Legislation

The core of what the HTA does is laid down in four pieces of legislation. These are: 

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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.

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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. This is defined as material that has come from a human body and consists of, or includes, human cells.

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 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.

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The Human Tissue Act 2004
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Relevant material under the Human Tissue Act 2004
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Guidance about material that may be considered relevant.

The first four offences only apply in England, Wales and Northern Ireland. The offence of DNA theft applies UK wide. 

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Offences under the Human Tissue Act 2004
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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.

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.

On 1 July 2022, an amendment was made to Section 32 of the Human Tissue Act 2004 and Section 20 of the Human Tissue (Scotland) Act 2006, which extended the offences set out in these sections so that they have extraterritorial jurisdiction. These offences relate to financial or commercial dealings in human material for transplant, such as buying or selling human organs. 

In practice, this means that any person who is resident in England, Wales or Scotland is committing an offence if they are involved in seeking, offering, or receiving payment or reward for donating organs for transplantation or initiating, negotiating, advertising or being involved in buying or selling human organs for transplantation, anywhere in the world. 

On 1 April 2024, the Human Tissue Act 2004 (Supply of Information about Transplants) Regulations 2024 came into force. These Regulations make it mandatory for relevant clinicians in England, Wales and Northern Ireland to report:  

  • a reasonable suspicion that an organ donation and transplantation related offence may have been committed under the Human Tissue Act or Modern Slavery legislation, and  

  • a patient who has received an organ transplant outside the UK. 

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. 

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The Human Tissue Act 2004 regulations
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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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