National Cervical Screening Programme: Statements

I thank the House for providing the opportunity to provide an update on matters relating to CervicalCheck, to speak about the progress that has been made to respond to the issues raised while driving continued improvement in the service, and to respond to questions Deputies may have.

Crucially, the screening service has continued to focus on continuation of a programme which, despite the failings which emerged, has reduced the burden of cervical cancer for women in Ireland. Cervical screening saves lives, and we must and will keep that at the forefront of our minds. Members will be very conscious of the impact of this disease and of non-disclosure on the 221 women and families affected. Supporting these women and families has been a priority for me, and the Government decided to ensure that a package of primary and social care supports would be made available to this group. The HSE now has an established and stable process in place to ensure that these supports are being provided.

In December, the Government agreed to establish an independent statutory tribunal, chaired by Ms Justice Mary Irvine, to deal with claims arising from CervicalCheck. My Department is working on drafting heads of a Bill, and this is a Government priority and therefore is included in the spring legislative programme. I will also shortly seek Government approval for the establishment of a non-statutory scheme to provide ex gratia payments for the women affected by the non-disclosure of the audit. This will be an important development where the State will accept its responsibility in respect of non-disclosure and make ex gratia payments to the women and families affected.

Separately, the independent expert panel review, which is being carried out by the Royal College of Obstetricians and Gynaecologists, will provide much-needed clarity and independent clinical assurance to the women involved. More than 1,000 women have consented to be included in the review, or approximately 63% of those eligible to participate. This is a very welcome level of participation and allows for a robust and comprehensive aggregate report to be provided. There will be an individual report for each woman. I am pleased to say that the transfer of slides for the cytology phase of the review has begun.

When the issues first arose in connection with CervicalCheck, the Government acted quickly and worked with the Opposition to establish a scoping inquiry led by Dr. Gabriel Scally, a renowned expert in public health. I must acknowledge that it was with the input of Oireachtas Members that the scoping inquiry and its terms of reference were established. With his report, Dr. Scally brought much-needed clarity to the CervicalCheck issues and also to the limitations of screening and audit. This clarity and understanding is crucial if we are to address effectively what went wrong. In September, when I brought the report to Government, I committed to returning to Government within three months with an implementation plan for all of Dr. Scally's recommendations. In December, following Government approval and Dr. Scally's consideration and analysis of the implementation plan, I published it with 126 actions for all 50 of these recommendations. These actions cut across a wide range of relevant areas: women's health, the issue of organisation and governance, laboratory services and procurement, open disclosure, cancer registration, other screening programmes, and resolution. My Department, the HSE and the National Cancer Registry of Ireland, in particular, all have important work to do on implementing these actions.

I am very pleased to report that Dr. Scally has reviewed the plan and commended the commitment it shows as well as the work done to date. This level of independent scrutiny provides very welcome assurance about the plan, which sets out an ambitious programme of work and a necessary one. Dr. Scally said to me last week that this is the first time he has been asked to oversee the implementation of recommendations from a report he has done on something that went wrong. He very much welcomes that involvement and I am very grateful for it. I intend to publish updates regularly on progress on implementing these actions, and in fact implementation of many of these recommendations is under way.

The establishment of a new independent patient safety council is a key action in the Scally implementation plan. Its first priority will be to undertake a review of all open disclosure policies, so that one approach is consistently applied across the whole health landscape, and that we put in place an optimum environment for the operation of open disclosure. The proposed membership and terms of reference of the independent patient safety council are being progressed as a matter of priority. It will include strong patient and public representation and international patient safety expertise. In addition, there can be absolutely no ambiguity about informing patients of serious adverse events. That is why, in bringing forward the patient safety Bill, we are providing for mandatory open disclosure and mandatory reporting of serious incidents. This Bill was approved by the Government in July, and in September underwent pre-legislative scrutiny in the Oireachtas Joint Committee on Health. It is currently undergoing drafting, and I want to be in a position to introduce it into the Oireachtas as soon as possible.

A further key priority is the establishment of a national screening committee this year, and my Department is actively engaging with the UK National Screening Committee as part of informing the process of establishing this committee. Dr. Scally has committed to providing a supplementary report into certain further aspects of the laboratories such as procurement, quality and accreditation arrangements, and governance structures. I expect to receive Dr. Scally's further report in the coming weeks, and it is my intention to give full and detailed consideration to any further recommendations it provides.

Members will recall that Dr. Scally provided valuable assurance on the quality management processes in our existing labs, and the HSE negotiated tirelessly in complex circumstances to ensure extension of laboratory contracts to allow for continuation, which was crucial for Irish women. We could not have had a situation where the screening programme stopped. In tandem, the HSE has been working to address the significant capacity issues we have following on from the much greater levels of screening in 2018. This is an issue that will take time to resolve, and I have always been clear on that. It is not a question of additional resources. If that were the solution, we would not have a problem. There is a global challenge in cytology capacity which impedes the HSE's ability to source additional capacity easily. The key priority now is to address the backlog and stabilise the programme, and the HSE is developing a capacity plan which I hope to receive in the very near future.

I want to take a moment to contradict assertions made in this House with regard to my decision to offer women the opportunity of a free repeat smear test where their GPs felt it was appropriate. It is not the case that I was advised against this decision; quite the contrary. I have set out the rationale for and context of this decision many times. Many thousands of women contacted the CervicalCheck helpline. Requests for additional supports and reassurance were considered in this context, including the provision of an opportunity for a GP consultation for women who wished to discuss their request for a repeat smear. GPs also contacted me about this, and the offer was welcomed at the time by Deputies on both sides of the Oireachtas. A fee to provide for this free repeat smear was agreed with the Irish Medical Organisation. This was discussed with and agreed by my senior officials, including the Chief Medical Officer, at the end of April and was followed by a Government decision on 1 May. To those who persist in saying that I acted against official advice, that is incorrect. They have misled the Dáil and stated incorrect information on the record of the Dáil. They need to stop doing that because it is not helpful in assuring women of the decision-making process that we all took in good faith.

The level of uptake shows that many women were seeking this reassurance. However, the backlog which has arisen is not solely due to the repeat smears but also - and this is a welcome development - because of an increased uptake in the programme generally. I have acknowledged many times, including in this House, the difficulty of the backlog, of which there is no doubt, and the priority with which this is being treated. It has also been asserted that I ended the provision of free repeat smear tests in December because of issues related to the expiry of tests. This was said on the record of this House. This is also untrue. I approved the cessation of the free out-of-cycle smears in October, at which point the HSE, as it was responsible for the operation of the system, proposed that as tests would at that stage be scheduled into December, the arrangements would run to the end of the year. I followed official advice on the cessation of the programme post the publication of the Scally report. I followed that advice in October with a programme of repeat smears ending in December.

I want to clarify again that the backlog is separate to the issue which has arisen with Quest and secondary HPV testing. It relates to cervical smear tests where secondary HPV testing is required and the timeframe within which that secondary test should take place. Of the approximately 500,000 samples tested by Quest since 2015, the HSE has advised that some HPV tests have been performed outside of the recommended 30 day timeframe in that laboratory. The HSE advises that, subject to final confirmation, approximately 4,600 women are being called for a retest, and that the vast majority of letters to these women have now issued. The director general of the HSE put information on the record of the Joint Committee on Health this morning. The HSE has advised that clinical research shows that HPV tests remain effective even when they are performed outside the recommended timeframe and that there is little risk of inaccuracy due to the issue that Quest has identified. Indeed Dr. Peter McKenna has said on the record and in the media many a time that the clinical risk was exceedingly low. These tests will be processed by the laboratory as a priority.

Last week I had the honour and privilege of spending much of the afternoon and evening with the wider 221+ patient advocacy group.

I was very glad to have an opportunity to meet with the group face-to-face and to listen to its members. I sincerely thank them for taking the time to attend in large numbers, for telling me their stories and experiences and for sharing information about their personal lives in order that they can be sure that my officials and I have the best possible understanding of the impact of this awful disease and of non-disclosure on their lives. This meeting and all of my interactions with affected women and families underlined for me the need to keep the interests and health of the women of Ireland to the forefront of all our minds. I know that is a goal we share. This is why my focus is, and will firmly remain, on supporting these women and families and on the continuation and improvement of the cervical screening programme. We can and must make it our aim to effectively eradicate this awful disease. We can do that through the measures we are taking here and the measures we will take together.

Deputy Stephen S. Donnelly

I will be sharing time with Deputy O'Loughlin. I will focus my attention on the latest developments concerning the CervicalCheck screening programme and, more particularly, on the long delays that are being experienced by women all over Ireland. I would first like to take the opportunity, however, to acknowledge the women and families who came forward last year. Putting themselves into the public domain to champion this cause was not an easy thing to do. Actions like this come at a cost. They require bravery and perseverance. I would particularly like to acknowledge Ms Emma Mhic Mhathúna, who tragically passed away in October.

We all hoped that the issues surrounding the CervicalCheck screening programme would be resolved last year, and I acknowledge that genuine progress has been made on the issue of non-disclosure. We are, however, now facing another serious issue. Today women in every corner of this country are waiting for the results of their own smear tests. While just last year it took a few weeks to get these, it now takes many months. There are four questions I would like to ask on this issue. Just how long are the delays women are facing? Do these delays pose any clinical risks? What is causing these delays? Could these delays have been avoided?

