very much, convener. I have heard what the minister has to say about amendments 58 to 61, but, nevertheless, if I might set out the reasoning behind them, those amendments relate to the formulation of the consent principle, and rather than it being a negative, indeed, as it set out in the bill, a double negative, the amendments change it to a positive. This is in keeping with modern best practice such as set out in the European Convention on Human Rights and Biomedicine, ETS 164, and its additional protocol concerning transplantation of organs and tissues of human origin, ETS 186. I think that the simplest way to illustrate it is, for example, the most up-to-date European-based GDPR regulations, which require a conscious affirmative consent to be given in relation to personal data, rather than the previously allowed passive consent. As it is a probing amendment, it has been drafted in relation to one section only if to be followed through with further amendments would be brought at stage 3 in relation to the wording intended to be amended where appropriate in the rest of the bill. Thank you very much, and can I ask other members to indicate? I see my crumbles. Thank you very much, convener. This set of amendments from the minister is all about the potential donor's wishes. It is about the safeguards in the bill that ensure that. I am absolutely delighted that I was pleased to withdraw the men's that I lodged on Friday because we reached an agreement with the minister on this. We have both agreed that we want to do the right thing here. From my background here, I have been on the organ donor and registered myself for the past 20 years. It was the first campaign that I was involved in when I was elected to the Scottish Parliament. I was on the health committee previously when we took through the 2006 act and spent many months, of course, with the convener being the minister at the time. When I saw the bill, I was supportive of it except for this one phrase that was in the bill, which was to convince a reasonable person, which was a particular standard of law, which is used in many other bills. I think that that is what happened here. The legal team perhaps put that in the bill. I have to say that, in my view, the key amendment is amendment 38, and the other amendments from the minister are setting the rest of the bill as a result of the amendment 38. I voted against it in stage 1 because I was really worried about the word convince. I felt that it was unintentionally, and it was clearly when I met the minister, unintentionally, putting a barrier to the success of the bill. I was worried in case there might be a problem further down the line. What the minister has done has used the phrase lead a reasonable person to conclude. I want to put it on record because I do want to put it on record how pleased I was that the minister himself listened to the arguments, accepted the arguments, and we all want to achieve the right thing with this bill. I just wanted to put that on the record, so I would hope that the committee would unanimously support the minister's amendments in this section. Very much. A reasonable person would conclude that Mr Rumble's supportive of those amendments. Can I ask if any members of the committee wish to comment on either group, either of the sets of amendments within this group? If not, can I ask the minister to wind up? The principle behind the bill is to respect the primacy of the views of the potential donor. That is why the safeguards are in the bill to ensure that it is their views, which establishes whether or not donation is authorised. Against the backdrop of the move to a soft opt-out system and the awareness raising that will take place, it is entirely appropriate to set the default in favour of donation where an adult has not opted out, with the safeguards in place as the check to make sure donation would not go ahead against the donor's wishes. I think that that is the appropriate balance and the Government amendments additionally have sought to address concerns that might happen. I urge members to support amendments 35, 37, 38, 39, 41, 43 and to resist amendments 58, 59, 68 and 61. The question is that amendment 35 be agreed. Are we all agreed? The question then is that section 5 of the bill be agreed. Are we all agreed? Thank you very much. Call amendment 36. In the name of the minister, I have already debated with amendment 34. Minister, to move formally. Thank you very much. The question is that amendment 36 be agreed. Are we all agreed? Call amendment 37. In the name of the minister, Minister, to move formally. Formally moved. Thank you very much. The question is that amendment 37 be agreed to. Are we all agreed? Call amendment 6. In the name of Jeremy Balfour, I have already debated with amendment 5. Jeremy Balfour, to move or not move. I do not move. Thank you very much. The question then is that section 6 of the bill be agreed. Are we all agreed? Thank you very much. Call amendment 7. In the name of Jeremy Balfour, I have already debated with amendment 4. That is okay. Do you want to move away? Because I do not move. Thank you very much. I call amendment 8. Those amendments are rhyme. I call amendment 9. In the name of Jeremy Balfour, I have already debated with amendment 5. Can we say that just because it is helpful that I am happy to withdraw 9, 10, 11, 12, 13, 14, 15— I can take you 9, 10 and 11, because they are consecutive with them. I will draw three then, come on up. So, amendment 9, amendment 10 and amendment 11, already debated, are not moved. The committee are agreeable, therefore—sorry, and amendment 