Micheál Martin (Cork South Central, Fianna Fail)
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The Irish public, especially the women of Ireland, have been genuinely shocked at the failure to inform Vicky Phelan and many other women of the false negative screening results of smear tests which they undertook, and also at the appalling manner in which Vicky Phelan was treated since. It is particularly objectionable that she was forced all the way into the High Court before settling her case. The State denied until then that a breach of duty occurred in not informing her of the false negative smear test. The State and Minister subsequently apologised after the court settlement.

It is genuinely shocking that the Minister for Health, Deputy Simon Harris, was not informed about the case by his departmental officials until Monday, 16 April in a memo which referenced wider issues. He should publish the memo, as agreed. I am disappointed that we have not yet received it. Deputy Stephen S. Donnelly and I had discussions this morning with the Minister and his officials, during which it was revealed that there had been intense discussions between departmental officials and CervicalCheck about the case in advance of it being brought. However, the Minister was not told about these discussions. What was their nature and why was the Minister not brought into the loop at that point?

We know that in July 2016 the former clinical director of CervicalCheck sent a letter to clinicians in which a three-point plan was outlined. The last of the points was that in cases in which a woman had died, the clinician should simply ensure the result was recorded in her notes. It was that clinically cold. One could argue that the intention of the plan - to deprive a family of such vital information - was illegal. The senior management team of CervicalCheck would have been aware of and approved the plan. The question is who else at senior level in the Health Service Executive, CervicalCheck and the Department was aware of it.

The memo prepared for the Minister anticipated adverse publicity in the event that the case became public. Some of the information in it appears to be inaccurate and false, as it gives the sense that women were informed of their results. However, we now know that, contrary to the impression I got from the memo, women were not so informed. The failure of the Department and, latterly, the Minister when he was informed to anticipate the earth shattering nature of the case is very worrying. The frenzied reaction and appalling communications of the State and its services since have created genuine worry and shock across the country. It took so long to find out how many women had died. Seventeen women whose cases were reviewed have died and up to 162 were not told their results. There have been 8,000 calls to the CervicalCheck helpline. The failure to anticipate this matter in order to prepare for it and have the homework done in advance of the case becoming public is genuinely shocking and must be reflected on.

Three years ago, in November 2015, it was announced that open disclosure would be legislated for in the context of the health information and patient safety Bill and that a packet of measures would be brought forward by the Taoiseach in his then role as Minister for Health. The Bill has not yet been completed. This morning the Minister and his officials stated there was a culture of paternalism within the medical profession. The Bill was brought forward after the scandal surrounding the death of a baby in Portlaoise. Nearly three years later, it is extraordinary that it has not been progressed and that the open disclosure commitment made by the Taoiseach, on which he subsequently changed his mind, has not been provided for.

Leo Varadkar (Dublin West, Fine Gael)
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I say once again how saddened I was to hear about the case of Vicky Phelan and emphasise the extent to which I feel for her and her family. I am full of sorrow that she was not diagnosed sooner and wish her and her family the very best on the difficult road ahead. I pay tribute to her for her bravery, particularly in calling on women and men to go for cancer screening which we know saves lives.

I am very angry on behalf of the approximately 160 women who were not told the results of the audit. Even though it would not have made a difference in their case in terms of treatment, the prognosis or outcome because they had already been diagnosed with cancer at that stage, they should have been told. It was information pertinent to their cases, lives and health which they had a right to know.

I know that this controversy is having a huge impact on the women of Ireland. It is about women's health and lives and many women now feel very vulnerable and are worried. It comes after a very difficult year with controversies surrounding issues such as #MeToo, sexual harassment, difficult rape trials and other matters. This country has not always treated women very well and even today perhaps treats them very badly, as evidenced by issues such as mother and baby homes, the Magdalen laundries, the marriage bar and the hepatitis C scandal.

That is why I am determined to get to the bottom of this matter and establish the facts. We do not yet know all the facts, and I ask people not to jump to conclusions until we do that, but we do want to establish the facts. I am determined to restore confidence in our cancer screening and I also want to ensure that this does not happen again.

In terms of the actions that will now take place, there will be a statutory inquiry led by the Health Information and Quality Authority, HIQA. We believe that is the best and quickest way to do it. We need answers in months, not years, and it has the skills and the statutory powers to do so. We have also offered a repeat smear test. Any woman who is concerned about her smear test can go to her general practitioner, and if they agree an additional test is warranted, that will be done and paid for. We also plan to move to a more accurate test and will be one of the first countries in the world to do so. We are moving to a HPV-based test for cancer screening.

