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Select Committee on Health díospóireacht -
Wednesday, 24 Jan 2024

Health (Assisted Human Reproduction) Bill 2022: Committee Stage

The meeting is being convened to consider Committee Stage of the Health (Assisted Human Reproduction) Bill 2022. The primary objective of the Bill is to protect the rights and safety of all those involved in surrogacy arrangements. The Bill will achieve these objectives through the introduction of a regulatory framework for both domestic and international surrogacy arrangements in Ireland and the recognition of legal and parental status of persons involved in a surrogacy arrangement. In addition, the Bill will provide for the establishment of a surrogacy governing body, the assisted human reproduction regulatory authority, AHRRA. Provisions within the legislation will ensure that safeguards are in place for assisted human reproduction practice and research, and that oversight of the surrogacy process for Irish residents is provided. It is envisaged that, due to the size and scale of the Bill and the number of amendments, that more than one meeting of the select committee will be required.

Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against either a person outside the House or an official by name or in such a way as to make him, her or it identifiable. I also remind members that they are only allowed to participate in this meeting if they are physically located on the Leinster House complex. In this regard I ask all members, prior to making their contribution to the meeting, to confirm they are on the grounds of the Leinster House campus. I also remind members that should a division be called, members must physically come to the committee room to vote.

For consideration of the Bill, I welcome the Minister for Health, Deputy Stephen Donnelly, to our meeting. A total of 256 amendments have been tabled. The grouping list has been provided to members. We will now consider each amendment. Before the meeting formally starts, I intend to suspend at around 11 a.m. for a comfort break. I believe that the Minister has some opening remarks.

I thank the Chair. I am delighted to be here today. It is a landmark day as we commence the Committee Stage of the Bill.

There are people I want to thank, starting with the members of the committee. They put a lot of work into this, attended briefings and submitted a list of very well thought-through amendments. There was pre-legislative scrutiny, PLS, some time ago. In fact, I was on the committee at the time of the PLS in 2019. A great deal of work has been done and I thank the committee for facilitating what will probably be several days of Committee Stage.

I also thank the officials in my Department. The officials who are present have been working night and day on this to get it to the point where it is now. Officials from the Departments of Justice and Children, Equality, Disability, Integration and Youth have been working on this because the Bill is so wide-ranging. I gave a commitment to the advocacy groups that we would have the Committee Stage amendments through government by the end of the year. I put a lot of pressure on my Department, and the other Departments were under a lot of pressure to meet that. They did it by working long hours, weekends and late nights across the three Departments. I just want to acknowledge that without that work this committee hearing would not be happening today at all.

I also want to thank the advocacy groups. It has been my great honour to meet on numerous occasions with many of the advocacy groups who have been pushing both on the assisted human reproduction, AHR, side and on the surrogacy side, both domestic and international. As we are all aware, the reason that we have 256 amendments over 100 pages is essentially we have a Bill within a Bill, which is the international surrogacy piece. I acknowledge the work of the advocacy groups. They have been fantastic.

Obviously, I need not tell members what we are dealing with is complex and sensitive and I am acutely aware that at the heart of the scenarios that we will tease through are individuals and families, many of whom are faced with very difficulties or who are in very difficult situations.

The Bill, as initiated, is to regulate assisted human reproduction. This focuses on the regulation for the first time in Ireland of a wide range of AHR practices. The Bill, as initiated, provides for domestic altruistic surrogacy but did not contain provisions to regulate surrogacy arrangements abroad. It is complex, far-reaching legislation and it will for the first time encompass regulation on a wide range of practices undertaken in Ireland. It includes gamete and embryo donation for AHR and research. It includes domestic altruistic surrogacy, pre-implantation genetic testing of embryos, posthumous AHR, and embryo and stem cell research. That is the Bill, broadly as initiated.

However, as colleagues will be aware, we have more than 100 pages of amendments that cover a great deal more. I certainly have no recollection of a Bill having 100 pages of amendments previously. The clerk to the committee might be able to tell us if we are making a little bit of history.

The amendments broadly have four aims. The first is to legislate for future international surrogacy arrangements. As far as the Department can ascertain, Ireland is the first country putting this legislation in place. Many other jurisdictions will look to see how we approach it, the decisions we make and how it goes.

The second is to legislate for the recognition of past surrogacy arrangements, both domestic arrangements and international arrangements. Committee members will join me in wishing those families and children the best. We have hundreds of families around Ireland today where the children do not enjoy the rights, protection and recognition of a full parental legal recognition to one of their parents and that is something that we are fundamentally going to change. I want, and I know all colleagues want, full parental recognition and rights for all of these families, some of whom both I colleagues have had the great pleasure of meeting. What we will put in place through these amendments is a full retrospective route to full parentage for these parents and wonderful children. Getting this right has taken up a great deal of time and I am delighted that we are here today with these amendments to do that.

The third aim is to amend the 2022 Bill, as published. This includes the use of ovarian and testicular tissue, AHR counselling, pre-implantation genetic testing and genetic counselling. Therefore, we are further evolving and improving the domestic AHR services as well.

Fourth, we are amending the Children and Family Relationship Act 2015. I have met with the advocacy groups. There are numerous requests they had on provisions that needed to change in that Act and to the greatest extent possible, we are facilitating that. There are one or two where we cannot at this time but maybe in the future we can. Certainly, I have a list of nine, and we will go through various of them here. We are fully facilitating six of them, we are working on one and in the case of two of them, it has not be possible for various reasons. However, we are making some important changes to the Children and Family Relationships Act.

I accept that we still have a long way go to before the Bill is enacted. Given the size and complexity of the newly expanded Bill, it will take a number of meetings of the committee but important progress has been made and I look forward to the hearings and getting this Bill through.

I want to inform colleagues and the parents who will be watching these proceedings that we are getting the authority set up in parallel. We cannot formally establish it until the legislation is enacted but the regulations which will come after this Bill, the design of the AHRRA, the staffing of the authority and the funds all are being put in place by us now so that when the Bill is signed, hopefully, by the President, we will be able to move much quicker than would normally be the case in terms of getting that authority set up. It will be relevant for one of the issues we will come to, which is the interim period in terms of retrospective versus prospective.

On a different matter, colleagues will be aware of a rare disease called metachromatic leukodystrophy, MLD. They will be aware of a man named Les Martin, who has been one of the most powerful patient advocates I have ever seen. Many of us here have met and know Les. Les's son Cathal died of MLD when he was aged five. Les, for years now, has been advocating for treatment. There is a treatment called Libmeldy and he has been advocating for newborn screening so that in Ireland we can identify quickly children who have MLD and then provide an effective treatment. I am delighted that, just in the past hour, we announced that Libmeldy has been approved for use in Ireland. There were three conditions we need in place. The first is the money. We have allocated €30 million this year for new medicines and that will cover the cost. It is an expensive treatment. It costs several million euro per child. We have the money in place.

The second thing we needed in place was approval for Libmeldy. We have that as of this morning. How it works is the child and the family go abroad to a treatment facility, the child is treated abroad and they come home.

The third thing we need is it included in the newborn screening programme. I am writing to the chair of the advisory group this morning to ask that this be given consideration as a matter of urgency because we now have an effective treatment. Obviously, the group's advice is independent but I am seeking its advice on this as a matter of urgency.

I spoke this morning to a dad, Seán Kenny, whose son, Aidan, died of MLD recently. Seán and Les know each other. There is no doubt that part of Cathal's and Aidan's legacy is Libmeldy being authorised and a crucial step in being able to identify newborn infants with MLD and provide their treatment. I want to acknowledge Cathal and Aidan, two five-year-old boys, who both died of MLD. They inspired and drove their parents to fight, agitated and engage with all of us in the Oireachtas. Part of their legacy will be an Ireland now where MLD is found early and children get this very effective treatment. I wanted to acknowledge both Cathal and Aidan this morning. I thank the Chair for the time to say that.

I thank the Minister. It is always good to hear good news. I am sure it is fantastic news for all those affected by MLD. We send our sympathies to the families of those who have died of the disease.

Before we move on, I said at the start that there are 256 amendments. No doubt there probably will be more again before the Bill is passed.

Before I bring members in, I thank Ms Pamela Carter for the technical briefing that she and her officials gave to the committee last week. It was useful for all of us who attended. We look forward as a committee to try and proceed with this as quickly as possible. We are conscious that there are other issues there as well but we have agreed at a private meeting that we would try and fast-track the passage of this Bill where possible in respect of our work programme. We will meet after this meeting, I presume, to decide when we will bring the Minister in again next.

Deputy Cullinane wanted to say something.

I want to make a number of quick points.

First, I support the moves on MLD, the potential addition of that rare disease in the newborn baby screening programme and the treatment that will be available, and commend all of those who have advocated for it. It is a good-news story.

It is important from my perspective to commend the work that has gone into the Bill. We have a lengthy process with a lot of amendments to get through in the next few weeks. No one on this committee wants, or certainly I do not want, to hold up progress on this. While we want to get through the Bill as quickly as we can, there are issues we need to probe. I say that to advocate groups that are watching. I commend them on the work they have done. As was said, a full route to retrospective recognition has been made available and there is an urgency to get this done as quickly as possible. We all agree with that but we have a bit of work to do in the next few weeks. I hope we can get it done as quickly as possible.

It is rare for us to do this as a committee, but I commend the Minister and his officials on their work in bringing forward this Bill. As we said in the private session, the briefing we got was top class, as was the work by the officials that has gone into this. It is a difficult, challenging and complex piece of work. There is no doubt about it. When I first looked at this issue, I was struck by the difficulty in legislatively balancing all the moral and ethical issues that arose and all the different requests from different groups An appropriate balance has been struck, by and large. Having said that, we have tabled amendments and there are issues we need to work through, but I want to put on the record my appreciation of those officials especially, who I believe worked for months in a bunker putting this together. They have done a very good job. I wanted to make that point.

I will also say thanks. These comments are normally reserved for the end of the process. There is a long process ahead of us. I appreciate all the work that has been done to date and look forward to getting through this monstrous task as regards the volume of the Bill and the amendments. I hope we can do so as expeditiously and as thoroughly as possible.

I echo those words and recognise and acknowledge the complexity of the legislation. We have dealt with relevant individual cases over many years and have had to have regard to the relevant legislation in other jurisdictions. Presumably, as we proceed through the amendments, we will deal with the issues that have come up before in a fairly adequate way.

I remind members that the Minister is the witness today. He can, if he wants to, bring in some of his officials on some of the questions, but Deputies should direct questions to the Minister.

SECTION 1

Amendments Nos. 1 to 4, inclusive, and 31 are related and may be discussed together.

I move amendment No. 1:

In page 11, between lines 27 and 28, to insert the following:

“(2) Section 156 and the Irish Nationality and Citizenship Acts 1956 to 2004 may be cited together as the Irish Nationality and Citizenship Acts 1956 to 2024.”

These are technical amendments to add cross-references that are required as a consequence of new sections proposed to be inserted by later amendments. We will discuss the proposed later amendments in due course.

Amendment agreed to.

I move amendment No. 2:

In page 12, line 1, to delete “sections 156, 157” and substitute “sections 156, 157, 157,157, 158"

Amendment agreed to.

I move amendment No. 3

In page 12, line 5, to delete “Sections 156” and substitute “Sections 156, 157, 157,”.

Amendment agreed to.

I move amendment No. 4:

In page 12, between lines 8 and 9, to insert the following:

“(5) Section 158 shall come into operation on such day or days as the Minister for Foreign Affairs may, after consultation with the Minister, appoint by order or orders either generally or with reference to any particular purpose or provision, and different days may be so appointed for different purposes and different provisions.”.

