National Cervical Screening Programme: Statements

I welcome the opportunity to update the House on issues of concern that have arisen with regard to CervicalCheck, the population-based national cervical screening programme. I wish to share as much information as I can and that I have, and to set out the actions I have taken. I again recognise the contribution of Vicky Phelan in bringing this matter to our attention. I thank her and her family. I especially thank her for her support for screening programmes.

I recognise that across the House, while raising their legitimate concerns, colleagues have also endorsed that message about the importance of the screening programme. I thank everybody for that also. I hope we can try to work together collectively to identify any shortcomings in our screening programmes and learn from them to make sure that our screening services are improved. I look forward to hearing the contribution of Deputies across the House. I have to inform the House of some emerging information that I have received this evening from the serious incident management team, SIMT, that has been sent into CervicalCheck.

Is there a script?

There is one being sent. Will we wait for it?

No, that is fine.

There is one on the way.

There is one on the way.

On the way like the HSE.

No interruptions, please. The Minister to continue, without interruptions.

While I had been advised, and it had been commonly understood, that the CervicalCheck clinical audit covered all cases notified to the national cancer registry, I have been informed this afternoon that this is not the case. While CervicalCheck has audited all cases notified to it, I have been informed that a potentially considerable number of cases will not have been subjected to an audit of their screening history. These are not new cases of cancer, nor is it a group of women wondering if they have cancer. These are women who have been diagnosed with cervical cancer and treated as such but their cases have not been included in a clinical audit. Having identified this issue, the SIMT will take steps to identify any additional cases of cervical cancer that occurred during this period and which were not audited. The screening history of these additional cases will be established, and if any of these women were screened through the CervicalCheck programme, their case will be reviewed in further detail with cytology review where necessary. This is an evolving situation but I am giving as much information to this House as I have as soon as I have it to be transparent with the Dáil.

We are all here, I think we can agree, because Vicky Phelan spoke out. I recognise that to do so cannot have been easy for her or her family. Her courage and tenacity has done a great service to the women of Ireland and her actions will ultimately lead to improvements for all. I think the background to the case is well understood at this point, but I want to be very clear about my own level of knowledge prior to the case becoming public and with regard to the information note I received on 16 April, which I have published today with only personal information redacted.

I was not notified at that time of the information which later became available, information such as the correspondence chain between doctors and the clinical director of the programme.

The full implications became clear to me only on Wednesday, 25 April, when Vicky Phelan spoke, and on Thursday, 26 April, at which point I acted swiftly.

The note outlined the details of an individual case. lt informed me of a legal process that was already underway. It informed me that mediation discussions had been held on 9 April and pre-trial discussions had been held with a judge on 10 and 12 April. It said that the matter may progress to the High Court on 19 April but that the case was likely to be settled before going to court. It said that the claim against the HSE was likely to be dropped in the absence of any bad faith by the HSE. It informed me that my Department had been advised by the National Cancer Control Programme that it did not consider this to be a patient safety incident. It informed me the National Screening Service had assured the Department that no quality issues have arisen in respect of the UK laboratory that performed the 2011 test referred to in the case. In an appendix with background information, the note outlined the clinical cancer audit process, including the fact that all current and historical clinical cancer audits had been communicated to treating clinicians in 2016 and that more recently women are informed of this audit process and have the option to request information on the outcomes of these reviews. It was not clear until after the details of this case became public that this process was not ensuring women were informed. Once I became aware of that I ordered immediate change, as is well documented.

Since 2008, a total of 3 million smear tests have been carried out by CervicalCheck. The cervical screening test is not a diagnostic test; it is a screening test. It is a test to indicate the possibility of pre-cancerous or cancerous lesions and to identify women who require further investigation or follow-up. Tests can produce false positive and false negative results. Women are screened at three-yearly intervals but cervical cancer may develop in the interval between a negative screening test and the next scheduled screening in any cervical screening programme.

It is a fact that the current primary screening test used by CervicalCheck is a cytology test that produces a not insignificant number of false negative results. I can, however, confirm that primary human papillomavirus screening will be introduced later this year. I took that decision in February and it will be introduced by October. I understand that the accuracy of HPV testing is significantly higher than liquid-based cytology testing, which is the testing used now. HPV testing is expected to result in fewer women receiving a false negative result. I am also of the view that testing for the HPV virus will be a more appropriate strategy for the cohort of women who have received vaccination against HPV. My decision to approve primary HPV screening was informed by a HIQA health technology assessment. The assessment found that HPV screening would benefit women by making the screening process more clinically effective as well as reducing unnecessary tests for most women. The HSE has advised that 1,482 cervical cancer cases have been audited by CervicalCheck covering the period from 2008 to 2018. The audit found that the majority of these cases involved patients who already had been referred for further investigation or treatment by CervicalCheck. In the case of 208 patients who were the subject of a detailed cytology review it found that the review differed from the original test.

Last Friday, the HSE established a serious incident management team. The team worked through the weekend to confirm the number of women involved and the extent to which the audit results had been communicated to them. Yesterday, it was reported to me that 162 of the 208 women involved had not been informed of the outcome of the audit process. Over the past two days we have been communicating with these women and I believe significant progress has now been made. Obviously, there will be a small number of cases where we might not succeed in initially making contact, such as a case where a woman may have moved abroad.

Like all Deputies, I was very sorry to learn that 17 of the patients involved have since died and I would like to sincerely express my sympathies to their families on the record of the House. Obviously, as yet we do not know the cause of death of these individual women but we will work with the families to ensure that is established. A helpline has been in operation since Friday and appropriate clinical staff will follow up on specific clinical questions. Between Friday and the close of business yesterday, approximately 6,000 calls were received. Unfortunately, there were some technical issues with the telephone line but I am informed that the HSE had worked to address this.

I am conscious that some women will be worried that they might have received an incorrect smear result and they might want a further test to be reassured. I have heard many women say that in recent days. This was one of the most persistent issues that came in through the helpline we established. I have, therefore, asked CervicalCheck to make the necessary arrangements to enable any woman who has had a CervicalCheck smear test and whose general practitioner considers that the woman should have a further test to access such a further test without charge. These arrangements are currently being worked through and will be confirmed this week. I wish to thank the doctor representative organisations for their co-operation and support in this matter.

Vicky Phelan's case has highlighted a number of major weaknesses in how people experience our health service. I believe that immediate actions are required to address these weaknesses and to provide assurance to the public with regard to the quality and performance of the cervical screening programme. Given the gravity of the situation as well as the impact it has had on Vicky Phelan and a number of other women, I think it is vital that we ensure we put in place a process to allow all of us - patients, doctors and policymakers alike - to understand exactly what happened and what steps we need to rectify the situation. I have, therefore, directed HIQA to commence a statutory investigation to examine the clinical and managerial governance of CervicalCheck. This investigation will place a particular focus on the quality assurance systems, clinical audit processes and communications with patients. It is crucial for all of us to get this information. A statutorily empowered investigation by HIQA, the body established by these Houses for this very purpose, is the most appropriate way forward in this instance.

As part of this investigation an international peer review group will be established to examine our cervical screening programme against international best practice and standards. HIQA has been asked to identify any implications that may apply to other cancer screening programmes. This will ensure that any learning will have wider impact and serve to improve all our screening programmes. I am conscious, while looking at a programme and how to improve it, that individual women have been impacted and we need to ensure they can get independent clinical answers. I have now decided to appoint an international expert clinical panel to provide all women concerned with an individual clinical review. A liaison nurse specialist will be appointed to ensure the women involved receive all the support they require. I met the Irish Cancer Society this afternoon to ask that the society would meet the panel and ensure the panel and the relevant processes are put in place in a way that is supportive of women patients as well as to ensure women get the answers they need. The work of the expert panel will be completed as soon as possible. I hope it will have its work concluded by July.

Since 2008, CervicalCheck has undertaken tendering processes to award contracts for cytology testing of cervical smear tests. In 2013, the national cytopathology training centre at the Coombe Women and Infants University Hospital was engaged to carry out some of the laboratory tests. Currently, the testing of cervical smear tests is carried out by three institutions with approximately 50% of the testing done in Ireland and the remaining 50% done abroad. I realise this has been the source of much public discussion in recent days. I have been assured that all three laboratories meet quality assurance standards and are certified by the relevant national authorities. However, the introduction of HPV testing later this year as the primary screening mechanism for CervicalCheck, with cytology as reflex test, will involve a reconfiguration of laboratory work. It will also provide an opportunity for further tendering processes to be undertaken for any laboratory work carried out outside the public sector.

This issue in recent days has shone a real spotlight on our open disclosure practices or lack thereof in some cases. Of course open disclosure involves an open and consistent approach to communicating with patients and their families when things go wrong in healthcare. It is a human experience for all involved and one that should not be hindered by other concerns and fears. The HSE open disclosure policy has been in place since 2013 and the HSE committed to its full implementation in the HSE service plan this year. The Medical Council Guide to Professional Conduct and Ethics for Registered Medical Practitioners sets outs the duties of medical doctors in respect of open disclosure and duty of candour. It states that patients and their families, where appropriate, are entitled to honest, open and prompt communication about adverse events that may have caused them harm. When discussing events with patients and their families, doctors should acknowledge that the event happened and explain how it happened; apologise, if appropriate; and assure patients and their families that the cause of the event will be investigated and efforts made to reduce the chance of it happening again.

The Civil Liability (Amendment) Act 2017 includes provisions for open disclosure of serious events including certain protections for information given to the patient at an open disclosure meeting. This approach creates a safe space for healthcare staff to be open and transparent with patients, who can be given as much information as possible as early as possible, including an apology. In the course of Dáil consideration of the Civil Liability (Amendment) Bill, I gave a commitment to bring forward separate legislation to provide for mandatory open disclosure of serious events. I wish to acknowledge the work of Deputy Clare Daly in this regard. I intend to bring a memorandum to Government next week proposing a patient safety Bill. This Bill will include measures to support patient safety objectives and to provide for mandatory open disclosure to patients of those serious events which will be the subject of mandatory external notification. I will prescribe a list of reportable events that are required to be notified by public and private providers and this will include screening.

There has been much criticism about the way the State handled Vicky Phelan's legal proceedings. I accept that criticism. I think there is a difficulty with our tort laws in that they are slow to provide for persons who have suffered harm within the health care system. However, the State Claims Agency is delegated to manage all claims against the State and neither I nor my Department has any role or function in this regard.

There also have been calls for greater accountability across the health system. For my own part, I am clear that accountability and good governance are central to the organisation and functioning of the health system. I have called it out in recent days where I did not see that come to the fore. As part of my Department's response to Sláintecare, it is proposed to examine how best to strengthen accountability in our health care system. Other jurisdictions have managed to do this, therefore, why can Ireland not? Steps will be identified to consider how accountability for all staff across the health service can be strengthened.

My Department also expects to publish a new code of conduct for health and social care providers this month. This will be an important driver in the delivery of the patient safety agenda, both in terms of policy and service delivery. The code will apply to all service providers and individuals who come into contact with a user of health or social services.

I want to assure this House and, more importantly, the women of Ireland that I am taking every possible action to ensure that an incident such as this does not happen again. I acknowledge the very difficult circumstances that Vicky Phelan and her family are now in, and I would like to thank her for her bravery in bringing this to light. I still think it is bizarre that doctors had information in relation to patients that they did not share with their patients. That paternalistic attitude is something that should concern us all.

In all of this debate, however, it is important we do not lose sight of the fact that many cancer screening programmes have resulted in the lives of many women being saved. We must do all we can to ensure women continue to attend for smear testing. We acknowledge things went wrong but we are determined to put things right. I hope the actions I have outlined will help in that regard. Tomorrow the Joint Committee on Health with meet relevant officials from the HSE, CervicalCheck, the National Cancer Control Programme and my Department. I expect all those agencies to be upfront and forthwith and I do not expect a commencement of any investigation to stop that exchange of legitimate democratic debate here in our Parliament.

This evening I will continue to do what I have done since this incident came into the public domain and since I have known all about it, which is to be as transparent and open as I can, and I hope to work constructively with colleagues across this House to put this right.

I call Deputy Stephen Donnelly who has ten minutes.

The withholding of important information from patients is completely unacceptable. What we have seen so far in the case of CervicalCheck is nothing short of an outrage. It constitutes a fundamental breach of trust between patients, their doctors and the HSE and it has led to widespread fear and anger across Ireland in the past few days, and I will speak to that shortly.

Before I do so, I want to commend the bravery and determination of Vicky Phelan and of her family. If Ms Phelan had not made the stand she did, what has happened in CervicalCheck would remain a secret. Ms Phelan’s lawyer has said that "enormous efforts and energies were put into forcing her to remain silent". If Ms. Phelan had not faced down those efforts, what has happened in CervicalCheck would remain a secret. Ms Phelan’s courage has laid bare a conspiracy of silence. Her courage has ensured legislation on mandatory disclosure will be introduced. It has ensured that many other women, also kept in the dark, will now be told the truth. It has prompted Government to fast-track patient safety legislation. It has led to an investigation being launched to see what was going on in CervicalCheck and to see if similar withholding of patient information is happening in other screening programmes. For all of these reasons, and more, Ms Phelan’s courage will lead to important changes in health care in Ireland, which I believe everyone in this House will support.

The focus this week must be on the 162 women who, like Vicky Phelan, were not told of screening errors. It is imperative that all these women are engaged with quickly, and are provided with the support they need. In the 17 cases where women are now deceased, their families must be met similarly.

The establishment of an investigation is also essential, and the Government’s announcement on this is welcome. As answers are required quickly, the Health Information and Quality Authority, HIQA, seems to be a reasonable choice to lead the investigation, at least in the first instance. However, HIQA’s focus is clinical quality, and this investigation must be broader than that. At the core of this issue is the withholding of patient information, and Fianna Fáil will support this investigation only if the Government can provide an assurance that this will be covered. Specifically, HIQA must be able to investigate the question of who decided what, and who knew what in CervicalCheck and in the broader HSE. The investigation must not be used by the Government to avoid answering questions in the short term. There is very considerable public worry, and it is essential that information continues to be made available, including while the investigation is carried out.

There are many other questions that need to be investigated. Why did it take two years for the HSE to inform Ms Phelan’s consultant, Dr. Hickey, of the false negative? The HSE has a policy of open disclosure. Why then was the HSE telling doctors to use their judgment as to whether they should openly disclose, and in the cases of the deceased, why was the HSE saying that the doctors should simply make a note on their files? Why did Ms Phelan’s consultant not share the information about the screening error with her until the year after he found out about it? When senior managers within the HSE were informed of the disagreement between Ms Phelan’s consultant and CervicalCheck, why did senior management within the HSE not act to ensure all patients were told? Why did the HSE adopt such an aggressive legal position in the proceedings brought by Ms Phelan? Why was the HSE agreeable to a confidentiality clause? Does this not run entirely contrary to a culture of open disclosure? How are we meant to learn how to make things better in health care if agreements like this are met hand-in-hand with gagging orders?

There are important questions to be answered too regarding the Department and the Government. When did the Department become aware of Ms Phelan’s case? Was the Department aware that it took three years for Vicky Phelan to find out about the screening errors and that these had been kept from her? Was the Department aware, or did it suspect, that this practice was more widespread than the individual case? Why did it take so long for the Department to prepare a note on the case for the Minister?

There are also questions for the Minister to answer, following on from the note he gave today, and I acknowledge he has made that note available. Did the Minister make any follow-up inquiries of his officials based on the content of the note? That is one of the key questions we want to understand. The note states that the case was being taken for two reasons, the first is the error in the 2011 screening, which is the responsibility of the US laboratory. The second reason was the non-disclosure of the error, which is the responsibility of the HSE. Did the Minister ask why this non-disclosure happened? Did he ask how many other screening errors there might be? Did he ask how many other non-disclosures there might be? The note also states, "The State Claims Agency is of the view that publicity around the case and/or settlement is likely." Should this not have prompted further questions and earlier action? The Minister did act when he found out about the scale of the issue last Thursday, but if these questions had been asked of officials when the Minister was given the note, they would have alerted him to the wider issue, which would in turn have led to quicker action from the Minister and the Government and avoided several very difficult days of concern in this country and avoided a lot of fear and a lot of confusion.

A further question is whether the Minister could or, to be fair to him, should, have intervened to stop the court case. I would like to quote Ms Phelan’s lawyer who said the following:

The entire court process could have been avoided. We have heard Minister Harris confirm that he was made aware through an information note on this case on the 16th of April. That's three days before the trial began.

While he said ... that the one time a minister cannot intervene is during a court case. If that is so, there wasn't a court case at that time. There was nothing preventing him from asking further questions or directing those through the State Claims Agency or through the Department of Health to prevent steps being taken to force Vicky Phelan into court.

That is a question that Vicky Phelan's solicitor has asked.

Vicky Phelan describes what has happened to her as "an appalling breach of trust".

Many people across Ireland feel the same way. I have been approached by constituents. I imagine all Members have. People are scared. People are furious that this has happened. That an error in diagnosis or in screening would have been spotted, that the State would have waited two full years to let anybody know of that error and that one's own doctor would then have engaged in correspondence with the State as to who should tell the patient is simply outrageous. The danger is that this appalling breach of trust leads to a lack of confidence in screening, and that cannot happen.

The screening programme introduced in 2008 has saved many lives. I talked to a consultant last night who told me that he reckons 400 to 500 women's lives are saved every year thanks to the cervical screening programme, but if we are to maintain confidence and if we are to rebuild trust, then many serious changes are need. Mandatory disclosure must be brought in quickly. It should be in by now but it is not. We must move to a culture of transparency. The default option of the State seeking gagging orders where it settles with patients must be reviewed otherwise how else will we learn from the mistakes that are made. Critically, a way must be found for the public to seek justice that does not incur such high legal fees that one could lose one's house. We all know how this works. Somebody goes to a solicitor and gets a legal team. He or she potentially incurs very serious upfront costs. We know how the State responds. The State walks in with an army of lawyers. The State walks in with senior counsel and junior counsel, solicitors and experts and it is the individual citizen against the State. That fear and threat of legal costs is used as a weapon against people in this State and it is an effective weapon. Ms Phelan could have been excused for not risking all of that in dealing with everything that she did. She decided to fight. She decided to put everything on the line. It is incumbent on us all to make sure that we take some serious steps on what will be a long and tough journey to ensuring that confidence and trust is rebuilt and that we begin to have an era of transparency and genuine openness in this country when it comes to people's health.

At the outset, I commend the bravery of Ms Vicky Phelan. Without her determination and fight, this scandal probably would never have come to light and those affected and their families may never have known the truth.

