Human Tissue (Authorisation) (Specified Type B Procedures) (Scotland) Regulations: consultation

7. Annex B: Further information

7.1 Practical context

94. Only around 1% of people die in circumstances where they might become an organ donor. Around 40% of deceased donations are from donors who die following circulatory death. In 2019/20 there were 35 DCD donors (donation following circulatory death) from a total of 109 deceased donors overall, during this period across Scotland. DCD donation is where the donor has been pronounced dead following cessation of the heart and respiratory activity. Donation following diagnosis of death using neurological criteria (DNC), where the donor has been confirmed deceased using neurological criteria (i.e. brain death) accounts for the rest of deceased donation.

95. In practice, to facilitate transplantation, organs have to be removed immediately after the death of a DCD donor and quickly transported to the transplanting hospital. This means there are significant time constraints and some of the vital tests which are necessary to ensure that the organs are likely to be successfully transplanted and are a good match for the transplant recipient need to be carried out shortly before death. These may include blood and urine tests, x-rays or tests on the heart such as an electrocardiogram or echocardiogram. All of these tests, or procedures, may be considered to be routine as part of the patient's care. For example, all patients in intensive care will have had a urinary catheter inserted, meaning that urine samples taken for the purposes of facilitating organ donation can be taken. Similarly, blood samples taken for the purposes of facilitating organ donation are likely to be taken from an existing line.

96. DCD donation has been carried out in Scotland and the rest of the UK since 2003. Before 2009/10 a far greater proportion of donation proceeded with DNC donors, however, there has been a significant increase in donors who have donated following circulatory death since that time. The increase in this type of donation is as a result of developments in clinical practice and processes and is now a very important element of deceased organ donation in Scotland.

97. DCD donation began to expand significantly after Guidance was issued by the former Chief Medical Officer in 2010 (CMO Guidance) which provided reassurance around the carrying out of some of these tests – including blood tests on a potential donor where it was clear that the person, or their family, were happy for that person to be a donor. Similar Guidance was issued by the Department of Health for England and Wales in 2009, but this reflected the different legal regimes in those countries for people who are not capable of consenting to this type of medical procedure.

98. It was recognised in the 2010 CMO Guidance that the basis for medical consent to these tests and procedures for the purposes of transplantation should be considered further as practice develops.

99. The 2019 Act supports this consideration by setting out a clear and dedicated statutory provision for the completion of these tests that support DCD donation and transplantation.

Tissue

100. The carrying out of pre-death procedures to facilitate transplantation is required for tissue-only donation far less frequently than in relation to organ donation. This is because, for example, eyes can be retrieved from a donor up to 24 hours after the patient's death, while other forms of tissue can be donated up to 48 hours after death. This means the necessary tests can be carried out following the death of the patient. However, for completeness, the framework in the Act covers both organ and tissue donation for transplantation as it may affect organ donors who are also expected to donate tissue, following circulatory death.

7.2 Deemed authorisation for transplantation

101. Following the responses to the 2016 consultation and passage through the Scottish Parliament, the 2019 Act introduces an additional form of authorisation called 'deemed authorisation'. This means that in the absence of an explicit authorisation, or an opt out declaration, authorisation for deceased organ and tissue donation for transplantation may be deemed to have been given. Unlike Type A procedures, Type B procedures are not directly linked to the introduction of the new deemed authorisation system. This is because authorisation for carrying out a Type B procedure is not linked to authorisation for donation being in place, which is the case for Type A procedures.

102. There are safeguards in the legislation which seek to ensure that donation does not proceed where a potential donor would have been unwilling to donate. This includes that inquiries should be made about a potential donor's most recent views.

103. In addition, deemed authorisation for transplantation will not apply to certain groups, who will continue to require explicit authorisation, either from themselves or a nearest relative (or a person with parental rights and responsibilities in the case of a child):

• Children under 16 years of age;
• Adults who lack the capacity to understand a deemed authorisation system;
• Adults who have not been ordinarily resident in Scotland for more than 12 months.