The Human Tissue Act 2004 (the Act) came into effect on 1 September 2006, having become law in 2004, in response to recommendations following inquiries into several high-profile cases, where organs had been removed, stored and used after post-mortem without the knowledge and consent of the relatives, from this it became clear that existing laws on human tissue use and storage were inadequate. The Act applies to England, Wales, and Northern Ireland. There is a separate Human Tissue Act 2006 which covers Scotland.

The Act makes informed consent the fundamental principle underpinning the lawful storage and use of body parts, organs and tissue from the living or the deceased. It applies to 'relevant material' from living persons.

The Act defines 'relevant material' as 'material, other than gametes, which consists of or includes human cells'. It also states. with references to 'relevant material' from a human body, that this does not include embryos outside the human body or hair and nails from the body of a living person.

The Human Tissue Authority (HTA) has issued further guidance on materials considered ‘relevant material’ under the Act. The Act has created a new offence of DNA “theft”. Having human tissue with the intention of its DNA being analysed, with the consent of the person from whom the tissue came, is unlawful.

The HTA was established in April 2005 to ensure that the requirements of the Act are implemented and adhered to. It regulates relevant activities through a system of licensing and the production and provision of directions and guidance. Non-compliance with the Act can lead to severe penalties, ranging from fines to imprisonment of up to three years.

Human Tissue Act Licenses held:

• Queen Mary University of London, Barts and The London School of Medicine and Dentistry – Charterhouse Square (hub)
• Human Tissue Resource Centre - St Bartholomew’s Hospital (Satellite)
• Queen Mary University of London – Mile End (Satellite)
• Blizard Institute (Satellite)
• Institute of Dentistry (Satellite)

The HTA has Codes of Practice and Standards that provide practical guidance for carrying out activities within the scope of the Act’s remit.