Oireachtas Joint and Select Committees
Wednesday, 28 February 2018
Joint Oireachtas Committee on Health
General Scheme of Assisted Human Reproduction Bill 2017: Discussion (Resumed)
We will now go into public session. We are meeting this morning with acknowledged experts in the area of human fertility as part of our ongoing pre-legislative scrutiny of the Assisted Human Reproduction Bill 2017. On behalf of the committee I welcome Dr. John Waterstone, president of the Irish Fertility Society, Professor Mary Wingfield, Merrion Fertility Clinic, and Dr. John Kennedy, National Fertility Centre, Rotunda Hospital. I draw your attention to section 17(2)(l) of the Defamation Act 2009. Witnesses are protected by absolute privilege in respect of their evidence to this committee. However, if they are directed by the committee to cease giving evidence in relation to a particular matter and they continue to do so, they are entitled thereafter only to qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that where possible they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him or her identifiable.
I also wish to advise you that any opening statements you have made to the committee may be published on the committee's website after this meeting. Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside of the Houses or any official either by name or in such a way as to make him or her identifiable. I call on Dr. John Waterstone to make his opening statement.
Dr. John Waterstone:
I am a medical doctor who has been working in assisted reproduction for 30 years. My specialist training took place in the NHS in London and I currently work in the HSE as a consultant obstetrician, as well as being the medical director of a large IVF unit. I am here today to represent the interests of the patients I care for. As president of the Irish Fertility Society, I have contributed to the submission to the joint committee made by the society and the majority of the views I will express today are shared by the majority of its members. I am very concerned that some elements of the Children and Family Relationships Act, although not implemented, and of the legislation which is now before the joint committee are insensitive to our patients’ needs and unreasonably coercive. I want to thank the committee for the opportunity to present my views today. I cannot overemphasise the vital role the committee plays if legislation is to result which is fit for purpose. A list of more specific technical issues is included in my opening statement but I do not have time to dwell on those now. However, I would be very happy to answer questions about them afterwards. I will only address key issues now.
With regard to the issue of statutory legislation versus practice guidelines, many clinical issues such as the number of embryos which can be transferred at a time in IVF treatment should be the subject of practice guidelines and not of statutory legislation, which is too inflexible. The guidelines involved are going to be formulated by the new regulatory authority, the assisted human reproduction regulatory authority, HPRA, which the draft legislation has proposed. This means that the composition of this new authority is important and it is important to consider how the functions of this new authority will overlap with the functions of the Health Products Regulatory Authority. The joint committee needs to understand that all IVF units in this country are already strictly regulated, licensed and inspected by the Health Products Regulatory Authority and it implements the EU tissues and cells directives. All the processes that take place in our IVF units and any adverse reactions that occur after treatment must be reported. Control is already very strict.
After a decade of activity, the HPRA has accumulated valuable practical experience with regard to inspecting IVF units. It is vital that the functions currently carried out by the Health Products Regulatory Authority are not duplicated by the new authority. Unnecessary duplication will generate unnecessary costs which are likely to be passed on to our patients and to the taxpayer. It is important that the new regulatory authority be effective and in order to be effective the exact composition of its 11 strong board members is vital. I would urge the joint committee to scrutinise carefully both the specifications for board membership and the manner in which people are appointed to that board.
The joint committee needs to know that assisted reproduction has become extremely commercialised and to understand that IVF treatment, even at the best of times, is expensive and often is not successful. Patients deserve safeguards which promote success and which protect against financial exploitation. An additional specific function of this new regulatory body which I have suggested is regulations to safeguard patients against financial exploitation and I am happy to dwell further on that issue afterwards.
With regard to restrictive human reproduction legislation and conscientious objection, in general in northern and western Europe the legislation concerning assisted reproduction has been restrictive, particularly with regard to financial compensation of egg and sperm donors and of surrogates and also with regard to anonymity versus identifiability of donors.
The committee should be aware that every year hundreds of thousands of European citizens travel to other jurisdictions in Europe and beyond to escape restrictions in their own countries. This huge amount of reproductive tourism exemplifies the fact that mechanisms to regulate assisted reproduction in Europe are failing citizens. The draft legislation before the committee, although in the main progressive, is restrictive with regard to egg and sperm donation and surrogacy. The danger is we may slavishly imitate mechanisms of controlling assisted reproduction that have already proved a failure in other jurisdictions. Unduly restrictive legislation will give rise to ethical dilemmas on my part and on the part of colleagues in assisted reproduction in Ireland because we may have conscientious objections to unreasonable restrictions on our patients' reproductive rights. Clinicians insist on our rights to such conscientious objections.
This brings us to Parts 2 and 3 of the Children and Family Relationships Act. Outsiders might wonder why two Acts are necessary to control assisted reproduction in Ireland. I am happy to go into the details of the history of how this came about. In retrospect, Parts 2 and 3 of the legislation are regrettable and only came about as a result of a lack of appropriate oversight in the Department of Justice and Equality. The legislation sets out to totally ban anonymous gamete donation in Ireland, to ban the payment of any sort of financial compensation to donors and to give the State the right to intervene and inform 18-year-old children who are the product of gamete donation that they were donor-conceived and to give them identifying details of the donor concerned even though it may be against the wishes of the parents involved. To me and my colleagues who think as I do, it is an unacceptable degree of coercion and is unconstitutional. I will not be able to comply with these stipulations on conscientious grounds.
Together with my colleagues in the Irish Fertility Society, including Jenny Cloherty who is sitting in the room today, we have the following view about how donor sperm and donor egg treatment should take place in this country. We feel that donor egg and donor sperm treatment are good things. They allow couples who would otherwise never have been able to enjoy the fulfilment of family life to have children and, as they are good things, we need to facilitate the process. We feel that in order to do so some degree of slight financial compensation is allowable and ethically justifiable for the donors concerned. We feel that gamete donation should be identifiable or anonymous; we feel that both are ethically acceptable. We support identifiable donation but we also think that people have the right to anonymous donation. It should be left up to the people concerned, the donors and recipients, to decide which form they want and which is appropriate for them.
We feel the parents of donor-conceived children should be very strongly urged to tell the children concerned as they grow up that they were donor conceived but we do not think it is the function or duty of the State to intervene and give the children involved that information. We certainly do not think it is the role of the State to forcibly intrude into the private family lives of citizens and to tell donor-conceived patients about the identifying details of donors against the wishes of the parents involved. We feel it is going too far. We strongly urge the committee to consider Parts 2 and 3 of the Children and Family Relationships Act and suggest they are replaced by more acceptable and workable legislation.
I urge the Joint Committee on Health to devise mechanisms for bringing the opposite sides of the coin together in this legislation. It should bring together representatives of the Department of Health, who drafted the legislation, and representatives of the IFS and the IOG, which Dr. Wingfield represents, so we have a coming together of the people who formulated the legislation and of the people who must apply it and who represent the patients whose lives would be impacted by the legislation. We urge the committee to take its time because it needs due consideration. The committee needs to ensure the issues concerned are given the consideration they deserve in order to bring about a better future for parents, families and children.
There is mobile phone interference. Dr. Wingfield should turn off her phone; it interferes with the recording of proceedings.
Deputy Kelleher is indicating he wants to contribute once we have heard the opening statements.
Dr. Mary Wingfield:
I am delighted to have this opportunity to speak to the Joint Committee on Health about the general scheme of the assisted human reproduction Bill 2017 and I thank the Chairman and the committee for inviting me to speak. I am a consultant in Holles Street hospital and the clinical director of Merrion Fertility Clinic, which is affiliated to Holles Street hospital. I was a member of the commission on assisted human reproduction, which produced its report in 2005, and I am delighted to see that except for the proposals on parenthood in surrogacy the draft Bill accords with the recommendations of the commission.
Before I talk about specifics of the proposed Bill, I will mention some important issues related to infertility and assisted human reproduction. The first thing I want to say is that the experience of infertility is one of the most distressing and painful experiences one can have. People who have not been through it often do not appreciate it and can be relatively unsympathetic.
For many years now, infertility has been recognised by the World Health Organization and other medical bodies as a medical condition. Assisted human reproduction is a medical treatment. It is not an optional luxury. IVF is probably one of the greatest medical advances of our time. Sadly, however, assisted human reproduction is an area of medicine that has become extremely commercialised, partly due to the lack of public funding in countries such as Ireland and partly due to the involvement of multinational commercial companies in the area. Merrion Fertility Clinic, where I work, is the only not-for-profit fertility clinic in Ireland and the only one linked to a public teaching hospital. We definitely need more public engagement in this area. People with infertility are often desperate to have a child and this makes them very vulnerable. They are vulnerable to financial exploitation, to spurious treatments with no proven value and they are vulnerable in our courts. For all of these reasons we need legislation.
