I do not believe I have ever done this before, but I welcome the Minister of State, Deputy Butler, back to the House after a gap of perhaps two minutes.
Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill 2022: Committee Stage
Sections 1 to 31, inclusive, agreed to.
SECTION 32
Amendments Nos. 1 to 18, inclusive, are related and may be discussed together by agreement. Is that agreed? Agreed.
Actually, we will not be moving these amendments.
Amendments Nos. 1 and 2 not moved.
Section 32 agreed to.
Amendments Nos. 3 to 12, inclusive, not moved.
Section 33 agreed to.
Amendments Nos. 13 to 18, inclusive, not moved.
Section 34 agreed to.
Sections 35 and 36 agreed to.
SECTION 37
I move amendment No. 19:
In page 43, between lines 3 and 4, to insert the following:
“(n) by the substitution of the following Regulation for Regulation 25:
“25. The HSE shall—
(a) keep a record of and publish the annual activities of procurement organisations and transplantation centres, at hospital level, including aggregated numbers of living and deceased donors and the types and quantities of organs procured and transplanted, or otherwise disposed of in accordance with European Union and national provisions on the protection of personal data and statistical confidentiality, to include:
(i) deaths in hospitals;
(ii) number of potential donors;
(iii) number of donors actually requested to donate;
(iv) number of donors assessed as being medically suitable for donation with classification of reasons why donation is not feasible;
(v) families or next of kin response to organ donor requests with classification of reasons;
(vi) number of organ retrievals with classification of reasons why retrieval was not feasible;
(vii) number of transplants with classification of reasons why transplantation was not feasible,
(b) draw up and make publicly accessible an annual report on activities referred to in paragraph (a), and
(c) establish and maintain an updated record of procurement organisations and transplantation centres.”,”.
I will speak to this amendment relatively briefly. The Irish Kidney Association has raised a number of concerns about the Bill. Having reviewed the debates in the Dáil, I was keen to get an explanation for why an amendment on annual audits would not be accepted. Transparency breeds accountability. If we cannot measure it, we cannot improve it. This is a maxim of public policy. We need high-quality data collection to ensure that donations go as smoothly as possible. Legislating for an annual published audit would improve accountability in respect of incidents such as happened in the Mater hospital in November 2021 when an available organ was not transplanted due to a lack of resources.
The “Audit of Potential Organ Donors Republic of Ireland 2009” was the first national audit of potential organ donors undertaken in Ireland. Its executive summary highlighted the need to identify and monitor the potential for organ donation in order to ensure adequate consideration was given to donation in all relevant circumstances. The audit’s overall conclusion reads:
There is no evidence of a large population of potential organ donors who are being missed by current procedures. Nevertheless the audit provides evidence of a number of areas where small improvements in our performance could cumulatively lead to a significant increase in organ donors.
We are looking for increased transparency and accountability to help improve outcomes for organ transplants.
On behalf of the Minister, Deputy Stephen Donnelly, I cannot accept this amendment. It is not necessary to include a requirement for an annual report on organ donation and transplantation activity in primary legislation. The HSE’s Organ Donation and Transplant Ireland already publishes an annual report on organ donation and transplantation activity. I have asked my officials to engage with the ODTI on expanding this report to include more information on donation patterns and why retrieval and-or transplantation was not possible, where appropriate.
Separately, the National Office of Clinical Audit undertook a potential donor audit feasibility study, which was published in March 2022. This turned into a larger potential donor audit development study, which was published in September 2023. The report from this study provides us with a more in-depth understanding of how the organ donation and transplantation system is functioning and will identify areas where improvements can be made. The Minister stated on Report Stage in the Dáil that it was his intention, subject to resources, that this audit would take place on an annual basis. I confirm his intention now and reiterate that I do not feel it is necessary to include an audit in primary legislation.
Amendment put and declared lost.
Section 37 agreed to.
Sections 38 to 109, inclusive, agreed to.
Question proposed: "That the Title be the Title to the Bill."
I welcome the Minister to the House. He wishes to inform us of amendments he will bring forward on Report Stage.
I thank the Acting Chairperson and the Senators. I give notice of a number of amendments I intend to bring forward on Report Stage. They are intended to align this Bill with changes relating to the legal framework of capacity and consent following the commencement of provisions in the Assisted Decision-Making (Capacity) (Amendment) Act 2022.
I will be introducing an amendment to include a definition of "capacity" in this Bill. The definition of "capacity" included in the 2022 Act provides for a functional assessment of capacity to be undertaken, which is the appropriate means of conducting capacity assessments in the State. It is intended that this definition of "capacity" will become the norm across the Statute Book and should, therefore, be included in this Bill.
The Bill contains a definition of a "specified family member", who, for the purposes of the Bill, is the person who may give appropriate consent in certain situations where a living adult who lacks capacity may be involved in the donation of organs, tissues or cells. The current list of specified family members is being reviewed to ensure there is consistency across the Bill and the Assisted Decision-Making Acts. If necessary, an amendment will be brought forward to ensure alignment, as appropriate.
Both this Bill and the Assisted Decision-Making Acts contain provisions governing the donation of organs by living persons lacking capacity. However, there are differences in the arrangements for dealing with such donations. It is intended to bring forward an amendment on Report Stage to align the Bill with the legislation on assisted decision-making. This will necessitate an amendment to the Bill, as drafted, and an amendment to the Assisted Decision-Making Acts, as amended. The Bill sets out the conditions that must be met and steps that must be followed before the donation of cells and tissue by living adults who lack capacity can take place. The Assisted Decision-Making Acts are silent on this matter. Consideration is being given to what extent, if any, amendments may be necessary to the Acts to ensure the provisions of this Bill can be given effect. Discussions between officials in my Department, the Department of Children, Equality, Disability, Integration and Youth and the Office of the Parliamentary Counsel are ongoing on how best to align this Bill with the Assisted Decision-Making Acts.
Question put and agreed to.
Bill reported without amendment.
When is it proposed to take Report Stage?
Next Tuesday.
Is that agreed? Agreed.
I commend the Acting Chairperson on his handling of this Bill and the preceding business in such an efficient manner. It is very much appreciated.
Thank you very much, Senator. I am always willing to let in any Members who want to say those kinds of words.
Report Stage ordered for Tuesday, 12 December 2023.
Cuireadh an Seanad ar fionraí ar 1.17 p.m. agus cuireadh tús leis arís ar 3 p.m.
Sitting suspended at 1.17 p.m. and resumed at 3 p.m.