Let us start with what we know about the delays. Up to last year, women typically waited two to four weeks for the results of a smear test. The HSE tells us that the waiting time is currently 22 weeks, which is almost six months, from the time of testing. My understanding is that there is variance around the country and that some women are waiting more than six months. Late last year my colleague, Deputy Lisa Chambers, uncovered that approximately 1,000 women needed to be retested because their samples had expired. They had not been put onto the slides quickly enough. We then found out that an additional 4,600 women would have to be retested. These women have what are called low-grade abnormalities and therefore have to receive HPV testing. The HSE advises that, due to the delays, these samples were not tested within the required time and that retesting is required. Added to this is an as yet unknown number of women who may have more serious diagnoses and who are potentially waiting longer than six months to get the results of their tests.

In light of all of these delays, we need to know if there are risks to patient safety. When the CervicalCheck scandal broke last year, loose language, some of which unfortunately originated from Leinster House, caused very serious and unfounded fears about the clinical impacts of non-disclosure. I therefore want to be very careful in what I say here this evening. I am making no assertions about clinical links between the delays and treatment or any other issues for the women affected. Rather, I would like to pose my questions to the Minister and ask him to provide a detailed response not for me, but for the many tens of thousands of women around the country currently waiting, many of whom are genuinely concerned about these delays.

The Minister stated yesterday that there was an exceedingly low clinical risk for the 4,600 women who need a recheck. Will he expand on that? How many of the women who are found to have more serious diagnoses, including high-grade abnormalities or worse, have been waiting many months to receive these diagnoses? If they are diagnosed with high-grade abnormalities or worse, does a delay of four, five, six or seven months matter clinically? If so, to what extent does it matter? I will leave the clinical issues at that. I just want to ask the questions, but the women involved need some very detailed responses to them.

The third issue I would like to address is the cause of these delays. In April of last year the Minister announced that any woman who had concerns about cervical screening could avail of a free repeat smear test with a registered CervicalCheck GP. This was done, as the Minister said, as part of efforts to reassure patients. The free rechecks started on 1 May and finished on 31 December. I want to be very clear; I welcomed this, as did many people in the House, as a part of reassurance efforts. However, I welcomed it with the understanding that resources would be put in place to deal with the additional demand. It would appear to be the case that such resources were not made available or could not be found. CervicalCheck usually processes approximately 250,000 screening tests a year. In 2018 there were an additional 84,000 tests. The HSE has referred to this as unprecedented demand and it led to a total of approximately 350,000 tests last year. The mid-west region saw an increase of 300% in referrals for further examination by October. Sufficient additional resources were not put in place.

While I accept that had the Minister not made the offer, it is highly likely that the demand for testing would have increased anyway based on concerns, the amount of coverage cervical screening had received and on women finding out the information on the leaflets was misleading. These leaflets said that the test was not 100% accurate when describing its accuracy as 70% would have been more accurate. It is, however, reasonable to conclude that at least a portion of the additional demand was due to the offer of free testing. It is also reasonable to conclude that the additional material demand on the system contributed, at least partly and probably very materially, to the delays experienced. This link has been backed up numerous sources including the laboratories, the clinicians, and the CervicalCheck team itself.

This brings us to the final issue. Should the offer of retests have been ended more quickly, thereby addressing the lengthening delays and any potential related clinical issues? As the Minister said, it has been alleged that he acted against official advice and that he was advised repeatedly to stop the tests as they offered no clinical benefit and were overloading the system. Yesterday the Minister strongly refuted those claims, and has done so again today. He said:

The charge was that I offered free repeat smear tests to women against official advice. That is false.

I remind the Deputy that he is sharing time.

Deputy Stephen S. Donnelly

I will be sharing one minute at the end. I thank the Acting Chair. The Minister went on to say, "That decision was made in conjunction with my officials, including the Chief Medical Officer, and it was supported by Opposition politicians". As an Opposition politician, I will accept that it was. The Minister also said that he accepts that this "has caused a backlog, which cannot be easily fixed merely by resources," and stated: "It is not true for Members to state in this House that the repeat smear test was offered against official advice." That is the Minister's position.

I would like to put a point to the Minister to get his response. These charges were made based on documentary evidence seen. In the interests of full transparency, I will put the evidence to the Minister and then he might respond. On 15 June the chief executive officer of Sonic Healthcare, which runs the laboratory in Sandyford that deals with approximately half of the testing in the country, wrote to the Minister saying that urgent intervention was needed to cope with the increased demand after the announcement of the free rechecks. Dr. Colin Goldschmidt wrote that there had been a fivefold increase in requests for smear tests which was resulting in "increasing delays in the delivery of results to CervicalCheck". That is the chief executive officer essentially asking the Minister to stop the smear test rechecks. I believe he offered to fly to Dublin to meet the Minister in order to talk that through.

In August 2018, GPs wrote a letter to the National Screening Service, which was copied to the Minister and the Taoiseach. The GPs warned that a chronic backlog is cervical cancer smear tests was putting the quality and accuracy of the checks at risk. On 15 October a gynaecologist located in the mid-west region warned the Minister that his announcement of free repeat smear tests was "dangerous" and put the CervicalCheck screening programme at risk.

On 21 October, the CervicalCheck project team wrote to the Minister asking him to end the offer of the free smear rechecks as it was putting pressure on the healthcare system. On 24 January, the Taoiseach admitted in the Dáil that a significant number of women taking the repeat smear as well as the regular test had led to immense pressure on lab capacity. I believe we will have time for responses from the Minister in this debate. That is the evidence and the basis of the allegations made.

My colleague, Deputy Donnelly, has asked four very clear, concise and pertinent questions and we look forward to hearing the Minister's response. No one in this House can underestimate the trauma, hurt and anxiety that was caused to women last year because of the scandal of the CervicalCheck programme and the withholding of information from women and their families. We also have to note that public confidence in the CervicalCheck system has been shaken and the trust of thousands of women has been breached.

We recognise the bravery of and pay tribute to Vicky Phelan, who did so much work to bring this to our attention. It is completely unacceptable that she and her family had to go through the courts to find out information that should have been provided to them in the first place.

I am sharing time with Deputy Ó Caoláin. I thank those women and their families who came forward. I remind the House that the State wanted Vicky Phelan to sign a non-disclosure agreement. Due to that non-disclosure agreement being resisted, information came into the public domain. Now everybody says we all are in favour of such information always being in the public domain but let us be under no illusions. The outcome of that court case could have been very different. It could have been a secret and we might never have had the opportunity to have the conversations we have had. It is a testament to that woman and her family that we have that information in the public domain. That women still continue to go to court is testament to the fact that not everything that was promised was delivered on.

I spoke to the Minister yesterday on this matter and he elaborated on the situation in some detail. I am conscious that there may be a certain amount of crossover with this evening's debate but I do not think that will do any harm.

On 5 December, the Minister told us he was informed by the Department of Health that this issue had arisen and that the HSE was establishing the facts. He then received subsequent interim updates, pending the completion of the work of the expert clinical team and the final confirmation.

As I said yesterday, the National Association of General Practitioners, NAGP, wrote to the Minister to outline the backlog in August of last year. That was a fairly strongly worded letter that came from Maitiú Ó Tuathail of the NAGP. However, it does not appear that the Department or the Minister's office acted on the concerns that were raised therein. There are four months between when the NAGP wrote to the Minister and when he advised that he had this matter in hand.

What work did the Minister and his Department do to proactively ensure that a backlog did not build up? We know that on average, the service tests 230,000 smears each year. The extra tests amounted to between 90,000 and 100,000, which is about a 43% increase. Did the Minister speak to the labs at any stage? Did he find out if the additional capacity was going to be there? The Minister referred yesterday to the "Jade Goody effect".

Once awareness of an issue like cervical cancer is raised, notwithstanding the problems, demand is going to go up. That was already known, yet it does appear that no work was done to ensure that the capacity existed. It was very easy to see that there was going to be an increase in demand yet it seems no work was done to ensure that the extra capacity was added. Extra capacity was going to be needed. It is not good enough for the Minister to say there is a worldwide shortage of cytology practitioners. Realistically speaking, that is information he could and should have had before he made the promise and commitment.

We agreed that guaranteeing free smear tests for all women was a good idea. However, it is not up to us in opposition to ensure that the conversations take place to make sure the capacity is there. We did agree it was a good idea; it was a good idea. Getting screened is a good idea, getting a smear test is a good idea, having confidence in a smear test is also absolutely imperative. Public confidence in the screening programme has been knocked. I said this yesterday and will continue to say it. Screening saves lives. However, what has happened has further diminished the confidence that women are entitled to have in their screening service. My belief is that this happened for no good reason. The conversation should have happened in respect of capacity. God knows, we talk enough about capacity and the lack thereof and all the rest of it all the time. The Minister must have known, with the Jade Goody effect or whatever name he wants to put on it, that demand was going to increase. However, the conversation does not appear to have taken place in terms of ensuring that capacity was put into the system.

