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

Closed 11 Dec 2019

Opened 30 Oct 2019

Feedback Updated 21 Feb 2020

We Asked

The Human Tissue (Authorisation) (Scotland) Act 2019 (‘the 2019 Act’) provides a framework for the authorisation and carrying out of pre-death procedures.  When the 2019 Act is implemented in autumn 2020, 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 whether a proposed list of medical procedures that will form the content of the Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations was both accurate and comprehensive. It was explained that pre-death procedures are the routine medical procedures normally completed in an intensive care unit to assess the suitability of organs and tissue for transplantation, or to increase the likelihood of successful transplantation for the recipient.

 

Type A procedures are those medical procedures which are currently routinely carried out 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.  They include procedures such as the taking of a blood sample, taking of a urine sample and other routine procedures such as an electrocardiogram (ECG).

You Said

19 responses were submitted, including nine from organisations. Responses were primarily from those directly involved in the deceased donation and transplantation pathway across NHS Scotland.

In response to consultation questions on the proposed list of procedures, a number of respondents highlighted two procedures that they recommended for removal as a Type A pre-death procedure (which were computerised tomography (CT) scan and magnetic resonance imaging (MRI)). A number of other potential amendments were variously put forward to more accurately reflect current practice and also to suggest inclusion of a variety of other medical procedures which are less common, in the context of facilitating deceased donation and transplantation.

We Did

The responses to this consultation have informed and shaped the content of the  Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations 2020, which have now been laid before the Scottish Parliament on 03 February 2020. This can be viewed here: http://www.legislation.gov.uk/sdsi/2020/9780111043981/contents

Where permission to publish has been provided, the 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/publications/human-tissue-authorisation-specified-type-procedures-scotland-regulations-analysis-consultation-responses/ 

Published Responses

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

Overview

On 11 June 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.

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 a 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 A procedures are those medical procedures which would be considered routine within the context of facilitating transplantation, and are procedures a person may reasonably expect to be carried out by authorising donation, including where that authorisation for donation is deemed.

This consultation seeks views on the list of Type A procedures that will be specified in Regulations. The Type A list was developed in consultation with representatives of the clinical community working in deceased organ and tissue donation and transplantation.

Why We Are Consulting

The Scottish Government is seeking views on specified procedures which facilitate deceased donation and transplantation and are medical procedures normally carried out in an Intensive Care Unit (ICU) setting across NHS Scotland.

Views are particularly sought from those in the clinical community who have experience of the deceased donation and transplantation pathway, and their representative organisations and bodies.

Responses to this consultation on the listed procedures will assist the Scottish Government in ensuring that Type A pre-death procedures, that will be specified in Regulation, fully capture current clinical practice and the listed procedures are appropriate to be defined as Type A, to meet the requirements of the 2019 Act.

Read the consultation paper.

Please review the consultation paper in full before answering the questions.

What Happens Next

Once the consultation closes, all responses will be fully considered and the listed Type A procedures reviewed and revised, as appropriate and if necessary. The Scottish Government will then begin the process to lay Regulations in the Scottish Parliament to introduce a dedicated statutory framework governing the authorisation and carrying out of pre-death procedures, where these are for the purpose of increasing the likelihood of successful transplantation.

Interests

  • Health and Social Care