Truth, compassion, and honesty should be evident at all levels of our health service, and even more so at the higher institutional levels of our screening programmes, our hospitals, and the HSE. Nobody is saying for a moment that a health service can be run without human error but when a mistake is made, there should be an apology and the relevant parties must be informed. The reality could not have been more different for Ms Phelan and those women affected by misdiagnosis or, indeed, for the potential considerable number of cases only notified to us this evening.

The scale of the problem is still not known. That is outrageous. There are women who are watching this who are very concerned. There are women who are watching us this evening who are not aware of their own medical records. That is outrageous.

When we look at what has happened, we see the response of the State was to fight a terminally ill woman and her family, to force her to give evidence in a courtroom, to talk about her personal life, her health and her sex life in a room full of strangers. It was then to try to force that same woman into a confidentiality agreement so that she could not speak about what had happened. That was the response of the State. The response was for CervicalCheck to tell doctors treating women to exercise their judgment on whether to tell them about the misdiagnosis and to "simply ensure the result is recorded" if any of the women affected by this had died in the meantime. It should not be at the whim of a doctor to exercise judgment in whether to inform a woman where her health is at risk, and even more so in the incidence of a misdiagnosis. We have the right to know.

Where we should have truth, compassion and honesty, we had malice, vindictiveness and dishonesty. How did the scope for this dishonesty materialise? Why is it not mandatory for the health service to disclose errors and to always tell the truth?

We saw it in this House on 8 November 2017. On a vote on Report Stage of the Civil Liability (Amendment) Bill 2017, the Government, in concert with Fianna Fáil, which abstained, voted through amendment No. 31 which ensured that the process for open disclosure would be voluntary and not mandatory. I welcome yet another U-turn on this issue and I hope that we will now see mandatory reporting - voluntary reporting is simply not good enough. We in Sinn Féin opposed making it voluntary. We voted to make it mandatory but we lost.

A year earlier in a Joint Committee on Health debate on open disclosure, I argued forcefully for mandatory open disclosure. Indeed, I argued for it again on Leaders' Questions with the Taoiseach, Deputy Varadkar, on 21 February last in light of the case of Ms Alison McCormack, who had a breast cancer misdiagnosis. The practice of keeping quiet when things go wrong is often prevalent in our medical culture and only a statutory duty of candour will address the situation. I welcome that the need for mandatory open disclosure with legislative underpinning is now accepted right across this House but it should not take a scandal to achieve this.

The gendered nature of this scandal is not lost on me, my friends, my daughter, my mother or any of the women who are affected by this. In fact, many women who contacted me have said they are not surprised at the failures of the health service and the State as regards how it treats women. The Minister described it as "bizarre". No woman who has spoken to me about it has described it as bizarre. Unfortunately, it seems to be par for the course. We are not surprised at the gendered nature of this.

Three times in the past six months I have taken Leaders' Questions and raised significant issues which solely affect women. In November last, I raised the issue of the drug Epilim and the side effects for children born to women who took the drug while pregnant. In January, I raised the transvaginal mesh scandal, and in February, I raised the case of misdiagnosis of breast cancer. Men often talk about historic injustices perpetrated against women in this State but when we women talk about it, we talk in terms of the present day. This scandal reinforces for women why we should be afraid of the gendered nature of our health service and how the State treats us.

The outsourcing of women's healthcare through testing of smears in the United States was warned against in 2008. Concerns were raised at that time by Dr. David Gibbons, the chair of the cytology-histology group within the quality assurance committee of the National Cervical Screening Programme. I want to know whether complaints were made at that time to HIQA and how HIQA responded to those complaints because when we know that we will be able to judge whether HIQA is, indeed, the correct authority to undertake this investigation. The then CEO of the National Cancer Screening Service, the outgoing head of the HSE, Mr. Tony O'Brien, insisted that it would be possible for doctors to talk to the person who analysed the smear test in the United States through teleconferencing. There is no evidence that this happened and the Minister might be able confirm that for us.

The then Sinn Féin health spokesperson, Deputy Ó Caoláin, criticised the 2008 decision of the Fianna Fáil-led Government to outsource the screening service during a Dáil debate, stating: "The Minister for Health and Children would rather listen to corporate executives in the private health business". The Deputy went on to state that the "HSE has awarded the contract for cervical cancer tests to Quest Diagnostics, a US company that has an unacceptably high rate of errors and has been convicted of fraud." Deputy Ó Caoláin has been proved right and the issue of outsourcing must be incorporated into any investigation.

The Minister must explain to this House if any concerns were raised with the Department of Health over the past ten years regarding the outsourcing of these tests and if any internal concerns were raised about the efficacy of the tests. Were any audits carried out on the companies concerned and does Clinical Pathology Laboratories still hold a contract with the State for smear tests or any other screening or diagnostic work?

The Minister says he became aware of Ms Phelan’s case on 17 April. Was he aware of the audits from 2014 and subsequent analysis of the misdiagnosis which was continuing since 2017? Tony O’Brien has said he only found out about the issue when he heard of Vicky Phelan’s case from the media. I find it hard to believe the Minister only found out on 17 April but it is even harder to believe that Mr. O’Brien found out from the media. I do not see it as plausible. The State was being sued for a substantial sum of money. Surely the nature of the case and the cost involved would have sent alarm bells through the HSE, the Department of Health and up to the level of Government.

The Minister articulated his lack of confidence in the leadership of CervicalCheck last week. It will be interesting to ascertain his confidence in Mr. O’Brien and in his role in this scandal. Maybe it is the case that their fortunes are inextricably intertwined and it might account for his reluctance to relieve him of his duties. The general public would also welcome a statement from Eunice O'Raw, general counsel for the HSE, on the decision of the HSE to fight the case of Vicky Phelan and on what information was provided to Ms O’Raw regarding the case by the HSE and what information she provided to the HSE and the Minister.

The toxic culture of concealment and harassment pursued by the HSE and the Government against women who have been wronged by this State is now in full public view. It is a disgrace that the State, the Government and the HSE consistently behave the way they do when such cases arise. It is unacceptable that agents of the State pursue victims of their failures and do so in such an aggressive manner. They behave this way because they take their cue from Government. The Minister must ensure that other affected women are not forced to fight the State through the courts as Vicky Phelan and others have been made to do.

I will finish by saying that in the course of my work before I was elected, I had occasion to represent people who were engaged in a dispute with the HSE. I have seen how vicious and aggressive it is when it pursues people. I have seen people's lives destroyed by the HSE, some by virtue of the fact they were whistleblowers and others by virtue of the fact that they found themselves on the wrong side of a reported incident and of which they were subsequently found innocent. I have seen what the HSE and the machinery of the State is like when it goes up against an individual. For that reason, I commend Vicky Phelan on what she has done. She should not have had to do it.

Nobody believes the health service can be run without error or risk but they demand that it will show compassion and be truthful and honest. That is not what has happened to date. The people deserve better than this. Vicky Phelan deserves better than this. The victims of misdiagnosis deserve better than this. Not only do the women of the State deserve better, but we demand better than this. I hope for the Minister's sake that he has the answers the women of Ireland seek this evening.

Here we go again - Magdalen laundries, hepatitis C, Brigid McCole, Susie Long, Rebecca O'Malley, a neighbour of mine, Amanda Mellet, who I brought to meet the Minister, and now Vicky Phelan. We have a real problem in this country protecting women's health. This issue is on the Minister's watch. He needs to do the right thing. I join with thanking Vicky for her openness and for the way she has put herself in the public spotlight. I am sure she is watching me speak now and is listening to all of us. She has put herself in a very difficult situation out in the open and she is doing it for the betterment of women across Ireland. We need to stand with her and deal with this issue on her behalf because of the bravery she has shown.

The most important thing we need to deal with is the 208 affected women. They need our protection and support, our endeavours and a health system that will support them. Of the 208, 46 have been told, two of whom have passed away, and 162 are in the process of being told, 15 of whom have unfortunately passed away. We need to deal with the bombshell the Minister has just landed tonight, which I was not prepared for. We need to know the number of cases that have not been audited. The Minister has not told us in his speech. It is a bombshell. What number of women have not had their cases audited? Are they recent? Here is the real issue. If they are not recent, what was the basis for not selecting them in the first place from the national cancer register? We will be having questions later, but these are fairly obvious questions and worrying times. This is a very live issue for the people and the women of Ireland. I hope the Minister will be able to answer that in detail because it is concerning. If the Minister has that detail, he has not given it to the House. The shake of his head indicates he does not have it. We cannot get near the detail of this without that information.

We all have a duty to ensure there is public confidence in the screening process for cervical cancer and in the other screening processes. It is a duty we should all honour. The screening process along with the HPV vaccine, which our party has pushed, are essential to prevent women getting cancers throughout their lives. We all have a duty to ensure that confidence is maintained in these.

I met with officials from the Minister's Department for an hour and 20 minutes recently. What did his Department know about the issue? What did it know about similar cases? I accept what the Minister is saying, that he did not find out until 16 April. Was no human being in the Department of Health aware of this case or any similar case or issue preceding that? It is an answer the Minister will have to give. The words that jump out of the memo are: "The SCA is of the view that publicity around the case ... is likely." I do not think this memo would have ever seen the light of day only for the potential publicity that would surround it which we all know now is causing serious issues and worry for women across Ireland. It says a lot to me about the Department of Health. It says a lot to me about the political culture. It says a lot to me about the way in which we administer health in the country that this note was justified on the basis of the potential publicity.

The NCCP has an awful lot of questions to answer. In the briefing note, it says that they do not consider this to be a patient safety incident, which it is not credible. It is not acceptable and it is deeply worrying. That it would put in the memo to Government is far more worrying than the clinical director resigning. I took the trouble this evening to look up the governance of CervicalCheck. We all know about the resignation of the clinical director. She reported to the head of screening, an assistant national director. What is his role in this? Where is the accountability? The people are sick to their back teeth of the lack of accountability. He reports to the national director of the national cancer control programme. What was his role in this and did he have knowledge of it?

Who reports to the recently appointed chief clinical officer who reports to the director general who we now know found out from RTÉ? Does it not say a lot that the Minister knew about this issue before the director general of the HSE did? There has to be accountability for all of the layers. I know that this lady resigned after the Minister had expressed no confidence, but does he have confidence in the structure, in the people in it, or was it just because of weak media performances somebody had to be chosen to go under a bus?

The investigation cannot be led by HIQA. With respect, I completely disagree with Deputy Stephen S. Donnelly. If the Minister goes down this route, he will end up with a commission of investigation. This is a national scandal and, for many reasons, HIQA is not the organisation to carry out the investigation. It has powers to investigate, take documents, go into organisations and seize computers, etc. but under the legislation, it only has limited powers to do so in certain circumstances. It has no powers whatsoever to compel the attendance of witnesses, direct a witness to answer questions or take sworn evidence. Witnesses are given no immunity in giving their evidence. Given what we now know about medical candour and the profession, does the Minister honestly think that unless the witnesses have to do so, they will give all of the information needed? HIQA will not have the capacity to cross-examine personnel, which will mean that in many cases the evidence given will not be able to used in the making of findings. I guarantee, for all of these reasons, that if the Minister, with Fianna Fáil, pushes this through, we will be back in this House looking for a commission of inquiry because the public will demand it. I ask the Minister to, please, listen to me, measure this appropriately and do the right thing because we will soon be back debating this issue. HIQA does not have the powers to deliver. I do not believe it even has the capacity or the resources to do so, even it is the right authority. The Minister needs to change his mind in that regard.

We need to act quickly. General practitioners, GPs, have not been given guidance on what to tell people. We need to ensure the women of Ireland know where to go with their concerns and that when they go to GPs or other medical professionals, there will be a structure in place such that their concerns will be addressed. We also need a guarantee that resources will be available to deal with far more inquiries which will be needed and that all those being screened will have their problems addressed, too. The Minister needs to give a guarantee to the House that all of this is in place and that everyone will have the information they require.

On behalf of People before Profit, I salute Vicky Phelan, a national hero, and wish her the very best of solidarity in the struggle she faces so bravely. We know some details of what happened, but we do not know enough. The Minister is conducting an investigation, etc. but the Academy of Clinical Science and Laboratory Medicine has asked him to publish the results of the 2014 audit. When will that happen? It is very important to know.

We know that what happened in 2014 was the result of a policy decision and its consequences were debated and well known in 2008. I am sure all Members have read the Official Report of the debate at the time. There were very articulate cases made to the then Minister, Mary Harney, and the Fianna Fáil-Green Party Government against putting the service out to tender. It did not have to be tendered for. She said it had been put out to tender "for reasons of transparency, fairness and equity to make sure it got the best quality assured service" and that "80% of points were allotted for quality and turnaround time and 20% for price". We had a political choice in 2008 to invest in several laboratories based in Irish hospitals, using Irish experts and training new scientists in the Irish public service. As in many other cases, however, where we justify privatisation and outsourcing, we use the excuse that the system is in crisis, that there is a backlog, that it takes months to get a result and that we have to go to the wonderful private market. We treated cervical cancer screening, a vital service on which tens of thousands of women rely and for which they understand the need, like every other service or good and organised a tendering competition for it, inviting firms from around the world to bid for it and awarded it to the lowest bidder. That is the logic of the market in privatisation. That was the action of the Fianna Fáil-Green Party Government, with Mary Harney, in 2008. The justification was that market competition and private companies were better than publicly funded and run health services.

In 2008 very definite and reasoned arguments were made in this Chamber against foreign multinational control of this vital service. Many of the arguments were made by the then Fine Gael health spokesperson, Senator James Reilly, and Deputy Jan O'Sullivan of the Labour Party. Their arguments were sound and clear. The firm that won the initial contract, Quest Diagnostics, had been found guilty of repeated episodes of fraud in overbilling; several studies found that the detection rate for higher grade pre-cancers was low, while we know from several sources in Ireland that there were severe and real problems in allowing a US firm such as this to provide screening for cancer. Dr. Gibbons warned that cases would be missed if we outsourced to the United States. The union which represents workers and scientists in laboratories warned that the outsourcing of smear test screening would mean that we would lose the ability and expertise to conduct such screening in this country. Many experts, doctors, scientists and consultants in the field were shouting at Fianna Fáil, the Green Party and Mary Harney that this was bad, that it would cause problems, that women would suffer and that cancer cases would be missed. They were ignored and the political decision was made to pursue tendering and outsourcing. A couple of years later the very people who had railed and shouted against it got into power. When Fine Gael and the Labour Party were in power, Senator James Reilly did nothing as Minister for Health and the subsequent Minsters for Health, Deputy Leo Varadkar, now the Taoiseach, and Deputy Simon Harris, did nothing about the issue about which they were so worried.

The policy of outsourcing has continued and today we are hearing defences from the Taoiseach, the Minister and the HSE on the basis that the problem was not outsourcing but something else and that these things happen. One thing is clear: the privatisation of the health system is ideologically driven by the main parties in the Dáil and in every area where it has been implemented people have suffered, continue to suffer and, worse in this case, women have died and will die as a result. We have no faith or belief the Government can address this crisis. It might succeed in pinning the blame on something else, but the scandal is political and involves the political choices made by various Ministers and those in power. If the Minister was a bus driver and crashed and killed 17 people, or even one person, he would be sanctioned by his employer and before the courts. Heads have to roll in this Dáil for what has happened. It is not good enough to pass the buck. "Something is rotten in the state of Denmark" and, ultimately, somebody will have to take responsibility and take the consequences.

We have a very patronising attitude to women in this society, as evidenced by the outrageous treatment of the women involved in this case, a paternalistic attitude among doctors to women, and a refusal to allow full disclosure to patients. I want to speak about an issue which some of the parties in this Dáil do not seem to be interested in, namely, privatisation, which has led to this situation. The outsourcing of cervical smear tests in 2008 was part of the privatisation of health services. A critically important part of health services for women was starved of funding and resources. A HSE recruitment ban meant test backlogs inevitably built up and outsourcing became the solution. This is the way in which privatisation is usually forced through.

Individuals must account for themselves but the majority of parties in this Dáil also must account for themselves. In 2008, the then Minister for Health and Children, Mary Harney, was warned by senior people that private testing would be less rigorous and unsuitable for a three to five year frequency, that detection rates on tests carried out by Quest Diagnostics would be lower, at 85% versus 95% in the Irish laboratories, and that Quest Diagnostics had been fined $40 million for fraud and false claims. In response, Mary Harney and the then Fianna Fáil Government opted for value for money and we got the worst of both worlds, with less frequent and low-quality testing leading us to where we are today. Dr. David Gibbons should be heroically saluted for warning about this ten years ago. How prophetic was what he said. It is likewise with Sam Coulter-Smith. The Rotunda Hospital had a world-class testing service and the majority of parties in this Dáil opted for testing on the cheap.

Profiting from health had been good value for Quest Diagnostics. Only two weeks ago, it reported revenue of almost €8 billion and profits of more than €1 billion in 2017. It is a company that carries out 80 to 100 smear tests per staff member per day when a maximum of 50 per day is the National Health Service recommended rate. In Ireland, 30 to 35 tests was the norm but nothing happened. The unusually low percentage of negative results was highlighted but nothing happened. The former Minister for Health and Children, James Reilly, and the then parties in power also did nothing. The test results never reached the 1.8 average which is international best practice, the reason being that the system chosen was not as good as that which pertained in the US never mind in Ireland. This outsourced service was retendered in 2010, 2012 and 2016 but no action was taken by those who were Ministers for Health and Children during that time, including Mary Coughlan and James Reilly. Despite the warning issued by James Reilly to Mary Harney in 2008, he chose not to act. The former Minister for Health and now Taoiseach, Deputy Varadkar, and current Minister for Health, Deputy Harris, also have questions to answer in regard to why they did nothing about the low rate of results. There were many debates in this House on the national screening programme down through the years but the nothing was done because the Government does not support public health services. It continues to underfund them and to look for the next privatisation opportunity. Thanks to this State, MedLab, the company which Vicky Phelan had to sue, has the contract for the privatised bowel screening programme. Does the Minister propose to do anything about this?

The brutal treatment of Brigid McCole by Deputy Michael Noonan was eventually exposed. Despite all of the solemn undertakings, we now learn about the appalling treatment of the women in this case. What will be the next catastrophic failure of privatisation in this country? Will it be the privatised bowel screening programme? Will the Minister stop cutting corners on women's health and return to a nationalised public testing laboratory system that is adequately staffed and carries out deep screenings? The Minister said in his speech that a further tendering process will take place for testing carried out outside of the public system. Following on from the platitudes we have heard today, this Dáil must ensure that the testing system is returned to public ownership and adequately funded and staffed. It is unbelievable that we do not have two pairs of eyes on every test result, as is standard in other countries.

The next speaker is Deputy Clare Daly, who is sharing time with Deputy Connolly.