I have spoken to the Minister previously about the outsourcing of the smear tests. I want to find out how many slides have left the State. We know that some went to Honolulu when they were supposed to be going to Texas. Are there any plans or is there any work to repatriate that work and ensure the tests are done here in this State? How can we ensure that the backlog can be dealt with and women can have their smear tests in a timely way? I know we will have a chance for questions and answers later. That is the flavour of the questions I will be asking.

I would like to pay a special tribute to Emma Mhic Mhathúna, who tragically passed away in October and who did so much to expose the cover-up which was undertaken by the State and its agencies. I hope Emma's five brave sons are today safely in the care of their family. This is my first opportunity to pay my personal tribute to Emma in this Chamber. Ar dheis Dé go raibh a h-anam dílis.

I would also like to commend the ongoing work of Vicky Phelan, Stephen Teap and others who continue their ardent work pressuring Government to stand over its promises and commitments that such a scandal will never happen again and that appropriate measures will be put in place to support all women who have found themselves caught up in the scandal. It is, however, most disappointing that the measures referred to earlier have not been put in place. There is still not an effective process in place to manage the fallout from this scandal. Quest laboratories, one of the companies implicated in the scandal, is still conducting smear tests outside the recommended 30-day limit. Most worryingly, this time is counted from the time the smear arrives at the lab, not even from the time at which it was taken. The backlog caused by the need for retesting required additional facilities to be put in place and this has not happened. I argued fervently in 2007 and 2008 that the cancer screening programme in this country should never have been outsourced and privatised in the first place. It was grievously irresponsible, at best, for Fianna Fáil and the Progressive Democrats back then not to listen, not to look into the facts, not to inform themselves properly. We could have expanded the capacity of laboratories here in Ireland. Very sadly, privatisation took precedence over public services and wholly misinformed, lame-duck economics ruled the day. Look now at the real cost of those decisions.

Ruth Morrissey is currently in the High Court taking a case against the HSE and two laboratories over alleged misreading of her cervical smear tests. There is now a question mark over whether the slide attributed to Ms Morrissey was hers at all. This is outrageous. This woman is extremely ill and she is being forced through a legal process despite the Government and the Minister saying that would not happen.

The judge in this case said that it is getting stranger and stranger.

I appeal to the Minister not to put this woman through further uncompassionate and unnecessary stress and strain. He should do the right thing and take this woman out of court and meet his obligations to her. This scandal has been a very sorry episode in the contemporary story of this State's relationship with women. I encourage all women to continue with the screening process. I acknowledge that there will continue to be problems, but the best and safest way of reducing the risks of getting cervical cancer is by undertaking the screening process in the first place. This is the case with all screening programmes. I encourage all members of the public to adhere to best clinical practice in line with the advice given to them by their GPs and other clinicians.

The Government has to reach out, on behalf of the people, to all of the affected women. No woman should be forced to go through the courts on this matter, and I urge the Minister to take the appropriate steps to ensure that this does not continue and that it will not occur in the future.

This is a very important discussion, and I have taken a huge interest in the detail of it. I thank everybody in this House for the support provided over recent months which resulted in pembro being made available to all women with stage four cancer whose clinicians prescribed it. I acknowledge the Minister's contribution towards getting that legislation over the line. Other issues will arise, particularly around its availability for other cancer patients. The Minister knows that. It is something I am seriously concerned about. However, that is a debate for another day.

I will pick up where Deputy Ó Caoláin left off. My main contribution tonight is on the topic he raised. There is a woman in the High Court at the moment called Ruth Morrissey. What is happening there is another national scandal. We have almost become immune to situations like this. What is happening in the High Court is very strange. It is not tolerable. The Government owes a debt to the women who have been affected by the CervicalCheck controversy. The Minister, Deputy Harris, knows that the Taoiseach appeared on the "Six One" news and promised something that could never be delivered. He promised that no woman affected by this issue would end up in the High Court and that the Government would go after the laboratories if necessary. He met Vicky Phelan subsequently and again said that this would not happen. However, it is happening today. It is happening before our very eyes. It is completely immoral and it is unacceptable. Those women should not be going through this.

Mr. Justice Meenan's report has been completed. Frankly speaking, I do not know how many women are going to end up in the High Court in the coming months, but I do know that there will be quite a lot of them. I have spoken to those women and their representatives. There will be many Ruth Morrisseys, unfortunately, who will end up in court before Mr. Justice Meenan's recommendations are in place. The Minister knows it, and I know it. When will the legislation be brought before the House? This is complicated legislation. The Minister has admitted as much. We have to pass it so that the tribunal can be set up and so that it is ensured these women do not have to go into the High Court. That is probably the most important question the Minister is going to be asked tonight. It is intolerable that this lady and others, some of whom I have met, have to go through the High Court to tell their personal stories. Many people do not know their stories. Some members of their families may not know the full details of their stories. It is unacceptable. This legislation must be prioritised, it must be passed and it must be completed so that these women do not have to go through this. I implore the Minister to take that position.

The Royal College of Obstetricians and Gynaecologists, RCOG, review will not be completed this year. I will make a bet with the Minister on that. From my information it is clear that it will not be completed this year. How can we get to the bottom of what happened if this famous review, which was supposed to be completed within months, is not going to be completed in the calendar year of 2019? That is also unacceptable. Will the Minister give me the timelines and show me how the information is going to cross over to ensure that this happens? I do not believe it will happen. It is way behind schedule. We depend greatly on the information that will come from that review. The Minister and I know that, as do those who are affected.

When one gets into the detail of this, it is clear that there are a significant number of women - the total is not yet known - who are not part of the 221+ group but who come from a separate cohort which crosses over from the cancer registry. I want to make a plea to the Minister. I have spoken to and met some of the women affected who are not part of the 221+ group, but their issues and their circumstances are equally as concerning. In some cases, they are in very difficult circumstances. Indeed, I raised the case of one of those women with the Minister as recently as this morning. Those women deserve to have the same opportunities and to have access to the same package that is given to the women in the 221+ group. I implore the Minister to look at those individual cases and give them the same package and the same opportunities as the women in the 221+ group. They are not outside of this. It is an accident almost, due to the manner they came through the cancer registry. It would not take a lot to isolate the most severe cases and to treat them. Some do not have access to medical cards or various other services. In one or two cases there may not be access to pembro. Their clinicians may decide that it may or may not suit them. The Minister can deduce why I am asking that they be treated the same.

I have a deep concern about the fact that so many women and their legal teams are fighting for access to their slides. Progress has been made, but the length of time it has taken women to get their own slides is inexcusable. They are entitled to access the slides. The consequences are that their cases, or the way in which they are dealing with the problem, are taking more time. The commentary to that end from some people in the HSE is not acceptable.

I am totally in favour of implementing the Scally report, and I am glad that Dr. Scally is being kept on. I am a massive advocate for HPV screening and HPV vaccinations. The Minister in his response might outline timelines for both of those matters. I want to acknowledge, on the record, the work of Laura Brennan and her amazing colleagues who have advocated for the HPV vaccination and the target of achieving herd immunity.

I have some specific questions about the laboratories involved. There are capacity issues in this area, but if the Minister is to have a legacy in this area, it will be established by how he can bring this screening process to Ireland and ensure that we control the screening programme ourselves. It is going to have to happen incrementally over time. I accept that. We must do that to ensure that, in the future, quality control is something we participate in, have knowledge and control of, and that the work is done close to home. We know that the contract that existed included provision for the outsourcing of contracts without the knowledge of the contracting authority, in this case the HSE. Is it true that Dr. Scally has, in the recent past, discovered extra outsourcing? I understand that he has found out about other places, such as Wyoming in the United States, where laboratories received contracts without the knowledge of the actual contractor, that is, the HSE.

We still do not know about quality assurance. This is another layer. How did he not find out about that when he was doing his inquiry? What does that tell us about the contracts? What does that tell us about the legacy of what happened? What does it tell us about what was agreed? I call on the Minister to elaborate.

Obviously, when it comes to the Scally report, implementation of the 50 recommendations is critical. I will support the Minister in implementing them, as will the majority of Members. The matter has been raised in the House. When the Minister made the decision to give a free smear test to all women, we supported him. Questions have been raised about whether this was the right decision. I will not criticise the Minister for this. I have said publically that I believe the Minister made the right decision for the right reasons. However, there should have been analysis of the resources and capacity available. I am not going to criticise the Minister for that, but I am going to put it on the record. There needed to be analysis.

I must make this point because I am concerned following information I have received in the recent past. I asked the Minister a specific question regarding the clinical outcomes for women if they had a 24-week delay. The Minister said that it was low-risk, and I accept that, but I do not believe it is exclusive. We all know about false negatives and that some tests had errors. In a scenario where something like that happens and then women have a 24-week delay on top of that, I am afraid there is capacity for other issues for those women further down the line. I realise the Minister cannot rule out that possibility and I do not expect him to do so. I am simply pointing to the difficulty of a scenario where we know there are issues relating to the past and we have much documented evidence about that. On top of that, we have a situation whereby women were coming back for their tri-annual smears and they had a 24-week delay. That posed some form of risk. In turn, that risk came on top of the fact that it has been proven to me that on numerous occasions when I asked the question, it seems for a long period and even up to the present in the case of some exceptions, we know the HSE could not prioritise between women who needed six-monthly or yearly smears or those who were sent forward for smears versus those who were getting tri-annual smears. That is a concern to which I will return.

