Dáil Éireann debate -
Wednesday, 23 May 2018

Vol. 969 No. 5

Leaders' Questions (Resumed)

Deputy Mary Lou McDonald

Prior to this referendum campaign, many people did not know of the existence of abortion pills, much less the frequency with which Irishwomen were ordering them online and consuming them with absolutely no medical supervision. The Department of Health estimates that every day three women and girls consume these abortion pills. It is a story that has featured but has not been openly expressed in the public domain in the course of this campaign, not least because the consumption of the pills carries with it a potential criminal sanction of 14 years' imprisonment.

This morning I had the pleasure of meeting Ms Elaine Bedford, who is from Killester in Dublin. She has now stepped into the public light to tell her story and that of her daughter, Kate. Kate was diagnosed with type 1 diabetes at the age of seven. As she got older, she suffered from polycystic ovaries and was prone to infection. From the age of 11, when she hit puberty, she was always warned against unplanned pregnancy because of her diabetes. In late 2016, Kate became very ill. Her mother tells me that she spent three days and nights in intensive care at Beaumont Hospital. She recovered from that. The following year, she fell pregnant. It was not a planned pregnancy. At that stage, Kate was 25 years of age. She was frightened. She felt cornered and snookered and believed she had very few, if any, options. She decided on abortion pills. Elaine recounted today, in the most graphic detail, the experience of her daughter consuming these pills at home alone. She said Kate took the tablets at home, was in agony and was bleeding. Kate seemed to move in and out of consciousness and Elaine could not lift the telephone to tell the doctor because Kate was terrified of that. Elaine said this hell continued for three days, with pain and bleeding. Kate's boyfriend and her mother took shifts to look after her. Elaine told me she will never forget the fear and panic in her daughter's eyes. She said that no mother should ever have to see that fear in her child's face.

Kate is not alone, as we all know. Women take these pills alone, scared and in silence. They do so knowing that the eighth amendment prevents them from gaining access to the medical care they need. The result is women bleeding in their beds unable to seek help, daughters pleading with their mothers not to call the doctor out of fear, and loved ones watching on wondering how bad the situation might get. Nobody should ever be left in that position. I am sure the Taoiseach will agree with me. I hope everybody in the Dáil agrees with me on this point. I ask the Taoiseach to speak to Elaine, Kate and the women and girls who will consume abortion pills today.

The Taoiseach

We estimate that three women today will order abortion pills online. Three women today will receive them in the post and three women today will take them. No matter what the result is on Friday, or rather, on Saturday when we count the votes, that will continue. Deputy Mary Lou McDonald is correct that these pills did not exist in 1983 but they are around for a number of years now, or are more readily available because of the Internet. Certainly, if people did not know about them they certainly do now after the debate we have had for the past few weeks. The number of women who decide to end their pregnancies by taking an abortion pill will certainly rise in the years ahead. That is inevitable, no matter what the result on Friday. Therefore, it is my view and I believe the view of most people in this House, that it would be better if it were done safely. What we are proposing in the draft scheme of the legislation and what will become possible if the eighth amendment is removed from our Constitution is the putting in place of a doctor-led system whereby women can obtain the pills from their doctor, not from a website. They would be able to go to their doctor and the doctor could talk to them about other options, which a website does not do. Options could be continuing the pregnancy or adoption. The doctor could offer the woman counselling and, of course, there would be a 72-hour period during which women could reflect on their decision. If they decide to go ahead, it can be done safely. It is dangerous to take the pills if one is too far along but one needs a doctor to check how far along one is. It is dangerous to take the pills if the pregnancy is ectopic because they will not work. It is dangerous to take these pills if one has a bleeding disorder. How does a woman know if she does not go to see her doctor? What we want to do is put in place a new system that is much safer than the one we have now, that allows people to discuss alternatives and that is compassionate.

In addition to the availability of the abortion pill, there has been another change since 1983. Pregnancies are now increasingly complex. Women are becoming pregnant much older than in the past. Owing to IVF, pregnancies are much more complex. Women with diabetes, severe epilepsy and neurological disorders must be borne in mind in this regard, and women with cystic fibrosis, for example, who might not have lived to reach the point where they could have children now can have children because of the improvements in healthcare. Therefore, there are much more complex pregnancies than in the past. Professor Mary Higgins speaks about this so well.