Amendment agreed to.
Section 1, as amended, agreed to.
SECTION 2

Amendments Nos. 5 and 8 are related and may be discussed together.

I ask members to bear with me as we move into this process.

I move amendment No. 5:

In page 12, line 22, to delete “16 years” and substitute “12 years”.

Please bear with us all because it is difficult to manage the various documents.

Amendments Nos. 5 and 8 relate to providing access to birth details. The Bill currently provides for that to happen at the age of 16 years. I am proposing that 16 years be substituted with 12 years. There are a lot of grounds for this. Certainly, the Joint Committee on International Surrogacy recommended that when children reach the age of 12, they should be entitled to access their information in the national surrogacy register. It does not mean they would have to, but they could at any point from 12 onwards. It is also significant that Professor Conor O'Mahony, the special rapporteur on child protection, also recommended that the age should be 12 in his report on the implications of donor assisted reproduction and surrogacy for the rights and best interests of the child. That principle should inform all our work on this Bill. He stated "the right to identity is a right of the child, and is held while a child; it is not the case that the right only crystallises upon turning 18", or even 16 years. It was felt that by 12, most children's capacity is evolved enough and that they could navigate the process if they so wished. Parents deal with this issue in different ways and, to a large extent, being aware of their identity at an age-appropriate stage should be part and parcel of children growing up. Many young teenagers inquire about their background and personal information. It is hard to see any reason that should be denied to children until they are 16. The recommendations from two strong sources suggest that the age should be 12 and I hope the Minister might consider that.

I thank the Deputy. I do not think there is a right answer to this. I am aware that the special rapporteur on child protection said the age should be 12. Other expert advice says it should be 16. It was 18; it has come down to 16. We discussed this at length with the Minister, Deputy O'Gorman's, Department, which settled on the age of 16 in the 2022 Act on adoption. As we would expect, that is still firmly its view. That is the decision the Minister, Deputy O'Gorman, brought through in 2022. I am open to this. We now have experts with different views. Some say 12, some say 16. I need to stay aligned with the other Acts, which all say 16. Essentially, at the moment, it is Government policy that the age is 16 and that is reflected in the various Acts. It could certainly be looked at, not only in the context of this Bill, but as regards the right to information generally. We now have the special rapporteur's report. In the light of that, should there be a review of broad Government policy? It would not be for the Department of Health. I am open to it, but I cannot do it in this Bill. It would need to be done across the Government and then amending legislation would be brought in, a miscellaneous Bill, to change the ages in their entirety. I understand the argument and have a lot of respect for it, but it is not something we can do here. However, I would be happy to support a committee letter or to add my voice to a broader review in light of the special rapporteur's advice and that of the other gentleman the Deputy mentioned. Is this something the Government should look at as a matter of policy?

It was actually the Joint Committee on International Surrogacy that made the recommendation, along with Conor O'Mahony. This is an important point.

I will press it because of the strong recommendations that have been made.

Does anyone else want to come in on this? No.

How stands the amendment?

Amendment put and declared lost.

Amendment No.6, amendment No. 1 to No. 6, and amendments Nos. 46 and 47 are related and will be discussed together.

I move amendment No. 6:

In page 12, to delete lines 24 to 35 and substitute the following:

" "AHR counselling"—

(a) in relation to AHR treatment, other than AHR treatment to be provided pursuant to a surrogacy agreement attached to a section 51 application, means a service provided by an AHR counsellor under which he or she counsels a person regarding the potential social and psychological implications that may arise in the case of the person where that person, or another person with whom the first-mentioned person is connected, is provided such treatment, or

(b) in relation to AHR treatment to be provided pursuant to a surrogacy agreement attached to a section 51 application, means a service provided by an AHR counsellor under which he or she—

(i) if the application involves two intending parents, counsels such parents regarding the potential social and psychological implications that may arise in the case of such agreement being approved under section 51 and, if applicable, such parents, or one of them, as the case may be, being provided such treatment,

(ii) if the application involves a single intending parent, counsels such parent regarding the potential social and psychological implications that may arise in the case of such agreement being approved under section 51 and, if applicable, such parent being provided such treatment, or

(iii) counsels the potential surrogate mother regarding the potential social and psychological implications that may arise in the case of such agreement being approved under section 51 and such mother being provided such treatment;".

This group of amendments relates to the provision of assisted human reproduction counselling. Amendment No. 6 is a technical amendment adding specificity to the definition of AHR counselling. This is in relation to counselling in domestic surrogacy arrangements. The is a separate definition of AHR counselling included in the new international surrogacy provisions.

I thank Deputy Shortall for her proposed amendment to amendment No. 6 concerning counselling for the partner of the surrogate. The advice I have is that it is not necessary for the following reason. We are amending the Status of Children Act 1987 to allow for the removal of the presumption of legal parentage in respect of the husband of the surrogate mother. Therefore, we want very much to empower the surrogate mother. It is very much up to the surrogate mother as to how she involves her spouse if, indeed, she has a spouse, in the entire surrogacy process. This includes potentially attending counselling sessions. Critically, his consent to the surrogacy is not required. It very much ensures full agency for the surrogate mother.

Section 17 of the Bill as initiated requires every intended parent to receive AHR counselling prior to being provided with AHR treatment. There is no stipulation for those making a donation of gametes or embryos. The intention behind amendments Nos. 46 and 47 is to make AHR counselling non-mandatory where the AHR treatment does not involve donor gametes, surrogacy or posthumous assisted human reproduction, although such patients will still be offered AHR counselling.

On the other hand, AHR counselling will be compulsory for donors in Ireland as well as those looking to undertake donor-assisted human reproduction procedures or any form of surrogacy arrangement or any posthumous AHR. This is because it is deemed that the receipt of counselling is essential prior to being provided with these more complex types of AHR treatment, involving implications and issues surrounding identity of the child and the commitments required in respect of personal information being recorded in the national donor-conceived person register and the national surrogacy register.

I move amendment No. 1 to amendment No. 6:

In paragraph (b)(iii), after "mother" to insert ", and if any, her spouse, civil partner or co-habitant.

This does not interfere with the agency of the surrogate in any way. It simply recognises, in circumstances where the woman has a partner, that the social and psychological implications for the partner are quite significant. Because of this it is advisable that there should be counselling provided. This is not a legal issue. It does not interfere with any legal right or provision but it does recognise the human situation for a potential partner. This is why I propose the amendment. It makes sense that we recognise the counselling needs of a potential partner.

I thank Deputy Shortall. I guess it is a question of voluntary versus compulsory. The direction of travel we are going in with the Bill is to recognise the surrogate. There are no obligations for her to convince a partner or ask a partner. There is no obligation on the partner. We are saying with regard to her marital status, cohabiting status or relationship status that there is no compulsion required. However, to Deputy Shortall's-----

This does not suggest compulsion. It speaks about the need to provide counselling. It is not that it is compulsory.

It can certainly-----

It is that counselling is provided for a person in those circumstances.

It can be provided on a voluntary basis but we are moving away from a legislative underpinning for it, which is really just around saying the surrogate is being identified under law as a single individual.

I do not see how providing counselling for that person's partner diminishes that.

It can be provided voluntarily but the direction of travel-----

But will it? The question is whether it will if it is not referenced.

There are a lot of cases. In many of the cases we have read out there is voluntary provision. We are investing in this.

I will not press the amendment.

Amendment to amendment, by leave, withdrawn.

If amendment No. 6 is agreed to, we will now move to amendment No. 7.

Were we not discussing amendments Nos. 46 and 47 in that grouping?

They are in the grouping.

We will vote on them when we come to them.

I know we did not vote on them but we did not discuss them either.

For clarity purposes, there are a lot of groupings and when we get to a grouping, it is incumbent on all of us to speak to whatever amendments we have in that grouping.

Do members wish to discuss amendments Nos. 46 and 47?

I covered them in what I said. I am happy to discuss them further.

Does anyone want to say anything on amendments Nos. 46 and 47?

Are we also discussing the entire section now?

No, we are speaking about just those two amendments that are related to amendment No. 6.

We will move on.

Amendment agreed to.

Amendments Nos. 7, 9, 21 to 23, inclusive, 25, 40, 50, 52, 53, 56, 66 to 68, inclusive, 84 to 87, inclusive, amendments Nos. 1 to 5, inclusive, to amendment No. 87, and amendments Nos.188 and 253 are related and will be discussed together.

I move amendment No. 7:

In page 13, line 14, to delete "or embryos" and substitute ", embryos or tissues".

There is a substantial number of amendments in this grouping that deal with one of the material changes being made. They seek to allow for cryopreservation and the storage of ovarian tissue and testicular tissue. This is for the purpose of assisted human reproduction. It is mind blowing to be honest. If somebody is going to go through treatment for cancer then ovarian tissue and testicular tissue can be taken out. It is a procedure about which I am not entirely sure so I will spare the details. Essentially it can help a patient to produce eggs and sperm after treatment later on in life. It is amazing new technology. It is another method of fertility preservation. It is not widely used in Ireland but it is very relevant for prepubescent children and, typically, cancer patients. It is the type of treatment we hope to see become more widely available in Ireland. This is what the amendments seek to do.

The amendments as tabled state that where a person has defaulted on a payment for storage of their tissue, the clinic can dispose of that tissue. Deputy Shortall's amendment, if I understand it correctly and I ask Deputy Shortall to correct me if I am wrong, removes this clause and replaces it with an obligation on the clinic to further engage with the person whose tissue is being stored.

I have a lot of sympathy with the amendments the Deputy has put forward. On reflection, I agree with the principle I think she is seeking to bring in here, whereby it seems a bit harsh that if somebody misses a single payment, the clinic could just say that is it. Anyone could miss a single payment. They could lose their job or God knows what. They might have to pay some other bill. It seems harsh that that would allow a clinic to immediately say that because they had missed their 2024 payment or their quarter 1 payment and that is that. I agree with the Deputy in that regard.

I think, however, that we need to go a bit further than "engage with" because if, ultimately, all the clinic can do is engage if somebody never pays, my fear is that, commercially, people might not provide the service. I would like to reflect on it further and we might discuss it outside of committee, or now, with a view to potentially bringing forward Report Stage amendments. It might relate to, for example, where somebody has not paid for a period of a year or something. I do not quite know, but I agree with what I think the Deputy is seeking to do here.

I welcome the Minister's approach to this. These proposals came directly from clinics and professionals working in the area, and they made the point anybody can go through a difficult financial period where they are not able to keep up with payments they should be making. Very often, there are very legitimate reasons for that and it should not exclude somebody, but they felt this is too prescriptive. If the Minister is prepared to look at that and come up with some kind of conditionality around it or to soften it somewhat, I will be happy to withdraw my amendments on the basis of that commitment.

We might discuss further what the correct balance is. I thank the Deputy.

Amendment agreed to.

I move amendment No. 8:

In page 13, line 25, to delete “16 years” and substitute “12 years”.

Amendment, by leave, withdrawn.

I move amendment No. 9:

In page 13, to delete lines 35 and 36 and substitute the following:

“ “disposed of”, in relation to a gamete, embryo or tissue (howsoever described in this Act), means the gamete, embryo or tissue is destroyed (by whatever means);”.

Amendment agreed to.

Amendments Nos. 10, 14, 15, 17, 18, 24, 26, 101 and 102 are related and will be discussed together.

I move amendment No. 10:

In page 13, between lines 36 and 37, to insert the following:

“ “donor-conceived child” has the meaning assigned to it by the Act of 2015;”.

These are technical amendments that will move definitions from the definition sections of the other Parts of the Bill, as initiated, specifically the definitions for “surrogacy” and “PAHR”, to the general interpretation section, given each is now referenced in more than one Part of the Bill.