11, I think you also said, was not moved. Yep, you did. The question I therefore call amendment 58 in the name of Gordon Lindhurst, already debated with amendment 35. Gordon Lindhurst, to move or not moved? Well, I'm not sure the minister responded to my point, but I'm not going to move that amendment. Amendment 58 is not moved. Call amendment 59 in the name of Gordon Lindhurst. Again, convener, for the system, I'm not going to move any of these amendments. Call amendment 38 in the name of the minister, already debated with amendment 35. Moved. That is moved. The question is that amendment 38 be agreed to. Are we all agreed? Are we now come to amendment 60 and 61 in the name of Gordon Lindhurst? I take it from your previous comment. These are not moved. That is correct. Amendment 60 is not moved. Amendment 61 is not moved. If the committee is agreeable, then call amendment 39 in the name of the minister, already debated with amendment 35. Moved. Thank you very much. The question is that amendment 39 be agreed to. Are we all agreed? Call amendment... I come now to amendment 12 in the name of Jeremy Balfour. Jeremy Balfour, to move or not move? I'm not moved. Thank you very much. That is not moved. The question then is that section 7 be agreed to. Are we all agreed? The question is that sections 8 and 9 of the bill be agreed to. Are we all agreed? Call amendment 13 in the name of Jeremy Balfour, already debated. To move or not to move? Thank you very much. I mean that 13 is not moved. The question then is that section 11 be agreed to. Are we all agreed? Sorry, section 10 is agreed to. Are we all agreed? The question is that section 11 be agreed to. Are we all agreed? Thank you very much. I now call amendment 40 in the name of the minister, already debated. Minister to move formally. The question is that amendment 40 be agreed to. Are we all agreed? Call amendment 41 in the name of the minister, already debated. The question is that amendment 41 be agreed to. Are we all agreed? The question is that section 12 be agreed to. Are we all agreed? Call amendment 42 in the name of the minister, already debated. Aversead Minister, to move for me. Awegwtion hynny er picnw Felly, os ydym yn gwneud ddwybr gwylladeu cyfnodau o'r ffots, ac rwyw ddim yn25 yma'r siaradau gyda'r ddwybr gwylladeu cyfnodau. Labour cwrwp yn 64 yn nabod cyfair, o'r ddwybr cyfair ynaniau cyfair yn 45-49. Rwy'n gwneud ymmygol yn 44, ac yn bryg ar涉 o gwisefau yn pareceig, dechrau yn 44-49, lleion yn 49. Rwy'n gwneud yn 49 o'r ddwybr cyfnodau diolch o'r ddwybr cyfyrngau cyfwyrnadau yng Nghymru. SNBTS sefydlu'r eich cyfnodau i gynnwys yng Nghymru 21 yng Nghymru 11 yng Nghymru Scotland Act 2006, ac mae'n gweithio'r ysgrifennu, ac mae'n gweithio'r eich cyfnodau i gynnwys yng Nghymru. The amendments that are brought forward are intended to amend section 111 to 114 of the 2006 act to clarify the role of the registered medical practitioner in cases where another person has been authorised to retrieve tissue. The amendments will allow SNBTS to operate more effectively and to be responsive to practice development. Section 111 of the 2006 act provides that removal of a body part for transplantation must be undertaken by a registered medical practitioner or someone authorised to do so in accordance with regulations. Regulations can provide that a registered medical practitioner to authorise the removal by a non-practitioner. The current regulation provides that a registered medical practitioner may authorise any person provided that they are satisfied that the person undertaking the retrieval is sufficiently qualified and trained to perform the operation competently. Amendments 44, 45 and 47 to 49 will amend section 11 of the 2006 act to make it clear that the body parts of a deceased person may be removed by a person who is authorised to do so under a general authorisation made in accordance with regulations and enable the regulations to make provision about general authorisations for a description of persons. The amendments also remove section 113b of the 2006 act, which implies that authorisation must be given in individual cases and ensures that it is only the person who proposes to remove the body parts who is required to be satisfied that the requirements of section 114 of the 2006 act are met. Amendment 46 will amend section 114a of the 2006 act so that where the person proposing to remove a body part from a donor is a registered medical practitioner, that person may examine the donor's body to confirm that the donor is deceased or satisfy themselves that another registered medical practitioner has examined the donor's body to confirm that the donor is deceased. Amendment 46 will also add a new paragraph a b to section 114 of the 2006 act so that where the person proposing to remove a body part from a donor is not a registered medical practitioner, that person must satisfy themselves that a registered medical practitioner has examined the donor's body to confirm that the donor is deceased. I ask the committee to agree to amendments 44 to 49, which will allow SNBTS to continue to respond effectively to increases in tissue retrieval, and I move amendment 44. Thank you very much minister. Can I invite any other members of the committee who wish to comment on any of those amendments? Sandra White. Thank you, thank you very much minister. I fully support, I just want a piece of clarification on amendment 46 when it mentions the fact that personal examination of the body is satisfied that life is extinct and that a registered medical practitioner also does not have to be a registered medical practitioner. In