Organ and tissue donation and transplantation: analysis of consultation responses

3.Views on a soft opt out system (Q1)

3.1 Chapter 1 of the consultation paper considered ways to increase authorisation for organ and tissue donation. One option considered is that of a soft opt out system. In such a system individuals are deemed to have agreed to being an organ or tissue donor unless they have indicated that they do not wish to donate, but family members are nevertheless asked if they were aware of the patient having expressed any objections to donating before the donation proceeds. Although the consultation paper states that there are other options available - including retention or reform of the current opt in system - much of the chapter is devoted to exploring various issues related to the possible introduction and operation of a soft opt out system in Scotland.

3.2 Question 1, a tick-box question, asked respondents for their views on the principle of a soft opt out system:

Question 1: What do you think of the principle of a soft opt out system for Scotland? [I support the principle of a soft opt out system in Scotland / I do not support the principle of a soft opt out system]

3.3 A total of 801 respondents - 771 individuals and 30 organisations - answered Question 1. Table 3.1 shows that there was a clear difference in the views of individuals and organisations. A majority of individuals (more than four-fifths) supported the principle of a soft opt out system, while organisational respondents were divided in their views (16 supported the principle while 14 did not). However, among the organisational respondents, charities and other voluntary sector groups were largely in favour, while faith groups were mainly opposed.

Table 3.1 - Question 1: What do you think of the principle of a soft opt out system for Scotland?

Respondent type	Supports principle	Does not support principle	Total
NHS and / or local authority	4	5	9
Charity, voluntary sector or patients' rights groups	8	1	9
Professional groups and regulatory bodies	3	3	6
Faith groups	1	5	6
Organisation total	16	14	30
Organisation percentage	53%	47%	100%
Individual respondents	644	127	771
Individual percentage	84%	16%	100%
Total (organisations and individuals)	660	141	801
Total percentage	82%	18%	100%

3.4 The consultation questionnaire did not include space for respondents to provide additional comment. It was, however, common for respondents to expand on the reasons for their answer, ^[4] and the sections below present an analysis of the views of those who supported and those who did not support the principle of a soft opt out system.

3.5 There are several points which should be noted about the analysis:

• More than a quarter of organisations provided comment relevant to the question (e.g. on overall attitudes to organ donation, or the pros and cons of different approaches) without indicating clear support for or opposition to an opt out system - this included representative bodies who reported that there was no consensus amongst their membership on this issue, and organisations that indicated that their remit precluded them from offering a policy view. The views of this group are not presented separately, as the points they made reflected the points made by other respondents.
• Most individuals provided brief comments only, whilst organisations provided lengthier and more detailed responses. Furthermore, individuals tended to offer a single reason for their support or opposition to a soft opt out system while organisations provided more in-depth responses, covering multiple, linked points and recognising advantages and disadvantages of different approaches. However, the basic points made across both groups were often similar in nature.
• Among both groups (i.e. those supporting and those not supporting a soft opt out) there were respondents who identified themselves as having a personal interest in this issue - they or a family member had received or were waiting for a transplant, they had experience of a family member becoming a donor, or had professional experience of organ donation and transplantation.

3.6 In addition, some respondents said that the exact nature of the opt out system being proposed by the Scottish Government was not clear, or the comments made suggested respondents may have interpreted the concept differently, e.g. some may have been talking about a hard rather than soft opt out system; in other cases, it was not clear what type of system respondents were referring to.

3.7 With few exceptions, respondents indicated support for organ donation and transplantation in general. They were positive about the benefits transplantation could bring to those in need in term of saving lives and enhancing quality of life, but also saw organ and tissue donation as a positive and powerful act in itself which allowed one human to help another. For some, an opt out system was seen as a way of further enabling this process; for others such a system risked undermining what they saw as the essential altruistic nature of the donation.

Views of those who supported the principle of a soft opt out system

3.8 Those who supported the principle of a soft opt out system for Scotland offered the following main reasons focusing on efficacy, evidence and ethical considerations:

• They did not think the current opt in system was working, and did not think an opt in system could be made to work sufficiently well. They thought an opt out system provided the most effective way of increasing the number of donors.
• They thought that the available evidence, including emerging evidence on the Welsh opt out system, indicated the effectiveness of opt out systems - organisations were particularly likely to offer this view. They also argued that such a system was supported by public opinion.
• They thought an opt out system was justifiable on ethical grounds, suggesting that such a system respected the rights of individuals, in that everyone had a choice, and those not wishing to donate would be motivated to opt out. They also noted that most people would accept an organ if they or a family member were in need of a transplant, and that society as a whole would benefit from such a system.

3.9 Additionally, respondents identified a number of more specific advantages or benefits which would result from a soft opt out system, such as:

• Encouraging discussion within society as a whole and within families, and helping change attitudes to make organ donation the 'norm'
• Addressing the problem of people not getting around to opting in
• Making the job of approaching families easier for healthcare staff, and making donation authorisation decisions easier for families, if donation was seen as the default position.

3.10 However, respondents - organisations in particular - also offered a range of caveats and qualifications to their support. Most commonly they emphasised:

• The need for appropriate safeguards, and the importance of support for families and respect for their views
• The importance of any new opt out system being introduced as part of a broad strategy which would involve appropriate publicity and information, health service infrastructure, staffing and staff training, etc.

