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 that there is valid consent in place for the removal and use of the organ or part organ for the purpose of transplantation. 

Independent checks

We do this by providing an independent check to help protect the interests of living organ donors. In doing so, 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, as outlined in the legislation that governs living organ donation. The regulatory requirements for living donor transplantation are set out in the HT Act and the Regulations.

Human Tissue Act

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 HTA also assesses all living organ donation cases on behalf of the Scottish Government. In Scotland, the law covering living organ donation is similar to the law in the rest of the UK, although there are some significant differences. 

The legal framework for Scotland is set out in section 17 of the Human Tissue (Scotland) Act 2006. 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, which is when an organ or part organ is removed for the primary purpose of a person’s medical treatment.

Consent

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 Regulations is the secondary legislation that sets out legal requirements that must be met in order for the HTA to give approval for living organ donations.

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 , unless the conditions specified in the Regulations are satisfied.

Section 32 of the HT Act also creates offences associated with commercial dealing in human organs, such as offering or receiving a reward for the supply of an organ or part organ. 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

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

 

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Last updated on: 20 Jul 2020