Amendments Nos. 1 to 3, inclusive, 23 to 30, inclusive, 37 to 42, inclusive, and 50 and 51 are related and will be discussed together.
Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill 2022: Report and Final Stages
I move amendment No.1:
In page 7, to delete line 13 and substitute the following:
“the carrying out of post-mortem examinations in hospitals and other non-hospital settings and the regulation of such activity;”.
We are making amendments to some of the terminology in the definitions in the Bill. This is to ensure consistency of terminology and definitions across the legislation and to assist with interpretation. Most of these amendments relate to Part 2, which deals with post mortems, providing consistency of terminology across this part and ensuring that the regulations to be introduced under this legislation apply to both coronial and non-coronial post-mortem examinations that take place in hospitals, and to better align provisions with clinical best practice. This was the policy intention on publication, and opportunities to refine this further in drafting have been identified in the interim. These amendments have no material impact on the legislation and the policy intent remains the same.
Another amendment in this grouping provides for the addition of the Chief State Pathologist to the list of people the Minister may consult with before making regulations under this Part of the legislation.
Amendment agreed to.
I move amendment No. 2:
In page 12, to delete lines 31 to 33 and substitute the following:
“(iii) the seeking and obtaining of post-mortem consent in relation to any proposed post-mortem activity in respect of a relevant person in accordance with Part 3.”.
Amendment agreed to.
I move amendment No. 3:
In page 13, to delete lines 3 to 5 and substitute the following:
“(iii) seeking and obtaining of post-mortem consent in relation to any proposed post-mortem activity in respect of a relevant person in accordance with Part 3,”.
Amendment agreed to.
Amendments Nos. 4, 16, 17, 31 to 36, inclusive, 48, 49, 52, 53 and 65 are related and will be discussed together.
I move amendment No. 4:
In page 15, line 35, to delete “2005),” and substitute “2005), or”.
These are technical amendments to correct a number of errors in the text. They have no material impact on the provisions of the Bill.
I was at a conference and I have only just arrived back. Are the amendments in this group all the Minister's amendments?
Amendment agreed to.
Amendment No. 5 not moved.
Amendments Nos. 6 and 21 are related and will be discussed together.
I move amendment No. 6:
In page 24, between lines 23 and 24, to insert the following:
“Review of operation of Relevant Organ Donation Opt-Out Register
17. (1) The Minister shall, not later than 3 years after the commencement of this section,
carry out a review of the operation of the Relevant Organ Donation Opt-Out Register.
(2) In carrying out a review under subsection (1), the Minister may consult with such and
so many persons and he or she considers appropriate.”.
We are inserting a new section 17 which will provide for a review to be carried out examining the impact of the opt-out register on organ donation and transplantation in Ireland, three years after commencement of Part 2 of the Bill. This is an amendment I have added on Report Stage after a meeting with the Irish Kidney Association. I believe there are representatives of the Irish Kidney Association present and I will take the opportunity to acknowledge the extraordinary work it does. This amendment comes specifically from a meeting I had with representatives of the association recently, so we will review the operation of the opt-out register.
That is good news and as the Minister knows we had very lengthy discussions about this on Committee Stage. We asked that the Minister work with the Irish Kidney Association but also take on board the views of the Opposition. That is really positive. Obviously we support the Bill and I think this will go through fairly quickly. We have tabled a number of amendments but it is very positive that there was that discussion and that this amendment is now being tabled.
I welcome the Minister's decision in this regard. On the different opinions about opt-in and opt-out, does the Minister accept there are genuine issues there to be considered? Will all of those questions be considered in the review of the operation of the legislation? I wanted to check that with the Minister.
I thank the Deputy. I do not think anyone knows what is the right thing to do here. I know the committee discussed it at length and we discussed it on Committee Stage. I had a very useful discussion on this recently with the Irish Kidney Association as well. As we are all aware, it would like to see an opt-in as well as an opt-out register. What I am proposing to do is to stick with the opt-out register, the reason being that we want real clarity here. We will have very significant public communications on this as well so that people in the country know what we are doing and that essentially we will all now be signed up as organ donors unless somebody wants to opt out. I very much respect where the Irish Kidney Association is coming from. It has a lot of expertise in this and it is its view that it would like both. I told the Irish Kidney Association that we would stick with the current approach, which is an opt-out system. However we want to make sure we get this right, hence the review clause. As for Deputy Shortall's question, absolutely, we can look at how it has worked. We can look at whether, given several years of operation, it would be better to have an opt-in. I do not think we should ever rule out having both. We need to be very respectful of where the Irish Kidney Association is coming from, its expertise, and the lived experience of its members. We spoke about Spain, for example, which is referenced as one of the best. Spain does not have an opt-in system. Other countries do. Yes, we need to keep it under review and it will form active consideration within the review we are bringing in now.
There is an issue about the messaging of all of this. A negative spin has been put on it by some media outlets, some individuals, and some organisations. That has partly created concern and doubt in people's minds. That is where the Irish Kidney Association is coming from on this. There is probably a bit of work to be done in terms of the messaging of this and the important role families have, ultimately. While the individual may have taken the decision it is ultimately the family who will make the final decision. That message has not got across clearly in the public awareness of this. I very much welcome the Minister's decision on this and thank him.
Amendment agreed to.
I will now move to amendment No. 7 which has been discussed with amendment No. 5. No, it has not been, because amendment No. 5 was not moved.
I move amendment No. 7:
In page 24, between lines 23 and 24, to insert the following:
“Transplantation and Donation Audit
17. The Minister shall by way of regulation direct the Executive to publish an annual audit of
the activities of procurement organisations and transplantation centres which includes:
(a) The number of deaths in hospitals;
(b) The number of potential donors;
(c) The number of donors requested to donate;
(d) The number of donors assessed as being medically suitable for donation and
where donation was not feasible, identifies the reasons;
(e) The responses of families or next of kin to organ donor requests, classified by
reason;
(f) The number of organ retrievals, classified by the reason retrieval was not
feasible; and
(g) The number of transplants, classified by the reason transplantation was not
feasible.”.
My amendment relates to an audit and, again, the Irish Kidney Association are very keen that we legislate for an annual published audit. The reason for that call is that there is a sense it would improve accountability and help to ensure that dedicated funding is not diverted. It would also help to identify missed organ donation opportunities. It strikes me as being good practice. In November 2021 an available organ was not transplanted due to a lack of resources in the Mater Hospital and we all remember that. In 2022 the National Office of Clinical Audit also recommended an annual audit, stating that, "a potential donor audit is a key driver of improvement in organ donation rates". Also, out of 72 countries worldwide, Ireland ranks 28th in terms of organ donation rates. Pre-pandemic, Ireland's rate was 18 per million of population compared to Spain, for example, at 49 per million of population. The first and only potential donor audit was carried out in 2009 and I do not know why we have not had an audit since then. The discipline and regularity of an audit helps to refocus attentionon it and ensure funding is being spent in the right way. It is good practice and I hope the Minister will consider supporting the amendment.
Does Deputy Cullinane wish to speak?
No, that is okay.
I thank the Deputy. I share some of the concerns she has raised and indeed the Irish Kidney Association was also looking for this to be incorporated as an amendment. We had a good discussion on this on Committee Stage and I had a good discussion on this with the Irish Kidney Association. What I propose to do is not to bring it into the legislation as I do not think it needs to be in the legislation.
We can act on it quickly. The HSE's Organ Donation and Transplant Ireland publishes an annual report on organ donation and transplantation activity. I have asked my officials to engage with the Organ Donation and Transplant Ireland on expanding this report to include exactly the kind of information that Deputy Shortall and the advocacy groups have raised. This will include information on donation patterns, the reasons retrieval was not possible and the reasons transplantation was not possible, where appropriate - for example access to ICU, access to appropriate transportation, both for the patient, potentially, and for the organ. Separately, the National Office of Clinical Audit, NOCA, undertook a potential donor audit feasibility study which was published in March of last year. This developed into a larger potential donor audit survey which has just been published in the past few weeks. It was published in September. The report from this study will provide a much more in-depth understanding of exactly the issues we all are keen to get to the bottom of and that the Deputy has raised, for example, how the system of donation transplantation is working and where we need to see it improved. What I discussed with the Irish Kidney Association was that we would move this more robust or expansive report to an annual basis which is exactly what we are all trying to achieve here, as Deputy Shortall laid out in her contribution.
The Minister is therefore on the record as saying there will be an expanded report, including all of those elements I listed in the amendment, and a clear commitment that it will be an annual report and that we will not have to wait a number of years to find out the progress of the programme. I am taking it that is what the Minister is saying on the record and we will come back to him if there is any slippage on that.
On that basis, I am happy to withdraw that amendment.
