The Human Tissue Act 2004 covers England, Wales and Northern Ireland. It established the HTA to regulate activities concerning the removal, storage, use and disposal of human tissue. Consent is the fundamental principle of the legislation and underpins the lawful removal, storage and use of body parts, organs and tissue. Different consent requirements apply when dealing with tissue from the deceased and the living. The Human Tissue Act 2004 lists the purposes for which consent is required (these are called Scheduled Purposes).
There is separate legislation in Scotland - the Human Tissue (Scotland) Act 2006. While provisions of the Human Tissue (Scotland) Act 2006 are based on authorisation rather than consent, these are essentially both expressions of the same principle.
The key points of the Human Tissue Act 2004
- The Human Tissue Act 2004 regulates the removal, storage and use of human tissue. This is defined as material that has come from a human body and consists of, or includes, human cells.
- The Human Tissue Act 2004 creates a new offence of DNA ‘theft’. It is unlawful to have human tissue with the intention of its DNA being analysed, without the consent of the person from whom the tissue came.
- The Human Tissue Act 2004 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 a qualifying relationship.
Offences under the Human Tissue Act 2004
- Removing, storing or using human tissue for Scheduled Purposes without appropriate consent.
- Storing or using human tissue donated for a Scheduled Purpose for another purpose.
- Trafficking in human tissue for transplantation purposes.
- Carrying out licensable activities without holding a licence from the HTA (with lower penalties for related lesser offences such as failing to produce records or obstructing the HTA in carrying out its power or responsibilities).
- Having human tissue, including hair, nail, and gametes (i.e. cells connected with sexual reproduction), with the intention of its DNA being analysed without the consent of the person from whom the tissue came or of those close to them if they have died. (Medical diagnosis and treatment, criminal investigations, etc., are excluded).
The first four offences only apply in England, Wales and Northern Ireland, although the Human Tissue (Scotland) Act 2006 has similar offences and penalties. The offence of DNA theft applies UK-wide. To find out more about the offences you can download the Human Tissue Act 2004 and Human Tissue (Scotland) Act 2006.
Please use the links to the top left of this page to access the Office of Public Sector Information (OPSI) website where the Human Tissue Act 2004 and Human Tissue (Scotland) Act 2006 are available. Please note that the legislation provided on the OPSI website is the original 'enacted' version and so will not include any subsequent amendments.
The Human Tissue Act 2004 regulations covering transplantation
- The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006
- The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006
Updated July 2010