Every patient who has been affected will be offered an individual clinical review. The approximately 160 who have not been contacted will be contacted today or tomorrow and will be offered an individual clinical review about their case.

As I mentioned, we will now bring forward legislation for mandatory open disclosure to build on the legislation for voluntary open disclosure passed by the Dáil only a few months ago. I have asked the Attorney General to examine if there are any outstanding cases that are similar that we may now be able to settle quickly without requiring further legal actions.

To answer one of Deputy Martin's questions, the Minister was only informed of this case in the week before it was settled. He was informed that the case against the HSE was likely to be dropped or struck out, and it was. He was informed that the case against the laboratory was likely to be settled, as it was. The note reads that patients were informed and that the message had been passed on to doctors to inform their patients. We now know that was not the case in most circumstances. He was also informed that the Department did not consider this to be a patient safety incident as it fell within what they believe to be the normal error bars of screening tests.

In terms of publishing the note, that note will now be published. The Minister did not want to publish the note until he had the permission of Ms Phelan to do so. He has that permission now, and if it has not been done already, it certainly will be done today.

Micheál Martin (Cork South Central, Fianna Fail)
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The Taoiseach has commented a number of times that it would have made no difference if women had been told about this in advance. He is making that from a clinical perspective in terms of the actual diagnosis of cancer and the response to it, but I suggest it would have made a hell of a difference to the women involved, and to their families, because in not informing the women their families were being deprived of vital information. When a family loses a mother, they lose a lot in terms of the subsequent care of children in such a family and in the duty of care to the spouse of a woman who has passed away as a result of cancer, or indeed any illness. That goes to the heart of this case, and that is why Vicky Phelan fought so hard. Families have needs. It seems to me that the fact there was a deliberate policy decision that, in the event of women having died, the information was merely to be noted on a file and the family denied that information, which is their entitlement in terms of knowing the circumstances surrounding their mother's death, is truly shocking.

What is extraordinarily disconcerting is that senior people within CervicalCheck in particular approved of this policy. It seems to me that someone must have known at senior level within the HSE because the State Claims Agency does not act in isolation. It is a Government agency. It takes instructions. It is under the Department of Public Expenditure and Reform, yet in recent days the Government has been articulating a view that it is somewhere out there in the ether and that it does its own work independent of anybody. That cannot be true. Likewise, senior people in the Department of Health must have known because it was said to me this morning that there were intense discussions between the Department of Health and CervicalCheck.

Pat Gallagher (Donegal, Fianna Fail)
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There will be more time later in the day. I call the Taoiseach.

Micheál Martin (Cork South Central, Fianna Fail)
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Everybody knew but nobody knew, and nobody could tell us anything in the past week. It had to be dragged and drip-fed in a frenzied way. I have to put that to the Taoiseach.

Leo Varadkar (Dublin West, Fine Gael)
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As I said, I am personally very angry that the women were not informed. They should have been. It was their health, their lives and their families and they had a right to know. We need to do everything we can to make sure this will never happen again. Patients should always be informed of clinical information pertinent to their case. I come from the medical profession. I am the Taoiseach, a doctor and also the brother of two sisters and know that a lot of women are afraid today. The 160 women who know that they have cervical cancer but who may not have been told about their previous false smear test result will be told this today, if they have not already been told. They will be offered an individual appointment this week in order that their clinical case can be discussed. I also know that a lot of women are very afraid today that the HSE knows that they have cancer but has not told them. That is a real concern for women, but I want them to know that that is not the case. There is nobody today with a diagnosis of cervical cancer who has not been told by the HSE. There has been a misunderstanding and I reaffirm that point very clearly. I reassure people that there is no one walking around today with a cervical cancer diagnosis from whom that information is being withheld by the HSE. I also reassure women who have had smear tests. One of my girl friends with whom I spoke over the weekend was very concerned. She had a smear test in the past couple of months and is now very worried as to whether the result was accurate. I reassure women that while no screening test is 100% accurate, the tests are as accurate as they can be and pick up the vast majority of cancers.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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Today people are trying to make sense of how profoundly the State has failed the women affected by the cervical cancer scandal. A total of 208 women went for a vital screening for a life-threatening illness and were wrongly given the all clear, of whom 162 were not told about this devastating error. I understand some of them have still not been contacted, but if I have that wrong, the Taoiseach might correct it for me. Of course, for some of the women affected by the scandal there will be no telephone call, no news, no disclosure and no truth because 17 of them are dead. They passed away not knowing that their cancer should have been caught earlier, that their treatment programmes, prognosis and possibly outcomes could have been different. They died unaware that this information was known to the HSE and others. They had been kept in the dark, not because of some communication error but because of a toxic culture of concealment within the HSE and a refusal to take responsibility, a culture in which women were literally allowed to die before fault was admitted. Vicky Phelan's solicitor has described what he regards as a cover-up within the HSE.