what way would that be? I presume that someone would examine it first and they would go to them and they would get paper, you know, authorisation from a registered medical practitioner. I just want to read that clarification on amendment 46. Thank you very much. Are there any other members who wish to comment or seek clarification before I invite the minister to respond? If not, minister? I think that the kind of point from my contribution earlier was that, you know, the person that is removing the organ needs to be satisfied that another registered medical practitioner, so that could be the hospital, has examined the donor's body to confirm that the donor is deceased. So, I mean, it's confirming that that will be done. It's about making sure that the bill works in practice and doesn't. Thank you very much minister. You have no further comments to add to those at this stage. In that case, the question is that amendment 44 be agreed to. Are we all agreed? Call of amendment 45 in the name of the minister. Minister to move formally. Moved. Question is that amendment 45 be agreed to. Are we all agreed? Call of amendment 46 in the name of the minister. Minister to move formally. Moved. Question is that amendment 46 be agreed to. Are we all agreed? Thank you very much. Call of amendment 14 in the name of Jeremy Balfour, already debated. Jeremy Balfour to move or not moved? No move. Thank you very much. That amendment is not moved. I call amendment 47 in the name of the minister, already debated with amendment 44. Minister to move. Thank you very much. Question is that amendment 47 be agreed to. Are we all agreed? Thank you very much. Call of amendment 48 in the name of the minister. Question is that amendment 48 be agreed to. Are we all agreed? Thank you very much. Call of amendment 15 in the name of Jeremy Balfour. Moved to all. Moved or not moved? No move. Thank you very much. Call of amendment 49 in the name of the minister. Question is that amendment 49 be agreed to. Are we all agreed? amendment 16 yn y ffordd Jeremy Balfour. The question therefore is that section 21 will be agreed to. Are we all agreed? Thank you very much. We then move on to section—sorry, the grouping, which relates to pre-death procedures relating to transplantation. Can I call amendment 50 in the name of the minister, which is grouped with amendments 51 and 18? Minister, to move amendment 50 and speak to all amendments in the group. I'll speak to amendments 50 and 51, which make minor amendments to the provision about pre-death procedures in the bill. Those amendments are aimed at ensuring that the provisions will work effectively when applied in practice. The provisions in the bill will support the carrying out of pre-death procedures are robust and provide a clear legal framework in providing the circumstances when they may be carried out and when they must be authorised. Transparency is important to this, and amendment 50 will enable the procedures that may be specified as type A to be described more accurately by making it clear that they may also be described by reference to how they are carried out. The ability to specify the procedures in regulations also ensures that the statutory framework is robust, responsive to changes in practice and particularly to developments in medical practice and care. The minor change introduced by amendment 50 to the enabling power further enhances that. Amendment 51 will also make it clearer how the system is intended to work in practice. As the committee is aware, pre-death procedures are not new. Those that are currently carried out include taking blood and carrying out x-rays, and it is not intended that, for example, a radiographer who is asked to carry out an x-ray has to be involved in the authorisation process nor carry out the duty to inquire. Amendment 51 makes it clear, while retaining important safeguards provided in the bill, including that the procedures cannot be carried out if it is known that the person who was unwilling for it to be carried out. I hope that members share my aim to ensure that the bill works in practice, and I therefore invite members to support those amendments. I move amendment 50. I would also like to speak to amendment 18 and understand Mr Balfour's concerns that carrying out pre-death procedures should not bring about the premature death of a potential donor. As I have mentioned, the provisions in the bill that support the carrying out of pre-death procedures are robust and include significant safeguards around how and when they can be carried out. Importantly, those include that they should not be carried out if it is likely to cause more than minimal discomfort or harm to the person. I believe that not shortening life expectancy would be captured by the requirement not to harm. Of equal importance, the bill also explicitly provides that procedures can only be carried out if, in the view of those responsible for the patient's care, the person is likely to die imminently and where life-saving treatment is being administered, a decision has been taken to withdraw the treatment. That takes account of the very specific contexts in which they are carried out. It is a very narrow window at the very end of a patient's life where they are being cared for by medical professionals with family involvement in discussions about care and end of life. I am satisfied that the bill includes significant safeguards and I am not persuaded of the need for this amendment. I hope that I have provided sufficient reassurance and invite Jeremy Balfour to withdraw amendment 18. Thank you very much. Can I invite Jeremy Balfour to