Select Committee on Health díospóireacht -
Wednesday, 21 Jun 2023

Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill 2022: Committee Stage

An Cathaoirleach

Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the Houses, or an official, either by name or in such a way as to make him or her identifiable. I also remind members they may participate in this meeting via MS Teams if they are physically located in the Leinster House complex. In this regard, I ask any member participating via Teams to communicate that he or she is on the grounds of the complex prior to making his or her contribution. Should a vote be called, such members must come to the committee room to vote.

The select committee has been convened for Committee Stage of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill 2022. I welcome the Minister for Health, Deputy Donnelly, to the meeting. There are 67 amendments, most of which have been tabled by the Minister and all of which are in order. The committee will attempt to consider as much of the Bill as possible before the meeting ends, which will be no later than 12.30 p.m. I am told some members may have to leave at a certain point to contribute to a debate on a health motion.

I invite the Minister to make his opening remarks.

Minister for Health (Deputy Stephen Donnelly)

I thank the Chair and sincerely apologise to him and all members for the delay. I had a different time that I was asked to be here. That is entirely on me, so I sincerely apologise to the Chair and colleagues.

I thank the committee for the opportunity to present the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill 2022 on Committee Stage. This Bill is important and will change the culture in our health services in some important ways. I acknowledge the broad support it has received from colleagues in the House on Second Stage.

The Bill essentially has provisions on four separate but related areas. The first is organ donation and transplantation, the second is post-mortem practices and procedures, the third is anatomical examination and the fourth is public display of bodies after death. It is somewhat of a miscellaneous Bill in that way.

The Bill seeks to embed in legislation the idea that consent is the defining principle in these matters, while also introducing a statutory framework for consent to organ donation with the critical aim of making organ donation the norm when individuals pass away in circumstances where donation is possible. This is important. We will essentially be moving from an opt-in organ donation system to an opt-out one. I am happy to share with colleagues the healthcare professionals working in organ donation are doing a commendable job. In the first quarter of this year, there was more successful organ donation than in any first quarter on record and I acknowledge the huge work done by our transplant teams, as well as all the care that goes around the patients and families. I also acknowledge the civil society organisations, including the Irish Kidney Association, the Irish Heart Foundation and others, that have advocated for this measure for a long time. We have several hundred people waiting this morning, some of whom might be watching these proceedings, who are waiting for an organ transplant. This Bill is undoubtedly going to increase the supply of organs for people and, as we know, these are lifesaving operations, so it is very positive legislation and I acknowledge the broad support in the Houses for it.

The Bill also includes provisions in respect of storage, handling, transportation, disposal and return of organs, tissues or body parts. The aim is to ensure these will be undertaken with due regard to the dignity, bodily integrity, and privacy of the deceased. As colleagues will be aware, Cabinet approval for publication of the Bill was given on 29 November 2022 and the Bill was subsequently published on 20 December 2022. The Bill passed Second Stage on 24 January.

I would like to outline the position on several amendments, some of which were part of the Government decision when the Bill was approved in November of last year, that will ensure the proper functioning of the legislation in line with the policy objectives. I will outline the detail of the amendments as they arise during our scrutiny of the Bill today and will flag several amendments that I will be introducing on Report Stage.

First, I intend to amend the Coroners Act to provide for the regulation of the retention, storage use, disposal, and return of organs and tissue from deceased persons following all post-mortems in hospital settings including those directed by a coroner. This will improve communication with families and will address issues with regard to material removed and retained by providing parity of regulation for the management and final treatment of material retained for post-mortem examination in line with clinical practice and updated HSE National Clinical Guidelines for Post Mortem Examination Services 2023.

Second, I propose to introduce amendments to expand HIQA's role to include monitoring of regulations for post-mortem examinations that take place in locations other than in hospitals. This would include, for example, Dublin City Mortuary. This will be done by making several amendments to section 52, which will in turn amend the Health Act 2007. I will be making an amendment to the Health Act 2004 to expand protected disclosure provisions to HIQA to include disclosures made to the authority relating to its roles to monitor compliance with regulations under the human tissue Bill and coroners Act.

Third, I will be bringing in an amendment to reflect changes relating to the legal framework of capacity and consent brought in by the commencement of the Assisted Decision-Making (Capacity) (Amendment) Act 2022. If the Chair or members of the committee would like technical briefings ahead of Report Stage, because it is obviously a different setting and format to this, they should let me know and we can arrange either formal or informal briefings with officials.

An Cathaoirleach

I thank the Minister. I wish to inform him that there are representatives of the Irish Kidney Association here with us. I welcomed them earlier on during the meeting. I am told that as staff of the Bills Office are present, I better be on my toes this morning.

Section 1 agreed to.

SECTION 2

Deputy Stephen Donnelly

The Chair will correct me if I am wrong but in terms of groupings, I have amendment Nos. 1 to 3, inclusive, 6, 12, 13, 15, 24, 30, 39, 40, 41, 48 and 67. I will speak to them broadly now if that is okay.

I move amendment No. 1:

In page 9, between lines 5 and 6, to insert the following:

“ “coroner” has the same meaning as it has in section 2(1) of the Act of 1962;”

We are making an amendment to a number of definitions in the Bill to assist with interpretation and to align the definitions with their meanings as already defined in other Acts. They are largely technical amendments, and we will go through them. Amendment No. 1 amends section 2 to include a definition of "coroner" to assist with interpretation and to align with the Coroners Act 1962. Should I speak to all the amendments in the group?

An Cathaoirleach

Yes.

Deputy Stephen Donnelly

Amendment No. 2 amends the definition of "nurse" to include reference to the relevant section to the Nurses and Midwives Act 2011 to assist with interpretation.

Amendment No. 3 amends the definition of "pathologist" to ensure it captures trained and qualified pathologists who may not be registered in the specialist division of the register of the medical practitioners under the speciality of pathology but who have the required training and expertise to preform post-mortem examinations. Previous texts would have excluded pathologists such as, for example, forensic pathologists for whom there is not a medical speciality on the register. A pathologist means a registered medical practitioner who is qualified by virtue of their training and expertise to perform post-mortem examinations.

Amendment No. 6 amends section 23 to take account of the conditions that must be met in the context of non-directed altruistic donors for reason of clarity and to align with the policy intention that a donor will not be able to discriminate in terms of the organ they have. To be clear, altruistic donation can be directed to an individual, be it a family member or somebody known, but if it is a blind altruistic donation, what we are not allowing is to say that an organ can only be for a man or a woman, or only for an Irish person or whatever. If it is a general donation, we cannot specify different categories of people who may or may not be eligible.

Amendment No. 12 amends the definition of "stillborn child" in order that it will have the same meaning as it has in section 2 of the Civil Registration Act 2004 to ensure alignment with existing legislation.

