CervicalCheck Screening Programme: Statements

I welcome the Minister for Health, Deputy Simon Harris, to the House.

I am very glad to address Seanad Éireann this afternoon on this very important issue which has arisen and which I know has caused a great deal of concern, particularly to women, right across the country. I thank Senators on all sides for providing me with an opportunity to address them today. I reiterate my gratitude to Vicky Phelan for her courage in bringing this issue to light and acknowledge the important role she has played in highlighting a number of weaknesses in respect of how people have experienced our national cervical screening programme, CervicalCheck.

I wish to provide the Seanad with an update on the actions the Government has taken since the full impact of this issue became apparent. As Senators know, I took immediate actions, including: sending a serious incident management team into CervicalCheck to get to the bottom of the information that was emerging about the extent of non-disclosure; ordering an immediate change to the process, which was not ensuring that women were automatically informed of reviews of their screens; and announcing that we would have an international review. The Government has since taken a series of further actions, including the establishment of two clinical reviews by international experts: one in respect of the individual cases of women whose screening results were reviewed and who were not told; and a second to conduct an audit of all previous screening results of every woman diagnosed with cervical cancer in the past ten years. All of the work under way as a result of these actions will, of course, feed into a wider inquiry on this matter.

Last evening, I met members of other political parties and groupings in the Oireachtas to discuss the best way forward on the issue. It was agreed that there is a need for early answers here and, as a result, I am now working on a scoping inquiry which will led by an international expert and which, I hope, could conclude by June. I consider that to be an important approach to establish some basic facts which can be quickly put in the public domain, while also identifying issues which may merit a full statutory investigation and developing terms of reference for such an investigation. Let me say clearly that I think we are going to need a commission of investigation with full statutory powers so that people might find out who knew what, where and when and in order that we might learn from this. What we do not want to do - I am conscious of what Vicky Phelan said we do not want to do - is jump straight into a process that could go on for a period. What we need to do instead is gather as many facts, data and information as we possibly can through a scoping process, let that process also benefit from the knowledge of the international medical review panel and allow the scoping process talk to women who have been impacted, engage with them and come up with draft terms of reference as well.

I want to say on the record of this House that it is my clear intention that the process will include engagement with Vicky Phelan and other women who may wish to have an input. Last night, I also invited party spokespersons to continue to input into the consideration of this matter and I intend to bring a proposal to Government next week. It is important that the Government moves forward in respect of this matter next week. We have had a lot of very important discussion this week but now we need an independent expert to get to the bottom of who knew what, when and where, gather the basic facts and look at the terms of reference - and also the process - so that we could perhaps have a modular process to get the answers for women and also the answers that our health service needs.

For the information of the Seanad, I would like to again go through some of the numbers and facts which have been established. When the controversy surrounding Ms Phelan's case came to light, the HSE initially advised that between 2008 and early 2018, 1,482 cervical cancer cases were notified to CervicalCheck. The majority were women who had already been referred for further investigation or treatment by CervicalCheck. As part of the clinical audit process, these notified cases were re-examined and 277 were flagged for further cytology review. In 208 of the 277 cases, the cytology review recommendations differed from the original test. On Friday, 27 April, the HSE established a serious incident management team at my request to go into CervicalCheck and oversee and direct the management of this incident. The serious incident management team has reported that, as of yesterday, 172 of the 208 women involved have now been informed of the outcome of the audit process and arrangements have been made for them to have appointments with their treating clinicians. Efforts to reach the remaining 36 women are ongoing and I expect that this work will be largely completed today. I sincerely regret to say that 17 of the patients involved are deceased and I express my sympathies to their families. In these cases, contact is being made with the next of kin. Let me be clear about this: where a woman is deceased the next of kin, the family, has every right to know and be contacted and that will happen.

Arising from the work of the serious incident management team, it transpired that the number of cases of cervical cancer notified to CervicalCheck does not represent all cases of cervical cancer occurring in Ireland since the establishment of the CervicalCheck programme in September 2008. That was a most astonishing revelation which was brought to my attention approximately 20 minutes before I was due to address Dáil Éireann and take questions and hear statements for the best part of four hours. At that late stage, I was landed with the fact by an official that there may be many other cases. It is the most frightening position to be in, namely, when one hears that what one has been told and what one has truthfully been putting out there now may not be factually correct. It is not frightening in the sense of looking for sympathy for me but it is frightening knowing that I had a choice to go into Dáil Éireann and tell the truth of what I knew but also that it would add to the uncertainty and concern of women throughout the country. I find the situation appalling and it is one I want to get to the bottom of, because regardless of whomever is the Minister for Health of the day - across party lines - citizens in this country should expect that the facts that are given to a Minister are the facts.

That they are correct.

The events of that evening were quite appalling.

Work has started to ascertain this number now that it transpires that there are cases of cervical cancer known to the national cancer registry that were not known to CervicalCheck. I have directed that immediate steps be taken so that information from the registry can be provided to the CervicalCheck programme on any additional cases of cervical cancer that occurred during this time. The screening history of the additional cases will be established, and if any of the women were screened through the CervicalCheck programme, their cases will be reviewed in further detail, with cytology review where necessary. It is important to say that not all of the cases will have a screening history, so we should be careful in putting numbers out there. I hear people speaking about definitive numbers. We need to see how many of the cases had a screening history because not every woman who had cervical cancer may have a screening history.

A helpline has been in operation since Friday and appropriate clinical staff will follow up with women on their specific clinical questions. The helpline has received in excess of 8,000 calls which gives Members an idea of the extent of concern that exists around the country. I have been advised that waiting times for calls to be answered have reduced significantly following my decision to bring in 40 additional public health staff to deal with the volume of calls being received. From here on, the serious incident management team and the screening service will give a daily update on progress on all matters directly to the director general, who will provide a daily update to me. The HSE will also publish a public update each day. I think that is really important. A lot of people are worried and I understand why they are worried and why they have been frightened. We need to show progress each day so that people can see, by means of a published daily update, what is the current position in order that we might try to reassure as many people as possible.