I understand Deputy Bríd Smith is sharing with Deputy Coppinger.

It is more than ten months since this scandal broke but it has been the recent tragic deaths and the ongoing court battles which have kept it in public view. We have seen the new scandal involving the expired samples, the problems with one laboratory, ongoing problems with backlogs as a result of greater demand and women seeking reassurance of a second test. Side by side with these events, we are told that the Royal College of Obstetricians and Gynaecologists will produce a report in six months' time on the 221 cases at the centre of the scandal. Separately, we were told the HSE has now found an expert who is analysing and examining the false negative smears, what laboratories they came from and what grade of change was involved. I am told this report is weeks away. We await new reports from Dr. Scally.

In this blizzard of information and new twists it is easy to forget what lies at the heart of the scandal. I am sick of hearing the same mantra in every response from the Minister, the HSE and the self-professed experts on CervicalCheck, whether in the media or otherwise, that it is complex, that we do not understand the intricacies of testing, that it is not a diagnostic test, that every screening process has errors and that no process is 100% correct. The Minister's response and the response of many in the media and in scientific circles are laced with impatience and dismissal of our concerns and of any political implications that we may draw from this scandal. To be clear, I know screening is not a diagnostic check. I know there will be natural and unavoidable errors in screening. I know false negatives can mean really different things depending on the actual smear. I know that not all false negatives are negligent and that there are different grades of error in each individual test. I understand all of this as do other women. I also know something else. Since May 2018 I have asked in numerous different ways a simple question of the Minister and his Department. The Minister has the answer. From which laboratories did the recorded false negatives come and will the Minister provide a breakdown of how many laboratories per case contracted? I still have not got an answer. It has been ten months and counting. Instead, I get the same stock dismissive answer. It amounts to saying that I would not understand it, that I do not understand the figures and that those responsible will have to get an expert to analyse the figures and give me more information. I was told this by Mr. O'Brien when he was head of the HSE and by the Minister personally twice, as well as by the Taoiseach and the Minister for Public Expenditure and Reform. All of these people assured me that the answer would be forthcoming but I am still waiting.

It is interesting when I compare that question to a leaked report published in The Sunday Business Post. The report suggested there was an ability to do complex analysis of the patient status of the 221 women affected. This amounted to spinning the lie that they are really not so badly affected and that only 25% of them have active cancer. That sounds great until we think about these facts: 21 of them are already dead, 50 have active cancer diagnosis and many have a poor prognosis. I do not accept that it is impossible to get an answer to my question. If someone wants to spin it in certain ways, he or she will do so.

I believe that when we get to the core answer to the question of which laboratories these errors came from and what grade of errors were involved, we will find a disproportionate amount came from the private for-profit laboratories that operated to different standards from those in the public service. Alongside the barely-concealed and patronising attitude of commentators on the scandal, there is the immediate defence of the decision taken in 2008 to outsource to private for-profit laboratories the cervical screening process. The decision has been confirmed since by every Minister with responsibility for health, including Mary Harney, Senator James Reilly, Deputy Leo Varadkar and the current Minister, Deputy Simon Harris. This is compounded by the decision to outsource the HPV testing. We know for certain from the Scally report what happened when the outsourcing took place: not all US laboratories were ISO accredited at the time; the work practices were different and the workload was different in those laboratories; the criteria for awarding the contracts centred on the cost; and that one of the US laboratories subcontracted work out unbeknownst to the HSE.

We know that the decision to privatise meant that the capacity to conduct the screening in Ireland was lost and that cytologists trained in this country to our standards were lost to us. We know that university courses were lost and that laboratories were closed down for good.

Multinational companies always insist there must be evidence. Thus, it cannot be claimed that there was no problem. Why then did they settle in big numbers with the women with whom they settled in the courts? Multinational companies do not do this out of the goodness of their hearts. There had to be evidence that they were negligent. There had to be strong evidence that they were seriously negligent.

At some stage the truth will come out. What we have to realise is that at the heart of this lies the problem of outsourcing. We need to realise that at some stage we are going to have to return to a publically-funded and resourced screening programme in this State so that it can be controlled fully by the health services here.

The Minister said in his speech it was not the case, it was not true and it was said incorrectly in the Dáil that the Minister offered extra tests against medical advice. Who did advise the Minister? I do not think the Minister answered that.

It was the Chief Medical Officer.

Was any cost-benefit analysis done? There seems to have been a 35% increase in take-up either through that offer or through general heightened awareness if we look at the figures given. Did the Minister or the chief medical officer not realise that they would have to put extra resources in place when such an offer was made? What extra resources did the Minister put in place? Did he check with the laboratories? The fundamental question comes down to what control we have over the testing process. Did anyone check if the Minister asked Quest laboratory whether it recruited extra testers? It is striking that we even have to ask that question and that the Minister did not know. This boils down to the outsourcing and privatisation of cervical cancer testing. That is at the root of the problem, because we cannot question these laboratories.

At least, for all its faults, we can get answers from the public health system. We know from the Scally report that we do not even know where many of the labs were doing their tests. Up to one third of tests were being outsourced and re-outsourced to places such as Honolulu, but Dr. Scally could not establish exactly where.

The Minister has stated there is a low clinical risk - he has been asked to tell us how low - after the samples were being tested outside of recommended timeframes. Will the Minister give the House more information on that? One would think that the length of time would matter in a cytology test and there is a huge difference between 100 days and ten days.

I do not feel the Minister has given answers on particular issues raised in the Scally report. Many problems seem to emanate from Quest Diagnostics. According to chapter 6 of the Scally report, Quest said that it had a false-negative reading rate of 3.19% whereas the Scally report identified the rate as being 17.6%. We still do not know what the difference is in the assessment. We assume it may be explained by labs in different countries with different testing and definitions of abnormality being used. The different processes of accreditation were a problem identified in the Scally report.

Cost is another issue. Why did it become an increasingly important consideration when contracts were being awarded to different labs? The Scally report notes that 20% of the proposal’s scoring was based on cost but it had doubled by 2012 to 40%. A bailout was under way, along with the austerity juggernaut. Costs had to be cut. Is the Minister seriously suggesting that when cost was made such a high criterion, it had no impact on those tests and their efficacy? By 2016 there were competitions where 80% could be the cost criterion. The profits of Quest Diagnostics have risen exponentially.

I will finish with a key question relating to HPV testing. The Government is fond of saying that we are cutting edge and we are one of the first countries to use the new test. Why not bring this back into public ownership and control as part of our public health system? There is no need for the number of cytologists and the upskilling of people, which was the excuse given in relation to smear tests.

Go raibh maith agat.

We need to know that we have democratic, public control. Why not start anew? Why not scrap the smear tests completely and just start with the HPV test, which is of a much higher standard? This was supposed to start in November but has been put back. We are now retelling women to get smear tests. Why not start with HPV testing and do so under public ownership in control under the Irish health system? Why not have done with the outsourcing of the past and restore the faith of women in the cancer screening service?

We now have Independents 4 Change. Deputy Clare Daly is first.

I am sharing with Deputy Joan Collins. I find this entire discussion utterly depressing from start to finish. It should not be necessary, but we have to start by reaffirming that our screening service is a public health initiative that saves lives. It does not guarantee that someone will not get cancer, it does not guarantee that if someone does get cancer that it will be picked up and there is no guarantee that someone's life will be saved by it but it massively improves the odds. It is not good enough for us to pay lipservice to that and then come in and eviscerate the service with non-evidence-based comments, as though the two can be tallied and we are all on the one side. Everybody in here, on all sides of the House, supported and egged on by the media, has created a situation where the trust of women across the country in our public screening system has been seriously eroded and damaged. That is an extremely serious situation when we want people to take up that programme. We must be very upfront about this from the outset.

The very fact we are here tonight is indicative of that. We are here tonight because around ten days ago, this was the big scandal and everyone was looking for Dáil time. Now, CervicalCheck has moved off stage and it is the children's hospital and no one is here because no one gives a toss. They do not give a toss because the print masters in the media do not give a toss either. They are not prepared to undertake any serious scrutiny on these matters; they are just interested in a cheap headline.

The latest scandal is around writing to these 4,600 women as a result of the delay in checking for HPV in one lab outside the debate. The media is asking how these women are supposed to feel. I am in the middle of the screening process and I do not feel especially great about this, nobody does when their health is in question, but what they should feel is that it is great that a retest is being done and a quality check has picked up a weakness in the system that in normal terms - and I have heard nothing to contradict this - would not have batted an eyelid because the risk is negligible. Is that not good? While I am sure that people will be sick if they get a letter telling them there has been a retest and there has been something different, is it not great that they will know and there is a chance of an intervention?

To be honest, I am a bit sick at how all this has been dealt with because that issue has been conflated with the backlog and the delays in the Minister's decision to have a retest. If anyone is even half honest, they will know that if the Minister had not offered the retest, there would have been an avalanche of demands for retesting from the media and the world in general. Everyone must take responsibility for this because it is a fact that medical advice said the retest should not be done because it would cause problems for our system. That point was made earlier. That is a fact and we must take the consequences of that. The biggest consequence, I think, is that it has potentially delayed the introduction of HPV screening. The responses from departmental officials on this issue are written in real Civil Service speak. They speak of needing to stabilise the programme and the operational challenges during the year but they mean that they were dealing with this bloody crisis and could not get on with making the system better. That should be our key job and I want to hear more on that.