Amendment No. 13 updates section 40(1)(c) to emphasise that consent is only for the purposes of that consent. We are also inserting a new paragraph (d) to clarify that additional consent is not needed for subsequent use of materials for the same purpose but will be needed to be obtained for any secondary use that is different from the purpose included in the original consent.

Amendment No. 15 amends section 40(1)(i) to link provision back to regulations that are to be introduced under section 39. This will set out conditions for the management and the return of material removed during post-mortem examinations.

Amendment No. 24 inserts a new subsection (2)(c) into section 41. Its purpose is to provide for a definition of "part of a body" in this part of the Bill.

Amendment No. 30 amends section 42(4), which prohibits the removal of a part of the body during a post-mortem examination other than the part of the body in respect of which consent was given. We are doing this by deleting the phrase “within the meaning of this section” and replacing it with “indicated in that behalf under section 40(2)(b) as likely to be removed”. This links it into the consent general provisions which detail the information that must be given in order for consent for a post mortem to be obtained.

Amendment No. 39 is a consequential amendment to section 43(a). It deletes the phrase "cause of death" and replacing it with "the medical cause of death". We are doing this to further differentiate between non-coronial post-mortem examinations and a post-mortem examination directed by a coroner.

Amendment No. 40 is a consequential amendment to align section 44(1)(b) with other consent provisions in the Bill. The obtaining of consent can be undertaken by a designated healthcare worker as per relevant sections in the Bill. It is for the pathologist or the doctor under the supervision of a pathologist to check that consent is in place. This will provide due diligence for the conduct of non-coronial post-mortem examination or activities.

Amendment No. 41 amends section 44(2), which relates to the assistance in conduct of post-mortem examinations, to provide further clarification on who can provide technical or clinical assistance in the conduct of a non-coronial post-mortem examination and to ensure that such assistance is provided by someone with relevant qualifications or training to provide this assistance. The purpose of this amendment 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.

Amendment No. 48 amends section 46(2) by replacing the word “adult” with the term “family member”. This is just to correct a typo in the previous version of the Bill.

Amendment No. 67 amends section 49 by inserting a new subsection (12) to provide clarification on who qualifies as a person in charge of a hospital for the purposes of this part of the Bill.

An Cathaoirleach

I thank the Minister. I imagine that a number of members will want to come in on those amendments.

Deputy David Cullinane

I thank the Minister for his opening statement. As he knows from Second Stage, I will be supporting the Bill.

I have a number of general points relevant to all of the amendments grouped here. We have to basically use this opportunity to speak about some of the issues and put it on the record on Committee Stage that we will be introducing amendments on Report Stage. If we do not do that, the amendments will not be accepted. As the Minister pointed out, he has identified and highlighted a number of areas to which he intends to return by means of further amendments on Report Stage. A number of the amendments I am speaking to are those which were submitted to this committee by the Irish Kidney Association. Some of them are very important.

Our proposed amendments relate to the inclusion of parameters for an annual audit for potential donors, inclusion of an opt in and opt out system, issues around required requests, inclusion of a donor family representative to be appointed to the independent panel and statutory responsibility for organ donor awareness and organ trafficking. These are some of the issues the Irish Kidney Association have raised with us. It asked that we would table amendments on Report Stage. It will be necessary to have a technical briefing on the Minister's amendments but my understanding is that the association may also be meeting the Minister in due course regarding its proposed amendments. It would be useful to have a technical briefing similar to previous Bills where we had that relationship between the Select Committee on Health and the Minister. If we were able to have discussions with him informally at that technical briefing on those amendments that have been proposed by the Irish Kidney Association, that could be useful as well as an indication that some of those amendments could then be brought forward.

One of the amendments the association is proposing, which is relevant to some of the amendments we are discussing, is an opt in and an opt out provision and whether that is something which the Minister would consider. Part of the problem is that in the first instance we do not have an existing register of organ donation in the State. The association says that if we were to have an opt-in and opt-out, we could use the 1.4 million people who have proactively expressed a wish to donate that is recorded on their driver's licence but that information cannot be accessed by the Department of Health. That could be used to build a register, or to build an opt in, and even with the opt out, because family consent is still important, if someone proactively expresses an interest in making a donation and when a family has to make a decision, I imagine that it would be quite traumatic and a very difficult time. If at that point the family was aware that the family member had proactively expressed an interest to donate, it might make the decision easier.

The association makes points in respect of the difference between what we are proposing, the Welsh model and the UK model. These are some of the issues we might perhaps tease out in a technical briefing, or a briefing which might also involve some of these issues.

I have two other quick points to make. One of the important Parts of this Bill, as well as organ donation, relates post mortem practices. I was talking to some of the Minister's officials outside of the room while we were waiting for the session to begin. Essentially, the Bill is the scaffolding but most of the substance of this Part will be done by way of regulation. In many ways, as a committee, we are being asked to take a leap of faith, which we will take, that the issues raised in the Madden report in 2005, the Michaela Willis report in 2007 and the Carter report in 2009 in respect of the disposal of body organs, which need to be part of those regulations, will be addressed. We raise this on Committee Stage because we may then table amendments on Report Stage. The drafting of the Bill would not prevent the sending of remains overseas for incineration nor would it require the Minister to prevent this. That needs to be examined further.

I assume that the Minister understands the sensitivities of this issue and I may also speak later to issues in pathology because that is what led to the crisis in this area and the fact that we simply did not have enough pathologists. One locum pathologist was acting outside of standard practices, which was a problem. I just wanted to flag those issues at this point to give the Minister notice that amendments may be tabled on some of those issues on Report Stage and if he is open to the suggestion of a technical briefing, and following his meeting with the Irish Kidney Association and his consideration of these amendments and of our own views, that at a technical briefing, we could come to some understanding on Report Stage. We can table the amendments but history tells us that if the Opposition tables amendments, they will not be accepted, and it is better that they come from the Minister. If he see the offer in that light, he might respond as to whether he is supportive of that proposition.

Deputy Stephen Donnelly

I am fully supportive of that. My officials are meeting the Irish Kidney Association next week to go through all of their amendments in detail. My position is that we should take on the ones we can. There will inevitably be some where there may be technical reasons we cannot, or there may be a difference of view. Some of this is a judgment call. If we take the example of opt- in versus opt out, as I understand it, the association's position is exactly as the Deputy has articulated, which is that if there is an opt in, where I have and I am sure most of us have on our driver's licence the code that says we have opted in, then it is much easier, perhaps, for the family to say "Yes" because there has been a stated preference rather than an absence of a stated preference to opt out. The officials raised with me that while that may well be true for those who are on the opt in register, for everybody else, which is a great number, would families consider that the fact that they had not actively opted in mean that they are passively opting out, in a manner of speaking and could we end up with having less donations? There is no right answer to that and these are exactly the kinds of issues we want to tease out.

We are all lined up on the policy objective which is dignity, respect, consent, transparency and then, within those parameters, that as many organs are available as possible for people who are waiting for a transplant. I will certainly arrange a committee briefing and my understanding, Chair, is that Report Stage is not scheduled in this Dáil session, so that gives us some time.