Amendment agreed to.

Amendments Nos. 11, 12, 19, 29, 30, 33 to 36, inclusive, 51, 70 to 74, inclusive, 82, 83, 97 to 100, inclusive, 107, 111, 118, 119, 123, 126 to 128, inclusive, 130, 132, 139, 140, 142, 144, 186, 193 to 195, inclusive, 197 to 200, inclusive, 248 to 251, inclusive, 254 and 256 are related and will be discussed together.

I move amendment No. 11:

In page 14, line 23, to delete “man” and substitute “male”.

This is a large grouping of amendments. They are purely technical and relate to edits and typographical corrections.

I would like to make a couple of points. I think there is an issue with the gendered nature of the language in the Bill and I am not sure to what extent the Minister or his officials have thought this through. It refers to a gamete formed in the body of a male and a gamete formed in the body of a female and so on. I wonder why we cannot use more straightforward language, such as "egg" and "sperm". Moreover, a few groups have inquired as to whether the Department has carried out any research into whether it is more appropriate to refer to a "surrogate mother" or just to a "surrogate". That is of concern to some groups. What thought has gone into that area of non-gendered language?

I might ask one of my officials to give a bit of background on the work that was done on that issue.

Ms Pamela Carter

I appreciate this is complex and that different terminology is used. We did seek legal advice and the advice of the Attorney General, also consulted other Departments and sought the views of clinical experts in this field who are familiar with the terminology. We ran it through their lens and this was the advice they gave us. We also consulted colleagues in the Department of children, which has other legislation using terminology in this field. Based on the legal advice and the advice of clinicians and people with experience with legislation, we reflected their views on the use of language. Having said that, we are certainly open to hearing whatever views the Deputy might have.

Is Ms Carter referring to legal advice or opinion?

Ms Pamela Carter

Legal advice.

Okay. I think being more specific would not affect the legal implications of it. Could consideration be given before Report Stage to changing some of the language to make it more inclusive?

That is no problem. If the Deputy has specific examples with which she has been approached, she might send them on to me or the officials and we will take a look.

Yes, I am happy to do that. I outlined some examples earlier.

Turning to the amendment on posthumous AHR, why is it that that is available only to women? Recommendations were made, again by the committee, but as it stands the Bill allows for only surviving females to access posthumous AHR. I am not clear on what the justification is for the exclusion of surviving males, especially in circumstances where there is an existing child, one of the partners has died, there is a desire to have a second child and the deceased has given consent. In those circumstances, why are we restricting posthumous AHR to women? Furthermore, the pre-legislative scrutiny report found this provision was inconsistent.

I am very happy to talk about them now. They are coming up in amendment No. 27. I think the Deputy may have tabled amendments as well, but I am very happy to discuss them now. The questions she has raised are exactly the same questions I have raised. The Bill, as I understand it, and the officials can correct me if I am wrong because there is an awful lot of detail in here, is as the Deputy has outlined. Let us take the example of a man and a woman, where the sperm and eggs are frozen and they both consent that, in the event one of them dies, the other, posthumously, could avail of the gamete, be that an egg or a sperm. The Bill would allow the woman to use the sperm to get pregnant through assisted human reproduction using her deceased partner's sperm. There is a stipulation that there would have to be a wait of a year before it could be done, which is not one I am comfortable with. I think the original thinking in the Bill as drafted some time ago was that there would be a period of mourning and grief. My view is that people can decide what they want to decide if they have full agency and they do not need to be asked to wait a particular time. We are reflecting on this and I may bring amendments on the time period on Report Stage. One part of it is that a woman can do this but must wait a year, and I am not entirely comfortable with that waiting period.

Second, as Deputy Shortall said, the man cannot access the frozen eggs. Obviously, he would need a surrogate to do that. As we are now legislating for surrogacy, I have posed the Deputy's exact questions to the officials. I think this requires a bit more consideration and that we need to reflect and see if we will amend this on Report Stage. I am not yet satisfied that I have a satisfactory answer as to why the woman can access the sperm but the man cannot access the eggs. There is a precedent for it, as we know. It is more straightforward for the woman to access the sperm and then, through AHR, seek to become pregnant herself. It is obviously more difficult for the man because it is necessary to find a surrogate. The question is whether this should be enough to say that he is not allowed to try to access that option. I am not convinced. I thank the Deputy for the amendments because it helped to kick off exactly this conversation. What I want to do is reflect further on this issue. I will be very happy to meet the Deputy or, indeed, have informal briefings with members to get their views and then come to a position for Report Stage.

I thank the Minister.

One of the amendments concerns the substitution of the words "surrogate mother" with the word "surrogate". I know the Minister touched on this but is there a particular reason the words "surrogate mother" need to be put in as opposed to "surrogate"?

I will ask one of my officials to answer that question.

Mr. Colm McGennis

I think this was based on the advice of the Attorney General. It connects with the fact that the surrogate is still considered the mother at birth. It is only after birth and the parental order court process that that would change. I think the words "surrogate mother" are there to reflect that fact.

One of the groups - Deputy Shortall has raised this point as well - has submitted that the words "surrogate mother" be substituted with the word "surrogate".

Mr. Colm McGennis

We can maybe go back to the Attorney General on this point, but this was the advice we were given.

That explanation does not seem to add up, intuitively. A surrogate is a surrogate. I think the term "mother" is superfluous there. There is no confusion about who the surrogate is.

Mr. Colm McGennis

That is the opinion we have been given. I understand where the Deputy is coming from. It is something we can go back to.

It is the case that the language is going to be looked at again. Okay, that is fine.

Amendment agreed to.

I move amendment No. 12:

In page 14, line 24, to delete “woman” and substitute “female”.

Amendment agreed to.

I move amendment No. 13:

In page 14, line 28, after “treatment” to insert the following:

“or, in the case of such treatment provided to any other person (including a child), to safeguard that person’s possibility of becoming a person first-mentioned in this definition”.

This amendment seeks to amend the definition of "intending parent" by adding a reference to those undertaking AHR treatment for purposes other than seeking to become a parent at the specific time of the treatment. Essentially, it affords more protections and rights to people who are, for example, engaged in cryopreservation or AHR treatments whereby they would look to become pregnant or have a child in several years' time. The amendment is just expanding that element.

Amendment agreed to.

I move amendment No. 14:

In page 14, between lines 28 and 29, to insert the following:

“ “legal practitioner” has the meaning assigned to it by the Legal Services Regulation Act 2015;”.

Amendment agreed to.

I move amendment No. 15:

In page 14, after line 37, to insert the following:

“ “PAHR” means posthumous assisted human reproduction;”.

Amendment agreed to.

Amendments Nos. 16 and 37 are related and may be discussed together.

I move amendment No. 16:

In page 15, line 1, after “means” to insert “(other than in Part 8 or 11)”.

Amendments Nos. 16 and 37 are technical amendments confirming that any references to "parental order", "surrogacy" or "surrogate mother" throughout the Bill will generally not relate to the international surrogacy or retrospective surrogacy Parts except in those two, largely self-contained new Parts themselves, which are Parts 8 and 11.

I wish to comment on the language used in the Bill, namely, that "The AHHRA shall produce a format of the AHR information document in both plain English and easy read". I think we are all struggling with the complexity of the provisions and the language in this Bill. This is why I am proposing this format would be the case.

I do not have this amendment in the grouping. Which is the Deputy's amendment?

It is amendment No. 38. I am sorry. That amendment is a little further on.

That is fair enough.

We are discussing amendments Nos. 16 and 37.

Yes, we will come to amendments Nos. 38 and 39 in a while.

Amendment agreed to.

I move amendment No. 17:

In page 15, between lines 2 and 3, to insert the following:

“ “person (D)”, in relation to a surviving partner, means the deceased person referred to in the definition of “surviving partner”;”.

Amendment agreed to.

I move amendment No. 18:

In page 15, between lines 6 and 7, to insert the following:

“ “posthumous assisted human reproduction” means AHR treatment involving the use of the gametes of person (D), or of an embryo created by the use of such gametes,

subsequent to the death of such person;”.

Amendment agreed to.

I move amendment no. 19:

In page 15, to delete lines 28 and 29 and substitute the following:

“(i) a designated institution of higher education (within the meaning of the Higher Education Authority Act 2022) in receipt of public funding;”.

Amendment agreed to.

I move amendment No. 20:

In page 16, to delete lines 14 to 25 and substitute the following:

“ “relevant donation (E)” means, as appropriate—

(a) a donation of supernumerary embryos made in accordance with—

(i) section 29(1), or

(ii) the law of a jurisdiction other than the State,

for use in the provision of AHR treatment in accordance with this Act, or

(b) the supernumerary embryos the subject of such donation;

“relevant donation (ER)” means, as appropriate—

(a) a donation of supernumerary embryos made in accordance with—

(i) section 30, or

(ii) the law of a jurisdiction other than the State,

for use in the undertaking of ESC research in accordance with this Act, or

(b) the supernumerary embryos the subject of such donation;

“relevant donation (G)” means, as appropriate—

(a) a donation of gametes made in accordance with—

(i) section 26(1) or (2), or

(ii) the law of a jurisdiction other than the State,

for use in the provision of AHR treatment in accordance with this Act, or

(b) the gametes the subject of such donation;”.

This amends the definition of relevant donation of gametes and embryos to clarify that in relation to the use of donated material from outside the State it must be ensured that such donations were made in accordance with the law of the jurisdiction concerned.

Amendment agreed to.

I move amendment No. 21:

In page 17, between lines 8 and 9, to insert the following:

“ “relevant storage (T)” means, as appropriate—

(a) the storage of tissues by the holder of a licence pursuant to the provisions of the licence, or

(b) the tissues the subject of such storage;”.

Amendment agreed to.

I move amendment No. 22:

In page 17, between lines 16 and 17, to insert the following:

“ “relevant storage period (T)”, in relation to a relevant storage (T), means —

(a) if applicable, the shorter storage period (T) specified for such storage, or

(b) in any other case, the period specified in section 41*(1)(a)(ii)(I) or (II), as appropriate (including any such period as extended under section 41*(3)(a));”.

Amendment agreed to.

I move amendment No. 23:

In page 17, between lines 20 and 21, to insert the following:

“ “relevant storer (T)”, in relation to a relevant storage (T), means the holder of the licence undertaking such storage;”.

Amendment agreed to.

I move amendment No. 24:

In page 17, between lines 24 and 25, to insert the following:

“ “section 51 application” shall be construed in accordance with section 51(2);”.

Amendment agreed to.

I move amendment No. 25:

In page 17, between lines 30 and 31, to insert the following:

“ “shorter storage period (T)”, in relation to a relevant storage (T), means the shorter period (if any) specified for such storage in a section 18 consent pursuant to section 18(2)(d)*;”.

Amendment agreed to.

I move amendment No. 26:

In page 18, to delete line 21 and substitute the following:

“ “surrogate mother” means, subject to sections 52(2) and 87*(2), a woman referred to in the definition of “surrogacy”;”.

This looks to amend the definition of surrogate mother by adding reference to provisions limiting the number of times a woman can act as a surrogate.

Amendment agreed to.

Amendment No. 27, amendment No. 1 to amendment No. 27 and amendments Nos. 57 to 65, inclusive, and 88 are related and will be discussed together.

I move amendment No. 27:

In page 18, between lines 21 and 22, to insert the following:

“ “surviving partner” means the surviving female spouse, female civil partner or female cohabitant of a deceased person at the time of the person’s death;

“tissue” means —

(a) human testicular tissue which has been retrieved from the body of a male, or

(b) human ovarian tissue which has been retrieved from the body of a female.”.