Mistakes happen no matter what systems are in place. Tragedies happen and they will continue to happen, but the issue facing us as a society is how we respond to those mistakes and tragedies, how we treat the victims of those mistakes and tragedies and whether we learn the lessons. I find the shock and horror expressed in some quarters a little hard to take. The saddest thing about this latest scandal is that it is just the latest one. It is not new to see the State Claims Agency taking people to war. It has been doing this for a long time. It is not new that the HSE drip-feeds information. Even tonight, the Minister has been put in the unenviable position of coming in here with new information. The Minister is continually being drip-fed and having to clarify information. We need to get to the heart of what is going on. This is the only way that we will serve Vicky Phelan and all of the other victims of our appalling health service.

The Minister correctly said that this issue puts the spotlight on our open disclosure policy, which has been in place since 2013. It has been a policy of the HSE since 2008 that all instances should be disclosed, which is coincidental timing in terms of this issue, but it is long known that this is not the case and that what we have had is not enough. This was known in 2015 when we questioned the then Minister for Health, Deputy Varadkar, on why there had not been a mandatory duty of candour inserted into medical contracts and why, given the weekly medical negligence claims and legal fees, a failure to disclose was not a criminal offence and so on.

It was obvious in the discussions last year around the Civil Liability (Amendment) Bill that there was a problem with open disclosure. Lest anyone is confused, this is only about indemnifying doctors and nurses. This is not an open disclosure policy, it is legal cover. We made the arguments at the Committee on Health and Fianna Fáil was swayed by those arguments and came on board. What happened next? I got more attention from the HSE than I have got in my life. Over the summer, there were emergency calls and meetings arranged with the chief medical officer, all to tell us that we were wrong about our amendments. We had a meeting with the Department of Health and the HSE in which we asked for the evidence to support their argument and we were told that making open disclosure mandatory would make it less rather than more likely that open disclosure would happen. This was the line put forward by the Department of Health and the chief medical officer, the same line that was given to the then Minister for Health, Deputy Varadkar, when he came before the health committee in 2015 and argued for mandatory disclosure. In my opinion, he genuinely put forward that view. He made the point as a doctor that failing to live up to a duty of candour was the equivalent of a motoring hit-and-run. He was fully signed up to mandatory open disclosure.

The health committee, having heard from several stakeholders which said that mandatory open disclosure was necessary, did not recommend it. What happened? The arguments were made, the science and international evidence was produced and previous Ministers, Fianna Fáil colleagues and others supported mandatory open disclosure, yet behind the scenes the HSE went to work and put out the argument that it was not the best way forward. The HSE can dress it up whatever they like, but at the heart of that dressing up is a fear of litigation. The HSE tells Ministers that this and that cannot be done because it will cost the State money. It is symptomatic of problems in that organisation. It gives me no pleasure to say, "We told you so". We stand over the arguments we made last year. Sadly, if they had been incorporated in the legislation, we would be further down the road and not moving after the horse has bolted.

I am open to a HIQA inquiry in the sense that HIQA is good, but I echo the point that it is limited in its scope to an extent. I think we have to go further. In 1987, the New Zealand Government ordered a full-scale independent judicial inquiry into the deaths of 26 women who died in the 1970s and 1980s from cervical cancer, again a national scandal. This inquiry was an independent inquiry along the lines of the Commission on Nursing in this State, which is what we need if we are to get to the root of this and get to the heart of way in which women's health and reproductive issues are dealt with, or rather are not dealt with, in the State.

Not too long ago I praised the Minister for Health, Deputy Harris, for his speech on the eighth amendment. I warned the Minister that night that I would not be praising him permanently and I certainly do not praise him tonight. The Minister's speech tonight is more of a spin than an elucidation of what has happened. Reference was made to Brigid McCole who died in October 1996, just over 21 years ago. There has been time to reason and learn from that. At that time the Office of the Chief State Solicitor, acting for then Minister for Health, Deputy Michael Noonan, warned Positive Action that unless it went quietly to the compensation tribunal it would face "uncertainties, delays, stresses, confrontation and costs," and so on. The State pursued Brigid McCole almost right up to the day of her death. It said she had tried to sue under a pseudonym in order to keep her privacy. The State also fought that. I do not have to time to go into the details but we could see the full power of the State coming down on the body of a woman, Brigid McCole, and her family. Here we are 22 years later with the same type of spin.

The Brigid McCole case was absolute bullying but what is coming across now is more of a patronising attitude that "we know best". As a woman, I do not want reassurance. I do not believe that the women of Ireland want reassurance. They would like full information so they can make up their minds on what screening they will access. With regard to this specific issue, the women who are affected need full information. The Minister told the House tonight that information is "emerging" as we speak.

The Minister has given Members a copy of a note in regard to the briefing memo. The Minister's speech has a mistake in it. On page 2 of the speech, the Minister refers to the note which said that the claim against the HSE was likely to fail or be "dropped in the absence of any bad faith". That is not accurate. The note had referred to exemplary damages and the advice from the State Claims Agency that the exemplary damages might not succeed because of lack of faith, not that the case would be dropped. The note also mentions that there was no chance of the case settling because - I believe very bravely - the woman in question would not accept a confidentiality clause. The lab had said that it absolutely had to have a confidentiality clause. Deputy Alan Kelly has already referred to the extraordinary aspect that the National Screening Service and Mr. Jerome Coffey, the head of the National Cancer Control Programme had advised the Department in writing that this was not a "patient safety incident". Perhaps the Minister will explain how anybody could possibly say this was not a patient safety incident.

There is so little time. I do not believe a HIQA investigation is the answer. There are so many questions and to say that HIQA is the answer is certainly, at the very least, premature. We need to establish the full facts and reports on how many women have not been contacted. It is not good enough for the Minister to come to the House tonight to tell us that facts are "emerging".

I received an email from a person who pointed out that a smear test in 2012 had a result that was interpreted wrongly, or a wrong result given. This happened on two different occasions and radical surgery ensued in August 2015. I understand that this person wrote to the head of the screening programme, but no reply was received.

How many letters have been sent by women throughout the State that have not been replied to? What other legal proceedings have been instituted, settled or are still pending? How many cases have been settled with confidentiality clauses because the women had to cave in given their circumstances? At the very least, all this information should be before the House tonight.

It is extremely worrying to me as a woman when I have heard language being used on the radio over the last week or two, which seeks to reassure us. Reassurance cannot, and should not, be given. That is not our role at this point nor is it the Government's. It is the Government's role to give full information and to set up a proper, independent inquiry that, with full information, will give some trust back to the women who have been affected and to the women of Ireland. I do not want any platitudes nor do the women who are writing to me.

It is extremely important that women, not the process of investigation, remain the focus in this regard. While the process is important women should remain the focus. Population health screening is an important part of our health service, and none more so than cervical screening. Confidence must be restored in the cervical cancer screening programme because this programme has identified 1,482 cases of cancer over the past ten years. The majority of those cases have been identified by the cervical screening programme. Many thousands of pre-cancerous changes have also been identified, preventing people from developing cancer and preventing the progression of cancer in some people. The importance of the scheme is without doubt. Hundreds of thousands of consultations take place in general practice each year where sexual health is the subject of the consultation when people attend for screening. This is also very important. There are many aspects of the screening programme that must be maintained and confidence in the programme must be restored.

The cervical cancer screening programme works for the vast majority of women in Ireland who engage on a regular three-yearly cervical screening smear. The regularity is essential - one smear is a case in point. If a woman has a regular smear it adds to the value of those smears.

Like all screening programmes, cervical screening has its limitations and false negatives will arise no matter what the screening programme is. These must be kept to a minimum by having a double reading, by having high-quality screening laboratories and by upskilling those who perform the screening. This will keep mistakes to a minimum.

This scandal is what transpires when mistakes are identified but the information is not transmitted. This is the core issue. The failure of open disclosure of false negatives to patients is unforgivable, and there may be additional false negatives now because we are hearing that not all cases have been audited. It is true that disclosure would not have affected the treatment of these patients' cancer but that is not the point. Disclosure would have helped the women to deal with their illness. It would have provided them with knowledge and it would have given them the opportunity to take legal action if they felt they had been damaged or injured by the process and if they wished to do so.

The issue now is that the process has trumped the patient. This is so often the case in many health scandals; the process becomes much more important than the patient. Governance and poor judgment are the key to this. Such paternalistic attitudes towards transmitting information have to be eradicated from our health service. In one sense Vicky Phelan was lucky in that she had the capacity, the will and the knowledge to pursue her case. Many of the patients whose false negative results were not transmitted to them have not had that opportunity. This scandal has arisen by not disclosing these issues for fear that the cervical screening programme had something to hide and by not being upfront and honest. Being upfront and honest, admitting that a mistake had been made and transmitting the knowledge would have empowered the programme and the patient. Admitting a mistake is very empowering for the person who admits it but it is also empowering to the patient who receives the information. By not disclosing these issues we now have the current scandal and the lack of confidence in the cervical screening programme. Quite often it is the cover-up of the issue that attracts the attention rather than the original mistake. We have to recognise that it is most likely that the cervical screening programme did not wish to reveal the false negatives for fear of litigation, but now we are in midst of this scandal. Open disclosure is the only way to go and mandatory open disclosure is extremely important.

We have to engage in a root-and-branch review of the cervical cancer screening programme. We have to review outsourcing, the frequency and quality of testing, the governance of the cervical screening programme, the responsibility, and the transparency in it. We have to review open disclosure and have mandatory disclosure. We have to review compensation and try to restore credibility in the service.

Here we are again, debating once more the chronic and apparently unresolvable dysfunction within both the HSE and sections of the health service. We know that at least 17 women have died. We also know that this is far from the end of the matter and that in all likelihood, as time goes on, more women and families will emerge. Children will be and have been robbed of their mothers' precious love. Young girls and boys will now grow up with no mother to share their concerns and their hopes and dreams. It is an appalling dereliction of care and a catastrophic failure that is making the people of this country sick to the core. The infuriating thing about this is that we never seem to learn our lessons sufficiently well from the previous debacle and mistakes. We all lament the deaths of these women. We all praise and support the courage of Vicky Phelan and her husband and children, who are now enduring a living hell. I salute Mr. Cian O'Carroll, a solicitor from Cashel, too.

All of this was brought to light out of the murky shadows of legal wrangling by a mother who was determined to find answers and to have accountability, on her own. If Vicky had not done this, would we still be living in blissful ignorance of the shocking failures of oversight and governance that have brought us to this situation? I say that we would. The Taoiseach had the gall to say today that we should not call for the head of Mr. Tony O’Brien, head of the HSE, because, the Taoiseach said, "everyone deserves a fair hearing". My goodness. How many fair hearings must Mr. O'Brien get before he is sacked? What fair hearings have the unfortunate ladies who have died, and their families, got? That is arrogance of the highest order. What about fair hearings and fair procedures for the women and families caught up in this sickening spectacle?

Last week I criticised Uisce Éireann on another matter by saying that it had displayed institutional arrogance. The very same could be said of the HSE. This is institutional arrogance and indeed political arrogance on the most horrifying scale. What hope can any of us place in such a body as the HSE, the most senior management of which seem indifferent to the realities of human life and whose first response is to ring for the barristers at the first hint of trouble. It is continuous and the barristers are creaming it all the way. The person or persons involved are then bombarded with legal challenges and intimidated further, adding to already existing stress. Where is the shame then? Where is the mock rage or sense of outrage then, when we do this daily? I salute the extraordinary courage of Vicky Phelan and all those women and families who have been dragged unwillingly into a scandal of enormous dimensions. Agencies of the State have robbed them of peace and subjected them to an horrific ordeal.

At the very least it is a scandal which demands the resignation of Mr. O'Brien and the Minister, Deputy Harris. The Minister is the head. As I said earlier today, the governance structure of the HSE is absolutely clear. The buck stops with the Minister, Deputy Harris, as the person who has overall responsibility for the leadership of those who direct and control its functions and who manage its business. In light of that, it is completely unsatisfactory for the calls for resignations to be reserved to Mr. O'Brien, the CEO, whom the Minister defended here recently, saying he was right to call parents emotional terrorists. I called the Minister a puppet of the HSE that day, and he is still a puppet. This is disgraceful and the Minister must go. Any objective observer who analyses the Minister's stewardship of the health service can only conclude that he has been an unmitigated disaster. There are record levels of patients on trolleys, chronic lack of bed capacity, a recruitment and retention policy of front-line staff that has had abysmal outcomes and last but not least a systemically dysfunctional HSE that has caused dozens of lives to be lost. What on earth will it take for the Minister to be sacked or to resign? Has he no shame? Look at Theresa May's Government. She has lost four Ministers in a short time and nobody died. This is manslaughter at least. The gardaí in any other country would be out arresting people and charging them with manslaughter or worse. This is shameful. It is wilful destruction of people's lives and families, perpetrated by the HSE ad nauseam. The Minister came to Cashel with me and looked at a pristine new building that was empty. This is outrageous. The Minister has to open it and put beds in it. There is still not a bed in it. The Minister has no say whatsoever in the HSE so he should stand aside and let in someone who can stand up and do the job. The Minister is clearly unable, unfit and unwilling to do it. Shame on the Minister and on his colleagues. He must go now and bring Mr. O'Brien with him.

I am sharing time with Deputies Eamon Ryan and Seamus Healy. I pay tribute to Vicky Phelan, who has done this State some service. We know something of this scandal that is unfolding because of her determination and courage. Thanks to her bravery and refusal to sign a confidentiality clause, we are now beginning to find out just what happened behind this whole debacle. Had it not been for that, we might not have known anything about this. We were very lucky that Vicky Phelan is the brave person that she is. This may all have been hidden behind a court case and confidentiality clause.

The priority in all of this has to be the women concerned. We have to ensure that everything possible can be done for them. It has not been done up to now but at this point the Minister has to give an absolute commitment that everything possible will be done for those women in the provision of whatever health services and supports are required. There is also a requirement that the Minister give a commitment that the State will not contest any cases that are in process or that might arise as a result of this scandal. There can be no question of the State pursuing any of these women in the aggressive manner that we saw displayed with Vicky Phelan and many other cases through the years. That has to be a priority.

The other priority has to be all of those women who are now so nervous and are wondering if they will get a phone call. For that reason, I think there was mishandling of this in recent days. The information that was available to the Minister and HSE was not made available and huge uncertainty was allowed to develop over many days. The Minister has made a shocking disclosure to us tonight, that there is a potentially considerable additional number of women who are not subject to audit and we do not have any information about them. It is not acceptable to put all of this into an inquiry where we may or may not get answers in 12 months or longer. Experience with other inquiries and tribunals is that we have been told that an issue is all a matter for an inquiry or tribunal. That is not good enough in this case. We have to get answers now, not in 12 months. The Minister needs to come into this House in a matter of days when he has further information about that shocking disclosure that he made tonight.

There is a fundamental question at the heart of this issue, about how it is that an audit was carried out, not acted on, why there was such a long delay in notifying the clinicians' concern and, more importantly, why there was such a delay or utter failure to notify the women concerned. We need to know what policy is being pursued. Is the Minister still talking about a situation that is utterly paternalistic where women are kept in the dark? Will the Minister clarify that for us? What is the policy in that respect now? Will the Minister clarify, with regard to the duty of candour, when action will be taken and when the medical and legal professions will be faced down in this regard? We have no more time to waste with that.

We owe it to Vicky Phelan, her family and her courage and honesty to correctly set up a means through which to find out what happened, who was responsible, and how we can prevent it happening again. I have listened to various views expressed in that regard. I have a concern about the view that we should opt for a commission of inquiry because all Members know that in spite of constant promises to the contrary such inquiries take years and always have, which would not be in the interests of families caught up in this scandal. I agree with Deputy Clare Daly that perhaps a way to approach this would be to immediately instigate an inquiry by the Health Information and Quality Authority, HIQA, and set up a wider commission which would investigate how to create a patient-centred healthcare system and would consider the key issue of how to avoid a recurrence of what the Minister referred to as the paternalistic approach to medicine displayed in this case. That commission would be key because the scale of the change we must make is huge.

Any inquiry should begin with the question of what happened in 2008. There was a clear Dáil debate on the issue at the time. Dr. David Gibbons and Dr. Sam Coulter-Smith have made clear that at the time they placed on the record real concerns with the policy approach that was taken. I have asked colleagues and friends who were then in government to recall the Government internal mechanisms around the issue. To the best of our recollection, it was not a contentious issue. Whether it was motivated by a desire to scale up the number of cervical smear tests in order to save lives or, as some have argued, an attempt to save money by contracting out that service must be investigated. I have no recollection of it being the latter rather than the former.

Neither the Taoiseach nor the Minister in his statement addressed the argument of Dr. David Gibbons which I heard yesterday, that the divergence between an annual versus a three-year screening system may have been the cause of some of the problems. Although that question may have been answered elsewhere, I hope it will be answered here this evening. The Taoiseach clearly stated that there does not appear to be a difference between the various screening processes being used in terms of the level of accuracy and so on but we must have more detail on that issue.

We must have answers to key questions, such as who was involved in the 162 of 208 cases in which the information was not passed on and the reason for that. Which clinicians were involved? Who was responsible for that lack of disclosure? The most numbing and frightening effect for everyone involved in the Irish health system is the question mark over whether a patient can trust that he or she is being told the right thing. We must have further details on that issue.

I listened with interest today to Members I respect and who have much experience in this area, and from them I heard the common theme that the lack of candour or disclosure may have been due to a fear of litigation. That brings me back to the wider commission of inquiry. I raised earlier with the Taoiseach and the Minister for Justice and Equality, Deputy Flanagan, who answered my question on promised legislation, the issue of whether there are plans to move away from a legally based system to a no-fault medical liability system. As Deputy Shortall and others stated, we must ensure that everyone involved in this process of inquiry will not be shut down by the fear of legal action. How can that be done without a shift away from the current system? As the Taoiseach stated earlier, there always will be a small percentage of false negatives or false positives. Given that is the case, surely it would be better for us to move away from this being a legal process towards admitting fault, helping patients and being patient-centred in what we do.

I commend the bravery and determination of Vicky Phelan. Without her courage, we would be still in blissful ignorance of this scandal.

This is another shocking and shameful episode in the history of this State. Women have been again badly failed. On this occasion, 162 women had medical information withheld from them and, sadly, 17 have passed away. The scandal is the result of a toxic culture of dishonesty, cover-up and concealment. It is a profound ethical failure and an appalling breach of trust. What is worse is that this policy of deliberate deceit was signed off on and agreed by the senior management of CervicalCheck. It was not the decision of an individual. The policy agreed by that committee deprived women of their absolute entitlement to know their medical conditions. It was also fraudulent because it deprived women of their entitlement to claim compensation if they so wished.