By agreement with the committee, I will ask the officials to meet the representatives of the Irish Kidney Association, and to come to a position on that and, hopefully, there will be full agreement. There may still be some places where there would be different views, but to then provide a full technical briefing to the association so that we can run through the full list of its amendments, and then the amendments I am proposing to bring forward, if that works.

Specifically, to address the issue of the disposal of organs for the Deputy, when we are talking about Cork, I express again my sympathy, as we all have, to the families involved. What happened should not have happened at all.

Two levels of protection will be in place. The legislation provides protection and the regulations will also provide protection and, therefore, we are not asking for a leap of faith from the Oireachtas for those protections to be in place. Under the Bill, family consent will be needed for any arrangements relating to burial, cremation, return or retention. What happened in Cork under the Bill could not happen again without the express consent of the families. That is the first layer of protection.

As the Deputy said, there will also be detailed regulations in place to govern some of the operations of that. Critically, the Bill itself will rule that out without consent from the family.

Deputy Bernard J. Durkan

I thank the Minister for making his opening statement and for coming before the committee this morning. I tend to agree with the previous speaker in respect of the Irish Kidney Association and its submissions. The association is coming from the position of being directly involved in the issues that can, do and will arise from time to time, and from its own experience. If the association can be accommodated, I ask that this be done. It might seem, on the face of it, a contradiction to opt in and to opt out but it actually is not. It is a double safety measure taken at the time of a particular incident where the family may be in a better position, for whatever reason, to make a judgment that will be covered and will be possible in the event of the opt in and opt out scenario. I ask that this be considered.

Stillbirths is a very emotive and very sensitive issue that has been discussed many times over the years. The parents, and, in particular, the mother, can be very concerned and traumatised by the manner in which the situation is handled afterwards. Whether the disposal of remains or parts of remains takes place is a sensitive issue with them.

I know previous legislation covers most of it but there have been, and will be, other situations that arise from time to time that can and should be dealt with at this particular time from this particular vantage point, given the experience that we have gleaned from them over the years, if their concerns are adequately represented in the Bill the Minister has mentioned before us.

Public display of bodies after death is a very sensitive issue for families and that needs to be borne in mind. By doing a little, an awful lot can be achieved to meet the concerns of families in such situations. I ask if the Minister is satisfied that the Bill in its present form is sufficient to deal with these particular issues and whether or not further consideration might be necessary.

I have to go to the House. I am sure other members have to, too. The final point I would make is that this gives an opportunity to address the issues that have caused concern over the past 20 years, some of which have been partially addressed or otherwise and some of which have not been addressed at all. My question is simply whether the Minister is satisfied that all the issues that have caused concern are adequately provided for in the Bill at present.

Deputy Stephen Donnelly

I thank the Deputy. I am satisfied with the amendments we have before us today and with the proposed amendments on Report Stage. There has been much work in the background, as he will be aware, between my Department and the Department of Justice. We have coronial post mortems and hospital or non-coronial post mortems. We wanted to make sure that it was all being governed in a similar way. The coronial post mortems do not require consent in the way hospital post mortems do. They are different from a consent perspective for all the obvious reasons. The guidelines and so on are being aligned, which is important. Some amendments needed to be made. I believe with the combination of these amendments and the Report Stage amendments that the issues are dealt with.

Deputy Neasa Hourigan

I welcome the Minister. I want to focus on a specific suggested amendment from the Irish Kidney Association. It is about the statutory responsibility for organ donor awareness. Could we have a conversation on that? Organ donation in general requires huge public trust and confidence. We exist in a climate where there is much misinformation. It speaks to the issue of managing misinformation. I am trying to get a read from the Minister and Department on who would own the process of communicating with the public and ensuring there was public trust and confidence. We have been given an example of how it was treated in the Welsh legislation, where not only was it handed to somebody as a statutory elements to be responsible for, and presumably funded in that regard, but there was also active outreach to local health boards. For us, I presume it would be CHOs or the next rung up. The outreach was about resourcing skills or competencies on the ground. What would the Department's approach to that be? It seems to me that it is one of the problems we might face once this legislation is in place.

Deputy Stephen Donnelly

I thank the Deputy. We are planning a comprehensive public awareness campaign for when the Bill is commenced or shortly before it, whatever the appropriate timing is, so that people know this is a fundamental change in our society with regard to all our consent. We are moving from an opt-in to an opt-out system. From a few perspectives, we have an obligation to let people know that is what we are doing and the default for all of us is changing. We have an obligation to let people know, on that basis, that they can opt out, that there is a register and here is how they do it. Equally, on the Deputy's point, it is really important that family members know ahead of time, particularly when they are in such an awful situation where they might have to consider this for their loved one, that we have moved to an opt-out system. It is important that they are fully aware of their rights.

Deputy Neasa Hourigan

Who will own that? Does the HSE own that?

Deputy Stephen Donnelly

Yes.

Deputy Neasa Hourigan

Is it the HSE broadly or a particular spine of the HSE?

Deputy Stephen Donnelly

The HSE broadly. The HSE does public awareness campaigns all the time.

Deputy Neasa Hourigan

So it will take that on.

Deputy Stephen Donnelly

It will take that on.

Deputy Neasa Hourigan

Will the Department consider putting it into the legislation that it is the HSE's role to engage in public education?

Deputy Stephen Donnelly

I would not rule anything out in this session. I want to engage with the Irish Kidney Association. Typically, we do not need to do that. Typically, the HSE is pretty good at public awareness campaigns. Let us consider all that went on with the Covid vaccines. That is not done on a statutory basis. There are a few layers to this. The HSE will roll out the programme. The Department needs to allocate a good chunk of funding. I also refer to the role of civil society. It will not just by the HSE. It will be bodies such as the Irish Kidney Association and other phenomenal patient representative groups, which will continue to play an important role. Also, regarding the change that it makes, I was invited to the organ donation week launch in the Mansion House recently and met some of the families involved, both those who had received organs in life-saving transplants, including a good friend of mine, and a family who lost their son, whose donations saved five people's lives here in Ireland. That kind of message is more powerful than anything the State could do. It gets the personal testimonies out from both sides about organ donation and organ recipients to say just how important this is.

One of the amendments relates to situations where consent is required, while consent is always required from the family, so that it can involve more than just the doctor. It can be the social worker, psychologist, counsellor or an appropriate person in the hospital. That is part of the awareness work too.

Deputy Neasa Hourigan

The thinking is that if there is a statutory delineation of those powers, resources and funding might follow. I notice in the Welsh legislation that there is a requirement for the minister, for the first five years, to report back to the Welsh Parliament or maybe a committee, since it is a significant change for people. Has the Department looked at this?

