Report on the Organ and Tissue Donation (Deemed Consent) Bill
Session: Session currently unavailable
Date: 16 December 2021
Reference: NIA 130/17-22
Ordered by the Committee for Health to be published on 16 December 2021.
Report: NIA 130/17-22 Committee for Health.
The Committee for Health is a Statutory Departmental Committee established in accordance with paragraphs 8 and 9 of Strand One of the Belfast Agreement 1998 and under Assembly Standing Order 48. The Committee has a scrutiny, policy development and consultation role with respect to the Department for Health and has a role in the initiation of legislation.
The Committee has power to:
- consider and advise on Departmental budgets and annual plans in the context of the overall budget allocation;
- consider subordinate legislation and take the Committee Stage of primary legislation;
- call for persons and papers;
- initiate inquiries and make reports; and
- consider and advise on matters brought to the Committee by the Minister of Health.
The Committee has 9 members, including a Chairperson and Deputy Chairperson, and a quorum of five members. The membership of the Committee is as follows:
- Colm Gildernew MLA (Chairperson)
- Pam Cameron MLA (Deputy Chairperson)
- Paula Bradshaw MLA
- Gerry Carroll MLA
- Alan Chambers MLA
- Deborah Erskine MLA
- Órlaithí Flynn MLA
- Colin McGrath MLA
- Carál Ní Chuilín MLA
- 2004 Act: The Human Tissue Act 2004
- 2016 Act: The Health (Miscellaneous Provisions Act (Northern Ireland) 2016
- BMA: British Medical Association
- CASC: Church and Society Commission
- DHSC: Department of Health and Social Care (UK)
- DOH: Department of Health
- HSC: Health and Social Care
- ICU: Intensive Care Unit
- NHSBT: NHS Blood and Transplant
- PCC: Patient Client Council
- PHA: Public Health Agency
- SNOD: Specialist Nurse in Organ Donation
- The Bill: The Organ and Tissue Donation (Deemed Consent) Bill
1. This report sets out the Committee for Health's consideration of the Organ and Tissue Donation (Deemed Consent) Bill.
2. The Organ and Tissue Donation (Deemed Consent) Bill was introduced in the Northern Ireland Assembly on 5 July 2021 by the Minister of Health, and was referred to the Committee for Health for consideration on completion of the Second Stage of the Bill on 20 September 2021.
3. The purpose of the two-clause Bill is to amend the Human Transplantation Act 2004, to provide for a 'soft out' system of consent for organ donation. The Department advises that the policy intent of the Bill is to increase the rate of consent in the small number of cases where it is clinically possible for organ donation to proceed after a person's death.
4. The Committee received 30 written submissions to its call for evidence on the Bill. Of these, 11 submissions were received from organisations and 19 were from individuals.
5. The Committee heard the views of 6 organisations during 3 oral evidence sessions held on the Bill on 11 November 2021. In addition, the Committee heard from Department of Health officials on the principles of the Bill on 9 September 2021. Departmental officials also provided a response to issues raised by stakeholders at the Committee meeting on 25 November 2021.
6. The main issues identified in the written submissions and oral evidence related to:
- the role of the family (or qualifying person) in agreeing to the donation of a loved one's organs;
- the resource implications of the Bill, including workforce;
- exemptions to deemed consent, including children;
- the duty on the PHA and the DoH to promote transplantation and report on the effectiveness of the legislation; and
- the list of permitted organs and tissues included under deemed consent.
7. The Committee deliberated on the evidence it heard on the Bill at its meeting on 2 December, and undertook its formal clause by clause scrutiny of the Bill at the meeting on 7 December 2021.
8. The Committee agreed that it was content with the Bill as drafted.
9. At its meeting on 16 December 2021, the Committee agreed its final report on the Organ and Tissue Donation (Deemed Consent) Bill and ordered that it should be published.
1. The Organ and Tissue Donation (Deemed Consent) Bill ("the Bill") was introduced to the Northern Ireland Assembly on 5 July 2021 and was referred to the Committee for Health for consideration in accordance with Standing Order 33 (1) on completion of the Second Stage of the Bill on 20 September 2021.