Amendment, by leave, withdrawn.
Amendments Nos. 8 to 15, inclusive, are related and may be discussed together.
I move amendment No. 8:
In page 27, to delete lines 32 to 34 and substitute the following:
“(b) the removal of the organ for the purpose of transplantation is for therapeutic benefit and no reward has been or is to be given, and there is no other alternative therapeutic method of comparable effectiveness;”.
Amendments Nos. 8, 11 and 13 are similar and relate to the same issue. The amendments are in response to correspondence we received from a number of people who, having gone through transplants, raised concerns with us and asked us to table amendments. I will listen to the Minister's reply.
I will speak to amendments Nos. 10 and 15 in the group. I agree we have been requested to consider future-proofing the legislation by providing for the possibility of a sharing or swap scheme. I am not qualified, and I do not think any of us is, to express a view on whether that is wise. On the face of it, however, it would seem to make sense, notwithstanding that we have a relatively small, albeit growing, population, that we may get to a point where we can have a sharing or swapping scheme. The current wording would not allow for swaps as the person who donates an organ is not solely concerned with the benefit of the recipient. Section 21(1)(c) and section 23(1)(c) will still ensure that there is not financial gain. The preclusion of financial gain is contained in some of the amendments but I understand financial gain is ruled out by the legislation in any event. The Irish Kidney Association is of the view that while the population is relatively small, as I said, it would be a good idea to plan for the future and consider the possibility of having such a scheme in future without the need for primary legislation.
I thank the Deputies for the amendments. I agree with both of them on the principle that, as regards the paired arrangements, these have to be voluntary and unpaid. The legislation prohibits coercion of any living donor and does not allow for payment or for any non-financial award to be made for the donation of organs or tissues and cells.
Section 12 outlines the principles for organ, tissue and cell donation. These include that donation must be voluntary and unpaid. It actually goes further by making it an offence to seek or offer financial or non-financial rewards by advertising the need for or the availability of organs or tissues and cells. Specifically, section 12(1) provides: "Subject to subsection (3), any donation of an organ or tissues and cells from a deceased or living donor shall be voluntary and unpaid and any financial compensation or other like reward given in respect of a donation of an organ or tissues and cells shall render any consent provided null and void." The section allows for a living donor to receive expenses for loss of income and costs connected to the donation and it sets out the conditions for this. The Minister for Health has the authority to make regulations in respect of compensation under the scheme.
Further to this, sections 21(1)(c), 22(1)(c) and 23(1)(c) provide that a condition in relation to the donation of organs, tissues or cells by living adults and the donation of organs by non-directed altruistic donors is that "subject to section 12 and any regulations made under that section, the donor has not and will not receive any financial compensation or other non-financial inducements for donating". As such, I hope colleagues will agree that the legislation is robust and clear with regard to the principles of donation and the conditions around donation. While I agree with the intent of the amendments, they are robustly covered in the Bill.
In respect of Deputy Shortall's amendments Nos. 10 and 15, I examined this matter in detail to make sure that it was covered in the Bill. The clear advice I have from the officials is that the Bill captures circumstances where there are paired organ donations and, therefore, multiple recipients. Paired organ donations are an important part of the living donor programme in Ireland and there will be no change to this on foot of the Bill. The current provisions of the legislation enable the continuation of paired donation arrangements.
That is not my understanding of the Bill. I cannot dig out the reference but maybe the Minister can provide a reference to where the Bill allows for such a sharing or pairing scheme. I understand it is quite specific in referring to the intended recipient, which means there would be just one donor to the recipient rather than a potential pairing or swapping arrangement.
If the Deputy gives me a moment, I will get the relevant note.
I can assist the Minister as I see the reference now. Section 21(1)(b) states: "the removal of the organ for the purpose of transplantation is solely for the therapeutic benefit of the recipient and there is no other alternative therapeutic method of comparable effectiveness". It seems that this provision envisages only a one-to-one donation. That is my reading of the wording.
Organ Donation Transplant Ireland, ODTI, has confirmed that the paired donations, which the Deputy is seeking to protect, will be allowed and that any transplant will have a donor and recipient in the chain in this context.
That is the pairing arrangement where there is a donor and a recipient. What I am saying is that we should future-proof the legislation to allow for a swapping arrangement where there may be more than two people involved.
The advice I have is that what the Deputy is proposing is not precluded, that can continue and there is nothing in the Bill that would stop that happening.
I will not take up the time of the Dáil on this. I ask the Minister to send me a note because that is not my reading of it. It would seem to be quite explicit based on the existing wording. If there is a different interpretation, I would be interested in seeing it in writing.
I have allowed latitude on this. This is Deputy Cullinane's amendment. How stands the amendment?
I will press the amendment.
Amendment put and declared lost.
Amendment No. 9 not moved.
I move amendment No. 10:
In page 27, line 33, after “recipient” to insert “or recipients in the case of an approved State sharing scheme,”.
This amendment is quite explicit so I will press it and amendment No. 15.
Amendment put and declared lost.
I move amendment No. 11:
In page 28, to delete lines 20 to 22 and substitute the following:
“(b) the removal of the organ for the purpose of transplantation is for therapeutic benefit and no reward has been or is to be given, and there is no other alternative therapeutic method of comparable effectiveness;”.
Amendment put and declared lost.
Amendment No. 12 not moved.
I move amendment No. 13:
In page 29, to delete lines 8 to 10 and substitute the following:
“(b) the removal of the organ for the purpose of transplantation is for therapeutic benefit and no reward has been or is to be given, and there is no other alternative therapeutic method of comparable effectiveness;”.
Amendment put and declared lost.
Amendment No. 14 not moved.
I move amendment No. 15:
In page 29, line 9, after “recipient” to insert “or recipients in the case of an approved State sharing scheme,”.
Amendment put and declared lost.
I move amendment No. 16:
In page 30, line 35, to delete “section 10 and any regulations made under that section” and substitute “section 10”.
Amendment agreed to.
I move amendment No. 17:
In page 31, lines 16 and 17, to delete “Minister for Public Expenditure and Reform” and substitute “Minister for Public Expenditure, National Development Plan Delivery and Reform”.
Amendment agreed to.
Amendments Nos. 18 and 19 will be discussed together.
I move amendment No. 18:
In page 32, to delete line 4 and substitute the following:
“(e) at least 2 shall be patient advocates and, of those 2, at least one may be a donor patient advocate.”.
I am moving an amendment to section 27 so that there are two patient representatives on the independent panel for organ donation, at least one of whom may be a patient donor advocate. This doubles the number of patient advocates on the independent panel and is to ensure that there are members of the panel with personal experience of the organ donation process who can offer real insight into the subject and represent the most important people in this process. This arises from discussions with colleagues on Committee Stage. It was also a request of the Irish Kidney Association that there be a patient representative or representatives with experience on the donor or recipient side. This amendment aims to accommodate that within the Bill.
I will withdraw amendment No. 19 on the basis of the Minister's clarification.
Amendment agreed to.
Amendment No. 19 not moved.
I move amendment No. 20:
In page 35, to delete lines 34 to 38, to delete pages 36 and 37, and in page 38, to delete lines 1 to 4, and substitute the following:
“CHAPTER 50
RELEVANT ORGAN DONATION REGISTER
Relevant Organ Donation Register
31. (1) The Executive shall, as soon as practicable after the commencement of this section, establish and maintain in such form as it considers appropriate, a register to be known as the Relevant Organ Donation Register (in this Part referred to as “the Register”).
(2) The Executive shall make an entry in the Register of the details specified in subsection (3) of section 32 in respect of an adult who has registered their wishes in relation to their relevant organs in accordance with that section.
(3) Where the Executive has made an entry in the Register, it shall contact the person in respect of whom the entry has been made, in the manner specified by the Executive, to confirm the details of the entry.
(4) Only the Executive may access the information contained in the Register and the contents of the Register shall not be available to the public.
(5) The Executive shall take such steps as it considers necessary to ensure that the particulars entered in the Register are accurate.
(6) The Executive may, for the purposes of maintaining the accuracy of the Register and, where it considers it appropriate to do so, amend or delete any particulars entered in the Register.
Application to register choice in relation to being relevant organ donor
32. (1) An adult (in this section referred to as the “applicant”) may apply to the Executive to register their choice in relation to being an organ donor of their relevant organs and where they do so, the Executive shall register that choice on the Register.
(2) An application under subsection (1) shall—
(a) be in writing or online, and
(b) subject to subsection (3), be in such form and manner as is specified by the Executive.
