Oireachtas Joint and Select Committees
Thursday, 3 July 2014
Joint Oireachtas Committee on Health and Children
Fertility Issues: National Infertility Support and Information Group
This morning we have two sessions. We must finish the first session by 11 a.m. at the latest to allow for turnover time. Our second session will start shortly after that. Is that agreed? Agreed.
Our first session concerns fertility issues in Ireland. I welcome Ms Geraldine Fitzpatrick, vice-chairperson of the National Infertility Support and Information Group, NISIG, who will make a presentation to us shortly. The group was established in 1996 by a number of dedicated people who needed or wanted to be in contact with others who understood the difficulties involved in conception and fertility. I welcome Ms Fitzpatrick and thank her for being here this morning.
Before we begin, I remind members and witnesses about privilege. Witnesses are protected by privilege in respect of the evidence they give to the committee. However, if they are directed by it to cease giving evidence in relation to a particular matter and they continue to so do, they are entitled thereafter only to a 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 or entity by name or in such a way as to make him, her or it identifiable. Members are reminded of the long-standing parliamentary practice and ruling of the Chair to the effect that they should not comment on, criticise or make charges against a person outside the House or an official either by name or in such a way as to make him or her identifiable.
I apologise to members for the croakiness of my voice but I have a chest infection. We have received apologies from Deputies Peter Fitzpatrick, Regina Doherty and Billy Kelleher. Senator Imelda Henry is being replaced by Senator Martin Conway. I ask Ms Fitzpatrick to make her opening statement which will be followed by questions from members.
Ms Geraldine Fitzpatrick:
I thank the Chairman and members for giving us the opportunity to speak on behalf of people who have difficulty conceiving. We sent the committee a submission, which I will go over very briefly. The National Infertility Support and Information Group, NISIG, was established in 1996 by three people, including myself. In 2005, the report of the Commission on Assisted Human Reproduction was published and we had a representation on that commission. We were established in 1996 and, nine years later in 2005, we took part in the commission and, nine years later in 2014, we are here, so we are probably making a little bit of progress, which has to be welcomed.
Unfortunately, the whole area of infertility is still very unregulated. The unmet needs we have are as follows. We need equal access for everybody, regardless of income, and we need independent governance and regulation of assisted human reproduction services in Ireland. As a consequence of that, we would get robust, independent and Irish-specific data which people should be able to access when they want treatment. Currently, they cannot do so and must go to the websites of all service providers to find out what services they provide and where. We believe that if these unmet needs are met, the patient, the clinician and Exchequer funds will be protected.
The population of Ireland is 4.5 million and one in six people are affected, but not everybody will seek infertility treatment. The pie chart in the submission shows that approximately 7,800 different types of treatment are carried out in Ireland annually, including IVF, intracytoplasmic sperm injection, ovulation induction and intrauterine insemination. We have included the websites of the different IVF clinics because people use social media and do their research on the Internet.
We also refer to the Human Fertilisation and Embryology Authority, HFEA, in the submission. We usually refer to UK governance when talking about infertility. The HFEA issues its report annually and was established in 1991. In recent years, it set up a new maximum multiple birth rate of 10% and it believes it has achieved that. We do not have any independent data which tell us what the Irish multiple birth rate is from IVF, but an audit on high-order multiple pregnancies in three Dublin hospitals was published in the Irish Medical Journalin January of this year. Between 1999 and 2008, 101 high-order multiple pregnancies were recorded. We also included the ESRI statistics in the submission because singleton births have reduced the stay in hospital by 16% from 2003 to 2012 whereas multiple births continue to have a high stay in hospital. We believe that some of those multiple births are probably caused by infertility treatment and if Ireland decides to have a target of reducing multiple births, it will reduce the cost to the Exchequer.
The report of the Commission on Assisted Human Reproduction was published in 2005 and the recommendations are exactly what we are looking for, which is a regulatory body, national statistics, the availability of counselling and the availability guidelines for general practitioners and gynaecologists. We believe our needs are in line with the commission's recommendations.
