Human Tissue Act 2004
What this means for your business
- Applies to
- United Kingdom
- On this page
- 14 compliance obligations, 2 practical guides
What you must do
14 compliance obligations under this legislation — 8 can result in imprisonment.
Management duties 1
Ensure licence holders are suitable and follow licence conditions
If your business holds a licence under the Human Tissue Act, you must appoint a designated individual who will be responsible for making sure anyone else covered by the licence is appropriate to carry out the work, that the work is done using proper practices, and that every condition of the licence is obeyed. In practice this means checking competence, maintaining appropriate procedures and monitoring compliance on an ongoing basis.
Other requirements 1
Comply with any direction that sets requirements for your licensed activity
If your business holds a licence under the Human Tissue Act, you must follow any specific requirements that a regulator later orders you to meet. These requirements could relate to how you carry out the activity the licence covers, and they apply as soon as the direction is issued.
Offences and prohibitions 12
Breach of licence requirement for human tissue activities
3 years imprisonmentIf your business carries out any activity involving human tissue that is covered by section 16 and you do so without a licence, or outside the terms of your licence, you commit an offence. Conviction can result in an unlimited fine, and if tried in the Crown Court you could also face up to three years’ imprisonment (or both a fine and jail).
Carry out activity on human tissue without appropriate consent
3 years imprisonmentIf you perform any activity involving human tissue that requires consent – such as collecting, storing, or using tissue – without having that consent, or you falsely claim consent, or you fail to follow the required death‑registration steps before using tissue, you commit a criminal offence. On conviction you can be fined an unlimited amount and/or sentenced to up to three years in prison.
Commercial dealing in human tissue for transplantation
3 years imprisonmentIf you give, receive, offer, seek, arrange or advertise a reward for the supply of any human tissue or cells intended for transplantation, you commit a criminal offence unless you have been formally designated by the regulator to do so. A conviction can lead to up to three years’ imprisonment and an unlimited fine for the core offences, and up to 51 weeks’ imprisonment and a level‑5 fine for advertising offences.
Commercial dealing with human organs overseas
Unlimited fineIf you are habitually resident in England & Wales, or you are a UK national (but not habitually resident in Northern Ireland) and you carry out a commercial activity involving a human organ outside the UK that would be illegal under UK law if done here, you can be prosecuted in England and Wales. The offence is treated as if it were committed in the UK, so you face the same penalties as for the domestic offence.
Conduct DNA analysis without consent
3 years imprisonmentIf you analyse DNA from human tissue without obtaining qualifying consent and use the results for a purpose that isn’t an exception, you commit an offence unless the material falls within a specific exception (e.g., very old material, held without identifying information, or an embryo outside the body). On conviction you face an unlimited fine and/or up to three years’ imprisonment.
Corporate liability for Human Tissue Act offences
If your company (or Scottish partnership) breaches any provision of the Human Tissue Act and a director, manager, secretary, similar officer or a member acting as a director consents to, connives with, or neglects the breach, both the organisation and that individual can be prosecuted. The offence carries the same penalties as the underlying Human Tissue Act breach, which are set elsewhere in the legislation.
Fail to comply with inspection requirements or obstruct inspection
Unlimited fineIf you do not provide the records that the regulator asks for under the Human Tissue Act, or you deliberately block them from carrying out an inspection, you commit a criminal offence. Conviction in the magistrates' court can result in an unlimited fine.
Fail to comply with transplant information regulations
Unlimited fineIf you are required to give information about a transplant operation under the regulations made under the Human Tissue Act and you either do not supply it (without a reasonable excuse) or you knowingly give false or misleading information, you commit a criminal offence. On conviction in the Magistrates’ Court you face a fine – up to £1,000 for merely failing to provide the information, or an unlimited fine if the information supplied is false or misleading.
Possess anatomical specimen off‑licensed premises
3 years imprisonmentIf your organisation holds a human anatomical specimen in a location that does not have an anatomy licence, you are committing an offence unless you fall within one of the specific exemptions (e.g., authorised storage licence, lawful possession right after death, transport to a licensed site, research/education use, coroner authority, or reasonable belief of a different status). Conviction can result in an unlimited fine and up to three years' imprisonment.
Possess former anatomical specimen away from licensed premises
3 years imprisonmentIf your business keeps a former anatomical specimen (e.g., tissue from a human body) in a location that does not have a storage licence, you are committing an offence unless you have written authorisation, are transporting it to a licensed site, using it for education, training or research, disposing of it properly, acting under a coroner’s authority, or reasonably believe it is not such a specimen. Conviction can result in an unlimited fine and/or up to three years’ imprisonment. The offence can be tried either in the Magistrates’ Court (summary) or the Crown Court (indictable).