There is a new management team in CervicalCheck. The doctor in charge of the CervicalCheck programme has resigned from her post. The manager who was in charge of running Cervical Check on a day-to-day basis is no longer in charge. Mr. Damien McCallion, a national director of the HSE with responsibility for emergency management, is now the official in charge of CervicalCheck, reporting directly to the director general, reporting directly to me. It is important that we remind everybody of the importance of the screening programme. I have heard some people say that they do not need reminding. We need to be very careful at a time like this that while we must get to the bottom of this and establish the answers we approach it in a non-complacent and non-arrogant manner. We do not take the view that a screening programme could never be better. There are weaknesses in so many areas, but we need to remember that CervicalCheck has also saved lives, that the rate of cervical cancer in this country has dropped by 7%, on average, each year. More than 3 million smear tests have been carried out by CervicalCheck. It is not a diagnostic test. It is a screening test that indicates the possibility of pre-cancerous or cancerous lesions and thereby identifies women who need to be referred for further investigation or follow-up.

Naturally, many women are now concerned about their own health following the publicity surrounding CervicalCheck. To provide assurance, CervicalCheck will make the necessary arrangements to enable any woman who has had a CervicalCheck smear test, to have a consultation with her GP, in order to help her determine whether she wishes to have a further test without charge. These arrangements are being confirmed with doctors currently. I thank the Irish Medical Organisation and the National Association of General Practitioners for their engagement and support in relation to this situation.

In addition, I wish to inform the House that in February this year, I approved the introduction of primary HPV screening for cervical smear samples and I can confirm that primary HPV screening will be introduced later this year. A Health and Information Quality Authority, HIQA, health technology assessment has found that HPV screening would benefit women by making the screening process more clinically effective as well as reducing unnecessary tests for most women.

I want to address some of the questions which have arisen with regard to the director general of the HSE and, in particular, news reports in recent days of his role on the board of a US company. I want to inform the Seanad that I spoke with Mr. O'Brien this morning and he has advised me that he has taken a leave of absence from his non-executive directorship until July at which point I will appoint a new interim director general until the recruitment process is complete. I recognise that he has resolved to devote the short time he has left to serve as director general in working to deal with the CervicalCheck issue, and I appreciate that he began his HSE career in the screening services and wishes to end it by working to restore confidence in them. He has an awful lot of work to do in that regard.

Ms Vicky Phelan said very clearly, publicly and in her conversations with me, that she wants to see action taken in order that some good can arise from the most horrific situation that she, her family and other women are facing. I assured her that this will be the case. I know that is a desire shared by Senators throughout this House and Deputies in the other House. It is my intention to take all necessary steps to ensure the integrity of the cervical screening programme, while at the same time ensuring that any lessons we need to learn are extended to all cancer screening programmes. These programmes are an important component of the progress that we have made over the past ten years in cancer survivorship for our citizens.

However, we also have to ask ourselves a broader question about the culture of disclosure and candour in our health service. The fact that we know that healthcare professionals in many institutions around this country had information that pertained to a woman's health record and chose not to share that with her should be a cause of concern for all of us involved in the health service, and for all of us who use and depend on it. We cannot have a paternalistic culture in the health service. Regardless of whether it would affect their medical outcomes, which is an issue for somebody more qualified than me, this information belonged to those women. This information was not shared with those women. We have to learn from that. Next week, I will bring to Cabinet a proposal to draft a patient safety Bill, which will deal with mandatory open disclosure for serious reportable incidents. I will ensure that the definition of serious reportable incidents includes our screening programmes.

I am fully committed to the further development of our cancer services and to delivering on our new national cancer strategy. Accepting that nobody has a monopoly of wisdom or ideas, I wish to extend the hand of bipartisanship to all in this House and the other House, to work together in the national interest to get this issue right for the women of this country and for the benefit of all who live here.

I thank the Minister for coming before the House today. This is a really serious issue. Ms Vicky Phelan's case really is a tragedy that could have been avoided. She is a hero to all Irish women. She has been an example of what a woman can do. She was relentless, she was tireless, she was exhausted. She was a solitary soul fighting against the State. That is what she was. The Minister should hang his head in shame that the State and the Department he represents put this woman through legal hell as she went through medical hell. Fianna Fáil welcomes the recent move to set up an independent investigation into the CervicalCheck scandal. However, Vicky Phelan was the woman affected by this and she must be part of the terms of reference. I am glad the Minister mentioned that she will be, and that he has met her. That is good.

The inquiry must be fast and the Minister has indicated that June is his timescale. I ask him to ensure that he delivers on this. Such an inquiry must not be used to withhold information from the public. We need full disclosure from CervicalCheck, the HSE and the Minister. Following an audit of the 208 cases, the news that more than 17 women have died is truly shocking. It is beyond belief that today we may still not know the full extent of this. A serious incident management team is continuing to gather information from about 13 hospitals on the scale of this controversy. It is unreal. It is staggering that one woman, her family and her legal team have to go to court to access her own medical truth. The way that this State continues to treat its women is nothing short of shameful and deplorable.

When will someone stand up? At the first sign of an error or an admittance that something is wrong, the buck is passed. Why do we leave it up to one brave soul to fight all the battles? The practice of keeping secrets, whatever the reason - be it fear of litigation or fear of upset - has to stop. Things are best out in the open. We can no longer have people hauled through courts just to get what is their own truth, their own information in the first place. I want the Government, the Department of Health and therefore the Minister to tell us what steps are being taken to hold the HSE accountable. I acknowledge the Minister has outlined the different steps he is to take, and I welcome this. However, it is with the Minister that the buck stops at the end of the day. We cannot allow the HSE to run this Department, and that is what is happening. The HSE is a law unto itself but the Minister is allowing it. That cannot happen.

Vicky Phelan has recently started on a new drug and is hopeful of being accepted into a US programme offering radical, innovative treatment. It is disgraceful how this State has let her down, robbed her of her time, her life and peace of mind. She was made to go through the courts, not knowing what the outcome would be. The fact that more than three quarters of the 208 women whose cases are being examined by this audit were not told that they had a delayed diagnosis is scandalous. These women and their families have been failed by the CervicalCheck programme. All the surviving women must be informed of the situation and given all the supports they need. There must be full disclosure as to what mistakes were made. There can never be secrecy again, and I am asking the Minister to ensure that this never happens again.

