The Human Tissue Act 2004 came into effect on 1 September 2006. It 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.
Key functions of the Human Tissue Act are to:
- establish the Human Tissue Authority (HTA) to regulate activities concerning the removal, storage, use and disposal of human tissue
- make appropriate consent a legal requirement for the removal, storage and use of body parts, organs, tissue and cells (“relevant material”). The Human Tissue Act lists the purposes for which consent is required (these are called “scheduled purposes”)
- introduce licensing requirements for the removal, storage and use of bodies, organs, tissue and cells
- sets out offences and penalties for breaching the requirements
The following regulations supplement the Human Tissue Act:
- Human Tissue (Quality and Safety for Human Application) Regulations 2007 – additional requirements for the use of tissue for patient treatment
- Quality and Safety of Organs Intended for Transplantation Regulations 2012 – additional requirements for organ donation and transplantation
- Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006
- Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006
Royal Brompton & Harefield NHS Foundation Trust holds licences under the Human Tissue Act in the following sectors:
- research,
- post-mortem
- heart valve bank (storage of relevant material for use in research)
(Please note that the Heart Valve Bank is also licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007).
Scheduled purposes in the Human Tissue Act 2004
The Human Tissue Act 2004 sets out a list of purposes for which material might be removed, used or stored. Collectively, these purposes are referred to as “scheduled purposes” and can be found in schedule one of the Human Tissue Act.
The Act describes when consent and / or a licence is needed to carry out scheduled purposes, and different requirements can apply depending on whether the tissue was removed from the body of a living or a deceased person.
There are two categories of scheduled purposes, depending on whether the tissue was removed from the body of a living or deceased person:
|
Part one: purposes requiring consent – living and deceased |
Anatomical examination |
|
Determining the cause of death |
|
|
Establishing after a person’s death the efficacy of any drug or other treatment administered to them |
|
|
Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person) |
|
|
Public display |
|
|
Research in connection with disorders, or the functioning, of the human body |
|
|
Transplantation |
|
|
Part two: purposes requiring consent – deceased only |
Clinical audit |
|
Education or training relating to human health |
|
|
Performance assessment |
|
|
Public health monitoring |
|
|
Quality assurance |
Offences under the Human Tissue Act 2004
The following are offences under the Human Tissue Act 2004:
- removing, storing or using tissue for scheduled purposes without appropriate consent
- storing or using tissue donated for a scheduled purpose for another purpose
- trafficking in human tissue for transplantation purposes
- carrying out licensable activities without a Human Tissue Authority (HTA) licence (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)
Committing any of the above is a criminal offence with the potential for serious penalties, including imprisonment.
Any concerns or queries about these offences should be directed to the tissue governance manager.