Currently, the eighth amendment ties the hands of doctors. Doctors can intervene to end a pregnancy only if there is a risk to the life of the mother, not a risk to health. To me, a risk to life is a very low bar when it comes to what we offer Irish women facing complex pregnancies. If we have a "Yes" vote on Friday, we can change from a risk to life to a serious risk to the health of the mother. That will allow doctors to sit down with the patient, weigh up the options and offer a termination if there is a serious risk to her health. Some mothers might decide to take that risk but others might not.

Deputy Mattie McGrath

The child does not matter.

The Taoiseach

That is really what we need to change in the period ahead.

Deputy Mary Lou McDonald

Kate will turn 27 in October. Her mammy says she is a good girl. She is still a girl at 27. She is on her honeymoon but she will be home to vote. She is going to vote "Yes".

There is a fundamental question for all of us as citizens, but particularly for all of us as legislators, on this matter. It boils down to this: are we prepared to look the other way as Kate and hundreds and thousands of other women take abortion pills in circumstances that we know are unsafe?

Are we prepared to do that as the legislators for this jurisdiction and as people who have responsibility to shape thoughtful, responsive, inclusive public policy? I am not. I am not prepared to look the other way. Elaine, Kate's mother, is not prepared to look the other way. That is the challenge for people as they, in good conscience, arrive at their decision on Friday. Do we look the other way? Do we create this jeopardy, this threat, to the health and potentially to the lives of our women and girls?

An Ceann Comhairle

Thank you, Deputy. The time is up.

Deputy Mary Lou McDonald

The Taoiseach has been out on the campaign trail, no more than the rest of us, and I know he has spoken to countless parents - fathers and mothers - as I have, who told him that their greatest dread is the thought of their girl taking an abortion pill in their bedroom in silence and loneliness.

The Taoiseach

I know that people will vote on Friday, no matter how they decide to vote, in accordance with their conscience and will do what they believe is right based on the information available to them. I also know, however, that many people have been influenced by hearing some of those individual stories such as Kate and Elaine's or stories about young couples who were forced to travel to Liverpool for a compassionate early delivery, something we cannot offer in our hospitals. If there are people who are undecided, and I know many people are still undecided at this point in time, I would ask them to set aside an hour or so this evening or tomorrow evening and think about some of those individual cases because, ultimately, laws are just written in black and white. They are text on a piece of paper but what has to be behind all those laws is individuals - people and families - and how those laws will affect them in practice. I would encourage people to consider some of those real lived experiences before they vote on Friday.

Deputy Ruth Coppinger

When the Taoiseach is thanking the parties that support the referendum he might mention parties like Solidarity-People Before Profit and others in this Dáil that brought repeal Bills here, whose members have not voted down repeal Bills and whose members are not out campaigning against repeal.

In 48 hours, people will have begun voting in the referendum on the eighth amendment. Will he agree with me that this is one of the most important votes in decades in this country? It is obviously about abortion but it also about the status of women and the type of society we want. In the past two months, we have got a glimpse of what the "No" campaign think of women. They are spreading lies and half truths and whipping up fear. In fact, spreading out and out misogyny is their stock-in-trade. They meet each morning in the "No" campaign headquarters, rub their chins and wonder if there is anything to be said to put on another misogynistic poster. How about one suggesting that women will flock to have abortions once it is made legal? How about another suggesting that women will go through a physically painful procedure as their regular form of contraception? Even though we know late abortions happen in rare and tragic circumstances, let us suggest that women will hang on for six months of pregnancy, which is obviously a cakewalk, then suddenly decide they want an abortion on demand.

The message behind these type of posters is thinly veiled misogyny. Instead of acknowledging that women are intelligent and equal beings who are highly responsible, as well as being the nurturers and carers of children, sick people and old people, they want to demonise women and present us as a threat.