speak to amendment 18 and other amendments in the group? Thank you. First, I am supportive of amendment 1551. My amendment 18 simply puts down in-law what should happen and what we all hope should happen. I think that the thinking behind it, from my perspective, is that it gives those individuals who decide to opt in absolutely guarantee that they will be treated no differently from those who have not opted in. I think that that will happen anyway, but I think that it gives that absolutely legal requirement. I do not think that this takes away from anything that the minister is moving in his two amendments. I do not think that it makes any difference, hopefully, in practice for the medical teams, but I do think that there has been, perhaps, in the past slight concern that people are treated slightly differently if they are on the donor list or the not on the donor list. This absolutely just clarifies that that is not the case. I do think that it is a safeguard that will give people an assurance to go on to the list after all, which is what we want people to do, so that is the reasoning behind my amendment 18. Thank you very much. I invite other members of the committee. Having worked in transplant at both the donation side and the recipient side, it is a really difficult situation. In my professional working life, I have never seen anybody wish to hurry up somebody's death so that we can get them to an organ donation site or operating theatre. The amendment, although well intended, is not required because of the way that current healthcare practice is delivered across Scotland. Thank you very much. Thank you very much, chair. I thank the minister for the amendments. This is an area that I had raised from the very beginning. Being a layperson, I did not know a lot about pre-death procedures, and having met various people whose loved ones had passed away and seen what had happened and the information that they got, I was comforted but still raised the various questions. I thank the minister for pushing it forward in the type A category and also the transparency that you are talking about and the families that are going to be involved. That was always my concern that we did not know a lot about what was happening. I can understand Jeremy Baill for bringing forward, I think that it is probably just a probing amendment and maybe another not moved. I am not sure that I cannot speak for Jeremy, but I am very pleased with those amendments and thank you very much. Thank you very much. Are there any other comments? If not, can I invite the minister to wind up? As I said earlier, the bill is setting out provisions about pre-death procedures, which are robust, transparent and responsive to change and the important aim that they can work in practice. Amendment 1551 are minor changes, which further add to this again, and again I invite the committee to support them. Safeguards are important and the provisions in the bill about pre-death procedures have been carefully developed to ensure that they recognise the particular circumstances in which they are carried out. People will be under the care of health professionals who work within an ethical framework and where patient care is a priority. The bill also provides that procedures may only be carried out if necessary and are not likely to cause any harm, which unsatisfied addresses Jeremy Balfour's concerns. I therefore urge the committee to reject amendment 18. Thank you very much. The question is that amendment 50 be agreed to. Are we all agreed? Call of amendment 51, the name of the minister who is already debated. The minister to formally moved. The question is that amendment 51 be agreed to. Are we all agreed? Call of amendment 17 in the name of Jeremy Balfour who is already debated with amendment 5. Jeremy Balfour to move or not move. Call of amendment 18 in the name of Jeremy Balfour who is already debated with amendment 50. Jeremy Balfour to move or not move. The question is that amendment 18 be agreed to. Are we all agreed? That seems to me to be clear. Are there any votes in favour of amendment 18? There are not. That, therefore, is not agreed. Thank you very much. We'd better have a vote against just to be absolutely clear. Can I see those voting against amendment 18? Thank you very much. Amendment 18 is not agreed. The question is that section 22 be agreed to. Are we all agreed? Thank you very much. We move then to the next grouping, which relates to the meaning of health worker. Can I call amendment 52 in the name of the minister group with amendments 53 and 54? Minister, remove 52 and speak to all amendments in the group. I'll speak to amendments 52 to 54, which seek to change the definition of health worker in the bill. Following the bill's introduction and after speaking to key people who deliver donation and transplantation services, we've reviewed how the definition of health worker currently in the bill will work in practice and are of the view that those amendments are necessary. To be able to work properly in practice, we consider that there needs to be more flexibility in the definition of health worker in the bill. The definition should also consistently apply to those who may be involved in the authorisation process and those who may be carrying out inquiries into potential donor's wishes, which is likely to be the same person. That is also relevant to pre-death procedures as other people working in healthcare who might not be a registered medical practitioner nor a registered nurse might be involved. For example, a radiographer who might carry out x-rays would be covered by the current definition. Our