I move amendment No. 1 to amendment No. 27:

In the definition of “surviving partner”, to delete “female spouse, female civil partner or female cohabitant” and substitute “spouse, civil partner or cohabitant”.

Amendment No. 27 is to do with the discussion that Deputy Shortall and I have just had. As well as the definition of "surviving partner" for posthumous human assisted reproduction, or PAHR, the amendment also includes a definition of "tissue", which is related to the grouping of the earlier amendments beginning with amendment No. 7.

Amendment No. 88 also includes my amendment to delete the definition section from the PAHR part as these definitions have all been moved to section 2 of the Bill.

The rest of amendment No. 88 and amendments Nos. 57 to 65, inclusive, are directly related to the discussion we have just had around posthumous access for a man or a woman to frozen gametes.

Which the Minister is prepared to look at again.

Yes. It needs to be looked at. I thank the Deputy for the amendments.

Is Deputy Shortall withdrawing her amendment to amendment No. 27?

Amendment to amendment, by leave, withdrawn.

The only chance we have to speak on these is in the grouping. I have proposed amendment No. 88. I apologise to the Minister as I had to step out of the meeting for a few minutes. With regard to amendment No. 88, I am not sure if it is the same issue the Minister has just said to Deputy Shortall that he might be able to resolve. The current draft allows women to use these embryos in the event of the death of their partner but it does not allow men, regardless of whether it is a heterosexual or same-sex couple. Is that the same issue that was discussed to be looked at?

Yes, exactly the same.

Is that on Report Stage?

What I would like to do, and which would be quite useful to have, is a discussion on it and get the views of the committee. I am aware the Deputy has tabled the amendments. It is a complex area. I would be very happy to have a discussion around the various options. I am not convinced that what we have before us is entirely correct. I believe this is partly to do with the previous iteration of the Bill. It needs another look on two counts: on whether it is only the woman who can access the gametes, and on a provision I am not comfortable with, which was in the original drafting, where the woman must wait 12 months from the death of her partner before she can have access.

I appreciate that maybe there is an element of work there but I believe it was agreed at the briefing session we had with the Minister's officials that there will be a number of sessions. We are getting through it reasonably quickly but there will still be a number of sessions of this committee. In between those sessions we have an ability to put in additional Committee Stage amendments, to which I am sure the Minister has the same entitlement. On this issue and maybe other issues where the Minister will reflect, is it the case that he could come back with Committee Stage amendments for future sessions or does the Minister believe these would be Report Stage amendments?

I am happy to be open to correction on this but my understanding of the process is that we will not be able to come back here because we are moving through the Bill. We can all submit for parts coming up in next while.

In the future. Okay.

What I would like to seek agreement on is Report Stage.

Report Stage. Perfect.

Amendment agreed to.

Amendments Nos. 28 and 104 are related and will be discussed together.

I move amendment No. 28:

In page 18, after line 38, to insert the following:

“(6) A reference in this Act to a single intending parent includes a reference to a surviving intending parent referred to in section 51(3) or 86(2)(b)(i), as appropriate.”.

Amendments Nos. 28 and 104 seek to provide that any reference to a single intending parent includes the surviving partner in a couple who were involved in a surrogacy agreement but one of whom died subsequent to any relevant embryo transfer. I wish to flag that this particular issue is being looked at again by the three Departments and the Office of the Attorney General. We want to make sure before Report Stage that this provision is consistent with those in the rest of the Bill and aligns with other legislation.

Amendment agreed to.
Section 2, as amended, agreed to.
Sitting suspended at 10.57 a.m. and resumed at 11.13 a.m.
SECTION 3

I move amendment No. 29:

In page 19, line 7, to delete “section 116” and substitute “section 77 or 116”.

Amendment agreed to.
Section 3, as amended, agreed to.
SECTION 4

I move amendment No. 30:

In page 19, line 15, after “Expenditure” to insert “, National Development Plan Delivery”.

Amendment agreed to.
Section 4, as amended, agreed to.
SECTION 5

I move amendment No. 31:

In page 19, line 18, after “Act” to insert “(other than in Part 11)”.

Amendment agreed to.
Section 5, as amended, agreed to.
NEW SECTION

I move amendment No. 32:

In page 19, between lines 28 and 29, to insert the following:

Review of operation of Act

6. (1) The Minister shall, not later than 3 years following the passing of this Act, carry out a review of the operation of this Act, subject to subsection (2).

(2) Where sections of this Act have yet to be commenced within the timeframe set out in subsection (1), these sections shall not be subject to the review under subsection (1) but shall be subject to a subsequent review not less than 5 years following the passing of this Act.”.

My amendment is very straightforward. We seek a new section 6 review of the operation of the Act. As in a lot of Acts, we always seek to have a review built in.

Earlier the Minister mentioned the complexity of this issue and that there will be issues that we may need to come back to, at some point, that we cannot deal with here. My amendment proposes that there be an initial review within three years, which is a very reasonable period, and then a statutory obligation to review it. I am not sure if that is an option that the Minister has examined himself or given consideration to in terms of what a review process would look like or what reasonable timeframe there should be for a review. I do not want to hold up the meeting and will only say that because of the complexity, and range of issues that are at play, my amendment is important. Given this is a big Bill with all of these amendments, and a whole new Bill going into an existing Bill, it is prudent to make provision for a review.

I thank the Deputy. Given the complexity of the Bill and what we are trying to achieve, it is inevitable that some things will work well and some things will not work as well as we want them to work or there may be unforeseen circumstances, particularly some parts of this Bill like international surrogacy for which we believe Ireland will be the first country to legislate. Inevitably, there will be things that a future Government and Oireachtas will want to examine. Therefore, a review makes a lot of sense.

I agree with the timing stipulated in the amendment. I have asked my officials to check the exact wording of the amendment to see if it fits technically and they have told me that it does. Therefore, I am happy to accept the amendment.

Amendment agreed to.
Section 6 agreed to.
SECTION 7

I move amendment No. 33:

In page 20, line 10, to delete “both” and substitute “the”.

Amendment agreed to.

I move amendment No. 34:

In page 20, line 12, to delete “use” and substitute “provision”.

Amendment agreed to.

I move amendment No. 35:

In page 20, line 15, to delete “both” and substitute “the”.

Amendment agreed to.

I move amendment No. 36:

In page 20, to delete line 17 and substitute the following:

“(4) Subject to section 126(6), nothing in this Act shall be construed to prejudice the operation of the Act of 2007 or the Act of 2015.”.

Amendment agreed to.

I move amendment No. 37:

In page 20, between lines 23 and 24, to insert the following:

“(6) A reference in this Act to a surrogacy, not being a reference to a surrogacy in section 2 or 52(2), Part 8 or 11 or the long title to this Act, does not include a reference to a surrogacy to which Part 8 or 11 applies.

(7) A reference in this Act to a surrogate mother, not being a reference to a surrogate mother in section 2 or 52(2) or Part 8 or 11, does not include a reference to a surrogate mother in so far as she is a surrogate mother under a surrogacy to which Part 8 or 11 applies.”.

Amendment agreed to.
Question proposed: "That section 7, as amended, stand part of the Bill."

Section 7(1) states: "In the case of two intending parents, they shall be spouses, civil partners or cohabitants of one another." Again, what I want to say is in line with some of the issues that I have raised. Some groups would argue that cohabitation should not be a requirement. The reference that I was given is that in 2015 the European Court of Human Rights ruled on gay marriage in Italy and found that the right to respect family life does not require a cohabitation element. Has that been considered?

It has been considered. I might ask one of my officials to provide some more background.

Mr. Colm McGennis

Yes, from the point of view of the welfare of the child and other issues to have some kind of a "durable relationship". I know that term is fashionable at the moment in another context. It is the only way that we can verify that a relationship is durable.

What is that based on now?

Mr. Colm McGennis

If we say somebody is married or in a civil partnership and then-----

I just think we are getting into the area of opinion there. I have quoted the ruling of the European Court of Human Rights and surely that should be a reference point at least. Was it taken into consideration? We can talk about supposition or individual feelings about this but there is a ruling. I am just putting this matter out there and I ask the Department to take a look at it.

Mr. Colm McGennis

Yes. I suppose it is just finding a way to kind of have that permanent relationship, and it ties in with maybe people needing AHR treatments because they have been trying for a sufficient period to conceive.

The referendum does not refer to cohabitation. The Department might take a look at this and we will come back to it on Report Stage.

Ms Pamela Carter

I suppose it will be included in looking at other jurisdictions and precedents, given that this is a new area. We will certainly look at it.

Question put and agreed to.
Sections 8 to 11, inclusive, agreed to.
SECTION 12

Amendments Nos. 38 and 39 are related and may be discussed together.

I move amendment No. 38:

In page 22, between lines 7 and 8, to insert the following:

“(d) The AHHRA shall produce a format of the AHR information document in both plain English and easy read.

(e) The AHR information document shall use gender neutral terminology and shall include information specific and relevant to the lives and needs of disabled people.”.

I have already made reference to this. The amendment is about the need for information about this complex area to be in plain English and easy to read. I have already made a couple of references to the need for gender-neutral terminology and also that this information would be specific and relevant to the lives and needs of people with disabilities.

My amendment is very similar but there is an additional provision in Deputy Shortall's amendment. I will withdraw mine and support her amendment. The thrust of my amendment came from an advocate or colleague from the Independent Living Movement Ireland, Ms Selina Bonnie. Sadly, Selina passed away earlier this year. Essentially, what she was looking for was that we would recognise the importance of accessibility and inclusivity in the AHR legislation. This was a suggested amendment that came through that body and was authored by Selina. We were asked to submit it, which we did. As Deputy Shortall said, it is to ensure the language is accessible for people with disabilities but also in plain English. I missed the previous response the Minister may have given to this. I will withdraw my amendment on the basis that there is a similar one with an additional provision and will be supporting Deputy Shortall's amendment.

I thank both Deputies for the amendments. I certainly agree with the intent. It is complex and it will be essential that the information provided is easy to understand and breaks everything down. On the back of receiving these two amendments, I have asked my Department to engage on this, most importantly with the Department of Children, Equality, Disability, Integration and Youth, with a view to either coming back on Report Stage with an amendment or a recommendation that this is included in regulations. It might be the kind of instruction to the authority that we want to tweak and update, which is much easier to do through regulations than legislation. If colleagues are willing to bear with us, we can come back with an advisory note on how best to proceed. I certainly agree with the intent.

I am happy to withdraw the amendment on that basis.

Amendment, by leave, withdrawn.

I move amendment No. 39:

In page 22, between lines 7 and 8, to insert the following:

“(d) The AHHRA shall produce a format of the AHR information document in both plain English and easy read and shall include information specific and relevant to the lives and needs of disabled people.”.

Amendment, by leave, withdrawn.
Section 12 agreed to.
SECTION 13

I move amendment No. 40:

In page 22, between lines 26 and 27, to insert the following:

“(4) The AHR information document for a type of AHR treatment to be provided for the purposes of facilitating a relevant storage (T) for a person shall inform the person that, when the relevant storage period (T) expires, the tissue, if it remains unused at the time of such expiration, will be disposed of unless, before such expiration, the AHRRA grants under section 41 an extension to the relevant storage period (T).”.

Amendment agreed to.
Section 13, as amended, agreed to.
SECTION 14

Amendments Nos. 41 and 69 are related and may be discussed together.

I move amendment No. 41:

In page 23, to delete lines 38 to 40, and in page 24, to delete lines 1 to 13.

