Consultation on the content of the Human Tissue (Authorisation) (Specified Type B Procedures) (Scotland) Regulations

Closed 20 Nov 2020

Opened 8 Oct 2020

Feedback updated 13 Jan 2021

We asked

The Human Tissue (Authorisation) (Scotland) Act 2019 (‘the 2019 Act’) provides a framework for the authorisation and carrying out of medical procedures which are necessary to facilitate transplantation, helping ensure transplantation is as safe as possible for the identified recipient.  These are termed in the Act as ‘pre-death procedures’.  When the 2019 Act is implemented on 26 March 2021, pre-death procedures must be specified as either Type A or Type B in order for them to be carried out.

We asked for views on a proposed list of medical procedures to be specified as Type B pre-death procedures, what conditions might be attached to their completion and how they may be authorised to be carried out.  

You said

15 responses were submitted, including five from organisations. Responses were from those directly involved or with knowledge of the deceased donation and transplantation pathway across NHS Scotland.

Generally, the majority of respondents expressed support for the proposals. The majority of comments were focused on the proposed conditions, particularly a requirement for two registered medical practitioners to agree that the conditions were met for carrying out a specified Type B procedure.

We did

The responses to this consultation have informed the content of the Human Tissue (Authorisation) (Specified Type B Procedures) (Scotland) Regulations, which have now been laid before the Scottish Parliament on 11 January 2021 and can be viewed here: https://www.legislation.gov.uk/sdsi/2021/9780111048580/contents

Where permission to publish has been provided, consultation responses are now available to view online.

An analysis of the responses to the consultation has been published on the Scottish Government website and can be viewed here: https://www.gov.scot/isbn/9781800045491

Published responses

View submitted responses where consent has been given to publish the response.

Overview

On 11 June 2019 the Scottish Parliament passed the Human Tissue (Authorisation) (Scotland) Act 2019 (‘the 2019 Act’). The 2019 Act provides for a deemed authorisation system of deceased organ and tissue donation for transplantation in Scotland. This is more commonly referred to as an ‘opt-out’ system, replacing the current ‘opt-in’ model.

It has now been announced that this legislation will come into effect on 26 March 2021.

The 2019 Act also introduces a dedicated statutory framework governing the authorisation and carrying out of medical procedures before death, where these are for the purpose of increasing the likelihood of successful transplantation – termed in the Act as ‘pre-death procedures’.

The 2019 Act establishes two types of pre-death procedures - either ‘Type A’ or ‘Type B’. 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

This consultation seeks views on the proposed list of Type B procedures that will be specified in the Regulations; how they may be authorised and what conditions may be applied to them. 

Why we are consulting

The Scottish Government is seeking views on certain medical procedures that may be specified Type B pre-death procedures, including what specific conditions should be attached to their completion and how they may be authorised.

The medical procedures being consulted upon are procedures which can be considered as generally routine in an Intensive Care Unit (ICU) setting across NHS Scotland. However, it is in the context of transplantation they are less routine, or novel. The specification of a medical procedure as a Type B pre-death procedure will provide greater scope for diagnostic information being available to help ensure transplantation is as safe and effective as possible. 

Views are in particular sought from those in the clinical community who have experience of the deceased donation and transplantation pathway, and their representative organisations and bodies. However, this consultation is open to all and views from members of the public, patients’ groups and others are also welcome.

Responses to this consultation will assist the Scottish Government in ensuring that the drafting of Regulations governing Type B pre-death procedures will be appropriate and proportionate in their content, taking account the wider requirements of the 2019 Act.

Read the consultation paper.

What happens next

Once the consultation closes all responses will be fully considered and the proposed Type B procedures, as well as proposals for the way in which a Type B procedure may be authorised and what conditions may be applied to them, will be reviewed and revised as appropriate and if necessary.

The Scottish Government will then use this input to inform the process of drafting Regulations that will govern Type B pre-death procedures and laying these Regulations in the Scottish Parliament.

Interests

  • Health and Social Care