Deputy Stephen Donnelly

It is not typically something that we would put in legislation such as this. It is always up to any committee to ask the Minister to come in to get an update. We sometimes stitch progress reports into the legislation so the Minister reports to the Oireachtas on progress within three years, for example. I am more than open to those kinds of things. I think they are generally quite positive.

Deputy Neasa Hourigan

I refer to the issue of data if we have a register. One of the amendments is about having an audit. That will require a considerable body of data. Significant work is being done in the health service to move towards electronic records and having more access to those data. In the collation of those data, has work been done to align what is outlined in this legislation with the plans up to 2030 and beyond, as we discovered in a previous meeting? How will the electronic, online, digital nature of health data in the future operate? Is that fully encapsulated in this legislation?

Deputy Stephen Donnelly

The protections are fully enshrined in legislation. The GDPR legislation is the main Act. This will all be compliant with GDPR. As the Deputy rightly refers to, as we begin to improve the HSE's digital and e-health capabilities, the where and who may change over time, but, critically, it will all be in compliance with GDPR protections.

Deputy Neasa Hourigan

I accept the GDPR point but we have also had the Health Information Bill come through this committee. Does the Minister envisage that this legislation will need to be updated at any point to align with any electronic health record requirements?

Deputy Stephen Donnelly

Not at this point, but possibly in the future.

Deputy Neasa Hourigan

That is okay. I thank the Minister.

Deputy Róisín Shortall

I very much welcome this legislation, and as I indicated on Second Stage, I will fully support it. It can only bring huge improvements and we all hope for that, and a very significant increase in the number of organs donated and lives saved as a result. I welcome the fact the Minister said his officials will meet the Irish Kidney Association. I support the proposal to have a technical briefing for members of the committee where we might be able to tease out the six key amendments proposed by the Irish Kidney Association and the implications of those with a view, it is hoped, to having agreed amendments on Report Stage. I would very much welcome that approach by the Minister if we could do that as we have done previously in other Bills. The first amendment proposed by the Irish Kidney Association is a very important one regarding data and Deputy Hourigan referred to this already. It is particularly important because there are a number of organisations that are organ procurement organisations and then there are the various centres where transplants are carried out. The somewhat disjointed nature of the health service means data are not relayed to the centre automatically. For that reason it is very important to have an annual audit to look at all aspects of organ donation and to keep a record and keep tabs on what is actually happening and what the numbers are like relating to the various organs and so on and the parts of the country, etc. That would be very good.

I am proposing another amendment related to that and my concern is that I may not be in the room when that comes up because I have to be in the Chamber for another debate. Related to the whole issue of data is ensuring we have adequate resources and infrastructure. It is very important that there is an annual report on the adequacy of infrastructure and resources, because if what we all hope for comes to pass, there will then be a need for a significant increase both in the facilities and infrastructure for facilitating organ transplants and in the necessary staff resources. That is very important and I hope the Minister will accept that proposal.

I will leave it at that. I hope the Minister will approach this in a collegiate way, that we all get agreement at the end of this process to take the advice of those people who are experts who have been working in this field for such a long period, and that we can move forward on that basis. I thank the Minister.

Deputy Stephen Donnelly

Yes, I hope we can, absolutely. There is broad support for this. It is not a political Bill. It is just a good, proper healthcare thing to do. We will try to do this as much as we can.

Deputy Róisín Shortall

If there are good proposals for amendments, I am sure the Minister will take them on board.

Deputy Stephen Donnelly

Yes, I am very open to them. Let us let the officials and the Irish Kidney Association meet up and tease the amendments out and see where they all get to.

Deputy Róisín Shortall

That is good. I thank the Minister.

Deputy Colm Burke

I thank the Minister. This is comprehensive legislation. On the issue of communication, in particular between people in the hospital structure, between coroners, and all those involved when a person dies. one of the issues in that respect regarding the hospital structure is that the people at the coalface are junior doctors in a lot of cases. I am not sure whether there is a proper structure there about that communication system between them and those involved, say, if an inquest is required and they must consult the coroner. In dealing with this legislation, additional work will have to be done to make sure all the boxes are ticked. I am not sure about the planning of additional resources and staffing within the various areas, whether it is the coroners, the hospitals, and everyone else involved, because the feedback I get from a number of different areas is that the wrong people are being contacted when, say, an inquest is required and we are talking about the coroners being involved as well. Has the Department looked at that? The big problem in our hospitals is the constant turnover of staff because most of our hospitals are training hospitals. I am not sure whether there is a structure in every hospital to deal with the communications that will be required when it comes to this kind of issue. Will that be looked at as well, in particular the issues of staffing and staff training in this area?

Deputy Stephen Donnelly

I thank the Deputy. There are a few parts to his question. One is around the resources. Certainly within the HSE we need to ensure there are sufficient staff numbers available for the post-mortems themselves and then to engage with families. The staffing of coronial post-mortems is a matter for the Department of Justice but we are aligning the regulations to a great extent.

In terms of the engagement itself, this Bill and the regulations will make very clear what is required, and it is comprehensive. For example, when consent is being requested prior to a non-coronial post-mortem - coronial post-mortems do not require consent - a significant amount of information must be given to the person from whom the consent is being sought to enable him or her to understand what the procedure will involve, the types of organs and tissue that are likely to be removed, other information to help him or her to make a decision, the person's entitlement to further information before or after he or she gives consent, options available for burial-disposal, return of organs and return of tissue retained as part of the examination, and the length of time it is likely material will be retained. In cases where organs or tissue may be used by third parties, information relating to the proposed use will be given, and the report of the non-coronial post-mortem examination will be made available to the person. On top of that, as I referenced in this group of amendments, if there are any additional asks of those involved in the post-mortem in terms of other organs, other uses of organs, or third parties looking at them, they have to seek consent for those as well. We are tightening up in these amendments and being very clear that if consent is being given for one organ, that does not apply to any other organ, and if consent is being given for one third-party use that does not apply to any other third-party use.

Deputy Colm Burke

My point is that with the turnover of staff in hospitals, especially in the training hospitals with junior staff in, I am not sure whether they have the required backup support in many cases as regards advice on this issue. One of the issues I have seen on a few occasions is where people have contacted me who have been unhappy about the way the matter was dealt with. I wonder about the structure, especially when there is that turnover of staff, either on a six-monthly, 12-monthly, or two-year basis. Fair enough, after 12 months someone would know the process, but what if he or she was new when something occurs?

Do we need to look at that as well as regards making sure the correct information is provided and the immediate family are aware of all the options that are available.

There is one other issue I want to touch on. We now have a huge number of people of different nationalities in the country and, in many cases, they do not have immediate family here in Ireland. That is an issue that we need to start planning for as well. It is already arising. I am wondering about the checks and balances in that scenario. It is something that will be a growing problem within our health service.

Deputy Stephen Donnelly

On the Deputy's first question around oversight, I will ask the officials to come back to him with a detailed technical note.

Deputy Colm Burke

Okay.