The root of the scandal is found in the decision in 2008 to outsource screening. At the time the Government was told of the dangers of this move, that it would jeopardise women's' health and their lives, but it went ahead with it. Subsequently the flaws in the system were highlighted, not least by members of the quality assurance committee. Members of that committee resigned in protest because their words had fallen on deaf ears. They had fallen on the deaf ear of Mr. Tony O'Brien, formerly of CervicalCheck and now chief executive officer of the HSE. He knew this information but did nothing about it. His position is untenable and he needs to go. If he does not, the Taoiseach needs to sack him-----

Pat Gallagher (Donegal, Fianna Fail)
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I ask the Deputy to refrain from naming names.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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I have named names and repeat that the Taoiseach should sack the named individual. Of course, we would know nothing about this scandal were it not for the bravery of Vicky Phelan which the Taoiseach has acknowledged. She is terminally ill and was coerced and harassed through the courts by the State in her fight to get to the truth.

The legal strategy pursued by the State and stood over by the Government was shameful. The State bullied her and then tried to silence her. This cannot happen again to any woman or any family that takes the State to task for its failures in this scandalous episode.

Pat Gallagher (Donegal, Fianna Fail)
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Go raibh maith agat.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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The Taoiseach has said that he defends the right of patients to know the full facts about their own health. The fact is that he has opposed a mandatory duty of candour. He failed to support it as Minister for Health in 2015 and he failed to support it again in February of this year when he was questioned by my colleague, Deputy O'Reilly. His failure in this area reinforces the State's strategy, which is to withhold information, to dodge liability and to aggressively face down patients - women, in this instance - and their families.

Pat Gallagher (Donegal, Fianna Fail)
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The Taoiseach to respond.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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What we see here is concealment, harassment, cover-up and death. I have three questions for the Taoiseach.

Pat Gallagher (Donegal, Fianna Fail)
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Deputy, please.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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When did he become aware that there was an issue with the cervical cancer screening programme, particularly the review carried out in 2014?

Pat Gallagher (Donegal, Fianna Fail)
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The Deputy will have another opportunity.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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Is the Taoiseach prepared to support the introduction of a mandatory duty of candour? Will he remove Mr. Tony O'Brien from his position immediately?

Pat Gallagher (Donegal, Fianna Fail)
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The Taoiseach to respond. I know it is a very important issue.

Leo Varadkar (Dublin West, Fine Gael)
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I first became aware of this issue on Thursday or Friday of last week. Obviously, I tried to spend as much of the weekend as I had free reading up on it and trying to understand it. Even now, I do not think it is the case that anyone or everyone in this House knows all the facts. That is why it is necessary to have the statutory inquiry that has been initiated by the Minister, Deputy Harris.

The decision to proceed with outsourcing to the laboratories in the US was made in 2008. The Deputy is correct when she says that Mr. Tony O'Brien was the head of the cancer screening service at the time. To this day, there are differing views on whether that was the right decision. It is important to mention some facts that might not yet be in the public domain. Approximately half of smears are read in laboratories in Ireland and approximately half are read in laboratories in the US. Three different laboratories are used - two in the US and one in the Coombe Hospital. We do not yet have any evidence that there are significant statistical differences between the numbers of false negatives emanating from each of these laboratories. If there are such differences, we need to know that is the case. We should not jump to conclusions until we know that such differences exist. Of course that will have to form part of the inquiry. Three laboratories are used. It probably makes sense for us to use different laboratories because it allows us to see if there is an outlier for some reason. We now need to examine that. I am told that the audit which was done did not show any significant statistical differences between the results of the three laboratories.