Does the Taoiseach agree that the question needs to be posed to voters about the type of Ireland they want? Do they want one advocated by the "Yes" side where women are listened to and not silenced and forced abroad or should the nation be reminded of what a "No" vote would mean? As well as saying "No" to the right of a woman to have a choice, the leaders of the "No" campaign have said "No" to contraception. They have said "No" to sex education. They said "No" to same-sex marriage three years ago. They have said "No" to divorce, to equal employment, to married women being in the public service, to working mothers, to LGBT+ rights and to gender recognition. I do not have time to go on. Does anyone think that if they somehow snatch a victory against the tide on Friday, they would not seek to impose a ban on the right to travel, a ban on the right to information and to maintain the 14-year jail sentence faced by five people using abortion pills each day?

I am hopeful the "Yes" vote will be delivered by a youth and gender quake on Friday, by the thousands I see campaigning on the ground and by the 120,000 mainly young people who registered to vote, which is twice the marriage equality referendum rate, and by the women and men on the doors who have reflected back their lived experience of the reality of life now.

The Taoiseach

I want to add to what I said earlier by acknowledging the role of smaller parties and indeed Independents in this campaign, whether it is the Green Party, the Social Democrats or others, as well as parties of the left. As regards my constituency colleague, Deputy Coppinger, I want to particularly recognise her early role in putting this matter on the political agenda and raising it in this House, perhaps at a time when many of us would have preferred not to deal with it. It is only right, now that this question is being put to the people, to acknowledge the early role of Deputy Coppinger, Deputy Clare Daly and others in that regard.

In terms of the women of Ireland today, there are approximately 60,000 births here every year, which means that at this moment in time there must be about 40,000 women in Ireland who are pregnant. I absolutely agree with the Deputy. I do not believe for a second that one of the 40,000 women who are pregnant today is walking around waiting to decide on whether she will continue that pregnancy based on the decision we make on Friday or Saturday. I cannot imagine any of those 40,000 women saying that if there is a "Yes" vote she will have an abortion and if there is a "No" vote she will not. That is not how it works. Women who feel they need to end their pregnancies will do so anyway but they do so in a dangerous way, whether it is by importing the abortion pill online or, not in a dangerous way but in a higher-risk way, travelling overseas to end their pregnancies, often much later in their pregnancies than they would if they were able to access those services here in Ireland.

In terms of the type of Ireland we want, I believe a "Yes" vote says that we want to have a more compassionate and caring Ireland and one that helps women in particular in a time of crisis. I believe it says that we accept the reality of abortion that already exists in Ireland and that we will manage it and regulate it here. However, I want the people who are worried about this decision, and there are many people who are worried about it and who will vote "No" in clear conscience, to know that if there is a "Yes" vote this weekend, Ireland will still be the same country it was before the vote. It will just be a little bit more compassionate.

Deputy Ruth Coppinger

We saw in the debate last night just how backward and reactionary the "No" side is. There are some people in this Dáil who claim to love both but they were not showing too much love in several debates in this Dáil. For example, one of the Deputies in a debate in 2010 on social welfare talked about the elephant in the room, the considerable number of young women "many of whom are still teenagers, who consider single parenthood a choice which can be financially rewarding" and about people having babies outside of committed relationships and how that must end - it was Deputy McGrath - and the idea of people having children as an escape from poverty.

Deputy Finian McGrath

Mattie.

Deputy Ruth Coppinger

That is how much they love both, and we heard all the guff in 1983 about how they were going to help people.

I will finish by mentioning one inaccuracy that needs to be corrected and it concerns the abortion pill. Based on two of the websites, Women on Web and Women Help Women, five people a day in Ireland are estimated to use these pills. We should be accurate and not scare people about the pills. The pills are very safe. There is medical supervision in that there is a doctor-led service. It should be acknowledged that they are doctors who stepped in when doctors in Ireland would not. The real danger, however, is the fact that the law prevents people from seeking any help in the 3% of cases where they may need follow-up care. I am proud to have promoted abortion pills with ROSA and others.

They are described as safe by the World Health Organization and I think we should be accurate about that.