Amendments Nos. 41 and 69 in combination remove the requirement from section 14 for a donor in a surrogacy agreement to receive an AHR information document. Instead, they specify, in section 24, more detail on the important relevant aspects as part of such a donor's informed consent process. This is in line with the approach followed in respect of donations under the Children and Family Relationships Act 2015. It will ensure the informed consent of donors, as they will be required to confirm that they understand the legal effect of their donation as part of the consent process.

Amendment agreed to.
Question proposed: "That section 14, as amended, stand part of the Bill."

I just want to raise a couple of points under this. The LGBT+ parenting alliance has made three proposals in relation to this section. I would like to hear the Minister's views on them. The first is that the surrogate would not be automatically assigned legal recognition as the mother.

Will the Deputy repeat the last point she made?

This is on section 14. Some general points have been made by the LGBT+ parenting alliance. The surrogate is not automatically assigned legal recognition as the mother but she would have an objection period prior to the birth. We discussed this at the briefing last week, namely, the status during the period between the child being born and the parental order being made. I asked the Department of Justice how long it would be likely to take, given the waiting lists in the courts and so on for a parental order application to be heard. Could that be a lengthy period? I am thinking of the difficulties as regards what happens in the meantime.

The other request is that in the event of a conflict, there would be a legal mechanism to dispense with the surrogate's consent to the parental order where it is in the best interests of the child. Instinctively, you would be inclined to think that should not apply to the surrogate but there may well be circumstances where the best interests of the child are not served, for example, if there is a change of mind or the agreement is not followed through. The other area is that the surrogate should not be registered on the birth certificate but, rather, only on the national surrogacy register. The alliance argues that the child needs legal certainty from birth, since it may be some time before a parental order is granted, in terms of who can make decisions and who will have legal custody. There may well be critical medical decisions that have to be taken during those early weeks and months of the child's life. The Department is of the view that the birth mother is the legal mother and has determined that her parentage has to be transferred and her consent is absolute. In the context of surrogacy, should that "absolute" remain? Given that the surrogate would have no gestational link to the child and there is no legal precedent, should she have absolute discretion?

I am not looking for an answer here and now. These are some of the very tricky issues that will arise. In circumstances where the prior agreement goes wrong or the surrogate does not follow through on that, possibly changes her mind, moves or whatever, what is the legal status, then, of that child? Is there no input in relation to the agreement that has been reached prior to the pregnancy? Do the intending parents have no rights? Who takes on responsibility where the best interests of the child may not be served? You would hope this situation would not arise but it is quite possible that it would. There is a need for clarity on the status of the child and who can take critical decisions.

I have the same issue.

I was going to let the Minister respond to Deputy Shortall and then take Deputy Cullinane individually. It is up to the Deputies. What is easier, Minister?

Whatever the members prefer.

This is a useful time to get clarity on that process in respect of a parental order and what happens from the time of birth until a parental order is granted. We had some lengthy discussions with the Minister's officials on that issue when we got a briefing. One of the issues was the capacity of the courts to make a decision and hear these cases, and what would be a reasonable timeframe for a parental order to be granted or for a hearing.

Obviously, that will be an important part of it because we do not want a lengthy gap between the birth and a parental order being granted. However, my understanding of the briefing we got was that the intending mother would be a guardian of the child until such time as a parental order is given, in which case all rights of the birth mother would then be extinguished by virtue of the court order. I would appreciate if that could be clarified.

Other issues arose in terms of status, so it is just important for us to get clarity. If the intending mother is a guardian, does that intending mother have access, for example, to maternity leave and other entitlements under social welfare protections? There are other issues Deputy Shortall raised with regard to other rights of that mother in the intervening period. It is such an important part of the process and there is that gap. There is maybe some confusion as to what the intending mother may or may not be entitled to. I would like to get clarity on that main point that the intending mother would be a guardian until such time as there is a parental order. However, what rights then in terms of social protection and other legal rights does the mother have or maybe not have from the point of having guardianship to a full parental order, if that makes sense? I will leave it at that.

I will take Deputy Durkan and then Deputy Hourigan.

This is a particularly complex aspect of the legislation. As Deputy Shortall pointed out, the things that can happen, will happen. It has already happened, in fact. The situation could arise where an agreement is entered into in good faith by both parties but for some reason, and there may well be compelling reasons, one or either party could break that agreement. That raises a whole series of issues that I do not know that we have anticipated at this stage without a particular course of action in a series of circumstances. The change may come about as a result of the surrogate, the child and the rights of the child afterwards in the event of one party being removed from the equation for a variety of reasons, perhaps by passing away. It gets very complicated at that stage.

We have all dealt with those cases already and they are not simple to deal with. We have to be very specific on what happens because otherwise we are seen to be unfair to one or other of three parties. If then a third party or relative of either of the parties enters into the equation as well, it makes it even more complicated. I would like to see that issue very well fleshed out with the assurance that we are eliminating as many of the pitfalls as possible. That is all we can do because there will be pitfalls.

Deputy Cullinane has dealt with one of my questions around the clarification of the position of parents who are in that guardian role in the interim period and what their entitlements would be in terms of maternity and paternity leave and all of those kinds of social supports.

There is a significant issue around the early weeks of birth where there might be medical issues and decisions to be made. They are often not black and white issues. Sometimes, they are grey area issues and judgment calls. We need some clarification around the absolute nature of the rights of the surrogate in that regard. Perhaps there might be a role for a guardian ad litem system where a third party is involved to ensure that all stakeholders, shall we say, or all parents and the child's best interests are considered.

I thank the Deputies very much. I will come to some of the substance now but on a procedural note, we have moved into a discussion on surrogacy. My understanding was that we were going to try to do the assisted human reproduction bits in this session and then move to surrogacy in the next session. These are many of the pressing questions, however. I suggest that I give some short answers now, but I propose that we arrange another informal briefing session in the Department covering the various issues we have discussed already, such as the posthumous issues and this issue as well. We have been dealing with and teasing these out for a long period. In fact, exactly the issues members have just raised are one of the reasons it has taken so long. There are constitutional issues here. It goes right to the core of the surrogacy piece. I propose a brief answer now and we will then have a briefing in the Department of Health. The officials have taken note of all of these questions. We will also get a briefing document together and then we will get into the specifics of it on the next Committee Stage meeting, if members are agreeable to that.

I am sorry, Minister. On a point of order, I thought we were required to go through the Bill section by section.

Yes, and the surrogacy parts are later in the Bill.

Yes, but section 14 addresses some of that. I am raising this question under section 14.

Some is the issues cross over and have impacts across both.

They are not entirely separate.

That is fair. The way we had intended to deal with it was section by section, so I accept that. Some of the issues that-----

I am sorry; does the Minister want us to park section 14?

The substance of these questions is dealt with later on if colleagues are happy enough.

I am being told that we cannot do that anyway.

Okay. Some of the issues that have just been raised-----

I am sorry, Minister. We cannot agree to section 14 unless we tease out some of these questions.

Fair enough. However, the legislation and the amendment are speaking exactly to this. I note there is a lot of cross-referencing in this section but the substance of the issues that are being raised are dealt with in later parts of the Bill. Therefore, if we wanted to make changes, it is to later parts of the Bill rather than this section. At least, what we were trying to agree with the committee is that this how we would move through this.

It is not that cut and dried, really.

I beg your pardon.

It is not cut and dried.

It is not, no. Some of the issues raised include the status and rights of the birth mother, the status and rights of the intending parents, the entitlements of the intending parents, maternity leave, maternity pay, etc. Also, I do not think colleagues raised it, but it works in the opposite direction as well. What if we have a surrogate and intending parents, and some way through the pregnancy those intending parents say they have changed their mind or something catastrophic has happened in their own lives and they cannot. Have they any obligations or is the surrogate mother left with the child, which was not the intention? It is complex. There are significant differences between birth certificates at home and abroad because if children are born abroad, they get a birth certificate from abroad. We are trying to incorporate all of that into birth certificates at home.

Yes. The length of the interim period and so forth. To give some brief answer to some of the questions, the current status and proposals-----

I am sorry; before the Minister gives those brief answers, he is saying there will be a comprehensive briefing note in advance of a further briefing on all those issues he just listed and the other issues we raised.

And a meeting. Many of these issues will arise anyway in the later sections.

They all will. I am happy with that.

They all will. It goes right to the heart of the surrogacy parts of the Bill.

Will that include a potential resolution to cross-border situations where a different law applies in different jurisdictions?

Fully and comprehensively.

Yes, both in terms of assisted human reproduction or donor assisted and surrogacy. For example, let us say a woman is pregnant through IVF in New York and goes into labour New York. The birth is recorded in New York and not Ireland and the birth certificate is issued in New York. Therefore, yes, it covers domestic and international surrogacy and domestic and international birth through non-surrogacy AHR.

How does that apply in general? For instance, we could find a situation where the mother was maybe in two or three jurisdictions for climatic reasons, flights, storms or whatever the case may be.

Has that been fully anticipated so that what should happen can happen or will prevail? It could be in a different area. It could be in Asia, Europe or the United States. The Minister said it is anticipated in this particular section that we will do everything possible to resolve the potential hazards.

I will give the Deputy an example. It is of a couple who live in Kerry who go to France for donor-assisted IVF treatment, the sperm comes from Holland and they are on holidays in Morocco when she goes into labour.

It is getting complicated.

The Minister did say Kerry.

That is right. We have had to think through all of these scenarios as a committee. That is why this Bill has taken so long. In response to Deputy Shortall's point, insofar as we can, we have to anticipate all of this and legislate for it. It is complex. The point has been made to me that some of this is being addressed through the Children and Family Relationships Act as well, hence some of the amendments to it as well. It is complex.

Will that briefing take place before we meet again as a committee?

Yes, if colleagues are agreeable. Several issues have been raised. We will arrange a briefing in the Department. In some cases, we will ask a bioethics expert and, in others, a legal expert. In some cases, it will be my officials; in others, it will be officials from the Department of Justice. We will bring all the relevant expertise around the table.

What was absent from the latest briefing was any feedback from the Department of Social Protection. Issues obviously arise in that regard, some of which I have raised. They are issues on which we would want to get a bit more clarity at the next briefing. It may not have been fully resolved yet.

Yes, it is being followed up. The Deputy raised that point. Maternity benefit is a matter for the Department of Social Protection and officials will engage with that Department.

What about child benefit?

Yes, child benefit and all of that.

Child benefit is easier, but issues relating to maternity benefit, parental leave and maternity leave must all be considered. There is a position. I could give Members a brief answer now or we can wait until the briefing and then get into it when dealing with the surrogacy parts of the Bill.

We will wait for the briefing.

Okay, we will wait for the briefing.

Question put and agreed to.
SECTION 15

Amendments Nos. 42 and 43 are related and may be discussed together. Is that agreed? Agreed.

I move amendment No. 42:

In page 24, to delete lines 19 to 23 and substitute the following:

“(b) the provider is satisfied that, in all the circumstances of the case—

(i) such treatment is necessary to—

(I) enable pregnancy or birth or both,

(II) enable fertility preservation, or

(III) avoid, in accordance with the provisions of Part 6, serious disability or illness in a child,

(ii) such treatment does not pose a disproportionate risk to the health of a child that may be born as a result of such treatment, and

(iii) where the person is a woman, pregnancy or birth, following such treatment, does not pose a disproportionate risk to her health.”.

This amendment clarifies that AHR treatment can be provided for reasons including fertility preservation or pre-genetic testing, PGT.

I might read this Part because I am referencing different subsections and paragraphs and it is easier if I read it.

I intend to move amendment No. 43. A concern was raised with me that the section, as currently drafted, would exclude persons who wish to freeze their eggs. Such persons would not necessarily comply with the section 15(b), which requires a woman receiving AHR treatment to be unlikely to become pregnant or give birth without such treatment.

