Human Tissue Act 2004
The Human Tissue Act 2004 (HT Act) repeals and replaces the Human Tissue Act
1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 as they
relate to England and Wales, and the corresponding Orders in Northern Ireland.
The HT Act makes consent the fundamental principle underpinning the lawful
storage and use of body parts, organs and tissue from the living or the deceased for
specified health-related purposes and public display. It also covers the removal of
such material from the deceased. The HT (Scotland) Act is based on authorisation
rather than consent, but these are both expressions of the same principle. Further
information about the Human Tissue (Scotland) Act 2006
Wrongful breaches of the Act are a criminal offence and punishable with prison
sentences of up to three years.
The Act does not cover the removal storage and use of human gametes or embryos
which is covered by the Human Fertilisation and Embryology Act 2008.
The key points of the Human Tissue Act 2004
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The HT Act regulates removal, storage and use of human tissue – defined as
material that has come from a human body and consists of, or includes,
human cells. It is unlawful to carry out these licensable activities without a
licence.
The HT Act lists the purposes for which consent is required (the Scheduled
Purposes).
The HT Act specifies who may give consent for the Scheduled Purposes.
The HT Act created a new offence of DNA ‘theft’. Having human tissue with
the intention of its DNA being analysed, without the consent of the person
from whom the tissue came is an offence under the Act.
The HT Act makes it lawful to take minimum steps to preserve the organs of a
deceased person for use in transplantation while steps are taken to determine
the wishes of the deceased, or, in the absence of their known wishes,
obtaining consent from someone in an appropriate relationship.
Appropriate consent
Section 1, of the Act makes it lawful to engage in a number of activities only with
appropriate consent. These include:
Storage or use of the body or parts of the body of any person living or dead for the
purposes of
 Anatomical examination.
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Determining the cause of death (coroner’s autopsies are exempt).
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Establishing after a person’s death the efficacy of any drug or other treatment
administered to him.
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Obtaining scientific or medical information about a living or deceased person
which may be relevant to any other person (including a future person).
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Public display.
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Research in connection with disorders, or the functioning, of the human body.
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Transplantation.
Storage or use of the body or parts of the body of any deceased person for the
purposes of
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Clinical audit.
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Education or training relating to human health.
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Performance assessment.
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Public health monitoring.
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Quality assurance.
For deceased persons removal of body parts requires appropriate consent under the
Act. For living persons removal of body parts is covered by the Common Law on
consent.
What is appropriate consent?
Adults For a living adult (aged 18 or over) consent must be explicit, given by
the adult, and comply with the requirements of a valid consent (Capacity,
information and voluntariness). In the case of a deceased adult the consent
requirements depend on the purpose of the use for which the body part is
removed or stored.
a. For anatomical examination or public display only the explicit consent
in writing and witnessed of the deceased person prior to their death is
appropriate.
b. For other purposes appropriate consent means:
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‘The deceased’s own consent before her death;
The consent of her nominated representative(s) –person(s) chosen by
her before her death;
The consent of someone in a ‘qualifying relationship ’with her
immediately before she died – her ‘nearest relative’ or other person
close to her’
Qualifying relationship is specified in the Act and there is a hierarchy which must be
followed by the person seeking consent in approaching someone in a qualifying
relationship.
1. Spouse or partner (including civil partners recognized under the Civil
Partnerships Act 2004);
2. Parent or child;
3. Sister or brother;
4. Grandparent or grandchild;
5. Niece or nephew;
6. Step-parent;
7. Half-sister or -brother;
8. Friend of long standing (s 27(4)).
Children When a child is alive then appropriate consent is the consent of the
child if he or she has given valid consent. If a child is not competent to consent,
or although competent has ‘failed to do so’, then consent should be by someone
with parental responsibility for the child. When a child has died the following
consents apply:
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Removal, storage or use of body parts for public display or
anatomical examination. The consent of the child (witnessed and in
writing) when alive is required.
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For other Scheduled Purposes. The consent of the child prior to death, if
valid, is appropriate consent. If the child did not consent or make a
decision not to consent prior to death then appropriate consent is required
from someone with parental responsibility, or if there is no-one with
parental responsibility, someone in a qualifying relationship with the child
(see above).
Living organ donation
There are two types of living organ donation regulated by the HT Act.
1. Directed donation: This is a form of donation where a healthy person
donates an organ or part organ to a specific recipient. The recipient could be
known to the donor (in the case of genetically or emotionally related donation)
or unknown to the donor (in the case of paired donation).
a) genetically related donation: where the potential donor is a blood
relative of the potential recipient
b) emotionally related donation: where the potential donor has a
relationship with the potential recipient, for example, spouse, partner, or
close friend
c) paired donation: where a relative, friend or partner is fit and able to
donate an organ but is incompatible with the potential recipient, and
they are matched with another donor and recipient in a similar situation,
so that both people in need of a transplant receive a compatible organ
d) pooled donation: a form of paired donation whereby the pair are
matched with other donors and recipients from a pool of pairs in similar
situations, and more than two donors and two recipients are involved in
the swap, so that more than two people in need of a transplant receive a
compatible organ
2. Altruistic non-directed donation: This is a form of living donation whereby
an organ or part organ is donated by a healthy person who does not have a
relationship with the recipient and who is not informed whom the recipient will
be.
All living organ donations must be approved by the Human Tissue Authority
before they can take place. The HTA must be satisfied that:
1. ‘no reward has been, or is to be, given
2. consent to removal for the purpose of transplantation has been given (or
removal for that purpose is otherwise lawful)
3. an Independent Assessor has conducted separate interviews with the donor
(and if different from the donor, the person giving consent) and the recipient
(or the person acting on behalf of the recipient) and submitted a report of their
assessment to the HTA’
HTA Code of Practice 2
Additionally in cases of directed genetically or emotionally related donation, the HTA
requires evidence of relationship to be provided, so that it can be satisfied the
relationship between donor and recipient is as stated.
Commercialisation of body parts
The Human Tissue Act makes it an offence to engage in commercial dealings in
bodily material, such as organs or tissue, for the purposes of transplantation (section
32). A person guilty of an offence under section 32 is liable to imprisonment for up to
a year and/or a fine.