view is that the amendment achieves the appropriate level of flexibility by enabling health workers not only to be clinicians or nurses but also others who are suitably qualified. We think that this is also precise enough to maintain appropriate restrictions as to who can fulfil the health worker role in the different contexts in which it applies. With the additional powers for ministers to issue direction, it also includes adequate safeguards to maintain the integrity of the process. Importantly, as we all know, practice and procedures develop all the time. We are mindful that the system has to work in practice, so our view is that amendments are also responsive enough to allow for further development in procedures and practice. I therefore ask Members to support amendments 52, 53 and 54. I move amendment 52. Thank you very much. Can I invite any member who wishes to comment on those amendments? If not, have you any final comment? We will therefore move directly to the vote. The question is that amendment 52 be agreed to. Are we all agreed? Thank you very much. The question is that section 23 be agreed to. Are we all agreed? And the question is that sections 24 and 25 be agreed to. Are we all agreed? Thank you very much. Call of amendment 53 in the name of the minister. Already debated with amendment 52. The question is that amendment 53 be agreed to. Are we all agreed? Call of amendment 19 in the name of Jeremy Balfour. Already debated with amendment 5. Give me a minute. No, it's not for you. You may, if you wish, minister, but you may not. We suspend for a moment. Jeremy Balfour will, I understand, be back with us any second. That's quite right. Call of amendment 19 in the name of Jeremy Balfour. Already debated with amendment 5. Jeremy Balfour to move or not move? Not move. Thank you very much. Call of amendment 54 in the name of the minister. Already debated with amendment 52. The question is that amendment 54 be agreed to. Are we all agreed? The question is that section 26 be agreed to. Are we all agreed? Call of amendment 20 in the name of Jeremy Balfour already debated with amendment 5. No moves. Thank you very much. The question is called amendment 21 and I may call these on block amendments 21, 22 and 23 in the name of Jeremy Balfour already debated with amendment 5. The question then is that section 27 be agreed to. Are we all agreed? Thank you very much. We now come to the group with one amendment, which is in my name, on review and report on operation of the act. This again follows some discussions and reflects on the experience elsewhere. Amendment 62 inserts a new section to the bill, placing an obligation on ministers to research and report upon the impact of the provisions so as to determine the efficacy of the act. It imposes a duty to undertake a review and report back to Parliament. A similar exercise was carried out in Wales with the evaluation published in December 2017. However, that was done so close to the passage of the bill or of the act that the evidence of the benefits did not appear in that evaluation. The committee members will recall that we heard that in the 12 months following the publication of that evaluation, the evidence began to come through of an increase. Therefore, this amendment is designed to ensure that there is adequate period, a period of five years, beginning with the day of royal assent. I move section 62 in my name. Before I invite the minister, I would invite any comments from other members. Alex Cole-Hampton. Thank you, convener. I would like to seek some additional clarification, because, although I am generally in favour of reviewing the impact of legislation, I am concerned because the bill is so needed that it might open the door for it to be repealed or reversed. I just want to check your motivations behind that and to give assurances that you would not imagine that that would be the case. I will be happy to do so when I have the opportunity in a moment. Are there other members who wish to comment? Just a quick point, convener. I agree that if we are looking at increasing the number of people that are registered on the opt-in system or whether we see that opt-out might increase, we should be able to review the bill to see whether it is working or not. Thank you very much, minister. Thank you, convener. In supporting amendment 62, I am content that this is not a so-called sunset clause and I am happy on that basis to recommend its acceptance today. However, I think that it would be preferable to amend the start of the review period so that it begins not at royal assent but at the date of introduction of the opt-out system. I am suggesting this on the basis of the experience that the convener mentioned from the Welsh Government where evaluation, which concluded that two years of data were not enough to give an indication of the early impact of the design. Five years after introduction of the system feels like the right length of time, so I am happy to work with the convener before stage 3 to achieve that. Thank you very much. In winding up those that suggest that I am much appreciated and likewise happy to do so, as with the previous amendment that we discussed, and I hope that Alex Cole-Hamilton will agree with the minister that there is no intention here and no real route here for this to become a sunset clause. The intention is simply to ensure a review. I will take an intervention. On that clarification, I would be happy to support the amendment. Thank you very much. I will press that amendment. Can I therefore ask the question that amendment 62 be agreed to? Are we all agreed? Thank you