2. At introduction the Minister of Health made the following statement under section 9 of the Northern Ireland Act 1998: 'In my view the Organ and Tissue Donation (Deemed Consent) Bill would be within the legislative competence of the Northern Ireland Assembly.'
3. The purpose of the two-clause Bill is to amend the Human Tissue Act 2004 concerning consent to activities done for the purpose of transplantation, and make consequential amendments about the provision of information about such consent.
4. The current law on organ donation provides that consent for activities such as organ donation must be expressly given by a decision of an individual before their death, or by decision of a person appointed by them or who is in a 'qualifying relationship' with them (as defined by the 2004 Act). This is referred to as an 'opt- in' system.
5. The Organ and Tissue Donation (Deemed Consent) Bill seeks to amend the 2004 Act, to provide that consent to organ donation will be deemed to have been given by a potential adult organ donor before their death, unless they have indicated otherwise. This is referred to as an 'opt-out' system. However, the Bill also provides that deemed consent will not apply if a person in a qualifying relationship to the deceased provides information that shows that the individual would not have consented; this is referred to as a 'soft opt-out' system.
6. In addition, the Bill seeks to amend the Health (Miscellaneous Provisions) Act (Northern Ireland) 2016, to include the impact of the Bill in the Department's existing statutory duty to report to the Assembly on its views on the effectiveness of the legislation in promoting transplantation. The Bill also includes a duty on the Department to inform the public, at least once a year, on how they can record their decisions about organ donation and transplantation.
7. Further information on the background and policy objectives of the Bill can be found in the Bill's accompanying Explanatory and Financial Memorandum5.
8. In view of the limited time remaining in this mandate, and the heavy legislative workload of the Committee, the Committee agreed at its meeting on 8 July to proceed with the call for evidence ahead of the Bill passing second stage. A public notice inviting written submissions on the Bill was placed in the Belfast Telegraph, Irish News and Newsletter. In addition, the Committee invited views from a number of key stakeholders. The Committee received 30 written submissions in response to its call for evidence. Copies of the written submissions are included at Appendix 5.
9. The Committee was briefed by Department of Health (DoH) officials on the principles of the Bill at its meeting on 9 September 2021. The Minutes of Evidence of all the other evidence sessions held with departmental officials can also be found at Appendix 4.
10. During the period covered by this report, the Committee considered the Bill and related issues at 7 meetings. The related Minutes of Proceedings are included at Appendix 3 of this report.
11. At its meeting on 7 October, the Committee agreed a motion to extend the Committee Stage of the Bill to 21 January 2022. The extension was sought to ensure that there was sufficient opportunity to take oral evidence and carry out robust scrutiny of the clauses and schedules of the Bill while also ensuring there was time for the Bill to complete its passage before the end of the mandate. The motion to extend Committee Stage was supported by the Assembly on 1 November 2021.
12. The Committee heard oral evidence from 6 of the organisations who provided written evidence. The Minutes of Evidence for these sessions are included at Appendix 4 and a list of witnesses who gave oral evidence is included at Appendix 7.
13. In addition, Committee members heard from stakeholders at a virtual engagement session hosted by the Assembly Engagement team and the Patient and Client Council (PCC) on Wednesday 15 September. A copy of the PCC report on the engagement event is included at Appendix 2.
14. The Committee would like to place on record its thanks to the organisations who responded in writing and provided oral evidence on this Bill.
15. The Committee explored the issues raised in the evidence it received with the Department both in writing and in further oral evidence sessions. Memoranda and papers from the Department, including its response to the issues raised in written submissions on the Bill are included at Appendix 1. Minutes of Evidence of all briefing sessions with the Department officials are included at Appendix 4.
16. The Committee sought advice from the Examiner of Statutory Rules in relation to the range of powers within the Bill to make subordinate legislation. The Examiner was satisfied that the delegation of legislative powers presently provided for in the Bill was not inappropriate and that the exercise of these legislative powers was, in each case, subject to an appropriate Assembly scrutiny procedure.
17. The Committee carried out informal deliberations on the Clauses of the Bill at its meeting on 2 December 2021. The Committee undertook its formal clause by clause scrutiny of the Bill on 7 December 2021.