A similar concern was raised that this section does not take into consideration that the surrogate is a recipient of AHR treatment, as defined under the Bill, and that she would not qualify for treatment under section 15(b). I ask the Minister to clarify those issues.

I thank the Deputy very much. I understand the intention. Amendment No. 42 addresses the concerns he quite rightly raises and it goes that bit further in being more broad as well. I agree with him and I think the issue is covered.

Amendment agreed to.

I move amendment No. 43:

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

“(2) Notwithstanding subsection (1), an AHR treatment provider may provide AHR treatment to a person for the purposes of retrieving and cryopreserving a gamete in anticipation of a DAHR procedure in the future.

(3) Nothing in this Act shall be construed as excluding the provision of AHR treatment to a surrogate who is a party to a surrogacy agreement approved by the AHHRA pursuant to section 51 of this Act.”.

Is it the Minister's view that the issue is covered under amendment No. 42?

On that basis I will withdraw my amendment.

Amendment, by leave, withdrawn.
Section 15, as amended, agreed to.
NEW SECTIONS

Amendment No. 44, amendment No. 1 to amendment No. 44, and amendments Nos. 45, 105, and 106 are related and may be discussed together. Is that agreed? Agreed.

I move amendment No. 44:

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

“Safety of children - AHR treatment provider

16. (1) This section shall not apply where section 52* applies to the relevant person in relation to the surrogacy agreement concerned.

(2) An AHR treatment provider shall not provide AHR treatment to a relevant person unless the provider is satisfied that the relevant person, and each other relevant person, does not present a potential significant risk of harm or neglect to—

(a) any child that may be born as a result of such treatment, or

(b)any other child.

(3) (a) Subject to paragraph (b), the AHR treatment provider shall, for the purposes of subsection (2), make a request in writing to each relevant person to complete and submit to the provider within the period specified in the request (being a period reasonable in all the circumstances of the case), a return in the specified form (in this section referred to as a “section 16 return”) attached to the request.

(b) Subject to paragraph (c) and subsection (7), the Minister—

(i) shall, as soon as is practicable after the commencement of this subsection, by regulations specify the information, or information falling within a class of information specified in the regulations, that a section 16 return may require a relevant person, or a relevant person falling within a class of relevant persons specified in the regulations, to provide, and

(ii) may by regulations specify the circumstances (if any) in which such information may be further disclosed by an AHR treatment provider in addition to further disclosures required by law.

(c) Where the Minister makes regulations under paragraph (b), he or she shall, in addition to having regard to the other provisions of this Act, have regard to the following:

(i) that, in determining the information to be specified, the paramount consideration is the safety of any child referred to in subsection (2);

(ii) that the information sought needs to be appropriate and proportionate to satisfying the AHR treatment provider as referred to in subsection (2);

(iii) that any information sought which may reasonably be regarded as sensitive information is protected from any unnecessary further disclosure by the AHR treatment provider concerned except where such further disclosure is required by law.

(d) The AHRRA shall, in specifying different forms of section 16 returns, ensure that the forms are consistent with the regulations made under paragraph (b).

(4) Subject to subsection (5), where the AHR treatment provider is not satisfied after having assessed the section 16 returns concerned, as referred to in subsection (2), the provider shall, as soon as is practicable after the expiration of the period concerned referred to in subsection (3)(a), by notice in the specified form (in this section referred to as a “section 16 notice”) given to each relevant person, state the reasons why the provider is not so satisfied.

(5) For the purposes of subsection (4), the AHR treatment provider may also assess information obtained otherwise than from a relevant person.

(6) An AHR treatment provider shall retain the original or a copy of—

(a) a section 16 return,

(b) a section 16 notice,

(c) information referred to in subsection (5) which is in writing, and

(d)any note made in writing, by the provider, of information referred to in subsection (5) which is not in writing, for not less than 30 years after receiving the return, issuing the notice, obtaining the information or making the note, as the case may be.

(7) On and after the establishment day, the Minister shall not make regulations under subsection (3) except after consultation with the AHRRA.

(8) In this section, “relevant person”, in relation to any child that may be born as a result of AHR treatment, means—

(a) in the case of two intending parents, each of the parents,

(b) in the case of a single intending parent, that parent and the parent’s spouse, civil partner or cohabitant (if any), and

(c) in the case of a surrogate mother, that mother and her spouse, civil partner or cohabitant (if any).”.

Amendment No. 44 proposes to replace section 16. However, this is mostly due to a number of refinements in some of the terms used. The major change brought by amendments Nos. 46 and 106 is to confirm that while the relevant fertility clinic will undertake the safety of children assessment for AHR treatment provided in Ireland, the AHRRA will do so in respect of surrogacy as part of its pre-conception application process.

I move amendment No. 1 to amendment No. 44:

In subsection (2), to delete “unless the provider is satisfied that the relevant person, and each other relevant person, does not” and substitute “if the provider is aware that the relevant person, and each other relevant person, would”.

This amendment was proposed by AHR professionals. They have probably been in touch with the Minister. While they are fully supportive of efforts to ensure the welfare and safety of any child born through AHR, they are concerned about the implications of the current wording. They argue that AHR providers may not have the skills, expertise or means of access to sensitive data to fulfil this role. Furthermore, they suggest that over-investigation of a case by a provider may be inappropriate and could lead to discrimination of vulnerable groups. Instead, they call for a greater reliance on child protection laws. There is a question there of whether we are expecting too much of medical professionals who do not have access to data and if some other mechanism should be provided.

I have a very similar amendment on the same issue. We had a lengthy discussion with the officials on this issue and we got some clarity on it. What was explained to us is that the threshold of the obligations on providers to ensure there is not any risk to the child is lower than originally intended because of some of the changes that were made. Having said that, it is a very extensive obligation to place on fertility clinics and providers of services. We all want to make sure there are very robust protections for children. Nobody is arguing that they should not be there.

My understanding of what was said by the officials is that there is a self-declaration process, so the intending parents, for example, will have to fill in a self-declaration form, as any of us do if we are going to the United States, about whether they were ever in jail. The Minister knows the obvious questions that people are asked. Perhaps there are some very similar questions asked in this regard. That declaration is fine from the perspective of the intending parents, but we are setting a legislative bar here and we are saying there is an onus and responsibility on the provider to satisfy itself on the risk. That is something that will be very difficult for providers to do because, for example, they do not have access to Garda vetting. We are asking them to essentially take at face value what is being said by the intending parents but the obligation is onerous.

Deputy Shortall has suggested an amendment along the lines of the provider being aware, which might be better wording. Legislative thresholds and bars that have to be hit are very important. As I said at the briefing, it is always the hard cases that get the attention and become subject to very critical questions if, for example, something was missed, possibly through no fault of a provider. People could say the providers had an obligation and they signed off on it, even if they had no way to investigate and nobody wants them to do that. For those reasons, we had a very lengthy discussion. This is a very important issue that needs to be clarified. If we could amend the provision while still having a level of protection, that might be a better way to deal with this from a legislative perspective.

I am interested in the Minister's thoughts on it.

I thank Deputies Shortall and Cullinane for the proposal. We are trying to find a balance here. We want some level of assessment and the question is where we set the bar. In other jurisdictions, the bar is set even higher than what we are proposing, which is that they are "satisfied". The providers are seeking to lower the bar to "aware" but I think that is too low. We must remember that we will have providers who intending parents go to off their own bat. There will be cases where there is no State involvement so we have to have some sort of protection in place. I know that the providers want "aware". That is their proposal but I am not inclined to accept that. As Deputy Cullinane said, the "satisfied" bar is achieved via a self-declaration, where at least there is some material to be looked at. It requires the intending parents to answer some questions and at least then there is a requirement on the provider to look through those. It does not require Garda vetting. That is not the point.

Both Deputies have asked the fair question as to what "satisfied" means. Legally, how can the clinics say they have met their legal obligations under the act? Perhaps what we should do is get a clarifying note on "satisfied" because it is less onerous than some of the providers might think in the context of concerns about Garda vetting and so on. I do not think we should move to just "aware" because it places a pretty passive obligation on the provider rather than an active obligation to at least look at it. I am not going to accept the amendments but we can discuss this further and what might work is a clarifying note as to how the bar of "satisfied" is met.

Yes, I think a clarifying note would be helpful. For me, the thrust of the issue is the legal threshold here. The Minister hit the nail on the head when he asked what the definition of "satisfied" is because the organisations are concerned about what their legal obligations are. Insofar as they can, they will try to meet those obligations but it needs to be made very clear what they are. We do not have access to the legal advice the Minister and his officials have received but I am assuming that lots of legal opinion was sought on many issues in relation to this Bill. It is important that we clarify, not for me or for anybody on the committee, but for those providers, that what is being asked of them is exactly as was outlined to us in the briefing session. There is a self-declaration form that intending parents will have to fill out. There obviously has to be a level of trust, that those providers can trust the information they are getting and that has to be accepted but if there are any other obligations on providers, they need to be spelled out. That is not really clear and that is why there is some confusion as what the bar is and what they need to do to be "satisfied". A briefing note for us is one thing but what is in legislation is something else. In that context, has the Minister looked at a definition of "satisfied" or something in the Bill that outlines what the term means a bit more clearly? Is that something that could be looked at on Report Stage? We have seen this previously, where notes were given to Oireachtas Members as part of debates but it is what is in the legislation that is important.

I do not think a clarifying note will do it because there is a potentially very significant liability being placed on the providers to state that they are "satisfied" there is no reason intending parents should not be able to proceed. Medical professionals have no way of establishing that. On what basis do they say they are satisfied? A lot of the groups would have no difficulty with Garda vetting, for example. An Garda Síochána has access to PULSE and can conduct background checks and so on, whereas medical professionals are not in a position to do that. However, by stating that they "satisfied" they are leaving themselves liable to a claim being made against them about something that they have no means to establish. That is a very high bar to set. It is very prescriptive. It is not the principle of doing background checks that people are objecting to; they do not have a difficulty with that but those checks need to be done by an individual or agency that is capable of doing them. This goes further than just requiring a clarifying note. The Minister said that the term "aware" is not sufficiently strong and that is fine but there has to be something in between a statement that a medical professional is "satisfied" or is "aware". The former is a very strong statement for them to have to make without being able to satisfy themselves or to access the information that would satisfy them. This could be quite an obstacle. It is certainly putting a lot of medical professionals into a very dangerous or challenging situation and the Minister needs to look again at the wording on this.

The primary concern, which we all share, is to protect the child. That comes first.

I accept that, yes.

That is why it is "satisfied" rather than "aware". The advice we have received from the Department of children is that "satisfied" is what we want in the context of the protection of the child. We are now discussing what is reasonable to expect a provider to do. The way this can be dealt with is through very clear regulation from the AHRRA that will say, for example, that the following three things need to happen: there needs to be an open conversation; there needs to be a self-declaration; and there needs to be whatever else we decide. It is through regulation that we provide the legal certainty.

When the Minister says Aire does he mean himself or does he mean the AHRRA?

No, I mean the authority. It might be better if we had a different acronym for the authority because it is quite confusing.

Regulation is probably the way to deal with that because it might change over time. The Department of children might say that we need to keep in line with other things and might want to add something. I can say there is no intent here that providers would be conducting background checks. That is not the intent but I fully accept that from providers' perspective, it would be useful if they saw that written down. What clinicians have said to me is that sometimes they know instinctively that there is something there which means that this is not the right time for the intending parents. It is useful for them to be able to say, "Hang on a second, I am not entirely sure everything I am being told is true." There could be a risk to the child but they are not aware of it because they have no evidence of it but there is something that does not feel quite right. It at least allows for a mechanism to engage, when intending parents are asked to fill out the self-declaration.