The Institute of Obstetricians and Gynaecologists has made a submission to the Joint Committee on Health regarding the Bill. I chaired the working group, which prepared the institute document and I have authority to present that opinion, which mirrors my own. I have also submitted the institute's submission to the committee.
It is impossible in five minutes to cover everything in the Bill but I will outline some of the key issues that concern us. Assisted human reproduction is one of the most rapidly evolving areas of medicine and science so it is important that any legislation we introduce is not overly prescriptive and that it does not prevent future adaptation to new medical developments, which are happening all the time in this area. Particularly in the context of the forthcoming referendum on the eighth amendment, it is important that assisted human reproduction treatments are not confused with those of early pregnancy. Assisted human reproduction concerns only the in vitroor pre-implantation embryo to which Article 40.3.3° of the Constitution does not apply.
We all agree it is essential to avoid multiple pregnancies following assisted human reproduction treatments. However, the recommendations in the Bill regarding the number of embryos to transfer are not entirely appropriate and we would like to discuss it further. It is suggested that a person can donate gametes - that is, eggs or sperm - at the age of 18 but cannot receive treatment until the age of 21. We recommend that those ages are reversed.
We are delighted to see that posthumous assisted reproduction is being legislated for. The proposal, however, allows this only for women and we feel it is discriminatory to men. A surviving male partner should be allowed to use his deceased female partner’s eggs or their joint embryos, if she consented to this prior to her death.
Counselling is an essential part of assisted human reproduction treatment and must be encouraged. However, in line with international opinion we do not agree it should be mandatory for everybody having AHR treatment. It should only be mandatory in cases of donor-assisted conception, posthumous assisted reproduction or surrogacy or where health care staff have particular concerns about a patient’s emotional well-being.
We agree that a pre-implantation genetic diagnosis should be allowed. Pre-implantation genetic screening should also be included and, while it is a very new technique, mitochondrial donation should not be banned.
With regard to surrogacy, it is clear to us that the restrictive provisions proposed would mean that the demand for surrogacy by Irish citizens would not be met by domestic surrogacy. Irish patients will continue to travel overseas and bring their children home to Ireland. The legal position of these children and their intended parents is not addressed in the Bill. We believe it should be. A worrying suggestion made in the Bill is that professionals not be allowed to aid people in planning surrogacy abroad. I would certainly find it unethical as a doctor not to be able to help my patients in that regard and suspect counsellors and lawyers would feel in a similar way. Regarding the legal parenthood of children born after surrogacy, we support the recommendation of the Commission on Assisted Human Reproduction that the intended parents, rather than the birth mother, be the legal parents from the outset. We also make other suggestions to protect the health and legal status of the surrogate.
Regarding donor conception and surrogacy, I personally wholeheartedly support the view that a donor conceived person has a right to know his or her biological parent. However, with regard to the proposed national surrogacy register and the donor conception register under the Children and Family Relationships Act, we are totally opposed to the notion that a donor-conceived person who applies for a birth certificate would be told by the State that he or she was donor conceived without ever seeking that information. We believe that would be irresponsible, dangerous and a gross invasion of privacy. It is important that donor conception and surrogacy services be provided altruistically and non-commercially. However, if we want them to be available in Ireland, as we do, we need to look at ethical ways of encouraging the practice.
I will stop there, but in the institute's document there are other suggestions relating to age limits for treatment, storage limits for gametes and embryos, consent procedures and the proposed regulatory authority. My colleagues and I in the Institute of Obstetricians and Gynaecologists hope we can have an input into the final Bill, as we are the doctors most intimately connected with this issue and who will need to deliver the services to be provided.
Dr. John Kennedy:
I apologise to the joint committee for my attire. I was called into the clinic this morning and it was not until the eleventh hour that I realised I would be able to make it here. I certainly do not mean any disrespect.
I thank the committee for giving me the opportunity to talk to it about something that I think is critically important to us and our patients. I am the medical director of the Rotunda Hospital IVF unit, the National Fertility Centre. I am also the medical director of Sims IVF in Clonskeagh and Cork. Between the three clinics, we probably account for over 2,000 IVF cycles per annum in Ireland, which is not quite half but as close to it as to make no odds. The statement I will make is not just my own work but that of the medical teams at the three clinics, the embryologists, compliance specialists and nurses, all of whom had a great input in determining what we thought of the proposed legislation. I echo the sentiments of my colleagues who have already spoken to the committee that we very much welcome the introduction of the legislation, but there are a number of points which cause us to pause and cause us concern. We would like to have an input in perhaps changing them as time passes.
I have submitted a document on this issue, but there are specific concerns that I would like to address, many of which arise under head 6 of the draft Bill and which mainly concern the age at which we can treat patients. There seems to be a minimum age of 21 years and a maximum age of 47. They appear to us to be very arbitrary figures. The legal age of consent and at which one has voting rights in Ireland is 18 years, the time at which he or she becomes an adult. I struggle to think of any other circumstance or event in which one cannot partake between the ages of 18 and 21 years. Fertility treatment is uncommon between the ages of 18 and 21 years, but it is not unheard of. There are associated medical conditions which preclude somebody of that age from conceiving spontaneously and which necessitate the use of assisted human reproduction if she wants to have a child. The upper limit of 47 years is also heavily prescriptive. We have audited our practice in the past five years. Not many patients over the age of 47 years come in for treatment, but there are a few. We counted approximately 160, of whom over half had a successful treatment. Over 80 children have been born in the past few years who would not have been born had this legislation been passed.
We have concerns about the restrictions on male patients. While there is no age range, in particular, it is stated in the proposed legislation that to proceed with assisted human reproductive technology the man must reasonably be expected to survive until the child reaches adulthood. This would have a major impact on many people, especially our oncology patients whom we look after in the Rotunda Hospital, who come with a cancer diagnosis and where the timelines for their survival are very much in doubt.
I echo the concerns of Dr. Wingfield about counselling being non-mandatory and of Dr. Waterstone about the requirements in respect of single embryo transfer. It is something to which the field is moving and that we most commonly do and that we believe should be down to practice guidelines, not the focus of legislation. There does not appear to be any provision in the legislation on double donation - the use of donor eggs and donor sperm. There is provision for the use of surplus embryos, created in other cycles, but it is prescriptive. We have same-sex couples where a donor egg is required and in respect of whom there may also be a need for donor sperm. Iit looks like these patients will have to travel abroad for treatment as they have done in the past. We would, therefore, like to see proposals introduced to allow for double donation.
We welcome the limitations on the storage of embryos but wonder if they will be applied retrospectively to embryos already created. Will there be a five-year storage limit? How will it apply to oncology or younger patients where five years may not be a relevant timeline?
I share and echo Dr. Wingfield's concerns about the surrogacy portion of the Bill. It appears to us that patients will travel to avail of surrogacy and that we may be liable for fines or face criminal action if we advise or help patients in that regard. Furthermore, if we treat patients and there are surplus embryos frozen, will we be permitted to release them to the care of patients to do with them as they will, even if it involves travelling to avail of surrogacy?
There are other provisions which I hope to address during the question and answer session. We welcome the formation of the assisted human reproduction regulatory authority, but I share Dr. Waterstone's concerns about how it will be made up, who will be on it and how they will be chosen. My other concern is the cost that may be incurred by the patient. In the United Kingdom the maintenance of the Human Fertilisation and Embryology Authority, the equivalent UK authority, is funded by an additional charge on every single cycle. Is this the proposed mechanism to fund the new organisation, as it would put further financial strain on an already difficult process for patients?
I thank the committee for its time.
I welcome the delegates and thank them for their presentations. As the assessment of the general scheme of the assisted human reproduction Bill is ongoing, we want to engage with those who have a professional opinion, but there are also varying views on the issue. In that context, Dr. Wingfield who sat on the commission says she is, by and large, happy with what is proposed in the general scheme of the Bill because it includes all of the recommendations of the commission. Of what expertise did it avail in assessing what it considered was appropriate? Did it look at the position and legislative imprint in other jurisdictions in assessing what should be done here?
Did the commission make comparisons with Europe and elsewhere regarding the regulation of AHR? The reason I ask that is there are varying views on AHR. The US has a liberal, commercialised regime whereas the UK and other European countries have adopted restrictive practices. Within Europe, there is a disparity in legislative underpinning and regulation. Will Ms Wingfield elaborate on the commission's research, recommendations and findings?
