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

1. Introduction

1. On 11 June 2019 the Scottish Parliament passed the Human Tissue (Authorisation) (Scotland) Act 2019^[1] ('the 2019 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 intention is that this framework will strengthen the processes supporting donation following circulatory death (DCD donation) and ensure clarity for clinicians on the legal framework governing these medical procedures. It will also provide transparency for the public about what is involved in the donation and transplantation process.

4. The Scottish Government intended to introduce the opt-out system and statutory framework for pre-death procedures in autumn 2020. Due to the COVID-19 pandemic, implementation of the Act has been revised to 26 March 2021.

5. 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. Following consultation, The Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations 2020^[2] ("the Type A Regulations"), which specified the permitted Type A procedures, were considered by the Scottish Parliament and approved on 4 March 2020.

6. Type B procedures are procedures which are likely to be less routine, or novel, in the context of transplantation. This means they may need some additional authorisation or additional requirements before they could be undertaken.

7. In developing the proposals for Type B regulations, the Scottish Government has continued to work closely with those directly involved in donation and transplantation across the NHS, with the aim of ensuring an effective regulatory framework for Type B pre-death procedures is implemented.

8. 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.