The Taoiseach

They may well be safe but when it comes to any medicine that is bought online, one cannot always be sure it is what it says it is. Obviously, there are legal consequences as well. I think we all agree that it would be safer if they were legal and available here in Ireland.

There are two aspects to this conversation that perhaps have not got the recognition or notice they deserve. First, abortion rates in Ireland are falling. The number of women who travel overseas to end their pregnancies giving an Irish address has actually been falling in the past number of years. That is a good thing. It is something to be welcomed. Teenage pregnancies in Ireland are at their lowest since the 1950s. We do need to ask ourselves why that is. It is because of funding provided to groups like the Rape Crisis Centres and the Crisis Pregnancy Agency. It is because of sex education in our schools, the wider availability of contraception and the availability of the morning-after pill. These are changes and reforms that have happened in the past ten or 20 years that have reduced the number of crisis pregnancies, abortions and teenage pregnancies. There is a certain irony in the fact that those who are most opposed to the change we are proposing - those who are so convinced that a "No" vote is the right thing to do - are very often the same people who opposed the morning-after pill, contraception and sex education - all the things that have actually made abortion less common in the past number of years. One thing I do want to say to people because I think it is one thing on which everyone agrees regardless of whether they are on the "Yes" or "No" side is that we should continue in our efforts to reduce the number of crisis pregnancies in the first place regardless of the result at the weekend. This will mean delivering on our commitment and implementing the recommendations made by the all-party committee to make contraception more available and to improve sex education in our schools so that we can continue to see a fall in the number of crisis pregnancies in the first place.

Deputy Thomas P. Broughan

I am also voting "Yes" and calling for a "Yes" vote on Friday but I want to raise another health matter of public importance. The Taoiseach set up the National Rare Diseases Office when he was Minister for Health in 2015. By definition, rare diseases are rare but the office estimates that something like 300,000 Irish people will develop a rare disease at some stage in their lives. Recurrent complaints to us concern the lack of clinical supports and the tortuously slow process for the approval of orphan drugs for these diseases. A case in point is the failure since 2009 to approve the drug Kuvan, or sapropterin dihydrochloride, under the process for national pricing and reimbursement. Kuvan was developed to assist citizens with the rare metabolic condition phenylketonuria, PKU, where patients have difficulty processing the amino acid phenylalanine and must live on very restricted low-protein diets. Kuvan helps many of those affected to live more normal lives. PKU was first identified in the 1930s, although the widespread heel prick test screening did not start until 1960s. Failure to give treatment to a child after the first 48 hours results in serious cognitive impairment and often severe brain damage.

In 2009, the European Medicines Agency and 20 countries approved the use of Kuvan. The Minister for Health told me that at that time, insufficient evidence was submitted by Merck Serono, the manufacturers. It passed on the market authorisation to BioMarin in 2016. BioMarin submitted a new health technology assessment for sapropterin to the HSE. Nine months ago, I asked the Minister for the results of the assessment by the National Centre for Pharmacoeconomics. My constituents and I were very disappointed to find that Kuvan was not recommended for reimbursement last September. It was said to be not cost-effective, although even a 100% uptake has been estimated to cost only around €2.5 million per year. The figure for the per capita cost, the Taoiseach may note from his past work, is relatively small. In several Dáil replies, the Minister has told me that the assessment process is ongoing and that the rare diseases medical products technology review committee is engaged with prescribers, specialist centres and the patient representative group to try to bring forward clear reimbursement guidelines that would be expected to target sapropterin to the patient cohort for which it may be a cost-effective intervention. I appreciate the Minister's diligent responses relating to Kuvan over the past two years but after nearly ten years of assessment and as one of the countries most affected by this condition, is it not time to approve it? As the Taoiseach may be aware, one in 4,500 babies is born with PKU in Ireland. This is double the European average. I think only Italy and Turkey are somewhere near us. It is said to result from one of our Celtic genes. In 2015, the Minister told me that there were something like 350 or so referrals and 20 new PKU patients per year in the metabolic disorders unit at Children's University Hospital, Temple Street. It is estimated that around 750 patients with PKU are receiving hospital treatment. Representatives from the PKU Association of Ireland, the European association and other patients and relatives have been in regular contact so there is a very strong request that this drug would be approved.