(3) When making an application under subsection (1), an applicant shall provide the following information to the Executive:
(a) their forename, surname and any former surnames;
(b) their mother’s birth surname;
(c) their address;
(d) their sex;
(e) their nationality and date and place of birth;
(f) their personal public service number (if any) (within the meaning of section 262 of the Social Welfare Consolidation Act 2005);
(g) where known, their individual health identifier (within the meaning of the Health Identifiers Act 2014);
(h) such other information as the Executive may, from time to time, reasonably specify for the purposes of maintaining the Register.
(4) A person may apply to the Executive to—
(a) amend their information on the Register provided in accordance with subsection (3), or
(b) change their choice provided in accordance with subsection (1) and have their details amended in the Register.
(5) An application under subsection (4) shall—
(a) be in writing, and
(b) be in such form and manner as specified by the Executive.
(6) A registered decision on the Register by a person under subsection (1) shall remain on the Register for the lifetime of that person unless they change their choice in accordance with subsection (4)(b).
(7) A person shall not make—
(a) an application under subsection (1) to register any person other than themselves on the Register, or
(b) an application under subsection (4)(a) or (b) in respect of the information or choice contained on the Register relating to any person other than himself or herself, without that person’s knowledge and consent.
(8) A person who contravenes subsection (7) shall be guilty of an offence.
Application to ascertain if choice is registered on Register
33. (1) A relevant professional shall, for the purpose of determining whether or not deemed consent applies in respect of a deceased person, apply to the Executive to ascertain whether or not the deceased person has registered their choice on being an organ donor in accordance with section 32.
(2) On receipt of an application under subsection (1), the Executive shall, as soon as practicable, consult the Register and confirm whether or not the person the subject of the application has registered their choice on being an organ donor.
(3) An application under subsection (1) shall be made in such form and manner as may be specified by the Executive.
(4) Where a relevant professional has received information provided by the Executive in relation to a person in accordance with subsection (2), they may disclose such information to the designated family member—
(a) where the person the subject of the application has registered their choice in relation to organ donation on the Register in accordance with section 32 and the designated family member has enquired about potential organ donation relating to the person concerned, or
(b) where the person the subject of the application has not registered their objection to organ donation on the Register in accordance with section 32 and deemed consent applies to the proposed donation.
(5) A relevant professional shall not remove any relevant organ for the purposes of transplantation activities from a person where the person has registered their objection to organ donation on the Register in accordance with section 32 and that objection has not been withdrawn at the time of the person’s death.”
Could the Minister respond first while I find my pages?
We discussed this briefly. It concerns the opt-out versus opt-in. I think amendment No. 20 is about opt-out and opt-in. The opt-out only register makes organ donation the clear default option and signals the move toward organ donation being the norm. I agree with the Deputy's earlier contribution that we need a really robust public communications campaign. This is a fundamental change to how we deal with organ donation in this country. We all hope it will accelerate the chances of organ donation for the 600 or so people on the waiting list.
The opt-in register would not have the status of the opt-out register. We discussed this at some length. While I fully appreciate where it is coming from, we want this to be very clear and not have three different categories - opt-in, opt-out and neither. We want it to be very clear.
The success of this will depend to some extent on public communications. We must get that right so that everybody understands that we are all now organ donors. We are all opted in unless we decide to opt out. I believe this is the right approach but I want to be very cognisant and respectful of the views of people who have lived through this and advocacy groups and, therefore, this will be included very clearly in the review of the legislation. If in the future, having looked at the operation of the legislation and the scheme for a few years, the view is that an opt-in register should be included, it is not something we are not ruling out. For now, we want to proceed with a very clear change in philosophy to one where everyone essentially is an organ donor unless he or she chooses to opt out.
We discussed this at great length on Committee Stage. The discussions the Minister has had with the Irish Kidney Association and his amendment pre-empted the amendments we moved. These are very lengthy amendments that were crafted by the association. The association's main ask was for an opt-in and an opt-out and absolute certainty that if a decision had to be made, the family could take comfort from the fact that the person's expressed wishes are clearly being delivered.
We had a lengthy over and back on this. If the Minister remembers what was agreed, it was that he would meet with Opposition Deputies and members of the Oireachtas Joint Committee on Health and we would try to agree an amendment to deal with this. I accept that we have to put the foundations in, get this right and start somewhere. The Irish Kidney Association provided comparisons with other countries, including Great Britain, in terms of what has worked there.
I will not labour the point. I have already acknowledged the Minister's engagement, which has given me the comfort I need that we can review this if this needs to be reviewed. That is the most important thing. I do not want to hold this Bill up. We want this Bill passed. We all accept that what is being done here is really important. If we do need to change and review how this is done, we can come back to it in the future. On that basis, I will not press the amendment to a vote.
When the Minister explained the core of this a minute ago, he said that we must get the message across that we are all regarded as having opted in but the other part of that needs to be spelt out as well because it is the assumption of people being considered to have opted in that is of concern to some people.
The other side of the new measure is that ultimately the family of the person concerned can opt out. The final decision is theirs. We need to keep on saying that. When we talk about opting in, we should say that it is ultimately the family who decides in the end. My amendment calls for a review or report on the operation of the measure after two years. The Minister has said three years. I think two years might have been better but I am not going to stand on ceremony in that regard.
Does the Minister want to respond?
It is fine; I think we have covered it. We are all broadly in agreement. I acknowledge the very legitimate points Deputies have raised.
Amendment put and declared lost.
I move amendment No. 21:
In page 38, between lines 4 and 5, to insert the following:
“Review of the Opt-Out Register
34. The Minister shall, within two years of the passing of this Act, lay a report before both Houses of the Oireachtas reviewing the organ donation opt-out register and examining the merits of introducing a corresponding organ donation opt-in register.”.
Is an Teachta Shortall pressing the amendment?
No. I would prefer two years but I am not pressing it. I accept the Minister's amendment, which is welcome.
Amendment, by leave, withdrawn.
I move amendment No. 22:
In page 43, between lines 24 and 25, to insert the following:
“(2) By the substitution of the following regulation for Regulation 25:
“25 (1) 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 is not feasible;
(vii) Number of transplants with classification of reasons why transplantation is 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.”.”.
Amendment put and declared lost.
I move amendment No. 23:
In page 44, to delete line 1 and substitute the following:
“ “coronial post-mortem examination” means a post-mortem examination directed by or on behalf of a coroner under the Coroners Acts 1962 to 2023 in relation to a deceased person;”.
Amendment agreed to.
I move amendment No. 24:
In page 45, to delete lines 35 to 38 and substitute the following:
“38. (1) Subject to subsection (2), this Part shall apply to post-mortem activities and coronial post-mortem examinations that take place on or after the commencement of this section in a hospital (whether public or private) and a reference in this Part to a “hospital” includes a reference—
(a) to a private hospital, and
(b) to a facility (howsoever described) other than a hospital or relevant facility, within the meaning of section 2 of the Act of 1962, where post-mortem activities are carried out in accordance with this Part by service providers (within the meaning of section 2 of the Health Act 2004), pursuant to section 38 of that Act.”.
Amendment agreed to.
I move amendment No. 25:
In page 46, to delete lines 4 to 7 and substitute the following:
“(b) subject to the operation as necessary of sections 33(2B), 33(2C), 33(2D), 33(3A), 33(3B), 33(3C), 33(3D), 33F, 33G, 33H, 33I, 33J, 33K, 33L, 33M, 33N and 33O of the Act of 1962, coronial post-mortem examinations.”.
Amendment agreed to.
I move amendment No. 26:
In page 46, to delete lines 10 to 13 and substitute the following:
“39. (1) Subject to subsections (3) and (4), the Minister may make such regulations as he or she considers necessary or expedient for the management in the most respectful and appropriate manner possible of post-mortem activities and coronial post-mortem examinations that take place in a hospital.”.
Amendment agreed to.
I move amendment No. 27:
In page 46, to delete lines 16 to 27 and substitute the following:
“(a) procedures for the retention, storage, disposal or return of material removed from the body as part of the coronial or non-coronial post-mortem examination, where such action is consistent with guidelines but shall not include tissue samples held on blocks or slides, trimmings or bodily fluids removed during the examination;
(b) the arrangements to be put in place by hospitals for—
(i) the management of authorisations (within the meaning of section 2 of the Act of 1962) under section 33F of that Act,
(ii) the designation of persons or classes or persons responsible for the management of such authorisations, and
(iii) the carrying out of the authorisations received from the coroner in that regard;
(c) incidents and particulars of incidents to be notified to the Authority;
(d) prescribing the retention periods for records and samples arising from non-coronial post-mortem activities, each of which periods (other than in the case of records and samples which are toxicology samples, trimmings or bodily fluids) shall not be less than 5 years;”.
Amendment agreed to.
I move amendment No. 28:
In page 46, to delete lines 30 to 33.
Amendment agreed to.