Remove or use transplant material from a living donor unlawfully
51 weeks imprisonmentIf you take tissue or other transplantable material from a living person, or you use such material for transplantation, and you know (or ought to know) the donor is alive, you are committing a criminal offence unless a specific regulatory exemption applies. On conviction you face up to 51 weeks’ imprisonment, an unlimited fine, or both.
Use or store donated human tissue for non‑qualifying purpose
3 years imprisonmentIf you use or store donated human tissue for any purpose that is not listed as a qualifying purpose (e.g., medical diagnosis/treatment, decent disposal, or other permitted uses), you commit an offence unless you reasonably believed the material was not donated. A conviction can lead to an unlimited fine, and on a Crown Court trial you could also face up to three years’ imprisonment or both a fine and a prison term.
Penalties for non-compliance
12 penalties under this legislation. 8 can result in imprisonment. 11 carry an unlimited fine.
Breach of licence requirement for human tissue activities
Unlimited fine and/or 3 years imprisonment
Carry out activity on human tissue without appropriate consent
Unlimited fine and/or 3 years imprisonment
Commercial dealing in human tissue for transplantation
Unlimited fine and/or 3 years imprisonment
Conduct DNA analysis without consent
Unlimited fine and/or 3 years imprisonment
Possess anatomical specimen off‑licensed premises
Unlimited fine and/or 3 years imprisonment
Possess former anatomical specimen away from licensed premises
Unlimited fine and/or 3 years imprisonment
Remove or use transplant material from a living donor unlawfully
Unlimited fine and/or 51 weeks imprisonment
Use or store donated human tissue for non‑qualifying purpose
Unlimited fine and/or 3 years imprisonment
Commercial dealing with human organs overseas
Unlimited fine
Fail to comply with inspection requirements or obstruct inspection
Unlimited fine
Fail to comply with transplant information regulations
Unlimited fine
Corporate liability for Human Tissue Act offences
Penalty applies
Practical guidance
Our guides explain how to comply with the requirements above.
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Sections and provisions
69 classified provisions from this legislation.
Duties 6
Offences and penalties 12
- s.5 Prohibition of activities without consent etc.
- Schedule 5 Powers of inspection, entry, search and seizure
- s.8 Restriction of activities in relation to donated material
- s.25 Breach of licence requirement
- s.30 Possession of anatomical specimens away from licensed premises
- s.31 Possession of former anatomical specimens away from licensed premises
- s.32A Offences under section 32 committed outside UK
- s.32 Prohibition of commercial dealings in human material for transplantation
- s.33 Restriction on transplants involving a live donor
- s.34 Information about transplant operations
- s.45 Non-consensual analysis of DNA
- s.49 Offences by bodies corporate
Powers 14
- s.1 Authorisation of activities for scheduled purposes
- Schedule 2 The human tissue authority
- s.4 Nominated representatives
- s.7 Powers to dispense with need for consent
- s.10 Existing anatomical specimens
- s.14 Remit
- s.24 Changes of licence circumstance
- s.27 Provision with respect to consent
- s.28 Effect of codes
- s.29 Approval of codes
- s.42 Power of Human Tissue Authority to assist other public authorities
- s.46 Power to give effect to EU obligations
- s.55 Financial provisions
- s.58 Transition
Definitions 15
- s.2 “Appropriate consent”: children appropriate consent
- s.3 “Appropriate consent”: adults appropriate consent excepted adult permitted material
- Schedule 4 Section 45: supplementary qualifying consent
- s.11 Coroners
- s.12 Interpretation of Part 1 excepted material
- s.13 The Human Tissue Authority
- s.17 Persons to whom licence applies
- s.21 Procedure on reconsideration reconsideration
- s.26 Preparation of codes
- s.40 Religious relics
- s.41 Interpretation of Part 2 the 2007 Regulations the 2012 Regulations anatomical specimen
- s.48 Powers of inspection, entry, search and seizure
- s.53 “Relevant material” relevant material
- s.54 General interpretation adult anatomical examination anatomical purposes
- Schedule 1 Scheduled purposes
Exemptions 10
- Schedule 3 Licences for the purposes of section 16
- s.6 Activities involving material from adults who lack capacity to consent
- s.9 Existing holdings
- s.16 Licence requirement
- s.19 Right to reconsideration of licensing decisions
- s.35 Agency arrangements and provision of services
- s.37 Directions
- s.39 Criminal justice purposes
- s.43 Preservation for transplantation
- s.52 Orders and regulations