The broader issue of surrogacy has been mentioned a lot and the fact that people have to travel abroad. Is that because there are not sufficient surrogates available in this country or is there another reason for that? Is there potential for the exploitation of surrogacy by using women from poor countries? What are the ethical, moral and clinical guidelines to make sure surrogates are observed, have medical support and so on? Given the scheme of the Bill recommends no form of compensation should be made available to surrogates, how does that fit with the requirement to have surrogates for this purpose and to ensure they have resources available to them to look after their own needs, health care and so on?
The issue of financial exploitation is another concern. People go to extraordinary lengths to find alternative medicines to survive if they are diagnosed with a terminal illness and they also to go to extraordinary lengths to conceive or to have a baby. Is the current legislation strong enough or should other provisions be included in same to ensure there is no exploitation through the commercialisation of the fertility industry not only in Ireland but globally? Should we depend on the ethical and moral standards of the clinicians involved or do we need to ensure they are strengthened?
Consanguinity is an issue that is raised sometimes, primarily by people opposed to IVF and AHR, given the potential for sexual relationships with brothers, half brothers, sisters and all that flows from that due to the anonymous nature of the treatment. Is that issue being raised to a level that is unnecessary in this debate or should we be conscious of it in view of that fact that there are varying views on it?
The age profile or limit is 21 to 47. Are the witnesses saying there should be no upper age limit for women, in particular? What should the age be if that is the case? At some stage, women can no longer conceive naturally. Where is the boundary in this regard? Recently, a woman in Italy who was approaching her 70s was impregnated and had a child. Is there a medical cut-off point at which it becomes dangerous for both the baby and the woman carrying the baby? In the age of surrogacy, what age limits should be applied in that context?
I thank the witnesses for their contributions and for the work they are doing in this complex area. Deputy Kelleher has put many of the questions I wanted to ask, but I would like to address the issue of people travelling abroad. How many people travel abroad for IVF treatment, surrogacy and egg donation? Is there any way to establish the figures? One of the complaints that is made relates to the cost of treatment in Ireland compared to other jurisdictions. Why is the cost higher here compared to other EU member states? What are the figures for the number of people travelling to EU member states and outside the EU?
Dr. Waterstone said the legislation may be overly restrictive. Is there a particular jurisdiction we should examine where he believes that the correct structure is in place, which we should try to follow? I do not just refer to Europe; it could be Australia, New Zealand, Canada and so on. Are there countries we should consider that we have not examined previously to put in place a comprehensive system that is not overly restrictive but, at the same time, has the necessary structures to deal with this complex issue?
I presume all clinics provide counselling where it is deemed appropriate. Some people say it should be mandatory but the witnesses said this should be at the discretion of those managing the patient. Should that remain the position? Should the medical practitioner make that call rather than dealing with the issue through regulation or legislation?
Surrogacy is a complex issue. Is the current legislation sufficient to deal with it or is it overly restrictive as well?
Dr. John Kennedy:
There is a great deal to get through. With regard to age, which is a subject close to my heart, of course there should be age limitations and nobody disputes that. The average age of the menopause is 50.8 and that is a natural barrier. The chance of conceiving spontaneously as a woman approaches her late 40s is low and the risk of miscarriage is high. Advances in medical technology, specifically with regard to donor eggs, have overcome these limitations and, therefore, it is possible for women to conceive as they get older, but medical risks are associated with that. Our clinic has an age cut-off of 50. It is self-imposed and we adhere closely to it. If somebody is in or around that age or if they have embryos created and they are looking to use them but they have passed the age of 50, we involve a multidisciplinary team. We get the input of obstetricians in a pre-pregnancy phase to assess the risk and deem whether the patient is suitable. One of the issues is we do not have much data on women pregnant in their 50s. The numbers are low and we do not know what the risks of high blood pressure or pre-eclampsia are but we certainly think they increase. There should, therefore, be age restrictions. The UK, for example, has an age restriction of 50 but it is 55 for oncology patients. We would be comfortable with that in our organisation but 47 is arbitrary. At the other end of the age profile, the number of patients seeking treatment aged between 18 and 21 is low but it is not zero. One would not want to tell a woman who is 19 or 20 years old, who wants to conceive and has gone through appropriate testing and counselling but who is unable to conceive spontaneously, that she should wait for no reason when she could conceive spontaneously if she did not have an underlying medical condition.
Counselling is available and encouraged. There are certain instances where it is mandatory. For example, when somebody is using donor egg or donor sperm, we require them to attend at least one session. That is called implications counselling. It is about information gathering as well as exploring some of the issues that we want patients to consider.
Therapeutic counselling, which is counselling after a negative outcome with fertility treatment or beforehand if we feel the patient is struggling, is something we encourage and that is available for our patients. In one of the clinics in the past, counselling was a mandatory requirement for a number of years and the feedback we got from a significant number of patients was that they did not believe it was either necessary or helpful. Many patients did find it helpful, but we found that the patients who self directed counselling got more from it than the patients who were forced into doing it. It is something we encourage and make available, but is not something I believe should be a requirement.
With regards to surrogacy, nothing is being done in Ireland. If someone wants to avail of surrogacy, they have to go abroad. They have to go to the United States or Canada, where they will be looking at paying upwards of €100,000 for treatment, to eastern Europe, where they may pay approximately €40,000 for treatment, or to India, where there is a great deal of exploitation, and nobody is in favour of that. The problem with this legislation is that it does not govern those patients except to say they cannot do it. However, patients are still going to do it because it will be virtually impossible for couples in Ireland to avail of surrogacy. As it is not advertised and is non-commercial, they need to have a close family member who is willing to give up nine months of their life for nothing in return. It is not feasible. It is also not feasible for certain other subsets like homosexual couples. They will require surrogacy to have a family. Unless a close family member or somebody else volunteers, that will not be a viable option for them.
The notion that we cannot facilitate, test, treat or advise those patients is ridiculous. It will not work in practice. These are patients who are coming to us. The women who require surrogacy generally have been through an incredibly tough time. Invariably, they have had a number of failed cycles and there are major issues which can only be overcome with surrogacy. We would ask that something be put in place to help facilitate care for these women. We are not allowed pay surrogates. If that is the decision of the legislative body, that is fine, but we cannot advertise so we cannot even try to recruit surrogates. I have absolutely no doubt that there is a shortfall of available surrogacy in this country.
Dr. John Kennedy:
Absolutely. The medical clinical oversight of the surrogate generally would be undertaken at the obstetric level because these are women who have now become pregnant. I believe the obstetric care in Ireland is of an incredibly high standard. All these patients would be screened thoroughly by an obstetrician and a multi-disciplinary team before they ever became pregnant in the first instance. I do not have many concerns in that regard. I believe couples who avail of surrogacy and women who are used as surrogates in Ireland enjoy a very high standard of care. I believe the complication rate will be low comparative to international figures and that they will be very well looked after. The problem is that they will not have the opportunity to do so.
Dr. Mary Wingfield:
Deputy Kelleher asked about the Commission on Assisted Human Reproduction. The first comment I would make is that the commission reported in 2005, which is 13 years ago, and so much has changed in assisted human reproduction in that time medically and also legally. There have been some High Court cases and a Supreme Court verdict on matters to do with assisted human reproduction. One issue that exercised the commission was the status of the embryo, and that has been clarified in legislation. That just emphasises the way the area is changing so quickly and how important it is that whatever legislation we put in place is not over detailed because in terms of issues we have been discussing such as the age limits for treatment, medicine is moving on. Ten years ago, nobody would have countenanced a 47 year old woman being pregnant whereas now, not just in assisted human reproduction but in medicine generally, it is much safer for people to conceive in later life. In the past, we would not have conceived of people with cystic fibrosis getting pregnant. Now, in certain circumstances, they do. This legislation has to be flexible so that it can be adapted as time goes on. We do not want to have to come back here every year or second year looking to change legislation. That is just wasteful of everybody's resources.
There was a wide range of expertise on the commission - medical and nursing, science, genetics, legal ethicists - and we consulted with people internationally. Experts from Italy were invited. Since that time, Italy has had to change its laws because some of its laws at the time were deemed to be against the European Court of Human Rights human rights legislation. That again shows that it is a very complex area, and the legislation needs to be very carefully thought out.
Dr. Mary Wingfield:
The commission met for three years and cost a great deal of money. It produced an excellent report but it was then left on the shelf. That is a total waste of taxpayers' money and all our time. This matter needs to be carefully debated. On the other hand, those of us working in the field believe that Parts 2 and 3 of the Children and Family Relationships Act 2015 were rushed through because of the same sex referendum. There was a need to clarify legislation for that and they were rushed through. We certainly believe that the aspects concerning donor conception were not debated sufficiently. We would like there to be a debate, but it cannot continue forever.