The White Paper on universal health insurance states that health care will be available based on need and not on ability to pay. Therefore, we hope assisted human reproduction technology will be included in that in order that people can get access to it. The problem with infertility treatment in Ireland is that it is quite an expensive treatment so, therefore, it is only available to those who can afford to pay. Some people travel abroad to have it in countries where it is less expensive but that causes problems because the patient is vulnerable as a result of having to travel abroad. Nobody really knows who is responsible for the patient's treatment.
The White Paper on universal health insurance states that the universal health insurance landscape will include a number of regulators, including the Health Information and Quality Authority, which will deliver good governance and good quality. We believe our needs fit into the UHI model which the Government proposes. What NISIG wants is the recognition of infertility as a health need. It needs to be addressed under the UHI model and good governance will actually save the Exchequer money in the long term as a result of fewer adverse events and fewer multiple births. There is a benefit for everybody.
I welcome Ms Fitzpatrick and thank her for her contribution. I have a small number of questions. I was a little taken aback by the World Health Organization's definition of infertility as a disease. It jumped out at me. I had a number of such experiences in terms of coeliac, which is also described as a disease, and many other things which I would see as conditions or whatever. The word "disease" has a particular connotation or impact, certainly among lay people like myself. I wonder what Ms Fitzpatrick's view is of the World Health Organization's definition, which struck me as strange but maybe it is not. People having to deal with infertility would not necessarily appreciate it. I wonder about that.
In regard to the number of people in the population affected by infertility, Ms Fitzpatrick indicated that more than 300,000 Irish people are affected by infertility. I am making an assumption here that they are made up of both males and females. Perhaps Ms Fitzpatrick could elaborate as to the number. Is it known? Do we have figures on the number of females and males? Does Ms Fitzpatrick believe the number is a true reflection of the real level of infertility across our population?
The specific actions she would commend or expect, primarily from Government, include a regulatory body to be established by an Act of the Oireachtas to regulate AHR services in Ireland. I presume this has been a lobby going back some considerable time. I wonder would Ms Fitzpatrick elaborate on what engagement she has had. Was it specifically with the Department of Health? Are there other Departments which could, or should, have a direct input? What progress, if any, has there been in terms of any stated commitment or intent?
I am not aware of any promised legislation on the programme of legislation. I do not have it with me to check but I cannot recall that there is even the promise of legislation in terms of the programme, as published, but I wonder whether Ms Fitzpatrick has something more definite at this point in time.
My party would fully support the introduction of such legislation, which, as Ms Fitzpatrick outlined, is her number one recommendation. That is not in any way to relegate any of her other recommendations, but legislation is one of the areas in which we can best assist. I undertake to continue to pursue this matter.
It is one of the sad realities for those of us working in the area of oncology that we sometimes make people infertile. We try to ensure infertility is not a side effect of the treatments we administer, but that is not always possible. The consequences of infertility are devastating for individuals and families and it is an issue we need to address.
I will begin by offering Ms Fitzpatrick some advice, if I may. Seeking as a priority the provision of new regulations and the establishment of new regulatory bodies is a reasonable approach. In that context, however, I will put forward something of a guerilla view on how our health system works. When people come in here and ask for increased bureaucracy or more inspectors, they are likely to receive a warm response from Government. If, on the other hand, they argue that what they actually need is more services and staff and better access and resourcing, they are pushing a much stiffer door. The truth is that the Titanicneeded more lifeboats, not more lifeboat inspectors. This brings to mind the Health Information and Quality Authority, to give an example, whose public relations department has mushroomed at a time when we cannot deliver basic services.
How many designated fertility specialists are there in the public sector at this time and how many designated fertility clinics? When public patients approach their GP seeking a referral for a fertility issue, how long do they have to wait to be seen? What method of triage is used to decide whether they can access publicly a fertility service and how long will they wait to access that service? These are key questions and I suspect the answers to all of them will be quite sad. Nevertheless, I would be grateful to have that information.
