Human Tissue (Authorisation) (Scotland) Bill: EIA

The Equality Impact Assessment (EIA) outlines how the Human Tissue (Authorisation) (Scotland) Bill impacts on the different equalities groups.

Recommendations and Conclusion

The EQIA process has demonstrated that none of the proposals are discriminatory and that it will not be necessary to make any specific amendments to the proposed soft opt out system as given effect to by the Human Tissue (Authorisation) (Scotland) Bill.

Impacts on equalities groups have been considered throughout the development of the proposed soft opt out system and mitigating elements have been incorporated where necessary. These include not applying deemed authorisation to certain groups of people on the basis that they might not reasonably be expected to have sufficient awareness, knowledge or understanding about the operation of the opt out system to understand the implications of not opting out. This is balanced with a continuing ability for people (aged 12 and over) in these groups to make a donation decision if they wish.

The Bill provides for a framework where the views of the potential donor take precedence, which will mean in all circumstances, including deemed authorisation, it should be the views of the potential donor, where they are known, which determine whether donation goes ahead. Additionally, specific provision about the circumstances of death will ensure that donation only proceeds where it is consistent with the person's views, which seeks to address the needs of those who would be opposed to donation following certain circumstances of death, for example on faith grounds.

More broadly, the public information and awareness raising work about the opt out system will be extremely important in explaining how the system will take account of the needs of equalities groups and the choices people will be able to make about donation. It will also be crucial that it meets the communication needs of different equalities groups, which will be informed by the consultation responses and the in-depth qualitative research. This work will be in addition to the on-going awareness raising work about donation in general, which will continue to help increase understanding and support for donation.

Fairer Scotland Duty

Summary of aims

Currently, donation and transplantation in Scotland is underpinned by the Human Tissue (Scotland) Act 2006. This legislation sets down the legal basis for authorisation of donation for transplantation and other purposes. The legislation provides that organs and tissue can only be donated from someone if either the person themselves authorised donation before they died or if their nearest relative authorises the donation on their behalf at the point of death – this is known as an opt in system.

The Human Tissue (Authorisation) (Scotland) Bill will provide for a soft opt out system of organ and tissue donation for adults. The proposed soft opt out system will mean that a person can continue to register a decision to donate or not to donate. In cases where a person does not register a decision they may be deemed to have authorised donation for transplantation if they die in circumstances which would allow their organs or tissue to be donated, subject to certain safeguards.

Moving to a soft opt out system of donation will add to the package of measures already in place to increase donation and will be part of the on-going long term culture change to encourage people to support donation.

This assessment focuses on the impacts of the specific changes to authorisation, rather than the potential impacts on transplant recipients.

Summary of evidence

The consultation sought views on any impacts there would be on equalities groups as a result of moving to an opt out system . In the responses some respondents also noted a range of other groups who, they suggested, needed additional protections because of their personal situations, and / or were less likely to be aware of an opt out system or less able to exercise their right to opt out. Additionally, some respondents argued that people in these already disadvantaged groups were more likely to become organ donors for the benefit of others.

Respondents were concerned about a wide range of groups in society who might be less likely to know about or understand an opt out system and the right to opt out, and / or less likely or less able to exercise that right. They were, thus, more likely than other groups to become organ donors against their wishes. Such groups could included homeless people; prisoners; recent immigrants; those with poor English; those with low reading / literacy skills; and those less likely to have internet access.

In addition focus groups were held with young people, young people with experience of being looked after, and people with learning difficulties to understand what they thought about particular elements of the proposals and how the change should be communicated to people. The groups highlighted the need for communication methods to be inclusive, for example so as not to exclude people who do not have internet access or those who were homeless.

There is some data from the evaluation of organ donation marketing campaigns which suggests that those in the lowest socio-economic groups are somewhat less likely to wish to add their name to the Organ Donor Register than other groups, although campaigns are successful in encouraging people in these groups to join.

Summary of assessment findings

In order to ensure as broad access as possible, and not disadvantage people who do not wish to join the Organ Donor Register, the Bill provides for flexibility in how decisions to opt in or opt out are recorded, meaning that decisions can simply be written down. This is in addition to being able to be recorded on the Organ Donor Register, which can be done online, by telephone or by post.

As well as children, certain groups of adults wouldn't be subject to deemed authorisation and would instead require explicit authorisation, either from themselves during their lifetime or from a nearest relative. This would include adults resident in Scotland less than 12 months; and adults without the capacity to understand deemed authorisation, both categories which are likely to include some of those at socio-economic disadvantage.

Additionally, those working in donation would be required to check with any potential donor's family members about any views the potential donor held on donation. This would mean for example that where a person had not opted out of donation, but family members or friends advise of an objection the deceased held, the donation wouldn't proceed. More broadly, the Bill provides for a framework where the views of the potential donor take precedence, which will mean in all circumstances it should be the views of the potential donor which determine whether donation goes ahead.

In the very small number of cases where a potential donor has no relatives, friends or other person they had known for a long time who are available to be consulted, donation would not normally proceed. This is because, as well as providing information as to the potential donor's views on donation, there is a need to check their prior lifestyle history to ensure their organs are likely to be safe to transplant.

It is intended that ahead of the opt out system coming into force there will be an awareness raising campaign for at least 12 months to inform people about the new system, and the implications of not recording a donation decision in a deemed authorisation system. It will be important that this awareness raising campaign takes account of inequalities in access to information to ensure as wide a reach as possible. Campaign tracking and evaluation will incorporate analysis that looks at awareness raising performance based on socio-economic groups.


The soft opt out system as given effect to by the Human Tissue (Authorisation) (Scotland) Bill has no detrimental impact on inequalities. It includes safeguards to protect vulnerable groups and also safeguards which enable the potential donor's views to determine whether donation goes ahead even where no donation decision has been recorded. It will be important that the awareness raising campaign takes account of inequalities in access to information to ensure as wide a reach as possible.

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Name: Gareth Brown
Job title: Deputy Director, Health Protection Division


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