The Taoiseach and the Minister for Health have also committed to introducing public funding for in vitro fertilisation, IVF, treatment. We desperately need that, but they have made it contingent on dealing with the legislation first and setting up the regulatory authority. That is another reason we need to move on this, and it needs to be done in the next year or so.
Regarding the matter of financial exploitation, in terms of the provision of IVF treatment outside Ireland, if we consider other countries similar to Ireland such as the Scandinavian countries, Belgium, Holland, France and Germany, IVF treatment is not cheaper in those countries or the United Kingdom compared to Ireland. It is cheaper in other southern eastern European countries and many people are travelling abroad to access that. Many of those couples come back with multiple pregnancies and most of the high risk multiple pregnancies related to assisted human reproduction that we see in Holles Street and the other big maternity hospitals in this country tend to be related to couples having donor egg treatment abroad with multiple embryos transferred. If we introduced public funding in Ireland, it would help many of the people who cannot afford treatment here to have their treatment here and would reduce some of that reproductive tourism for financial reasons. I believe they would be getting a better service. It is a stressful treatment and to have to travel to another country where they do not have the support of their family or friends around them while they are having treatment is not easy.
Mention was made of consanguinity and anonymity. Over the years, Irish embryologists have been very responsible in that regard. Ms Jenny Cloherty is a member of them. They have self regulated for donor sperm treatment in Ireland and have monitored among themselves the number of families that were created from any one sperm donor. There are proposals in the legislation to limit that. For treatments occurring in regulated clinics it will not be a problem, but we cannot control people travelling overseas, particularly for donor egg treatment, and it would be very difficult to get any numbers on that.
We spoke about the upper age limits. I do not know that the actual ages should be specified in the legislation because that is one of the detailed items that could come back to haunt us in a year or two and we would have to come back and change the legislation. We would prefer to see that implemented by the regulatory authority.
As regards surrogacy, we in the Institute of Obstetricians and Gynaecologists felt that the Bill proposes that surrogates should be allowed do surrogacy up to the age of 47. We believe there should be a younger age limit for surrogates because they are carrying the pregnancy altruistically and they will not have a child at the end of it. There are increased risks in pregnancy over the age of 40, which couples and women are willing to take on if they get a baby from it.
As the surrogate would not have a baby from it, we felt the upper age limit for surrogacy should be 40 years.
Senator Colm Burke asked if any jurisdiction had the correct structure. I attended a meeting last week with the European Society of Human Reproduction and Embryology at the Council of Europe which discussed legislation in place around Europe. It is safe to say no jurisdiction has ideal legislation. Many of the countries that introduced legislation in the past ten years have had to change it and there are many parliaments looking at assisted human reproduction legislation. If we have a debate and were to take on board most of the comments made in the document of the Institute of Obstetricians and Gynaecologists, we could lead the way by having some of the best legislation in Europe. We are all very aware of the position in different countries. One of the advantages of the process having taken so long in Ireland is that we can benefit from the experience of other countries. For example, in the United Kingdom any payment for an egg or a sperm donation was banned, but it has subsequently had to row back on this provision. A small amount of compensation is now paid to people who donate eggs and sperm. It is not something from which somebody could make a living. This issue was discussed at the meeting of the Council of Europe and there is a very strong opinion that a person can be altruistic and also receive financial compensation, not just to cover expenses such as the bus fare to the clinic but also for the inconvenience of donating eggs. To donate eggs, a woman has to go through the equivalent of the first part of an IVF procedure. She has injections and scans and sees the side-effects of treatment. There is egg collection which, although safe, is still a surgical procedure which brings a risk of complications. The United Kingdom has rowed back on its original legislation and had to introduce a small payment. At last week's meeting when the comment was made that somebody could be altruistic and compensated, the example of doctors was given. They do their work primarily as an altruistic act, but they are paid for doing it and we do not think there is anything wrong with that.
Dr. Mary Wingfield:
Exactly. If a woman is willing to be a surrogate to help another person have a child - a really good act - or to donate some of her eggs, bringing a risk to her, or if a man is willing to donate sperm to help others, it is only fair that they should receive some compensation. However, we must ensure it will not be like what happens in some countries such as India and others in Africa where people are exploited and the companies running the surrogacy service get the money. In these places the surrogate receives very little money. We can do it ethically if we discuss the issue properly.
Dr. John Waterstone:
Most of the matters have been addressed by colleagues, but there are a couple to which I would like to speak. We have not really delved into the financial exploitation of patients everywhere, including in Ireland, who undergo assisted reproduction treatment. It might be worthwhile pointing out to members of the committee what we are talking about. The problem is we do not currently have controls in Ireland for the successful outcome of treatments available to couples; therefore, it is very hard for couples to know which clinics do better and which do worse. Most clinics in Ireland have reasonably acceptable success rates, but some do not. However, the general public does not know that. In other jurisdictions - I single out the United Kingdom and the USA, in particular - there are mandatory and transparent reporting systems. There is pressure on the clinics involved to keep up their success rates. That is important as otherwise it is hard for patients to know how to avoid clinics that, to be frank, are not doing well enough. If there are no controls in place, it means that clinics can advertise exaggerated success rates to attract patients under false pretences. Once patients are in them, it opens the possibility that couples may spend thousands of euro more than they had originally budgeted for because of expensive add-on investigations and treatments which cost a lot of money and make more money for the clinics involved but which do not necessarily improve the chances that the couple will go away with a baby. These are the matters the joint committee must address. It is a difficult area to police and recently in the United Kingdom the Human Fertilisation and Embryology Authority seemed somewhat powerless to speak out against add-on investigations and treatments. It is, therefore, a matter that must be addressed. It is not easy, but one of the major problems legislation in Ireland needs to address is financial exploitation.
Deputy Kelleher wondered about unwitting consanguinity in surrogacy, or the possibility that a half-brother and half-sister could unwittingly have babies together if they are the product of the same gamete donor. It is a theoretical possibility but I point out the elephant in the room, which in this case would be misattributed paternity. There are many people out there who conceive quite naturally without assisted reproduction at all and whose daddies are not the men they think they are. Even conservative estimates indicate that between 2% and 5% of children are in this position because of extra-marital affairs and such. Already in society, there is the possibility of unwitting consanguinity and it is not just assisted reproduction that can bring about that possibility; there is a far more common situation of unwitting consanguinity for children naturally conceived. It is a point for the committee to consider.
I echo the sentiments of my colleagues on age limits. The age limit of 47 years is ridiculously low as in the natural course of affairs very occasionally women will conceive naturally up to the age of 48, 49 or 50. I will not dwell on the issue further.
The legislation proposes a lower age limit of 21 years for donors. Some of my colleagues have said it should be 18 years. In my clinic we have a known donor programme or, in other words, the sister or a friend of a woman in a couple can donate. It is an identifiable form of donation that we promote in our clinic and successful. It usually is a sister, but we once had a donor who was the 21 year old niece of the patient who wanted to have a baby. We went ahead and a baby was produced. There was counselling which is mandatory in this position. We felt afterwards that it was ethically slightly questionable in that she was too young. Perhaps 21 years would be a sensible lower age limit to volunteer as an altruistic donor of eggs and not 18.
With regard to the upper age limit, the programme to which I refer in my clinic has a fairly generous upper age limit of 37. We allow the donors, usually sisters, to be as old as 37 years. We assess them to ensure they would have good prospects to be a donor - they might have good egg numbers and perhaps they might have had children - and if they are, we allow them up to 37 years of age. The draft legislation indicates that donors can be no older than 35 years. It would certainly restrict the programme we have in operation and is unreasonable. It should be at least 37 years, not 35. That is enough about age limits.
Senator Colm Burke asked about international examples of the ideal regulatory system. In Ireland we should aim to have something between the overly restrictive regulations that are the norm in some European countries and America where it is very open and there is little statutory legislation in place and having more guidelines. We should aim to end up somewhere in the middle. As I said in my opening statement, we should not slavishly copy some of the European examples as they are too restrictive. That hundreds of thousands of Europeans must travel to other countries to avail of reproductive services illustrates the fact that European citizens have been let down by these practices.
We can speak of ethics and bioethics in the area, particularly about donor anonymity and paying donors. It needs to be evidence based and much of the argument in the past has not been evidence based but more dogma. I think we need to proceed more with an evidence based model for the ethical standards we propose.
I agree with Professor Mary Wingfield, that the joint committee should understand that we should not feel that the impetus for this assisted reproduction legislation is because we are ashamed that we are the last people in Europe to regulate. The only point of introducing legislation is that it does good rather than harm. This is a valuable opportunity as we have the luxury of being able to look at the other countries that have legislated in the past and pick and choose. There is no reason that we should not punch above our weight as we do in rugby and end up with the best regulatory system in the world.
