Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations 2020: no CRWIA required declaration

The Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations 2020 - Child Rights and Wellbeing Impact Assessment (CRWIA)

CRWIA Stage 1

Screening- key questions

(Hyperlink will only work within SG)

The Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations 2020

1. These regulations are made under the Human Tissue (Scotland) Act 2006, as amended by the Human Tissue (Authorisation) (Scotland) Act 2019 ('the 2019 Act) and will specify medical procedures that are Type A pre-death procedures.

2. Pre-death procedures are routine medical procedures carried out on a person for the purpose of increasing the likelihood of successful transplantation of a part of the person's body after the person's death, and which are not for the primary purpose of safeguarding or promoting the physical or mental health of the person. Type A procedures are those medical procedures which 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.

3. Specified Type A pre-death procedures reflect the medical procedures that may be currently carried out in an intensive care unit (ICU) on a potential donor, where organ donation has been authorised and is proceeding.

The 2019 Act and the pre-death procedure statutory framework

4. The 2019 Act sets out a statutory framework that governs how pre-death procedures may be authorised, when they can be carried out and that Scottish Ministers may, by regulation, specify these pre-death procedures. This statutory framework states that medical procedures specified as Type A pre-death procedures can be deemed to be authorised to be carried out by a person, when authorisation for donation is provided.

5. A specified Type A procedure can only be carried out if the supervising clinician responsible for the patient's care is satisfied that the requirements, as set by the statutory framework, are met. This includes that the procedure is authorised, it is necessary and will not cause more than minimal discomfort or harm to the patient.

6. In practice, the requirement to apply this statutory framework to every potential donor, regardless of their age or form of authorisation for donation (which under the 2019 Act, as amending the Human Tissue (Scotland) Act 2006, may be by an express opt-in decision or by deemed), will mean that a potential donor's family, regardless of age, will always be consulted before any specified pre-death procedures are carried out.

7. However, the provision for authorising Type A pre-death procedures and associated statutory framework for their completion, as set out by the primary legislation, is separate to the actual specification of medical procedures by this regulation. The regulation being laid only specify medical procedures that Scottish Ministers consider appropriate to be carried out and subsequently authorised as a Type A procedure.

2. What aspects of the policy/measure will affect children and young people up to the age of 18?

8. Specifying Type A pre-death procedures in regulation will not create or have any new impact upon children and young people (up to the age of 18) as these are medical procedures which are currently routinely carried out. The setting out of specified procedures, with a clear and robust framework governing their authorisation and carrying out will increase and strengthen the protections of a potential donor. It will also increase the overall transparency of the wider deceased organ and tissue donation process for all, including children and young people.

9. Carrying out of specified Type A procedures will be done so with regard to the provisions provided by the statutory framework governing pre-death procedures.

3. What likely impact – direct or indirect – will the policy/measure have on children and young people?

10. The specification of medical procedures as Type A pre-death procedures will have no adverse impact on children or young people.

4. Which groups of children and young people will be affected?

11. Specified Type A procedures may be carried out on a potential donor, subject to the statutory framework provided for by the 2019 Act.

5. Will this require a CRWIA?

12. Taking into consideration the above, the Scottish Government considers there is not a requirement to complete a full CRWIA for the Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations 2020.

13. The applicable provisions in the 2019 Act that directly affect children and young people have been considered in a previous CRWIA, examining authorisation for deceased donation. Pre-death procedures specified by the Type A regulations would not proceed without authorisation for donation being in place, their carrying out then subject to a number of requirements provided for by the primary legislation.

14. The relevant CRWIA can be accessed here: https://www.gov.scot/publications/human-tissue-authorisation-scotland-bill-childrens-rights-wellbeing-impact-assessment/.

CRWIA Declaration

Tick relevant section, and complete the form.

CRWIA required

CRWIA not required

Authorisation

Policy lead

Sharon Grant

Policy lead: Implementation: Human Tissue (Authorisation) (Scotland) Act 2019

Health Protection Division

Date

22/01/20

Deputy Director or equivalent

Derek Grieve

Interim Deputy Director

Health Protection Division

Date

23/01/20