We also want the Minister to ensure that no other family is forced to go through the courts to find out what errors were made in their care. We in Fianna Fáil welcome an examination of other national screening programmes, because there are real fears among the population using them. People are living with the fear of not knowing. People need to be checked. If we cannot trust the system and the system is failing then somebody is accountable and that is the Minister. However, there should not be interference in the work of the inquiry into this CervicalCheck programme, which must be carried out immediately. I am asking the Minister to make sure that he comes back to us with the answers in June.

There are a lot of questions that the Minister still needs to answer. Every woman and family in the country has been affected by this. One can feel people's fear when talking to them. People are calling my office. It makes one ashamed. One wonders how professionals could let this happen. It is unheard of. We cannot allow this.

Mandatory reporting is needed to achieve this. Fianna Fáil believes that mandatory disclosure must be provided for under law for all patient care. We need a system of checks and balances. When something is flagged, it should never take ten years, a lengthy court case, 17 deaths and a resignation for the truth to be revealed. Listening to the reports about the court case and reading the information the Minister has put before the House, it is hard to believe that such a serious case was being fought in the High Court by the State, and yet no-one seemed to know. I believe the Minister was not informed until 16 April. Someone must be accountable here. Ms Phelan has been fighting a case for a long time, and yet the Minister says that he did not know until 16 April. I am not happy with that, and I think something here does not add up.

I am asking the Minister to never allow anything like that to happen to an Irish woman ever again. We must never put anyone through that. The cases of the 17 women who have died are absolutely tragic. I am looking for a full commitment from the Minister that he will hold the HSE accountable. Deputy Harris is the Minister and he is over the HSE.

The issue of Versatis patches arose recently. The HSE restricted them, even though people are in severe pain.

The Senator is running into injury time.

I have cancer patients fighting for medical cards because they cannot get them. I hear from people with long-term illnesses. The HSE needs to have an overhaul.

I welcome the Minister and thank him for coming to the House today, in what has been a hectic week for him, to set out comprehensively in his statement to the House how he has identified the issues and, more importantly, how he proposes to proceed from here. This is a time for cool heads. It is a time to stand in solidarity with the people who are suffering, anxious and concerned about their health going forward. That has to be the key message of our deliberations here today. Across the Houses and among politicians from all groups, there is a genuine sense of keenness to get on and to set out the stall, because people want to know the facts. I am particularly encouraged by the Taoiseach's announcement last night that he would seriously look at redress. A slap on the wrist is no good any more, for anybody. There must always be redress when people have done wrong. Ultimately this is about life. People are fighting for their very survival. People value their lives. People want to live and be supported by their loved ones and families, and that is critically important.

We all know that the cervical cancer check scandal constitutes a major breach of trust between patients, their doctors and the HSE. That has been said time and time again. We have to learn from that and address it. There are women in the dark today. What a horrible place to be; in the dark about their health this very day. There are people and families anxiously waiting to know what the outcome was. What was the real outcome of a test that they thought was a positive thing to do in pursuit of early intervention against cervical cancer, something that is very important?

I understand that the Minister is angry - the nation is angry - and he made that anger and his frustration clear in the House. Ultimately, however, we must hold people to account. I met a woman on Grafton Street yesterday who asked me if politicians are supposed to be at the centre of the universe in the political establishment, what is this monster that is the HSE and who are all these people? On another occasion, we will have to have a another debate on how we, as the political establishment, have let go of so many powers which have been devolved to the HSE. Many people are responsible for that. We would need a lot of time to go through it but it is a timely reminder that we need to look at how we can dismantle this monster that is the HSE.

We need due process. People are entitled to that and to set out their stalls in order to explain the rationale, or lack thereof, behind their decisions. We must give people the space and time to do that. People have the right to be angry but we must have accountability, responsibility and consequences. The independent investigation with full powers has to be welcomed but it must have the power to demand documents, direct attendance of witnesses, and to demand and receive sworn evidence in a timely manner. Everything in this process must be done in a timely manner.

It is the task of the Government and the Minister to establish all the facts relating to this case, to restore confidence in cancer screening and to ensure controversies such as this never happen again.

I want to ask the Minister one question. Why did he give written consent to the director general of the HSE , Tony O'Brien, to take up a lucrative role in a San Diego-based company, Evofem Biosciences, at a time when the executive is in crisis? The Minister and the Taoiseach continually field crises relating to the HSE. Hindsight is a great thing but it was a terrible call to give written consent for this man, who we charged to lead this organisation as its director general. We cannot undo the past, and I am not asking the Minister to do that. However, I ask that neither he nor any of his successors should give consent for the director general of such an important organisation - whether it is the HSE or whatever its successor might be - to take his eye off the ball. The director general should do the job that he is paid damn well to do and that he has 100% failed to do.

I join the Minister in paying tribute to Limerick woman Vicky Phelan and her family. She is very courageous for being prepared to fight for her rights and ensure that this serious matter became public. The women of Ireland owe her a deep debt of gratitude for exposing this dreadful situation. My thoughts are with her and her family, as they are with all women affected by this and the families of the 17 women who, unfortunately, have died.

I agree that we need to fully investigate and determine exactly what happened, how it happened and where the systems failed. It is important to establish where failures occurred and if individuals did not accept or carry our their responsibilities. There can be no excuse for the concealment of facts by those placed in positions of trust. People are very angry and upset, which is clear from the 8,000 phone calls to the helpline. It is most important that we learn lessons from this episode, which has seriously damaged the reputation of the screening programme and the health service overall.

I fully acknowledge that the Minister responded quickly and positively having become aware of Vicky Phelan's plight and the continuing revelations to the effect that many others have been made aware of mistakes in their diagnoses. The serious incident management team, which the Minister established so promptly, must be fully resourced and empowered to undertake this investigation and complete it as soon as possible in order to restore confidence in this very valuable service. Has the Minster been given an indication of the period necessary to undertake this work? I want his assurance that whatever resources the team requires will be continue to be made available until the work is completed.