Dr. John Kennedy:
It is difficult to get exact figures on this because many patients who travel do not tell us. Some patients are travelling for conventional IVF treatments, some are travelling for egg donations specifically and a very small number will be travelling for surrogacy. The numbers for surrogacy are very low but I would estimate there are probably in the region of 3,000 women travelling abroad every year for fertility treatment in Europe.
I welcome the witnesses to the committee. Being parochial, it is great to see a Cork connection.
It is very important to acknowledge that people who undertake fertility treatment have already been on a very long and painful journey and do not enter this new chapter very lightly. I would like to see in any proposed legislation on fertility treatment a statement to mark the pain that the couple have experienced already. It should be borne in mind that in these circumstances people are very vulnerable and desperate and will spend any amount of money.
Many of my questions were asked already but will the witnesses comment further on how the treatment process can be offered in a non-commercialised way? How can we ensure that this service does not become over-commercialised?
When a child is conceived in a different way, often it can impact on him or her when the hormones kick in. Have the witnesses any proposals on how to support a child conceived through surrogacy during their teenage years? Professor Wingfield said that infertility has been recognised as a medical condition. Does she not agree with that statement and will she expand on her thoughts on this?
Dr. Kennedy made a reference to subsection 5(d) that there should be a one year delay to treatment.
I welcome our witnesses this morning. We all empathise entirely with the people who require the assistance of the witnesses. We have all read and learned and know of people who were delighted to avail of such services.
Will the witnesses comment on the extent to which we can isolate ourselves from worldwide practices, some of which would be repugnant to our interpretation of what is morally right? There have been legal challenges to some fertility services throughout Europe and how can we proof our legislation on such services from the worst excesses of the practices elsewhere?
I can understand the need for a reasonable level of flexibility in the provision of services in Ireland. I know the current legislation, Children and Family Relationships Act 2015 impinges somewhat on what the witnesses see as their ability to provide services in a way which they believe is ideal. Will they give us some further information on that? I may not be able to remain at the meeting for the answer, because I will have to sprint to another Chamber.
Can we be sure that we can isolate ourselves sufficiently from the worst practices in the unregulated areas such as the United States of America and some other countries? Given that there will be a demand for these services, can we ensure best practice for those people who may decide to go to India or the United States and who may not be advised by virtue of our standards?
The witnesses referred to some of the unregulated practices and the undesirability of going abroad, although there is a cost benefit of going to India versus the United States, where one can receive a similar services. How can we reduce the level of risk that people might be exposed to?
I welcome all the witnesses to the meeting. I welcome the recent media coverage on infertility. I refer to the advertisements on television and I think that raises public awareness of the whole issue.
I agree this is a complex issue because medicine is moving fast in this very sensitive area. I concur with my colleague Deputy Murphy O'Mahony. I am a GP. I listened to the contributions on the concept of counselling. I understand that it is not mandatory with the exception of implication counselling for sperm donors. Most couples who embark on infertility treatment have had a rough road prior to that and invariably they have attended their GP on multiple occasions. All of the blood samples would have been sent off initially and the results would be back and the usual investigations would have been carried out. Personally I think much of that counselling would have already taken place in the primary care setting. This is an important point to highlight. Many GPs may not be familiar with or comfortable in this area because one cannot have an expertise in everything, and the primary care setting is the place for this counselling to occur, prior even to a referral for or to a recommendation on infertility. I would like to hear the views on that.
The issues on the ground are the cost of such treatment for couples. Couples compare fertility clinic services on cost. They will google for information and then come to the GP and discuss it.
Most clinics cost around the same for a service. However, we all know the different levels of treatments can be complex be it ovulation induction or intracytoplasmic sperm injection, ICSI. There is a wide range. I am often told that when people have embarked on a treatment they feel they are hooked and have to complete that treatment. There are many hidden costs which concerns me. I had a patient recently who was informed of a cost but was not informed it was necessary to go to the UK for a test for natural killer cells in the womb. The travel was a greater cost as was paying the separate clinic for the test.
There many discrepancies from clinic to clinic. I would like to hear the views of the witnesses. Can we regulate this more stringently? The other thing Dr. Waterstone alluded to, and I agree, was reporting systems and rates of success. It is a moveable feast. We can all have great success rates if we limit the couples we take on to simple cases. We need to have some kind of regulation.
I refer also to the reproductive tourism sector and couples going to eastern European countries, especially for donor eggs and the implanting of multiple embryos. I know it is outside our jurisdiction and impossible for us to regulate. However, inevitably our obstetrical system is going to deal with any outcome, fallout or complications from that. That is not proper. The medical staff here might be dealing with a multiple pregnancy and the mother's life could be at risk or that of the babies. We need to have some kind of control on that issue.
There is also a great deal of discrepancy in the cost of storing embryos. While the costs generally for the treatments may equate from clinic to clinic, I heard recently there is a big discrepancy in the cost of the storage of embryos. I am not sure if that is correct and I would like the opinion of the witnesses.
Dr. John Kennedy:
With regard to the posthumous use of gametes, there is a provision in the proposed legislation that people would have to wait a year after their partner had died before they could use those embryos. That, in conjunction with an age restriction of 47, seems ridiculous. I have had women come through whose partners have passed away. Most would have waited over a year because that is what happened organically. I have had one who has not. She went through counselling. The counsellor, myself and the team deemed she was fit for treatment and she went on to have treatment. I thought it was a good thing. One year seems arbitrary to me.
A couple of the questions referred to how we curb the worst excesses. It is simple: provide the care here in Ireland in an affordable way. Publicly fund IVF. Make donor eggs available, in a cheaper sense, in Ireland, both anonymous and open. Then we will stop people travelling. People are travelling because of costs and availability. It is not purely about cost. People are travelling because they want to avail of anonymous egg donation or they want to do it in a cheaper fashion. Many of the eastern European clinics are going to be persistently cheaper. There may be some diminution in terms of quality and care. There is certainly not anything at all like the follow up that Irish clinics have. The European clinic does the treatment. Then the patient goes back to her own country and never the twain shall meet again.
If we want to curb the worst excesses of travel and people shopping around, provide it here. We know most European countries have some degree of publicly-funded IVF and AHR programmes. Israel is the example that springs to mind. There is free IVF for everybody up to the age of 45 or until a woman has two children, after which seven free cycles are provided. That is very idealistic. However, it shows the differing priorities. We need some form of publicly-funded IVF.
Another question was on costs and add-ons. Publicly funding IVF would go a long way to curbing that as well. I think publication of success rates for all of the clinics is a great idea and that is something the AHRRA will be able to do. It will designate the parameters by which success rates are published. It will not be possible to pick a good patient cohort or a good six months. That is going to be fantastic.
In respect of add-ons, one of the problems is IVF and AHR have become very commercialised. Most IVF and AHR success rates, in my experience, come down to having a good lab collecting eggs, creating embryos and storing them. If we have a patient in front of us, 90% to 95% of the success that is possible will be within that framework. There is a place for a number of add-ons. Some have a degree of evidence, others less so. We are looking for the small margins, the small percentage points to try to improve a couple's chance.
In our practice, and I cannot speak for other clinics, I do not believe there is exploitation of couples. I refer to appropriate counselling, care, attention and explaining the pros and cons, and specifically the limitations and lack of evidence associated with the tests. Natural killer cells were mentioned. There is a good theoretical basis they may make an impact. There is no evidence to suggest they will increase the chances of having a baby. Patients need to be clearly informed of that. However, these patients are self funding and the cycles are expensive. Costs are between €5,000 to €6,000 or €7,000 for a cycle of IVF. If there is an extra test which costs €200, that amount is a demand even if it is only on a theoretical basis that it is going to improve the outcome.
If we publicly fund IVF we will get to take control of that situation. We get to say we are paying for the treatment and a couple will not get a test. We can do a side-by-side comparison of the success rates and see if there is any value in the add-ons.
Dr. John Waterstone:
There was a question about how we avoid the commercialisation of IVF. I am afraid the cat is out of the bag. IVF has become commercialised. It is becoming almost embarrassing for me to work in this area. I started off working in the National Health Service, NHS, in London with some of the pioneers of IVF. Gynaecologists who were interested in fertility were drawn towards that area because it was new and exciting. Now, IVF has been bought up by big money. In Ireland today, of the nine IVF labs in this country, only my unit in Cork and Professor Wingfield's unit in Dublin remain owned and operated by Irish people, the people who set up those units. Everybody else is employed by big business. That is something we have to bear in mind. The cat is out of the bag. The question is not how do we avoid it, it is here. The question is how we control it and protect patients against it.
