Human Tissue (Authorisation) Act: consultation on Type A draft procedures

Introduction

1. On 11 June the Scottish Parliament passed the Human Tissue (Authorisation) (Scotland) Act 2019^[1] ('the Act'). The 2019 Act amends the Human Tissue (Scotland) Act 2006 and 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.

2. The 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'. It does not cover medical procedures that are primarily for the care and treatment of the patient; considerations around these interventions will continue to be governed by the Adults with Incapacity (Scotland) Act 2000.

3. This framework is being put in place both to provide greater legislative clarity around what is and is not permitted in relation to pre-death procedures, but also to ensure that in progressing towards deceased donation, potential donors' interests are fully protected. The Scottish Government intends to introduce the opt-out system and statutory framework for pre-death procedures in autumn 2020.^[2]

4. 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 authorisation for donation is deemed. Type B procedures are likely to be less routine, or novel, and so may need some additional authorisation (for example authorisation by a nearest relative) or additional requirements before they could be undertaken.

5. Both Type A and Type B procedures will be set out in Regulations (a form of secondary legislation) and considered by the Scottish Parliament. This approach 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.

6. The Scottish Government will discuss with the Scottish Donation and Transplant Group arrangements which might be put in place to ensure that there is a clear process for proposing and considering any future amendment to these Regulations, once enacted.

7. 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.

8. This consultation seeks views on the list of Type A procedures that will be specified in the Regulations. See below for more information about Type B procedures.