Hansard

Thank you for the opportunity to make an opening statement. The draft Human Tissue (Excepted Body Parts) (Scotland) Regulations are a necessary component of Scotland’s new deemed authorisation donation system, which was established under the Human Tissue (Authorisation) (Scotland) Act 2019. As the committee will know, the legislation will introduce what is commonly referred to as an opt-out organ and tissue donation system, whereby a person is deemed to have authorised transplantation unless they have expressly opted out of being a donor. Following a delay in the implementation of the 2019 act as a result of the Covid-19 pandemic, I have now confirmed that the act will be implemented, subject to parliamentary consideration of secondary legislation, on 26 March 2021. Implementation of the act will add to the on-going long-term work to increase the opportunity for donation and transplantation. The effect of the regulations that are before the committee is to specify the body parts to which the new system of deemed authorisation will not apply. Deemed authorisation for donation under the opt-out scheme will apply only to what are considered to be commonly transplanted organs and tissues. That includes the lungs, kidneys and heart, for example. Public information will make clear which organs and tissues can be transplanted when authorisation is not expressed but deemed. The regulations set out the organs, tissues and material that are considered to be novel or rare in a donation and transplantation setting. It is important to be clear that most of the body parts that are specified in the regulations are not currently able to be transplanted in the United Kingdom. In preparing the regulations, the Scottish Government has worked very closely with a variety of clinical stakeholders, including NHS Blood and Transplant, which is responsible for co-ordinating organ donation across the UK, and the Scottish National Blood Transfusion Service, which is responsible for tissue donation in Scotland. The Scottish Government has taken into account the responses that were provided to a formal consultation to ensure that the regulations correctly reflect current clinical practice. The regulations will formalise and reflect current practice in a deemed authorisation system, and setting out excepted body parts is one of the legal safeguards that is provided for under the 2019 act, in relation to the functioning and extent of deemed authorisation. Those safeguards also include fulfilling the statutory duty to inquire and establishing the latest known views of a person on deceased donation for transplantation. Those safeguards will also have to be undertaken in the rare circumstances where donation of an excepted body part may be able to take place. Their effects are that, where authorisation for transplantation is deemed under provisions in the 2019 act, the specified body parts under paragraphs (2) and (3) of regulation 2 will only be able to be removed for transplantation purposes following nearest relative authorisation. That reflects current practice regarding how such novel transplants are managed by specialist nurses for donors who have recorded an express authorisation in the rare circumstances in which that arises. Nearest relative authorisation for the removal of an excepted body part for transplantation is consistent with the robust authorisation requirements under the 2019 act. Safeguards in the act ensure that donation would not proceed without discussion of the donor’s most recently held views and any unwillingness to donate an excepted body part, which will be taken account of before a nearest relative may authorise a listed part for transplantation. The regulations also make specific provision in order not to inadvertently impact on routine tissue donations through the functioning of paragraphs (3) and (5) of regulation 2, whereby tissue can still be removed from certain body parts listed in those paragraphs where someone is deemed to have authorised transplantation. For example, a patch of skin could be removed from a leg as part of deemed authorisation for tissue donation, but the leg itself could not be removed in its entirety, as it is specified as an excepted body part. Specific exception is also made in the regulations for the trachea—otherwise known as the windpipe—which is routinely retrieved for transplantation as part of a dual lung or heart-lung block transplant. The regulations create an exception for the trachea to be included within deemed authorisation in so far as it is attached to a lung; otherwise, the trachea remains an excepted body part. I hope that that summarises the purpose of the regulations and is helpful. I am happy to take questions from the committee.