Deputy Stephen Donnelly

Essentially, there are several layers to it. One is the Act itself, which sets out a lot of the requirements in terms of what must be conveyed and what consent covers. There is a layer of regulations on top of that. Then there are the hospital guidelines, hospital by hospital, and the appropriate oversight mechanisms there. For example, one question is, if you are a family member being asked to give consent and you are being provided with all of the correct information you should be provided with, where do you go if you are not happy for some reason? It is exactly those kinds of questions we need to ask. What is the patient or family advocacy and what oversight mechanisms are in place? I will ask the officials to revert to the Deputy on that.

I will come back to the Deputy with a note either during the meeting or afterwards on his question about what happens when there is nobody available to consent. I think that is what he is asking. I will ask the officials here to put a note together on that.

Deputy Colm Burke

I think the Minister would accept that is a problem. For instance, last year we issued 305,000 new PPS numbers to people from 202 different countries. That shows us the scale of the change that is occurring here, with people coming in from abroad. If there is a tragedy, it is about which immediate family members to contact and ensuring we have adequate structures in place to deal with that scenario.

Deputy Stephen Donnelly

We will get the section in the Bill that references that for the Deputy.

Deputy Gino Kenny

I have two quick questions. When does the Minister envisage the Bill will be enacted? I am not sure if anybody will be able to answer my second question. Where a person has opted in, and obviously the hospital has an understanding that person has given consent to donation, has there been a situation where a family member has contested that and has said they do not agree with that? Could that happen or has it happened before?

Deputy Stephen Donnelly

In terms of when the legislation will be enacted, my hope is we will have this tabled for Report and Final Stages in the Dáil in the autumn session, we will, it is hoped, bring it straight into the Seanad, and I will seek to commence it straight away. I hope to enact it this calendar year.

On the Deputy's second question, the way the Bill will work is that it is not that anyone opts in. The default now is that we have opted in. If someone has opted out, then no consent is sought and there is no organ donation. That person has stated themselves that is not something they want if they die.

Deputy Gino Kenny

How do they do that?

Deputy Stephen Donnelly

There will be a register available and there will be a full public communications campaign. At the time, people will be able to put themselves on an opt-out register and say they do not want to be organ donor.

Deputy Gino Kenny

Would that involve them carrying a card or some kind of identification on their person?

Deputy Stephen Donnelly

I will get back to the Deputy with the exact details, but essentially, if somebody opts out, no consent is sought. It does not matter what the family thinks; the person is out. If you have not opted out, you are presumed to have opted in. In that case, there is a hierarchy of family members. If it is your partner, your husband or your wife, then they are the designated family member. They are engaged with and the whole process is explained to them. All the various information laid out in the Bill is provided and they are asked for their consent. If they say "No", the organ donation does not happen. The designated family member can say "No". In the case of a child, it is both parents, if two parents are available. If there is a disagreement between the two parents, and one says "Yes" and the other says "No", the answer is "No". That is how it is set up. There is a hierarchy in terms of family members. I will get the note from the officials for the Deputy, but the default order is husband or wife, parents, brothers, sisters, etc. It is laid out. Whoever the first person is, they can say "No".

Deputy Gino Kenny

Let us say the person has no relatives whatsoever and there is a John Doe situation. What happens then?

Deputy Stephen Donnelly

I think that is exactly what Deputy Burke just asked. We are just getting the detailed answer to that.

Deputy David Cullinane

I want to make a quick point following on from that. It goes back to the point I was making earlier about having maybe an opt-in and opt-out process. It is implied we are all opting in if we have not specifically opted out. As the Minister has said, there is a hierarchy of family members who will then have to be contacted to give consent. That is the check and balance, I suppose, to avoid potential clashes in families. These are sensitive issues, as we know, and even within that hierarchy there may be others who have different opinions. The Minister raised the point earlier in response to me that we may have to strike a balance here when we are looking at what the Government is proposing versus what the Irish Kidney Association is saying. If a person does not opt in, that person dies and the family says they did not opt in, I can see that issue. The converse of that is that if a person does opt in, then under this proposed system there is not any real advantage, if you think about it. There should be an advantage. Certainly, I think it would make it easier. I know we will tease it out in the technical briefing, but the more I hear of what is being proposed and the more I think about the issue, I would be of the view that perhaps an opt-in and opt-out system might be a better way to go about it, but we will come back to the issue at the technical briefing.

Deputy Stephen Donnelly

Yes, let us reflect on it. I have been thinking about it myself over recent days. For what it is worth, I would be worried that if we have both, it will create uncertainty. Imagine the situation the Deputy is talking about where there is a family and one person is saying "Yes" and the other person is saying "No". They might say the person did not opt in, and if they had wanted this to happen they would have opted in. You can imagine the situation. What we are trying to do with this Bill is fundamentally change our mindset as a nation to say we are all opted in. You cannot be extra opted in; you are just opted in. Everyone in the country will know exactly what the deal is, and anyone who does not want to be opted in will not be opted in. We are trying to do something quite fundamental here, which is to change our entire national view of this.

Deputy David Cullinane

I might ask the question in a different way. Let us say there is a scenario where a person has the code for organ donation on their driving licence, they pass away and consent is required from the hierarchy of family members, whether that is the mother, father, spouse or whatever. Would that family member be made aware of the fact that person had a driving licence with a code on it suggesting they had a preference for this to happen?

Deputy Stephen Donnelly

I am sure they could.

Deputy David Cullinane

This is the thing. They may not be made aware of that,and that could be problematic.

Deputy Stephen Donnelly

Let me take a look. In terms of donor cards, apps and codes on the driving licence, we are not suggesting these be abolished. The Irish Kidney Association itself played an instrumental role in setting these up.

Deputy David Cullinane

I am going back to the point where there may be a discussion and different views within a family. If the family is not aware of the fact that the person had a code on their driving licence, there could be a discussion and they may weigh it up. At least if they were aware the person had, from their perspective and in their own way, opted in by going for the driving licence option and having the code on their driving licence, it might help.

Deputy Stephen Donnelly

Let us take a look.

Deputy David Cullinane

Not having that information might mean they do not have the full picture.

Deputy Stephen Donnelly

Yes, we will take a look at that.

Deputy David Cullinane

Okay.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 2:

In page 9, to delete lines 29 and 30 and substitute the following:

“(b) a registered nurse or registered midwife within the meaning of section 2(1) of the Nurses and Midwives Act 2011, or”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 3:

In page 10, to delete lines 25 to 27 and substitute the following:

“ “pathologist” means a registered medical practitioner who is qualified by virtue of his or her training and expertise to perform post-mortem examinations;”.

Section 3 agreed to.

Amendment agreed to.

Section 2, as amended, agreed to.

SECTION 4

An Cathaoirleach

Amendments Nos. 4, 7, 10, 27, 28 and 32 are related and will be discussed together. Rather than going back and forward with the Minister, if members have something to say or questions to ask, we will just ask him to reply in order to speed things up.