We must have accountability. The entire senior management team of CervicalCheck must resign or be removed. This scandal is the result of the neo-liberal policies of the Fianna Fáíl-Progressive Democrats Government and successive Governments since then. These policies were initially implemented by the extreme capitalist free marketeer and then Minister for Health Mary Harney, supported by the then Taoiseach, Bertie Ahern, and then Minister for Finance, Charlie McCreevy. The policies have been continued to this day by successive Governments and Ministers.

The HSE was established specifically to allow Ministers to evade responsibility for our health services, including debacles and scandals such as this one. It was never fit for purpose. It should never have been set up and must be abolished forthwith. Its functions should be reabsorbed into the Department of Health, and the Department and Minister made responsible for the health services.

That concludes statements on the CervicalCheck screening programme. We will now have a question and answer process. A period of 15 minutes has been allocated for each question and answer session with a two and a half minute limit on questions and responses.

I thank the Minister for agreeing to this question and answer session, which will be very useful.

I will begin by addressing the new information the Minister revealed to the Chamber this evening. There is a great deal of public confusion, fear and anger over this issue. Women have asked me if they might get a phone call to tell them the caller is very sorry but they have cervical cancer. We know that is not the case and that the women who will be contacted have been already diagnosed with cancer. However, it gives an indication of the level of fear out there. I acknowledge the Minister coming to the Chamber and sharing the information as he did before a carefully crafted response on the issue was prepared but I wish to get into the detail of it.

The Minister stated, "While CervicalCheck has audited all cases notified to it, I have been informed that a potentially considerable number of cases will not have been subjected to an audit of their screening history." CervicalCheck carried out an audit in the case of 1,482 women who had been diagnosed with cervical cancer and a review was warranted in 442 of those cases. Some 208 false negatives were discovered and 162 of the women affected by those findings were not told of them.

In terms of trying to understand how many more cases might exist, a total of 2,100 cases are recorded on the registry between 2008 and 2014. Assuming there were approximately 250 new cases per year - it used to be approximately 300 but has decreased - for the period 2015 to 2017, inclusive, and 2018 to date, it would total approximately 900 additional cases. Therefore, from 2008 until now there have been approximately 3,000 cases. CervicalCheck stated it has been informed in approximately 1,500 cases but a back-of-the-envelope calculation suggests there may be approximately double that number. I appreciate it may be unfair to throw numbers at the Minister in this manner and I am not trying to catch him out but does he have a sense of whether we are talking about a few more cases, double the number or many times more?

I thank Deputy Donnelly for his important question. I reassure Members that I had no intention of putting any Member in a position whereby they were not prepared to debate this issue. This information was brought to my attention minutes before I came to the Chamber. Had I come here but not shared that information with Members, I would face far more serious questions.

That in itself is shocking.

I have been fully truthful and open on this issue since I became aware of it and wanted to continue in that vein tonight but what I was told of this evening is as Deputy Donnelly correctly outlined. I had been told, and I believe most Members of this House would have understood, that CervicalCheck was notified of all cases of cervical cancer by the national cancer registry. I have said to this House consistently that CervicalCheck has audited all cases of cervical cancer of which it is aware. That is true, but what is now emerging is that there are cases of cervical cancer known by the national cancer registry that are not known by CervicalCheck. This has literally come to light from the serious incident management team's work. That is the team we sent in to CervicalCheck to get to the bottom of all these issues on Friday. I do not want to put out specific figures because, quite frankly, I do not know them but the figures Deputy Donnelly has presented sound about right based on my knowledge of the prevalence of cervical cancer in this country on a yearly basis. However, that comes with a major caveat that I have not been given any figure in regard to the number.

I need to say, however, because Deputy Donnelly's point about not causing unnecessary fear and concern above the level that is understandably already there is important, that these are women who know they have cancer. The State does not have an audit or a file on them it has not shared with them but because they were never passed on to CervicalCheck or were never with CervicalCheck, they were never subject to the clinical audit to which cases like Vicky Phelan's or others would have been subjected. They will now be included in the clinical audit, and I am aware that all the relevant agencies will appear before the Oireachtas health committee tomorrow, but I am sharing all of the information I have with this House, as I have it, right now.

I thank the Minister for that. I will move on to the second question shortly, which is around actions to date, but to come back to the issue of the current level of fear, I ask the Minister to consider any other possible measures that could be taken in terms of public communications tonight, tomorrow or in the coming days. I am very happy to offer Fianna Fáil's support or co-operation if it is of any use, but I believe there needs to be clearer communication in terms of the exact points we are discussing now because, strange as we may find it, not everyone in the country is listening to the Dáil debates. There is a need for further clear public communication and reassurance on the points raised this evening.

The second set of questions I want to ask the Minister is about his response to the note he received. Political accusations are being thrown around the Chamber, some of which are unseemly given what we are dealing with. I am not asking these questions to score political points. I am asking these questions because it is our constitutional role to hold the Minister to account, and we need to know what happened from his perspective when he got the note. The note references non-disclosures, the screening errors and the likelihood of publicity. I acknowledge there was nothing in the note to tell the Minister that there were numerous cases and that there was a much bigger issue coming down. That was not in the note, but I put it to him that there were several things in the note which could reasonably have led him to ask more questions, and maybe he did that. My question is: further to the note, did the Minister make further inquiries as to the scale of this? On Vicky Phelan's lawyer's charge, did he seek advice as to whether the State Claims Agency should be instructed to pull back from the situation? Did he start to put in place any of the responses that it appears from this side of the House only began to be considered from Thursday morning?

I thank Deputy Donnelly for his constructive offer of support, and I would appreciate the support of any Member of this House in terms of what we can do to reassure the public. I take the point Deputy Connolly makes about that but there are women asking many questions and I want to provide them with the right information.

I would point out for the information of the House that new guidance has been put up on tonight and any woman can log on to that. There is a section on frequently asked questions. It also highlights answers to many of the questions that have been coming in to the helpline. Guidance for general practitioners, GPs, on how to deal with the issue of repeat smears and women who are coming into their clinics, of whom I believe there are many, for understandable reasons, asking if they should get a repeat smear test or if their smear will be reassessed will issue this week. Dr. David Hanlon, the Health Service Executive's clinical adviser on general practice, is working with the GP representative organisations on that as well.

I met the Irish Cancer Society today and it had some very constructive suggestions as to what we could do to help provide information to women. I intend to act on many of those suggestions. I will be happy to update the Members as I progress them. I am scheduled to meet it again next week to update it on actions. It can be a very important conduit in terms of providing information to cancer patients throughout the country and to their families.

Deputy Donnelly asks a perfectly legitimate question that I should be asked, that I am happy to be asked and that this House has an obligation to ask, namely, what I did when I got the note. I received this information note, which I have published with only personal details of the individual redacted, on my Department's website. I received it just before 7 p.m. on the evening of Monday, 16 April. I was in a meeting with the Taoiseach and the Minister, Deputy Donohoe, at the time. I then had a meeting of Fine Gael Ministers and Ministers of State later that evening, Cabinet the next morning and pre-Cabinet from 8.30 a.m. I suspect I read the note around Tuesday afternoon. As the Deputy knows, the case was on the Wednesday or Thursday of that week. I read it about the Tuesday afternoon, so a huge period of time had not elapsed. That is an important point to make. I was not sitting on a note, nor did I have a note and days or weeks elapsed.

I read the note, and I have read it thousands of times since, as the Deputy can imagine, because when one reads the note now one reads it very differently from how I read it then. I read the note as stating that an individual patient was taking a case against a laboratory and against the HSE. Rightly or wrongly, I read it that the case against the HSE was likely to be dropped. I specifically read the line that "[i]n its view the case is likely to be settled shortly before going to court", never expecting this issue would go to court. Regarding the section on clinical audit, I read it that all historical and current audits had been given to clinicians for communication onwards to patients. If I read the note now, in the light of what I know, one would read it differently but I did not know about other cases. I did not know about Dr. Flannelly's correspondence. I did not even know what is emerging this evening. I read the note as an information note to me, of which I get very many as a Minister, and not in the context of receiving a note today.

On the same question, and I appreciate we are all pressed on time, can we take it there was no follow-up from the Minister at the time?

I thank the Minister. The final question I want to ask is around this conspiracy of silence because this is not an isolated case of one official or one doctor. The HSE has a 300-page policy document on open disclosure and yet what we have here is evidence of widespread and, I would argue, systematic withholding of patient information. We know there is a circular stating that doctors should exercise their judgment. We know that before 2015 there was no policy of even telling the doctors and that that decision was only taken in 2015. We know that in 13 different hospitals, doctors did not tell their patients. We know that Vicky Phelan's doctor got into correspondence with the HSE and CervicalCheck about who had responsibility.

It is worth pointing out that Ms Phelan made the point in an interview that when she was told, she was told there was a query. Perhaps she was being told in an open and forthright manner. We are in no position to judge. We are not privy to that conversation but Ms Phelan's assertion was that even when she was told, she did not register what she was being told. She used the word "query". She was told there had been a query. It was only when she was handed her own patient notes and was sitting in a waiting room that she discovered what was meant by "query" was that there was an error in her screening in 2011, which is very different from a query.

At this point, what does the Minister know in terms of who knew about this? The question Ms Phelan has asked is who knew what, and who decided what? I know this is early days but in terms of the HSE, we know that a senior official within the Limerick hospitals group was brought into the dispute between the doctor and CervicalCheck. We know that was escalated to the head of acute hospitals for the entire HSE. At a very senior level within the HSE, therefore, at least one person knew. Does the Minister have a sense now of how widespread was the knowledge within the HSE?

Does the Minister have a sense of whether the Department was aware not specifically of Ms Phelan's case because we know that it was but of the suppression or even withholding of information from patients like Ms Phelan?

What I have learned in recent days is that the only thing I can say with absolute 100% certainty is what I know. That is why I want to have a statutory inquiry to establish the exact answers to the Deputy's very important questions about who knew what, when and where. As the Deputy can imagine, in recent days and since last week I have spoken extensively with my departmental officials. I am very clear that they have informed me that they had no knowledge of a suppression of information or certainly anything that emerged in the national media through the discovery documents presented in Vicky Phelan's case. My officials will be before the Oireachtas Joint Committee on Health and, rightly, should be asked questions about this issue.

The Deputy makes an interesting point. A clinical audit is really good. If one is the Minister for any Department and one hears that there is to be a clinical audit or audits, one welcomes it because a clinical audit is good. What happened was, as Deputy Michael Harty said, that the patient clearly was completely lost in the process. We see the most unedifying situation where doctors were writing letters about who should tell the woman in questin or whether they should tell her. What is even worse is that we now know that for many doctors there was not even an exchange of correspondence. Information was simply put on file, with the paternalistic view that Ms X or Ms Y did not actually need to know the information. We need a statutory review. Of course, we expect doctors to exercise their judgment, but I would certainly expect doctors with any information on my health or my health files to tell me. That did not happen and it points to the need for this House to take very practical action on the issue of mandatory open disclosure.

On page 2 of the memo published it is stated the "National Screening Service and Jerome Coffey, Head of the National Cancer Control Programme, have advised the Department in writing that they do not consider this to be a patient safety incident". Will the Minister share with the House when that advice was given and when exactly the Department knew? I do not think it is credible that it knew but that the Minister did not. However, that is what we are being led to believe. Will the Minister confirm when the Department knew?

On the same page of the memo it is stated BLM solicitors "have shared a copy of an expert report with the SCA which we understand will form part of the laboratory's defence in the context of liability and causation". Again, no date is given. I find it a little curious that there are no dates given in this document. There does not seem to be any information on when it was sent or received. It does not seem to have been stamped. The two specific questions I have posed are really important.

Elsewhere in the memo we read that the Department "is in consultation with the HSE in regard to their preparation of a press statement on the matter". We have all sat through criticisms from all sides of the House of the obsessive fixation of certain members of the Government with spin. I suggest it was very much known that this was going to cause an issue and that it would be a national incident which would be added to the list of scandals that have surrounded the Government because in the briefing note to the Minister we see that preparations were being made for the inevitable press fallout.

My final question on this section relates to the assertion that Jerome Coffey advised that the National Cancer Control Programme did not consider this to be a "patient safety incident". It is absolutely outrageous that the NCCP would not consider it to be a patient safety incident. The memo was prepared for the Minister. I ask him to let me and everyone else listening know whether he regards it as a patient safety incident. Does he regard it as something that should have that tag? I certainly would consider it to be a patient safety incident.

The Deputy has the document I had, as it was given to me, with the exception that the personal information of Ms Phelan has been redacted. The Deputy asked a very specific question about when my Department knew about or became aware of the advice of the National Cancer Control Programme and the National Screening Service. My understanding is that it was in the immediate days before the note. I believe the Department was first contacted-----

Could I get the date, please?

Yes, I have a date-----

The memo states, "advised the Department in writing". I presume, therefore, that a date was put on-----

I do not have the date on the letter, but I am informed that my Department was first made aware on 6 April. I expect my Department to provide the Deputy will all relevant dates tomorrow at the Oireachtas committee meeting, but 6 April was the date on which my officials tell me that the Department was first made aware. On the evening of 16 April, the note to which the Deputy refers arrived to me.

What Dr. Coffey is saying or is alleged to have said is that it was not a patient safety incident but rather one related to the known limitations of screening. He goes on to point out that the current primary screening test used by CervicalCheck is a cytology test which can have low sensitivity and which produces a not insignificant number of false negative results. It was certainly the view in the note, based on the fact that it was an individual case, that, sadly, sometimes our screening programme could produce false negatives. That is certainly how I read it. Obviously, knowing what we now know-----

And what the Department knew on 6 April.

No, my Department did not know on 6 April about 208 other patients, about Dr. Flannelly's correspondence with Dr. Hickey, or a range of other issues. Knowing what we now know, namely, that there was a much more widespread issue for women in this country, clearly it was an issue of significant patient concern.

On the press statement, if one reads the statement, one will see that it was aimed at reassuring people about our cancer screening programmes and how they actually saved lives. I am not getting into the political space, but the statement was such that if the Minister of the day happened to be asked a question on foot of an individual case, he or she would have been able to express confidence in the screening programme, but obviously not now, knowing what I now know.

I restate that there was a heavy emphasis on spin, no matter what way one looks at it, in terms of the answer being given to the Minister if anyone were to ask a hard question. It is not credible that the Department knew of this but the Minister did not. This is a very serious case which involves a young woman with two small children who is gravely ill. It was known that it was going to hit the headlines. That is clear. In what format did the Minister receive this advice? Was it emailed to him or was a hard copy handed to him?

It was emailed to me and I was given a hard copy.

That underlines that it was considered to be important. I appreciate that the Minister is busy, but the note was not read until the following day. I still find it odd that officials in the Department knew for ten days but did not feel obliged to bring the matter to the Minister's attention. It makes me wonder about how many other cases there are of this nature that the State Claims Agency might fight vigorously and aggressively and which might end with a gagging clause, meaning that we would never find out about them. The fact that ten days elapsed is a source of serious concern. The Minister received the note and then read it the next day. As the Department had had it for ten days, 11 days had elapsed at that stage. At any stage did the Minister ask if there were more women involved? Did he ask if it was symptomatic of a wider problem within the health service? In that regard, to be fair, the Minister has shared the information he had with the House. He is correct in suggesting there would be uproar if he had not done so. I fully appreciate that, but officials had all weekend to review it and we still cannot say with certainty what the numbers are. The Minister is making his best guess and Deputy Stephen S. Donnelly was trying to work it out, as I was, on the back of an envelope. That is absolutely outrageous. I have used the screening service and all weekend was taking calls from friends and family members who wanted to know if they could have faith in it. I told them that the questions would be answered in the Dáil, but the Minister has come here and given us his best guess. The serious incident management team had all weekend to do nothing other than review the matter. Does the Minister think it is acceptable at this stage that we still cannot say anything with certainty?

I assure the Deputy that I do not think it is acceptable that I am coming into the House to address it on such an important matter and that I am hearing this information only moments before coming into it and hoping I have enough time to explain to it, factually, what I have been told.

If I had more detail, Deputy O'Reilly would have it right now. I provided my best indication of the detail during my exchange with Deputy Donnelly. Having just checked the matter with my officials, I can inform the House that the correspondence from Dr. Jerome Coffey was dated 11 April. The Department first became aware of the matter on 6 April and I have been informed by my officials that Dr. Coffey made the comments referenced in my note on 11 April. The Deputy has suggested that the fact that I received this by means of email shows that it is important. She should see the volume of emails I get from officials through my private secretary each day. If something is viewed as very important or very urgent, it is usually followed by a phone call, a face-to-face briefing or a formal submission to the Minister. I read this information note when it was sent to me. I would read it in a very different context now. I read it thousands of times over the weekend. I thought "if I knew then what I know now", but I did not know that then. I read it in the context of what I knew then. I read it as an individual case. I read it as a situation in which doctors and women had been informed, but it is clear now that this was not the case. The moment I became aware that this was not the case, I took very swift action. I think I have answered the Deputy's questions.

We have raised the issue of outsourcing. When a cytologist who gave evidence to the HIQA inquiry into the case of Ms Rebecca O'Malley raised queries about the inferiority of the US screening, the chair of the inquiry advised him that the terms of reference of the inquiry did not allow it to consider this aspect of the matter. He said that the question of outsourcing was outside the scope of the inquiry, but he offered to make a note of it. As a woman who uses that service, I am absolutely reassured when I hear that someone made a note of this somewhere. How many audits were carried out regarding these outsourced companies? How regularly were they carried out? How many of the teleconferences on which Mr. O'Brien has advised he relies for the exchange of information actually took place? At what level did they take place? Who was talking to whom?

Have the contracts for outsourced smear testing been renewed since 2011? Does the company, Clinical Pathology Laboratories, still hold a contract with the State for smear tests or for any other diagnostic work? I think this is an extremely important question. It appears from what happened in the HIQA inquiry I have mentioned that it will be precluded from looking at outsourcing. If so, that inquiry will be deficient from the very beginning. I am not alone in expressing the view - it has been expressed by clinicians - that the decision to outsource this service is at the root of this problem. The then Minister for Health and Children in the Fianna Fáil-led Government of the time, Mary Harney, was quite prepared to say she believed the savings were in the magnitude of one third. Mr. O'Brien would not comment on the cost of it at the time. I voiced my opposition to it at the time. At no stage do I recall anyone relying on quality or other evidence. The then Minister was very quick to point out that we would be getting it cheap. As we know, if one buys cheaply, one will pay twice. I would be interested to know about the scale of the audit. Were any concerns raised? When the cytologist who was giving evidence to the Rebecca O'Malley inquiry advised that the tests in the US were inferior, was that flagged?

I would like to go back to the note that was received by the Minister. He has said it would be normal for him to get a formal note as a ministerial briefing. He has pointed out that he gets many emails and I am sure that is the case. Does he not think officials in his Department should have flagged this up to him as important? From the moment they knew about it, they should have been asking questions about how many people were going to be involved in it. They should have been bringing the potential impact of this issue to his attention in order to avoid the Minister coming into the Dáil, as he has done tonight, to give us his best guess at the figures without knowing what the actually are.

