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The Human Tissue Act

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The Human Tissue Act

The Human Tissue Act (2004) (HT Act) is the legislative framework which governs the storage and use of relevant material from the living and the removal, storage and use of relevant material from the deceased, for a scheduled purpose.

The Act focuses on both consent and licensing making consent fundamental to the removal, storage and use of human tissue for certain scheduled purposes.

Relevant material, as defined by the HT Act, is material derived from a human body (other than gametes*) which consists of or includes cells (including bodily waste products). 

The following are excluded from the Act:

  • hair and nail from the body of a living person;
  • embryos outside the human body;* 
  • cell lines and other material created outside the human body; 
  • any sample that has been rendered acellular within seven days of initial sample receipt.

*Regulated by Human Fertilisation and Embryology Act 1990. 

supplementary list of relevant material is available from the Human Tissue Authority (HTA). This list is neither exhaustive nor exclusive. Potential users of human tissue are asked to seek guidance from Human Tissue Authority website where classification of human tissue is unclear.

View the Human Tissue (Quality and Safety for Human Application) Regulations 2007

Find out more about the regulator for human tissue and organs