The proposal to proceed with a scoping inquiry to report within two months is excellent. Hopefully, that inquiry will answer most of the outstanding questions and point to the way forward. We need to establish where responsibility lay and, above all, how we can ensure that this programme and all other cancer screening programmes have clear governance procedures, to define the actions to be taken and the persons responsible for their implementation. There must be no doubt about what actions need to be taken and who must take them at all levels of the programme. There must be a clear and definitive procedure to ensure that test results are conveyed to patients.

Every effort must be made to eliminate error, although I accept that mistakes can happen. Where a mistake is discovered there can be no delay in putting up the hand and admitting it. The onus must be placed on the appropriate personnel to ensure that this happens immediately and that the patient is informed without delay. A person's GP is the ideal individual to do so but that is a matter for the Minister and his officials to decide. Any delay can make a difference between life and death.

I join Vicky Phelan in encouraging women to continue going for cervical smears. I advise everyone to partake in the other cancer screening programmes such as BreastCheck, colon cancer screening and prostate testing that are available and which have saved lives. It is true there have been weakness and failures which we need to identify and redress but many lives have been saved.

It is essential that we all remember that the patient is at the centre of all healthcare provision. The rights of the patient must always be respected and protected. They must be treated with understanding, respect and kindness. Adverse results must be communicated immediately with compassion and the offer of ongoing support.

Quality of care is paramount in any aspect of healthcare. Using preventative medial care represents best use of financial resources, keeping people out of intensive care facilities. News that the Government is planning on moving to the more accurate HPV tests for cervical cancer is very welcome, and I welcome the Minister's announcement that it will happen this year. Perhaps the Minister can give us more detail on this.

It should be mandatory for the HSE to give proper weighting to quality of service and other non-financial elements when assessing tenders for outsourced testing. It is very important that we adopt a more balanced approach to assessing tenders. It is essential that cervical screening and all other health screening services are built on the principles of trust, transparency and governance. These are basic requirements which must be met and constantly monitored for the duration of the contract. I also support an ongoing internal-external quality audit of these contracts to ensure that the accepted terms of engagement are being adhered to. There can be no room for any slippage from the standards agreed to in the contract. We must aim to obtain a service which meets international best practice guidelines and standards. While we must acknowledge the Trojan work done by many healthcare professionals, it is essential that our healthcare systems have proper procedures for reporting abnormal practice behaviours and suspicious poor practice that jeopardises patient safety. There can be no room for poor practice, carelessness or any form or casual approach to patient safety. I particularly welcome the Minister's commitment to introduce a patient safety Bill that will provide mandatory disclosure of events such as we are considering today and ensure that patients are made aware of events which have the potential to adversely affect their health. I hope this legislation can be prioritised and progressed without delay.

I thank the Minister for coming to the House. I know that many of my colleagues wished to raise the matter and make suggestions. We all share the same aim, that this will not reoccur.

I thank the Minster for coming to the House. I appreciate that he has had a busy few days.

I want to go back to 2008. As a woman, I cannot understand how the then Minister with responsibility for health, former Deputy Mary Harney, along with the Fianna Fáil members of the Cabinet, made the decision to outsource such an important service to America.

It just does not add up. Something stinks here. Something is wrong when there is advice from experts like Dr. David Gibbons and others and when someone like him feels strongly enough to resign over this matter. There also were the Well Woman clinics and that was on top of statements from politicians like Deputy Ó Caoláin, Senator Reilly and many others stating this was the wrong thing to do and this is what would happen in ten years' time. They still went ahead and decided in their wisdom that this was the right thing to do. It does not add up. That requires forensic and intensive investigation and I intend to play a part in that.

Even from a data protection point of view, it does not sit well with me that all these women's details were being held in America. In terms of making the decision to bring back that service to the country, how would the Minister envisage that happening, how long might it take and what would it cost? I do not believe we lacked the capacity in this country to do it. We had gone through a boom in which money was coming out of the ears of those in the golden circles. How were the facilities here not given proper investment? I am apologise to Senator Murnane O'Connor but Fianna Fáil's protestations on this hold no credibility for me. As for the open disclosure book, what concerns me is whether the Minister now thinks it was a mistake for the Government, supported by Fianna Fáil, to put in the amendment for a voluntary rather than mandatory disclosure in the duty of candour Bill that went through the Oireachtas last year. Was that a mistake? It is important that we admit the mistakes that were made and face up to them as otherwise, we cannot hope to find solutions to them.

The current scandal is unfolding day by day and more is learned from the media than is being given to concerned women by the HSE. I found the health committee yesterday very frustrating. I found some of the language being used by Mr. Tony O'Brien in particular, deeply condescending and insulting to women and to the families of the women who are deceased. It does not fit. Yesterday in the Dáil the Taoiseach described this cover-up as a cock-up. I was also deeply disturbed to hear him use such glib and dismissive language about such a serious issue as life and death. This morning, Ms Vicky Phelan has called on Mr. Tony O'Brien to resign. If we say we are listening to her, we need to hear what she is saying. Accountability cannot exist where responsibility is not accepted by individuals. The Minister cannot have it both ways either. Either he has full confidence in Mr. Tony O'Brien or he has to go. The fact is that Mr. Tony O'Brien has presided over negligence, concealment and misinformation with the most serious consequences for women and their families. He cannot remain as director general. That is the very least the women affected and their families need to see.

The Minister says he wants a full investigation to discover all the facts and to restore confidence in the screening programme but we do not need an inquiry to determine that women with cervical cancer were not given critical information on their healthcare. We know that at least 17 women went to their graves not knowing. We still do not know how many more women did not know and we do not know how many more women do not know right now. I appreciate that the Minister is putting things in place with the GPs. I was deeply concerned on Monday morning, because I have experience of it myself, that the GPs said they had not been given anything and they did not know what to do or put in place. I am also concerned - as I was told - that people can go to a consultant and pay €150. That is all right, as I am in a position to do that but many women are not. If one's GP does not do smear tests and there are referrals to consultants, will the consultant's fee be paid as well or to where do those women go?