Some 19 countries do screening, 12 of which conduct audits. Of those 12, only seven use the results and only one has a policy of telling people. We are different. It is not necessarily a bad thing, it is a better thing.

It has been said that privatisation has caused this situation. Has it? Maybe it has but I have not seen any evidence that it has. We are all very fond of coming in here and quoting the Scally report. Dr. Scally did not say that we should not continue to use the labs. He did not say that and I have seen no evidence that says that the rates are any different. It is the case that the US labs operate to a different standard but it is not necessarily a lesser standard. Again, I have not seen evidence that it is a lesser standard. Honolulu is the capital of Hawaii, which is a state in America. I do not think that America is the be all and end all - which enough of my record in the Dáil will confirm - but it is not Ethiopia. I am not being derogatory in saying that but it is not a developing country. It has state-of-the-art colleges, high medical standards and so on. We must be very careful. I do not know. We know that a lot of people are suffering because of uncertainties and because of misinformation around this issue.

I want to make a point about the 221 cases and litigation. These are claims at the moment. I am not saying that their situation is not traumatic - all these people have cancer and we know that - but we do not know how many of them were caused because of normal problems with false negatives or how many were the result of negligence. How many were so glaring that they should have been caught? We do not know that. We should know that. I am very concerned about why the review by the obstetricians and gynaecologists has not been done and I would like the Minister to tell us why not.

We should know whether our rate differs from that in other countries.

The two issues we really need to address are the ones within our control and that Dr. Scally flagged as the main problems, the first of which is open disclosure. It is all very well for the Minister to tell the House that a patient information and safety Bill will be delivered this year. I was told by the Taoiseach last May that the Bill would be delivered last year on foot of this evidence, but it would have been delivered the year before if the amendments to require mandatory open disclosure that we had succeeded in having approved at the justice committee had not subsequently been removed by the relevant Ministers at the behest of officials in the Departments of Health and Justice and Equality. If we are serious about this, that is key.

The second issue is legal costs. In other countries people do not sue over delayed diagnoses caused by false negatives because they have much better systems in place than ours. We need to consider these lessons. The way in which the entire matter has been handled from start to finish is regrettable.

Deputy Clare Daly covered many of the points I was going to raise, but I wish to discuss the court case of Limerick woman Ruth Morrissey who is suing the HSE and two laboratories, Quest Diagnostics and MedLab Pathology. It is a scandal that she has ended up in court. The Government gave a commitment that no woman would have to go to court over the cervical cancer scandal, yet here we see another case. This issue must be addressed quickly in order that no other woman will have to go to court and we can avoid being back here in two months' time saying "No other woman should have to go to court" again.

Last May, the HSE confirmed that 208 women who had been diagnosed with cervical cancer had earlier been given the all clear incorrectly. That situation was compounded by the fact that, even though the HSE had become aware of the false negatives in 2014 when it audited its test results for women who had developed cancer after being given the all clear, it did not automatically tell all women that their smear test results had been incorrect.

A number of gynaecologists and healthcare staff warned the Government a decade ago about moving testing to private companies overseas, as they feared that incidents of cancer would be missed. Dr. David Gibbons resigned his position on the quality assurance committee of the cervical screening programme after his warnings had been ignored. He made a point about the difference between checks in America and checks in Ireland. Many people shared the serious concerns raised.

Dr. Scally stated in his report that, although there were shocking failures, they were not in the screening process. He went on at some length in defence of the programme and to assure people that the laboratories where the tests had been conducted were operating to the highest standards. I accept his point, although there are still questions to be answered and he is reviewing some of the tests. As the Minister stated, there will be a supplementary report on certain further aspects of the laboratories.

Is the Minister proposing that cytology services be brought back into the public domain? There are question marks over the ethos of private companies and how they do their jobs, but I have seen no evidence that indicates that they are riskier or more dangerous.

I will finish on my main point which has to do with mandatory open disclosure. The introduction of this requirement must happy more quickly. As Deputy Clare Daly rightly stated, there was an opportunity in 2017, but we missed it because the Government and Fianna Fáil came together. We are still waiting for that requirement to be introduced. It is crucial that there be mandatory open disclosure.

We now move to the Rural Independent Group.

The Minister told the Dáil that 4,600 women would need to be tested again, as opposed to the original figure of 6,000. While this slightly lower figure might be spun as good news by him, it is in no way good news or a comfort for the 4,600 women who have to be retested. The Minister stated the vast majority of the 4,600 had been contacted, but the "vast majority" is not enough. Even if one person has not been contacted, it is one person too many. It is a shambles. Is the Minister forgetting that the women in question are grandmothers, mothers, daughters, sisters, nieces and much more? They are invaluable to the people in their lives. The least the Government can do is offer free repeat smear tests to every woman in the country who believe she needs a retest. In my constituency of west Cork many women are living in fear and have no confidence left in the CervicalCheck programme. They are concerned the results they have received in the past may be wrong. They deserve the right to a free retest, if that is their wish.

The Minister is sidestepping the issue and saying free tests would put additional stress on the system, but how much more pressure would be put on the system if, God forbid, it turns out that some of the women in question have cancer? World Cancer Day was only two days ago, yet the Government still believes one can put a value on life. Does the Minister not believe it is in everyone's best interests for the Government to ensure women will be retested in order that no more lives will be lost unnecessarily to cancer when early detection could prevent that loss?

While the average waiting time is 22 weeks, some women are waiting for more than six months. Will the Minister guarantee that women's health will not be put at risk as a result of these unacceptable waiting lists? I doubt that he can reassure me. A wise person once told me that, when a doctor gave someone medical advice and the patient needed to make a decision, the patient should ask the doctor what he or she would do if it were his or her wife or mother who was involved. Without getting personal, I ask the Minister to consider whether he would accept his mother or wife having to wait for up to six months for CervicalCheck results.

That is personal.

The CervicalCheck crisis needs to end now and we need to give the women of Ireland the reassurance they deserve.

The Minister cuts a lonely figure in the Chamber. Not one backbencher in his party or member of the Independent Alliance which is keeping the Government in power is present to support him. There are five Ministers in the Department of Health. Where are the other four?

I have nothing personal against the Minister. I congratulate and compliment him and his wife on their new baby and wish them well, but will he ever look in a mirror or at his conscience, if he has one, and resign? It is shocking that he is presiding over such an appalling vista of catastrophes. As Minister for Health, he should be wearing inflatable armbands, given how he is so obviously out of his depth on this and a host of other issues. He is swimming against the tide. Anyone else would be gone. If he had any conscience, he would go under and let the tide do the rest. Amid the confusion and the number of women who require retesting and despite all of the Minister's confidence and spin, it is clear that he is struggling at sea with scandals and dysfunctionality in the Department of Health and the HSE.

The leader of Fianna Fáil tells us that 6,000 women need to be retested, but the Minister says the figure is 4,600. Regardless of whether the number is 420 or four, the Minister should not play with figures and say it is great that the number has decreased from 6,000 to 4,600. That is if we believe him, but I do not believe one syllable that comes out of his mouth. I came to that conclusion a long time ago.

The Minister assured us that he worked "hand in glove" with his officials and that the decision was made in conjunction with them, including the Chief Medical Officer, with the support of Opposition politicians because women wanted that reassurance. My goodness, but of course they wanted that reassurance. The constituency of people in the State who believe the Minister is managing this and other crises afflicting health services is decreasing by the minute. Can he not see that? Can he not talk to his family, friends and supporters and use them as a barometer? Plenty of people in County Wicklow - he knows who they are as well as I do - have no faith whatsoever in the way he is carrying on.

Almost on a daily basis, we hear claim and counterclaim that CervicalCheck is in jeopardy and that tests have overwhelmed the system. It is crazy. Twenty-two weeks is the average waiting time, but it is longer than six months for some women. The lack of clarity is a downright disgrace and I ask the Minister to, please, go. It would be good riddance to bad rubbish, as far as I am concerned.

This evening, I want to remember a sad occasion I attended in Dublin, that being, the funeral of the late Emma Mhic Mhathúna.

She was a sword-bearer for the other people in Ireland and a person of great personal courage who, with a very young family, tried to highlight to Government what had happened in her case, and to other ladies in the same position as she who were presented with false negatives and inaccuracies, which led to her death. Nothing - not all the money in the world nor all the talk inside in this House - can do anything to bring her back to her children and extended family. There are others also, but Emma put herself out there. In a way, disregarding the little bit of time she had left, she became a campaigner and an advocate for others. We would do her an awful injustice here tonight not to remember her name with respect and dignity and to say that she did so much to highlight it - more than any politician in this House, ourselves included, could ever do - in her short few months of campaigning, but are any in the Government listening?

I raised here in the Dáil one day with the Taoiseach the delay in the processing of the results which meant that women were put in this awful vulnerable situation that they did not know whether they were all clear or not. We cannot allow this situation. We need confidence to be put back into the screening programme system. There is no confidence in it right now. The exact opposite is the case. To be blunt about it, and like Deputy Mattie McGrath I do not want to be personal either, they do not have confidence in the Minister either. I am here to represent people from County Kerry. Ladies from all over County Kerry have contacted me and what they are saying is they do not have confidence in the Minister or in the screening programme, and I am asking the Minister to do something about that.

