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

Introduction and background

18. Between 8 October and 20 November 2020 the Scottish Government undertook a public consultation to gather views on a list of medical procedures that will be prescribed as Type B pre-death procedures in regulations and the associated authorisation requirements and additional conditions. Undertaking consultation before the laying of the regulations is a requirement set out by the 2019 Act. The intention is that the regulations will be enacted on the same day the new deemed authorisation system ('opt out') is implemented in March 2021.

19. The consultation paper contained seven questions, which sought views on whether a proposed list of medical procedures that will form the content of the Human Tissue (Authorisation) (Specified Type B Procedures) (Scotland) Regulations was both accurate and comprehensive.

20. Type B procedures are medical procedures which are likely to be less routine, or more novel, in the context of transplantation. This means they may need some additional authorisation or additional requirements before they could be undertaken and the consultation also sought views on these aspects of the regulations.

21. Pre-death procedures are medical procedures and tests, normally carried out in the intensive care unit (ICU) of a hospital, that will facilitate donation and transplantation of organs and tissue from a potential donor.^[1] In the clinical community these are also referred to as ante-mortem interventions.

Policy context

22. The Human Tissue (Authorisation) (Scotland) Act 2019 sets out a dedicated statutory framework for the authorisation and carrying out of medical procedures for the purpose of facilitating transplantation. These are referred to as 'pre-death procedures' in the Act. Scottish Ministers may, by regulation, specify pre-death procedures as either Type A or Type B. The purpose of this consultation was to determine those medical procedures that would be appropriate to be specified as a Type B pre-death procedure and to seek views on the proposed authorisation methods and additional conditions.