My Department will be covered by any inquiry or investigation and indeed will appear before the committee tomorrow. In fairness to the officials in the Department, we are again having a conversation in the context of information that is known now but was not known to them then, as far as I am informed. There is a reason we are having a statutory review and a statutory inquiry. It will answer some of the questions the Deputy has asked. I think we need to be very careful. If we are telling people that screening in Ireland is good, works and saves lives, all of which is true, we should not then cast doubt on the locations where smears are being read.

We absolutely should if we do not have confidence in them.

It is absolutely the Deputy's prerogative to do so. I want Irish women to continue to access the screening programme now.

The Minister does not have a monopoly on that.

I do not have a monopoly on that. I have heard the Deputy saying that as well. It is more useful if I say a few sentences before she comes back in. Even if we are saying that our screening programme is really important, I think it causes unnecessary alarm to express concern about where smears are being sent and about the validity of the results from there. I do not believe the Deputy intends to do that. She has been very responsible in regard to all of this. She knows a lot about it. I fully accept that there are legitimate issues to be raised regarding the laboratories we use. It is also important to say that these laboratories are accredited. According to a note that has been posted tonight on the frequently asked questions section of, "the laboratory involved in the case reported in the media, CPL, is not one of the laboratories currently used by CervicalCheck". The website names the three laboratories that are used: Quest Diagnostics in New Jersey, MedLab Pathology in Dublin and the Coombe Women and Infants Hospital in Dublin. That is the factual information today. As I said in my opening speech, when we move to HPV screening we will have an opportunity to reconfigure our laboratory services as well. The Deputy can question officials from the HSE on what was audited when they are at her disposal at the joint committee tomorrow. This matter will also be considered by the inquiry. When I speak as Minister for Health about the laboratories we are using, I have to say that countries like the US are not exactly the wild west in terms of medical technology. A great deal of progress has been made since the programme was set up and it was decided to outsource some testing to these laboratories, which was not a decision made by me. We have gone from a situation pre-programme where we had 300,000 smears in Ireland to one where we have 250,000 smears. We have gone from a situation pre-programme where the programme was showing no benefit in relation to mortality to one where we see mortality reducing by 7% a year. We have gone from a programme of no clinical audit to one of clinical audit.

I asked about audits.

I am making-----

I asked the Minister a specific question about the number of times it has been audited.

I do not have that answer at my disposal.

The Minister could have said that instead of trying to put a load of figures into the-----

I am making an important-----

I am aware of the figures.

We have to move on before we get any answers.

I know. I am sorry. We should have moved on before now.

I have a duty to inform people of the information.

The Minister can put it on the website.

Obviously, we know that only for Vicky Phelan and the publicity that the Department of Health figured out was going to be generated, we would not be here talking about this tonight. We are thinking about her tonight. She is watching this debate. I wonder what she is thinking as further revelations are literally happening live in this Chamber. She tweeted a while ago to say "I will be appearing on @RTE_PrimeTime tonight to react to the latest disturbing developments in this ever deepening scandal". I am referring to her tweet for a reason. The information that was provided during Leaders' Questions earlier today when the Taoiseach was questioned on this issue is already out of date. It was actually a waste of time. The Minister for Health needs to assure us that the information he is giving us tonight will not be out of date by tomorrow. I have no confidence that this will be the case. It is extraordinary that the Minister has walked in here to say he does not know how many cases there are. What in the name of God were all the senior management officials in the National Screening Service doing all weekend? There are nine people in the central service and three people in CervicalCheck. The lady who has resigned was reporting to the head of screening. The national director is next. There is also the chief clinical officer, etc. There are 17 people in management alone, but they could not bloody well tell the Minister that there were extra cases outside the national registry. It is not acceptable that the Minister has come in here tonight without knowing how many cases there are and neither is what the Minister was told as he was coming in here acceptable.

What in the name of God did the Minister say to the people who told him this? Who told him this as he walked in here tonight? What did the Minister do? I know what I would have done if somebody told me that and had not done his or her job all weekend. What are all these people doing? Instead of having confidence tonight, this is the main story on RTÉ and it will be the main story around the country.

Ms Vicky Phelan will be talking about this on "Prime Time". Instead of maintaining confidence, the people who did not do their jobs and said this to the Minister as he walked in here tonight are causing a crisis.

He has 15 minutes to use as he would like.

I have 15 minutes and it is a sensitive enough issue.

I am sorry but you have the same as everybody else. It is not fair to use all the time.

The Acting Chairman is taking up my time now.

The Deputy has the same amount of time. Please allow the Minister to reply. The Deputy will have the chance to ask another question.

He can use the 15 minutes as he would like.

We are trying to ensure an even debate, with everybody having the same amount of time.

I will move on but the Acting Chairman is taking up my time. He should put on a minute at the end. This is ridiculous and it is too sensitive an issue to be like that.

Hold it a second. The intention is to give every speaker who is asking questions reasonable time to ask them.

It is 15 minutes.

The Minister should have reasonable time to reply. There will be no exceptions. I am sorry.

The Minister is a reasonable person.

I am sorry but you have gone on for far too long. The Minister should reply. The Deputy will have the opportunity to ask another question, unless he wants to use all his time in one go.

How will the Minister deal with this? Who told him this? Why did those people not do their job? Why, as a result, has a national crisis been caused tonight? Will the Minister assure the House now that there will be no revelations tomorrow?

I thank the Deputy. The person who told me is not the person who did not do the job. I was told by the chief medical officer this evening that he was informed by the-----

Who did not do his or her job?

-----serious incident management team based in the CervicalCheck offices. The Deputy can imagine what my reaction was.

The response would not have contained parliamentary language. Along with everybody in this House, I have been working in a responsible manner to try to put facts into the public domain and get to a point where we can establish answers for women, care for the women who have been let down and try to ensure we have a screening programme that can be improved as a result of Ms Phelan. This landed this evening.

It is important, however, to specify what this is. I have made the point already but it is important. This does not amount to more people at home with cancer who did not know they had cancer. This does not amount to more people at home who had an audit that was not shared with them. These are people who were not known to CervicalCheck who are on the national cancer registry, who have had a diagnosis of cervical cancer and who have received or are receiving treatment for cervical cancer. They never benefited from the clinical audit process. That is utterly unacceptable.

In light of what is happening this evening, I am very much moving in my mindset in the direction outlined by the Deputy earlier. The Acting Chairman will probably tell me I have run out of time but I would like to interact with Deputies in this House. I heard Ms Phelan make the point during the week that she does not want a long inquiry or tribunal, and I know nobody wants that. HIQA has powers that could bring much good to this and we have used them in a number of other important areas, including the Portlaoise babies scandal and the case of Ms Savita Halappanavar at University Hospital Galway. The authority has got to the bottom of things and made our services safer. I also take the point there may be bigger and wider matters emerging.

How we address this as an Oireachtas and Government is an issue. Perhaps after the meeting of the Oireachtas Committee on Health tomorrow we should review where we are at. I am certainly willing to meet representatives of other political parties and groupings, as we have done with other difficult or important national matters, to work out how best to address this. I cannot decide matters for the Government on the hoof on the floor of the Dáil. I nevertheless take the point. I have heard from Deputies Shortall, Daly, O'Reilly, Kelly, Eamon Ryan and a number of other speakers - I apologise if I left out people - about the importance of getting the right mechanism to get answers. I agree with Deputy Shortall in that I do not want the mechanism to shut down debate in here or in any committee but it must have teeth.

That is the point we made today.

The HIQA mechanism has teeth but I am happy to engage with the Opposition on this. I suggest we do that after the Oireachtas health committee meeting tomorrow.

This is critical. There were one or two contributions tonight that were simply wrong, specifically the commentary relating to the Minister. I believe what the Minister is saying but there is a real issue. The Minister is managing a live process. He was told something earlier and he acted on facts over the weekend. This Dáil debated facts that were wrong, and that cannot happen again. The scenario in which the information came to the Minister tells me there is something wrong in the Department and the national screening process at the very least. It tells me there is something wrong if people are afraid to relay such information to the Minister's Department. This cannot happen again because if it does, we will get into a different space and I do not want to go there. This is too serious an issue. The political sideshow must end in the next couple of days because this is a serious matter. The Minister should send an email to everybody in the Department, the HSE and the national screening centre, asking that if people have any information, they should reveal it. It has nearly gone to that. There are 15 people who could not provide the Minister with accurate data over the weekend.

I am glad the Minister made those comments about HIQA. What will happen if HIQA is asking questions and requests people to turn up but those people refuse to do so? Nothing happens and the people just do not turn up. They do not answer questions and they are not compelled to do so. Where do we go then? The real issue is that HIQA does not have adequate powers, including power of compellability. It cannot force people to answer questions or attend meetings. People cannot be cross-examined. As a result, we will end up with a commission anyway. I will be helpful. There is a need for a period to scope this and it cannot be open-ended. This is to ensure it could be done quickly. I repeat that we will refuse point blank to support this being done by HIQA.

I appreciate that the Deputy has said this is too serious an issue to play party or personality politics with it. I appreciate the responsible way in which he and his party, along with most Members of the House, are approaching this sensitive matter. I want to work with all people in government and the Opposition in getting answers. I fully endorse the idea that this cannot be an open-ended process or a process that goes on for years. As the Irish Cancer Society indicated to me today, there are some women who have cancer who will be very sick and want answers. We must be conscious of another process, the independent clinical review, which should get under way forthwith. I am not suggesting the Deputy is saying we do not consider this. That review will mean that every woman affected by this can have an appointment with a team of experts brought in internationally, a liaison nurse and the Irish Cancer Society feeding into how best to do that. Those women should be able to find out their own facts and medical detail to know their cases were reviewed.

There is a real issue here and there is a reason I declared I did not have confidence in the management of CervicalCheck. The Deputy can imagine how that went down in the system but I could not say anything else. How could I have confidence when the information available to me, the Deputy and the public has been dripping out? That is not acceptable. It is too serious an issue. There is a reason I did not have confidence in the management, and notwithstanding the excellent work Dr. Flannelly did in many ways, there is a reason it was appropriate for her to step aside.

The Deputy has three minutes and 30 seconds left, including time for questions and an answer.

The Acting Chairman took a minute belonging to me.

He is taking some time now as well.

There is a real issue here. The Minister has said that anybody who wants a check can have one and I accept that. We need to give people assurance and we need to look at doing it in different ways.

There is the practicality of it.

Let us talk about what that means in a practical sense. There are 250,000 smear tests every year and if everybody with a concern wants a test, how will the system take it? The Minister has assured us the resources will be there.

I know many GPs. How in the name of God will they be able to do that? They are asking those questions tonight. We have to give public assurance by other mechanisms. We have to be practical and realistic. Will the Minister consider instructing that a qualified sampling process be done to give assurances to the women of Ireland and the public? Will he also ensure there is an immediate programme of promotion and media engagement by the appropriate people to address this issue? Please consider the sampling issue. We have got to be realistic and honest with people. There are 250,000 tests a year. This a practical not a political point. Given everybody who is concerned, and they no doubt have concerns, the system cannot take it. Please look at alternatives and take my suggestion on board to give assurances to the public. Statistically, if that comes out at what we expect, it would give the women of Ireland greater assurance.

I appreciate the good faith in which the comment was made. I am not going to decide - the Deputy would not expect me to - quality assurance methods on the floor of the Dáil but I will reflect on his point. Part of the international peer review - whatever the mechanism or structure - which I hope can get to work quickly, will look at how our screening programme compares with results in other countries. That could be of significant help in providing assurance.

The Irish Cancer Society, ICS, had some excellent ideas today on how we could provide assurance and information to women. That included the idea of the screening programme writing out to every woman with factual information about the programme, some of the steps taken and probably an apology as well for all the stress and worry caused. I am going to work with the ICS and other advocacy groups on how to best to build that assurance. The Deputy is right. The guidance to the GPs on this issue of repeat smear tests outside of the normal schedule will be issued this week. Before making such an announcement, I discussed it with the IMO and the NAGP, and both welcomed it. I am not speaking for them on the floor of the Dáil but I got a sense from them that they expected many women to turn up in their surgeries anyway. If a woman needed that as part of the reassurance process, then it should be available to her.

That is fine but what about the volume?

The IMO and the NAGP are involved in discussions with the HSE and CervicalCheck.

I agree 100% but what about the volume?

No. They believe it can work and I believe it can work. I checked that before I announced it.

Consider the alternatives as well.

I will. It is not on its own. It is part of a suite of measures that we need.

I call Deputy Bríd Smith, who is sharing with Deputy Richard Boyd Barrett.

I asked the Minister to comment on the statement by the Academy of Clinical Science and Laboratory Medicine on cervical screening. The statement said that for any screening programme to be successful, it must have the trust and confidence of the public and to ensure that confidence is maintained the results of the audit of 2014 must be published. Will the Minister comment on that please?

I want to tease out further how the screening is done. It is important. The Academy of Clinical Science and Laboratory Medicine asked if all the false negative screens were performed in the same laboratory, and I ask that question also. The Taoiseach told us today that three laboratories are involved, namely, the Coombe and two in the United States. However, MedLab Pathology in Sandyford, a sister company of CPL in Texas - the firm Ms Vicky Phelan sued - is given 50% of the samples by CervicalCheck. When I went for my smear about three weeks ago, the doctor was emphatic that it was going to the US.

How is it decided what goes to Sandyford, what goes to the US and what goes to the Coombe? Or where does it go? Can the Minister tell me when it is said that MedLab Pathology "deals with" 50% of the samples, what does "deal with" mean? Does it mean that it actually screens them? Does it do the tests on them or does it just package them and send them in Texas? I refer to Quest Diagnostics in the United States. How is that decided? Is the Minister concerned that MedLab Pathology in Sandyford is the sole laboratory dealing with the bowel screening programme? We should be informed of the connection it has to CPL in Texas.

Have I time to ask another quick question?

Yes, the Deputy has.

Mr. Tony O'Brien, the head of the HSE, was asked this morning on the "Today with Sean O'Rourke" show about his dismissal of the concerns of Dr. David Gibbons. Mr. O'Brien said he had not dismissed those concerns and that they were taken up in the contract before it was awarded to Quest Diagnostics in the US. Is the Minister happy that is the case? I know we are not going to see the contract given sensitivity and commercial secrecy, etc. Even if I asked for it, I would never see it. However, why did Mr. O'Brien then allow Dr. David Gibbons and several renowned scientists resign as result of him ignoring them? Why did he tell us that he wrote it into the contract before it was awarded?

I am accountable to the House for my role as Minister for Health. I do not have some of the answers nor would I be expected to in respect of some of the questions Deputy Bríd Smith asked. I refer in particular to the awarding of a contract in 2008 by the HSE or the screening programmes. Other witnesses will appear before the Joint Committee on Health tomorrow. They will be much more versed in that than I would be, should be or would be expected to be. I have to clarify an issue. I heard on a number of occasions in recent days a call for me to publish the audit report. That suggests people think there is a report sitting somewhere that needs to be published. My understanding and what I am informed - there is a caveat in that - is that the 2014 audit and, indeed, any of the audits refer to audits of individual women's smear tests as opposed to an audit report. I certainly do not have within my possession, nor does my Department, any audit report or document that could or should be published.

Does the Minister have the results of the audit?

No, I do not have the results.

Why would an outside body as renowned as this one be asking for it?

I cannot get into an exchange about press statements on the floor of the Dáil. These are individual women's smear tests and individual women have a right to know what is in them. In the last number of days since this came to light I have spent time making sure that individual women know, as they should have known. It is worrying that the paternalistic culture suggested that they were not told even when it was communicated to their treating clinician. I do not have them, nor should I, as they are individual women's smear tests.

I will come back in. I will not use the Deputy's time.

On Deputy Bríd Smith's question, the Minister was not around in 2008. However, he has direct responsibility for the concerns that were flagged by Dr. David Gibbons and Dr. Sam Coulter-Smith and other scientists. They went as far as resigning from the quality assurance committee over this issue. That is not insignificant. They were so concerned about the inferiority of the testing regime that would result from outsourcing it to the United States. They had evidence to back that up. I refer to the view that thtanumber of missed positives would be significantly higher with the outsourcing.

Can the Minister tell us they were wrong? That matters not just in respect of the 208 people but in respect of every single person who has been screened and who will be screened. I have been asked to ask the Minister about the retests now being promised to anyone who wants one. Who will do the tests? Will the tests be inferior? I refer to what Dr. David Gibbons and Dr. Sam Coulter-Smith said - he is saying it as we speak - about the problems that have emerged inevitably emerging because of the difference and the mismatch between standards here and in the United States. Can the Minister assure people that they were wrong? The academy that was mentioned, the Academy of Clinical Science and Laboratory Medicine, is saying the whole thing should be repatriated now. Does the Minister agree? Should it be repatriated?

I am not saying anybody is wrong. We have to look at all these issues as part of the inquiry. Concerns were clearly raised by eminent people. They are very eminent and far more qualified to speak on this than I am, including Dr. Coulter-Smith. Other views were also raised by other people. There was a process and a robust debate in 2008. A decision was made. However, the Deputy has to be careful in raising these concerns that he is not casting doubts over the success of the programme. It has saved the lives of Irish women. We have seen over 50,000 pre-cancerous cells detected as a result of this programme. We have seen 3 million smears take place.

We have seen the mortality rate from cervical cancer decline in this country.

We all agree with that.

It is important. Deputy Boyd Barrett agrees with that aspect of it - I do not mean to be antagonistic about it – yet he is saying that the laboratories to which the samples are being sent are inferior. There is a conflict between that statement and agreeing that there is a life-saving programme under which smears are being analysed and which is saving lives.

There is a real problem with it.

No, Deputy Bríd Smith has a problem. I believe she would accept that she has an ideological problem too.

I think thousands of people have a problem.

I accept the concerns Deputy Bríd Smith has raised, the sincerity with which she has raised them and the legitimacy of looking at them.

CervicalCheck published information on the company's website tonight as follows:

Our cervical screening samples are sent to one of three contracted laboratories. One of these in the US and two are in Ireland. The reason we use a US laboratory is because we do not have enough certified laboratories in Ireland.

The laboratories are:

Quest Diagnostics Inc, Teterboro, New Jersey, USA

MedLab Pathology Ltd, Dublin and

the Coombe Women and Infant’s Hospital, Dublin.

All three laboratories meet our quality assurance standards and are certified by national authorities. Every sample is checked by at least two screening staff.

The laboratories are also accredited to ISO 15189 standard or equivalent. This standard ensures that there are robust quality control procedures in place.

The laboratory involved in the case reported in the media, CPL, is not one of the laboratories currently used by CervicalCheck.