Deputy Danny Healy Rae has two minutes only.

I am glad just to get the chance. As the Leas-Cheann Comhairle states, I have only two minutes. The nation has lost confidence in the health service. There are so many different issues, day after day. There is one scandal after another. Deputy Harris will remember well, when he became Minister for Health, that I stated he was a young man and I wished him well, but I honestly have to say to him that he has failed in his time so far to deliver or to change anything. In fact, things are getting worse day by day, for instance, with the children's hospital. Maybe the CervicalCheck issue did not start out with the Minister, but there are radiology tests down in Kerry involving false negatives as well. We do not know how many people have died because of those radiology tests - maybe four, five or six. We are not sure. Even one is too many. There is the trolley crisis. How many times have we highlighted it? There are the accident and emergency queues and the waiting lists. There are cataract patients going blind who have to bussed elsewhere for treatment. We took a bus up, me and Deputy Michael Collins, on Friday last, and that bus was coming down when another bus was going up on Saturday. They are making the route - that is the truth - one day after another.

Michael spoke about the late Emma Mhic Mhathúna. We admired her so much. She gave her last days in Kerry. She was bubbly. She was so popular with everyone, and in a short space of time, she struck a chord with everyone. It is so sad what happened in her case, and her family so young left behind. She adored them all. It is so sad what has happened. We are appealing to the Minister in that regard to ensure that this debacle does not happen again.

I do not understand why we have to do these tests abroad, why we cannot have them done in-house, as with all the other areas, and have a service that we should be proud of. We talk about Cuba. It is a dictatorship. If a person presents with a problem or a need for an operation today, I am told, whether it is a hip or whatever, he or she will have it tomorrow. What is wrong here?

I am sorry, I must now call Deputy Catherine Murphy.

There is no accountability.

It is important - we probably all have done it - to start by acknowledging the brave campaigners, such as Vicky Phelan and those who went public, but also the quite sizeable number, with whom some of us engaged, who did not go public but where information was fed back and forth. All of them should be considered as having done the State some service. Even though we are in a difficult position in terms of the screening programme, it has been essential that we know we have a screening programme with a failure in it if we are to make sure that it is robust into the future. It must be remembered that had it not been for the bravery of Vicky Phelan and her refusal to sign that confidentiality clause, we might not have known anything about this entire scandal.

The priority in all of this has to be the women concerned, and we have to ensure that everything possible is done for them, and with them. The idea that the State would pursue any of these women in any kind of an aggressive manner, as we saw displayed with Vicky Phelan and in other cases, is unacceptable, and I am not sure it is entirely concluded. Despite what has been said, for example, about the slides being released, and some women looked for those slides in April and May last, some of the women who make up the 221+ group had to go to the High Court in December. I kept raising that particular issue. I was told at the Committee of Public Accounts that the matter would be turned around in 22 days, and it was not. The women went to the High Court on 20 December and the HSE committed to provide the slides in the format that was sought. That was a useable format from the point of view of some of the cases that would have to be taken. They went back to the court for mention on 18 January and still the slides had not been provided. I was talking to one of the people today. The slides were provided on Monday last, 4 February, and they had to go to the court to get that. We were told that there would be only 22 days of a turnaround. That was a less than honest approach. We were misled by the HSE in respect of some of this.

In the midst of all this, we are looking at the ongoing case and reading the newspaper coverage of Ruth Morrissey's appearance in court. It is the kind of thing that undermines the rebuilding of confidence when there is a question mark, for example, about whether it was the correct slide she had.

The Taoiseach made commitments here in the Dáil that no woman would have to repeat what Vicky Phelan had gone through in the courts. I wonder where the Taoiseach got the advice to make that statement because while one component of this relates to the non-disclosure, other components relate to the work of the laboratories. Whether the State would have the legal standing to have made that commitment is something that needs to be clarified here. A commitment was made and people took that at face value. It was never going to be possible. The Taoiseach must come back and put on the record exactly what advice was given allowing that to be said, which gave an assurance that may well not have been an assurance that could have been given in a fair and honest way.

I welcomed the Scally report. It was an excellent and comprehensive report. It established many of the facts and the truths about CervicalCheck. It has gone a long way to answering many of the questions we all have had over the months. Most important, Dr. Scally met the women and their families and he listened to them.

With regard to forms of communication, if one asks people to name seven different means of communication listening tends to be left off that list. People hear but they do not always listen. Dr. Scally definitely listened in a very meaningful way. He was quite definitive in his report and he lifted the lid on a highly paternalistic culture which he said bordered on the misogynistic with regard to many of the 30 consultants who were involved in these cases. Stephen Teap said that in some respects, there was a God complex.

Since the report I have spoken with women who told me they have lost confidence in their doctor or consultant, and it was mainly due to how they had been communicated with, how they were dismissed and how they had continuously raised their concerns without getting a fair hearing; they were not listened to. When these women tried to source other doctors or consultants, some were unwilling to take the women on as patients. Despite the fine words we have heard in this House, the women were left to their own devices in sourcing alternative medical cover - that is a doctor - for themselves. When we talk about a package of care and help and all the rest, I believe that those of us on the outside who are not personally experiencing this would have expected that kind of issue to have been addressed and overcome. I have met women who had all sorts of difficulties and they tell me that they sourced some of their treatments in other jurisdictions.

I put it to the Minister that apologies are very hollow when the apology is not underpinned or matched against practical assistance. Such assistance would make those who have been affected feel that they actually matter. When we consider the awful scandal in retrospect, lessons have to be learned about what was put in place and if it really met with what was expected or with what was articulated to be available.

I will now turn to the issues of the compensation promised, the HSE and non-disclosure. The compensation has to happen in reality. I really want the Minister to hear this particular point: I am aware of women who cannot meet the cost of having their slides independently assessed. Some women are being asked for upfront payments by solicitors and other women are trying to pay by instalment, for example perhaps €100 per week. Some who are in that situation are struggling to make ends meet, and they are stressed and worried about their own health. They need to be given assurances about when that compensation will be paid in order that they can have their slides independently tested. That has to happen or there is no point in making apologies. That is a very practical thing that is currently an impediment.

We are all aware of the number of laboratories that were used, but some labs were subcontracted. I understand that Dr. Scally discovered that this was much more extensive than was first thought. Will the Minister put on record just how many labs were there, and what were those labs? If we are to build up trust we need to know that. Let us not be finding things out by drip feed. We need to know what the situation was in that regard. What was the quality control around that subcontracting? When did that information come to light? When did the Minister find out about this information?

CervicalCheck, with all its faults and failures, is an incredibly important screening programme that saves lives. It is important that we say to people they should engage with the programme, but when we say it we must make sure the trust is rebuilt on the other side in order that people can have confidence there are checks and balances. People must be assured that the level of quality control is such that their results are as robust as humanly possible. We talk a lot about open disclosure. We have been dealing with it at the Committee of Public Accounts in the context of changing the culture. There is a €2.6 billion contingent liability for the health service. If, for example, we were to strip out the legal component of that - and I do not say cases should not be defended where they should be defended - we have to put in place a system where people can put their hands up if there is a failure, and the failure is remedied rather than having to rely on people like Vicky Phelan taking a court case and not allowing herself to be gagged on the results of the court case. There has to be an honesty about it and the system must be put in place that allows for open disclosure.

That is the first round. Do any Members wish to pose questions?

There were questions within some of those statements.

The order today is that the Minister will respond one to one, and then he will have five minutes to wrap up. Does any Member wish to pose a question? If not then-----

Deputy Stephen S. Donnelly

I have a question. The Minister has been asked a lot of questions. I imagine he has a lot of detail and he may not be able to address them all in five minutes, or perhaps he will. If I have five minutes now I am happy to cede that time and add it on to the Minister's time if he wants to go around. Would this give the Minister enough time to answer the various questions that have been posed? I am happy to cede my time but maybe other Members would rather use their time.

I have no objection to that but if we are not going to have a back-and-forth-----

We can have a back-and-forth format.

-----very specific questions have been asked.

The Minister has said that the Deputy can have that, if she wishes.

During the course of our contributions we have all asked questions. The Minister has been taking notes and if the Minister is confident to go ahead then I am happy to also cede my time on the basis that we get our questions answered.

We will use discretion. Deputy Kelly may pose a few questions but if he has already asked them we will be giving the Minister some extra time to answer the questions that have been asked.

I have a question.

Deputy Joan Collins would like to add one question to those she has already posed. Would Deputy Kelly like to add any question?

I have asked my questions.

My question relate to the Dr. Scally's supplementary report. The Minister said that it is his intention to give full and detailed consideration to any further recommendations. Will the Minister indicate for the record that this report will be published and distributed to everyone else?

Does Deputy Catherine Murphy have a question?

I too am happy to get the responses to the questions I posed and hopefully the Minister will have time to come back on them.

The Minister will wrap up now. We will give him extra time.

