Human Tissue Act 2004

The Human Tissue Act 2004 replaced 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 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).

Who needs a licence?

The activities licensed by the HTA under the Human Tissue Act are:

  • Carrying out of an anatomical examination;
  • Making of a postmortem examination;
  • Removal of relevant material from a deceased person;
  • Storage of relevant material for a number of “scheduled purposes”;
  • Storage of anatomical specimens; and
  • Public display of a body or relevant material from a deceased person.