I move amendment No. 29:
In page 46, between lines 38 and 39, to insert the following:
“(d) the Chief State Pathologist;”.
Amendment agreed to.
I move amendment No. 30:
In page 47, to delete lines 7 to 10.
Amendment agreed to.
I move amendment No. 31:
In page 52, line 4, to delete “shall be retained” and substitute “shall”.
Amendment agreed to.
I move amendment No. 32:
In page 52, line 5, to delete “with” and substitute “be retained”.
Amendment agreed to.
I move amendment No. 33:
In page 52, line 6, to delete “the medical records” and substitute “with the medical records”.
Amendment agreed to.
I move amendment No. 34:
In page 52, lines 8 and 9, to delete “be retained in accordance” and substitute “in accordance”.
Amendment agreed to.
I move amendment No. 35:
In page 52, line 12, to delete “for such period” and substitute “be retained for such period”.
Amendment agreed to.
I move amendment No. 36:
In page 54, line 28, to delete “there is a risk” and substitute “where there is a risk”.
Amendment agreed to.
I move amendment No. 37:
In page 55, to delete line 28 and substitute the following:
“51. (1) A hospital at which post-mortem activities or coronial post-mortem examinations, as the case may be, take place or will take place shall, subject to subsection (2), as soon”.
Amendment agreed to.
I move amendment No. 38:
In page 55, between lines 32 and 33, to insert the following:
“(2) A nominated person shall be an employee of the hospital concerned and shall be a suitably qualified person by reason of his or her training and experience to discharge the responsibilities of a nominated person.”.
Amendment agreed to.
I move amendment No. 39:
In page 55, line 34, to delete “activities” and substitute “activities or coronial post-mortem examinations”.
Amendment agreed to.
I move amendment No. 40:
In page 55, line 36, to delete “activities” and substitute “activities or coronial post-mortem examinations”.
Amendment agreed to.
I move amendment No. 41:
In page 56, to delete lines 6 to 9 and substitute the following:
“(3) A hospital in which post-mortem activities or coronial post-mortem examinations take place or will take place shall inform the Authority of the name and particulars of the person nominated under subsection (1).”.
Amendment agreed to.
I move amendment No. 42:
In page 56, to delete lines 14 to 16 and substitute the following:
“(5) A hospital at which post-mortem activities or coronial post-mortem examinations take place shall, notwithstanding the nomination by the hospital of a nominated person, at all times remain responsible for, and accountable to the Authority in respect of, compliance with this Part.”.
Amendment agreed to.
Amendments Nos. 43 to 47, inclusive, and 66 are related and may be discussed together, by agreement.
I move amendment No. 43:
In page 56, line 22, to delete “definition” and substitute “definitions”.
We are making several amendments to section 52, which amends the Health Act 2007. These amendments are being made to expand HIQA's role to include the monitoring of regulations for post-mortem examinations that take place in locations other than hospitals, such as the Dublin city mortuary. HIQA already has a remit within the hospitals. The purpose of these amendments is to provide parity of regulation for the management and final treatment of material retained from post-mortem examinations in line with clinical practice and updated HSE national clinical guidelines for post-mortem examination services from 2023.
We are also inserting a new section to amend the Health Act 2004. This will expand the protected disclosure provisions to include disclosures made to HIQA relating to its role in monitoring compliance with regulations under the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill 2022 and the Coroners Act 1962.
Amendment agreed to.
I move amendment No. 44:
In page 56, to delete lines 23 and 24 and substitute the following:
“ “Act of 1962” means the Coroners Act 1962;
“coronial post-mortem examination” has the same meaning as it has in section 38 of the Act of 2023;
“non-coronial post-mortem examination” has the same meaning as it has in section 38 of the Act of 2023;
“relevant facility” has the same meaning as it has in section 2 of the Act of 1962;
“relevant sections of the Act of 1962” means sections 33(2B), 33(2C), 33(2D), 33(3A), 33(3B), 33(3C), 33(3D), 33F, 33G, 33H, 33I, 33J, 33K, 33L, 33M, 33N and 33O;”.
Amendment agreed to.
I move amendment No. 45:
In page 56, to delete lines 25 to 27 and substitute the following:
“(b) in section 8(1)—
(i) in paragraph (n), to substitute “(S.I. No. 256 of 2018);” for “(S.I. No. 256 of 2018).”, and
(ii) by the insertion of the following paragraphs after paragraph (n):
“(o) to monitor compliance with Part 3 of the Act of 2023 and any regulations made under that Part;
(p) to monitor compliance with the relevant sections of the Act of 1962 and with any regulations made by the Minister for Justice under section 331 of that Act.”.”.
Amendment agreed to.
I move amendment No. 46:
In page 56, to delete lines 29 to 40, and in page 57, to delete lines 1 to 19 and substitute the following:
“ “Provision of information to Authority for purposes of monitoring compliance with Part 3 of Act of 2023 and relevant sections of Act of 1962 in accordance with subsection (1)(o) and (1)(p) of section 8
12A. (1) A hospital, within the meaning of section 38 of the Act of 2023, at which post-mortem activities or coronial post-mortem examinations take or will take place shall, as soon as practicable after the commencement of this section and in any event, not later than 3 months after such commencement, notify the Authority in writing of the following, namely:
(a) the name and particulars of the nominated person nominated in that behalf pursuant to section 52 of the Act of 2023;
(b) in the case of a hospital where post-mortem activities or coronial post-mortem examinations take place or will take place, the name and address of the hospital;
(c) in the case of a hospital where post-mortem activities or coronial post-mortem examinations take place or will take place, the details of post-mortem activities or coronial post-mortem examinations that take place or will take place on the premises.
(2) Where the hospital changes in a material way any of the matters notified under subsection (1), the hospital shall as soon as possible and, in any event, not later than 28 days after the material changes, inform the Authority in writing and provide it with details of the changes.
(3) Without prejudice to the generality of subsection (1), the Authority may require the Executive or the hospital at which the post-mortem activities or coronial post-mortem examinations take place or will take place to provide it within such reasonable period as the Authority may require with any information or statistics the Authority requires in order to determine the level of compliance by the Executive or hospital with Part 3 of the Act of 2023.
(4) Where a person receives a request under subsection (3) from the Authority, he or she shall comply with such request.”,”.
Amendment agreed to.
I move amendment No. 47:
In page 57, to delete lines 21 to 39, and in page 58, to delete lines 1 to 15 and substitute the following:
“(i) in subsection (1)(a), by the substitution of “section 8(1)(c),” for “section 8(1) (c), or”,
(ii) by the insertion, in subsection (1), of the following paragraphs after paragraph (b):
“(c) monitoring compliance with Part 3 of the Act of 2023 in accordance with section 8(1)(o), or
(d) monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act,”,
(iii) in subsection (2)(a), by the substitution of “section 8(1)(c),” for “section 8(1) (c), or”, and (iv) by the insertion, in subsection (2), of the following paragraphs after paragraph (b):
“(c) monitoring compliance with Part 3 of the Act of 2023 in accordance with section 8(1)(o), or
(d) monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act.”,
(e) in section 73—
(i) by the substitution of the following subsection for subsection (1):
“(1) If an authorised person considers it necessary or expedient for the purposes of—
(a) monitoring compliance with standards in accordance with section 8(1)(c),
(b) an investigation referred in in section 8(1)(d),
(c) monitoring compliance with Part 3 of the Act of 2023 in accordance with section 8(1)(o), or
(d) monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act,
the authorised person may enter and inspect at any time—
(i) any premises owned or controlled by the Executive, the Agency or a service provider,
(ii) any premises used or proposed to be used, for any purpose connected with the provision of services described in section 8(1) (b), or
(iii) any relevant facility.”,
(ii) by the insertion of the following after subsection (3):
“(3A) If an authorised person considers it necessary or expedient for the purposes of monitoring compliance—
(a) with Part 3 of the Act of 2023 in accordance with section 8(1)(o), or
(b) with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act in accordance with section 8(1)(p),
the authorised person, at any time, may carry out the functions conferred on the authorised person under this section and sections 75 and 76 to the extent that the functions relate to any premises referred to in subsection (1).”,
(iii) in subsection (4)—
(I) by the substitution of the following paragraph for paragraph (a):
“(a) inspect, take copies of or extracts from and remove from the premises any documents or records (including personal records) relating to the discharge of its functions by the Executive or the Agency or the discharge of the functions of the coroner in so far only as it relates to monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act, or to the services provided by a service provider or at a designated centre,”,
and
(II) in paragraph (c)(i), by the substitution of “section 8(1)(d), or monitoring compliance with Part 3 of the Act of 2023 in accordance with section 8(1)(o), or monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act” for “section 8(1)(d)”,
(iv) in subsection (5)(b)—
(I) in subparagraph (i), by the substitution of “section 8(1)(d), or monitoring compliance with Part 3 of the Act of 2023 in accordance with section 8(1)(o) or monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act,” for “section 8(1)(d)”, and
(II) in subparagraph (ii), by the substitution of “investigation or to the monitoring of compliance with regulations or,” for “investigation or,”,
and
(v) in subsection (7)—
(I) in paragraph (a), by the substitution of “section 8(1)(c),” for “section 8(1)(c), or”, and
(II) the insertion of the following paragraphs after paragraph (b):
“(c) monitoring compliance with Part 3 of the Act of 2023 in accordance with section 8(1)(o), or
(d) monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act,”,
(f) in section 75—
(i) in subsection (1)(a), by the substitution of “section 8(1)(d) or monitoring compliance with Part 3 of the Act of 2023 in accordance with section 8(1)(o) or monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act” for “section 8(1)(d)”, and
(ii) in subsection (2)(a)(i), by the substitution of “section 8(1)(d) or monitoring compliance with Part 3 of the Act of 2023 in accordance with section 8(1)(o) or monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act” for “section 8(1)(d)”,
and
(g) in section 77A(2), to substitute the following paragraph for paragraph (a):
“(a) the monitoring of compliance with standards under section 8(1)(c), compliance with Part 3 of the Act of 2023 under section 8(1)(o) and compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act,”.”.