I will do my very best. If any Member notices that I have missed a question I ask that they flag it with me. I will take Deputy Joan Collins' last question first while it is fresh in my mind. When I receive Dr. Scally's report - which is phase 2 of his work - I absolutely intend to publish it. Obviously, I also intend to act upon his recommendations. Dr. Scally very kindly attended a meeting with me when I met the 221+ group in my Department last Thursday and he made it clear that he hopes to get that report to me very shortly, possibly this week or next week. I expect to receive it this month and I will certainly act upon it. I would also like to make sure the women and their families are briefed first, as would Dr. Scally. I gave him the go-ahead to make sure he briefed them in advance of anybody else, once he also gives the report to me.

Dr. Scally has highlighted that some other labs had also been used and this has come up in a number of questions tonight. This is not news because from Dr. Scally's first report we already knew there were other labs. One of the terms of reference for the second report was to look at this matter and report back. There have been references in the media recently to one lab, and Wyoming was mentioned by Deputy Kelly. I understand that most of these laboratories are no longer in use, but I do not want to pre-empt what the factual situation may be.

New labs have been found.

Absolutely. That is my clear understanding. I want to do what I have always done along this process, which is to wait for Dr. Scally's report, publish it and then act upon it.

Deputy Donnelly asked a number of questions on the backlog, the waiting times, the clinical risk, what is behind the delays and if they could and should have been avoided. I shall take those questions in sequence.

I am informed that the average return time for a smear test is up to 22 weeks. I am also informed that many people get their tests earlier than that, but as with any average, some people wait longer. The HSE has apologised to patients for this and said it is doing everything possible to improve the situation. I accept genuinely and absolutely the HSE's bona fides in that regard having seen how hard it is working to identify additional capacity in a very challenging environment. I heard people accept in the House that it is not just a matter of writing a cheque. There is a global shortage in cytology and the HSE is working very hard to identify additional capacity. The HSE is due to present me with a capacity report in the next number of weeks and I will be happy to share it with the appropriate committee of the House or to set out in the Chamber, whichever is the appropriate course.

Importantly, Deputy Donnelly asked what the clinical risk here was. This is what women will want to know. I will read to the House what I have been told by the HSE from a clinical point of view. The HSE has advised clinically that the natural history of cervical cancer indicates that the disease normally develops over a period of ten to 15 years. Due to this very fact, it is important that women of screening age attend for cervical screening each and every time they are invited to participate. The HSE advises clinically that in this context, the delay being experienced for the return of cervical screening results, while undesirable, is not dangerous and poses a very low risk to women. That reassurance is important. I do not suggest that delay is any way desirable. Of course, it is not and the anxiety of waiting is certainly not good either. However, that is the clinical opinion.

Deputy Donnelly asked the fair question of whether the backlog could or should have been avoided. There are two parts to the answer. Not all of the backlog consists of free repeat smear tests, which we accept. I am waiting for exact figures from the HSE as to how much is made up of new women entering the screening programme but indicative figures suggest it could be up to one third. Truthfully, I must wait for that to be validated before I can fully stand over the figure. However, it means an awful lot of the backlog is made up of people availing of the repeat test, which I very much acknowledge. It was the right decision to make. The Deputy was good enough to acknowledge that if was not free, women who could afford to do so would have been tested which would have led to the bizarre, awkward and unfair situation in which women who could not afford it would not. The Deputy outlined a number of people who said the repeat smear test was not a good idea, all of them, by my calculation, did so significantly after the decision was made by me. It was not clear in some of the charges levelled in recent years, but the advice available to me within the Department, including working with the chief medical officer, was that this was an appropriate step to take as part of the reassurance process and it was welcomed, to be fair, by people here. All speakers have made the fair point that while they welcomed the decision, they would have hoped the resources would have been put in place. As I said yesterday in reply to Oral Questions, also fairly, nobody could have predicted the exact number of people who would go for this nor could anyone have predicted how long the public concern and anxiety would last. Deputy Clare Daly was very honest on the latter point.

Deputy Donnelly asked also about the approximately 4,600 people who will be invited for retests. He acknowledges that it is a separate issue to the backlog and relates to HPV secondary testing. It is not an issue caused by the backlog. Dr. Peter McKenna, whose view people would much rather hear than mine, given that he is acting clinical director of the programme, described the clinical risk as exceedingly low. Again, Deputy Clare Daly was very honest in this regard. This is a programme picking up errors and acting on them by inviting retests, albeit as a precautionary measure. The director general of the HSE gave information today to the Joint Committee on Health that the majority of retest letters had been issued. My understanding is that the rest of the letters will be issued by the end of the week.

Deputy Stephen S. Donnelly

Specifically on the clinical risk, it is good to hear, as we have heard previously, that it is exceedingly low. The Minister probably does not have the information now, but he might come back to us on the following. One of the cohorts involves women who have been diagnosed with more serious than low-grade abnormalities. There is an unknown number of women who have been diagnosed with high-grade abnormalities or more serious ones. The question for them is whether delays of four to seven months may be linked to delays in starting treatment. I do not know and am not asserting that they are. However, I am being asked the question by women who are waiting. I ask the Minister, therefore, to get the advice and to make a statement to the House or to the public personally or by way of a clarification from the HSE setting out whether there is any material risk to those women and how many women it might affect. As to the rest, I thank the Minister.

I will ask the HSE to correspond directly with the health committee on that. I thank the Deputy for reminding me that I have been assured that women who have been referred for colposcopy are triaged. It is an important reassurance for many that I am happy to record in the House.

Deputy Louise O'Reilly paid tribute to Vicky Phelan and others and I join her in doing so. The Deputy asked about the HPV secondary test and I think I have set out the position to Deputy Donnelly. Deputy O'Reilly asked the fair question as to what I was doing and what everyone else was doing proactively to deal with the backlog. It is often forgotten, which is why I state it for the record of the House, that there are weekly or near-weekly update reports on all of our activity on CervicalCheck being published on my Department's website after steering committees, which include patient representatives, meet. The reports provide a running update on all of the challenges, including in relation to the backlog. The HSE is constantly speaking with the laboratories we use and other laboratories to try to find more capacity. Of that, there is genuinely no doubt. However, it is somewhat missed, albeit not necessarily by Deputy O'Reilly, that the first priority must be to ensure we keep the screening programme going. Things came within a couple of days if not hours of not having screening continue in Ireland. As such, it was rightly the HSE's first priority. However, it has absolutely sought extra capacity. Deputy O'Reilly made the point about outsourcing which a number of Members made. She did not suggest outsourcing was dangerous or anything like that. Dr. Scally looked at the issue and while I do not have his exact words in front of me, he said it was appropriate to continue to use the laboratories. As we move towards HPV testing and the like, there will be an opportunity to look at what more we can or should be doing in Ireland. It is a decision we will have to take in due course.

To clarify, I asked what exactly had been done before the offer was made to every woman and whether steps were taken to inject that capacity into the system. My point on outsourcing was that it was a political decision, albeit not made by the Minister's Government. It was a political not a clinical decision. Regardless of what is in the Scally report, therefore, we have never seen any information to suggest that clinically it is better to outsource. That is not by way of scaremongering; it is simply a fact.

The decision to provide free repeat smear tests was made at a time when women were turning up to their GPs and asking for them. They wanted to know if they would have to pay or wait a number of years. I am not going to suggest an exercise was done to estimate or guesstimate how many women would come forward. I am informed by officials that it would have been almost impossible to do so, in fairness. None of us knew how long the period of concern would run or what capacity would be required. That is the truthful answer. I note that some of the organisations the Deputy referred to in the House tweeted calls or welcomes for these decisions. I am not talking about Members but also about some GPs who said it was the right decision. GPs were looking for this to be provided. It is true that well after the event, as referred to here and in news outlets, a number of people wrote to me to say I should cease the free repeat smear test cycle. When I was officially advised to do so in October, I acted immediately. I wrote to the director general of the HSE. As the HSE was operating the programme and had booked people in for tests, we agreed we would end this at the end of December.

I have four main questions. The first is on the RCOG review, on which I have a bet with the Minister. The second question is to ask when legislation in relation to Mr. Justice Meenan's tribunal will be passed to set it up. The third question is whether the Minister will include some non-221 women in relation to the provision of services. The fourth question is on HPV testing and the vaccination for boys.

One of those questions overlaps with questions from Deputy Ó Caoláin on Mr. Justice Meenan and the courts' process.

I thank Deputy Kelly for his work and advocacy on the issue of pembro and I am glad we could advance that issue. With regard to the Meenan report, we have taken the step to appoint Ms Justice Mary Irvine, a very experienced judge in this area, to chair the tribunal. Deputy Kelly will note that at a time when the Government has basically said the only legislation it is able to do is Brexit-related, the Meenan report and tribunal have made the list. In other words, such is the seriousness of it we are making an exception and Meenan is absolutely included in the Government's legislative programme. I will get to the timeframe and answer the Deputy's question. We have also brought in external assistance for legal advice to help us prepare it because, as the Deputy has acknowledged, it is complex and something we have not done before. I am hoping to get a general scheme to the health committee in the month of March. That is the timeline I am hoping for. That is my ambition for it and everything we possibly can do to do this is happening.

With regard to the RCOG review, I am not in the business of having bets on the floor of the Dáil but I do not accept the assertion the review cannot be completed this year. It is a review that will take six months from the time RCOG starts to receive the slides. It is independent and I do not want to speak for it. The slides have started to transfer so I am very hopeful it can progress. I am happy to keep the Deputy and the House informed. It is a process that is under way.