I would like to speak more generally about cancer care in Ireland. I know this is about women's health and women's lives. Like everyone in the House, I am among the many people who are very worried and upset about this. I do not think we should lose sight of the wider truth that cancer care in Ireland has improved considerably in recent years. More people now survive cancer than ever before. We have better treatment, quicker diagnosis and more prevention. Cancer screening works. In 2011, the incidence of cervical cancer in Ireland was 14 per 100,000. It is now ten per 100,000. Such a big decrease in a relatively short period can be attributed to things like the HPV vaccine and the screening programme. I want to encourage everyone who is offered BreastCheck, CervicalCheck or BowelScreen to go ahead and take up the appointment. These initiatives save many lives.

It might be useful for me to explain briefly how population cancer screening works. Before we had screening, a person was not diagnosed with cancer until he or she had symptoms. A person went to his or her doctor if he or she was bleeding from somewhere, was jaundiced, had a lump or a bump or had lost weight. A person might have been diagnosed with cancer on foot of tests organised by his or her doctor and he or she then received treatment on that basis. Cancer screening has changed all of that. Cancer can now be detected before it is symptomatic. A key factor is that these tests are not diagnostic. It is a screening test, rather than a diagnostic test. For that reason, it is not 100% sensitive or specific. There is a margin of error. If 1,000 women are screened for cervical cancer, for example, in 980 of those 1,000 cases the woman will be given the all-clear and can be confident that she has the all-clear.

In 12 of those cases, the cancer will be detected. In approximately eight from 1,000 cases, it will be missed. It is an error of approximately 0.8%. That error is not necessarily because anybody is negligent or incompetent. Even with two sets of eyes, or four eyes, looking at every film, there is an error rate of 0.8%. We need to explain that and try to get that message across. I want to encourage people to go for those smear tests, to have that BreastCheck and send back the colorectal screening. These tests are not 100% but they pick up many cancers early. By picking up those cancers early, people's lives are saved. Whatever we do in this House over the next couple of weeks, let us make sure that message keeps coming through.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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Do not underestimate the level of public understanding of the importance of screening. Women know full well that cervical screening and BreastCheck are essential parts of their healthcare. That is not a matter of public debate. We also know they are not diagnostic and there is no "100%". Furthermore, we know that in these cases, information was deliberately withheld from women and their families. That is the issue.

The Taoiseach tells us the first he heard of all this was on Thursday or Friday last week. I presume he is referring specifically to Ms Phelan's case. The Taoiseach was the Minister for Health in 2014. Is he saying he knew nothing about the audit or the review of the CervicalCheck scheme at the time as Minister for Health? What was his state of knowledge at that point in terms of the screening approach and, more particularly, the initiation of this audit and its findings?

The Taoiseach did not answer my question on the matter of a mandatory duty of candour. I find that very surprising as he went to some lengths to say that women and patients have a right to full information. Will the Taoiseach clarify the position? In the past the Government blocked a mandatory duty of candour and I want to hear that the Taoiseach will now support it as Head of Government. Will the Taoiseach also answer my question on Mr. Tony O'Brien, head of the Health Service Executive? Does the Taoiseach have confidence in him, because I certainly do not? Will he do what is glaringly apparent and relieve Mr. O'Brien of his duties?

Pat Gallagher (Donegal, Fianna Fail)
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There is an onus on Members to avoid referring to persons outside the House. It is a custom and practice.

Leo Varadkar (Dublin West, Fine Gael)
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I appreciate that. The basis on which the Deputy has called for the dismissal of Mr. Tony O'Brien is an assertion that the decision to outsource these tests to the US in 2008 somehow cost lives. I explained why that is not yet supported by the facts. Everyone, even Mr. Tony O'Brien, deserves a fair hearing before being condemned. We need to assess whether that decision was wrong. It may turn out not to be wrong. We need to be fair about it in that regard.

The Deputy asked about my state of knowledge on various occasions during my two years as Minister for Health. I was informed of major patient safety incidents and I was certainly informed of matters in Portlaoise, for example, as well as concerns with bowel screening in the south east. All those matters are in the public domain. I was never informed of any patient safety concern or potential scandal relating to CervicalCheck and certainly not the outcome of any audit such as this. I have asked officials in the Department to check that for me in case my recollection is incorrect.

With respect to open disclosure and the duty of candour, I point out once again that both open disclosure and duty of candour form part of the Medical Council's ethical guidelines for doctors.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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That is not what I asked.