Does Ms Fitzpatrick have any sense of where we fit on an international league table in terms of numbers of fertility specialists compared with other western European countries? As a rule of thumb, for most specialties across medicine in Ireland we have approximately one fifth of the European average. I suspect the figure for fertility services will be no better than that.
I urge Ms Fitzpatrick to keep up the good work. This is a very important fight. As I said, I have some sense of the unbelievable pain this problem can cause. It is an issue to which we must give a higher degree of priority.
I thank Ms Fitzpatrick and all the volunteers involved in the National Infertility Support and Information Group. Coming from a volunteering background myself, it is great to see that type of commitment. We might not even be having this discussion if not for their efforts, which speaks to Senator Crown's questions about the numbers employed and the types of services available.
Given that the Commission on Assisted Human Reproduction issued its report in 2005, the issue does arise as to whether its recommendations are still valid. I am not involved in the sector, but it seems reasonable to question whether proposals that were made nine years ago should be re-examined before being implemented.
In advance of this meeting, the issue was raised with me of the situation of thousands of people who are in a legal limbo in respect of the status of embryos produced by the IVF process. Will Ms Fitzpatrick comment on that and perhaps offer the committee some direction on the matter?
I welcome Ms Fitzpatrick and thank her for her presentation. This is an issue in which I am very interested and about which I have spoken at this committee and locally. I have personal experience of family and friends who were devastated because they were unable to have children. It is important and timely that the issue is now being debated by the committee. One of the most pressing issues in this area is the importance of ensuring there is equality right across the board. There are people who wish to have a family but simply do not have the financial resources to even begin pursuing fertility treatment. Others who are availing of treatment have taken on an enormous financial burden. Some of them are also dealing with negative equity and are struggling to balance their efforts to have a family with keeping up with their mortgage payments and other bills.
Senator Crown asked about the services available under the public health system. I discovered through my research into this issue that in the United Kingdom, assisted human reproduction services are available on the NHS. The system is administered in each borough by clinical commissioning groups which adjudicate on the eligibility of applicants, most of whom are aged between 23 and 39. In some cases, it is impossible to sanction initial or additional treatment, for a variety of reasons, but in many cases such sanction is given. The UK model is the one we should follow. It is not about money being thrown at people; the system is well researched and well managed and there is a comprehensive engagement with applicants. Part of this involves examining each individual's health history to ensure he or she is up to going through a process that is very difficult, especially for women. The physical demands alone include the injection of hormones and so on.
I agree with Ms Fitzpatrick's proposal that fertility treatment should be included in the standard package or basket - we always seem to be talking about baskets in this context - under any universal health insurance system. For most people, having a family is a great gift and the birth of their children a very happy time in their lives. Unfortunately, for many couples who want to go down that road, things just do not work out without intervention. I have personal experience of family members who succeeded in having children following fertility treatment and others who, after six or seven IVF attempts, remain childless. This can have a devastating impact not only on the individuals themselves and possibly their relationship, but also on their parents and extended families. In many cases, particularly where both partners have to work full-time to repay huge mortgages, couples are delaying children until the woman is well into her 30s, which may cause problems.
As I said, I would support any initiative to ensure universal health insurance covers people who are facing this crisis. It is a crying shame we have waited so long before moving to assist the thousands of people in this country who are facing or already going through this process and are obliged to take on a huge financial burden in order to fulfil the wish shared by most couples to have a family of their own. Anything I can do to assist as a member of this committee, I will be only too glad to do it.
I welcome Ms Fitzpatrick and commend her on the work she is doing. Some of my questions have already been asked by colleagues. Ms Fitzpatrick indicated that one in six people in this State is affected by infertility. How does that figure compare internationally and is the number increasing or decreasing over time? Ms Fitzpatrick outlined an array of options that are available in this State. Are there any options that are not available? Are certain treatments available to private but not public patients?
What are the long-term effects of multiple births on the babies? How can their needs be catered for?
In regard to the introduction of legislation, do other countries have such legislation? Has the Minister for Health indicated that he intends to introduce legislation?
