Human Tissue and Organ Donation Act – Codes of Practice and Secondary Legislation
Overview
Views are sought from the public on the Codes of Practice and Secondary Legislation required to implement the Human Tissue and Organ Donation (HTOD) Act 2021.
Recent statistics show that around 8,000 people in the UK (including some from the Isle of Man) are waiting for a transplant. On the Island, approximately 53% of residents have registered a decision on the NHS Organ Donor Register — a confidential record of people's organ donation preferences. Source: NHS Blood and Transplant ('NHSBT').
Many people have generously chosen to donate their organs and tissue after death, but despite this, there is still a shortage of donors. Moving to an opt-out system better reflects the majority view—that most people would be willing to donate their organs and tissue unless they have stated otherwise. At the same time, the system respects the rights of those who do not wish to donate.
The UK’s Human Tissue Act sets out how human tissue is removed, stored, used, and disposed of, with consent being the fundamental principle. Different consent rules apply depending on whether the tissue is from a living or deceased person. Recognising the need for a similar legal framework, significant work has been undertaken to develop this Act.
Legislative Journey of the Act in Tynwald
- October 2017 – Tynwald granted permission for Mr Martyn Perkins MHK to introduce a Private Member’s Bill on organ donation
- March to June 2018 – A public consultation on the proposed Bill was held, gathering views on whether the Isle of Man should move to a presumed consent system. The consultation results are available on the Organ Donation (Isle of Man) Bill 2018 (opens in a new tab)
- October 2020 – The Organ Donation Bill was introduced to the House of Keys for First Reading
- 2020 and 2021 – The Bill progressed through House of Keys and Legislative Council, undergoing detailed scrutiny, amendments, and debate
- July 2021 – The Bill received Royal Assent and became the Human Tissue and Organ Donation Act 2021
The Act introduces:
- An opt-out system: Individuals are presumed to consent to organ donation unless they actively opt out
- A regulatory framework: Licensing and compliance standards for the handling, storage, and disposal of human tissue, ensuring alignment with UK ethical and safety practices.
Public Health, on behalf of the Cabinet Office, are responsible for implementing this legislation.
Read more and access Hansard Recordings on the Tynwald website (opens in a new tab).
Progress so far
Under sections 26(5) and 75 of the Act, the Cabinet Office is required to consult with NHS Blood and Transplant (NHSBT) and any other persons it considers appropriate before publishing any Codes of Practice.
Additionally, consultation with the Department of Health and Social Care (DHSC) is required before issuing any documents or directions under the Act.
Ahead of publishing this consultation, Public Health has worked extensively with representatives from:
- Department of Health and Social Care
- Manx Care
- The Constabulary
- The Courts of Justice
- Manx National Heritage
- HM Attorney General’s Chamber
- Department of Environment, Food and Agriculture
Additional engagement has taken place with NHSBT, the Human Tissue Authority, Manx Care’s Organ Donation Committee, the charity Organ Donation Isle of Man, and the Lord Bishop.
Further advice has also been sought from the Governments of England, Scotland, Jersey and Guernsey, as well as the UK’s Department of Health and Social Care.
Why your views matter
Under the Act, the Cabinet Office must publish Codes of Practice which give clear guidance on how certain activities related to human bodies, organs, and tissues should be handled. This includes:
- How anatomical exams and post-mortems are carried out
- How human organs and tissues are stored, used, and disposed of
- How families of the deceased are communicated with
- How consent is handled for organ and tissue use
- Rules for importing and exporting human remains or tissue
In addition, the Cabinet Office holds the legal authority to issue regulations and orders on human tissue use, including organ donation. These include:
- Authorisation of organ and tissue removal: defining who can remove organs or tissues from a deceased person and under what conditions
- Licensing of activities: establishing licensing requirements for anatomical examinations, post-mortems, and storage or use of human tissues
- Entry and inspection of licensed premises: inspectors can enter and inspect premises where a licence is in force, to check compliance
- Ethically approved research: the use of human tissue for medical research is permitted if it is carried out anonymously and has been ethically approved
Eight draft Codes of Practice and five pieces of Secondary Legislation, largely derived from UK legislation, are available to view or download on the 'Related' section below.
A Keeling Schedule (a colour-coded document that shows the original text with changes highlighted for easy comparison) to illustrate the amendments to the Coroners of Inquests Rules 1988, is also available as a related document for the Coroners of Inquests (Amendment) Rules 2025. These should be considered alongside the Human Tissue and Organ Donation Act 2021, which is also available to view or download on the 'Related' section below.
Views are now being sought from statutory consultees and the wider public on these draft Codes of Practice and secondary legislation, which have been developed with input from key stakeholders.
This consultation ensures compliance with legal requirements while providing an opportunity for meaningful engagement. It is proposed that the Codes of Practice and Secondary legislation will be submitted for the sitting of Tynwald Court in July 2025.
Reasonable adjustments and alternative formats
The Department is committed to equal opportunities and our aim is to make our documents easy to use and accessible to all.
We will take steps to accommodate any reasonable adjustments and provide such assistance as you may reasonably require to enable you to access or reply to this consultation.
If you would like to receive this document in another format or need assistance with accessing or replying to this consultation, please email Peter.Shimmin@gov.im or telephone +44 1624 642646.
Responding to this consultation
You can respond to this consultation online by clicking on the 'Online Survey' link below. Alternatively you can download a paper version of this consultation in the 'Related' section below and email it to Peter.Shimmin@gov.im or post it to:
Peter Shimmin, Implementation Officer
Public Health, Cabinet Office,
Cronk Coar, Noble's Hospital
Strang,
Douglas
Isle of Man,
IM4 4RJ
Give us your views
Events
-
East - Organ Donation Consultation drop-in session
From 7 Apr 2025 at 16:00 to 7 Apr 2025 at 19:00Promenade Methodist Church, Loch Promenade, Douglas.
EventBrite link to East Organ Donation Consultation drop-in session:
https://www.eventbrite.co.uk/e/east-public-consultation-on-the-human-tissue-organ-donation-act-tickets-1306663609029 -
North - Organ Donation Consultation drop-in session
From 8 Apr 2025 at 16:00 to 8 Apr 2025 at 19:00Ramsey Town Hall, Ramsey.
EventBrite link to North Organ Donation Consultation drop-in session:
https://www.eventbrite.co.uk/e/north-public-consultation-on-the-human-tissue-organ-donation-act-tickets-1306669887809 -
South - Organ Donation Consultation drop-in session
From 15 Apr 2025 at 16:00 to 15 Apr 2025 at 19:00Morton Hall, Victoria Road, Castletown.
EventBrite link to South Organ Donation Consultation drop-in session:
https://www.eventbrite.co.uk/e/south-public-consultation-on-the-human-tissue-organ-donation-act-tickets-1306676136499 -
West - Organ Donation Consultation drop-in session
From 24 Apr 2025 at 16:00 to 24 Apr 2025 at 19:00Western Wellbeing Centre, Derby Road, Peel.
EventBrite link to West Organ Donation Consultation drop-in session:
https://www.eventbrite.co.uk/e/western-public-consultation-on-the-human-tissue-organ-donation-act-tickets-1306678002079
Areas
- All Areas
Audiences
- All residents
Interests
- Legislation
- Public Health
- Health
Share
Share on Twitter Share on Facebook