Hansard

I note Mr Rumbles’s interest in the standard of evidence. When we met to discuss the amendments that he intended to lodge on that point, we found that we shared the aim of ensuring that authorisation for transplantation is not deemed when it would be against the potential donor’s wishes. Safeguards that are included in the bill aim to achieve that. The Government agreed to look further at whether we could amend the test that is in the bill, in order to address Mr Rumbles’s concerns. Amendment 38 will amend the test; I am pleased that we have reached agreement and I am grateful that, on that basis, Mr Rumbles will not lodge amendments. Amendment 38 relates to the test to displace deemed authorisation for transplantation. The amendment will ensure that 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 will be about the potential donor’s most recent view. The revised test will also apply in establishing whether a potential donor would have been unwilling to donate in the circumstances—perhaps because, in the particular circumstances of death, donation would be incompatible with their faith. The formulation that evidence would “lead a reasonable person to conclude” will apply instead of the existing threshold in the bill, which requires evidence that “would convince a reasonable person”. When we met, Mr Rumbles expressed concern about the word “convince”, and I am glad to address his concern. The change to the word “conclude” rather than “convince” is also in line with the wording in legislation in England and Wales. As a consequence of amendment 38, amendments 35, 41, 37 and 43 will replicate the test that evidence would “lead a reasonable person to conclude” when an adult or a child who is aged 12 or over has expressed authority for or opted out of donation. That will change the test for the evidence that is required to show that a potential donor had 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 will be replicated in those contexts to reflect the intention that deemed authorisation should have equal status with other decisions and to avoid operational confusion from the application of different tests in different scenarios. I reassure the committee that, as with the previous test, the new test is designed to enable in all circumstances evidence about a potential donor’s views to be provided and to enable their views to determine whether donation is authorised. The test is robust enough to ensure that donation will proceed only when it would not have been against a potential donor’s wishes, and the test has been designed with the kind of decisions that take place with families by the bedside in mind. Operationally, evidence will most frequently come from a family telling a specialist nurse for organ donation or tissue donor co-ordinator about conversations that they had had about donation and the views that their loved one had expressed. However, the test is flexible enough to enable any evidence to be provided. In addition to the test to establish views on donation, a revised test will apply to establishing incapacity. Amendment 39 will amend the “example of when an adult is to be considered ‘incapable of understanding the nature and consequences of deemed authorisation’” in proposed new section 6D(4) of the 2006 act. Under new section 6D(2)(b), deemed authorisation will not apply when someone is considered to be 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 a patient are likely to be aware of whether they lacked capacity, but a potential donor’s family member could also provide evidence of incapacity. Although evidence is not required to establish incapacity, the example in the bill will make it clear that, when evidence 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 that are set out in the bill to ensure both that information can be submitted to respect a potential donor’s wishes and that there are sufficient safeguards for those who are incapable of understanding the nature and consequences of deemed authorisation. I confirm that NHSBT and the Scottish National Blood Transfusion Service were consulted and are content with the bill’s approach to those issues and with the associated amendments. I accordingly ask members to support them. I turn to amendments 58 to 61, which I am unable to support because 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 Scottish ministers’ duties to raise awareness about the new system. If an adult is made aware of how the system operates, and such operation is by means of deemed authorisation, we consider it reasonable to assume that they are willing to donate unless they opt out. We recognise that that assumption may be displaced in ways other than by opt-out declaration. If a person’s most recent view is that they are unwilling to donate, that should also be given effect. That is the reason for the safeguards in the bill, which ensure that evidence about an adult’s latest views can be submitted. Importantly, the bill provides that evidence of an adult’s unwillingness to donate can be submitted by a wide range of people, to ensure that relevant information is not excluded from consideration. However, amendment 59 restricts the provision of evidence to the adult’s nearest relative, which reduces the likelihood that relevant information will be produced. Taken together, the amendments would mean that deemed authorisation would apply only if a person’s nearest relative provides evidence that that person is willing to donate. It destroys the basis on which deemed authorisation operates, because there is no assumption of willingness; instead, willingness must be demonstrated by the nearest relative. Crucially, amendments 58 to 61 could risk the progress that we have seen happen under the 2006 act. Currently, under section 7 of the 2006 act, which would be repealed by the bill, if an adult has not authorised donation, their nearest relative may authorise it upon their death, unless that relative has actual knowledge that the adult was unwilling to donate, which is the opposite test to what the amendments propose. Part of the reason for introducing an opt-out system is that 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, which makes donation the default position. The Scottish Government hopes that the provisions relating to deemed authorisation, together with raising awareness of the new system, will contribute towards the on-going improvements that we have seen in donation rates. However, amendments 58 to 61 would damage that progress and undermine the efforts of those who are working in the system to increase donation. I therefore urge members to resist them. I move amendment 35.