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Human Tissue Act

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 Unrelated Transplant Regulatory Authority (ULTRA) and the post of HM Inspector of Anatomy will be abolished and their functions transferred to the HTA.

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. It lists the purposes for which consent is required (the Scheduled Purposes).

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

The key points of the Human Tissue Act 2004

Many of the activities covered by the HT Act are already regulated in statutory or voluntary form. The new legislation seeks to ensure that regulatory frameworks are consistent.

  • 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. Once the HT Act is in force, it will be unlawful to carry out these licensable activities without a licence.
  • The HT Act creates 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, will be unlawful from 1 September 2006.
  • 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.
  • The HT Act gives specified museums in England discretionary power to move human remains out of their collections, if the remains are reasonably believed to be those of a person who died less than 1000 years ago.

Offences under the Human Tissue Act

Existing offences under the Anatomy Act 1984 and the Human Organ Transplants Act 1989 have been carried forward into the HT Act, with increased maximum penalties. However, the HT Act contains several new offences with penalties ranging from a fine to up to three years’ imprisonment, or both.

These offences, which are all enforceable in 2006, are:

  • 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 HT (Scotland) Act will introduce 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).

Human Tissue Act guidance

Some further guidance on the Human Tissue Act produced by the British Medical Association's medical ethics department is available here