With regard to the issue of what the Deputy described as the non-221 group, and I have heard this from some patient advocates, I certainly will have a look at it and reflect on it.

I would appreciate that.

I will not give a response on the floor of the Dáil but I will speak to the Deputy about it, reflect on it and see what can be done.

With regard to the HPV vaccination, I am really pleased to hear the Deputy pay tribute to Laura Brennan because she is an inspirational woman and we all wish her well. The HPV vaccine for boys is something the Deputy has campaigned for and it will come in for the new school year in September. It is really important as we move towards herd immunity. Sadly, some of the people who have criticised my record in the House have opposed HPV vaccination-----

-----which, sadly, results in people actually getting cancer. It is a bizarre position to hold while expressing concern for women's health.

It is still the plan to introduce HPV testing in 2019. As Deputy Clare Daly said, the capacity report due from the HSE in the coming weeks will inform the specific timeline in 2019.

Deputies Bríd Smith and Coppinger-----

I can boil it down to two issues.

That would be useful. I thank the Deputy.

The first relates to moving forward on the HPV test, which we all know is superior. We have seen the problems with screening. Why not just cut our losses with the smear tests and set up HPV testing publicly under the healthcare system? My understanding, and perhaps the Minister will clarify, is that it does not need the same level of cytology and is a much easier test to diagnose. Why not start this now rather than going back and trying to clear a huge backlog with laboratories over which we do not have same control?

The second issue is clarification because a contribution was made earlier by Deputy Clare Daly that basically implied some of us were scaremongering and there was not really a problem with outsourcing and the laboratories. I would like to clarify this point. It is not the case the Scally report stated everything was fine with the laboratories. It stated the laboratories, and the Minister may comment on this, had local proper accreditation for the countries they were in-----

-----but many of them did not have international accreditation.

There were various levels. This is a problem.

Second, when they made mistakes they did not go back and review them, as is best practice. In fact, a proper mechanism was not put in place. The key problem arises if laboratories are operating purely for private profit, where cost increasingly becomes a criterion for granting those contracts. It is amazing we must make these points in the Dáil to people who are meant to be in favour of a public health system but I feel it is important to make them.

More damage has been done to people getting cancer in this country by people giving succour to anti-vaccination drivel-----

-----including Deputies and Senators, some of whom have been speaking on this topic.

Do not listen to lectures about us scaremongering. I fully believe in science and national screening but there is a huge problem with issues such as this being privatised in another country. We cannot have multidisciplinary clinical team meetings because there is a time-lapse. It has nothing to do with Honolulu; it is the fact there is a distance. Of course it is problematic.

Deputy Bríd Smith raised an issue on the validation report from the 221+ group and Deputy Kelly will know about this from his contact with the group. In the interest of fairness, this was a report sought by the patient advocates. They issued a statement, yesterday or the day before, very much welcoming the work. If Deputy Smith was of the view it was something the patient advocates did not want this was absolutely not the case. I agree with her that even though it does show, thankfully, that a large proportion of women in the 221+ group do not currently have an active disease, anyone reading the report will still see their treatment has been harrowing and what they have gone through has been harrowing and life-altering in many cases. I hope Deputy Bríd Smith does not get the impression that anyone is suggesting all is well. Far from it. It is important to have this information out there. It was information sought by the patients.

I am really pleased with what Deputy Coppinger has said about the anti-vaccers, some of whom are, sadly, elected to the House. In a debate about women's health to have people leading the charge who oppose any form of abortion for any woman even in a crisis and who oppose a vaccination for a woman that could prevent her from getting cancer later in life-----

It is not just anti-abortion Deputies.

-----and to suggest they are now champions for women's health is utter hypocrisy.

On the two issues referenced by the Deputy, the HPV testing is an important shift to make because, as Deputies will know, Dr. Scally very usefully in his report states that for every 1,000 women who are screened, 20 will have cell changes and the standard screening programme we use now will detect those cell changes in approximately 15 women but, sadly, will miss it in about five. From memory, when we moved to HPV testing the number will go from 15 to 18. There will always be false negatives but it will reduce the number of cell changes that are missed.

I have not made a decision on this yet, nor have I the information I need, on how we will configure our laboratory use with regard to what we do here and in other jurisdictions. As far as I know, before we make that move we will have to procure for these matters. The Deputy is correct; it will require less cytology but it will not require no cytology. Some people will still be referred. There is an opportunity to look at all of these issues. I do not believe the Deputy is saying this, in fairness, but I do not believe outsourcing is at the heart of what happened here. Perhaps the Deputy does believe this but I do not, based on Dr. Scally's evidence. The Deputy is correct that some of the laboratories have different accreditations. There was certainly not proper oversight, and there is no doubt of this from reading Dr. Scally's report. He did find they are still safe for us to use for our screening programme.

Did I leave out a question?

Is the Minister open to bringing the HPV test back into the public health system?

Yes, I have an open mind on how we deliver HPV testing. I will be led in the first instance by the capacity report I will receive from the HSE in the coming weeks.

My question was on mandatory open disclosure. I know it is being dealt with by the committee but there is a need for it to come through very quickly to deal with it. I also made a point on private and public healthcare.

Deputy Joan Collins raised the issue of the legal system and how we move to a better system. We are trying to do a number of things. We are reviewing tort law in general and how we deal with clinical negligence better and this body of work is still ongoing. We are introducing an ex gratia scheme and I mentioned this earlier. I first spoke directly to the 221+ group about this last Thursday whereby for the non-disclosure piece we want to make a payment to recognise the impact of the non-disclosure on women and their families. I intend to appoint someone, probably a retired judge, to start the scheme in the coming weeks. I intend to go to Cabinet for approval for the scheme this month. It will not deal with every case or situation but I hope it will deal with quite a few cases. I hope it will provide people with financial recompense to some degree for what they experienced in terms of non-disclosure.

Another element is the Meenan report. I have answered questions on the timelines for this. I want to get it done this year. It is a huge priority and I hope we can get a general scheme to the health committee in the month of March. With regard to open disclosure, Deputy Joan Collins is right. Deputy Clare Daly described the missed opportunities in the past, as did Deputy Joan Collins. On reflection, this may well be right. We need to rectify it now. It is in the patient safety Bill, which has been through pre-legislative scrutiny at the health committee.

It is currently being drafted. I intend to get it back here as quickly as possible - I do not have a definitive week now - with a view to enacting that law this year.

The Minister will answer the questions from Deputy Catherine Murphy. Does she have any to add to those she asked originally?

No, but some of them have been answered as the other Deputies have raised similar issues. The Taoiseach made a commitment in the Dáil that no woman would have to go to court, yet we are continuously seeing court cases. It is important there is an understanding of what the State can and cannot do in respect of court cases. Does the State have the legal standing to take a court case against the labs concerned? It is important we get some understanding of why that commitment was made and why it has not been followed through.

The Minister mentioned the ex gratia payments. Timing is really important for some of the women involved. They do not even have the money to have their slides tested independently. It is important those payments are put in place without a delay. On securing alternative doctors, was there a reasonable expectation that would be done if someone has lost confidence in a consultant and cannot secure access to another? That is a real issue for a woman very worried about her health.

The Taoiseach has spoken about why he, I and everyone else said we wanted to find alternatives to the court process. Deputy Catherine Murphy is right. It did turn out to be very complex. People do have a constitutional right as well and that cannot be infringed upon. As the Deputy also pointed out, there are also parties other than the State involved. We have since brought in the very eminent Mr. Justice Charles Meenan to try to come up with an alternative. I think he did come up with a good alternative. An adjudicative tribunal has never been set up in Ireland before for an issue like this. We did have the compensation tribunal for those affected by hepatitis C. That was different, however. There was no issue of potential negligence that had to be demonstrated. The adjudicative tribunal is our response in trying to provide alternatives to the court system.

Deputy Catherine Murphy is also entirely right about the ex gratia scheme. One of the reasons I am going ahead with that is a recognition it will take time to set up the Meenan tribunal, hopefully not too long. It will, however, take time to draft and pass the legislation. We have identified Ms Justice Mary Irvine as the judge who will preside. I hope I can have this scheme up and running within weeks. I expect to go to Cabinet this month to seek approval for the scheme and the appointment of the retired judge. The idea is that this scheme will not be about compensation and will not in any way interfere with any woman's right to go to court, pursue issues legally or access the tribunal in due course. It is a recognition that disclosure was not made to the women concerned and the impact of that non-disclosure is something the State, regardless of the law, has a moral liability, I believe, to address.

I am also glad Deputy Catherine Murphy raised the issue of doctor choice. People in the 221+ group raised it with me directly when I met them last Thursday. I understand the HSE will do everything it possibly can to find people an alternative consultant or doctor where trust may have broken down or been completely lost at this stage. That is often for good reason. I am informed that is being done through the liaison officers. From anecdotal conversations, I believe that it has worked very well in some cases. It may not have worked as well in other cases. If there are specific cases involved, we can escalate those to the national director overseeing this issue in the HSE. It is the liaison officers, however, that a woman should have a conversation with in the first instance.

I thank the Minister and the Members for what was a very orderly debate.