I have much more I want to say but will the Minister order an audit for BreastCheck and the other medical checks because confidence needs to be restored in all of those services? I absolutely believe in screening. Will the Minister confirm to me - it was very confusing in the committee yesterday - that there was a 30% failure rate on the cervical screening? Perhaps the Minister could explain that. Moreover, why can the redress scheme not be set up before an inquiry is concluded? Are the Minister and his Department involved in the decisions to fight medical negligence cases? Is an opinion sought from either the Minister or the HSE in that regard? I have much more to ask. I appreciate the Minister coming in and I am sure there will be more opportunities for Members to ask questions. I thank the Minister.

I thank the Minister for coming in. It has been the middle of a busy time but the Minister is right to have been busy and it is proper that he is busy. This is a very serious issue and one in which the Minister has become completely involved in the most proper way.

We would not be having this debate today if it was not for the courage of Ms Vicky Phelan. Many have said that but also I mention her persistence and fearlessness in refusing a gagging order. I want to remark on her generosity too, given the amount of time she has given to this issue and the public, which is precious time for her. I thank her for that. Equally, I repeat what she has said on her plea to women to continue to get their smears. I cannot say that often enough. Many issues have been raised here. The most important issue is that lives are being saved by cervical screening. We may have issues with the upper echelons of management and we certainly have major issues with a decision not to share information with patients which is what CervicalCheck is supposed to be all about, namely, saving the lives of women. Moreover, it is working and as the Minister has pointed out, the incidence of cervical cancer has fallen since 2011. That is to be welcomed. I also mention the importance of the HPV vaccine-----

-----and the manner in which it can protect women and girls from this illness, which robs so many families of their loved ones. I welcome that we will have an immediate Health Information and Quality Authority, HIQA, inquiry, that we are looking at a statutory inquiry and that a redress scheme is to be put in place.

There are broader issues that I want to speak to. I am glad the Minister did mentions GPs. He talks about the pressure on the call centre but I can assure him the pressure on GP surgeries at the moment is quite intense and I am grateful that we got the letter today from the HSE to bring people up to date and to remind people that if they are worried to come and talk to their doctor. I emphasise again the most important thing, which is that even if a women has had a clear smear, if she has worrying symptoms she must go and talk to her doctor. It is not a guarantee that all is well in the presence of other problems. I want to raise a number of issues with the Minister, the broader issues around this; the State Claims Agency, its approach to legal actions and its decision on when to proceed as opposed to when it should settle. I know the Minister is not directly involved in those cases but that must be reviewed. I also mention the Minister's patient safety Bill. I believe we need an independent patient safety authority that can advocate for patients and which reports directly to the Minister. It is something in which I strongly believe. I mean no disrespect to the Department of Health but it has to be seen to be totally independent. I agree with the Minister's plan to bring in open disclosure.

I want to thank another woman today, Ms Aisling O'Regan from Swords, who said that she was very lucky, that the service helped her a lot and that it has helped many women. She said that if she had not taken that test she would be telling a different story today. That is really important. It underscores what Ms Vicky Phelan said, that women should continue to go for their smears. There will be a new and improved test, and I welcome that, but the current test picks up 70% of cancers.

Senator Rose Conway-Walsh commented on the 30% failure rate. The test is known to be 70% effective, ergo 30% will not be picked up. That is normal. Sometimes, when looking back at slides five doctors will say that there is a problem and a cytologist will say there is not. It is those which fall outside that scenario, where all agree that there is a problem that should have been picked up, which are seriously worrying. I believe that the Senator's suggestion, that we should have a look-back audit on BreastCheck and other screening tests where positives transpire subsequently so that we can learn from it, is a good one. We must ensure that we learn from this and that all information is shared with patients.

I appeal to women not to lose faith in cervical screening. The Government has committed to getting to the bottom of this so that we can prevent similar appalling situations from happening again. I look forward to rapid results on the basis of the actions the Minister has taken.

I am sure that the Minister will agree that in the political sphere we operate in it is time to move beyond business as usual when it comes to political barbs, finger pointing and point scoring. The issue at hand is far too serious. The Labour Party absolutely stands with the Minister and accepts his bona fides. In his efforts to deal with this matter his interaction with our party and with other parties has been to his credit. Nobody could suggest that he does not treat this with the absolutely seriousness it deserves, as he is doing his absolute best to ensure that this does not happen agains.

The Labour Party has been quite strong on the need for a commission of investigation, and I believe the Minister has moved his own position towards that. That is to be welcomed. We feel strongly that no woman affected by this issue should in any way be liable for any medical costs whatsoever, and that no woman involved in this situation should have to put her hand in her pocket, nor should her family have to put their hands into their pockets.

On the overall structure of the HSE, it was suggested last night in the media that part of the problem with the HSE currently is that, in the effort by the last Government - which I was a part of - to abolish the HSE, the board was dispensed with. As a result of the board not being in place, one of the obvious corporate governance checks and balances that would be expected in an institution such as the HSE is no longer there. Subsequently, when the CEO of the HSE is going about his or her daily business, the lack of a board being there as a check and balance in that institution is a glaring omission. I am asking that the Minister discusses that with us this evening. When the HSE was established it was said that politics provides the policy and the HSE deals with the delivery. In the delivery there must be political accountability.

I would appreciate if the Minister would address those points.

I believe the concerns of the Minister are genuine. I welcome the interaction he has had with all political parties; he is trying to resolve the issue and put solutions in place. I have not had an opportunity to see the letter circulated to GPs; it would be helpful if that could be circulated to everyone.

We have to discuss good governance. I do not believe the HSE has good governance. It has been raised many times in this House in terms of the lack of boards for hospital groups. This has to serve as a wake-up call and be used to ensure there is good governance right across our systems.