Ms Geraldine Fitzpatrick:
I will start with Deputy Ó Caoláin's questions. I acknowledge the WHO has defined infertility as a "disease". It gives recognition to the condition. That is good because it is treated completely differently from simply an "I want to have a family" type situation. The WHO definition gives it clarity. That is the positive thing about the WHO defining infertility as a "disease". I guess each country deals with it in different ways in terms of whether it is chronic, acute or otherwise. The Deputy asked about the population and one in six being affected. It is 30% a female factor, 30% a male factor and 30% an unknown factor. It can be any type of condition. The average age of people seeking treatment is 37 years. People are delaying their conception years until later, so it is more difficult anyway. That is another factor in the equation.
The Deputy asked about other Departments. NISIG is the port of call for everything, whether IVF, ICSI, adoption or surrogacy. We are only volunteers and only a support group. It is much more than what we can actually do. However, the Department of Justice and Equality is dealing with surrogacy and we hope it will deliver satisfactory outcomes for people. The problem with all the people with whom NISIG deals is their vulnerability.
It is really interesting that NISIG has been established since 1996 at a time when there was one clinic or two clinics in this country and there was very little social media. One could argue we have information overload now but actually the patients or the people using the services are just as confused and just as vulnerable. The situation is no better than it was in 1996. We have access to information but we do not have proper structures in place to support these people. We look to the Department of Justice and Equality for developments on the surrogacy issue. Since I sought this meeting, I have been in contact with the Department of Health and I hope to pursue further meetings with it, but I am not quite sure about that. It is only the start, so there is nothing further on that yet.
Senator Crown asked how long people waited in the public system. Essentially, infertility treatment is done privately. There is one clinic or two clinics which will do a few GMS people in the year but, realistically, it is not accessible to people. That is the reality.
May I ask a supplementary question? If somebody who is not privately insured and who does not have private means goes to a GP stating they have been trying to conceive for a year and a half and they believe they need help with fertility, what will happen to them? I presume they are referred to a public gynaecology clinic.
I know there are a certain number of tests which can be done to rule out particular causes but if none of those causes is there and the recommendation is for assisted reproduction, is there no assisted reproduction available for public patients?
Ms Geraldine Fitzpatrick:
There is a minimum. There is intrauterine insemination. It depends on the local area. I cannot speak about the situation nationally but I know locally in Cork, they do one or two cycles. Again, one will wait as one does as a public patient until there is availability. There is not really a system in place.
Ms Geraldine Fitzpatrick:
That is a problem. There are no public centres. It is essentially private. What the support group is finding is that some people are going abroad to the Czech Republic because it is cheaper there but the problem is that they arrive back in Ireland with no support. One is on one's own.
Ms Geraldine Fitzpatrick:
It does as it does with any other patient. It is a problem because treatment is much cheaper there. One could argue it is an opportunity for these people and one cannot blame people for doing these things. In the Irish Medical Journalin January, one of the Dublin clinics talked about single embryo transfer. Deputy Byrne talked about the UK, which funds a certain amount of treatment. Maybe the Government needs to think about funding possibly one or two treatments. If certain criteria are met, it could fund the first one or two cycles. As Senator Crown said, one is then offering a service for people who cannot afford it so they can have it done in Ireland. There is less risk for the patient, less medication involved and less travel. The chances are they will have a singleton birth as opposed to a multiple birth which is less expensive on the Exchequer.
We need to consider how we can meet the needs of people who can afford it. Why should a person who can afford to pay €20,000 not be treated in the same way as somebody who cannot afford it? The UHI model states that it should be accessible to all. Currently, everybody pays and it is quite normal to pay €20,000 plus between clinics, treatments and so on.
Ms Geraldine Fitzpatrick:
No. Their treatment will possibly be less expensive in the Czech Republic but when they come back, they are vulnerable and there is no support. One could arrive back in this country with medication dispensed or prescribed in another jurisdiction which we do not have here. There are all those problems associated with it. We need to regulate the situation in Ireland. We should make this available to people, so they would not have to put themselves in that vulnerable position. Even if we could reduce the number of multiple birth rates in Ireland, the savings there would pay for a minimum of one or two treatments initially for people. Something needs to be done to overcome that type of vulnerability. The service is essentially private. That is the point.