Amendment agreed to.
I move amendment No. 48:
In page 58, line 37, to delete “within a period of 14 days from” and substitute “on and after”.
Amendment agreed to.
I move amendment No. 49:
In page 59, lines 16 and 17, to delete “district or circuit, as the case may be,” and substitute “district”.
Amendment agreed to.
I move amendment No. 50:
In page 59, line 25, to delete “activities” and substitute “activities or coronial post-mortem examinations”.
Amendment agreed to.
I move amendment No. 51:
In page 60, line 4, to delete “activities” and substitute “activities or coronial post-mortem examinations”.
Amendment agreed to.
I move amendment No. 52:
In page 61, to delete lines 14 and 15.
Amendment agreed to.
I move amendment No. 53:
In page 61, line 27, to delete “Court considers” and substitute “Court considers appropriate”.
Amendment agreed to.
Amendments Nos. 54 to 64, inclusive, are related, and may be discussed together.
I move amendment No. 54:
In page 61, between lines 29 and 30, to insert the following:
“Amendment of section 2 of Act of 1962
56. Section 2 of the Act of 1962 is amended by—
(a) the insertion of the following definitions:
“ ‘Act of 2023’ means the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2023;
‘Authority’ means the Health Information and Quality Authority;
‘designated person’ means—
(a) in relation to a hospital, the person designated in that behalf by the hospital concerned to receive and act in accordance with authorisations from family members of deceased persons under section 33F, and
(b) in relation to a relevant facility, the person designated in that behalf to receive and act in accordance with authorisations from family members of deceased persons under section 33F;
‘Executive’ means the Health Service Executive;
‘healthcare professional’ means—
(a) a registered medical practitioner,
(b) a registered nurse or registered midwife within the meaning of section 2(1) of the Nurses and Midwives Act 2011, or
(c) a member of one or more of the following designated professions within the meaning of section 3 of the Health and Social Care Professionals Act 2005, namely:
(i) medical scientist;
(ii) psychologist;
(iii) social care worker;
(iv) social worker;
(v) such other designated profession within the meaning of the said section as the Minister considers appropriate and may prescribe by regulations;
‘hospital’ has the same meaning as it has in section 38 of the Act of 2023;
‘operator’ means, in relation to a relevant facility, the person who has ultimate responsibility for the running of the relevant facility;
‘register of relevant facilities’ shall be construed in accordance with section 33J;
‘relevant facility’ means—
(a) the Dublin District Mortuary, or
(b) any other facility (howsoever described), other than a hospital, where post-mortem examinations take place in accordance with this Act and which is specified in the register of relevant facilities as being such place;
‘relevant sections’ means sections 33(2B), 33(2C), 33(2D), 33(3A), 33(3B), 33(3C), 33(3D), 33F, 33G, 33H, 33I, 33J, 33K, 33L, 33M, 33N and 33O;”,
and
(b) by the substitution of the following definition for the definition of “stillborn child”:
“ ‘stillborn child’ has the same meaning as it has in the Act of 2004;”.”.
The purpose of this group of amendments to the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill 2022 is to amend the Coroners Act 1962. It is doing this to align the relevant legislative provisions ultimately providing parity of regulation across coronial and non-coronial post-mortem examinations within hospitals and other settings. We are inserting a new section to the human tissue Bill to amend the Coroners Act to include definitions required to aid interpretation of other amendments that are being made to the Coroners Act. New definitions to be inserted into the Coroners Act 1962 include: "Act of 2023"; "designated person"; "hospital"; "operator"; "register of relevant facilities"; and "relevant facilities". The definition of a stillborn child is also being updated.
We are amending section 33 of the Coroners Act to align with section 44 of the human tissue Bill. This is to ensure that pathologists can continue to be supported by professionals such as anatomical pathology technicians or designated medical scientists in the conduct of their work. On foot of this amendment, there are a number of consequential amendments being made, including to numbering regarding what is included in the meaning of "technical or clinical assistance" and the deletion of section 33B of the Coroners Act 1962. We are further amending section 33 of the Coroners Act to clarify that coronial post-mortem examinations that take place in a hospital will be subject to regulation, under regulations to be introduced under the human tissue Bill. Meanwhile, coronial post-mortem examinations that take place in non-hospital sites will be subject to regulation under the regulations to be introduced by the Minister for Justice under the Coroners Act 1962.
In respect of the regulation of coronial post-mortem examinations, whether under the human tissue Bill or the Coroners Act 1962, we have further amended the relevant clause to expand responsibility for attained material, to ensure sufficient scope within the legislation to regulate this. We are deleting section 56(b) because we are no longer amending section 33(3) of the Coroners Act. We are further making an amendment to substitute new text in section 33 of the Coroners Act for the existing amendment under section 56(c). The purpose of this is to more clearly set out the process to be followed for engaging with a family when a coronial post-mortem examination has been directed by a coroner. This also clearly sets out the information that must be provided to the family and at what stage of the process. Under this amendment, the family will be told if material has been retained as part of the post-mortem examination as soon as is possible after the examination. The amendment also provides for arrangements to be made for the burial, cremation or return of material when retention is no longer necessary and sets out the information that must be provided to a family when determining their wishes. Under this amendment, the coroner can delegate duties to mortuary or hospital staff where appropriate. The amendment has been drafted in consideration of the updated HSE national clinical guidelines for post-mortem examination services 2023 and in consultation with the chair of the review group that drafted these new guidelines.
Finally, we are amending section 57 by substituting in new text for the previous amendments. These new provisions are required to regulate coronial post-mortem examinations in both hospital and non-hospital sites, such as the Dublin city mortuary. The provisions correspond, where appropriate, with those in the human tissue Bill for management of non-coronial post-mortem examinations, while also recognising the statutory independence and legal obligations of the coroner. The amendments set out the actions to be taken by the designated person, the facility where the post-mortem examination has been carried out to give effect to the family’s wishes for material retained from the post-mortem examination, the regulations that legally underpin activity, depending on the location of the post-mortem examination, the steps to be taken when there has been no direction from the family or other appropriate person and the steps to be followed when a designated person is not able to undertake his or her duties under the legislation. The amendments also give the Minister for Justice the powers to make regulations for the management of post-mortem examinations in non-hospital locations, and the Minister should be consulted in the drafting of these.
We support all of the amendments. This is an important part of the Bill in terms of the issues that are at the centre of it. We know that the retention of organ parts, against the wishes or knowledge of family members, has been traumatic. So too has the disposal of organ parts without the consent of the family, and in some cases without even the knowledge of the family. These are important issues and I thank the Minister for bringing this Bill forward and for dealing with these issues.
I ask the Minister to give clarity on what the following amendment means because I am assuming it deals with one of the issues I have just talked about. It is amendment No. 57, which proposes:
In page 61, to delete lines 38 to 40, and in page 62, to delete lines 1 and 2 and substitute the following:
“(2C) Where the post-mortem examination has been conducted in a hospital, any material removed from the body under a direction in subsection (1) shall be preserved, stored and recorded in accordance with regulations made in that regard by the Minister for Health under section 40 of the Act of 2023.”.
Are these future regulations that will come? Is that what is anticipated?
That is fine.
