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

2. Background

9. In a public consultation^[3], 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, the 2016 consultation document highlighted the importance of ensuring that the processes which support donation and transplantation work well and are underpinned by a clear legal framework. This included ensuring that there are clear processes for authorisation of 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, 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. Such routine medical tests help ensure the best matching and safety of transplantation for the patient receiving the donated organ. Analysis^[4] of the responses showed that the majority of respondents were in favour of these tests (or procedures) being carried out, either via 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.

2.1 Pre-death procedures legal framework

12. Responding to the growth in DCD donation over the last decade and taking into account the response to the public consultation in 2016, the 2019 Act provides a 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.

13. In practice the statutory framework applies only to patients who are not yet deceased, such as in cases where donation is planned following circulatory death, or, more rarely, prior to confirmation of death using neurological criteria.

14. 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.

15. The Act explains that the carrying out of a procedure is necessary if either of the following apply:

• it is necessary to carry it out for the purpose of ascertaining whether a part of the person's body is suitable for transplantation,
• it is necessary to carry it out for the purpose of increasing the likelihood of successful transplantation of a part of the person's body.

16. The Act requires that a pre-death procedure, as defined above, may only be carried out where certain minimum conditions are met, which are intended to reflect current clinical practice in NHS Scotland:

• a) in the view of the health worker primarily responsible for the person's medical treatment, for example the supervising consultant in ICU, the person is likely to die imminently (including as a result of withdrawing life sustaining treatment);
• b) where the person is receiving life sustaining treatment, the decision to withdraw that treatment has been taken by the person responsible for the person's medical treatment (i.e. supervising consultant);
• c) the carrying out of the procedure is necessary;
• d) the carrying out of the procedure is not likely to cause more than minimal discomfort to the person, and;
• e) the carrying out of the procedure is not likely to harm the person.^[5]

17. These apply to both Type A and Type B procedures and in addition, due to the nature of Type B procedures, other requirements may be applied to them (see from paragraph 42 for the proposed requirements).

18. Additionally, for both Type A and Type B procedures, in line with the wider approach to deceased donation, 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 a duty to inquire about a potential donor's most recent views about donation there is also a duty to inquire about a person's most recent views on completion of pre-death procedures. Procedures may only be carried out where the person carrying them out has no knowledge that the potential donor would be unwilling for them to be carried out, taking into account any evidence about their views provided as part of the duty to inquire.

2.2 Authorisation for Type B pre-death procedures

19. The 2019 Act requires that, in order to be carried out, pre-death procedures must be authorised. The Act explicitly sets out how Type A procedures may be authorised, which includes by virtue of a person authorising donation, either expressly or deemed.

20. As Type B procedures are those procedures which are more novel in this context and which a person might not reasonably expect to be carried out to facilitate transplantation. The Act does not enable Type B procedures to be authorised by virtue of authorising donation. The Act enables the ways in which Type B procedures may be authorised to be set out in regulations and is therefore part of the subject of this consultation. Views are sought on proposed ways to authorise Type B procedures, outlined from paragraph 55.

2.3 Type B pre-death procedures

21. Aside from the medical procedures which are considered to be routine, which may be specified as Type A, the Act enables the specifying of procedures that are more novel in the context of transplantation - Type B procedures. Because Type B procedures are likely to be less routine, or novel, they may need some additional authorisation or additional requirements before they could be undertaken, beyond the minimum standards as to authorisation and pre-conditions that are set out in the Act.

22. Where Scottish Ministers are satisfied that the procedure may be carried out, but subject to additional, appropriate safeguards, including requirements as to authorisation, the procedure may be specified as a Type B procedure.

23. This will enable the donation and transplantation process to keep pace with medical developments which may have an impact on the nature and necessity of pre-death procedures. This means the system of authorisation will be able to respond appropriately and flexibly to developments in practice, while also ensuring that appropriate safeguards apply to the carrying out of these procedures and provide reassurance about how these more novel procedures may be authorised.

24. Importantly, once the new framework is enacted a pre-death procedure may only be carried out if it is included in the list of procedures (Type A or Type B) specified in Regulations by Scottish Ministers, and brought into force by the Scottish Parliament.

25. It should be noted that not all DCD donors will require a Type B procedure to be carried out. The Type A Regulations contain the majority of procedures that will be required to progress a potential DCD donor safely for transplantation.

2.4 Ongoing care

26. The new statutory framework 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.

27. To fall within the scope of the Act and therefore be considered a pre-death procedure, the medical 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.

28. 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.

2.5 Updating the regulations

29. Setting out pre-death procedures in affirmative^[6] regulations (a form of secondary legislation) means that, subject to consultation, the procedures can be changed, including added to or amended, ensuring that the new framework can be responsive to developments in clinical practice. The appropriate conditions and authorisation methods related to any newly proposed procedures would also require to be considered, to ensure that they remained proportionate to the nature of the procedure(s) in question.

30. It is intended that future proposals for amendment of the regulations would be considered by a sub-group of the Scottish Donation and Transplant Group (SDTG), taking advice from bodies such as the Research, Innovation and Novel Technologies Advisory Group (RINTAG) and others with specialist expertise on the proposed procedure(s) such as the Scottish Intensive Care Society, which is represented on SDTG, to consider whether the proposed changes should be recommended to Scottish Ministers. Such changes would be subject to consultation before regulations are laid for scrutiny by the Scottish Parliament.

2.6 Public Information

31. 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.

32. Once approved by the Scottish Parliament, it is the intention that the Organ Donation Scotland website will list and explain what the specified Type B procedures are and information about when these procedures may be carried out and how they may be authorised. Raising awareness about pre-death procedures will encourage greater transparency about what can be involved as part of the donation process.