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. 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).
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 also created an 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.
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. The offence of DNA theft applies UK wide.
The Human Tissue Act 2004 regulations
Regulations covering transplantation
The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006 contain further specific examples of licensing exemptions.
The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 require the HTA to assess all cases of living organ donation (except domino donations) for transplantation and certain cases of bone marrow and PBSC donations for transplantation.
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. Find out more about the Human Tissue (Scotland) Act 2006.