I welcome these amendments, which are extremely important. It is an area that is extremely emotive and that can be traumatic for the family of the deceased individual, particularly where that individual is a baby or young child. It is important that there is regulation in this area. Sometimes people working in this area can view human tissue as something for research purposes and can overlook the fact that this is a part of an individual who is deceased and who was a loved and valued individual. To that extent, we have not always been good at maintaining adequate respect for human tissue samples in the past. I welcome the fact that this is being addressed in this Bill.
I thank colleagues for their support on this. I fully agree that things happened in the past which should never have happened. These amendments and this legislation will put that to bed. This puts the families front and centre in what they want in terms of mandated communications with them, right through the process, not just respecting their wishes but making sure their wishes are front and centre and that they are communicated with on an ongoing basis through this. I thank Deputies for their support. They are somewhat technical amendments but they speak to something very serious.
Amendment agreed to.
I move amendment No. 55:
In page 61, between lines 32 and 33, to insert the following:
“ “(2A) A registered medical practitioner may, when carrying out a post-mortem examination in accordance with subsection (1), be assisted (whether by way of technical or clinical assistance) in carrying out such examination by an appropriately qualified healthcare professional or other person who, in the opinion of the registered medical practitioner carrying out or supervising the examination, is sufficiently qualified or has the relevant training or experience to provide such assistance.”.
Amendment agreed to.
I move amendment No. 56:
In page 61, line 33, to delete “(2A) A registered” and substitute “(2B) A registered”.
Amendment agreed to.
I move amendment No. 57:
In page 61, to delete lines 38 to 40, and in page 62, to delete lines 1 and 2 and substitute the following:
“(2C) Where the post-mortem examination has been conducted in a hospital, any material removed from the body under a direction in subsection (1) shall be preserved, stored and recorded in accordance with regulations made in that regard by the Minister for Health under section 40 of the Act of 2023.”.
Amendment agreed to.
I move amendment No. 58:
In page 62, to delete lines 3 to 8 and substitute the following:
“(2D) Where the post-mortem examination has been conducted in a relevant facility, any material removed from the body under a direction in subsection (1) shall be preserved, stored and recorded, in accordance with regulations made in that regard by the Minister under section 33I.”.”.
Amendment agreed to.
I move amendment No. 59:
In page 62, to delete lines 9 to 15.
Amendment agreed to.
I move amendment No. 60:
In page 62, line 16, to delete “following subsection” and substitute “following subsections”.
Amendment agreed to.
I move amendment No. 61:
In page 62, to delete lines 17 to 34 and substitute the following:
“ “(3A) In providing the information under subsection (3), a coroner shall notify or cause to be notified a family member of the deceased person, the subject of the information, that approval by the family member (in this Act referred to as an ‘authorisation’) will be sought in respect of the final management of certain material of the deceased person.
(3B) Subsequent to the information being provided to a family member under subsection (3), the coroner shall further notify or cause to be notified the family member concerned that certain material has been retained for the purposes of the post-mortem examination.
(3C) Where at any time following a post-mortem examination, a coroner on foot of receipt of confirmation from a registered medical practitioner directed to make that examination is satisfied that retention of material from the body of the deceased is no longer necessary, or where the provisions of section 33(4) apply, he or she shall notify or cause to be notified a family member of the deceased person of that fact.
(3D) A notification under subsection (3C) shall inform the family member, the recipient of the notification of the following, namely:
(a) that the coroner has requested the designated person in the hospital or relevant facility where the post-mortem examination took place to contact the family member;
(b) the contact details of the designated person;
(c) that the designated person will request an authorisation from the family member for the final management of certain material retained following that examination;
(d) the authorisation for final management of material shall provide for—
(i) the return of material removed from the body where such return is consistent with guidelines, but shall not include tissue samples held on slides or blocks or trimmings or bodily fluids removed during the post-mortem examination,
(ii) the disposal of the material, by the designated person in a hospital or relevant facility, or
(iii) the use, by the hospital or relevant facility, of the material to further clinical teaching, medical education or research prior to ultimate disposal.”,”.
Amendment agreed to.
I move amendment No. 62:
In page 62, to delete lines 37 to 41 and substitute the following:
“(7) In this section, ‘technical or clinical assistance’, in relation to the carrying out of a post-mortem examination, includes the removal by a person providing the assistance, of a part of a body from the deceased adult, child or foetus, the subject of the examination concerned.”.”.
Amendment agreed to.
I move amendment No. 63:
In page 62, after line 41, to insert the following:
“Amendment of section 33B of Act of 1962
57. Section 33B of the Act of 1962 is amended by the deletion of subsection (1).”.
Amendment agreed to.
I move amendment No. 64:
In page 63, to delete lines 3 to 43, to delete page 64, and in page 65, to delete lines 1 to 7 and substitute the following:
“ “Authorisation for final management of material removed from body of deceased person
33F. (1) Where—
(a) a post-mortem examination of a deceased person has taken place in a hospital or relevant facility, and
(b) the designated person in the hospital or relevant facility has been requested by or on behalf of the coroner to request an authorisation from a family member of the deceased person, the subject of the post-mortem examination, the designated person in the hospital or relevant facility where the post-mortem examination took place shall request an authorisation from the family of the deceased person, the subject of the post-mortem examination, for the final management of certain material from the body of the deceased person which was retained following that examination.
(2) The designated person shall ensure, in so far as practicable, that the authorisation shall be provided in the terms referred to in section 33(3D)(d)(i), (ii) or (iii) in respect of the final management of the material concerned.
(3) When an authorisation is received by a designated person in respect of the final management of material, he or she shall, as soon as practicable—
(a) give effect to the authorisation,
(b) notify the coroner concerned that the authorisation has been so given effect, and
(c) make this information available to the family member of the deceased should it be so requested by the family member.
(4) Where no authorisation is received by the designated person under subsection (3) or where efforts to contact family members of the deceased have not proved successful, the designated person shall inform the coroner concerned of that fact and the coroner shall be authorised to direct the final management of the material concerned by the designated person.
(5) The final management of any material, other than material referred to in section 33(3D)(d)(i), removed from the body of a deceased person shall not be made where the coroner concerned is satisfied that such material may be required for evidential purposes in a relevant legal process and has notified the designated person in that regard.
(6) The management of any material stored—
(a) in a hospital shall be carried out in accordance with regulations made in that regard by the Minister for Health under section 40 of the Act of 2023, or
(b) in any relevant facility shall be carried out in accordance with regulations made in that regard by the Minister.
Provisions to apply when no authorisation received for final management of material removed from body of deceased person
33G. In a case to which section 33F(4) applies, the coroner shall direct that the final management of the material concerned be carried out by the designated person, or such other person as appears to the coroner to be appropriate in the hospital or relevant facility, as the case may be, where the material is stored, in accordance with section 33(3D)(d)(ii) or (iii) as is appropriate in the circumstances.
Provisions to apply when designated person not available or in position to receive or to act on authorisation for final management of material removed from body of deceased person
33H. (1) Where a coroner is notified or otherwise becomes aware that a designated person is not available or not otherwise in a position to receive or act in accordance with an authorisation for the final management of material removed from the body of a deceased person, the coroner shall—
(a) seek or confirm the authorisation of the family member in respect of the final management of certain material removed from the body of the deceased person, the subject of the authorisation, and
(b) direct the final management of the material in accordance with the authorisation received.
(2) When the coroner has completed the matters referred to in subsection (1), he or she shall endeavour in so far as is practicable to make this information available to the family member of the deceased should it be so requested.
Regulations in respect of management of material retained following coronial post-mortem examinations made in relevant facilities
33I. (1) Without prejudice to the generality of section 3, the Minister may make such regulations as he or she considers necessary or expedient for the purpose of proper management in the most respectful and appropriate manner possible of material retained in the course of coronial post-mortem examinations that are made in relevant facilities.
(2) In particular, but without prejudice to the generality of subsection (1), regulations under subsection (1) may provide for any or all of the following matters:
(a) procedures for the retention, storage and management of material removed from the body as part of the coronial post-mortem examination, where such action is consistent with any guidelines made in that regard;
(b) the arrangements to be put in place to facilitate receipt of notification of authorisations under section 33F(1), including the designation of persons or classes of persons to whom such notifications shall be given and the procedures for the carrying out of authorisations received in that regard;
(c) the return of any material referred to in paragraph (a) to a family member of the deceased person other than tissue samples held on slides or blocks or trimmings or bodily fluids removed during the examination;
(d) the form of notifications under sections 33(3B), 33(3C) and 33 (3D);
(e) the form of authorisations under 33F;
(f) the form of notification of details of relevant facilities under section 33J;
(g) any additional information as the Minister considers may reasonably be required for the purposes of the register of relevant facilities;
(h) the particulars of notification of incidents to be declared to the Authority;
(i) any other matters which are necessary or expedient for the purposes of giving effect to subsection (1).