very much. We now move to another group, which is on commencement only. I call amendment 55, in the name of the minister, to make it clear. In speaking to amendment 55, which seeks to remove reference to certain sections of the bill from section 28 so that they are not commenced the day after royal assent, following the bill's introduction and engagement with the key stakeholders, including NHSBT and SNBTS, we have reviewed the approach in the bill as introduced and consider that this amendment is necessary. That is to ensure that there is sufficient time for guidance to be produced and training to be provided to ensure that the pre-death procedures and timing of authorization provisions can be implemented successfully and so those working in the system are able to adhere to the new legislative framework. Further, following the introduction of the bill, sequencing issues were identified that make this amendment necessary. Before the pre-death procedures regime can fully be implemented, the regulations specifying the types of procedures need to be in place, so it would be unworkable to commence the provisions for the regime before that process is complete. Otherwise, the regime would be in place, but the procedures would not be specified and so could not be carried out. That also has an effect on the duties to raise awareness about pre-death procedures, which cannot be met if the procedures are not yet specified. It is the Scottish Government's intention to instead commence these and the remaining provisions in the bill by commencement regulations. As set out in the public consultation and the bill's accompanying documents, the intention is to carry out awareness raising over at least 12 months following the introduction of the opt-out system. As I have said previously, I think that at least 12 months awareness raising is appropriate given the increased exposure of debate about opt-outs across the UK since it was introduced in Wales in 2015 and, more recently, the start of the 12-month awareness raising period in England, which will inevitably have some reach in Scotland. I move amendment 55. Thank you very much. I see if other members wish to contribute in commenting on this amendment. If not, minister, you have no further points to add. The question is that amendment 55 be agreed to. Are we all agreed? We now come to amendment 63 in my name, already debated with amendment 4. I do not intend to move amendment 63. If members are content, we will move on. The question is that section 28 be agreed to. Are we all agreed? Thank you very much. Finally, we come to another group of a single amendment. This is an amendment again in my name and again a reflecting discussion with the Law Society really around the short title of the bill. Clearly, it is a bill to amend the Human Tissues Scotland Act, and, therefore, it should start with human tissue, and that is there. There is no reference currently in the short title to transplantation, given that, when it comes to newspaper comment and other public comment, it is the short title that is referred to. This was simply a suggestion that might improve the clarity and use the title of the bill itself as a means of raising awareness of its content. I move that amendment in my name. Can I invite other members of the committee who may wish to comment? I am grateful to you for your attention to the detail of the bill, but I am resisting amendment 64, which seeks to amend the short title. We take care in selecting titles of bills to ensure that they meet the Presiding Officer's recommendation that titles should be accurate and neutrally reflect what the bill does. Adding reference to transplantation to the short title was considered during development of the legislation, but that was not added because it felt that it would be potentially misleading to readers who might think that the bill was only about transplantation. The short title of the bill reflects that the bill is also about authorisation of donation for other purposes, not only transplantation. That is further reflected in the long title, which sets out that the bill is about authorisation for transplantation and other purposes. It seems to me that transplantation is given sufficient prominence in that way in the long title. The bill makes significant changes to authorisation for transplantation by introducing deemed authorisation for that purpose, but it also ensures that authorisation for other important uses, research, education or training, or audit or quality assurance, will require express authorisation from a potential donor or by the nearest relatives. The current short title of the bill acknowledges this, so, while I understand why Mr MacDonald has raised the issue, I would ask him to consider not pressing amendment 64. Thank you very much. In light of the minister's comment, I am minded not to press amendment 64 at this stage. It is, of course, open to members to revisit the issue at stage 3. I am content that I do not press and withdraw amendment 64. The question then is that section 29 be agreed to. Are we all agreed? The question is that the long title be agreed to. Are we all agreed? That completes stage 2 consideration of the bill. Can I thank the minister and his team for their attendance and members and non-members of the committee? The bill will now be reprinted as amended at stage 2, and members will be informed in due course when a date has been selected and when amendments can be submitted for stage 3. Thank you very much. We will now suspend briefly and then go, and we will resume in private session in five minutes' time. Thank you very much.