Donation and transplantation: plan 2021 to 2026

The Plan sets out our priorities for increasing organ and tissue donation and transplantation over the next five years.

Priority One – Implementation of the Human Tissue (Authorisation) (Scotland) Act 2019

Authorisation is an important factor which affects whether donation, and ultimately transplantation, can proceed. Presently, Scotland has the highest proportion of people registered on the Organ Donor Register in the UK (49%), but surveys show that even more people living in Scotland support donation. This suggests therefore that many people who support donation simply do not get round to registering their decision.

Additionally, each year a proportion of families refuse authorisation for their loved one's organs to be donated. In 2019-20, in 35% of cases in Scotland where family members were approached about deceased organ donation, authorisation was not given or (in a few cases) the family overrode the authorisation the person had previously given. It is important therefore to look at ways which will ensure that individuals who would want to donate are able to do so.

Following public consultation and evidence of a shift in public attitudes towards support for an opt-out system of organ and tissue donation, the Scottish Government introduced legislation to the Scottish Parliament providing for such a system. Following Parliamentary support, the Human Tissue (Authorisation) (Scotland) Act 2019[3] (which amends the Human Tissue (Scotland) Act 2006) was passed and will be implemented in March 2021. The primary aim of the Act will be to introduce a system of deemed authorisation (opt-out) for deceased donation for transplantation.

International evidence suggests that opt–out legislation can be effective as part of a package of measures to increase donation. Whilst there is insufficient evidence to conclude that opt –out legislation alone will increase donation, evidence highlights the importance of non-legislative measures which can work effectively in their own right to increase donation and transplantation and which are often associated with successful opt-out systems. The introduction of the opt-out system in Scotland should be seen in this context.

The Act also provides a legislative framework for carrying out medical procedures and tests prior to a potential donor's death to facilitate successful transplantation. This framework means that there are clear processes in place supported by specific requirements which must be satisfied before these procedures are carried out.

Public Information

1.1 Public awareness of organ and tissue donation has grown over the last 12 years as a result of the duty on Scottish Ministers to support and promote donation in Scotland. The 2019 Act builds on those duties by requiring Scottish Ministers at least once in every calendar year to provide information to the public about how authorisation may be deemed to be given, how to make an express authorisation to donate and how to make an opt-out declaration. The knowledge of the public of the new system will be important in supporting informed decisions on donation and we will ensure the information provided is accessible as possible.

In the lead up to the introduction of the new system, amongst other information routes, every household in Scotland will receive an information leaflet. This will be supplemented by a fully accessible public information campaign, delivered via a range of media, such as television and radio advertising and social media.

There will also be detailed information available on the Organ Donation Scotland website for anyone who wants to find out more, along with a focus on providing bespoke information for certain groups, such as Easy Read materials for individuals with learning difficulties, specific leaflets for people from a number of different faiths and leaflets available in a number of different languages. Linked to NHSBT's programme to develop a network of organ donation 'ambassadors', the Scottish Government will also be looking to coordinate how we make good use of the many committed volunteers who already make an important contribution to awareness raising and helping people to understand the benefits of organ and tissue donation. Many transplant recipients, along with peer educators and some donor family members, already give up their time to speak to groups about donation; hopefully we can support them to widen the reach of our awareness raising.

Training for Specialist NHS Staff

1.2 We will work to increase awareness amongst specialist NHS staff of the deemed authorisation legislation, as well as (where applicable) the requirements of the new statutory framework for pre-death procedures (PDPs). Alongside the detailed guidance for staff on the requirements of the legislation, a programme of training will be rolled out for Specialist Nurses for Organ Donation (SNODs), Tissue Donor Coordinators (TDCs), Clinical Leads for Organ Donation, other key medical and nursing staff who refer and care for potential donors, and retrieval teams. Organ Donation Committees will also be asked to support the implementation of the opt-out legislation by raising general awareness more widely across staff in their NHS Board area. This will help ensure that staff who do not have direct involvement in donation are still able to answer key questions or know who to pass queries on to if patients or their families raise questions about organ or tissue donation.

Evaluation of Deemed Authorisation

1.3 In line with the requirements of the Act, the Scottish Government will undertake an evaluation of the deemed authorisation legislation and publish a report on the evaluation at the end of five years following implementation of the opt out system. The evaluation will examine the effectiveness of the law change, by monitoring public awareness and whether public attitudes have changed as a result of the law change; monitoring authorisation rates and evaluating whether the legislative change appears to be operating effectively and whether it has had any negative impacts. The conclusions reached in the evaluation report will be considered by both the Scottish Donation and Transplant Group (SDTG) and Scottish Ministers to inform practice and continue work to improve outcomes for donation and transplantation.

Pre-death Procedures (PDPs)

1.4 In setting out a legal framework for authorisation of pre-death procedures it is recognised that medical science and processes are constantly progressing. Therefore the Act provides for the amendment of the regulations which support the framework for carrying out pre-death procedures.

We will ensure that clinicians are aware of how to refer any proposals for changes to the regulations to the Scottish Government. It is intended that proposals for amendment of the regulations would be considered by a sub-group of the SDTG, taking advice from bodies such as the Research, Innovation and Novel Technologies Advisory Group (RINTAG) and others with specialist expertise on the proposed procedure(s) to consider whether the proposed changes should be recommended to Scottish Ministers. Such changes would be subject to consultation before regulations are laid for scrutiny by the Scottish Parliament.

Key Recommendations Short term 1 – 2 years Medium term 3 – 5 years Lead
1 Raise awareness across Scotland about the change in legislation, aiming to reach as many people as possible, including harder to reach groups. Short term, although regular awareness raising will continue following introduction of deemed authorisation. Scottish Government
2 Ensure key staff likely to be involved in approaching families about deceased donation receive training and guidance on the new legal requirements in relation to deemed authorisation and pre-death procedures. Also put in place wider general awareness raising for other NHS staff. Short term – to be delivered by March 2021. Scottish Government, with support from Clinical Leads and Organ Donation Committees
3 Undertake an evaluation of the deemed authorisation system and seek to learn any lessons from the evaluation findings. Medium term – expected by 2025-26. Scottish Government
4 Keep pre-death procedures regulations under review. If changes to either Type A or Type B regulations are proposed, ensure these proposals can be considered and, if appropriate, amendments can be made. Short to medium term. Scottish Government



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