Views of those who did not support the principle of a soft opt out

3.11 The views of those who did not support the principle of a soft opt out system also focused on issues of efficacy, evidence, and ethics, but practical concerns also featured strongly in the comments made. The main themes in the comment are as summarised below:

• Respondents thought the current system worked effectively - they highlighted in particular that donations had been increasing over recent years as a result of ongoing initiatives, and thought that there was scope to continue with this work and improve donation rates further.
• They did not think that a move to an opt out system was supported by the available evidence. They argued that international evidence on the impact of opt out systems on donation rates was mixed, and indicated that a range of factors, rather than just the type of donor system in place, contributed to donation rates. As such, respondents thought that there were other initiatives which could be pursued in order to increase donations. They also queried whether enough was known about public awareness, attitudes and behaviours in Scotland and elsewhere in relation to different systems.
• They had moral or ethical concerns about the principles underpinning a soft opt out system. Respondents thought that organ donation should always require explicit, conscious authorisation, with no implied obligation. It was further suggested that an opt out system removed the right to choose whether or not to be an organ donor from those who had not considered the matter. Respondents highlighted the importance of organs being donated freely, as a 'gift', and thought that anything that detracted from this principle was damaging to human dignity and society; raised issues about the relationship between the state and the individual and ownership of the human body; and risked the commodification of human beings. Those with concerns based on religious beliefs attached particular importance to the need to protect human autonomy and the sanctity of the human body or noted that some religious groups were opposed to organ donation under any system. Respondents also highlighted a number of perceived risks which they felt raised ethical issues: (i) the risk of donation decisions being made which were not in line with the wishes of the individual - e.g. where an individual had not taken action to opt out and their family did not know their wishes; (i) the risk of mistakes being made as a result of administrative errors; (iii) the risk of the system being abused by medics, or of families being pressurised in pursuit of the 'greater good'. Those offering views of this type included a few individuals who personally did not wish to be organ donors; no organisation indicated an opposition to donation per se.
• Respondents also had practical concerns about how a soft opt out system would operate. They thought such a system would be expensive and difficult to administer for the NHS, and thought it would detract from other ways of increasing organ donations, or from developments which might reduce the need for transplants. Some queried whether priority should be given to this matter at a time when the health service was under increasing pressure. Respondents also thought the system would be difficult for the public to understand and would rely too much on people taking action to opt out and to update their wishes as necessary. There was also a concern that an opt out system might be counter-productive, in that it could: (i) lead to an increase in the numbers opting out ^[5] and the rate of family refusal if the person's nearest relatives were not confident about the wishes of the individual; and (ii) erode trust in healthcare professionals and the donation system, and damage the doctor-patient relationship.

Support for other types of organ donation systems

3.12 In some instances respondents indicated support for other types of system: e.g. variations on: (i) a 'hard' opt out system based on presumed consent with no account taken of the wishes of family members, (ii) a hard opt in system in which family members cannot overrule an individual's stated wishes, (iii) a 'mandatory choice' system in which people are required to either opt in or out, (iv) systems incorporating reciprocity (i.e. where eligibility to receive an organ is linked to willingness to donate) or allowing donors to state preferences regarding recipients.

3.13 In particular, it should be noted that some of the individuals who indicated that they did not support the principle of a soft opt out system in completing the tick box at Question 1 went on to note their preference for a hard opt out system, or their preference for a soft over a hard opt out option if an opt out model was to be adopted; conversely some of those expressing support for the principle of a soft opt out, also indicated that they would also support a hard opt out system.

Other issues raised by respondents in relation to an opt out system

3.14 Two more substantive issues were raised by respondents. These were: (i) the issue of human rights and compliance with human rights legislation, and (ii) the concepts of informed consent versus authorisation. These were discussed as follows:

• Informed consent versus authorisation: Respondents - particularly those opposed to a soft opt out system - were concerned that the 'deemed authorisation' proposed by the Scottish Government represented a move away from the concept of 'informed consent', i.e. explicit consent based on full understanding of relevant information. They thought that organ donation should always require explicit, conscious authorisation. Indeed, there was a view that joining the ODR within the current opt in system did not fully meet the standard of 'informed consent'. Other respondents stressed the importance of maintaining the concept of 'consent' as requiring an active decision, given its role in other aspects of life (medical and other). Related to this, some highlighted the importance of clarity regarding terminology on this issue, and ensuring this was appropriately reflected in relevant documentation and guidance.
• Human rights: Some respondents expressed general concerns that a system based on 'deemed authorisation' may contravene an individual's human rights. Others suggested that, whatever system was in place, it was important that the law in this area be compliant with human rights legislation, and in particular, that there was a clear legal basis for reconciling the rights of individuals and their families in the process for authorising donations. The importance of protecting the rights of children in particular and adhering to the United Nations Convention on the Rights of the Child in any system was noted by one organisation which recommended carrying out a Children's Rights and Wellbeing Impact Assessment.

3.15 Respondents also made a number of other more general comments, regardless of whether they supported or did not support the principle of soft opt out system:

• Current evidence is mixed or inconclusive and more evidence is therefore needed on: (i) what works (including in relation to the impact of the recently introduced soft opt out system in Wales), and (ii) public attitudes and behaviours.
• There needs to be more public debate on the implications, benefits and risks of the various options.
• Whatever system was in place there was a need to raise awareness of organ donation, encourage family conversations, and improve health service infrastructure, staff training and family support.