Deputy Stephen Donnelly

I move amendment No. 4:

In page 11, line 28, to delete “Minister for Public Expenditure and Reform” and substitute “Minister for Public Expenditure, National Development Plan Delivery and Reform”.

Amendments Nos. 4, 7, 10, 27, 28 and 32 are technical amendments to correct a number of errors in the text. They have no material impact on the provisions of the Bill.

Amendment No. 4 amends section 4 to reflect the change of ministerial title from “Minister for Public Expenditure and Reform” to “Minister for Public Expenditure, National Development Plan Delivery and Reform”.

Amendment No. 7 amends section 32(3), which relates to the provision of information to the executive. We are removing the legal obligation for a person to include his or her address in the information he or she gives. An address is not a reliable identifier of a person.

Amendment No. 10 amends section 37 by inserting an updated definition of “non-coronial post-mortem examination”. The updated definition requires the removal of the word "such" from paragraph (a).

Amendment No. 27 amends section 42(1) to take account of the substitution of the phrase "part of a body" for the existing text. We are making a consequential amendment in this section to replace the phrase "organs or tissues" with "part of a body". It is a consequential amendment to the inclusion of a definition for "part of a body" elsewhere in the Bill.

Amendment No. 28 amends section 42(3), which concerns the removal of a tissue sample for diagnostic purposes, by providing further clarification on what samples must be retained in the hospital record in line with the best medical practice.

Amendment No. 32 amends section 42(5) by deleting the words “the appropriate”.

Amendment agreed to.

Section 4, as amended, agreed to.

Sections 5 to 16, inclusive, agreed to.

SECTION 17

Deputy Róisín Shortall

I move amendment No. 5:

In page 24, between lines 23 and 24, to insert the following:

“Report on adequacy of infrastructure and resources to support organ donation

17. The Minister shall, within one year of the passing of this Act, lay a report before both Houses of the Oireachtas examining the adequacy of the infrastructure and resources required to support organ donation, including intensive care unit beds and dedicated healthcare professionals.”.

This amendment concerns a request for a report of the adequacy of infrastructure and resources to support organ donation. As stated earlier, we are all hoping that this legislation will result in a very significant increase in the number of transplants. However, the worst possible outcome would be where there are additional organs available and we do not have the infrastructure or staff to actually utilise those organs and save people's lives. I am proposing that one year after this legislation comes into force, the Minister should produce and lay before the Houses a report setting out an examination of the adequacy of the infrastructure and the staff resources required to support organ donation, including intensive care unit beds and dedicated healthcare professionals. This is a reasonable proposal because, given the shortcomings in both resources and staffing across the health service, we must ensure that the same problems are not set and enhanced and expanded in the organ donation service. I would hope the Minister would support that proposal.

Deputy Stephen Donnelly

I fully support the intent behind the amendment. I do not propose to accept it in the Bill but for good reason. Let me lay out why. Organ Donation and Transplant Ireland, ODTI, advises on the resource and staffing requirements for organ donation and transplant services. That is the organisation with responsibility for the national system. The good news is that this review for which the Deputy is calling in the amendment is already under way. ODTI is undertaking a comprehensive review with a view to identifying really what the Deputy has spoken to, that is, the adequacy of the infrastructure, staffing, resourcing currently in place and clearly setting out the requirements for the system in the short, medium and long term, including in the context of this Bill where we hope the amount of activity will increase.

Furthermore, the report is going to put on place a strategic plan that will identify the solutions to the gaps that are found and map out very clear targets that have to be met to address any of the gaps identified. It is a systematic approach to the donation and transplant service in order that we can deliver exactly what we are all looking for, which is a cohesive national service. The report will help ensure that resource allocation across and within transplant sites is properly co-ordinated and aligns with national health and transplantation objectives and donation and transplant services. Longer term resourcing requirements will also be mapped out with a comprehensive resource allocation model rolled out.

Based on the outcomes of its report, the ODTI will be engaging with officials in my Department in a continuous process, not just on a one-off basis. Therefore, once we have this report and strategic plan identifying the gaps and additional resourcing needs, we will sign off on that and then there will be an ongoing relationship between the ODTI and the Department.

In terms of the broader requirement for ICU beds, such beds are being rolled out. They were included in the strategic plan for critical care that identified transplant services as being very resource intensive, obviously, with regard to ICU capacity. As a result, ICU capacity is being increased in all three of the transplant centres. Since 2022, €77 million has gone into ICU services. There has been a very significant increase with several million additional euro going into organ donation and transplant services. Obviously, I will share the report with the committee when I have it.

I fully agree with the Deputy. The work is now well under way. It supersedes the need for another report, which would probably be towards the end of next year. We will have this report later on this year and then we just need to account for that within the Estimates to make sure we build out exactly the resourcing the Deputy is referencing.

Deputy Róisín Shortall

I welcome what ODTI is being asked to do. I am sure that report should be very useful. What I am looking for is something quite different. The ODTI presumably will set out targets. We are great at setting targets for various things in this country, particularly in the area of health, but we are not so good at reaching or meeting those targets. What I want is a report 12 months after this legislation comes into force that assesses the adequacy of the infrastructure and resources.

That is different from the targets that are set. How will we stand a year after the passage of this legislation? Will we have adequate resources and adequate infrastructure? I am proposing that we find out. I will press this amendment.

Deputy Stephen Donnelly

The amendment asks for a report examining the adequacy of the infrastructure and the resources required, including intensive care beds and healthcare professionals. That is exactly what ODTI is doing. I hope that we will have exactly what the Deputy is looking for later on this year. Therefore, in a year's time, when the report this amendment seeks would be done, we would already have the information. We will already have a report saying what is required. In a year's time we will be able say whether we have made the progress that needs to be made in terms of-----

Deputy Róisín Shortall

Where will be saying that?

Deputy Stephen Donnelly

-----all of the resources.

Deputy Róisín Shortall

Who will be asking whether we have met those targets?

Deputy Stephen Donnelly

I will be asking. I imagine we will all be asking.

Deputy Róisín Shortall

I am sure we will all be asking but would it not be much better if there was a requirement for a report on the adequacy to be laid before the Houses? That is the point I am making.

Deputy Stephen Donnelly

No. I hear the Deputy. ODTI compiles annual reports as well, so we are going to have exactly what the Deputy is looking for but we are going to have it a year earlier. We are also going to have it in a very comprehensive way that not only lays out the adequacy, but identifies the gaps and gives Government targets to fill them.

Amendment put and declared lost.

Sections 17 to 22, inclusive, agreed to.

SECTION 23

Deputy Stephen Donnelly

I move amendment No. 6:

In page 29, to delete lines 31 to 33 and substitute the following:

“(5) A non-directed altruistic donor may not direct or specify that his or her organ shall, or shall not, be donated to a person of a particular class or classes of persons.”.

Amendment agreed to.