Leo Varadkar (Dublin West, Fine Gael)
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These are not optional and one may be struck off for not following them. Open disclosure has been policy for all HSE staff since 2013. The Deputy is incorrect in that we commit to two actions in the programme for Government. The first is to legislate for voluntary open disclosure in all cases and the second is to legislate for mandatory open disclosure in cases of a serious reportable event. We did the first one in the Civil Liability (Amendment) Act 2017, which supports voluntary open disclosure and puts it on a statutory footing. The legislation was passed last year in this House and it will be commenced in the coming months. We will do the second action in the patient safety Bill, as the Minister committed to last year and we committed to in the programme for Government. That action is to legislate for mandatory disclosure in those serious incidents.

Turning to my own role - I do want to answer this - I did make a decision to make a voluntary open disclosure before a mandatory open disclosure. I made that decision having taken advice from the Chief Medical Officer and my Department which had listened to all stakeholders and heard their views. The all-party committee also considered this matter last year and recommended that approach in its published report - going for voluntary open disclosure first and then mandatory open disclosure. There was a Dáil vote on the matter.

Brendan Howlin (Wexford, Labour)
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Across Ireland today there are many thousands of women who are terrified following the revelations about the CervicalCheck screening programme. Following an audit of women diagnosed with cervical cancer, we know that 208 women should have been told and had earlier interventions. It beggars belief that 162 of these women were not told, and, from what has been said today, may not yet have been told about the outcome of the audit process. Of the 162, we now know that 17 have died.

The only audit carried out was of those who had developed cancer. Is it true that no other smear test result has been rechecked? Women and their families need reassurance that their health will be our paramount consideration in the days ahead and that they will receive the best advice, the best healthcare and the best support possible. The Minister for Health, Deputy Simon Harris, established a helpline. However, it is not clear who should be ringing it. Has a particular group of women been identified? Is there a concern about a particular age cohort, region of the country or date on which the tests were taken? There is not so far an identifiable cohort of women that the HSE believes is at risk; therefore, all women who have been tested are anxious and all are suspicious about their test results.

The first port of call for any woman concerned is likely to be her own general practitioner, GP. As far as we know, no guidelines have been provided for GPs on how to deal with the concerned calls they are receiving. The Government's first duty was to reassure women and put all of the necessary supports and guidances in place. Will all women be retested? That is the logical next step in providing reassurance, but is it a practical proposition?

The Taoiseach also announced yesterday that a statutory inquiry would be established through the Health Information and Quality Authority, HIQA. When HIQA carries out an inquiry, it is based on examining the systems and processes in place in a particular health facility. It was not set up under the Act to carry out a fact-finding inquiry to answer all of the questions that arise in this matter. It also cannot cross-examine witnesses under oath and I am advised that it is highly unlikely that it will be able to make findings of contested fact against any individual. The Department of Health, of course, does not come within HIQA's statutory remit. For these reasons, I ask the Taoiseach to think again. Will the Government establish a proper inquiry to investigate what happened? A commission of investigation is obviously required. Will the Taoiseach begin the drafting of terms of reference for a commission of inquiry and begin today to consult all interested parties?

Leo Varadkar (Dublin West, Fine Gael)
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I do not know if this was the only audit carried out. A clinical audit is a normal part of medical practice. Any doctor who wants to stay on the medical register has to be involved in a clinical audit; therefore, on any given day there are hundreds or perhaps even thousands of audits being carried out across the health service. There may well have been other audits carried out of cervical checks.

Brendan Howlin (Wexford, Labour)
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The Taoiseach does not know.

Leo Varadkar (Dublin West, Fine Gael)
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I do not, but my assumption is that other audits have been carried out. It is part of normal healthcare practice that clinical audits are carried out. Practice is checked and rechecked each cycle to see what can be learned. There are different audits that can be carried out.

For those women who are concerned, the helpline is open to any of them who wants to make a call and seek information. I thank the Irish Medical Organisation and the National Association Of General Practitioners for their co-operation. The Minister has been in touch with them.

If a woman is concerned, she can go to her general practitioner. If it is appropriate and they decide that a repeat smear test should be done, it can be done and we will meet the cost of that.

Again, I want to reassure the women of Ireland that our screening service is safe. It is not 100%, although no screening service is because there are false negatives. If a woman goes for screening there is a very good chance that, if she has cancer, the cancer will be diagnosed early and, as a result, she will get early treatment and a far better outcome and prognosis.