In regard to the 2005 report, the chairperson of NISIG was on that commission. I attended a few of the meetings. There is still the same problem. There is no regulation and we have no basic data to which we can refer. People should have that facility. If I remember correctly, that report took many years. There is no point doing another report if it sits on the shelf. We can take the basics from this.
Ms Geraldine Fitzpatrick:
If one has surplus embryos, one pays the clinic to store them for one. The support group is finding that people really do not want to be in that position anymore. They want the minimum treatment. If somebody has three children and suddenly they have six embryos being stored, it is a dilemma for them. Patients are obviously more informed now and they do not want that much medication used.
Some of the clinicians will point out that a patient who has paid almost €15,000 for three failed IVF treatments will want three embryos used in any subsequent treatment. In such circumstances, it is very difficult for a clinician to refuse the patient's wish and offer only two embryos on the basis that she is 37 years old. If the Government were to issue guidelines on these matters, nobody would be able to argue with a clinician's decision and the patient and clinician would be protected. We are not seeking detailed legislation, which appears to take forever to introduce, but short-term steps to regulate the area and solve immediate problems. We could then examine the models in place elsewhere in Europe to identify what works and does not work. My point is that we have not moved since 2005.
On the model in place in the United Kingdom, as with everything else, no health system is perfect. However, under the British system, treatment is funded to a certain level and patients can then pay more for additional services. This is probably a good model and while I am not an expert on the Human Fertilisation and Embryology Authority, HFEA, in the United Kingdom, I am sure the Department could examine what elements of the British system are suitable and could be applied here. As was noted, everyone has problems with money and trying to sort out a career. The United Kingdom system is a good model to adopt. It would be good if fertility treatment was in the universal health insurance basket.
In 2005, the Commission on Assisted Human Reproduction reported that Ireland did not have the basic elements in place, including guidelines for general practitioners and gynaecologists. For this reason, we must start at a basic level and put in place a structure that will support people who seek infertility treatment.
The figures on infertility are roughly the same here as the figures internationally. I was also asked what options are available here. I return to the issue of the vulnerability of the patient. Clinics A, B and C may each offer a menu of options. The HFEA guide in the United Kingdom provides information on what each clinic offers and applies strict rules in this regard. Transparent data are lacking here as we do not, for example, have a single website that sets out the services provided by the various clinics. Such information would be welcome.
I was also asked about multiple births and the long term picture for babies. While a study of children aged 0 to 5 years has been completed in Cork, its findings have not yet been published. Data are, therefore, available and the maternity hospitals are doing internal research but little of it has been published.
The issue of legislation was raised by several speakers. The priority is to issue guidelines and take simple steps.
Senator Crown referred to the public relations department of the Health Information and Quality Authority. The Human Fertilisation and Embryology Authority was established as a stand-alone agency but now collaborates with the Care Quality Commission to reduce costs. The reason we propose a role for the Health Information and Quality Authority is that HIQA has a structure in place and we do not want another stand-alone body established as that would create additional costs. We would like one agency to deal with all of these issues.
People contact the National Infertility Support and Information Group to discuss good news and bad news, for example, adverse events, and we are not in a position to deal with these types of issues. One can read horrific stories on websites such as rollercoaster.ie. As members will be aware, when a clinic closed earlier this year, people read about it on a website. The clinic's property, including embryos and tissue, was transferred to another clinic without any consultation with patients. We need a structure in place that protects everybody when adverse events occur.
Ms Geraldine Fitzpatrick:
The Irish Medicines Board has responsibility for the governance of laboratories and the continuing professional development, CPD, for doctors. That is a given. We could take what is appropriate from the HFEA in the United Kingdom and use the quality department of the Health Information and Quality Authority to set up structures. Roughly 60% of clinics in the UK are inspected every year and the HFEA publishes on its website tables featuring all the key data on the various clinics. We seek something simple that would protect patients and clinicians.