All of these issues, including the reconfiguration of our laboratories, have been moved to human papillomavirus testing. That is an active issue that should be looked at and will be looked at. We should be careful in raising these concerns that we do not cause widespread fear or panic about a programme that I believe we all support. I appreciate the support of Deputies in this regard.

We all agree with the screening programme.

I fully accept that.

We all know the screening programme saves lives. Let us be absolutely clear: we believe people should avail of that screening programme. Furthermore, anyone who is concerned should immediately seek to be screened. There is no question about that. The issue at stake – to be honest, the Minister knows this – is whether the standard of that screening system was inferior as a result of the decision to outsource it. That fear was well-flagged by eminent people who had evidence. It is not simply that they thought and speculated. They had evidence based on Quest and the fact that in the USA the particular nature of the screening programme meant that 1.2 out of 100 rather than 1.8 out of 100 – the rate achieved here – from the same sample population was the average rate. That means the tests were missing people who had abnormal cells. The difference is one third and that is very serious.

Were some of the 208 people victims? Were some of the others to whom the Minister referred in the bombshell that has been dropped tonight victims? Were others who have been tested and who may have had false negatives victims of the fact that we may have a screening system inferior to the system we would have had if we had taken the advice of David Gibbons, Sam Coulter-Smith and the scientists? That is very important. There is a political line of responsibility there. Does the Minister agree that it is very important?

If the politicians who made this decision were wrong, they are accountable for what is happening. If that contributed to the scandal that has now unfolded, they are accountable. Does the Minister agree with that? That is an important question.

Is it not strange? Can the Minister explain this to me? The then Opposition spokesperson, James Reilly, flagged these concerns in the Dáil in 2008. When he got into government, why did he not follow through on it? He expressed in the Dáil exactly the same concerns that Sam Coulter-Smith and David Gibbons had expressed very strongly. When he was appointed Minister, he did absolutely nothing about it. His successor, Deputy Leo Varadkar, did nothing about it. The Minister has done nothing about it.

My time is not up yet.

There will be further replies.

Having raised those concerns and echoed those concerns in 2008, why did Fine Gael not then immediately look into it-----

You are way over your time, Deputy.

-----when it got into power to see if Sam Coulter-Smith-----

In actual fact, you eroded the Minister's time, so your time is up.

It is not. He has two and a half minutes at the end.

Deputy Boyd Barrett should keep talking and not mind it.

Each person has two and half minutes.

The Minister has two and a half minutes at the end.

You raised the question and there is two and a half minutes for the reply. If you interrupt the reply, which you did-----

That is not in the Order.

I am sorry. The order is 15 minutes to conclude.

He has still two and a half or three minutes left.

This is a question and answer session.

This is just Fine Gael messing around in the Chair.

The Minister and the questioner have the same amount of time.

That is Fine Gael messing around in the Chair. That is outrageous.

Deputy, do not be so insulting.

What you have done is outrageous, Acting Chairman. You have just cut across my time.

You know what you are doing. You are trying it on.

That is rubbish. You are shouting us down when serious questions are being asked.

Deputy, you know what you are doing. You are eroding the time and not allowing equal time.

Now the Minister has two and a half minutes remaining, one minute after you interrupted me.

I am sorry, Deputy. You are out of order.

I am willing to stay here as long as it takes. There is no Fine Gael politics here.

As long as everyone observes the 15 minutes I do not mind. You can stay here until midnight and afterwards as long as everyone observes the 15 minutes and no more.

This is a serious issue and I do not intend to engage in a shouting match on it. Deputy Boyd Barrett should note that there are mistakes and errors made in this country and in many different countries. The Deputy has a viewpoint - others agree with him – that sending this screening service or the reading of the smears to the United States was a mistake. Deputy Boyd Barrett has asked several questions of people who are not here to defend themselves or to explain or account for their policy rationale at the time. The Deputy has accused me of not doing anything in this regard. What I am doing as Minister is taking a decision to introduce HPV testing. That will make us one of the first countries in the world to do this. It will save more lives and reduce false negatives. Moreover, it will provide us with an opportunity to reconfigure our laboratory services - I have said as much several times today – and look at all of it.

Second, I am putting forward the legitimate issues, whether I agree with them or disagree with them. I have no reason to believe the standard in the US laboratories is in any way lesser than the standard here. No quality assurance issue has been raised with me by my officials. I am putting all of those questions into a robust international external review so that they can be answered factually rather than what could end up being a tit for tat about different political views on an important matter.

Hold on, a minute is going begging. I will-----

The Taoiseach said today that failure to tell the 167 women would not have changed their outcomes. That is true because they had already been diagnosed with cancer. Had that disclosure happened then, the storm we are having now would have happened then prompting the changes and alerts about the possible problems with the tests. In fact, it may have saved other lives and prompted earlier diagnoses of false negatives that may have happened subsequently. Is that not the case?

I think the disclosure of women's health information to women at the earliest possible opportunity would have prevented a great deal of pain, hurt, suffering and worry. I fully agree with that.

The next slot is being shared, I understand, between Deputy Joan Collins, Deputy Clare Daly and Deputy Connolly. The slot is 15 minutes. There are questions and answers. At the end of 15 minutes whoever is caught on the dance floor will have to stand down.

These are the issues I raised this morning about outsourcing of the smear testing. We know that in 2008, a total of 300,000 Irish smear tests were sent over to the US firm Quest Diagnostics, and two years later clinical pathology laboratories based in Austin, Texas took over the National Cancer Screening Service. These are for-profit companies. There was a political furore about it at the time. It is not me saying that there is something wrong with the methodology, how it was done or how they were tested. Eminent doctors, including Dr. Gibbons and Sam Coulter-Smith, raised these concerns. They raised them at the time and said that this should not happen. As has been said, they resigned over it. That is a serious matter and it has to be investigated.

I commented this morning on the international peer review. At this point the Minister and his team should look into trying to bring the samples back for testing now under the HPV testing scheme that he intends to roll out in October because all of them will have to be checked again. We know they need to be checked twice or three times. We know there is a difference in how people are tested in America compared with here. I call on the Minister to come back on that. It is a serious issue. Although the current Minister for Health was not the Minister with responsibility for health at the time, he is now the Minister for Health and he must deal with these issues.

As Minister for Health, I regularly have to deal with serious issues from the past. I will not be found wanting in terms of working with people to try to deal with these issues.

The issues raised by Deputy Joan Collins will be investigated but they will not be investigated by me.

They will be investigated by people who have an expertise in this area. They will be investigated by people who come at it from an international perspective and who can look at it in a clinical, factual and evidence-based way. That is one of the purposes of the statutory investigation, that we have something that is not something of the Government, the Department of Health or the Minister for Health but fully external to look at all these issues, including the use of laboratories.

The Deputy made the point, and I appreciate her making it, that the human papilloma virus, HPV, testing will provide an opportunity to look at how we reconfigure our laboratory services in this country. It will also necessitate, as she would know, because of the expenditure of public money, a new tender, so there will be opportunities for all these issues not only to be revisited but also to be retendered. I am also happy to keep the House updated as that progresses.

If in the review it is found out that this outsourcing was the potentially the cause of the cases not being properly checked, and we know that Vicky Phelan won an award of €2.5 million from a US based laboratory, will the Minister demand answers of the people of the day who made those decisions?

I cannot be judge and jury here. The Deputy asked a question as to what a review or an investigation may find. We need an investigation into the breadth of issues regarding our screening programme, and we are going to have one. I think many people acted in good faith at that time. I think many people had different views. From my reading over the last while, and I have been reading a lot about this in recent days, I think a lot of people had different views. It was clearly quite controversial and well debated. However, it is important to say, and I know the Deputy backed the screening programme, that there is no evidence to suggest that the results people are getting back from that laboratory today are more inferior than the results that they would be getting from the laboratory in Dublin. I would like to see home-grown laboratory services.

I have brief questions to which, hopefully, the Minister will give brief answers.

The Minister said there is a better system now, the HPV testing, which has been assessed and will be implemented. When was it decided to assess that and move to the new system and what was the basis of that reassessment?

That was a very brief question.

They will all be brief.

I am getting my note on that. I decided to introduce it in February of this year, following on from a Health Insurance and Quality Authority, HIQA, health technology assessment, HTA, which recommended to me that it could reduce the number of false negatives for Irish women.

We know it is a matter of public record that the Taoiseach has said he changed his position on mandatory open disclosure on the basis of the advice of his officials. The Minister also has received similar advice, as have I. That advice was against best international practice and evidence. When we asked the Department and the Chief Medical Officer when we met him what was the evidence against mandatory open disclosure and the implication that it would lead to fewer disclosures, there was no evidence, and that was admitted. Given that the Minister and his predecessor have been sent out to act on bad advice, what will the Minister do to call to account the Chief Medical Officer and the chief executive officer of the HSE?

I do not think how the Deputy has represented the Chief Medical Officer's advice is how I would recall it, but perhaps we can pursue that some other time. We in the Department of Health and, more importantly, the Government - as indicated in the programme for Government - are fully committed to the introduction of mandatory open disclosure. I have already acknowledged that the Deputy has done Trojan work in this regard, and we will move forward with the patient safety Bill. I will bring it to Government for permission to draft next Tuesday, and I will work with the assistance of Members of this House to get it passed as a matter of urgency. It is one of the most practical things we can do for the people who are wondering why they were not told about this by their doctor.

The Minister was sent out with that advice but it could have been brought in before now.

In terms of litigation, the Minister will be aware that outstanding liability claims against the State for 2016 amount to €2.2 billion. Some 87% of those liabilities rest with the HSE and Tusla, an amount of approximately €1.9 billion in terms of claims. It is patently obvious that litigation and the manner in which the State Claims Agency is operating is a huge factor in what has happened here and what has happened in other cases. Given the comments that were made earlier about the request to ask the Attorney General to settle cases without further litigation, how can the Minister stand over that in this instance and yet another arm of the State is actively defending cases in regard to the prescribing of Lariam, whereby not only is it defending the cases and adopting the exact same tactic but it is also continuing to prescribe that drug? What plans has the Government to deal with this whole area of litigation, how it informs itself on other legislative provision and the impact that this has had on open disclosure?

This is an important area on which my colleague, the Minister, Deputy Flanagan, and I are working together. We have already taken a number of steps, including, with the Minister and his Department, the Legal Services Regulation Act 2015, which provides for the use of pre-action protocols in clinical negligence actions, the Mediation Act 2017, which promotes mediation as an efficient alternative to court proceedings, and the much-debated Civil Liability (Amendment) Act 2017, which gives the court the option to make periodic payment orders for catastrophically injured plaintiffs. I note the State Claims Agency tells me that it settles 98% of clinical negligence actions out of court. The Deputy has raised an important issue. The State Claims Agency plays a very important role in this State and it plays an important role on behalf of all the agencies and Departments of the State. The action the Taoiseach has taken is prudent in this regard, namely, to ask the Attorney General to do a body of work with the State Claims Agency to examine if there is a better way in regard to this case to make sure women can get access to the information and the support they need without needing to go to court. I hope also that the independent clinical review I am putting in place will help women get factual information without the need to go to court.

None of those Acts and actions the Minister has taken have addressed the fundamental structural issues behind that. While I note some of the concerns of other Deputies about the HIQA inquiry, I am not necessarily opposed to it. However, I absolutely believe that if we are going to get to the bottom of this that we need something along the lines of the Cartwright inquiry in New Zealand. If the Minister does not know about it now, I ask him to look into it. It came off the back of a cervical cancer scandal and they took the whole system and changed the whole way they did business regarding particularly issues relating to women's reproductive health and they provided for individual input into the process. There are huge lessons to be learned there. I would like the Minister to give a commitment that he will examine that model - it is "Yes" or "No" answer in some ways - and also the Dutch model where we know an Irish woman was misdiagnosed in regard to cervical cancer in the Netherlands. However, the approach that state took was radically different from that taken here, and litigation hardly exists in the Netherlands.

I appreciate the constructive and reasonable approach the Deputy has taken to the HIQA inquiry. We all want to get to the answers quickly but we also want to make sure that we have a mechanism that can get to all the answers and the full ambit of them. We have had a useful beginning of the teasing out of this tonight. I hope after the meeting of the Joint Committee on Health tomorrow, at which Members will have an opportunity to question officials and to fill in other important pieces in terms of information, we could then have engagement with the Opposition. I would be happy to do that. I will look into what the Deputy has referred to in New Zealand. We always look to international reviews if they there can be learning from them. I will look at that overnight.

I will preface my comments by saying that in the 1960s, Galway had the first cytology service. In 1999, it was chosen as the laboratory to implement the first phase of cervical screening. We had an excellent service in Galway until it was deliberately run down. I also sat on a health forum. I remember distinctly at the time that I and my colleagues raised the most serious concerns about Quest Diagnostics, with which the Minister has reassured us tonight that there is no difficulty. We had the most serious concerns about the outsourcing. My question is : how many other cases are there arising from this audit or any other audit in regard to cervical cancer? How many other cases are ongoing or have been settled?

I am certainly not saying there are no difficulties with anything in this regard. I am factually letting the Members know the information that I have as I have it, in the interests of full disclosure.

Regarding that issue, working out the number of other cases, if any, is under way as is looking to see if there are cases that could potentially come down the tracks that we could avoid. The Attorney General and the State Claims Agency are working on that. I am happy to engage with the House once I have that information.

What information does the Minister or his Department have to date on cases taken that are exactly like the case we are talking about tonight? How many cases have been initiated? How many cases have been settled? How many have been subject to confidentiality clauses?

I am very conscious of not putting information on the record of the Dáil that I cannot stand over. My officials do not seem to have a recollection of any other case similar to this one that has been settled, but I would suggest that we could more wholesomely answer the question with officials at the Joint Committee on Heath. We will have to engage with the State Claims Agency to get the full details on that. I am very happy to share it with Deputy Connolly.

I think that information should be before us.

I am happy to share that with the Deputy.

I am not blaming the Minister. He is telling me he is not aware.

He should be informed. The Minister should be told what cases are in being, what cases have been settled and what confidential clauses arise. Is there a mechanism by which this information is given to the Minister by the State Claims Agency? I want an answer to that question.

I am informed there is no mechanism by which this information is given to a Department from the State Claims Agency.

Theoretically, am I correct that there could be five cases, ten cases, 100 cases or more in being and there is no mechanism for the State Claims Agency to tell the Department?

I have no intention of engaging in theoretics. That I have asked the State Claims-----

No, this is a question. The Minister's officials seem to be nodding to him. Is there no mechanism in place for the State Claims Agency?

I ask Deputy Connolly to state her case.

Okay. I am waiting for the answer because I have two more questions.

We cannot keep crossing back and forth.

I do not want to take the time but I want to try to answer the question. The NTMA is the State body which operates with a commercial remit to provide asset and liability management services to Government and it is designated as the State Claims Agency when it is performing claims and risk management functions. The NTMA reports directly to the Minister for Finance in the performance of its State Claims Agency functions.

Under the NTMA Act - this is important - the management of claims relating to the clinical negligence arising in State authorities is delegated to the State Claims Agency. As I have said, the State Claims Agency informed me that-----

My time will be up.

I know but the Deputy does not wish my answer to be put on the record.

I do. The NTMA appeared before the Committee of Public Accounts, of which I am a member. I am asking a practical question. What mechanism is there to report back to the Department and the Minister on claims arising from similar circumstances as this case? That is one question.

Mr. O'Brien stated he was unaware of this case until he read about it in the newspaper. Is that credible? If that is so-----

-----my question is whether there is a mechanism? How can a health executive learn if it is unaware of the case?

Am I allowed to ask a question?

The time for the question and the time for the answer are taken out of the same slot. We cannot allow-----

I would like the Minister to answer my question.

The Acting Chairman is taking more time than anyone.

Do not waste my time anymore, a chathaoirligh.

Acting Chairman, that is disgraceful.

The Acting Chairman is taking more time than anyone.

I ask Deputy Mattie McGrath to restrain himself.

The Acting Chairman is taking more than anyone.

The Deputy should restrain himself.

On a point of order, you are taking more than anyone.

The Acting Chairman is interrupting all the time. He is on show.

My job is to chair the session.

Yes, but he is making such a bad job of it.

My job is to chair the session. Deputy Mattie McGrath's job is to sit down and wait his turn.

I am sorry. We have 38 seconds now. The Deputy can have it anyway.

The Acting Chairman is filibustering.

A chathaoirligh, I want to make a point of order.

Deputy Connolly is out of order-----

There is another one.

-----on such a serious matter.

I will not engage in this. I will take it up separately with the Minister.

Deputy Connolly can do that. An t-Aire.

In the meantime, I would appreciate it if the Minister could answer the question.

I am in the hands of the House but there is no need for this to be adversarial. I am not in any rush, if there is a few extra-----

Tell the Acting Chairman that.

If there is extra time needed, I have no difficulty with that being provided here. Deputies are asking me important questions-----

Inform the Chair.

-----and I would like to be able to answer them. I do not want to be cut off in answering and I do not want to cut off Deputy Connolly in asking the question.

Tell him, not us.

Talk to your Chair.

I am sorry. I am just a Member of the House like everybody else.

The hour is over. According to the order of the House, that slot is now completed. If Deputies want to use it in raising questions and making speeches, that is fine.

The Acting Chairman is making the speeches.

The next slot is covered by Deputies Harty, Mattie McGrath and Danny Healy-Rae. I call Deputy Harty.

On a point of order-----

Deputy Healy-Rae goes first.

Okay, I call Deputy Healy-Rae.

On a point of order-----

First of all, I sympathise with Ms Vicky Phelan.

On a point of order-----

Stop the clock, please.

I am sorry. There is no provision in the order for stopping the clock or points of order. We will move on with the debate.

Why is there no provision for points of order?

We will allow each Deputy an equal amount of time to raise his or her question and get the answer.

I do not interrupt other Deputies.

That means two and a half minutes for the question and two and half minutes for the reply for each questioner.

I beg the Chair's pardon but that is not the order.

The Acting Chairman is striking a very discordant note. We had been having a good debate until he came in.

I will tell the Deputy what the order is. The order is: the main spokespersons for Fianna Fáil, Sinn Féin, the Labour Party, etc.,-----

It is a filibuster.

----or a Member nominated in their stead shall have not more than 15 minutes each for questions, during which each question and each reply shall be limited to two and half minutes. Deputy Danny Healy-Rae, I am sorry about that.

First, I want to sympathise with Ms Phelan and all the other ladies who were misdiagnosed. I also feel for and sympathise with all the front-line staff who work in hospitals and give their very best to patients when they come in to be seen, whether they be nurses, doctors and front-line staff.

