Engagement Hub

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.

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

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.

We asked for views in relation to the establishment of a new Marine Nature Reserve on the east coast of the Island and provided three proposals. We also asked for views on re-zoning of existing Eelgrass Conservation Zones, to ensure that vulnerable habitats were protected.

There was a high level of public support for the designation of a new Marine Nature Reserve. However concerns were raised by some stakeholders who would be directly impacted by the changes. Concerns were also raised in relation to the re-zoning of Eelgrass Conservation Zones, specifically in relation to what activities would (or would not) be subject to measures.

We have analysed the responses from the consultation, and undertaken further direct engagement with stakeholders who raised concerns with some of the proposals. We will now present options to the Wildlife Committee for their consideration. The Department aims to make a decision on this issue following consideration by the Wildlife Committee.

The purpose of the consultation was to seek views on the draft Extradition Bill.

Feedback on any aspect of the Bill and extradition policy was welcomed but, in particular, views were sought on whether the Isle of Man should comply with international obligations on extradition, whether the Island should have its own extradition legislation (old UK legislation currently applies to the Island), and whether the Attorney General, along with the Island's Courts, should be the main decision maker under Isle of Man legislation.

External Relations, which ran the consultation on behalf of the Department of Home Affairs, received 18 responses to the consultation. Two of the responses were on behalf of organisations and the rest were from individuals. Two respondents said that their responses could be published in full, six said that their responses should not be published and ten said that their responses could be published anonymously.

Of those respondents who said that their responses could be published the majority agreed that the Island should comply with international obligations on extradition, should have its own extradition legislation, and the Attorney General, along with the Island's Courts, should be the main decision maker under Isle of Man legislation.

Please see the summary of consultation responses document below for more detail.

External Relations and the Department of Home Affairs reviewed all of the comments that were received. Following consideration of those comments it was agreed that the approval for the Bill to be introduced into the House of Keys should be sought.

External Relations and the Department of Home Affairs are grateful to all of the people who took the time to provide their views.