(3) Before making regulations under subsection (1), the Minister shall consult such persons as he or she considers appropriate, including all or any of the following:
(a) a representative of the Coroners Society of Ireland;
(b) a pathologist from the Royal College of Physicians of Ireland, Faculty of Pathology;
(c) the Chief State Pathologist;
(d) the Executive;
(e) the Authority;
(f) the Minister for Health.
Register of relevant facilities
33J. (1) As soon as may be after the commencement of this section, the Minister shall—
(a) request in writing each coroner who is for the time being holding office to provide the Minister in such form and manner as may be prescribed and within such period as may be prescribed details of any relevant facility where the coroner directs post-mortem examinations to be made in accordance with this Act, and
(b) establish and maintain in such form as he or she considers appropriate, a register of relevant facilities (in this Act referred to as the ‘register of relevant facilities’) to which the regulations under section 33I shall apply.
(2) Where a coroner receives a request in writing under subsection (1)(a),the coroner shall comply with that request.
(3) Notwithstanding the generality of subsection (1)(a), where, at any time, a coroner is of reasonable opinion that a facility (howsoever described) where he or she directs post-mortem examinations to be made in accordance with this Act is a relevant facility, he or she shall notify the Minister in writing of that opinion for the purpose of having that facility registered in the register of relevant facilities.
(4) The register of relevant facilities shall contain the following information, namely:
(a) the name of the relevant facility;
(b) the location of the relevant facility;
(c) the operator of the relevant facility;
(d) the chief executive officer (howsoever described) of the relevant facility;
(e) the nominated person in relation to the relevant facility;
(f) any additional information as the Minister considers may reasonably be required and as may be prescribed under section 33I.
(5) If a particular entered in the register of relevant facilities is incorrect, the coroner in respect of the relevant facility to which the particular relates shall, as soon as may be after becoming aware of its being incorrect, inform the Minister thereof accordingly.
(6) The Minister shall, at regular intervals as may be agreed between the Minister and the Authority and, in any event, when a material change is made to the register, provide a copy of the register to the Authority.
Nominated person
33K. (1) Subject to subsection (2), a relevant facility at which post-mortem examinations take place shall, as soon as practicable after the commencement of this section and, in any event, not later than 12 weeks after such commencement, nominate in writing at least one suitably qualified person for the purposes of the relevant sections (in this section referred to as a ‘nominated person’).
(2) A nominated person shall be an employee of the relevant facility concerned and shall be suitably qualified person by reason of his or her training and experience to discharge the responsibilities of a nominated person.
(3) A nominated person shall have the following responsibilities, namely:
(a) to notify, in accordance with any guidelines, the Authority of the post-mortem examinations that take place in the relevant facility in relation to which he or she is the nominated person.
(b) to ensure that an annual report of post-mortem examinations that take place in the relevant facility is compiled and submitted to the Authority;
(c) to maintain or cause to be maintained records in accordance with regulations under section 33I;
(d) without prejudice to the powers of the Authority under Part 3 of the Act of 2023 and section 8 of the Health Act 2007, to monitor compliance with the relevant sections and any regulations under section 33I and notify the Authority in writing when he or she becomes aware of any breach of a provision of those sections or regulations;
(e) to liaise with the Authority from time to time and when requested to do so by the Authority.
(4) The operator of a relevant facility at which post-mortem examinations take place shall, notwithstanding the nomination by the relevant facility of a nominated person, at all times remain responsible for, and accountable to the Authority in respect of, compliance with regulations under section 33I.
Authority to monitor compliance with relevant sections – authorised persons etc.
33L. (1) The Authority shall, pursuant to section 8(1)(p) of the Health Act 2007, monitor compliance with the relevant sections and any regulations made by the Minister under section 33I.
(2) An authorised person appointed under section 70 of the Health Act 2007 shall be deemed to be an authorised person for the purposes of this section.
(3) A relevant facility shall, as soon as practicable after the commencement of section 33K and, in any event, not later than 12 weeks after such commencement, notify the Authority in writing of the following, namely:
(a) the name and particulars of the nominated person nominated in that behalf pursuant to section 33K;
(b) the name and address of the premises at which the post-mortem examinations take place or are intended to take place;
(c) the post-mortem examinations which take place or are intended to take place on the premises.
(4) Where a relevant facility changes in a material way any of the matters notified under subsection (3), the relevant facility shall as soon as possible and, in any event, not later than 28 days after the material changes, inform the Authority in writing and provide it with details of the changes.
(5) Without prejudice to the generality of subsection (3), the Authority may require the coroner or relevant facility at which post-mortem examinations take place or will take place to provide it within such reasonable period as the Authority may require with any information or statistics the Authority requires in order to determine the level of compliance by the relevant facility with regulations under section 33I.
(6) Where a person receives a request under subsection (5) from the Authority, he or she shall comply with such request.
Compliance notices
33M. (1) Where an authorised person is of the opinion that there is non-compliance by a relevant facility with the relevant sections or any regulations made under section 33I, the authorised person may, following consultation with the Chief Executive Officer of the Authority or such other officer of the Authority so designated for that purpose, serve, or cause to be served, on the operator of the relevant facility concerned a notice (in this Act referred to as a ‘compliance notice’) in accordance with this section.
(2) A compliance notice shall be signed by the authorised person who is issuing the notice or the person referred to in subsection (1) whom he or she consulted with in relation to the notice concerned and shall—
(a) specify the requirement of the relevant sections or regulations under section 33I with which there has not been compliance,
(b) for the purposes of ensuring compliance by the relevant facility concerned, require the operator of the relevant facility by such date as is specified in the notice to do or refrain from doing such act or acts as is or are so specified in the notice, and
(c) contain information regarding the bringing of an appeal under section 33N against the notice, including information on the manner in which any such appeal shall be brought.
(3) A compliance notice shall, unless an appeal is brought under section 33N, come into operation on the expiry of 14 days from the date of service of the notice.
(4) Where a person on whom a compliance notice has been served fails to comply with the notice at any time on or after the date on which the notice comes into operation, he or she shall be guilty of an offence and shall be liable on summary conviction to a class C fine or imprisonment for a term not exceeding one year or both.
(5) Summary proceedings for an offence under subsection (4) may be brought and prosecuted by the Authority.
Appeal of compliance notice
33N. (1) The operator of a relevant facility on whom a compliance notice has been served may within 14 days of service of the compliance notice appeal to the District Court in respect of the notice or any requirement therein.
(2) Where an appeal is brought under this section, the District Court may—
(a) confirm the compliance notice, or
(b) direct the authorised person to withdraw the compliance notice concerned.
(3) Where the District Court makes an order under subsection (2)(b), the compliance notice shall cease to have effect.
(4) Where the District Court confirms a compliance notice, the notice as so confirmed, shall come into operation on the expiry of 14 days of the date of confirmation or such later date as the court may determine.
(5) The jurisdiction conferred on the District Court under this section shall be exercised by a judge of that court for the time being assigned to the district court district in which the person on whom the compliance notice is served ordinarily resides or carries on any profession, business or occupation.
Prohibition orders
33O. (1) Where an authorised person is of the opinion that—
(a) there is a serious and material non-compliance with a requirement of the relevant sections or any regulations under section 33I, and
(b) there is—
(i) a need in the public interest to immediately cease any or all of the post-mortem examinations, the subject of the opinion concerned, or
(ii) a failure to comply with a compliance notice, the authorised person may, with the approval of the Chief Executive Officer of the Authority, or another officer of the Authority designated for that purpose, serve, or arrange to have served, on the operator of the relevant facility, an order (in this Act referred to as a ‘prohibition order’) in accordance with subsection (2).
(2) A prohibition order shall be signed by the authorised person issuing it, or the person referred to in subsection (1) who approves the issuing of the prohibition order and shall—
(a) state that the authorised person is of the opinion that one or more of the grounds specified in subsection (1) for the serving of a prohibition order exists,
(b) specify the particular serious and material non-compliance, public interest need or failure, as the case may be, at issue,
(c) where relevant, identify the part or parts of the compliance notice with which there has not been compliance, and
(d) as appropriate, direct the operator of the relevant facility served with the order to cease, or arrange for the cessation of, any or all of the post-mortem activities specified in the order concerned.
(3) The approval referred to in subsection (1) or subsection (6), as the case may be, may be given orally or in writing and if given orally shall be recorded in writing as soon as practicable.
(4) A prohibition order shall take effect—
(a) where the prohibition order so declares, immediately upon receipt of the order by the person on whom it is served, or
(b) in any other case—
(i) where no appeal is taken against the prohibition order, on the expiration of the period during which such an appeal may be taken or the day specified in the prohibition order as the day on which it is to come into effect, whichever is the later, or
(ii) where an appeal is taken, on the day immediately following the day on which the prohibition order is confirmed on appeal or withdrawn or the day specified in the prohibition order as the date on which it is to come into effect, whichever is the later.