Dr. John Waterstone:
There is that issue but also the issue of fair treatment and not exploiting patients. It is up to the regulatory authority, when it evolves, carefully to do its best to protect patients. However, I am afraid commercialisation is here. We know there is no State funding for IVF treatment in this country per se, even though the drugs concerned are funded nationally which is a great advantage for our patients. The Department of Health undertook a useful exercise, it is out there and can be googled, looking at how IVF is funded worldwide and particularly in Europe.
What surprised me looking at many of the other jurisdictions was that there is funding but it is not unlimited. Most countries that I thought previously had unlimited funding have limitations. The State pays for a proportion of the treatment but not all of it. Even in the UK, where I worked for 12 or 13 years, even though there is a good standard of care generally, for fertility it only pays for 40% of the IVFs undertaken. It does not pay for everybody. There are strict limitations about the number of treatments couples can have and the age of the couple. It is restricted to younger people, whose chances of success are better, to try to get better value for the taxpayers' pounds, so it is not unlimited. However, it would help the least fortunate people in our country economically if we can have some State funding for sure. It is, however, over-enthusiastic to think that all IVF treatment in Ireland is going to be paid for by the taxpayer. That is never going to happen realistically, particularly with budgetary restraints.
Deputy Durkan asked about Parts 2 and 3 of the Children and Family Relationships Act. I urge the committee to scrutinise them. The fact that it had occurred at all was due to an oversight in the Department of Justice and Equality. That is inescapable. Dr. Wingfield referred to the report of the Commission on Assisted Human Reproduction, but that was 15 years ago. When the commission looked at the advisability of the State informing donor conceived children of the manner of their conception, the advice was that it would be a step too far and that, in fact, it would be against the constitutional rights of citizens. However, the Department of Justice and Equality did precisely that and went too far. As far as many of my colleagues in the IFS and I are concerned, this must be challenged. It is intolerable and has gone too far. The advice given at the time by the institute, particularly by Dr. Wingfield and others, was that it was going too far, but our warnings were not heeded and the legislation was enacted. I strongly make the point that it must be replaced by something that is constitutional.
Dr. Mary Wingfield:
Regarding commercialisation in the sector, I agree with Dr. Waterstone that it is unstoppable. There is big money and big business involved. It is a problem in every country in the world. We have private medicine in Ireland, which is fine as the State would not be able to cope if there was no private medicine. However, the difference between assisted human reproduction and other types of medicine is that one can go public or private in the case of any other medical condition. One can choose to go private, but the State will also provide a public service. Many politicians do not realise there is no public IVF or assisted human reproduction service available, even if one has a medical card. Unless someone can find a charity to help - there is a charity attached to Holles Street Hospital and our clinic; there are some other charities also available - there is no public funding available. People go into debt, sell their houses, relationships break up or people borrow from their parents and if the treatment does not work, they will have to go back again to their parents with nothing to show for it. On any ethical basis, there must be some public funding available. That would help in dealing with the commercialisation. It would be more similar to the private-public mix in other areas of medicine.
Deputy Margaret Murphy O'Mahony asked if there would be services available for children born through surrogacy. Again, it goes back to the Children and Family Relationships Act. Children born through donor conception often need counselling as they grow older, but it is provided in very few jurisdictions. There is certainly no provision for it. That brings us back to the draconian measure contained in the Children and Family Relationships Act whereby somebody who is over 18 years of age, going along happily in his or her life or, perhaps, very vulnerable in his or her life, on applying for a birth certificate is told by a civil servant that there is more information available on him or her and that he or she was donor conceived. If the person's parents have not told him or her this fact already, he or she has spent his or her life up to that point thinking his or her parents are his or her biological parents. There is no provision in the Act for counselling for such a person or even for who would give that information. The person who will be giving it knows nothing about the individual or whether he or she has a psychiatric history or attempted suicide last week. When we had discussions with the Department of Justice and Equality, the officials said, "It is not going to happen for 18 years, so we have plenty of time to work on it." That is not acceptable, but it was the response when we asked about-----
Dr. John Kennedy:
The United Kingdom threatened to do the same. When anonymous donation was banned there, it was said the same would be done and that provision would be made, but it pulled back from it at the eleventh hour. I do not know if it is too late to do something about it here as the Act has been passed, but almost every fertility specialist on this island is in absolute agreement that it is a terrible idea.
Dr. Mary Wingfield:
At the European meeting I attended last week there were people who felt the provision dealing with the situation where a person applied for a birth certificate could be challenged in the European Court of Human Rights on the basis of privacy. The only other jurisdiction in the world in which there is such a provision is the state of Victoria in Australia. As was said last week, that is okay for the Australians because they are not governed by the European Court of Human Rights.
On the question of infertility being a medical disorder, it is definitely a medical disorder, which is why treatment should be available under our medical system.
Deputy Bernard J. Durkan was worried about how we isolated ourselves from the rest of the world. I am not sure we want to isolate ourselves from the rest of the world-----
Dr. Mary Wingfield:
As I said previously, there is an opportunity to produce legislation that will be the envy of others, such that they will follow us. The draft Bill is excellent, if we have the right discussions and tweak it the way we suggest. Friends who are lawyers also have some issues with it, but if we have a meaningful discussion, I believe it can be really good.
Counselling definitely must be part of assisted human reproduction treatment. However, the Bill proposes that nobody have treatment without first seeing a counsellor. That is very prescriptive. Counselling is something that must be individualised. Many receiving fertility treatment find that starting it is a source of huge relief. They are finally getting to have treatment which is successful for most. It is often during or after treatment that they require counselling. There must be some leeway for the doctors and nurses looking after those involved. Even the embryologist in the laboratory would sometimes discuss things with them. Last week we carried out a quick survey of our patients in advance of this meeting. Some 170 people responded to the questionnaire, of whom 80% felt counselling should be offered, while 60% felt it should not be mandatory for everybody going through treatment. That would be the feeling of most people in Europe and around the world. In the past one clinic in Ireland insisted on everybody receiving counselling before they underwent treatment and many hated it. It was really a box ticking exercise. As people were not allowed to receive treatment unless they saw a counsellor, they just went to see the counsellor for the sake of it. Making it mandatory is not the way to go. It will waste precious resources which should be kept for those who really need them.
These are questions about opinions. There are other views not represented in the room. For example, there is the issue of multiple births. The worst excesses involve the perception of some poor women from the slums of Calcutta or Manila receiving multiple implantations. That is the reason many people have concerns about fertility treatment and the industry behind it. In some parts of the world children's kidneys are being removed for organ donation. Equally, there could also be this terrible exploitation of vulnerable poor women. In the context of the internationalisation and commercialisation of the industry, is the legislation, as presented, regardless of the concerns we might have about some parts of it, sufficient to address concerns about women being brought into the country in future years to be surrogates?
Dr. John Waterstone:
It is very tight.
If anybody here has a daughter or a niece who unfortunately discovers in the future that she does not have a uterus that is capable of carrying a baby and therefore needs surrogacy, she would be at a disadvantage as matters stand. If this legislation in its current form goes through, she would be crucified. If she does not have a sister or a best friend to carry her baby, she would be completely at a disadvantage. It really is not supportable.
Dr. John Waterstone:
It is too restrictive. To answer the Deputy's question regarding scandalous practices in countries such as India and Thailand to which people were travelling through agencies in a very commercialised way and many middle men were profiting from it, those countries are closing their doors to that. India and Thailand have closed their doors to international surrogacy. We are worried about that practice here but the countries concerned are clamping down on it. That, at least, is progressive and we should be aware of that change.
