If you work with human tissue in Scotland, do not assume you need, or are covered by, a Human Tissue Authority licence. The Human Tissue (Scotland) Act 2006 regulates post-mortems, and the removal and use of a deceased person's body parts, through authorisation. A different system of licences under the Anatomy Act 1984 covers anatomical examination and public display. The HTA licenses only tissue and cells for human application. This guide helps you work out which of these applies to what you do.
What are you doing?
Which Scottish rules apply to your activity
The system that governs each activity involving human tissue in Scotland, what you need, and the penalty for getting it wrong.
| Activity | What governs it | What you need | Penalty |
|---|---|---|---|
| Hospital post-mortem examination | Human Tissue (Scotland) Act 2006, sections 26 to 38 | Valid authorisation from the adult, a nominee or the nearest relative (or, for a child, the child or a person with parental rights), and procurator fiscal consent where the fiscal may need to examine the body | On summary conviction up to 12 months, a fine up to the statutory maximum, or both; on indictment up to 3 years, a fine, or both |
| Keeping an organ from a post-mortem for audit, education, training or research | Section 28(2) of the 2006 Act | Authorisation that specifically covers that purpose | As for an unauthorised post-mortem (section 37) |
| Organ and tissue donation for transplantation | The 2006 Act as amended by the Human Tissue (Authorisation) (Scotland) Act 2019 | Express authorisation, deemed authorisation (adults resident in Scotland who did not opt out) or authorisation by a nearest relative, after the duty to inquire has been met | On summary conviction up to 12 months, a fine up to the statutory maximum, or both; on indictment up to 3 years, a fine, or both (section 16) |
| Research or teaching use of tissue removed from a deceased person | Section 3 of the 2006 Act | Authorisation for the removal and use for that purpose. No HTA licence is needed for routine research on human tissue in Scotland | As for unauthorised removal or use (section 16) |
| Keeping records on body parts (other than tissue) used for transplantation or other purposes | SSI 2006/344 under section 19 of the 2006 Act | Permanent records held for at least 6 years, and information sent to NHS Blood and Transplant | Fine up to level 3 for failing to comply; up to level 5 for false or misleading information |
| Storing or handling tissue and cells for patient treatment | Human Tissue (Quality and Safety for Human Application) Regulations 2007 | HTA licence, which applies across the UK | See the HTA |
| Anatomical examination, holding anatomical specimens or bodies, public display | Anatomy Act 1984 (as amended for Scotland) | Licence; HM Inspector of Anatomy for Scotland inspects premises and examines applicants; licensed public display needs the Scottish Ministers' licence | Fine up to level 3 on the standard scale, or up to 3 months in prison |
The Scottish rules in detail
Steps to get compliant
- Map your activities to the table above. Note which ones involve a post-mortem, the removal or keeping of organs or other parts, transplantation, research or teaching use, or anatomy.
- Decide who checks authorisation and how. Name the person who will be satisfied that an authorisation is valid before each post-mortem, each organ removal for audit, education, training or research, and each removal for transplantation. Use the prescribed forms. They must be signed, and witnessed where the Act requires it.
- Build the procurator fiscal step into your process. Before any post-mortem where the fiscal may need an examination, get consent. Verbal consent must be confirmed in writing as soon as reasonably practicable.
- Train your donation and pathology staff on the duty to inquire. Health workers must take the reasonable steps the Act sets out before a pre-death procedure or a removal, and a nearest relative cannot give authorisation if they know the adult was unwilling.
- Set up the records. Keep permanent records for body parts other than tissue, for six years (or longer for a living donor), and send the prescribed information to NHS Blood and Transplant and the health board.
- Check whether you also need an HTA or Anatomy Act licence. If you store or handle tissue and cells for patient treatment, you need an HTA licence. If you teach anatomy or display bodies or parts, you need an Anatomy Act licence.
- Brief your board. A director, manager, secretary or partner can be guilty of an offence if it was committed with their consent or connivance, or through their neglect.
If you also work in England, Wales or Northern Ireland
The Human Tissue Act 2004 and its HTA licensing system apply mainly in England, Wales and Northern Ireland, and only limited parts of it extend to Scotland. If you operate across the border, check each site under the law of the nation where it is.
Legal basis
Primary legislation and key regulations
Official guidance
Scottish Government - Deceased organ and tissue donation, authorisation requirements guidance (opens in a new tab)
Scottish Government - HM Inspector of Anatomy for Scotland annual report (opens in a new tab)
Human Tissue (Scotland) Act 2006 (opens in a new tab)
Human Tissue (Authorisation) (Scotland) Act 2019 (opens in a new tab)