18. At its meeting on 16 December 2021, the Committee agreed its report on the Organ and Tissue Donation (Deemed Consent) Bill and ordered that it should be published.
19. The next section of the report sets out the Committee's consideration of the provisions of the Bill.
Consideration of the Bill
20. A total of 30 written submissions were received to the Committee's call for evidence on the Bill. Eleven submissions were from organisations and 19 were from individuals. The Committee heard oral evidence from 5 of the organisations that provided written submissions.
21. In addition, Committee members heard from stakeholders at a virtual engagement session hosted by the Assembly Engagement team and the Patient and Client Council on Wednesday 15 September.
22. The majority of written submissions received from stakeholder organisations were in support of the Bill, whilst the majority of submissions received from individuals were not. This section of the report provides a summary of the key issues considered by the Committee during its consideration of the Bill.
Support for change
23. In its submission, the Public Health Agency (PHA) said that both the PHA Omnibus survey carried out in November 2020 and the Department's public consultation, are evidence of public support for the introduction of the Bill; 62% of responses to the PHA survey supported a change to an opt-out system of consent; 90% of 1,917 responses to the public consultation also indicated support. The PHA further stated that, currently, the consent rate in Northern Ireland to organ donation is 64%; this has not increased significantly for several years despite consistently high levels of support for organ donation and consistent growth in registrations on the Organ Donor Register.
Evidence from other countries
24. Wales introduced a 'soft opt-out' system in 2015, followed by England in 2020 and Scotland in 2021. The Republic of Ireland currently operates an 'opt-in' system, but a Bill to move to a 'soft opt-out' system is undergoing pre-legislative scrutiny.
25. In its submission, the PHA highlighted the change in consent rates of organ donation in Wales since the introduction of an opt-out consent system, where rates from deceased donors have increased from 58% in 2015 to 70.7% in 2020. However, other stakeholders argued that the increase in organ donation rates in Wales could not be attributed to the change in legislation alone. The Church and Society Commission (CASC) of the Church of Ireland quoted from a study on the short term impact of the change to the legislation in Wales, which concluded that:
"Policymakers should not assume that soft opt-out systems by themselves simply need more time to have a meaningful effect. Ongoing interventions to further enhance implementation and the public's understanding of organ donation are needed."6
26. A number of stakeholders, including the Belfast Health and Social Care (HSC) Trust and the PHA pointed out that the Bill will bring organ donation in Northern Ireland into line with the legislative frameworks in the other UK nations, as well as the Isle of Man, Jersey and Guernsey, and that the experience gained through in Wales, Scotland and England will be invaluable in assisting clinicians through training and education in how to implement the Bill in practice.
Role of family
27. The Bill provides that deemed consent will not apply where a person in a qualifying relationship to the deceased (partners, certain family members or a friend of long standing) provides information that would lead a reasonable person to conclude that the deceased potential organ donor would not have consented to be an organ donor.
28. The Committee raised the issue of family involvement with stakeholders during oral evidence. Stakeholders were broadly in agreement that family members should remain central to the organ donation process. NHS Blood and Transplant (NHSBT), the organisation responsible for the delivery of deceased organ donation across all of the UK, stated that family involvement is vital for the following three reasons: to check with the family for their views on whether the deceased would have wanted to donate (where no decision to opt-out has been recorded); to obtain medical and lifestyle information; and because it is the right thing to do. NHSBT provided reassurance that the religious or other beliefs of a potential donor would be taken into account; currently family members are asked whether their loved one had any faith or beliefs that should be taken in to account and offered the opportunity to speak to a faith leader or counsellor. In addition, the NHS Organ Donation Register now contains a section where people can record that they wish to have their faith or beliefs taken in to consideration during the organ donation process.
29. The Belfast Trust assured the Committee that families are considered an intricate part of the conversation around organ donation. In evidence to the Committee it stated:
'Ultimately, it is the families who will say yes or no to organ donation. The final decision will always rest with the family. We have seen and been reassured by the evidence from Wales. The fears that existed around the role of the family were the same when soft opt-out was discussed in Great Britain. We have seen evidence from Wales that, in roughly 25% of family approaches where deemed consent comes into play, families still say no, and they can say no. At the end of the day, we are dealing with a grieving family; everybody involved in the process recognises and understands that. Their role will not be diminished.
