Human Tissue (Authorisation) Act: consultation on Type A draft procedures

Background

9. In a public consultation, published in December 2016, the Scottish Government sought views on how increasing numbers of donations of organ and tissue for transplant might be achieved in Scotland, including plans to move to a soft opt-out system of deceased donation. The proposed opt-out system attracted significant support in the consultation and will be given effect to by the 2019 Act, once brought into force.

10. As well as considering this wider system of authorisation for deceased donation, it was made clear in the 2016 consultation document that it was important to ensure the processes which support deceased donation and transplantation work well and are underpinned by a clear legal framework. This included ensuring that there are clear processes for authorisation for medical procedures which may be carried out on a person before they die to help facilitate successful transplantation, and requirements which must be satisfied before these procedures can be carried out.

11. The 2016 consultation sought views on whether deemed, as well as explicit ('opt-in'), authorisation for donation should encompass authorisation for certain routine medical tests to be completed before death, to help facilitate transplantation. This included blood tests, X-rays, urine tests, tests on samples of chest secretions and tests on the heart. Currently completed under Chief Medical Officer guidance, such routine medical tests help ensure the best matching and safety of transplantation for the patient receiving the donated organ. A majority of respondents were in favour of these tests (or procedures) being authorised via an explicit or deemed authorisation for donation. The consultation also sought views on the administration of medication to facilitate transplantation, which also attracted support from the majority of respondents.^[3]

Deemed authorisation for transplantation

12. Following the responses to the 2016 consultation and legislative 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 (opt-in), or an opt out declaration, authorisation for deceased organ and tissue donation for transplantation may be deemed to have been given by a potential donor.

13. 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 last known views.

14. In addition, deemed authorisation for transplantation will not apply to certain groups listed below, 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.

Pre-death procedures: the legal framework

15. Responding to the growth in donation following circulatory death (DCD) over the last decade and taking into account the response to the public consultation in 2016 and subsequent scrutiny in the Scottish Parliament, the 2019 Act provides a dedicated statutory framework for the authorisation and carrying out of pre-death procedures. This framework is tailored to the practical and ethical issues relating to deceased donation and includes safeguards to protect the interests of the donor.

16. The Act provides that pre-death procedures are medical procedures that are:

• carried out for the purpose of increasing the likelihood of successful transplantation;
• not for the primary purpose of safeguarding or promoting the health of the person.

17. Further detail on the wider context of pre-death procedures and the new statutory framework is set out in Annex A.

Authorisation for Type A pre-death procedures

18. The 2019 Act requires that, in order to be carried out, pre-death procedures must be authorised. The Act does not require express authorisation for the carrying out of specified Type A pre-death procedures but sets out that where donation for transplantation has been authorised by the potential donor (either expressly or deemed), then Type A pre-death procedures are also authorised.

19. Where authorisation for donation for transplantation has been provided by a nearest relative (or a person with parental rights and responsibilities in the case of a child), they will also have to provide express authorisation for pre-death procedures.

20. In line with the wider approach to deceased donation, particularly in relation to deemed authorisation, the Act seeks to ensure that pre-death procedures are not carried out where the potential donor would have been unwilling for them to take place. Therefore, alongside the duty to inquire about a potential donor's last known views about donation for transplantation there is also a duty to inquire about a person's last known views on completion of Type A pre-death procedures.

Ongoing care

21. The new statutory framework for pre-death procedures does not affect the ongoing care of a patient, regardless of the timing of any treatment i.e. before or after the decision to withdraw life-sustaining treatment has been taken.

22. To fall within the scope of the Act and therefore be considered a pre-death procedure, the procedure has to be:

• carried out for the purpose of increasing the likelihood of successful transplantation;
• not for the primary purpose of safeguarding or promoting the health of the person.

23. Any medical procedure which cannot be categorised in this way, including all ongoing care of the patient, will not fall within the scope of the Act and its provisions.

Public Information

24. The 2019 Act places a duty on Scottish Ministers to make available information to the public and raise awareness about pre-death procedures; when they are carried out and how they are authorised as part of the donation process.

25. Raising awareness about pre-death procedures will encourage greater transparency about what can be involved as part of the donation process and, in particular, make clear that if a person authorises donation for transplantation (either expressly or deemed) then Type A pre-death procedures are also authorised.

Type B regulations

26. This consultation is about the medical procedures being specified as Type A pre-death procedures. Type B procedures, which are those procedures which might be considered to be less routine, or novel, will be consulted on separately in due course.

27. Type B procedures are procedures which a person might not expect to be authorised by authorising donation, including via deemed authorisation. Therefore additional requirements may be put in place, both in terms of authorisation and also the circumstances or manner in which the procedures may be carried out. Views are not being sought on Type B procedures at this point, as there is focus on ensuring that the new statutory framework for pre-death procedures can reflect current clinical practice when it comes into force in autumn 2020, as set out by the Type A procedures.