We Asked, You Said, We Did

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.

The purpose of the consultation by the IOM CAA was to seek views on the proposed policy for ground handling at certified aerodromes in the Isle of Man.

Feedback was sought on a number of areas including definition and scope, responsibilities for ground handling service providers (GHSP) and certified aerodromes, reporting requirements, and IOM CAA oversight activity.

IOM CAA received 21 responses to the consultation. 7 responses were excluded from further analyses due to answers not being within scope of the consultation. Of the remaining 14 responses they were all broadly supportive of the policy being proposed with most responses receiving above 85% agreement.

Please see report for more detailed analysis.

IOM CAA have reviewed all comments and express are gratitude for the time taken by respondents in providing their views. CP8 has been updated based on the views expressed.

The Isle of Man Financial Services Authority invited feedback on a second consultation in respect of proposals in respect of the Insurance Regulations 2025, the Insurance (Fees and Miscellaneous) (Amendment) Regulations 2025 and the Insurance (Special Purpose Vehicle and Corporate Governance) (Amendment) Guidance Notes 2025.

The Authority received a total of 2 responses to the consultation paper which raised concerns over one particular proposal.

The Authority prepared a feedback statement, which provides a summary of the feedback submitted and responds to the questions raised (which led to the withdrawal of the proposal in respect of which concerns were expressed). The Authority has finalised the proposals which come into operation on 30 June 2025.

This consultation sought views on employment status and the rights for agency workers.

A summary of responses can be found in the documents below.

This consultation sought views on annual leave and rest breaks.

A summary of responses can be found in the documents below.

This consultation sought views on current maximum awards and qualifying periods in relation to Employment Tribunals.

A summary of responses can be found in the documents below.

This consultation sought views on the operation of the  Minimum Wage Act 2001.

A summary of responses can be found in the documents below.

This consultation in particular sought views on the operation of the Employment Agencies Act 1975.

A summary of responses can be found in the documents below.

This consultation in particular sought views on parental and caring rights including redundancy protections, Carer’s leave and neo-natal care leave.

A summary of responses can be found in the documents below.

The consultation on trade union legislation was part of a series of seven calls for views on different aspects of employment legislation. Opinions were sought on:

• Notice of industrial action
• Mandate for industrial action
• Ballot thresholds
• Industrial action in essential services
• Recognition of trade unions in the workplace

A summary of responses can be found in the documents below.

The Health and Care Services Bill will amalgamate and modernise existing primary legislation underpinning health and care services. The purpose of the consultation by the Department of Health and Social Care was to inform the public about work undertaken to date and hear your views about how to make our health and care system better.

There were 240 responses, received online and through the post. Responses were largely supportive of the work undertaken to date and can be seen below.

The Department is grateful to all those who took time to respond to the consultation. The results will be considered and used to inform the policy principles which will underpin the Health and Care Services Bill.

Next Steps

The Department continues to work on policy development for the Health and Care Services Bill. Further public consultation will be published mid-2025 with a focus on specific issues relating to delivery of health and care services. Example topics include community healthcare provision and social care assessment frameworks.

As part of the Built Environment Reform Programme ('BERP'), the Cabinet Office has proposed changes to some of the legislation that sets out what can be done without needing a planning application (Permitted Development Orders). The changes are intended to better apply a proportionate level of protection whilst not unduly preventing development, in particular small scale and routine works.

Public Consultation ran from 10 June 2024to 2 September 2024. The consultation was via the consultation hub and publicity included: E-mails to MHKs/MLCs, Government Departments, Local Authorities and the Planning User Group; Press release/social media posts; and presentations to Local Authorities and discussions with Construction IOM.

There were 58[1] responses to the survey (given Data Protection respondents were not required to provide details).

The available report is a summary of the responses and the issues they raise (appendix 1 gives overall results and appendix 2 gives detailed comments). The consultations results have informed the final iteration of the Order, which will be considered for approval by Tynwald.

The purpose of the consultation by the Isle of Man Civil Aviation Administration (IOM CAA), was to seek views on the current Mortgaging of Aircraft Order to inform our drafting of updated mortgaging of aircraft legislation and associated processes.

There were 4 responses to the consultation. The results are attached below, as a Consultation Response document.

The IOM CAA is grateful to all those who took time to respond to the consultation. The results are being considered and used to inform the development of new Mortgaging of Aircraft legislation which will be subject to further consultation in due course.

The Isle of Man Financial Services Authority ('the Authority'), issued a Call for Input seeking engagement and views on the nature, prevalence and provision of Family Office-type services being offered ‘by way of business’ in or from the Island.

The Authority received 17 responses to the Call for Input. The majority of these responses favoured a continuation of the current treatment of Family Office-type services being offered in for from the Island.

The Authority has prepared a response document, which provides a summary of the feedback submitted to the Call for Input. No change to the treatment of Family Office-type services is proposed at this current time. The Authority is currently reviewing its wider exemptions and exclusions framework, and further consideration around Family Office type activity will feed into this wider project.

Additional public and stakeholder consultation and engagement will be undertaken where necessary.

The purpose of the consultation by the Department of Home Affairs was to seek public views on policing in the Isle of Man to help shape the Constabulary's focus, priorities and where resources are directed to.

There were 324 responses to the consultation. The results are attached below, as a Summary of Responses document.

The Department is grateful to all those who took time to respond to the consultation. The results have been considered and used to inform the Policing Plan 2024-25, alongside what we heard at the Constabulary roadshows, consultation with the Chief Constable, Community Safety Partnership, reporting from the Constabulary and other research. 

The Isle of Man Financial Services Authority invited feedback on proposals to update and integrate the Insurance Regulations 2021 with simplified elements of the Insurance (Special Purpose Vehicles) Regulations 2015 and Guidance Notes for Insurance Special Purpose Vehicles into a combined single document: the Insurance Regulations 2024. The consultation also includes additional proposals relating to fast-track authorisation, regulatory sandboxing and potential restrictions on activities undertaken alongside regulated insurance activities.

The Authority received 11 responses to the consultation paper. The responses were generally supportive of the changes being proposed but queried how certain aspects might be implemented.

The Authority prepared a consultation response document, which details the feedback and responds to the questions raised.  In addition the Authority has revised its proposals and is issuing a second consultation (CP24-05).

The Isle of Man Financial Services Authority invited feedback on proposals to amend certain aspects of the insurance valuation and solvency framework, including amendments to the regulatory capital calculation.

The Authority received 10 responses to the consultation paper. The responses were supportive of the changes being proposed.

The Authority prepared a consultation response document, which provides a summary of the feedback submitted and responds to all questions raised. The Authority will now prepare the final Insurance (Fees and Solvency)(Amendment) Regulations 2024 to be laid before Tynwald.

The purpose of the consultation by the Department of Education, Sport and Culture was to seek stakeholder and public views on areas considered appropriate for update in the proposed Education (Amendment) Bill. The consultation ran for 6 weeks from 27 March to 10 May 2024

There were 509 responses to the consultation. The results can be found attached below.

The Department is grateful to all those who took time to respond to the consultation. The results will be considered and used to form the policy principles which will result in amendments to the existing Isle of Man Education legislation.