Section 23, as amended, agreed to.

Sections 24 to 31, inclusive, agreed to.

SECTION 32

Deputy Stephen Donnelly

I move amendment No. 7:

In page 36, to delete line 34.

Amendment agreed to.

Section 32, as amended, agreed to.

Sections 33 to 36, inclusive, agreed to.

SECTION 37

An Cathaoirleach

Amendments Nos. 8, 16, 18, 42, 43, 47, 49 and 40 are related and may be discussed together by agreement.

Deputy Stephen Donnelly

I move amendment No. 8:

In page 44, between lines 9 and 10, to insert the following:

“ “coronial post-mortem” shall be construed in accordance with section 38(2)(b);

“designated healthcare worker” 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,

(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 3 of the said Act as the Minister considers appropriate and may prescribe by regulations under section 3,

(d) an anatomical pathology technician, or

(e) a staff member nominated for that purpose by the hospital concerned,

who by way of training and expertise has the relevant understanding and experience to undertake functions under this Part;”.

These amendments relate to the designated healthcare workers. We are making an amendment in order to provide a definition of “designated healthcare worker”. Under consequential amendments to other sections within this part of the Bill, a designated healthcare worker will be able to take on functions relating to the legislation such as the obtaining of consent. In the published Bill, these functions were limited to a registered medical professional. Following consultation with the working group charged by the HSE with updating clinical guidance for the conduct of post-mortem examinations, we have designed to broaden this out to reflect best practice and to ensure that a multidisciplinary approach can be taken and supported through the legislation. The ability to take on functions as prescribed in the Bill will be conditional on the person having the relevant training, expertise, understanding and experience to undertake the role.

Amendment agreed to.

An Cathaoirleach

Amendments Nos. 9, 11, 17, 19, 20, 23, 26, 31, 34 to 36, inclusive, 38, 44, 45, 51, 52, 54 to 62, inclusive, 64 and 65 are related and may be discussed together by agreement.

Deputy Stephen Donnelly

I move amendment No. 9:

In page 44, line 25, to delete “organs, tissue samples or blood (or any material derived from blood)” and substitute “part of a body”.

These amendments relate to parts of the body. We are making an amendment, along with relevant consequential amendments in other sections, by inserting a definition of "part of a body". This is being done to reflect current post-mortem practice and to align with our policy intent. The definition better captures the material that might be removed as part of a non-coronial post-mortem examination. These amendments will replace "organs and tissues" with "part of a body" throughout Part 3 of the Bill.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 10:

In page 44, line 27, to delete “such”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 11:

In page 44, between lines 32 and 33, to insert the following:

“ “part of a body” means any part of the human anatomy and includes but is not limited to—

(a) an organ,

(b) tissue,

(c) a limb or part of a limb,

(d) blood or any material derived from blood, or

(e) any other biological fluid;”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 12:

In page 45, to delete lines 18 and 19 and substitute the following:

“ “stillborn child” has the same meaning as it has in section 2(1) of the Civil Registration Act 2004.”.

Amendment agreed to.

Section 37, as amended, agreed to.

Sections 38 and 39 agreed to.

SECTION 40

Deputy Stephen Donnelly

I move amendment No. 13:

In page 47, to delete lines 14 and 15 and substitute the following:

“(c) post-mortem consent given by a person is given, and given only, for the purposes of the post-mortem activities, specified in the consent concerned,

(d) where post-mortem consent is given by a person for the purposes of the post mortem activities specified in the consent, it shall not be necessary to seek consent in respect of subsequent use provided that the use is only for the purposes specified in the consent concerned,”.

Amendment agreed to.

An Cathaoirleach

Amendments Nos. 14, 29 and 46 are related and may be discussed together by agreement.

Deputy Stephen Donnelly

I move amendment No. 14:

In page 47, line 19, to delete “with the medical records of the mother,” and substitute “in accordance with the procedures of the hospital concerned and any guidelines made in that regard,”.

These amendments relate to the storage of fetal records. We are making amendments to three sections to ensure that records relating to a fetus are stored in a manner consistent with hospital practice and in adherence with relevant clinical guidelines. This is to reflect the fact that some hospitals might create separate records for a fetus to avoid any misreading of a mother's medical file.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 15:

In page 47, to delete lines 26 to 29 and substitute the following:

“(i) the non-coronial post-mortem examination and the burial, cremation or return, in accordance with regulations under section 39(2)(a), of any part of a body removed as part of that non-coronial post-mortem examination, other than any tissue removed and retained in accordance with section 42(3),”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 16:

In page 47, lines 35 and 36, to delete all words from and including “registered” in line 35 down to and including line 36 and substitute the following:

“designated healthcare worker shall, in accordance with any guidelines, provide the following”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 17:

In page 48, line 1, to delete “organs or tissues” and substitute “parts of the body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No.18 :

In page 48, line 9, to delete “registered medical practitioner” and substitute “designated healthcare worker”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 19:

In page 48, line 12, to delete “or return, of any organ or tissue” and substitute “or return, in accordance with regulations under section 39(2)(a), of any part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 20:

In page 48, to delete lines 14 and 15 and substitute the following:

“(g) an indication of the length of time a part of a body may, in accordance with regulations under section 39(2)(a), be retained and what the subsequent use, if any, of such part of a body may be;”.

Amendment agreed to.

An Cathaoirleach

Amendments Nos. 21, 22, 25, 33, 53, 63 and 66 are related and may be discussed together by agreement.

Deputy Stephen Donnelly

I move amendment No. 21:

In page 48, between lines 15 and 16, to insert the following:

“(h) in the case of the proposed retention and use of any part of a body, including for the use by a third party, information relating to the types of use that this may entail;”.

These amendments have to do with commercial considerations and donations. We are making several amendments and consequential amendments with regard to the commercial use of any material taken during a post mortem. This is to ensure that consent is always informed and only given for the reasons specified.

We are also tabling several amendments to sections which state that "a person or a hospital shall not receive financial compensation" for any part of a body, to include other non-financial inducements. This is to capture all types of possible compensation or inducements to ensure it is not restricted to those of a financial kind, which is in line with our policy intent.

Deputy Neasa Hourigan

Does this cover any data? We have a hybrid system where we have private hospitals. The physical aspects themselves are in question but the data collected in this context are also in question. Is this aspect covered by this legislation?

Deputy Stephen Donnelly

Not specifically.

Deputy Neasa Hourigan

Okay. I thank the Minister.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 22:

In page 48, lines 16 and 17, to delete “including the use of tissue by a third party for commercial purposes” and substitute “including for the use for commercial purposes”.

Amendment agreed to.

Section 40, as amended, agreed to.