I am disappointed with the HSE. People right across the country have lost their confidence in it. When a full and thorough investigation is carried out, will the Minister do something with the managers responsible, many of whom are getting big money? Will the Minister fire them or will they just get bigger pensions when they come to retiring? That is the question I am asking.

I cannot comment on the record of the Dáil about any individual's contract or pension entitlement. Such matters are set out in law.

That is the problem.

That may be the Deputy's view of the problem. Obviously, I cannot say that. What I will do - I think I have shown a determination to do so this week - is call it as I see it. I will share every bit of information I have with this House. I will work with the Opposition to establish whatever structures should be established to get to the bottom of this and I expect all officials, including in the HSE, to appear before the relevant Oireachtas committees and answer the many questions that require answers.

They should be sacked.

I will move on. The next question is from Deputy Harty.

Could the Minister tell me what is the reporting relationship between CervicalCheck, the HSE and the Department of Health and what is the chain of responsibility which led CervicalCheck to advise the treating doctor that it was at his or her discretion to make an open disclosure?

First, I thank Deputy Harty for convening a meeting of the Joint Committee on Health so quickly tomorrow. That is an important forum to have.

I was just clarifying the structure there. CervicalCheck reports to the National Screening Service, which reports into the National Cancer Control Programme which reports, to the best of my knowledge, to the chief clinical officer of the HSE who is the national director.

I apologise but I did not hear the Deputy's second question.

The other part of that question was: what is the chain of responsibility within CervicalCheck which led it to indicate to the treating physician that it was at his or her discretion to make a disclosure?

I can only rely on what I have read so far. Clearly, the clinical director of CervicalCheck was in correspondence with clinicians on what they should or should not do in regard to some of the audits. The clinical director seemed to have a liaison with other clinicians around the country but it is my initial understanding that the review needs to make that clear.

Could the Minister tell me why the action against the HSE was struck out in the court in Ms Vicky Phelan's case and what was the HSE's defence in that case?

I truthfully cannot. All I can tell the Deputy in regard to the case - the only information I have on it - is the information note that I received on 16 April that I have published. That is the full extent of the information that I have, other than what I have learned, in the same way the Deputy has, in regard to discovery documents and, obviously, the public commentary of Ms Phelan and others. I cannot provide the Deputy with any further information on that simply because I do not have it.

Can the Minister tell me what is the legal position of all those who have had false negatives and have not been informed?

There are two distinct issues. Deputy Harty, as a doctor, will appreciate there is obviously the fact that any screening programme will always have a number of false negatives and false positives. The issue I am concerned about is when individual women's cases were audited - we should talk about when individual audits of women's screenings were carried out rather than in the sense of a global audit - and that information came to the fore and why that information was not shared with the women. What I want to do is find a mechanism whereby we can: first, provide them with all the factual information, which I expect they would have had; second, provide them with an appointment with their clinician; and third, provide them with access to an international clinical panel that can objectively review their case, meet the woman and be co-ordinated by a liaison nurse. The Taoiseach, as he outlined in this House today, has asked the Attorney General to consider how we can best look at helping that cohort of women and I expect further developments in regard to that as we further establish the facts.

In regard to the outsourcing of testing, surely it makes sense that in a country this size we could provide in-house testing. Rather than spending considerable amounts sending samples abroad, surely we should be testing our cervical smears here in Ireland, thereby creating a bank of knowledge but also keeping the money in Ireland that is going abroad for these tests.

It makes perfect sense that there should be several laboratories in Ireland capable of providing these tests.

Instinctively I agree with the Deputy. I would like to see our own laboratories develop and be able to provide these services. I was not around in the political sphere, nor was Deputy Harty, in 2008 when these decisions were made. My understanding from reading back through the debate at the time is there was a view we did not have the capacity in the country. I note from CervicalCheck's website today, in the frequently asked questions it published, that it maintains the view we would not have adequate capacity in this country. It is not to say it should not be stress-tested, examined and looked at in the context of how we reorganise our lab services when we move to the HPV testing later this year which will, I am informed, result in the requirement for a new tender. I am informed, based on CervicalCheck's public information and from reading back on the debates at the time, that there was a view we did not have the capacity. Others would argue we did and it was run down but that is the advice given to me.

I salute the extraordinary courage of Vicky Phelan and all the women and families who have been dragged unwillingly into a scandal of enormous dimensions. As Deputy Healy-Rae and others said, I salute the front-line workers who are doing heroic work in the HSE and hospitals and everywhere else every day. It is an céad lá Bealtaine. In five days' time, the Minister will be two years in the job. He will have his pension entitlements, as will new Ministers. They are sticking like mud to a blanket to get their pensions and then the Government could fall apart. Does the Minister not accept the HSE is a totally dysfunctional, unaccountable and unmanageable outfit? Will the Minister give me his answer on that?

One day when I am not in the middle of trying to sort out a very serious health crisis that is worrying women right up and down the length and breadth of this country, I will come back and debate my record on women's health with the Deputy anywhere and at any time, and I look forward to that opportunity. Today my priority, rather than scoring political points, is trying to establish the facts, provide the support and build a better screening service. There is an awful lot of work we need to do in the health service. We have discussed it in the House many times and we will continue to discuss it. Deputy Shortall has shown leadership on this regarding the Sláintecare report. I am working on an implementation plan to get it to Government. Tonight is not a night for me to debate my record in the Department of Health or Deputy McGrath's view of it or for me to debate the Deputy's policy positions. There will be plenty of time for that. Tonight is a night for addressing the concerns facing the women of Ireland.

I reject that. Is the Minister going to wait until there are another 17 dead? Is he going to wait on the people dying on trolleys? It is not an answer; it is a cop-out. Deputy Harris is the Minister. The Government has collective responsibility under the seal of office handed to it by the President. The Government has to take some kind of action and not just give pipsqueak answers like that to score political points. I am not scoring political points. It does not give me any joy to have a 14-year-old child languishing on a children's ward for 11 weeks when she needs psychiatric treatment. The Minister of State, Deputy Daly, is meeting us tomorrow. There are other cases up and down the country. The lads behind me, Deputy Michael Collins, Deputy Danny Healy-Rae and Deputy Michael Healy-Rae are bringing bus loads up to Belfast to stop them from going blind. It cannot be done here. It is dysfunctional beyond the extreme. Any right-thinking person or second-class student would know it is not working.

Earlier today, the highly respected journalist, Gemma O'Doherty, who has done much to highlight corruption in the State issued a Tweet saying:

It has now emerged 162 women were NOT told their smear test results were wrong. 17 have died. @FineGael are ta[l]king about an enquiry. A functioning democracy with a decent [self-respect or moral compass and a functioning] police force would be talking about manslaughter, reckless endangerment, and imminent arrests.

We have become a banana republic. They can do what they like, people will die and the Minister will wring his hands and say he is not scoring political points. He is not fit for his job, he is not doing it and he has not done it. Will he resign?

I note the Deputy's comments. I fundamentally disagree with his comments and I intend to continue to do my job and discharge my duties to the best of my ability.

The Minister is not doing his job.

That is the Deputy's-----

He is not discharging his duties. Will the Minister sack Tony O'Brien? How many more scandals must he be involved in? He is going off in July with his big pension. He has a track record with the family planning agencies where there was no investigation into the blackguarding that went on there. He got a green light to go forward. The Minister wants to go out and canvass with Mr. Colm O'Gorman when he owes money to the State. He refuses to give back money. He is a law-breaker. It is okay for the Minister to go with him. I say to the Minister, as Cromwell said, to hell or to Connacht with the Minister because the people will do it anyway. Will the Minister sack him and will he go with him?

Thankfully it is a democracy we live in and not a world dictated to by the Deputy. The people will decide my fortunes and the fortunes of every Member of the House.

Níl mé críochnaithe. Of course it is a democracy. It used to be anyway.

I am democratically elected.

We are democratically elected. We cannot get an answer from the Minister. We cannot get him to take responsibility. He is terrorising people in hospitals every day of the week. It is to The Hague for war crimes the Minister should be brought the way he is treating people.

It saddens me to be here tonight talking on this issue but it is vital we learn from the mistakes that have been made. Last week we saw a brave woman, Vicky Phelan, who has been diagnosed as being terminally ill with cervical cancer being dragged through the courts to fight for her right to get the truth. Vicky Phelan had a smear test in 2011 that showed no abnormalities. While a later review found this was incorrect, the information was kept from Vicky Phelan for almost three years. In the court case, the State and laboratory used all their resources to fight against the brave woman and her family. This unfortunately shows how our State deals with vulnerable people. It is almost 20 years since the contaminated blood scandal became known and our State fully defended itself against these people, some of whom were on their death beds. Are there any other concerns with BreastCheck, cervical screening or bowel screening? Does the Minister have any concerns?

Deputy Collins raises a very important point about making sure when we are looking at the CervicalCheck programme that we also look at the implications for any other screening programme. I thank the Deputy for raising that important issue. Deputy Donnelly raised it with me yesterday. We will include in the scope of any review or investigation that we carry out, an examination of the implications for other screening programmes.

The audit of 2014, which there does not seem to be a report of, was an audit of individual cases. The information the Minister gave tonight is that all those cases have not been audited. Where did that information come from? Perhaps the Deputy mentioned it earlier. I may not have picked it up. Where did the information come from? How accurate is it?

I did answer it earlier but I am more than happy to answer it again because it is a very important question. I was advised by the Chief Medical Officer very shortly before I came into the Chamber this evening that the work of the serious incident management team, SIMT, the team that has been based in CervicalCheck looking through all of this issue, looking through the audits and ascertaining whether women had or had not been told, had come across this. It is the situation whereby all of the cases that CervicalCheck knew about - all of the cases of cancer - have been audited. That is where we get the 208 figure - it is the 208 where there was an issue raised and whether those women were told or not told. Those figures are now a matter of public record.

The issue is whether there are other cases of cervical cancer in the national cancer registry which had not been notified to CervicalCheck. The information provided to me by the SIMT tonight is that there are and there are likely to be a considerable number. This does not mean there are people sitting at home or anywhere else who did not know they had cancer. They are cervical cancer patients, people who have been treated or diagnosed with cervical cancer, but who never had the audit process because they were never part of the cervical check. Deputy Harty is a doctor and I am not. Some of them may not have had a screening history and some may have. That is the extent of the information I know. I expect it to be a considerable number of people and I expect the SIMT to be able to make significant progress on putting more information into the public domain very quickly. I am conscious that many of the relevant officials will be at the committee tomorrow.

Following on from that last question, we know that 1,482 cases have been audited. My understanding is the HSE estimates that 3,000 women were diagnosed with cervical cancer over the past ten years. What about the remaining 1,500 women? Is the Minister saying those remaining 1,500 women have not had their screening history audited?

I do not have a number and am not going to give a number to the Oireachtas that could be false. I think we all had the view when we got up this morning that every case of cervical cancer in the cancer registry had been notified to CervicalCheck but that is not the case, based on information given to me before I came in here a few hours ago. I have been here since and have not been able to secure further information. I expect it to be a considerable number. I do not disagree with the Deputy's mathematics for the number of people diagnosed with cervical cancer but I am reluctant to give out information that I simply do not have.

An appalling vista is certainly emerging. There is an even greater number of people who have not been audited.

That is why we need further information over the coming days. It is not enough for the Minister just to say he is setting up an inquiry.

Apart from the women who have been diagnosed with cancer, we are all very conscious of the thousands of women around the country who are very nervous about this and are beginning to question the validity of smear tests they have had. The Minister has given some assurance to people about services being available and retests. It was brought to my attention this evening that a person who made contact with CervicalCheck in order to arrange a rescreening of a smear received a message from the CervicalCheck website thanking her for her email and saying rescreening will be available and that it is currently assessing the impact of the Minister's announcement regarding rescreening for clients of the CervicalCheck programme. Further information on the implementation of this announcement will be provided in due course via the CervicalCheck website.

Would the Minister agree that response from CervicalCheck is completely unacceptable?

It is entirely unsympathetic and unhelpful for people who are worried sick about their potential condition and the validity of previous smear tests. Will the Minister undertake to get that message changed in the morning?

I absolutely agree it was unacceptable. Was that message sent today?

This is the information on the CervicalCheck website this evening:

Q4: Can I get a repeat cervical screening, before my next test is due?

The Minister for Health has announced that women can have a repeat cervical screening if they wish to do so. We will set this up shortly and will post details on as soon as possible.

Please bear in mind that cervical screening tests cannot be repeated within three months, to allow cells to grow back and to get the best samples, so you must wait a minimum of three months if you have had a recent cervical screening.

To reassure the person who has contacted the Deputy, the HSE's GP clinical adviser, Dr. David Hanlon, has been in contact with GP representative bodies. I expect the practicalities of how that will work to be posted on the CervicalCheck website this week.

I am sure the Deputy did not mean it when she referred to my simply setting up an inquiry and saying that is that, or words to that effect, that is certainly not what I am saying. Democratic accountability and the work of the Oireachtas committees, this Chamber and anywhere else should continue, and I will continue to give all the information I have when I have it. I will engage with the Deputy and her grouping, and others and their parties, on how best to put a structure in place to get these answers.

I read out a response to an email. That response needs to change rapidly.

The Civil Liability (Amendment) Act 2017 was passed last November. A key provision of the Bill was to force doctors to tell patients about mistakes that had been made but the Government introduced an amendment to make this voluntary rather than mandatory. The Minister for Justice and Equality recognised the input of his colleague, the Minister for Health, in changing that from mandatory to voluntary. Now, the Minister is committing to introducing mandatory disclosure. What has changed in the meantime and why did he think it was alright last November to suggest that he would water this down and move from mandatory to voluntary?

I am fully committed to open disclosure. A patient should always have a right to be provided with honest, open and prompt communication. That is already underpinned in the medical practitioners' code of conduct which is not exactly a flimsy document but I accept it does not happen on the ground and we have seen that in recent days. The idea was that in a Civil Liability (Amendment) Act 2017 we would deal with a voluntary open disclosure underpinned in legislation for all instances within the health service but the Minister for Justice and Equality said in the House, and I did say explicitly and in correspondence to Deputy Clare Daly last November, that we would proceed to mandatory open disclosure for serious reportable incidents and I have clarified now that will absolutely include screening.

That does not explain why that did not happen last November.

I am shocked that the 162 women at the centre of this scandal have not all been contacted. I expected after the Minister set up the expert group that those women would be contacted by Friday last. The number is 162 which should be a manageable number to make contact with. I cannot believe that five days later those women have not all been contacted. How many have not yet been contacted and can the Minister give us an assurance that tomorrow at the very latest they will all be engaged with?

I received the latest information before coming into the Chamber: 113 women had been contacted and offered appointments. I want every woman to be contacted very quickly and will provide a further update on the numbers tomorrow. I understand there may be difficulty contacting some people. I am not excusing that.

It is unforgivable.

The Minister intimated in a response to Deputy Kelly that he is moving to thinking that we would need a wider commission of investigation or inquiry. Does he think that would work best in conjunction with the HIQA inquiry or following it? What type of vehicle does he think would be most appropriate for that type of investigation?

I see validity in a HIQA inquiry. It has a track record, has built up significant expertise and has statutory underpinning. Under section 9(2) of the Health Act 2007 it has done a lot of good work, when it had those "teeth", for example, on the Midland Regional Hospital, Portlaoise, and the death of Savita Halappanavar. In respect of Portlaoise it not only produced a report but was then able to prove that, as a result of the report, maternity services were safer and better in the hospital. It has demonstrated great independence and an ability to do the work.

I am not, however, closing my mind to what other Deputies are suggesting in good faith. We should work on a cross-party basis in this respect. If there are concerns about broader issues or problems that cannot be captured by HIQA we should tease them out. That is particularly so in light of the fact that new information has come into the public domain this evening. It is important that we do that. I am open to discussing the sequence and what the different pieces may look like. I want to make sure we can get answers to all the questions that are legitimately being raised here. We could have some very useful engagement on this perhaps as early as tomorrow.

It appears that there is no difference between the number of false negatives or positives among those smear tests done in the US centres versus Irish centres. The point was made yesterday that the US one-year testing system is different from our three-year system. Does the Minister believe that is of consequence up to now, or to the quality of screening we were using?

I am informed by the Department that in the US a one-year smear is recommended but that is because it does not have an organised population-based health programme like ours. Many people in the US can be screened too often. It is similar to what happened here in the bad old days before we had a population-based programme, with some people being screened too often and some not screened often enough.

I appreciate the responsible way in which the Deputy asked the question. All of the laboratories being used are accredited and no quality assurance issue has been brought to my attention on that. That is important for women who are wondering tonight where their screen will be read. We can have a broader debate about the appropriateness of where it should be read but in terms of quality assurance that is an important message.

The Minister rightly said that shocking notes had been left on the files of those 162 cases where patients had not been informed. Has he had a chance to read the 46 where patients were informed? What characterised the different approaches, whereby a limited number of patients were given the history of the audit as against the 162 who were not? Is there any trend or pattern as to why some were informed and others were not?

I have no access to that information. It is a question we could usefully explore. Why did some doctors decide they should tell the women and others put it on the file.

When the serious incident management team was sent into CervicalCheck there was an expectation that the majority of doctors would have disclosed. I recall saying publicly in those days that expectation was not good enough in light of the Vicky Phelan case but still the expectation was that most doctors would have disclosed. This is clearly not the case and it raises serious questions about what I am concerned is a paternalistic culture in regard to information between women and their doctors. We need to get to the bottom of this and while open disclosure is important there are other issues we need to get into, including accountability.

We know that the senior management team at CervicalCheck agreed and signed off on a policy of non-disclosure. Does the Minister have confidence in that senior management team?

I have expressed my view on the management of CervicalCheck. I do not want the priority of my energies or, I would suggest, all of our energies to be placed in who should leave their job now. There is a time and place in regard to accountability. I want the priority in CervicalCheck to be on getting the answers, getting the information, contacting the women and getting the guidance up on how GPs could administer the repeat smear tests. There is a huge body of work that needs to be done in the coming hours and days and it is on this work I want the energies of CervicalCheck to be focused. I cannot currently express confidence. How can I? I came into this House tonight with new information that took Deputy Healy and I, and the whole country, by surprise. I cannot currently offer blank confidence cheques for people.

Mandatory open disclosure is an urgent matter. This House has been able to pass legislation at very short notice, often over night. Does the Minister have a timeline in mind for the urgent introduction of mandatory open disclosure?

I want to move towards mandatory open disclosure. I am sure it will come out in the review that we could have had a situation where doctors were replacing information on files to be given to a woman at her next appointment but given the lapse of such a serious period of time, clearly women were not told that information and this is not acceptable to anyone. I would like mandatory open disclosure for serious reportable incidents to become the law of the land. This is one of the practical things we can do as an Oireachtas, thus saying to Vicky Phelan and others never again will they not be told their information or, if they are not, it will be an offence. I will seek permission at Cabinet next Tuesday to draft that Bill. I have removed this measure from a larger Bill in the hope of getting priority drafting and, with the co-operation of Members of this House, having it passed as a priority.