With regard to regulation and ethical and clinical oversight, for example, if a woman cannot conceive naturally because of underlying health reasons but then becomes pregnant it could have a profound impact on her health, how would the witnesses regulate in that instance? Would they simply depend on the ethical obligations on the clinicians? If such a woman becomes pregnant it could have a profound impact on her health and where would the line be drawn in that instance in terms of-----
Dr. John Kennedy:
There is a proposed paragraph in the legislation to the effect that assisted human reproduction cannot be undertaken if it will have a seriously detrimental effect on the woman's health. That is very prescriptive. As a clinician, one works with patients and informs and advises them of the risks. The safest thing all in vitrofertilisation, IVF, clinics could do is bar their doors closed. Nobody needs IVF treatment. It is not oncology or cancer treatment. However, the trauma and hardship suffered by these couples in their desire to have a family is what we are about in our work. All treatment has risk attached to it. With respect to a woman who has associated risks, Dr. Wingfield mentioned cystic fibrosis earlier and in the past we could not have let a woman with such a condition get pregnant. Their risk of dying would have been astronomically high. However, with advances in medical treatment, one is mindful there is a risk associated with this treatment, it might have an impact on the woman's lifespan, on their lungs or kidneys if they have kidney issues. There are many conditions in this respect. One would work with the patient and the medical community at large and one would take a multidisciplinary approach and give recommendations. Ultimately, and this is an opinion, not a fact, I try to be non-paternalistic. I give the best advice I can and then the patient feeds back to me. Of course, there are limitations to that. If somebody comes into me and says "I want four embryos transferred into my uterus", I am absolutely not going to do that ever. I am not going to put three back in at this point. However, if at the end of my consultation process with that patient, she still says "I want four embryos put back in", that probably represents a failure on my part. One has to work with people, with one's colleagues and with multidisciplinary teams to make sure that the treatment one is providing is both safe and efficacious. I believe, in the main, that is already happening in Ireland. I do not know if there is a huge need for legislation. I do not believe so, my colleagues may differ but I do not know if they will. I do not believe women's lives are being put at risk through the provision of assisted human reproduction in Ireland at present.
Before I bring in Senator Swanick, I wish to put a number of questions to the witnesses. With regard to couples who are trying to conceive and have not been successful, what criteria do the witnesses use before they initiate the process of assisted human reproduction? What are the common types of assisted human reproduction in Ireland? Is it both parents contributing, or it is an egg and a non-parent sperm or a sperm and a non-parent egg? What are the proportions in that regard? Dr. Kennedy said he does 2,000 cycles a year.
Dr. Kennedy might speak about the number of eggs that are created and transferred. He might also refer to the use of embryos for training and research purposes and the ethical dilemmas that this causes. He might also comment on the significance and importance of pre-implantation genetic diagnosis. I call Senator Swanick.
I will be brief. I am concerned about couples, who are very vulnerable and would like to make their IVF treatment journey as seamless as possible when they are embarking on an IVF cycle, having regard to the sensitivity about that treatment. I have heard anecdotally from many couples that clinics vary in this regard. With regard to the sharing of information with couples, and this probably varies from clinic to clinic but I know in some clinics a number of couples who have agreed to embark on an IVF cycle would be invited to attend an information evening and a video of the process is shown. While that is very informative it can be offputting for couples as invariably they are sitting around the room looking at each other and wondering what is wrong with this or that couple. That needs to be considered. Is there any way that or the whole journey for the couple involved can be improved?
Dr. Mary Wingfield:
On the Chairman's question regarding who needs treatment, I often say to patients that to get pregnant the woman needs to be producing eggs, the man needs to have a sperm and the woman's pelvis needs to be normal for a natural conception. That is basically it. In the case of some couples the woman will not be ovulating and may need fertility drugs to help her ovulate but if her partner has a sperm problem as well, then IVF may be a better treatment. In the vast majority of male factor fertility where there are sperm issues, IVF is often the only treatment and people are often surprised about that. The first test one does on a man is a semen analysis and one can see straightaway that for many men no other treatment will work except IVF. People are often surprised about that and will ask if they could not try some other treatments first. Therefore, male factor infertility is a very big cause of the necessity for IVF treatment. If a woman has damaged fallopian tubes or has had ectopic pregnancies and has had her fallopian tubes removed, then the only way she can get pregnant is with IVF treatment, or in the case of women who have endometriosis or who have had many surgeries for Crohn's disease or other conditions, their pelvis will not be normal and they will need IVF treatment. There are many different reasons involved.
Couples may present and say they have been trying to get pregnant and have a baby for the past two months, two years or five years. When would the referral for treatment be initiated as against dealing with the underlying causes?
Dr. Mary Wingfield:
It depends very much on the couple. If it is a young couple and there is nothing obvious presenting and they are fit and healthy, we would usually say they need to be trying to get pregnant for a year, but if it is an older couple, most people would now say if they have been trying to get pregnant and have been unsuccessful that after six months they would need to be investigated and would possibly need treatment.
We collect the eggs and then we form embryos. The vast majority of eggs do not lead to embryos. We wait for three to five days for embryos to develop and then choose one or two, or occasionally three, embryos to put back in a woman's uterus. That would be the standard in Ireland. Very few people would put back in more than three. If the person has good embryos, there is a big trend towards ideally putting back in one embryo to reduce the chance of multiple pregnancy. However, some people do not get good quality embryos or they may have had two or three failed IVF cycles previously, or if the woman is older, she may need two and occasionally three embryos put back in.
In terms of embryos used for training and research purposes, most people going through the process will need and use all their embryos but some couples will end up with extra embryos they do not need. At present, they can donate them to another couple but that is very difficult, and very few people opt for that.
We can dispose of, or donate, embryos. Currently, there is nothing to stop us donating them for research, but no one in Ireland is conducting research on embryos.
Dr. Mary Wingfield:
A clinic may have embryos, eggs or sperm that are not suitable for use and are not normal. These are often used for training. If people undergoing treatment have eggs, sperm or embryos that cannot be used for treatment, are abnormal or are not developing normally and will be disposed of, we ask whether we can use them for training purposes prior to disposal.
Dr. John Waterstone:
I would hasten to add that some of the technical processes involved in a laboratory are complicated, for example, injecting a sperm into an egg. When scientists are learning the ropes and need to be trained, they need material on which to train. We must emphasise that they will be practising on eggs and embryos that are not viable. It is not that we are giving them viable eggs or embryos on which to practise. Rather, those eggs and embryos are ones that would otherwise not have been kept or used for the treatment of the couple concerned. They are surplus to requirements and are not viable. Obviously, it is ethically admissible for those to be practised on, but we would not use any other material that is viable for those purposes.
There was also a question about pre-implantation genetic diagnosis, PGD. I am unsure as to whether the committee is familiar with this area. In general, we in assisted reproduction services treat people whose problem is that they cannot get pregnant, but there is a subsection of society that can get pregnant naturally but where people are afraid to do so because they know that they are at high risk of transmitting a genetic condition to their offspring. The obvious condition that springs to mind is cystic fibrosis, given that it has such a high carrier rate in this country. There are other conditions as well, for example, Huntington's disease, fragile X and haemophilia. There are many conditions, some of which we have heard of and others that are very rare individually but, in aggregate, are significant. Unfortunately, the couples concerned only find out that they are in that situation because they have already had an affected child. All of a sudden, the penny drops and they know that they are carriers and that, if they have another child, there is a 25% or 50% risk of that child having a condition.
What do these unfortunate people do? Either they can play Russian roulette and take a chance or they can get pregnant and have the pregnancy tested by prenatal invasive diagnosis, which then puts them in a very difficult dilemma - do they terminate the pregnancy if it is affected by the condition? They can use donor sperm or donor eggs to get away from the fact that one of them is a carrier.
The most elegant solution is pre-implantation diagnosis. The idea is that, although the couples can get pregnant naturally, they try to get pregnant through IVF treatment. We collect a bunch of eggs, hopefully from the woman concerned, and we produce embryos. Before we choose which ones to put back, the embryos that look promising are analysed genetically by removing three to six cells from each embryo at a stage where there are approximately 150 cells present. It is a delicate process. The embryo concerned then has to be frozen to afford the time to do the analysis. The biopsy cells that have been removed are sent off. There are units in the country carrying out PGD, namely, us in Cork and another unit in Dublin. We use a genetics lab in the UK because there is no genetics lab in Ireland capable of doing the analysis. We send the biopsy cells over there, where the lab multiplies their DNA a hundred thousandfold, which gives it enough to analyse. The lab reverts to us in due course and tells us, for example, not to put embryo No. 1 back in because it is affected by cystic fibrosis and that No. 2 is safe to put back. The lab is able to identify which embryos are safe for transfer and which are not. As such, this is the most elegant way for these at-risk couples to avoid passing on a condition.
There is good funding for IVF generally in the UK, including a provision whereby if couples have a condition for which PGD is felt to be ethically applicable, up to three cycles of PGD will be funded by the state. That is reasonable. We in Cork who already carry out the treatment - other clinics will follow in our footsteps - feel that the State should be funding this because it is one of the purest forms of preventive medicine. If couples are proactive and paying for this treatment, which is even more expensive than straight IVF treatment, surely they need some sort of support. They are trying to take active steps to prevent transmitting a disease. If they do not and another affected child is born, that immediately means lifelong care is involved, and the cost of that could be hundreds of thousands, if not millions, of euro. There is an argument for supporting PGD. I strongly urge the committee to further as much as it can the provision of financial support for units carrying out PGD and the couples concerned.