SECTION 41

Deputy Stephen Donnelly

I move amendment No. 23:

In page 49, line 2, to delete “any organ or tissue removed from” and substitute “any part of a body removed from the body of”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 24:

In page 49, between lines 4 and 5, to insert the following:

“(c) the use of any part of a body retained after a non-coronial post-mortem examination, including the use of any part of a body by a third party;”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 25:

In page 49, to delete line 6 and substitute “examination, including the use of any part of a body for commercial purposes;”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 26:

In page 49, to delete lines 9 to 11 and substitute the following:

“(e) the burial, cremation or return, in accordance with regulations under section 39(2)(a), of any part of the body removed as part of a non-coronial post-mortem examination, other than any tissue, trimmings or biological fluids removed as part of the examination.”.

Amendment agreed to.

Section 41, as amended, agreed to.

SECTION 42

Deputy Stephen Donnelly

I move amendment No. 27:

In page 49, line 16, to delete “any part of the body, within the meaning of this section,” and substitute “any part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 28:

In page 49, line 23, to delete “subsection (2)” and substitute “subsection (2) and held on blocks or slides for this purpose”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 29:

In page 49, to delete lines 28 and 29 and substitute the following:

“(b) in the case of a non-coronial post-mortem examination of a foetus, form part of the medical records specified for that purpose in accordance with the procedures of the hospital concerned and any guidelines made in that regard.”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 30:

In page 49, line 30, to delete “within the meaning of this section” and substitute “indicated in that behalf under section 40(2)(b) as likely to be removed”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 31:

In page 49, line 32, to delete “organ or tissue” and substitute “part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 32:

In page 49, line 33, to delete “the appropriate”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 33:

In page 49, to delete lines 35 and 36 and substitute the following:

“(6) A person or hospital shall not receive financial compensation or other non-financial inducements for any part of a body removed during a non-coronial post-mortem examination.”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 34:

In page 49, line 37, to delete “organ or tissue” and substitute “part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 35:

In page 49, line 39, to delete “An organ or tissue sample” and substitute “A part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 36:

In page 50, lines 1 and 2, to delete “organ or tissue sample” and substitute “part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 37:

In page 50, to delete lines 4 to 7.

We are tabling an amendment to delete subsection (9) because, as drafted, it is in conflict with the HSE national policy for consent in health and social care research. It does not meet the standards for informed consent, in that consent for any activity should be specific, explicit and informed, and as informed as possible. The inclusion of this clause would not meet this threshold, so we are looking to delete it.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 38:

In page 50, to delete lines 8 to 12.

Amendment agreed to.

Section 42, as amended, agreed to.

SECTION 43

Deputy Stephen Donnelly

I move amendment No. 39:

In page 50, line 16, to delete “the cause of death” and substitute “the medical cause of death”.

Amendment agreed to.

Section 43, as amended, agreed to.

SECTION 44

Deputy Stephen Donnelly

I move amendment No. 40:

In page 50, to delete lines 35 and 36 and substitute the following:

“(b) is satisfied the post-mortem consent, where appropriate, has been provided in accordance with section 46, 47, 48 or 49.”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 41:

In page 50, to delete lines 37 and 38, and in page 51, to delete lines 1 to 4 and substitute the following:

“(2) A pathologist or a registered medical practitioner under the supervision of a pathologist may, when carrying out a non-coronial 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 pathologist carrying out or supervising the non-coronial examination, is sufficiently qualified or has the relevant training to provide such assistance.”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 42:

In page 51, to delete lines 5 to 9.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 43:

In page 51, line 11, to delete “or registered medical practitioner”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 44:

In page 51, line 13, to delete “organ or tissue” and substitute “part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 45:

In page 51, between lines 17 and 18, to insert the following:

“(6) In this section, “technical or clinical assistance” in relation to the carrying out of a SECTION 44

non-coronial 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.

Section 44, as amended, agreed to.

SECTION 45

Deputy Stephen Donnelly

I move amendment No. 46:

In page 51, line 30, to delete “with the medical records of the mother,” and substitute “in accordance with the procedures of the hospital concerned and any guidelines made in that regard”.

Amendment agreed to.

Section 45, as amended, agreed to.

SECTION 46

Deputy Stephen Donnelly

I move amendment No. 47:

In page 52, lines 2 to 4, to delete all words from and including “the” in line 2 down to and including “adult” in line 4 and substitute “a designated healthcare worker”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 48:

In page 52, line 6, to delete “adult” and substitute “family member”.

Amendment agreed to.

Section 46, as amended, agreed to.

SECTION 47

Deputy Stephen Donnelly

I move amendment No. 49:

In page 52, lines 13 and 14, to delete all words from and including “registered” in line 13 down to and including “child” in line 14 and substitute “designated healthcare worker”.

Amendment agreed to.

Section 47, as amended, agreed to.

SECTION 48

Deputy Stephen Donnelly

I move amendment No. 50:

In page 52, lines 28 to 30, to delete all words from and including “registered” in line 28 down to and including “foetus” in line 30 and substitute “designated healthcare worker”.

Amendment agreed to.

Section 48, as amended, agreed to.

SECTION 49

Deputy Stephen Donnelly

I move amendment No. 51:

In page 52, line 36, to delete “an organ or tissue” and substitute “a part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 52:

In page 53, line 7, to delete “an organ or tissue” and substitute “a part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 53:

In page 53, to delete lines 9 to 11 and substitute the following:

“(3) Subject to section 40 and the provisions of this section, an approval given under subsection (2), is approval for the commercial use of that part of the body.”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 54:

In page 53, line 13, to delete “an organ or tissue” and substitute “a part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 55:

In page 53, line 15, to delete “organ or tissue” and substitute “part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 56:

In page 53, line 17, to delete “organ or tissue” and substitute “part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 57:

In page 53, line 19, to delete “an organ or tissue” and substitute “a part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 58:

In page 53, line 21, to delete “organ or tissue” and substitute “part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 59:

In page 53, line 23, to delete “organ or tissue” and substitute “part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 60:

In page 53, lines 24 and 25, to delete “an organ or tissue” and substitute “a part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 61:

In page 53, line 27, to delete “organ or tissue” and substitute “part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 62:

In page 53, line 29, to delete “organ or tissue” and substitute “part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 63:

In page 53, to delete lines 30 to 32.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 64:

In page 53, line 34, to delete “organ or tissue” and substitute “part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 65:

In page 53, line 41, to delete “organs and tissues” and substitute “parts of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 66:

In page 53, line 43, to delete “payment for any organ or tissue” and substitute “financial compensation or other non-financial inducements for any part of a body”.

Amendment agreed to.

Deputy Stephen Donnelly

I move amendment No. 67:

In page 53, after line 44, to insert the following:

“(12) In this section, “person in charge” means, in relation to a hospital—

(a) the chief executive officer (howsoever described) of the hospital,

(b) the owner of the hospital, or

(c) a suitably qualified person specified in that behalf for the purposes of this Act by a person referred to in paragraph (a).”.

Amendment agreed to.

Section 49, as amended, agreed to.

Sections 50 to 105, inclusive, agreed to.

Title agreed to.