Will the Minister consider the introduction of a compensation scheme for women affected by this scandal? While I understand the current urgent situation in regard to the identification of the issues involved in this instance, I believe that the HSE is not fit for purpose, has never been fit for purpose and I ask that the Minister give urgent consideration to this matter.

I thank Deputy Healy for his comments, which I note. I have clear views in terms of how we need to reform the HSE, including putting in place a board with real powers, which it would take me longer than the 27 seconds available to me to outline. I am moving ahead with many elements of the Sláintecare programme and I would be happy to discuss that with the Deputy on another occasion.

What about a compensation scheme?

I am sorry, that is a very important question. The Government has not ruled out redress. It first needs to ascertain facts. There is a group of people in respect of whom an arm of the State had information that was not given to them. In my view, this is wrong. Whether it is legally wrong is neither here nor there. We need to look at how we can support those people. The Government will make a decision in that regard in due course.

Acting Chairman (Deputy Bernard J Durkan)

We move now to speeches in respect of which I have a list of 12 speakers, whose speaking time ranges from one minute to five minutes. There will also be a five-minute wrap up by the Minister. The first person on the list is Deputy Fergus O'Dowd.

I congratulate the Minister on the open and frank manner in which he answered all of the questions put to him today. It is unacceptable that the Minister would be provided with late information by whomever is accountable. I praise Vicky Phelan for her courage, conviction and determination. Our hearts go out to her and her family for the battle she is fighting in terms of her health and to all of the women of this country.

The key message from Vicky Phelan is that cervical smear testing should continue. The Minister, Deputy Harris, has been listening. New, more reliable tests are to be made available to women. I welcome the commitment to mandatory open disclosure, which is essential at this time. I support the Minister in his view that he could not express confidence in the clinical director. It is right that she resigned.

I believe that the Department is not responding adequately to this crisis. Does the Minister need additional staff? Are there sufficient staff in the Department to ensure that when crises like this arise, there is a commitment to providing the Minister with all of the facts in regard to any possible questions he could be asked? A Minister should never have to come into this House to read a statement to the effect that new information has come to light which indicates that there are an undetermined number of women who may be in difficult positions over the next few days.

I would like now to speak about the question of the legal case. In this regard, I want to give an example of a person who suffered greatly at the hands of HIQA and the HSE, in respect of which his family is now going before the courts. A lady named Mary rang HIQA five years ago to complain about the state in which she found her brother in Cherry Orchard Hospital. He had a disability and he had a stroke and she found him strapped to a toilet covered in faeces. Later, her brother, David, died in a Dublin hospital, having been admitted there in such an appalling physical condition that the admitting doctor attacked the family for not having cared for him properly. The doctor was surprised when he was told that the man had been under the tender care of the HSE.

The family fought tooth and nail to get an inquiry into his death. The HSE set up an inquiry but as there was no doctor involved the family rejected it. A second inquiry was set up but the doctor involved left mid-inquiry. He refused to finish the investigation he was appointed to carry out.

There were then discussions, to which I was party, on the establishment of another inquiry to be undertaken by a specialist team from Scotland. The third inquiry involved Irish experts. Following on from that inquiry, the HSE accepted responsibility for what had happened to this man. What happened then? Nothing. This family now has to resort to the courts system to get justice for their family member. This is appalling and disgraceful.

There are other people who have been wronged by the HSE and the health services in respect of which the HSE has admitted responsibility but is not being held accountable. As in the case of Vicky Phelan, these people are being forced to go through the courts system. This is appalling. I spoke to the family this evening. For five years they have been fighting for justice with no success. The Minister for Justice and Equality, Deputy Flanagan, and the Minister for Health, Deputy Harris, must come together and insist that in cases where there has been an admission of liability, people are not put through this appalling situation.

This debate has been very worthwhile for the people listening in.

The memo to the Minister stated, "The National Screening Service and Jerome Coffey, Head of the National Cancer Control Programme, have advised the Department in writing that they do not consider this to be a patient safety incident but rather a reflection of the known limitations of the current screening test." Will the Minister make that written information available to Members as it could be important to the debate?

Vicky Phelan's courage in the face of deception of the worst kind by the HSE is nothing short of amazing. All women who have been affected must receive the best care possible. Trust on any issue is hard won and in this case the HSE has lost the trust of the women in the State.

The concept of screening the population for potentially life threatening disease was forward thinking. Who, however, can trust a system when those responsible for running it have deceived patients and dragged them through the courts? Those within the HSE who are responsible should be ashamed of themselves. We must be very clear in this House tonight that no other women should have to enter into a legal battle with the HSE to get the truth about their medical records.

I wish to put onto the record of the House how much I admire Vicky Phelan. She is a strong woman and a very courageous woman. I send her my sincere best wishes.

I am a member of the Oireachtas Joint Committee on Health. At 2.30 p.m. tomorrow we will go through this issue in full detail. As the only female Oireachtas Member in County Cork and Cork city, I feel compelled to let the Government know how hurt and worried are the women of Cork and Ireland. What does the Government intend to do to instill confidence in the screening services and in the health services in general?

I extend my most sincere thanks and good wishes to Vicky Phelan. I wish to put on the record that she has done the women of Ireland a most heroic service.

Ten years ago in this House I stated my concerns, on behalf of Sinn Féin, about the process of privatising cervical cancer screening tests. That concern, unfortunately, rings true today and with the most distressing of consequences for so many women.

Questions remain and I would like them answered for the record. At which laboratory or laboratories were these screenings misread? I heard the Minister's comments earlier in this regard but I disagree with him. If these tests, or a significant number, are specific to one particular laboratory, then serious consideration should be given to ceasing any contractual arrangement with that entity.

I had intended to ask the Minister if we are absolutely at the end of this scandal and if he could clarify, without any ambiguity or doubt, if the 208 cases that had been identified will not increase in number. The Minister has now told us it is likely that it will increase. Who knew this and did not inform the Minister - as he has said - until shortly before he came into the House this evening? Who knew that information?

The Minister, Deputy Harris, has indicated that he was made aware of the then impending scandal on 16 April. The State still callously forced Ms Phelan to attend a court hearing to defend herself. How could those in the employ of the Minister and the State have been so cruel? Why was a stop not put to that immediately? I put it to the Minister, Deputy Harris, and Members of the Government who are in the Chamber, that I am tired of coming here to listen to litanies of "Sorry" to victims of scandals. "Sorry" is not good enough anymore. People want to know what is going to be done about it. People are listening to hear who is going to be held responsible. Somebody must be made accountable or else, assuredly, we will find ourselves back here once again responding to yet another tragic episode in the State's disgraceful relationship with the women of Ireland.

I had misunderstood the speaking situation this evening. I thought we would still be able to ask questions, but obviously it is statements at this stage.

The fundamental issue that goes to the core of the matter is the withholding of vital information. Why was Ms Phelan's doctor not told of the mistake with her case until 2016? The audit had identified that the issue took place in 2014. A key question is who took the decision to withhold this vital piece of information for two years. This is the nub of the issue. Who made the decision to allow Vicky Phelan to walk around for two years thinking she was cancer free when she could have been undergoing treatment? This is a simple question but it goes to the core of the issue.

The note received by the Minister from the HSE, which I am sure the HSE never expected to be circulated publicly, is an absolute insult to the Minister for Health. The note informed the Minister of the 2011 falsely reported negative screening test. The note informed the Minister that a routine screening in 2014 detected high grade abnormalities and that the patient was diagnosed with cervical cancer in July 2014. Why did the note not inform the Minister that neither Vicky Phelan nor her doctor were told of this diagnosis until 2016? The note to the Minister told him certain specifics but it left out the fundamental issues. The note never alluded to the other 207 cases that had emerged. I am stunned by this note. What is not included in the note is as important as what was included. The note then had the audacity to suggest a quote for the Minister of Health about Vicky Phelan who has a terminal illness due to inaction by the HSE and by withholding information. The quote suggested by the HSE for use by the Minister was: "I acknowledge the severe distress that this issue has caused to the patient involved, and to her family." This is cold comfort to Vicky Phelan, to her husband, to her two children and to her extended family. This cold culture of secrecy and the arrogant and unfeeling attitude in the HSE will have to change. It is absolutely sickening that Vicky Phelan was dragged through the courts because of the HSE's inadequacies.

The deaths have occurred of 17 women because they were given the all-clear following smear tests for cervical cancer checks. Since last Saturday some 8,000 women have contacted the HSE helpline because of these deaths. Out of the 17 women who died, 15 did not know of the misdiagnoses.

As with other issues such as the mother and baby homes, the Magdalen laundries and the hepatitis C scandal, the 208 women who were diagnosed with cervical cancer should have received earlier intervention. Of these women, 162 were not notified that an internal review of their cases had been carried out by CervicalCheck. They should have been told and they had a right to know. Vicky Phelan was one of these women. It is because of her courage that we are finding out what has happened. I pay tribute to her.

I am delighted that the Minister has confirmed that the Health Information and Quality Authority, HIQA, will conduct an independent inquiry into these women being given the all-clear results. They need answers.

CervicalCheck began in 2008 and more than 3 million smear tests have been performed. This has led to some 50,000 treatments for pre-cancerous cells. We must review all screening programmes regularly. Screening is the best way to detect cervical cancer. The screening programme has saved the lives of many women and we must reassure women that it is essential they continue to attend to have their smear tests. Vicky Phelan has said that she wants women to continue to go for cervical smear tests. It is very important that women get their smear test results and also the results of their back reviews.

Appropriate treatment of pre-cancerous changes to cells prevents 90% of all cervical cancers, as evidenced by a 7% decrease per year in cervical cancer in Ireland. Five times more women would die from cervical cancer if we did not have a cervical cancer screening programme. The cancer screening programmes, offered through the HSE National Screening Service, aim to detect cancer as early as possible, leading to better treatment options and outcomes for patients.

The Deputy's time is up.

I have three minutes. A member of my family had a smear test at Louth County Hospital in Dundalk. She went to her local GP. She was very nervous.

Go raibh maith agat.

The staff and doctors did a fantastic job. The good news was that she got good results.

Go raibh maith agat.

I have three minutes left. I have three minutes done so far.

The Deputy has exactly-----

I have three minutes to speak.

The Deputy has exactly three minutes and other Members, who will only have one minute each, want to speak. I call Deputy Breathnach.

Go raibh maith agat, a Leas Cheann-Comhairle.

The Deputy is welcome.

Excuse me one minute. Deputy Fitzpatrick should not make any inference. He got his three minutes.

The speaker before me had two minutes and the speaker before had four minutes.

The Deputy had three minutes.

Please check the record. I was allocated three minutes. I did not get my three minutes. I do not have a problem with that and I do not mind other people speaking. Please check the time. The Leas-Cheann Comhairle is totally wrong. It is very unfair that I was rushed in making my speech.

I had three minutes to speak. I did not get my three minutes.

Please check it. The speaker before me had two minutes to speak and, fair play to her, she got over four minutes.

As far as I understood, the Deputy had two minutes. Sorry about that.

It is not fair. The Leas-Cheann Comhairle accused me of being wrong when I am not wrong.

I am not accusing the Deputy of anything. We are wasting time now.

A Leas-Cheann Comhairle-----

I will check the record. If Deputy Fitzpatrick had three minutes, he has another 30 seconds.

Can the Leas-Cheann-Comhairle check the position?

The Deputy has another 30 seconds.

The Minister has stated that every action possible will be taken to ensure that this does not happen again. Our Government must move swiftly to establish the facts, restore confidence in cancer screening and ensure that this does not happen again. What happened to these 208 people should never have happened. I have full confidence in the Minister ensuring that this will never happen again.

Some say that doctors differ and patients die. Others say that doctors differ and patients survive. The core issue is that the public, the women of Ireland and, indeed, this House deserve answers in respect of this saga. Deputy Donnelly spoke about the need for clearer communication. I have no doubt that, in her humility and suffering, Vicky Phelan would like us to seek solutions in order to ensure that solutions will be found to the problems that have arisen in respect of smear tests. Is the Minister in a position to give new confidence to the ordinary women of Ireland? Can he reassure the House not only that the rescreening will be offered to all women involved but also that, particularly for those who are concerned, current smear test samples will be the subject of retests, and that there will be clear individual timelines in this regard. What steps will he take to ensure that the results of medical tests - whether smear tests or others - and what is often described as bad news for patients will be conveyed truthfully in the context of all diagnoses, and that this will be enshrined in a patients' charter of rights?

To be fair, we must thank the Minister for immediately bringing whatever information has come to hand to the Dáil. We must commend the bravery of Vicky Phelan. Even in her recent interviews, she mentions her determination to keep fighting this terminal disease. We wish her the best. One of the issues is the need for mandatory disclosures. We, as legislators, should set about dealing with that matter as soon as possible.

There are 113,790 women in my county, Kildare, and I know that every one of them stands with me as I speak here in solidarity with the brave, tenacious and courageous Vicky Phelan, who has done the State and the women of the State some service in uncovering this horrific scandal. We cannot begin to imagine how Vicky and her family feel, with the fact that her lifetime is potentially being cut in half. It is completely unacceptable that she and her family have had to go to the courts to uncover information which should have been provided to them as soon as it came to light. Their treatment by the State has been shameful and deplorable. We all need to know why Vicky's doctor was not told of the mistake in her case until 2016, even though that mistake was uncovered in 2014. We need to know who took that decision to withhold this vital information for two years. We need to know why information was withheld from families of patients who passed away from cancer. The CEO of the HSE said yesterday that he knew nothing about this case until he read details relating to it on the RTÉ News website. We need to know who in the HSE knew about this matter.

I understand that the HSE has received 6,000 calls in the past two days. Many women are very concerned. Many women who cannot get through to the helpline have contacted me. The helpline is ringing out. There is much concern. We need to help, support and reassure women with their concerns. I welcome the move to set up an independent investigation into the CervicalCheck scandal. We need full disclosure. The news that, following an audit of 208 cases, more than 17 women have died is truly shocking. That over three quarters of the 208 women whose cases have been examined by this audit were not told they had delayed diagnosis is scandalous. The issue that the Minister raised tonight, that an audit was not carried out in 1,518 cases, is appalling. There can be no more secrecy. We need full disclosure.

I have a couple of quick points. I thought there would be questions but that will not be the case. The Minister can take them as questions and come back to the House later. Why is the State not paying the €8,500 every three weeks for Vicky Phelan's treatment? She is doing that out of her own pocket or the goodwill of friends and family through a GoFundMe page. We need to do something about that. My second question relates to GP surgeries. I know from a family involved in that area that surgeries are being inundated with recheck requests. If somebody had a smear test this morning, yesterday or last week, is it going to the same laboratory in America? If it is and it was me, I would be a bit apprehensive. The problem is clearly with the laboratories. Before we even start the investigation, we know that a good proportion of the problem lies there. How can we give people confidence? I am of the view that the Minister needs to make a statement to the effect that one third of the activity is in the Coombe and the other two thirds are elsewhere. Are tests still being sent to the same laboratory with which there was a problem?

I heard a statement from the State Claims Agency on "Morning Ireland" earlier with which I fundamentally disagree because it is not borne out by the facts. The agency was referring to the level of compassion shown to patients and that it is fully understanding of this in the context in which legal fees are pursued. That is nonsense. We all know that the State Claims Agency's default position is to throw people under the bus, to use taxpayers' money and to throw good money after bad. That is borne out in media reports from earlier today which indicate that a child born in 2009 has been awarded a settlement of €9 million. How many years has the family involved had to suffer in order to obtain that settlement? This is nothing new. We need different protocols for how we approach claims from the point of view of the State, whether in the context of a health issue or otherwise. While the State cannot be an easy target, we cannot throw good money after bad just because we blindly say that the State is right. There is no compassion in doing so and that is why I do not agree with the statement this morning.

I do not care who was Minister with responsibility for health in 2000 or who has served in that capacity in between. We all know there were four or five from different parties. Irrespective of what is going to happen at a prospective inquiry, I ask that an examination be carried out in respect of all emails relating to this matter - from each Minister to each Minister and relating to CervicalCheck - in order that we might discover who knew what and when. I have no interest in going up the hill in two weeks' time against a former Minister or the current incumbent because certain issues may come to light. Let us have that matter examined now, get the information out there and see where we stand.

I thank the Minister for his replies so far about this concerning issue and for the swift explanation of the facts. I am sure he is aware that many women are seriously concerned and are seeking clarification from public representatives in respect of a wide range of issues. All of these women are suffering as a result of the uncertainty that exists. Will the Minister outline how many of university hospitals throughout the country are involved. It has been mentioned in the media that Sligo is one of the hospitals affected. That has given rise to more concern among women in my constituency of Sligo-Leitrim and their counterparts in Donegal. Would the Minister agree that despite the good work those responsible for this fiasco may have done in the past, they need to be brought to book by the State in order that real accountability can be restored within the HSE? Although the clinical director of CervicalCheck has since stood down, there are definitely more individuals in the various management structures who need to consider their positions.

I thank Deputies on all sides of the House for contributing to this constructive and very important debate and questions and answers session. Regardless of any statutory or other inquiry that we set up, it is very important that the women of Ireland saw that the Oireachtas has spent so many hours rightly discussing this issue in a constructive fashion to determine how the facts will be established, how a better screening programme will be delivered, how we will get answers for the women who need and deserve them, and how we will ensure accountability in that regard.

I assure the House of my determination to work with Members on all sides of the House to devise the best possible mechanism to get the answers the women of this country need and deserve in the most expeditious manner possible. The Joint Committee on Health will tomorrow have an opportunity to scrutinise in detail several of these issues with representatives of my Department, the HSE, the national cancer control programme and CervicalCheck. It is an important opportunity as we continue our work as an Oireachtas. I hope that, thereafter, we can have a cross-grouping bipartisan engagement on how to ensure that we have a statutory inquiry which can get answers in a quick and expeditious manner while also having enough of an ambit or remit to address all necessary issues.

I wish to end as I began, by thanking Vicky Phelan for her courage. However, I know that she does not want platitudes from me or anybody else but, rather, she wants action. I wish to assure her that we have started taking swift actions and I hope Members will work together to take several more swift and decisive actions in the coming days, including: mandatory open disclosure legislation; the establishment of a statutory inquiry; a protocol on information such that any woman who wants a repeat smear test can get one; moving towards HPV testing in October of this year; and ensuring that women are automatically informed of information to do with their own medical records. Ms Phelan stated outside the court and to me that she wished to ensure something good comes from the horrific situation that has been experienced by her, her family and now, sadly, other families. I wish to assure her and all Members that I will work day and night to ensure that happens.