Again, I want to pay tribute to Vicky Phelan for putting that message across. Despite what has happened to her she is sending out the message clearly that people should continue to attend for their smears, breast checks and that the same should apply to men and women for colorectal screening.

I was asked about the Health Information and Quality Authority inquiry. The Department of Health will, on a voluntary basis, agree to be covered by that. It is not in legislation but the Department has agreed to do that and arrangements will be made to do exactly that. HIQA is the body that has powers. It is the body that has done investigations into the health service before in Portlaoise, for example, and in respect of a death in Tallaght Hospital. HIQA has the expertise, knowledge and the statutory power of compellability.

I appreciate the Deputy's suggestion that a commission of inquiry might be an alternative and I cannot rule out that being necessary in the future. However, I would point out that commissions of inquiry take a long time. It is three years, for example, since the commission of inquiry on the Grace case was announced. The Siteserv inquiry could go on for many years. One thing Vicky Phelan has said, and I think she is right, is that she does not want an inquiry that goes on for years. A report could be received by a future Government perhaps. What we want is an inquiry that gives us answers quickly. The risk with a commission of inquiry, of course, is that everyone goes legal and lawyers up and it takes years before we get a report, with probably no answers at the end of that. That is why I am calling for the co-operation of the House in supporting the HIQA inquiry, which we believe will get answers quickly, and, if not, then we will consider a commission.

Brendan Howlin (Wexford, Labour)
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I have a second question. I have re-read the Act that established HIQA. It is very constraining in terms of what the authority can do. It refers to how HIQA must ensure that an investigation does not interfere or conflict with the functions of any other statutory body. HIQA can appoint an approved person with the approval of the Minister. It has limited power to demand production of relevant documentation. It has no power to direct the attendance of a witness, to direct a witness to answer questions or to demand or receive sworn evidence. Witnesses are not given any immunity in respect of the evidence they give. In the absence of any provisions, it is unlikely - I am advised legally - that the authority can come to any adverse findings against named individuals that might be contested. That is not appropriate to address the degree of issues that are rocking the country right now and I call on the Taoiseach to think again on that.

The first priority is to provide reassurance to women today. In truth, the only rechecked smear tests that we know about - the Taoiseach may say there are others - are for the 208 women who got cancer subsequently. They have been rechecked. I would love to hear some reassurance on that point. In the case of all the other smear tests, has there been a systematic recheck? Can the Taoiseach give reassurance to women who are looking in that their smear tests have been rechecked too and that there is no concern? The Taoiseach says that any woman who has a concern can have another test. Is it possible to have rechecks for the thousands of women who may want that now? Is that a practical proposition? How should they go about it?

Leo Varadkar (Dublin West, Fine Gael)
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On the first matter, the independent clinical panel that the Minister has established will offer an individual appointment with each of the 200 women affected and offer them the best advice in respect of their individual cases.

Brendan Howlin (Wexford, Labour)
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What about the women who do not know they are affected?

Leo Varadkar (Dublin West, Fine Gael)
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I was asked about audits. Since 2008, 3 million smear tests have been carried out by CervicalCheck. I do not believe it would be practical to repeat 3 million tests or recheck them and that may well not be warranted.

The HSE has advised, however, that between 2008 and early 2018, 1,482 cervical cancer cases had been notified to CervicalCheck by the national cancer registry. The majority of those cases were patients who had already been referred for further clinical investigation or treatment by CervicalCheck. As part of the clinical audit process, these notified cases were re-examined and 277 cases were flagged for further cytology review. In 208 of those cases, the cytology review recommendations differed from the original test and what I understand is done with all of these smear tests is that every single one of them - all 3 million - have already been looked at by two people, by two sets of eyes. There is a quality control process as well that does a cycle of rechecks to make sure that the laboratory is up to standard. As I explained, there is an error rate and that error rate, as we know so far, is no greater in this particular laboratory. That is something we need to check.

Pat Gallagher (Donegal, Fianna Fail)
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I call Deputy Joan Collins on behalf of her group.

Joan Collins (Dublin South Central, Independent)
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This scandal is and will go down in this State's history as one of the worst instances of serious medical neglect, particularly of women, along with the ingrained culture in the health service to deny and cover up this scandal. The response of the health service to the hepatitis C scandal, the deaths of babies in Portlaoise hospital, the cases of national maternal deaths and catastrophic injuries, symphysiotomy etc. has been to admit nothing and make patients jump through emotional and financial hoops to prove their case. That has been the history of this State.