A woman stopped me yesterday on Dawson Street to talk about the State Claims Agency. She made me aware of other areas the State Claims Agency is working in, and specifically discussed seven individuals. I am not going to mention them because I have no intention of ambushing the Minister; I will talk to him at a later stage about that issue. This matter is too important; we should not seek political gain from it but rather take it seriously and work to resolve it. I am asking the Minister for an audit of the cases the State Claims Agency is currently involved in. We do not want women such as Vicky Phelan being dragged through courts unnecessarily when a more humane approach is available. That audit of current cases should be done immediately. Once that is done I would like to see an audit of previous cases where the State Claims Agency has sought gagging orders on the result of the case. There may be other cases that we can learn from in which gagging orders were imposed and which have not emerged in the public discourse. If we are going to fix the problems with the HSE we have to know what all those problems are and how citizens are being dealt with by the State Claims Agency. I do not believe that anyone here would stand over the horror story I heard yesterday. If those two pieces of work could be carried out relatively quickly it would be a good service to the citizens of Ireland.

I welcome the Minister for Health, Deputy Harris, to the House and commend him on the work he has done. Vicky Phelan is a neighbour of mine and I know her very well. She is an incredible woman, and it is true to say that if she had not refused a gagging clause this story would probably never have come out. I believe the women of Ireland owe her an enormous debt of gratitude. One meets people in life occasionally that leave an imprint. For me, Vicky Phelan is one of those people. She is formidable and warm. She is unwell, but she has presented herself to the public. She is compelling viewing because what she is saying is the truth. I have been involved in many inquiries and would be worried that we might get bogged down in process. This problem was caused by people not communicating with each other. The women of Ireland want the truth. Vicky Phelan is entitled to the truth. We need to know why this information, which was available, was not communicated to the women of Ireland affected by this disease. Vicky Phelan would be in a different position today if that was done. It is disgraceful and shameful. No matter what way I think about it, all I can see is a young lady, at 43 years of age, being forced to go out onto the public airwaves and fight her case. What the State Claims Agency did to her is a disgrace in terms of human decency.

I heard Mr. Tony O'Brien, the CEO of the HSE, come out and say that this is a personal blow to him. It pales into insignificance compared to the personal blow dealt to the women affected by this scandal. He may have suffered a personal blow, but he should take some personal responsibility. He should look into his heart on this particular issue.

He speaks about lack of personal responsibility. I spoke about it earlier. A manager of a football team that is not preforming cannot claim not to have personal responsibility. He needs to do the decent thing. Vicky Phelan has called for it. People, who know me, know that I am pretty much down the middle. I feel very passionately and strongly about this one. This is one of the greatest scandals in the history of our State. It affects our mothers, wives and partners, sisters and daughters.

It is clear that the HSE is not fit for purpose. Its officials have been appearing before the Committee of Public Accounts for years. It is unwieldy, too big and not flexible. It does not meet the requirements for a modern population's health needs. It needs to be reformed as a matter of urgency. What form that takes needs to be looked at. It is not carrying out its job. This issue happened under the watch of the HSE. The Minister went into the Dáil having just been handed a piece of paper detailing something of which he was unaware. While the Minister was in the Chamber the HSE issued a press statement at the same time. We cannot have that type of behaviour; this is too serious.

Women have contacted me. I welcome that the Minister is allowing for the fact that women can go for a smear test. Women have contacted me with concerns over previous smear tests. I am meeting members of the medical profession and they are saying, "Was my previous smear test false?" Does that need to be looked at as part of this review? I understand that women in that cohort are getting phone calls, going to their GPs and their GPs are unaware of the reason for the phone call. The GPs need to be included in this measure.

I salute Vicky Phelan. The Minister will know of my relationship and contact with her. What she has done will go down in the history of Ireland as something heroic and for the betterment of women. Clearly it must have been difficult for her to have come out, but she feels passionately about it. I wish her well in her treatment. She is in the process of undergoing new treatment. I wish her well in that; I want her to get well.

I return to the key points. The truth is the key feature here. I do not want to see politicians fighting over process. They are not being affected; women such as Vicky Phelan are being affected. They are entitled to know quickly why this happened and why they were not made aware of it. We need to make certain about the process. Women are entitled to smear tests. Is there a need to look at the results of previous smear tests? I apologise to Mr. O'Brien, but he needs to look into his heart on this one. What happened under his watch is of such a monumental nature that it has affected people's lives. People have died because the results of smear tests were not picked up properly. This is what it is about.

I salute Vicky Phelan and wish her well in her current treatment. She deserves no less. The women of Ireland owe her an enormous debt of gratitude as we all do.

I thank the Minister for coming to the House. I thank him for having the courage to face this issue. People sometimes accuse me of being nice to Ministers, but it cannot have been easy to go out day after day and take on the responsibility for what has happened. More importantly, during his speech today he told us of being handed last-minute information minutes before going into the Dáil, which is totally unacceptable.

This morning I spoke about our propensity to look for the heads of Ministers when things go wrong, which is politicising what is a corporate failure within the public service. We take out the Minister and we leave the problem behind. I am delighted that Mr. Tony O'Brien wants to stay until July; I think he should go now. He should ring the Minister this evening and say he is leaving because he has not done the country a service and we do not want him. In particular Vicky Phelan does not want him to be here anymore. He should do us all a favour and go.

Before talking further about corporate governance, I wish to deal with an issue that has arisen. Women have rung the helpline 1800-454555 and sought information. A few women contacted me yesterday on this issue. One of the questions asked was about the repeat screening. The women were told that although the Minister had made an announcement, the helpline knew nothing about it. I ask the Minister to look into that because it is something within his power.

I return to corporate governance and will talk about certain things from the past. The anti-D issue affected 100,000 people in the country. Officials who knew about it kept their mouths shut and allowed the situation to develop. The country spent €1 billion settling hepatitis C cases and 80 women died after contracting hepatitis C. Throughout his career a particular Member of the Lower House has taken an unmerciful amount of stick over the Brigid McCole case. Some official somewhere started that case before it ever came to the attention of a Minister.

I spoke this morning about the Carltona principles or doctrine, which effectively means that when a departmental official speaks he or she speaks with the Minister's authority, irrespective of whether the Minister knows or not. This is one of the great things behind which the faceless bureaucrats can hide. They make a decision and when that decision is made it is the Minister's decision - not theirs - and they will never be called upon to answer for that decision save getting fired quietly with a large pension and out the backdoor. That is grossly unfair.

