Human Tissue Authority

The regulator for human tissue and organs

Living organ donation: Legal Framework

The Human Tissue Authority’s (HTA) role in living organ donation is to ensure that there has been no reward sought or offered for the organ donation and to provide an independent check to help protect the interests of living organ donors. We ensure that each individual donor has an opportunity to speak freely to someone not connected with the transplant Centre/Unit in order to confirm that their wish to donate is free from any pressure. This is achieved through an independent assessment interview process with both the donor and recipient.

The Human Tissue Act 2004 (the HT Act) provides a legal framework for living organ donation in England, Wales and Northern Ireland. The HT Act also sets out the licensing framework for the storage and use of human organs and tissue from the living and for the removal, storage and use of human organs and tissue from the deceased. The HT Act covers England, Wales and Northern Ireland.

In Scotland, the legal framework is set out in section 17 of the Human Tissue (Scotland) Act 2006. Scottish law covering living organ donation is similar to the law in the rest of the UK, although there are some significant differences. In Scotland, the word ‘authorisation’ is used rather than ‘consent’ and adults with incapacity and children (under 16) can only donate an organ or part organ removed as part of domino donation.

The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplant Regulations) 2006 (the Regulations) requires the donor’s consent for a specified purpose. 

The HT Act makes consent the fundamental principle underpinning the lawful storage and use of human bodies, body parts, organs and tissue and the removal of material from the bodies of deceased people. The HT Act requires consent for the storage and use of organs or part organs taken from a living or deceased person for the purpose of transplantation.

Under section 33 of the HT Act, a person commits an offence if they remove or use an organ from a living person for the purpose of transplantation.

Section 32 of the HT Act also creates offences associated with commercial dealing in human organs. The penalty for these offences is a prison sentence of up to three years, a fine, or both.

 

Further information:

Guidance to Transplant Teams and Independent Assessors
A guide for transplant teams and Independent Assessors

Guidance to Transplant teams, Independent Assessors and Accredited Assessors in Scotland
A guide for transplant teams and Independent Assessors​ in Scotland

Code F - Donation of solid organs and tissue for transplantation  
Donation of solid organs and tissue for transplantation

Organ/part organ that cannot be transplanted into the intended recipient
HTA policy on the steps transplant units should take to prepare living organ donors when it is not possible to transplant their organ

About Independent Assessors
About Independent Assessors, including how to become an Independent Assessor

HTA position statement on the absence of a presumed genetic relationship
HTA's current position on the absence of a presumed genetic relationship

Information about HTA Portal for IAs (including login)
Guidance on the online Portal for Independent Assessors

Donor declaration forms
Information about donor decelerations

Translator declaration
Guidance for when a translator has been required by an Independent Assessor or Living Donation Coordinator

European Commission Living Kidney Donation Toolbox (external site)

 

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