Dr. John Waterstone:
It makes provision for PGD, but there is an omission to which Dr. Wingfield and I have drawn attention in the various reports in which we have been involved. Provision is made for PGD more or less along the lines of what obtains in the UK, but obviously without any declaration of an intention to fund it. There is a subsection called pre-implantation genetical screening, PGS, which involves genetic analysis of embryos. The draft legislation has made no provision for it, which is a glaring omission. In PGS, embryos are analysed genetically, but it is not for a specific condition that people know they are at risk of, for example, cystic fibrosis. Rather, it is for sporadic chromosome abnormalities that anyone can have and cannot be predicted. Many human embryos are chromosomally abnormal. We call the ones that are aneuploidy. In general, these embryos do not implant at all or, if they do, they tend to end up in miscarriages. The tip of the iceberg that we are all aware of is Down's syndrome, which is an aneuploidy that proceeds all the way through pregnancy without miscarrying and resulting in a viable baby. PGS is done to detect aneuploidy, and it is becoming part of IVF provision. There is considerable debate about whether it should be furthered and whether it is an unnecessary add-on treatment. There is significant dispute between Europe and America about the merits of PGS, but it is taking place already. We carry it out in our unit to a limited extent. It is also being carried out in Dublin. PGS is a reality in Ireland already and it needs to be catered for in the legislation, but it is not at the moment. I believe that to be just an oversight on the part of those who drafted the legislation.
The concept of PGD is that, if there is a concern due to a previous pregnancy, testing could be done to eliminate the risk. The obvious assertion by people who oppose assisted human reproduction is that the next step will be genetic assessment, gender selection and all that flows from those. Where is this country in the context of gender selection, for example?
Dr. John Waterstone:
-----I have some slight issues. The planet is becoming overpopulated by human beings and the natural habitat is being destroyed. Fast forward 50 or 100 years and it will become unethical for human beings to have more than two children. Do we want to consider diversity if we have the means to ensure that? Supposing it is possible in the future to look at an embryo through a microscope and say whether it is a boy or girl embryo, would it be reasonable to restrict couples' choice to gender balance? I have slight reservations, although they are not shared by my colleague, Dr. Wingfield, at all. I am not sure whether-----
Dr. John Kennedy:
They are shared somewhat by me. There are situations in which one would want to select a girl rather than a boy so as not to transfer a known medical condition. That would be allowed for in the legislation. However, people are discussing family balancing. For example, should a family with three girls that is going through fertility treatment and is analysing the embryos anyway be allowed to select a male embryo preferentially from the pool of good embryos? That is one situation. The other is where there is a family history of a medical condition that, while not necessarily being absolutely on the male or female side, would have a preponderance in one gender more than the other.
Certain disorders on the autism spectrum would have more of a male preponderance so one might have a family with a child who is severely autistic and they want to have another child but they want to reduce their risk of that happening again so they want to have a female. In the UK that is not legislated for. I do have reservations. I do not like the black and white element of this.
Dr. Mary Wingfield:
I think for medical indications most people in the field would feel that sex selection is justifiable. Dr. Kennedy referred to autism. Again, this is an area that is going to evolve. The situation will change as we go forward, for example, as the diagnosis of autism changes, or Alzheimer's disease. All we can do is deal with it at the moment. There is a concern that international security forces are monitoring this area very closely. In the United States, China and other places around the world the gene editing of embryos is monitored so it is scary and dangerous but the legislation is conservative in that area. We need to be conservative at the moment but, undoubtedly, it will evolve in the next ten to 20 years.
On our evolution - this is a philosophical question - we have evolved through natural selection but now human science and technology is beginning to interfere with the natural selection process. Are we now entering into an element of science fiction in the sense that we are now creating ourselves?
Dr. John Waterstone:
We have entered an anti-Darwinian situation where, as Dr. Wingfield has already outlined, the problem with a big chunk of our patients in terms of being able to have a baby naturally is the man's sperm is of very low quality and reproductive medicine now has the power to overcome that completely. We can produce a baby so long as we have a few sperm to work with and as long as the woman is fertile enough. What about the children that are the result? Because this whole area of medicine is so young the children have not grown up yet but when they do, one could predict that many of those will not be able to reproduce naturally either because they will have poor sperm, if they are boys, and therefore, we are in a sense perpetuating a problem. We are creating a generation of people who will rely on assisted reproduction to reproduce themselves. Is that good or bad? I do not know. If I have a couple in front of me in my clinic and I say that the semen is very poor but I can do intracytoplasmic sperm injection, ICSI, treatment which is a variant of IVF or we can use donor semen, what will they say? They will say do ICSI because they want their own genetic baby. You are right, Chairman, that to some extent it is anti-Darwinian if one wants to be philosophical about it.
Dr. John Kennedy:
We hear this a lot, namely, that what we are doing is inherently unnatural, but so is penicillin and so is cancer treatment and stenting somebody's coronary arteries to prevent another heart attack. As has been alluded to, infertility is a medical condition so we are providing medical care for a known medical condition. There are underlying conditions which support it, enable it and make it worse but that is what we are doing. We are treating not elective physicians.
Dr. Mary Wingfield:
Because of the impact that it can have on society it emphasises how important it is for Ireland to have legislation in this area. We are one of the few countries in Europe that does not have legislation so it is fantastic that we are addressing it. That is why we really do need to introduce legislation now.
Dr. John Waterstone:
I think it is fair to say that we are totally frustrated by the lack of common sense in the engagement between the people who are formulating the legislation who to some extent are bioethicists and civil servants who are in ivory towers and us, the guys at the coalface, who know what the problems are because we are dealing with it day to day. We have asked them repeatedly to please talk to us. It is a small country. We ask why we cannot have a chat. We do not want to dictate the legislation but we at least want to provide some useful insights. There has been no meaningful interaction at all.
Dr. John Waterstone:
What has happened is there has been a window-dressing exercise which has left us even more frustrated. The committee needs to bring us together, namely, the people who are formulating the legislation and the people who are at the coalface to make sensible laws that are good for everybody. That is the job of parliamentarians and we beg them today to do it and to take as much time as they require.
Dr. John Waterstone:
As part of the backup to the statement I made today there is a letter from the Irish Fertility Society which was sent to the Taoiseach, Deputy Varadkar, who was then the health Minister. It referred in particular to the Children and Family Relationships Act and our reservations about it. We also talked about our wish to be involved in a meaningful way in formulating the legislation and not just having to deal with it once it had been finalised. That is on record and the committee should be able to access it.
The purpose of this committee is to hold a number of hearings and produce a report which will then be laid before the Houses and sent to the Minister. That is what we intend to do. If we can assist the witnesses in any way we will certainly do that.
It is important that we would encourage the Department of Health to engage with the witnesses because this is a complex area and they are the people who are working at the coalface who know the complications.
To go back to my own profession, when we were dealing with the legislation to regulate solicitors the Law Society had ongoing communication with the Department of Justice and Equality and other Departments. I do not see any difference in this case and why that should not happen here.
I would support that. There is a need for a formalised system of interaction and exchange of views so that both parties are aware of where they are at, where they are going and what is required on an ongoing basis. It is necessary to know the restrictions in which the witnesses are expected to operate and their areas of concern as well as the concerns of the Department.
In view of what we have heard and the fact that we are in a pre-legislative scrutiny phase, what we are trying to achieve is a practical outcome that benefits everybody so perhaps the committee would write to the Department calling for engagement with the witnesses who are before us today, and others, notwithstanding the pre-legislative scrutiny phase. The process could be a simultaneous one. It would short-circuit all the views and benefit the process. Would you do that, Chairman?
Dr. John Waterstone:
I might just come back to one specific point. Reference was made not just to IVF but to other treatments that are out there and that are available. One point that was made in the Irish Fertility Society submission, which others may have made also, is that simple treatments like ovulation induction which are carried out by GPs with Clomid fairly regularly are not covered by any controls at the moment. There is a lot of fuss about how many embryos we can put back on IVF treatment. If we put back too many embryos we get too many twins and sometimes we get triplets. We do not want that. There are simple treatments like Clomid that are dished out by GPs and general gynaecologists, often without any supervision at all, that can also generate multiple pregnancies. Luckily, with Clomid one does not often get triplets but one does sometimes. I have seen audits of the numbers of triplets in the UK a number of years ago and a third of them were due to IVF but another third were due to Clomid.
Therefore, if we are to be regulated in terms of how many embryos we can put back, which is very controllable, the practice of ovulation induction by Clomid should also be regulated as part of the whole system of regulation because it, too, can cause triplets, which are a problem.