30. The Committee also asked what could be done to protect the wishes of a potential donor in circumstances where the family object. In its response, the Belfast Trust said:
'we understand why, in those extremely stressful circumstances, some families will not be able to cope with the questions surrounding organ donation. The best way to avoid that scenario is through public health education and campaigning around the need for people to sign up to the organ donor register, tell their loved ones their wishes and be adamant so that somebody else does not speak for you when you are unable to at the end of life and take that decision away from you.'
31. In its response, the Department stated that, under the proposed deemed consent system, the focus of the donor family conversation will shift: unless there is a known expression or decision to become an organ donor or not to become an organ donor, then the patient is deemed to have consented. The Department advised that the family will be encouraged by the SNOD to support this decision; further guidance and training will be in place before the new system goes live, if the Bill becomes law.
32. The Department advised that the protection of an individual's decision to become an organ donor will be achieved through this engagement with families. However, it also stated that, although the Bill permits donation where consent is deemed, it does not mandate that it must proceed (this would be a 'hard opt-out' system). The Department advised that, in circumstances where the family strongly object, absolute protection of an individual's wish to donate could only be achieved through legal challenge. The Department stated that it would not support such a challenge, as it would risk losing the support of the medical professionals who have a duty of care to the bereaved family as well as to the patient.
Human rights issues
33. A number of stakeholders in opposition to the Bill expressed the view that the organ donation should remain a gift that should be given voluntarily, and not by default. This view was shared by a number of individuals, some of whom were transplant recipients or relatives of recipients, and who were otherwise supportive of organ donation. Some individuals questioned the right of a state to take the organs of an individual by presumed consent, and see it as an erosion of their human rights and bodily autonomy. Those who expressed this view also made the point that the opt out process must be simple to access and clearly communicated to the public to facilitate those who wish to opt-out.
Exceptions to deemed consent
34. Clause 1(4) provides for exceptions to deemed consent for people who were short-term visitors or temporarily resident in Northern Ireland for less than 12 months immediately before dying (e.g. overseas workers, students) and for people who lacked the capability to fully understand the consequences of deemed consent for a significant period before dying. The BMA NI questioned if the Bill could be amended to permit those who have lived in Wales, England or Scotland for 12 months (and would be covered by deemed consent if they died in their home nation) to also be covered by deemed consent if they die in Northern Ireland.
35. In response, the Department stated that although it had considered this matter, it could not support such a provision due to practical considerations; these include the complexity of determining whether or not deemed consent would apply in a potential donor's country of residence, the lack of support in the public consultation for inclusion of non NI residents and the fact that the potential net benefit would be miniscule (as only 1% of all deaths occur in circumstances where donation would be possible).
36. The Bill does not apply to children under 18. However, the Children's Heartbeat Trust expressed the view that the Bill should apply to those over 16. Referring to the Department's consultation on the Bill, it stated:
'The Children's Heartbeat Trust notes that 47.78% of respondents to question five in the consultation either strongly agreed or agreed that the opt-out legislation should not apply to children (those under 18). This means the majority either disagreed, strongly disagreed or neither agreed or disagreed. Heartened by this and through our work with teenagers and older children, it is our firm view that at age sixteen individuals have the capabilities to develop a robust understanding of the complexities of organ donation and thus make a fully informed decision regarding their own organs. As such the legislation should apply to age 16 and over.'
37. The Donate4Dáithí Campaign highlighted that 37% of respondents to the Department's consultation agreed that children should be included in the Bill; in oral evidence to the Committee it commented that:
'we agree that it should be only adults who are considered in the Bill. In the consultation, 47% said that children should be excluded from the Bill. I
want to give some attention to the fact that 37% said that children should be included. As I said, I believe that it should be adults only. However, the fact that 37% said that opens a door for us. There may be a different question about paediatrics and organ donation.'
38. In its response, the Department stated that it was advised by the Office of Legislative Counsel that to lower the age to 16 would require changes to the Human Tissue Act 2004, and potentially raise difficulties around the respective roles of persons with parental responsibility for the young person, and the other persons in a qualifying relationship.