Let us reflect on it. I accept the point around legal clarity but I think the way we deal with that is through regulations rather than in the legislation.

My concern about that is if a case ends up in court, it is the legislation that will be quoted rather than the regulations.

No. The regulations are------

They may also be referred to but the core interpretation will be in relation to what is set down in the primary legislation.

That core interpretation will be in secondary legislation. I am not a lawyer and correct me if I am wrong but it is my understanding that the courts will look to the regulations and determine whether regulation A, B, or C was satisfied. That is------

Why was there a reluctance to define "satisfied", as well as the requirements that would be on the provider, in the Bill itself? Is there a reason that was not considered and included in the Bill?

Yes, the reason being that it is a matter for the regulator or the authority to set that out. As per our previous conversation, this is new and it might be the case that with a bit of feedback or after the three-year review, issues-----

There are lots of issues that would be for the regulator, but we can be prescriptive. While the regulator has a job to do, it also has to take the lead from the legislation and what the Oireachtas has decided to do. If we wanted to, we could define what we, as legislators, mean in terms of "satisfied". The regulator then has to deliver on that and maybe add to it, but there is a basic threshold. The point is that we are not even at that stage. There is no definition of "satisfied" in primary legislation and that is problematic. The Minister said he will provide a briefing note. We can re-examine this, but there are some concerns. I will press my amendment and we can discuss this again on Report Stage.

On that particular issue, we need to acknowledge the level of responsibility on the provider and the need for the provider, in certain circumstances, to be able to stand over whatever decision was made on the basis that it was the best decision that could be made given the information available to him or her at the time. The counterpoint is that this should be in primary legislation and not dealt with by regulation. How does that leave the provider in respect of two cases that may be at loggerheads? There is a provider on the one hand and two points of view on the other being raised subsequently.

Clarity is provided through the regulations. The regulations are secondary legislation.

It has been argued that it should be dealt with by way of legislation rather than by way of regulation.

The regulations have legal standing. Most of the Covid measures, for example, were provided for through regulation.

The case is quite regularly made by various protagonists that something should be in legislation. A decision entered into on the basis of something being covered by regulation is not sufficient.

I ask the Minister to seek a legal opinion on the status of regulations in secondary legislation before the next meeting. We need to be satisfied that if it was included in secondary legislation it has the same level of protection.

I am open to correction, but it does. It is secondary legislation. Most of the Covid measures which were enforceable, and were enforced, were dealt with by way of statutory instrument rather than by primary legislation.

I ask for clarity. The Minister may well be right.

Sure. We could also potentially add a line stating that the AHHRA will stipulate the regulations which define the term "satisfied". We will get a note on it.

My understanding is that the regulations would be valid once the legislation provides for them. If they conflict in any way with the legislation, then the legislation will take precedent.

If the legislation provides for that, that is fine. If it in any way conflicts with the legislation, then the legislation is what a court will rely on.

We will get a note on it. In order to provide additional certainty, we may add a line stating the AHHRA will have regulatory power to define the term "satisfied". I take the Deputy's point. Providers need clarity. Let us provide clarity around the term "satisfied". I do not want to drop the bar and use the term "aware". I do not think that would be right in terms of child protection.

That seems to put a very considerable onus on the provider. The Minister can examine this. There may be some potential for tapping into child protection legislation and using some definition from that.

We will take a look.

Amendment to amendment put and declared lost.
Amendment agreed to.

There is a bit of confusion.

My understanding is that through my amendments we are seeking to delete and replace section 16.

That is amendment No. 44.

We dealt with that.

Yes. To be absolutely clear, amendment No. 44, which introduces the new section 16, has been passed.

If we delete section 16, how can the amendment state: "In page 24, between lines 23 and 24, to insert the following". It does not make sense. Are we deleting all of section 16 and replacing it with this amendment?

With the amendment, yes.

I might ask the official to give the Deputy a response to that.

Dr. Edward Keegan

The amendment to section 16 was of such a nature that the drafters removed section 16 and replaced it with the update wording. The new amendment-----

That is amendment No. 44.

I move amendment No. 45:

In page 24, to delete lines 25 to 29 and substitute the following:

16. (1) An AHR treatment provider shall not provide AHR treatment to a relevant person if the provider is aware that the relevant person, and each other relevant person, would present a potential significant risk of harm or neglect to-

(a) any child that may be born as a result of such treatment, or

(b) any other child.”.

Amendment put and declared lost.
Section 16 deleted.
SECTION 17

I move amendment No. 46:

In page 26, lines 7 to 13, to delete all words from and including “(1) Subject” in line 7 down to

and including line 13 and substitute the following:

“(1) (a) An AHR treatment provider shall not provide relevant AHR treatment to a person

seeking such treatment unless the provider is satisfied that the person and the relevant person have received AHR counselling in relation to such treatment.

(b) In paragraph (a), “relevant AHR treatment” means AHR treatment—

(i) involving the making or the use of—

(I) a relevant donation (E), or

(II) a relevant donation (G),

(ii) involving the provision of PAHR, or

(iii) involving surrogacy.

(2) (a) An AHR treatment provider shall inform any person seeking AHR treatment (not being relevant AHR treatment within the meaning of subsection (1)) that the person may, if he or she so wishes, receive AHR counselling as regards such treatment.

(b) The information referred to in paragraph (a) shall be in the specified form.

(3) Where an AHR counsellor is providing AHR counselling to two intending parents, he or she shall offer the counselling to the parents individually, together as a couple, or both.”.

Amendment agreed to.

I move amendment No. 47:

In page 26, to delete lines 26 to 30.

Amendment agreed to.
Section 17, as amended, agreed to.
SECTION 18

Amendments Nos. 48, 49, 54 and 55 are related and will be discussed together.

I move amendment No. 48:

In page 27, line 5, after “section 6” to insert “or 26(1)(b)(ii), as appropriate,”.

Amendments Nos. 48, 49, 54 and 55 are technical amendments to confirm that consent to donate a gamete or an embryo must be provided in accordance with the relevant provisions in both this Bill and the Children and Family Relationships Act 2015.

Amendment agreed to.

I move amendment No. 49:

In page 27, line 8, to delete “or 16” and substitute “, 16 or 26(2)(b)(ii)”.

Amendment agreed to.

I move amendment No. 50:

In page 27, to delete lines 20 to 40 and substitute the following:

“(c) specify the action to be taken in relation to a relevant storage (G), relevant storage (E) or relevant storage (T) if an intending parent dies or subsequently lacks capacity to make a decision in that regard where—

(i) the gametes concerned are their gametes,

(ii) the embryos concerned were created from their gametes or the gamete from one of them,

(iii) the embryos concerned were created for use in the provision of AHR treatment to one of the intending parents (or, in the case of a single intending parent, that intending parent), or

(iv) the tissues concerned are their tissues,

(d) specify that each intending parent (or, in the case of a single intending parent, that intending parent) may, in relation to a relevant storage (G), relevant storage (E) or relevant storage (T), specify in his or her section 18 consent a shorter storage period than the period referred to in paragraph (b) of the definition of “relevant storage period (G)”, paragraph (b) of the definition of “relevant storage period (E)” or paragraph (b) of the definition of “relevant storage period (T)”, as appropriate, where—

(i) the gametes concerned are their gametes,

(ii) the embryos concerned were created from their gametes or the gametes from one of them,

(iii) the embryos concerned were created for use in the provision of AHR treatment to one of the intending parents (or, in the case of a single intending parent, that intending parent), or

(iv) the tissues concerned are their tissues,”.

Amendment agreed to.

I move amendment No. 51:

In page 28, to delete lines 9 and 10 and substitute the following:

“(b) subject to the provisions of the Assisted Decision-Making (Capacity) Act 2015, the person had the capacity to give such consent at the time it was given, and

(c) section 17 has been complied with.”.

Amendment agreed to.

I move amendment No. 52:

In page 29, line 30, to delete “and 40(3)” and substitute “, 40(3) and 41(3)”.

Amendment agreed to.

I move amendment No. 53:

In page 29, to delete lines 32 to 37 and substitute the following:

“(a) any combination of shorter storage periods (G) applicable to the same relevant storage (G) to exceed, in total, the period specified in paragraph (b) of the definition of “relevant storage period (G)”,

(b) any combination of shorter storage periods (E) applicable to the same relevant storage (E) to exceed, in total, the period specified in paragraph (b) of the definition of “relevant storage period (E)”, or

(c) any combination of shorter storage periods (T) applicable to the same relevant storage period (T) to exceed, in total, the period specified in paragraph (b) of the definition of “relevant storage period (T)”.”.

Amendment agreed to.
Section 18, as amended, agreed to.
SECTION 19

I move amendment No. 54:

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

“(a) confirm that consent under section 6 of the Act of 2015 has been given by him or her as regards such donation,”.

Amendment agreed to.
Section 19, as amended, agreed to.
SECTION 20

I move amendment No. 55:

In page 30, to delete line 33 and substitute the following:

“(a) confirm that consent under section 14 or 16, as appropriate, of the Act of 2015 has been given by him or her as regards such donation,”.

Amendment agreed to.
Section 20, as amended, agreed to.
SECTION 21

I move amendment No. 56:

In page 32, to delete lines 6 to 21 and substitute the following:

“(2) The specified form of a section 18 consent shall, in the case of two intending parents who as a couple wish to effect a relevant storage (G) of their own gametes, a relevant storage (E) of their own embryos, or a relevant storage (T) of their own tissues, or any combination thereof, for use in their AHR treatment only, require each of the intending parents to separately—

(a) confirm that he or she has received the AHR information document concerned,

(b) subject to sections 39, 40 and 41, specify the maximum period for which the gametes, embryos or tissues, or any combination thereof, may be stored,

(c) specify what should be done with the unused gametes, embryos or tissues, or any combination thereof, if he or she subsequently—

(i) lacks the capacity to make a decision in that regard, or

(ii) dies,

and

(d) specify what should be done with the unused gametes, embryos or tissues, or any combination thereof, in the case of post factum differences of opinion or changes of circumstances.”.

Amendment agreed to.
Section 21, as amended, agreed to.
SECTION 22

I move amendment No. 57:

In page 32, line 29, after “sperm” to insert “or her egg”.

This provides for donor gametes to be used after a donor dies as long as he or she has consented. When we discuss that, there seems to be a lack of equality between males and females, particularly in circumstances where the donor is deceased and consent has been given to use the gamete. I do not know if the Minister is disposed to looking at that. Does he accept that there is an issue there? I think he has said that already-----

-----as regards equality. I am happy to withdraw amendments Nos. 57 to 65, inclusive, on that basis. We can return to this on Report Stage.

Amendment, by leave, withdrawn.

I move amendment No. 58:

In page 32, line 33, after “sperm” to insert “or her egg”.

Amendment, by leave, withdrawn.

I move amendment No. 59:

In page 32, lines 33 and 34, to delete “his death” and substitute “his or her death”.

Amendment, by leave, withdrawn.

I move amendment No. 60:

In page 33, line 6, after “that” to insert “he or”.

Amendment, by leave, withdrawn.

I move amendment No. 61:

In page 33, line 7, after “that” to insert “he or”.

Amendment, by leave, withdrawn.

I move amendment No. 62:

In page 33, line 8, after “that” to insert “he or”.

Amendment, by leave, withdrawn.

I move amendment No. 63:

In page 33, line 9, to delete “she understands that she” and substitute “he or she understands that he or she”.

Amendment, by leave, withdrawn.

I move amendment No. 64:

In page 33, line 11, after “that” to insert “he or”.

Amendment, by leave, withdrawn.

