Human Tissue (Authorisation) (Scotland) Bill: EIA

Background

Organ and tissue transplantation can save and significantly improve lives, but at present there are insufficient donors to meet the number of organs needed by people on the transplant waiting list, as well as the need for some forms of tissue transplants.

Through our plan, A Donation and Transplantation Plan for Scotland 2013-2020 and the work of the Scottish Donation and Transplant Group we have already made good progress in increasing organ donation and transplantation in Scotland over recent years, with an 89% increase in the number of people who donated organs after their death in Scotland between 2007-08 and 2017-18.

However despite all this activity and improvements made so far, there are still over 500 people on the active transplant waiting list in Scotland, waiting for an organ. It is important therefore to look at ways in which we can potentially increase the proportion of cases where organ and/or tissue donation is authorised, including moving to a soft opt out system.

Currently, donation and transplantation in Scotland is underpinned by the Human Tissue (Scotland) Act 2006. This legislation sets out the legal basis for authorisation of donation for transplantation, as well as a range of provisions relating to other aspects of donation and transplantation. 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, or person with parental rights and responsibilities in the case of a child, authorises the donation on their behalf at the point of death – this is known as an opt in system.

Following a public consultation, the Scottish Government is introducing the Human Tissue (Authorisation) (Scotland) Bill to provide for a soft opt out system of organ and tissue donation. 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 if they die in circumstances which would allow their organs or tissue to be donated.

However, it is important to ensure that there are safeguards in place. When a person is potentially deemed to have authorised donation, 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 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, where they are known, which determine whether donation goes ahead.

In addition, certain groups of people would require explicit authorisation, either from themselves during their lifetime or from a nearest relative, or person with parental rights and responsibilities in the case of a child, upon their death. This would include children; adults resident in Scotland less than 12 months; and adults without the capacity to understand deemed authorisation.

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.