The HSE eventually came out yesterday and confirmed at least 208 women, who have since been diagnosed with cervical cancer, were initially told their tests were negative, and of those, 17 women have died. In 173 cases women would have been given a different clinical treatment if earlier smears had been read correctly and 162 of the 208 were not told a review had been conducted by CervicalCheck or of the outcome. Cian O'Carroll, the solicitor acting for Vicky Phelan, for whom I have huge respect and admiration - we should be not only angry but livid about what is after happening in these cases - believes all 1,482 cases should be subjected to independent review.

Could this situation have been prevented? In 2008, the then Fianna Fáil-Progressive Democrats Government made a political decision to outsource our smear testing to private companies overseas. Why? It was because they made a political decision of not resourcing the services here. Sam Coulter-Smith, a former master of the Rotunda Hospital, said he warned the Government a decade ago against testing being moved to private companies overseas because he was worried that resulting problems would mean cancer cases being missed. He said: "Our cytology system in the Rotunda Hospital, which was well developed, fully accredited and world class, with very good quality assurance systems in place and numerous people analysing smears - two looks rather than one - the quality assurance was at a much higher level than the US."

Dr. David Gibbons, who was chair of the cytology-histology group within the national cervical screening programme, with a number of his peers, has stated that they raised with the then CEO of the National Cancer Screening Service, Tony O'Brien, their serious concerns. He said he warned Tony O'Brien when he saw the figures from the United States were showing one third fewer high grade dysplasias compared with Ireland. It was 1.8 in Ireland and 1.2 in the US. He was concerned about a mismatch of systems. Ireland tests for cervical cancer every three years where the US system would test annually. He predicted in 2008 that up to 1,000 women per year would be affected and that this would become apparent in ten to 15 years down the line.

That has happened. It is a reality for the women affected by these reviews and it must be seriously taken on board. Somebody has to be answerable for this. People in this country are sick and tired of these cases. In the hepatitis C case the CEO walked away with a gold-plated pension and people like Brigid McCole had to go to the courts to fight their cases.

I reiterate the call from the Sinn Féin Deputy that Tony O'Brien or somebody should be held to account. The political system should be held to account for this as well. An international peer review is being done on the screening. The Taoiseach said approximately half are done in the United States or outside the country and the other half are done here. We should have a clinical assessment of the exact number that came from the US and from here.

Pat Gallagher (Donegal, Fianna Fail)
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Deputy Collins, your time has expired. I call the Taoiseach to respond and he has three minutes.

Paul Murphy (Dublin South West, Solidarity)
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Everyone else got extra time.

Joan Collins (Dublin South Central, Independent)
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A Leas-Cheann Comhairle, everybody else got over a minute and a half or two minutes extra time on this.

Pat Gallagher (Donegal, Fianna Fail)
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Yes, but you are a minute over time-----

Paul Murphy (Dublin South West, Solidarity)
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Everyone else got more than a minute extra.

Joan Collins (Dublin South Central, Independent)
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I am 47 seconds over time.

Pat Gallagher (Donegal, Fianna Fail)
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I am taking note.

Joan Collins (Dublin South Central, Independent)
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I wanted to make the point about mandatory open disclosure. Deputies Clare Daly and Wallace last year brought an amendment to the Civil Liability (Amendment) Bill 2017 for mandatory open disclosure. It was rejected-----

Pat Gallagher (Donegal, Fianna Fail)
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The Taoiseach to respond.

Joan Collins (Dublin South Central, Independent)
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-----and Fianna Fáil abstained.

Pat Gallagher (Donegal, Fianna Fail)
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Deputy Collins will have another minute.

Joan Collins (Dublin South Central, Independent)
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That mandatory disclosure could have been in place at present and it could have affected those cases where women had the right to that disclosure. Would the Minister please bring in the Health Information and Patient Safety Bill immediately, not six months down the line?

Leo Varadkar (Dublin West, Fine Gael)
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To clarify, in all 1,400 cases the original smears have been rechecked. The way the audit worked is that if a woman was diagnosed with cervical cancer between 2008 and 2014, they went back and checked all of the smear tests to see if there were false negatives or false positives. To reassure people, in all 1,400 cases those smear tests were rechecked already. That is the way this audit cycle works.