I thank Ms Fitzpatrick for her presentation which I read before the meeting. She refers to regulatory issues. I understand all infertility clinics are registered with the Irish Medicines Board, which applies strict criteria when carrying out inspections of clinics. Is that not the case? I also understand that inspections take two or three days and involve going through every item, including all protocols and policy documents, and checking all information. It is important to send out the message that high standards apply to all clinics operating here and that they are all supervised by the Irish Medicines Board.
In the case of the closure to which Ms Fitzpatrick referred, I understand the clinic in question closed due to the ill health of the person who was running it. This has been explained, although I accept Ms Fitzpatrick's point about the work it was doing being transferred to another clinic without consent. The issue had to be dealt with in an expeditious manner, however, to ensure no one was left in limbo.
Does Ms Fitzpatrick envisage an expanded role for the Irish Medicines Board, rather than having another regulatory authority become involved, especially as the IMB already does much work in this area?
Ms Geraldine Fitzpatrick:
We are aware that the Irish Medicines Board regulates infertility clinics. While I fully agree with Senator Colm Burke that clinics operate to the highest standards, I do not know if the Irish Medicines Board has a quality department. The Health Information and Quality Authority has a model of quality and standards and is familiar with using key performance indicators and so forth. I accept that it is preferable to have one rather than two bodies with responsibility for this area. If the Human Fertilisation and Embryology Authority in Britain can work with the Care Quality Commission, why can HIQA not work with the Irish Medicines Board? I do not know the answer to that question.
There is no question about the quality of services and the standards operating in the clinics. However, we lack independent data and we would like the data from clinic A, B, C and D to be presented in one place in exactly the same fashion. While one clinic may provide statistics to show it has a success rate of 50%, the clinic in question may deal only with women aged under 35 years. One must take a reasonable approach in which all the data are presented in an identical manner in order that people can compare like with like. We need information on results and adverse advents. Perhaps the Irish Medicines Board has the ability to do this and it may have a quality department. We are so used to hearing the Health Information and Quality Authority mentioned in the context of quality that the name "HIQA" comes to mind when we think of quality. This area needs to be embraced by a single body.
All these doctors are well used to dealing with either HIQA or the Irish Medicines Board, so I do not see any of them having a problem with either as long as the expertise is at hand. There is no point in duplicating work if there are experts in one place but none in another. I absolutely take the point but we lack independent data and it is exactly the same for every clinic across the board. That is what is needed in this country.
Ms Geraldine Fitzpatrick:
We refer to the HFEA model. It is usually compiled annually and it gives all the details of the different types of services available. It is quite simple and a type of spreadsheet data collection. The clinics would report to the governing body and the data would be published annually.
Ms Fitzpatrick indicated that the HSE in advance of the meeting had been in contact with her and she hoped to pursue the issue shortly. It might be something for the committee to note, and we should check in a few months that those meetings have taken place.
I have been doing some research on this. One of the decisions from England is that special cases which fall outside the remit can also be considered. Three cycles of treatments can be received, which is a positive development in England.
Ms Geraldine Fitzpatrick:
Yes. Cystic Fibrosis Ireland funds its patients for treatment. Infertility people are not treated equally, and there should be a structure in place so that everybody, whether in Donegal or Waterford, would have the same access and services available. It is unfortunate as we are very vulnerable and spending a lot of money. The Government is stuck for money but something needs to be done, as what is said in one way is received in another. The data from the three units in Dublin are useful. For example, with the audit between 1999 and 2008 of 101 births, five were a normal delivery, 70% were elective Caesarean section and 25% were an emergency section. Even when considering the costs involved, we need to keep it simple and put something in place. The benefit will be repaid twofold.
I thank Ms Fitzpatrick for being here today and the members for their in-depth analysis and discussion of what is a very important and sensitive issue. Arising from today's meeting we will certainly take up the matter with the HSE. We will also examine the matters raised today before considering a response at our next meeting. I thank all the people in the organisation for the commitment given to the cause.