Legislation
The HTA is an Executive Non-Departmental Public Body sponsored by the Department of Health and Social Care (DHSC). As a statutory body the core of what the HTA does is laid down in four pieces of legislation. These are:
- The Human Tissue Act 2004 (HT Act) and associated Regulations.
- Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended).
- Quality and Safety of Organs Intended for Transplantation Regulations 2012.
- The Human Transplantation (Wales) Act 2013
These laws ensure human tissue is used safely and ethically, with proper consent.
Our aim is to ensure these laws are followed by setting standards that are clear and reasonable, and in which the public and professionals can have confidence. We help people to understand these requirements by providing Codes of Practice and other advice, guidance and support.
The Human Tissue Act 2004
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, 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.
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.
Other regulations
The Human Tissue Act 2004 (Powers of Entry and Search: Supply of Information) Regulations 2006
Scotland
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.
Test your knowledge
You can test your knowledge on the HT Act and our Codes of Practice by taking part in our online quizzes.
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