In relation to the laboratories, I hope I answered already - if I did not I am happy to repeat it or clarify - that we are moving towards a new more accurate test. No test is 100% accurate. There will still be false positives and false negatives, but we are moving to a new test which is a HPV-based test for cervical cancer screening. That new test will come in later in the year. That offers us an opportunity to reconfigure the laboratories and review which laboratories we use.

Whatever we do, it should be based on facts. We are letting women down and letting people's health down, in particular women's health, if we make decisions that are not based on facts. As I explained earlier, 50% of smears are checked in cytology laboratories here in Ireland and 50% are outsourced. Three different laboratories are used - two in the United States and one in Ireland - and so far there is no evidence that any of those laboratories is less accurate than the others in terms of false negatives in a statistically significant way. Whatever we do, it must be based on facts. We should not merely sack somebody or change the laboratories for some reason. In the interests of women and their health and doing what is right, we must base our decisions entirely on facts and evidence.

In terms of resignations, it is worth noting that the head of the programme, its clinical director, Professor Gráinne Flannelly, has already stepped down. We accept that she has made that decision, taking accountability for the appalling communication failures that occurred. However, it is also important to note that she is somebody who was involved in bringing in this programme over the years and as a consequence, helped not only to save many women's lives but also to ensure many women had much less invasive operations because their cancers were picked up earlier. We should be balanced in our response and recognition of that.

On the duty of candour issue, as I said, duty of candour is already in the medical council guidelines.

On the decision taken last November on mandatory open disclosure, this commitment was given to Deputy Clare Daly, who brought the amendment forward and made some good points in that debate in the Dáil, by the Minister both verbally and in writing that on foot of the legislation for voluntary open disclosure, which was passed by these Houses a few months ago, he would bring forward mandatory open disclosure in line with the programme for Government in cases where it is a serious reportable incident or error. The Minister is developing that legislation. It will be in the patient safety Bill. The Minister expects to bring a memorandum to Cabinet next week and we will get that legislation done as soon as possible.

If people think that merely changing the law or guidelines will resolve this problem once and for all, it will not. What is required is a change of culture in our healthcare. We need to move towards a culture of truth and that is something I would like to speak about later.

Joan Collins (Dublin South Central, Independent)
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I honestly believe this is not merely a communication failure. It is a service and resource failure. Mr. Tony O'Brien, in 2008, stated, "At the time there was not sufficient capacity of that type in Ireland." It was not resourced and they had to go abroad to private companies overseas. That is a fundamental issue in our screening.

I would like to get the facts. The Taoiseach correctly states we should get the facts.

The fact of the matter is we have women dying here because their screening was not tested adequately. They were screened in 2011, their smears came back negative and they were retested. That is the information I read and which the Taoiseach said he read over the weekend. If corners are cut it does not work. More often than not, in the longer term one pays more both financially and in terms of the human cost. At this point we should be looking at bringing all our screening back. Even if we bring in new HPV screening, it still has to be checked to World Health Organization standards. We should be looking at that now rather than waiting for reviews and peer reviews. I would like the Taoiseach to come back on that. Sam Coulter-Smith has said that very clearly.

Leo Varadkar (Dublin West, Fine Gael)
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I am still trying to figure out all the facts. I appreciate the Deputy's sentiment that decisions we make on this should be based on facts. We are really letting people down, particularly the women of Ireland, with regard to women's health if we make decisions that are not based on fact. We do not yet have all the facts. That is why we need to have the HIQA inquiry. That is why we need a little bit more time to get to the bottom of this. I want to get to the bottom of this. I want to know all the facts. I want to make sure we can restore confidence in our cancer screening service. If one takes the entire audit, which I think included 1,400 cases in total, there were 208 false negatives. That is 208 people who had smear tests that were reported as normal but who then went on to develop cancer. We cannot say how many of those were false negatives yet within the margin of error. We cannot say for certain. Very sadly, those 208 people have cancer. Some of them are very sick and 17 have passed away, very sadly. We cannot say with certainty that had there been a different test done in a different lab that those cancers would have been picked up. I see from one of the notes today that a slide was looked at by eight specialists - eight cytologists. They are scientists who are experts in this field. Eight of them were asked to look at a sample. They were told the woman had been diagnosed with cancer; five of the eight could not see the cancer cells and three could. These tests are not 100% accurate. They are subjective. There is a degree of margin of error. We will do our best over the coming period to try to explain.