Human Tissue Act 2004

Human Tissue Act 2004 (Background and Summary)

HTA LogoThe Human Tissue Act came into force on 1st September 2006, having been passed as law in 2004.It replaces a variety of existing laws and establishes an updated legislative framework for regulating body donation and the removal, storage, and use of human organs and tissues.  Informed consent is now the fundamental principle underpinning the lawful removal, storage and use of human tissue and organs. Non-compliance with the Act can lead to severe penalties, ranging from fines through to imprisonment of up to three years.  The Act sets up an overarching Authority (the Human Tissue Authority) to regulate relevant activities through a system of licensing and the production and provision of directions and guidance.

The Human Tissue Act 2004 (the Act) applies to England, Wales, and Northern Ireland.  The Human Tissue (Scotland) Act 2006 is applicable in Scotland, the provisions of which closely mirror the 2004 Act. 

The Act was introduced following investigations and public outcry following organ-retention ‘scandals’ at Alder Hey Children's Hospital, Liverpool, and Bristol Royal Infirmary, when it became clear that existing laws on human tissue use and storage were inadequate.  The 2004 Act replaces the Human Tissue Act 1961, the Anatomy Act 1984, and the Human Organ Transplants Act 1989.  The Act introduces new legal requirements on the removal, storage and use of human organs and tissue.

The Act is intended to provide a consistent legislative framework for matters relating to body donation and the removal, storage and use of human organs and tissue.  It applies to ‘relevant material’ from living persons.  This is defined as “material, other than gametes which consists of or includes human cells.”  Hair and nail are excluded but blood is included. 

Consent

The Human Tissue Act makes consent the fundamental principle underpinning the lawful removal, use and storage of human tissue.  The Act sets out detailed requirements for obtaining consent in different situations, including obtaining consent from adults who lack the capacity to consent,  children, and from the deceased or their relatives/representatives.

The Act makes the removal, storage and use of human tissue without consent, and the taking and testing of DNA without consent, illegal.  Organ trafficking is similarly illegal. 

The Human Tissue Authority

An over-arching authority, the Human Tissue Authority, which became effective on 1 April 2005, has been established to oversee the Act and regulate relevant activities through licensing.  The system of licensing is intended to restore public confidence in the proper use of human organs and tissue by ensuring compliance with the consent provisions of the Human Tissue Act. 

The Authority regulates and licenses the removal, storage, use, import and export, and disposal of human bodies, organs, and tissue.  It has the power to issue, revoke, review, and suspend licenses, and it may also stipulate the conditions that apply to individual licenses.  It has powers of inspection, entry, search, and seizure.

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