The Taoiseach

The Deputy will be aware that we have a rare disease strategy. I think it was published by the then Minister for Health, James Reilly, a few years ago. One of the recommendations in that was to establish the National Rare Diseases Office, which I had the pleasure of opening during my time as Minister for Health. If one takes rare diseases on their own, they are rare but when one adds them up together, quite a lot of people have one. They include diseases like PKU, which the Deputy mentioned, haemophilia, cystic fibrosis and others. When one adds up all of the people who have a rare disease, it comes up to a couple of hundred thousand people. It does not seem so rare when one does that.

In terms of any new medicine, including Kuvan, a couple of things must be assessed. First, its effectiveness must be assessed. Does it actually do what the manufacturers say it does in terms of modifying disease and improving quality of life and life expectancy? Second, is the price being put forward by the manufacturer fair because even the richest countries are budget-limited and if we pay too much for something, there is an opportunity cost relating to the other things we cannot do as a result? Another factor is whether alternative treatments are available that might be as effective or most cost-effective. I do not think there is in this case. I believe it is an orphan drug. The assessment is done by the National Centre for Pharmacoeconomics in St. James's Hospital. It carries out a detailed assessment of the medicine and makes a recommendation to the HSE's national drugs committee, which makes the final decision. It is not and should not be a decision that is made by politicians for lots of reasons we all understand. It is always the case that if the manufacturer has new information and data, it can submit that and it will be examined again. I understand that when it comes to Kuvan, that is currently being done and that the application is currently being reassessed. I know the Minister has met with the parents of children who have the disease and he will, of course, provide the Deputy with an update as soon as possible.

Deputy Thomas P. Broughan

Kuvan is actually a synthetic copy of the BH4 deficiency, which causes PKU. There are many heart-rending accounts of the daily struggles of families with children with PKU to stay within their low-protein allowance, particularly given that there are few low-protein foods available in Ireland. As I said, it is ten years since the European Medicines Agency approved it for market authorisation. The health systems in most of our EU colleague countries have supported it. The Orphanet Journal of Rare Diseases, of which the Taoiseach will be aware, published the complete European guidelines on PKU diagnosis and treatment last year. The journal says that diet plus medicine is the best control of the condition.

On the wider issue of orphan drugs, including Kuvan, does the Government foresee making any changes to the quality of adjusted life measurements in the National Centre for Pharmacoeconomics assessments? I have put that question to the Minister several times because it seems to be the key point when one starts talking about cost-effectiveness. Are officials in the Department of Health and the HSE working on a fairer way to assess the efficiency of treatments for rare diseases? The Taoiseach mentioned the national rare disease plan from 2014 to 2018. Are we preparing a new plan from 2019 onwards? I know that when the Minister set up the National Rare Diseases Office, it started with five part-time staff. I know the Government did not provide any additional funding in 2017 so are further funding and resources being provided for that? Above all, it is now time, as the Minister for Health will probably agree, to make sure Kuvan is approved.

The Taoiseach

The Minister has met the patients affected and their families.

He has committed to giving the Deputy an update on the status of approval for Kuvan specifically and also to give an update on funding for the rare diseases office.

As a broader issue, the Government acknowledges we have a problem here in that the process by which we approve drugs generally may be inappropriate for orphan drugs because it is the only one available; that is the nature of an orphan drug. However, the pharmaceutical industry takes advantage of the situation. When a number of medicines are available for a particular condition, pharmaceutical companies cannot overcharge for them. However, a sole producer of the only medicine can charge whatever it likes. That is an enormous problem that we and other countries are facing.

The process we have for assessing new medicines is robust and good. It is scientific and independent. However, I am concerned when I see medicines available in Britain that are not available here. The NHS is not renowned for approving new medicines quickly - for example, it has not approved Orkambi for patients with cystic fibrosis. I am concerned when I see medicines available in Britain but not available here. I find it very hard to justify. The Minister, Deputy Harris, and I are in conversation with the Minister for Finance as to how we might improve that in the near future.