Human Tissue and Organ Donation Act – Codes of Practice and Secondary Legislation

Closed 28 Apr 2025

Opened 31 Mar 2025

Feedback updated 9 Jun 2025

We asked

The consultation sought views on the Codes of Practice and Secondary Legislation required to implement the Human Tissue and Organ Donation Act 2021.

The purpose was to gather feedback on how various processes related to organ donation and human tissue management are handled on the Island, including the move to an opt-out system for organ donation. The consultation was focused on the following topics:

  • Knowledge, understanding and opinions on the current process of organ donation, and the planned transition to an opt-out system
     
  • Feedback on the procedures outlined in the draft Codes of Practice including:
     
    • The guiding fundamental principle of consent
    • Post-mortem examinations
    • Use of tissue for anatomical examination
    • The public display of human tissue
    • Research involving human tissue
    • Living and deceased organ donation, including for bone marrow and peripheral blood stem cells
  • The operation of a licensing system for the regulation of human tissue on the Island, including licensing standards and exceptions
     
  • How Public Health can best fulfil its duty to communicate with the public about organ donation
     
  • Comments and feedback about the proposed Secondary Legislation

The consultation ran for four weeks from 31 March 2025 to 28 April 2025. Feedback was gathered through a combination of methods:

  • Online survey hosted on the Government Consultation Hub
     
  • Public meetings: held in the north, south, east, and west of the Isle of Man, with two sessions at each location
     
  • Focus groups: with representatives from the funeral sector, medical staff in Manx Care, and individuals of different faiths.

Respondents answered a mix of closed yes/no questions and provided free-text comments.

You said

The Department received 124 submissions to this consultation, of which:

  • 121 were via the online consultation survey;
  • 2 were emailed;
  • 1 was handwritten.

When examining who responded to the consultation

  • 122 responses were from members of the public
  • 1 was from a special health authority (NHSBT)
  • 1 was from a public body (DHSC)

The responses set out in these submissions can be broadly categorised as –

  • Agreement with the Codes of Practice and Secondary Legislation
     
    • Around three quarters of respondents agreed with the proposed contents of the Codes of Practice and Secondary Legislation, answering 'Yes' to the main consultation questions
       
    • Many expressed strong support for organ donation and welcomed the move to an opt-out system
       
    • A common sentiment among these respondents was a desire for the opt-out system to be implemented quickly, ideally within six months or less
       
  • Opposition against the move to an opt out system
     
    • Around a fifth of respondents expressed concern about the transition from an opt-in to an opt-out system, preferring to retain the existing opt-in model to safeguard individual choice
       
    • A recurring theme among these responses was the belief that presumed consent infringes upon personal autonomy and freedom of choice
       
    • Concerns about trust were notable, with some respondents expressing a general lack of confidence in Government and healthcare organisations (such as Manx Care)

A detailed summary of the responses to each of the consultation questions is attached. 

Additional themes identified include:

  • Clear communication
    Many respondents highlighted the need for comprehensive public awareness campaigns to explain how the opt-out system will work, the safeguards in place, and the implications for individuals and their families

     
  • Safeguards and consent processes
    While the Codes of Practice set out detailed safeguards (particularly Code A on consent), respondents stressed that these protections must be clearly communicated, well understood, and strictly adhered to. Simplifying the consent process was a frequent suggestion

     
  • Respect for individual autonomy
    Some participants emphasized the importance of respecting individual decisions about organ and tissue donation. Concerns were raised about the risk of families overriding a deceased person's recorded wishes, with many calling for clear processes that prioritise the individual's choice

     
  • Role of families
    Others felt that family involvement is essential, particularly due to the sensitive and emotional nature of decisions following a death. There was a clear call for a balanced approach that considers both the individual's wishes and the family's circumstances

     
  • Support for oversight and licensing
    Most respondents agreed with the need for strong regulation of human tissue use, including licensing arrangements. However, there were diverse views — some strong — about activities such as public display of human remains, particularly regarding when a licence should be required

     
  • Whole body donation
    Public events and focus groups revealed considerable interest in the process of whole-body donation for medical education. Participants sought more transparency about how donations are handled, particularly regarding transfer to university hospitals and the respectful treatment of bodies

We did

Having considered the consultation feedback, and following further engagement with key stakeholders, the following matters will be addressed before implementation of the Human Tissue and Organ Donation Act:

1. Timetable for Implementation

  • The majority of respondents supported the introduction of the opt-out system within six months. In response, Public Health will aim to implement deemed consent from January 2026

2. Clear and Sensitive Communication

  • Effective communication about the opt-out system, consent process, and associated safeguards is critical
     
  • Public Health will develop a public awareness campaign that:
     
    • Clearly explains how the system will operate
       
    • Addresses ethical, religious, and cultural considerations sensitively
       
    • Emphasizes respect for individual autonomy while recognising the emotional impact on families during bereavement
  • Insights from the consultation will help shape communication methods, manage costs, and guide respectful advertising strategies

3. Safeguards and Consent

  • Feedback highlighted the importance of transparency around safeguards
     
  • Public Health will ensure that information about rights, decision-making processes, and family involvement is widely accessible and clearly explained

4. Oversight and Licensing

  • Consultation responses showed support for regulatory oversight but raised concerns about potential bureaucracy
     
  • Further work will be undertaken to refine the licensing requirements for scheduled purposes such as research and public display, balancing robust regulation with proportionality and efficiency

5. Full Body Donation

  • Public feedback identified a need for clearer information about whole body donation for medical education
     
  • Public Health will work to set clear expectations for potential donors and their families regarding the process, including how bodies are transferred, used, and treated with dignity and respect

Next Steps:

  • The feedback has been used to finalise the Codes of Practice and Secondary Legislation as they move to the next stage. Any necessary amendments have been made based on the responses received
     
  • Approval: Between May and June 2025, the final versions will be submitted to the Cabinet Office Board and the Council of Ministers for approval, and preparations will be made for Tynwald’s consideration in July 2025
     
  • Public Awareness Campaign: A comprehensive public awareness campaign will take place, aimed at helping people understand the new opt-out system and encouraging them to register their organ donation decision and share it with their next of kin
     
  • Training and Regulatory Functions: Public Health will begin its regulatory functions, including issuing licenses and ensuring compliance with the new laws. This will be supported by ongoing training for those involved, especially in Manx Care

Timeline:

  • July 2025: Final approval of the Codes and Secondary Legislation by Tynwald
     
  • 1 January 2026: Implementation of the opt-out system for organ donation
     
  • July 2026: First annual report to Tynwald, marking one year of the opt-out system in action

6. Conclusion

Communicating the Impact
The responses to this consultation will be communicated through various channels, including:

  • Web updates: on the Government website and the Consultation hub
  • Press release
  • Social media

We appreciate all who took the time to participate and share their views, and we are committed to ensuring the transparency for the process as we move forward with implementing the Human Tissue and Organ Donation Act.

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

What happens next

The responses will inform any necessary amendments before finalising the Codes of Practice and Secondary Legislation for submission to Tynwald. 

Events

  • East - Organ Donation Consultation drop-in session

    From 7 Apr 2025 at 16:00 to 7 Apr 2025 at 19:00

    Promenade 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 19:00

    Ramsey 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 19:00

    Morton 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 19:00

    Western 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