Consultation on the draft content of the Human Tissue (Authorisation) (Excepted Body Parts) (Scotland) Regulations
Feedback updated 23 Sep 2020
We asked
We asked for views on what parts of the body should be listed in regulations as exempt from deemed authorisation for organ and tissue donation under the new ‘opt out’ law.
It is proposed that deemed authorisation will only apply to certain organs and tissue which are commonly donated for transplantation from deceased donors in Scotland.
More novel or rare transplants, for example involving limbs, are carried out very infrequently across the UK. However it is necessary to set exclusions out in regulations in order to provide certainty and reassurance about what is included in the new system. These types of transplants will only be able to be carried out with explicit authorisation.
You said
Overall, 13 responses were submitted, including 8 from organisations. Responses were primarily from those directly involved in the deceased donation and transplantation pathway across NHS Scotland. Two responses were submitted via e-mail following the closure of the consultation, and were accepted.
The majority of respondents considered that the proposed content accurately reflected current practice and was comprehensive, though some raised questions around the inclusion of trachea in Group 1 as an excepted part, the inclusion of some tissue types in Group 2 and whether some body parts should be in different groups. There were also requests for future legislative guidance to be clear on the effect of these regulations.
A number of responses also addressed wider points about the ongoing implementation of the Human Tissue (Authorisation) (Scotland) 2019 Act, such as on public information and awareness raising.
We did
The responses to this consultation have informed and shaped the content of the Human Tissue (Authorisation) (Excepted Body Parts) (Scotland) Regulations, which have now been laid before the Scottish Parliament on 23 September 2020. This can be viewed here: https://www.legislation.gov.uk/sdsi/2020/9780111046562/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-excepted-body-parts-scotland-regulations-analysis-consultation-responses/
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 is proposed that deemed authorisation will only apply to the commonly transplanted organs and tissue and will not apply to novel or rare transplants. Applying deemed authorisation to only the more commonly donated types of organ and tissue reflects a measured approach in introducing deemed authorisation, and should avoid the unintended consequence of people deciding to opt out purely due to concern about donating a particular, rarely donated body part even though such donation would be extremely unlikely.
This consultation is seeking views on the proposed content of draft regulations which will make clear which parts of the body deemed authorisation will not apply to. In practice donation and transplantation of these parts of the body is rare or doesn’t happen in the UK, however it is important to set the exclusions out in regulations in order to provide certainty about what is included in deemed authorisation.
Why your views matter
The Scottish Government would welcome views on the proposed list of parts to be excluded from deemed authorisation and in particular on whether the proposed list would mean that deemed authorisation will include all and only those parts of the body which are currently commonly transplanted.
Responses to this consultation will assist the Scottish Government in ensuring that the list of excepted body parts, that will be specified in Regulation, fully capture current clinical practice and meet the requirements of the 2019 Act.
What happens next
Once the consultation closes, all responses will be fully considered and the listed parts reviewed and revised, as appropriate and if necessary. The Scottish Government will then begin the process to lay Regulations in the Scottish Parliament to bring these into effect for autumn 2020.
Interests
- Health and Social Care
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