The Minister sits around the Cabinet table; I do not. I ask him to do two things. I ask him to bring about a discussion within the political framework on the impact Carltona is having and has had since the 1940s on decision-making in Government and in politics in particular. Where a senior official takes a decision to commence a particular process, that official should be answerable for it.

Senator Humphreys spoke about the State Claims Agency. Has it learned nothing? It took Mrs. McCole to the point of a Supreme Court threat before settling with her the day before she died. What sort of people do we have in the State Claims Agency? Is there not a process that looks at a claim when it is submitted to see if there is a prima facie case to be answered and if there is, move it to a different track? Why do we become so aggressive to every poor individual bringing a case forward?

Ms Phelan, who is the centre of attention in the country now, did not want the publicity this has been brought to her house. She does not need it in her current state of health. She forewent the chance of getting more money, I am sure, in order to ensure that women in Ireland knew what was happening.

Journalists and anybody else who claim the Minister for Health can be on top of every single issue and decision every day of the week, are codding themselves. However, there is one thing he should be told about. When a case comes up that is likely to finish up in the courts, he should know about it the moment the Department is informed, not a year later, two years later or when some official decides, "Oh my God, I could get my head on the chopping block for this."

There are officials who knew things and, my God, the Minister had to be told when walking in the door of the Dáil that there was more coming. There are officials who knew these things. Political cover is being given to them and it is the Minister's neck on the block. People are looking for his head and that is not right. It is right for those who take decisions to be answerable for them. Like Senator Reilly, I ask for a look back over all the screening which has taken place. I get screened for cancer myself and I would like to know that the screening that has taken place is reliable. I do not expect it to be 100% accurate every time. I expect to be told that there is a certain rate of failure. That is fine. I can live with that if people are being honest with me. I will stand foursquare behind the Minister for as long as I see him doing what he is doing.

I have one last point to make. When the Minister brings political groupings together, I ask him to remember that there are a number of Independent Members in the House and that we would also like to know what is going on.

I know the Minister, Deputy Harris, has just left the House but I concur with other speakers on the job of work he is doing. I welcome the Minister of State, Deputy Catherine Byrne. Of course the people of Ireland expect nothing less than the job of work the Minister is doing. This is a scandal and it is happening on our watch. We have a responsibility to ensure that it is dealt with.

Senator Craughwell just mentioned the most important fact of all, namely, that all of the facts must be put out there in order to inform those who need to be informed. People should be informed as a matter of absolute urgency.

I know the Minister has updated us in respect of the number of people who have now been informed but we absolutely need the scoping exercise which is going to take place and the commission of investigation to establish the who, where, how, what and so on. More fundamentally, we need a change of culture not just within the HSE - although there absolutely must be such a change in the HSE - but across the public service. Something similar to what has happened in the HSE recently happened in the Department of Justice and Equality. There has to be a sea change in how information is filtered up from various Departments to Government and to the Minister's desk.

What has happened here has been appalling. We are talking about people's health and people not being informed of a particular situation. It is absolutely appalling and absolutely not acceptable. We need to put structures in place under which there will be clear communication and under which a Minister will not be handed a briefing document with additional information 20 minutes before going into the Dáil. We should not be in that situation. Whoever the Minister of the day is, regardless of his or her party, he or she should not have to be in a situation in which he or she is given this type of information. It needs to change.

How should it change? It is up to the experts in change management to come in and put the structures in place. It is fairly clear to me that information has to be channelled up to the Minister in an appropriate way, in good time and in a speedy fashion. I hope situations like this will not happen again, but other situations clearly will. There are going to be more court cases. Of that there is no doubt. A level of priority has to be given so that, when there is a court case which is settled, the various elements of information surrounding it are properly communicated in order that other people who may be affected are informed. The whole scenario in which there is no clear information or no information in good time is absolutely appalling. If we have learned anything from this, I hope we will put proper structures in place to ensure this type of thing does not happen again.

Like other people, I pay special tribute to Vicky Phelan because sometimes courageous people are a catalyst for change. I truly believe that Vicky Phelan will be a catalyst for change. The Minister has given an absolute commitment and I know that commitment will be followed up because Vicky Phelan and the other Vicky Phelans who have been affected by this deserve absolutely nothing less. We all have a role to play in supporting the people who are trying to do the right thing. This debate in the Seanad has been useful because we want to assist in articulating a voice for the people who have been affected and we want to ensure that the change does happen because that is what people want.

I welcome the Minister of State.

I also welcome the Minister, Deputy Simon Harris, who has had to leave, and the Minister of State, Deputy Catherine Byrne, to the House to discuss an issue which has involved many women right across the country. The real concern is that it may involve many more who we do not know of yet.

This is a very difficult time for many women and their families. Many Senators and Deputies have spoken this week of the huge courage and unwavering determination of Vicky Phelan. I imagine that it is difficult enough for one to deal with a diagnosis of cancer, never mind then finding out that information pertinent to one was withheld and, not alone that, but then having to fight against the State Claims Agency for truth and justice. The way these women have been treated is absolutely horrific and disgraceful. We expect better. We should never have to go through a week such as this in which we have heard of so many cases of women being treated totally disgracefully.

I just want to say a few things because we all want to be constructive. The Minister, Deputy Simon Harris, and the Government, along with Opposition parties and Independent Members, have worked very hard to ensure that solutions are put in place. It is very important that we establish the facts and I hope the scoping inquiry will lead us to that place. It is absolutely incredible that facts which were obviously available were not made known to the Minister until minutes before he went into the Dáil. That is absolutely incredible. We need to ensure a culture of accountability. I worked in St. James's Hospital for eight years. I was accountable for the people whom I assessed, treated and discharged. Everybody working in the health service needs to be accountable for all of their actions. We are clearly not seeing this. We need to make sure that this never happens again. We have wronged many women. We need to put it right. We need to ensure that we never see a situation in which information pertinent to individuals is withheld from them.