I move amendment No. 65:

In page 33, line 11, after “expressed” to insert “his or”.

Amendment, by leave, withdrawn.
Section 22 agreed to.
SECTION 23

I move amendment No. 66:

In page 33, lines 18 and 19, to delete “or relevant storage (E)” and substitute “, relevant storage (E) or relevant storage (T)”.

Amendment agreed to.

I move amendment No. 67:

In page 33, line 22, to delete “or relevant storer (E)” and substitute “, relevant storer (E) or relevant storer (T)”.

Amendment agreed to.

I move amendment No. 68:

In page 33, line 24, to delete “section 21(2)(e)” and substitute “section 21(2)(d)”.

Amendment agreed to.
Section 23, as amended, agreed to.
SECTION 24

I move amendment No. 69:

In page 34, to delete lines 6 to 11 and substitute the following:

“(a) consent to the recording of information required under section 59(2), and

(b) confirm that he or she understands that, under the law of the State—

(i) he or she shall not be a parent of any child born as a result of such use of such donation,

(ii) the information specified in section 59(2) in relation to him or her shall be recorded on the National Surrogacy Register,

(iii) the child, when he or she becomes an adult (AHR), may access the information specified in section 69(2) and seek to contact the donor,

(iv) the information that the donor is entitled to obtain from the National Surrogacy Register is restricted to the information specified in section 67(2),

(v) having regard to the child’s right to know his or her origins, it is desirable that the donor keep updated, in accordance with section 71, the information in relation to him or her that is recorded on the National Surrogacy Register, and

(vi) he or she has the right, in accordance with section 18(4), to revoke, or revoke and replace, such consent.”.

Amendment agreed to.
Section 24, as amended, agreed to.
Section 25 agreed to.
SECTION 26

I move amendment No. 70:

In page 34, lines 34 and 35, to delete “of such donation” and substitute “the gamete concerned was obtained by the provision of AHR treatment to that person”.

Amendment agreed to.
Section 26, as amended, agreed to.
Section 27 agreed to.
SECTION 28

I move amendment No. 71:

In page 35, line 18, after “embryo” to insert “, other than a supernumerary embryo,”.

Amendment agreed to.
Section 28, as amended, agreed to.
SECTION 29

I move amendment No. 72:

In page 35, line 33, to delete “of such provision” and substitute “the gametes concerned were obtained by the provision of AHR treatment to those persons”.

Amendment agreed to.
Section 29, as amended, agreed to.
Sections 30 and 31 agreed to.
SECTION 32

I move amendment No. 73:

In page 37, line 10, to delete “man” and substitute “male”.

Amendment agreed to.

I move amendment No. 74:

In page 37, line 11, to delete “woman” and substitute “female”.

Amendment agreed to.

Amendment No. 75 is in the name of Gino Kenny, who is not here, so it falls. I think he said he was doing Leaders' Questions. He apologised to the committee.

Amendment No. 75 not moved.

I move amendment No. 76:

In page 37, line 18, after “treatment” to insert “without the specific consent of the relevant donor (G) at the time of donation”.

Amendment, by leave, withdrawn.

I move amendment No. 77:

In page 37, line 22, after “treatment” to insert “without the specific consent of the relevant donor (E) at the time of donation”.

Amendment, by leave, withdrawn.
Section 32, as amended, agreed to.
Section 33 agreed to.
NEW SECTION

Amendments Nos. 78 to 81, inclusive, are related and will be discussed together.

I move amendment No. 78:

In page 37, after line 40, to insert the following:

“Payments in Respect of Relevant Donations

34. (1) Subject to subsection (2), the consent of a relevant donor under this Part shall not be valid where it is given in exchange for financial compensation in excess of reasonable expenses associated with the provision of the relevant donation concerned or the giving of consent under this Part.

(2) The consent of a relevant donor under this Act shall not be deemed to be invalid by virtue of the payment of a fee in addition to such reasonable expenses as defined in subsection (5), where the donation is made directly to a cryobank, as declared by order of the Minister pursuant to subsection (4) or (5) of this section to be a designated cryobank for the purposes of this Part.

(3) The Minister may, by order, declare that a cryobank is a designated cryobank for the purposes of this Part.

(4) The Minister may, by order, amend or revoke an order under this section (including an order made under this subsection).

(5) In this section—

“cryobank” means a bank, located within or outside of the State, which procures, cryopreserves, and makes available a database of, gamete donations for selection by intending parents;

“reasonable expenses” means, in relation to a donor, the donor’s—

(a) travel costs,

(b) medical expenses,

(c) any legal or counselling costs, and

(d) any loss of income while undergoing the relevant donation,

incurred by him or her in relation to the provision of the gamete or, as the case may be, the giving of consent under this Act;

“relevant donation” means—

(a) a relevant donation (G),

(b) a relevant donation (E), or

(c) a relevant donation (ER);

“relevant donor”, in relation to a relevant donation, means whomsoever of the following who made the donation:

(a) the relevant donor (G);

(b) the relevant donor (E);

(c) the relevant donor (ER).”.

This relates to the whole area of payment. It is a tricky area to legislate for. The point has been made that, given that Ireland does not have its own sperm bank and we are so reliant on other countries, such as Spain, Denmark and the Czech Republic, all of which pay fees to their donors, it is felt that this amendment is necessary; otherwise, we will rule out those countries. I appreciate the sensitivity of this and that we do not want to get into trafficking or that, but I think there are genuine issues here. I agree that gamete and embryo donation should be altruistic. The current section ignores the reality of existing AHR practices. If any kind of payment is ruled out unilaterally, we will greatly reduce the list of acceptable countries. This amendment would allow the Minister to designate which cryobanks are approved and ensure that all payments are made directly to the cryobanks and not to the donors. I feel this recognises the reality of the situation at present, while also having safeguards.

Rather than it being set down in legislation and being so restrictive, and maybe not taking into consideration existing practice but also expenses that are involved and how different cryobanks operate, it would be better to do that under regulation rather than primary legislation. I hope the Minister might consider that.

Amendment No. 79 is a technical amendment but will have the same effect. I have the same concerns as Deputy Shortall. My understanding is that the section as drafted will criminalise anyone who makes or receives a payment or makes a donation outside of what the Bill describes as reasonable expenses for their donation, which we support. As Deputy Shortall said, Ireland does not have its own sperm bank, so we will be reliant on cryobanks elsewhere. Will the Minister clarify the use of foreign cryobanks and how that will work in practice?

Other practical issues for donors have been raised with me in this context but I will not labour the point now. We might come back on Report Stage depending on the Minister's response. Genuine issues have been raised with us and we want them to be clarified.

I will read out the note I have before me. The amendments seek to allow for payments to donors beyond reasonable expenses and the Deputies have laid out the rationale for that. They also seek to allow the Minister to designate a cryobank or a donation facility for the purpose of the amendments. In line with EU law in the area, specifically the bloods and tissues directive, which has been transposed into Irish law through the European Communities (Quality and Safety of Human Tissues and Cells) Regulation 2006, the Bill allows for the payment of only reasonable expenses for the donation of gametes. This is an approach that was also followed in the Children and Family Relationships Act 2015. The directive will soon be replaced by a regulation on the standards of quality and safety of substances of human origin intended for human application, otherwise known as the SoHO regulation. This will similarly allow for payments to donors only for losses relating to their donation, as opposed to payment or profit. As a regulation, this rule will have a direct effect in Ireland. As such, the proposed amendments would be in conflict with the current approach in Irish legislation and our obligations under both current and incoming EU law. For this reason, I cannot accept the amendments.

I might ask my officials whether there is anything to supplement that.

Dr. Edward Keegan

To echo what the Minister said, this is a requirement at EU level. Most of the gametes used at the moment in donor-assisted human reproduction in Ireland, and as regulated under the Children and Family Relationships Act, come from cryobanks abroad, such as in Denmark. They will be subject to the same requirements and the payments in that regard relate to reasonable expenses. It is to ensure there is no financial incentive to donating, which could create risks relating to the safety of the donor, who might donate too many times, and to the veracity of any background information provided by creating that financial incentive. The EU law in the area relates to that and is to ensure it never goes beyond recompense but is always simply making up for the losses associated with it. That differs by country depending on the different standards in those countries, so there is no set sum and it is for national authorities to set. Under the Bill, therefore, reasonable expenses can be paid, which is the approach at the moment under the 2015 Act and allows for the use of those gametes from countries that are similarly transposing and using that body of EU law.

Is the Minister satisfied that the word "reasonable", as used in the legislation, is tight enough to avoid abuse?

Yes, I am. It is an established, existing practice that is happening now throughout Europe, as Dr. Keegan said. We do not have our own cryobanks. That does not mean we will not have them in the future and the legislation will facilitate that, but it is in line with the current EU directive and the current obligations.

The issue of reasonable expenses is adjudicated on as part of the court process but the court will have to be satisfied the expenses were reasonable and in line with what is intended. Is that correct?

I might ask my official to respond to that.

Dr. Edward Keegan

This will be for clinics when they are bringing in the gametes to ensure there has not been payment beyond payment for reasonable expenses, but it also goes towards the consent provided. It will vitiate the consent if it is based on a payment that was beyond reasonable expenses, that is, if there was a financial incentive to consent.

I do not think anyone wants there to be a financial incentive here - that is not the objective – but we also need to ensure we are not limiting the opportunities from different countries. There are a lot of variables in this, such as whether somebody is fully compensated for the loss of employment through a welfare scheme, and that may change over time. Rather than setting it in stone in primary legislation, it would seem to make sense that the Minister of the day would designate different banks and declare them acceptable for use. Things will change over time, depending on the government in a given country, and that flexibility would be helpful, rather than having this set out in primary legislation.

I take the Deputy's point, but all we are doing with the primary legislation is staying in line with EU law, that is, both the current directive and the incoming one. I fully agree we do not want this to be a financial incentive. That is not so much an issue for men but for embryo donation, which is an intrusive process. We do not want circumstances, and I presume the Deputy agrees, where women feel coerced or as though they have no choice, given it is an intrusive process. All we are doing here is staying in line with the EU directives.

Strictness and flexibility are built into the provision, based on what the Minister is saying. European law already governs this area and this is replicated in other EU legislation, so we can be confident about it in that sense. Is that it?

Yes, and it is already the case. Plenty of AHR is going on unregulated in Ireland, but it will be fully compliant with EU law. The gametes that are taken from abroad are already governed by EU law and they are covered under the Children and Family Relationships Act. It is an established practice and area of law.

What if it relates to a non-EU country?

In that case, we would need to establish there is not a financial incentive. I guess that would be a matter for the AHHRA. We might need a different word for the authority.

Yes, the regulator.

Is the Deputy pressing the amendment?

I will not press it now and I am happy to research it further and come back on Report Stage, but we should not do anything that will be overly restrictive of options for people.

Amendment, by leave, withdrawn.

I move amendment No. 79:

In page 38, line 10, after “section 35” to insert “or any payment made or received in accordance with section 36”.

Is Deputy Cullinane pressing his amendment?

I think the Minister's response was reasonable, so I will withdraw my amendment. Like Deputy Shortall, I will give the matter more consideration and might come back to it on Report Stage.

Amendment, by leave, withdrawn.
Section 34 agreed to.

I am conscious that Deputy Gino Kenny, who has tabled an amendment to the next section, is speaking in the Chamber, so I will bring the meeting to an end. That is only fair. We have got through quite a bit of the Bill. Further consideration will be required to complete it and the committee will schedule a further meeting for this purpose as soon as possible. I thank the Minister for Health and his officials for attending.

Progress reported; Committee to sit again.
The select committee adjourned at 12.30 p.m. sine die.
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