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

Executive summary

Introduction

1. Between 30 October and 11 December 2019 the Scottish Government undertook a public consultation to gather views on a list of medical procedures to be prescribed as Type A pre-death procedures, which will be specified by the Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations.

2. Type A procedures are those medical procedures which are currently routinely carried out to facilitate transplantation and which Scottish Ministers consider are appropriate to be carried out in accordance with the provisions of the 2019 Act and not requiring any further restrictions or requirements.

The respondents

3. The consultation received 19 responses, which included a response submitted via e-mail. Responses were submitted by nine organisations and ten individuals. These figures do not include clinical stakeholders and organisations that the Scottish Government engaged with during the consultation period.

4. All individual respondents were health professionals with a working knowledge of deceased organ and tissue donation. Organisational respondents were largely those working to deliver deceased donation or clinical representative organisations.

Overview of findings

5. The consultation was undertaken to establish if the proposed medical procedures to be specified were both accurate and comprehensive. Taking into account the relatively small number of respondents, there was little overarching variation or groupings which could be consistently drawn between organisational and individual respondents, or by respondent type, to the questions posed.

Question 1 – procedures not for inclusion

6. Notwithstanding the above, responses did however collate around one topic within the consultation, in response to Question 1, which asked if any proposed procedures for inclusion in the Type A regulations should be removed. A variety of respondents, primarily with experience of intensive care units (both individual and organisational) commented that both computerised tomography (CT) and magnetic resonance imaging (MRI) scans should be removed from the proposed list of Type A procedures. Both these medical procedures require that a patient is transferred to the relevant radiological department within a hospital.

7. Where explanation was provided, respondents focused primarily on the need to move a patient, in order to carry out these scans. It was highlighted that such movement would be routinely completed with agreement of the patient's family. Therefore, it was suggested these procedures would more appropriately require an additional form of authorisation to that required if listed as Type A.

Question 2 – missing procedures

8. In response to Question 2 a number of respondents suggested a variety of medical procedures for inclusion as Type A pre-death procedures. These are set out in detail on page 13. Such medical procedures could be considered less common or not currently carried out for the purposes of increasing the likelihood of a successful transplantation.

9. Where further explanation was provided, it was highlighted by respondents that there is a clinical requirement to have the widest diagnostic information available for each potential donor.

Question 3 – amendments to wording

10. Responses to Question 3 provided some suggestion for amendment of the proposed list to potentially be less prescriptive in its wording, for example, in relation to the manner in which a urine sample could be taken. Other comment to this question posed more general points on the wider function of the proposed list, in relation to continuing clinical practice and how specifying pre-death procedures will affect their completion in a clinical setting, if at all.

Question 4 – other comment

11. Following and related to Question 2, some responses to Question 4 also emphasised the need for the widest variety of diagnostic procedures to be specified as Type A pre-death procedures, to ensure that potential donor suitability can be established.

12. More broadly, beyond the proposed Type A list, other respondents used this Question to reflect on both the requirements and ongoing implementation of the Human Tissue (Authorisation) (Scotland) Act 2019 ('the 2019 Act'). For example, some respondents commented that the prescriptive nature of setting out medical procedures in a list by regulation may be problematic. It was commented that this approach may be unable to keep pace with advancing medical science and practice.

13. Other responses to the consultation variously highlighted other aspects related to the wider implementation of the 2019 Act. For example, it was noted that the requirement to raise awareness of pre-death procedures and how they are authorised must be both robust and accessible for members of the public. It was commented that this information should make clear that medical procedures being specified as Type A pre-death procedures are established clinical practice and are not a new aspect of donation