Legislative Framework


The legislative framework for donation in the UK is that of a hard 'opt-in' system of consent. The Human Tissue Act 2004, which governs practice in England and Wales, specifically uses the term ‘consent’, whilst The Human Tissue (Scotland) Act 2006 uses the term 'authorisation'. Practice in Northern Ireland is governed principally by common law, although broadly it follows the legal principles that are applied elsewhere in the United Kingdom.

Patient autonomy

The legislative framework for donation in the UK is that of a hard 'opt-in'. Practice in England and Wales is governed by the Human Tissue Act 2004, whilst in Scotland the Human Tissue (Scotland) Act 2006 applies. Both Acts describe how consent / authorisation for organ retrieval after death may be given.

The Human Tissue Act 2004 uses the term 'consent'. In contrast the Human Tissue (Scotland) Act 2006 uses the different term 'authorisation'. Practice in Northern Ireland is governed principally by common law, although broadly it follows the legal principles that are applied elsewhere in the United Kingdom.

Both the Human Tissue Act 2004 and the Human Tissue (Scotland) Act 2006 give primacy to the wishes of the individual however they have been stated and recorded. This can be done in various ways – verbally, by having a Donor Card, in writing or via the various means of accessing the NHS Organ Donor Register (ODR). All are regarded as equally valid forms of consent / authorisation for organ retrieval after death. If it is known that an individual has given their prior consent, this should be reflected in how the possibility of donation is introduced to a family. (Click here for more details).

The role of the family

There is no provision in either Act for family members to be able to overturn an individual’s wish to donate their organs after death. Scottish legislation requires families to complete a written waiver should they seek to obstruct organ retrieval in such circumstances.

However, if the wishes of the individual are not known or cannot be determined then authority for decision making passes to a nominated representative (England and Wales only), and then to a person in a qualifying relationship to the individual. For a list of the qualifying relationships as described in the two Acts.

Ranking order of family for consent and authorisation

Table - Ranking order of family for consent and authorisation


Common reasons for family refusal



It is important to understand that although the Acts give precedence to the wishes of the patient, when those wishes cannot be established, authority for decision making passes to the individual in the qualify relationship / nearest relative to the patient. Approaches that place exclusive emphasis upon honouring the wishes of an individual may lead families to erroneously conclude that donation should not happen when such wishes cannot be established, even though they then have the legal authority to consent to /authorise it.

Donation from children

Both Acts recognise the validity of the wishes of competent minors. Where the wishes of the individual are not known or the minor was not competent to deal with the issue, consent / authorisation passes to those with parental rights and responsibilities, or in their absence to an individual in a qualifying / nearest relationship.

There is no age restriction for self-registration or self-withdrawal from the register. A parent can register their child, or a child for whom they have parental rights and responsibility, providing the child is under the age of 16 years. Alternatively, a child can register themselves. Children under the age of 12 years at the time of registration are assumed to have been registered by their parents, whilst those 12 years and over are assumed to have self registered. As a consequence, whilst the parents of a child under the age of 12 years at the time of registration can withdraw this consent/authorisation, if the child was 12 years or over at the time of registration then parents must provide evidence that they (rather than the child) were responsible for the registration should they seek to reverse it.

Opt-out legislation in the United Kingdom

The British Medical Association are strong advocates of a soft opt-out system of consent for organ donation, and have re-affirmed this in their recent publication Building on Progress: Where next for organ donation policy in the UK? In November 2008, the Organ Donation Taskforce published an independent report into such a system, and advised that the time was not then right to introduce it into the UK. However, in November 2011 the Welsh Government published its Organ Donation Bill White Paper to introduce a soft opt-out system of organ and tissue donation in Wales. This would mean that unless an individual objects, their organs and tissues will be available for donation after their death. After publishing the White Paper, the Welsh Government will introduce an Organ Donation Bill in the National Assembly before the end of 2012. It is anticipated that this system of deemed consent will be in operation by 2015.

BMA report on organ donation


Organ Donation Taskforce report on Presumed Consent

Front cover - The potential impact of an opt out system for organ donation in the UK

Next section: Donation After Brain-stem Death

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