NHS Blood and Transplant and UK deemed consent

NHS Blood and Transplant (NHSBT) is a special health authority of the United Kingdom's National Health Service that is responsible for blood donation in England and for organ and tissue donation and transplantation across the UK.[1] In its transplantation role, NHSBT operates the UK Organ Donor Register, runs the national matching and allocation systems, supports specialist organ-donation staff in hospitals, and publishes activity and outcome data.[1] During the period 2015-2021, the four UK nations each moved from an opt-in consent system to a "soft" opt-out (also called deemed consent or, in Scotland, deemed authorisation) system: Wales in December 2015, England in May 2020 ("Max and Keira's Law"), and Scotland in March 2021.[2][3][4]

NHS Blood and Transplant

NHSBT was formed in 2005 and acts as the UK-wide organization coordinating deceased and living organ donation and transplantation.[1] Among its functions are maintaining the national waiting list and Organ Donor Register, operating the allocation schemes that match deceased-donor organs to patients, employing Specialist Nurses for Organ Donation (SNODs) who support potential-donor families in hospitals, and reporting national statistics.[1] NHSBT works alongside the health departments of England, Scotland, Wales and Northern Ireland, each of which sets the consent law for its nation.[1][2]

The shift to deemed consent

Under the previous opt-in model, an adult became a potential donor by actively recording a decision to donate (for example by joining the Organ Donor Register), and in the absence of a recorded decision the family was asked to decide.[2] Under a deemed-consent ("soft opt-out") model, adults are treated as having agreed to donate unless they have recorded a decision not to (opted out) or fall within an excluded group, while families remain closely involved.[3][4] The UK systems are described as "soft" because families continue to be consulted and their support is sought, and a known objection from the person or strong family objection is respected.[3][5]

Wales (2015)

Wales was the first UK nation to adopt deemed consent, under the Human Transplantation (Wales) Act 2013, which came into effect on 1 December 2015.[2][3] Studies of the Welsh change found that consent rates rose over the following years, with the increase reaching statistical significance after about 33 months for donation after brain death, although no significant change was observed for donation after circulatory death, underscoring that legislation alone does not uniformly raise consent.[6]

England (2020), "Max and Keira's Law"

In England, the Organ Donation (Deemed Consent) Act 2019 came into force on 20 May 2020, commonly known as "Max and Keira's Law" after a child who received a heart transplant and the child who donated it.[3] Under the law, all adults in England are considered to agree to donate their organs when they die unless they have opted out or are in an excluded group, for example, those under 18, people who lack the mental capacity to understand the change, those who have lived in England for less than 12 months, those not living there voluntarily, and people who have nominated a representative to decide.[3]

Scotland (2021)

Scotland moved to deemed authorisation under the Human Tissue (Authorisation) (Scotland) Act 2019, which took effect on 26 March 2021, with its own set of safeguards and excluded groups.[4][5] (Other jurisdictions in the British Isles, including Jersey, Guernsey and the Isle of Man, made comparable changes on separate timelines.)[2]

Evidence and interpretation

The UK changes are widely studied, and the consensus in the evaluation literature is cautious: deemed consent appears to have contributed to higher consent/authorisation rates and public engagement in some settings, but the effect is not automatic and not uniform, and family discussion, the work of specialist nurses, and donation infrastructure remain decisive.[5][6] Because families continue to be involved and can effectively decline, observers stress that recording a decision and discussing it with family still matters under the new law.[3][5] This UK evidence is part of the broader international finding that organizational capacity, rather than the default consent rule alone, drives donation rates. See comparative donation systems and PMP metrics and consent models: opt-in vs opt-out.

See also

• Consent models: opt-in vs opt-out
• Comparative donation systems and PMP metrics
• The Spanish Model and the ONT
• Donation after brain death (DBD) · Donation after circulatory death (DCD)

References

• NHS Blood and Transplant. About us / Organ donation and transplantation. https://www.nhsbt.nhs.uk/ ; https://www.organdonation.nhs.uk/
• House of Lords Library. Organ donation in England and the UK: statistics and law changes (timeline of opt-out adoption: Wales 2015, England 2020, Scotland 2021). https://lordslibrary.parliament.uk/organ-donation-in-england-and-the-uk-statistics-and-law-changes/
• NHS Blood and Transplant. Max and Keira's Law comes into effect in England (Organ Donation (Deemed Consent) Act 2019; effective 20 May 2020; excluded groups). https://www.organdonation.nhs.uk/get-involved/news/max-and-keira-s-law-comes-into-effect-in-england/
• NHS Organ Donation. Organ donation law in Scotland (deemed authorisation; Human Tissue (Authorisation) (Scotland) Act 2019; effective 26 March 2021). https://www.organdonation.nhs.uk/uk-laws/organ-donation-law-in-scotland/
• NHS Blood and Transplant, ODT Clinical. Consent and authorisation (soft opt-out; family involvement). https://www.odt.nhs.uk/deceased-donation/best-practice-guidance/consent-and-authorisation/
• Madden S, et al. The effect on consent rates for deceased organ donation in Wales after the introduction of an opt-out system. Anaesthesia. 2020;75(9):1146-1152. PMC7496553. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496553/