(5) The bringing of an appeal against a prohibition order which is to take effect in accordance with subsection (4)(a) shall not have the effect of suspending the operation of the prohibition order, but the appellant may apply to the District Court to have the operation of the prohibition order suspended until the appeal is disposed of and, on such application, the District Court may, if it thinks it proper to do so, direct that the operation of the prohibition order be suspended until the appeal is concluded.
(6) In the event of non-compliance or delay by the operator of a relevant facility on whom the prohibition order has been served, an authorised person shall, with the approval of the Chief Executive Officer or another officer designated for that purpose by the Authority, take whatever steps are considered necessary to ensure compliance with the direction given under this section.
(7) The operator of a relevant facility on whom a prohibition order is served who is aggrieved by a prohibition order may, within the period of 7 days beginning on the day on which the prohibition order is served on him or her, appeal against the order to a judge of the District Court in the district court district in which the prohibition order was served on him or her and, in determining the appeal, the judge may—
(a) if he or she is satisfied that in the circumstances of the case it is reasonable to do so, confirm the prohibition order, with or without modification, or
(b) where he or she is not so satisfied of the matters referred to in paragraph (a), allow the appeal and cancel the prohibition order.
(8) Where on the hearing of an appeal under this subsection a prohibition order is confirmed, notwithstanding subsection (5), the judge of the District Court by whom the appeal is heard may, on the application of the appellant, suspend the operation of the prohibition order for such period as in the circumstances of the case the judge considers appropriate.
(9) A person who appeals against a prohibition order or who applies for a direction suspending the application of the prohibition order under subsection (5) shall at the same time notify the Authority of the appeal or the application and the grounds for the appeal or the application and the Authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal or the application.
(10) The Board of the Authority shall be notified at the next available meeting of the Board of the service of a prohibition order.
(11) The Chief Executive Officer of the Authority may, for stated reasons, revoke or vary a prohibition order made in accordance with this section and the Board shall be notified at the next available meeting of the Board of any such revocation or variation and the reasons therefore.
(12) The Chief Executive Officer of the Authority shall, in the public interest make such arrangements as he or she considers necessary or appropriate to bring the matter giving rise to a prohibition order to the attention of the public.
(13) (a) Where a prohibition order has been served and activities are carried on in contravention of the prohibition order, the High Court may, on the application to it in that behalf by the Authority, by order prohibit the continuance of the activities.
(b) An application to the High Court for an order under this paragraph shall be by motion and the Court, when considering the matter, may make such interim or interlocutory order (if any) as it considers appropriate and the order by which an application under this paragraph is determined may contain such terms and conditions (if any) as to the payment of costs as the Court considers appropriate.”.”.
Amendment agreed to.
I move amendment No. 65:
In page 70, to delete lines 35 to 40, and in page 71, to delete lines 1 to 7 and substitute the following:
“(4) Upon receipt of an application for a licence under this section, the Medical Council shall—
(a) in the case of an applicant institution in respect of which more than 2 years has elapsed since an inspection was last carried out on the institution,
(b) where the applicant institution is making an application to become a licensed institution for the first time, or
(c) where the Medical Council with good reason considers it appropriate to do so,
cause an inspection to be undertaken of one or more premises which is or are identified in the application as being the premises at which anatomical examinations will be undertaken by the licensed institution if the licence is granted and prepare a written report following such inspection.”.
Amendment agreed to.
I move amendment No. 66:
In page 103, between lines 4 and 5, to insert the following:
“Amendment of Health Act 2004
100. The Health Act 2004 is amended, in section 55G, by the substitution of the following paragraph for paragraph (a):
“(a) an authorised person appointed by the Health Information and Quality Authority in accordance with section 70 of the Health Act 2007 to—
(i) monitor compliance with standards in accordance with section 8 (1)(c) of the Health Act 2007,
(ii) undertake an investigation under section 9 of the Health Act 2007,
(iii) monitor compliance, under section 8(1)(o) of the Health Act 2007, with Part 3 of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2023, or
(iv) monitor compliance, under section 8(1)(p) of the Health Act 2007, with the relevant sections (within the meaning of the Health Act 2007) of the Coroners Act 1962 and regulations made by the Minister for Justice under section 33I of that Act,”.”.
Amendment agreed to.
Bill, as amended, received for final consideration.
When is it proposed to take the Fifth Stage?
Question proposed: "That the Bill do now pass."
I thank colleagues for their contribution this evening and for the broad support across the House for this important legislation. It is legislation that has been long promised and long fought for, both by people here within the Oireachtas and obviously by patients and patient advocacy groups as well. Thanks to getting the Bill through this evening we are close to the end of the Bill and we will progress now to the Seanad in the coming weeks. This will deliver significant advantages for patients, which is ultimately what the organ donation part of this Bill is about. Already in the first nine months of this year 217 transplants have taken place from 80 deceased and 22 living donors. We know Covid had a big impact on the number of transplants going on and it is very welcome to see our numbers are going back up again. At any point in time around 600 people are on active waiting lists for an organ donation and this legislation will continue to bring those numbers down.
I thank the Irish Kidney Association and all of the representative groups - there are other fantastic groups as well - for all of the great work they do every day on behalf of patients. I know some are here in the Gallery for the debate this evening. As we discussed earlier on, I met with the Irish Kidney Association a few weeks ago and several of the amendments to the legislation have been incorporated from its requests and further to discussion on Committee Stage with colleagues.
I would like to flag some amendments which we will be bringing forward in the Seanad. The amendments will ensure alignment between this legislation and changes to the concept of capacity brought in by the commencement of sections of the Assisted Decision-Making (Capacity) (Amendment) Act 2022.
I conclude by again thanking all of those who have contributed to the development and the passage of this Bill to date. That includes a lot of healthcare professionals who have been very involved in this. It includes patient advocacy groups, legal experts, Members of the Dáil and Seanad, officials from my own Department and the Department of Justice. It is a weighty and technical piece of legislation. It is one that it is great to see that it is supported strongly around the House. I think we all agree it is going to make a big difference to organ donation, and it is also going to make a big difference to post mortems and the other aspects contained within the Bill. I thank everyone for the very considerable work that has gone into getting us where we are this evening.
I too thank the Irish Kidney Association for the support it has given all of us and for the input and advice it has given us. I hope that the Bill is strengthened because of its input. I hope that when the Bill is passed it really does make a difference on a whole range of fronts. Obviously organ donation is really important and it is coincidental that the Irish Kidney Association was actually in the audiovisual room today giving a presentation with others and healthcare professionals, including the HSE lead in this area as well, in relation to kidney disease. Organ transplants are one part of that but it is the one that we hope we can avoid for people. A lot of the discussion was on prevention, treatment and raising awareness in relation to symptoms and so on. That is an area where we have to do an awful lot more work. I obviously support that element of the Bill in regard to organ donation and the objective of what we are trying to do. I welcome the amendment that the Minister has moved in consultation with the Irish Kidney Association. I am sure we will be back debating the effectiveness of the Bill once it comes into operation. I hope we all want it to succeed.
The very sensitive issue the Minister spoke about is also a very important part of this Bill, which is the retention and disposal of organ parts, particularly of children. We know that there were a lot of problems in many parts of the country. I have met many families here in Leinster House and over Zoom when we had Covid. I know how traumatic it was for them to learn that body parts of their children who were deceased were incinerated or sent abroad in the manner that happened. The amendments that we have now made to this Bill and what we are bringing in is really welcome. A lot of work has gone into this so I commend the Minister and his officials. We have been waiting for this Bill for a long time on a whole range of fronts. I commend the Minister on the work he has done in this area.
I join with others in commending and thanking everybody involved in the production of this legislation, which is very weighty. There is no doubt about that, and a huge amount of work went into it. I also acknowledge the contribution of the Irish Kidney Association and indeed other groups and individuals that have assisted in improving the initial draft of this legislation.
I welcome the fact that we are moving to a new opt-out system and that legal certainty is being brought to it. I welcome the Minister's commitment to look at this further based on the operation of the legislation over the next three years.
The other point I would make is that we all hope that this is going to result in a substantial additional number of organs being available in order to save people's lives. That is what it is all about. That can only happen if the current supports that are available in hospitals and for the speedy transportation of organs and the availability of hospital beds, especially acute hospital beds, are adequately resourced. The law is one thing but the resources are another thing. I urge the Minister to ensure that those resources are prioritised. I thank everyone who was involved in this.
Question put and agreed to.