39. Stakeholders commented that promotional and educational activities should be extended to children, and include information on how children can be added to the organ register, if children remain exempt from deemed consent.
Resource and workforce implications
40. A number of stakeholders commented on the impact of the Bill on existing organ donation services in terms of workforce and other resources. A change from the existing opt-in to an opt-out system will require new administrative arrangements to be put in place, including a new IT system and promotional activities. Some stakeholders argued that an opt out system will be more administratively burdensome, and would need to be robust enough to withstand potential legal challenges. The Department estimates that the implementation costs of a statutory opt-out are in the region of £400-500k per year for up to 9 years; this includes public awareness, change management, IT infrastructure changes, processing additional registrations, evaluation and clinical training.
41. The Royal College of Physicians questioned if any impact assessment had been made on the cost of administration of an opt out system, and asked if the same results could be achieved by investing this cost in improvements in the existing system. NHSBT stated that, as the Bill aligns closely to the Acts in effect in Wales and England, the training and operational delivery will benefit from experience in those countries; any divergence from the English and Welsh systems may increase implementation costs as bespoke arrangements would need to be set up for Northern Ireland.
42. The aim of the Bill is to increase the number of organs available for transplantation which will require additional resources in terms of specialist staff, ICU beds, theatre capacity, and investment in new technologies to assist with organ preservation. Stakeholders emphasised that the proposed new system must be properly resourced to ensure the health service has the capacity to cope. The BMA NI highlighted that the Welsh Act places a duty on the Minister to ensure that the resources available to Local Health Boards include the specialist skills and competencies required for the purposes of the Act. In oral evidence, the Committee asked stakeholders if a similar duty should be included in the Bill; in response NHSBT commented that this was ultimately a political decision, but was hesitant about putting financial imperatives on future Ministers of Health.
43. In its response, the Department stated that it would not support the inclusion of a similar duty in the Bill. It stated that this may constrain future administrations' ability to prioritise resource allocation and service provision in accordance with need, for example, during a pandemic. It went on to comment that the introduction of a new statutory duty to implement a system of deemed consent, in addition to the Department's existing strategic commitment to implementing NHSBT's new strategy (Organ Donation and Transplantation 2030: Meeting the Need), provides sufficient rationale for the necessary funds to be prioritised within Departmental budgets, without the need for statutory ring fencing of specific funds.
44. The Committee was particularly interested in the resource implications of the Bill for the Department and the Trusts. When asked about the workforce required for the Bill, the Belfast Trust stated that it required 24/7 access to fully trained senior nurses and a consultant intensivist. The Committee wrote to the Belfast Trust to ask it for its estimation of the increase in workforce (including intensivists, specialist nurses etc.), infrastructure and other resources that would be required to fully utilise any increase in organ donation activity. The Trust responded that, as a first step, it proposed an on-call nursing service for the operating department to ensure out of hours' theatre access to support increased demand for transplant services; the Trust estimates that this will cost £60k in additional revenue to implement. The Trust also advised that work has commenced to ensure the renal transplant service keeps pace with the anticipated increased donation, such as the Clinical Leads for Utilisation pilot, and ongoing collaboration with NHSBT regarding the Organ Utilisation Programme to identify potential gaps in workforce, education, leadership and culture. The Trust further advised that the Organ Utilisation group, set up by the DHSC in Westminster with Observer status for NI representatives, will look at workforce challenges and support the Trust to maximise the use of organs donated.
45. In its response, the Department advised that four additional SNODs will be required regionally, and that costs associated with the increase in demand for specialist retrieval teams, IT infrastructure, clinical training and public awareness are included in a business case which is currently under consideration.
46. The Bill seeks to amend the Health (Miscellaneous Provisions) Act (Northern Ireland) 2016, to include the impact of the Bill in the Department's existing statutory duty to report to the Assembly on its views on the effectiveness of the legislation in promoting transplantation. The Bill also includes a duty on the Department to inform the public, at least once a year, on how they can record their decisions about organ donation and transplantation.