I listened to much of the debate at the Joint Committee on Health yesterday. Since becoming a Senator I have had many concerns about HSE management. The Minister of State will be aware of this as I have raised it as Commencement matters on several occasions. HSE management needs to be accountable.

Until people acting as managers are held to account I do not believe we will see real change, and real change needs to happen.

I apologise for the absence of the Minister, Deputy Harris. As Members are aware, he has been trying to do a lot of things in recent days and he has asked me to respond to the debate on his behalf.

I thank all the Senators who participated in what is probably one of the most important discussions that has happened in a long time in this Chamber and in the Dáil. As the Minister, Deputy Harris, said today, it is essential that we do not lose focus on the women who are at the centre of this case. I add my voice to those who have already paid tribute to Vicky Phelan and the courage she has shown in speaking out about what happened to her and her family. There are no adequate words to express my outrage, nor undo what has been done. I sincerely wish Mrs. Phelan well in her continued treatment.

As we all know, cervical cancer is a serious issue in Ireland, and we must establish all the facts in this case as quickly as possible, so that women can begin to feel trust and confidence in the cervical screening process again. The Minister has outlined the steps which the Government will take to ensure that. The main message I want to convey here this afternoon is that women can and should continue to participate in the CervicalCheck programme. The international evidence base is clear. Organised, population-based screening is the most effective way to reduce the incidence of cervical cancer. We have seen what happened in this country - since 2010 the incidence of cervical cancer has been falling. Every year in Ireland approximately 270 women are diagnosed with cervical cancer and, sadly, 90 of them die from it. Cervical cells change slowly and take time to develop into cancer cells, making cervical cancer a preventable disease. Even with the inherent challenges in screening, having regular smear tests can pick up early cell changes - precancerous growths - and reduce the risk of cervical cancer. I must emphasise how important it is that women continue to have their smear tests, which can and will continue to save lives.

In January of this year I launched the Pearl of Wisdom campaign. More than 200 women sat in a hall and listened to stories from women who had cancer and women who survived cancer. In recent days I have been haunted by the faces of many of the people who were there on the day. I know many of them because they are local women. I sincerely hope that whatever happens in the coming weeks and months, we can look into people's faces, in particular those of young women, and guarantee them that we will do as much as possible to ensure we never have such an incident happen again in this country.

Since the inception of the CervicalCheck programme, more than 1,200 cancers have been detected. In addition, 30,000 low grade abnormalities and over 50,000 high grade abnormalities have been diagnosed and treated. The identification and treatment of such abnormalities prevents them from developing into cervical cancer. That is incredibly important for all women and also for young women who have yet to begin or complete their families, as treatment for cervical cancer can have a significant impact on fertility.

As I have said, the incidence of cervical cancer is failing. Data published by the national cancer registry shows a significant downward trend in the incidence of invasive cervical cancer between 2010 and 2015, a reduction of approximately 7% annually. We also know that there has been an increase in the percentage of cancers diagnosed at stage 1, up from 41% between 1994 and 1998, to 47% between 2009 and 2013. The diagnosis of cancer at the earliest stage possible is an important determinant of survival. Cancers diagnosed at an earlier stage also result in less invasive treatment and better quality of life post treatment.

As Minister of State with responsibility for health promotion, I have responsibility for the implementation of policies under the Healthy Ireland framework. Cancer prevention sits fully into the Healthy Ireland approach as one of its main goals to protect the public from threats to their health and well-being. As well as screening for certain cancers, we are taking a population approach to encourage and support people to live healthier lives and to reduce the prevalence of cancer risk factors by making positive changes in terms of diet and physical activity as well as by managing mental well-being.

In order to set out our future path towards better health in terms of cancer, last year the National Cancer Strategy 2017-2026 was launched, which will govern the provision of cancer services in Ireland over the next decade. Cancer prevention is the cornerstone of this cancer strategy as it offers the most cost-effective, long-term approach for cancer control. The overall vision of the National Cancer Strategy 2017-2026 is to prevent cancer and work to improve the treatment, health and well-being, experiences and outcomes of those living with and beyond cancer.

The strategy also has a strong focus on patient involvement. Patients have direct experience of the health system and this provides them with insight which is not always available to policymakers. That is an important perspective which has not always been considered in policy decisions and can contribute to the provision of safe, high quality, patient-centred care. By focusing on what matters to patients we can enhance the quality of the service we provide and the experience of the patient using that service. As part of the development of the strategy, a cancer patient forum was established. The cancer patient forum had an extremely valuable impact on the strategy development process and the Minister and all involved acknowledged that its contribution resulted in a better strategy. In order to build on the work of the cancer patient forum, the Department will shortly establish a cancer patient advisory committee. Preliminary work has begun on the establishment of the committee and I expect that it will be in place by mid-year.

I would like to finish by again offering my most sincere apologies to Vicky Phelan, and to all those women who were not informed of their inclusion in the review process. I hope that the outcome of the investigation into these issues will provide some clarity for those affected and restore peace of mind for those women using the service. On a personal level I wish to say that I do not believe it is time for name calling or looking for people's heads. It is a challenging time in the history of the country. Women's health must now become a priority. Never again should women have to wait for three and four years to learn they had a problem with their health. If we continue to work together, on all sides of the Chamber, and in the Dáil, people will see a real change in the future in women's health.

I thank all Senators who contributed, and also the Members of the Dáil who contributed. It has been a challenging week for us all, especially for the young women in our families. I have four young daughters and two of them contacted the helpline. I also have nieces and cousins who have also contacted the helpline. For that reason I believe that women in every family across the country need assurance and peace of mind about their health. We are obligated, as women, but also given our privileged position in the Dáil and Seanad, to do our utmost together to bring closure and help to those people who are suffering today because of the mistakes that have been made in recent years. My sincere apologies to all of them. I hope to continue to work with the Minister, Deputy Harris, and the rest of the team in the Department of Health to provide some peace to those people who are needlessly suffering.

When is it proposed to sit again?

At 2.30 p.m. on Tuesday.

The Seanad adjourned at 3.10 p.m. until 2.30 p.m. on Tuesday, 8 May 2018.