47. In its written submission and oral evidence, the PHA outlined its plans for promotional and educational activities, including a communication strategy with two main phases. The first will run for a period of 12 months across 2022, preparing people for the fact that the law is changing. The second phase will commence in 2023, when the legislation comes into effect, and will make it clear that the law has changed.
48. The Committee asked how the communication strategy would address different cultural and ethnic backgrounds and potential language barriers in order to get the information across. In its response the PHA referred to its use of translation technologies for promotional materials, and its plans to engage with community groups and organisations to produce suitable material. The PHA assured the Committee that it will consider a range of channels for the promotional campaigns, including mainstream TV channels, social media and direct mailing.
49. The importance of the promotional and educational activities to accompany the change from an opt-in to an opt-out system was highlighted by a number of stakeholders, who referred to a study on the impact of the Welsh Act. This found that there was an increase in organ donation rates, but the authors stated that they were unable to differentiate whether the improvement in consent rate could be attributable to the legislation change alone or was associated with a number of other interventions introduced as part of opt‐out implementation, such as improved public awareness and staff training.7
50. Stakeholders also commented that promotional and educational activities should be available in schools, and that the opt-out process should be clearly explained. Some felt that it would be helpful if the organ donation process, including criteria for determining death, should be included to dispel myths around organ donation.
51. Stakeholders emphasised the need for monitoring of the Bill's effectiveness; the Royal College of Physicians commented that experience shows that move from opt in to opt-out does not necessarily increase organ donation rates.
52. In its submission, NHSBT stated that consideration should be given to the commissioning of a longitudinal study to assess the impact of the change in legislation across the healthcare system and general public. It recommended that this be conducted by an independent body to ensure impartiality. NHSBT stated that it will continue to monitor key donation metrics, including consent rate and this data would be able to support any longitudinal study.
53. The Bill provides that deemed consent will not apply in respect of all organs and tissues. Organs and tissues that are to be included within deemed consent will be set out in regulations made by the Department. In evidence, stakeholders were broadly content with this; NHSBT made the point that the list of permitted organs should include only the organs that are transplanted, and that others could be added by regulations, if technology made the use of other organs possible in the future. It also commented that deemed consent should not be used for purposes of research, as this could potentially damage public trust in the organ donation process. However, it also made the point that families who agree to organ donation and transplantation generally agree to research as well.
54. A number of stakeholders commented that promotional and educational activities should be extended to children, and should include information on how children can be added to the organ register.
55. The Department confirmed that the list of permitted organs will be included in secondary legislation to allow for the law to be responsive to advances in medical practices without the delays that would be involved in amending primary legislation.
56. The Committee asked if Brexit had any impact on the organ donation process. NHSBT responded it had seen very little impact on organ donation and transplantation as a result of Brexit, and that organs continued to be shared across Europe. The Department advised that it is working with UK colleagues to develop a Common Framework for organs, tissues and cells to facilitate ease of sharing this material in the future, but that individual Ministers would retain the right to make decisions for their own jurisdictions.
57. Having considered the written and oral evidence it received on the Bill, the Committee undertook its formal Clause-by-Clause consideration at its meeting on 7 December 2021.
58. The related Minutes of Proceedings and Minutes of Evidence of the Committee's clause by clause consideration can be found at Appendix 3 and Appendix 4 respectively.
Clause 1: "Appropriate consent" to adult transplant activities.
59. The Committee agreed that it was content with Clause 1 as drafted.
Clause 2: Short title and commencement
60. The Committee agreed that it was content with Clause 2 as drafted.
61. The Committee agreed it was content with the long title of the Bill.
You may re-use this publication (not including images or logos) free of charge in any format or medium, under the terms of the Open Northern Ireland Assembly Licence. To find out more about this licence visit: http://data.niassembly.gov.uk/license.aspx
This Report can be made available in a range of formats including large print, Braille etc. For more information, please contact:
Committee for Health
Keith McBride, Clerk
Northern Ireland Assembly
Belfast BT4 3XX
Telephone: 028 90 520348
 Madden S, Collett D, Walton P et al. The effect on consent rates for deceased organ donation in Wales after the introduction of an opt-out system. Anaesthesia 2020; 75(9):1146-1152 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496553/