CervicalCheck: Statements

Good morning to the Minister for Health, Deputy Harris, Deputies and the staff of the House. I wish all of them a good and productive day on behalf of the people of the nation as we start our business with statements on CervicalCheck. I call on the Minister to make his statement.

I thank the House for giving me the opportunity to provide an update on matters related to CervicalCheck. It is over a year since issues related to the CervicalCheck audit emerged. I welcome the opportunity to address a range of issues that have arisen in the past year and outline the work that is well under way in my Department, the HSE and the National Cancer Registry of Ireland to address them and, moreover, drive continued improvement in the screening service.

It is worth reflecting on what the CervicalCheck programme has achieved since it was set up in 2008. Since its inception, the programme has carried out more than 3 million screening tests. It has detected over 100,000 cases of abnormal cervical cells, many of which could have developed into cancer if not detected through screening and treated, where necessary. Cervical cancer rates have reduced, from around 14 cases per 100,000 women in the years 2009 to 2011, inclusive, to 10 cases per 100,000 women in the years 2013 to 2015, inclusive. The lifetime risk of a woman getting cervical cancer fell from one in 96 women in 2007 to one in 135 women in 2015 which, as Dr. Gabriel Scally noted in his report, represents a substantial improvement.

Dr. Scally also included in his report something to which I want to draw attention again - the substantial contribution CervicalCheck staff have made to women's health since the programme was established. I know how difficult a year it has been for them also.

Dr. Scally's report was produced following the in-depth scoping inquiry carried out by him and his team following a Government decision. This House's contribution in drafting the comprehensive terms of reference for the scoping inquiry helped to ensure his report identified the core issues and provided the framework to fix the flaws he identified in the screening service. He provided a progress report and a first report in June 2018 and his final report in September. All told, he made 56 recommendations which addressed a range of issues, including governance, audit, procurement and women's health.

An implementation plan for all recommendations has been developed and was published on the website of my Department on 12 December 2018, following a Government meeting. There are more than 120 actions in the implementation plan which, together, address all of Dr. Scally's recommendations. Some of the actions relate to work that had already been under way such as the establishment of a new board for the HSE and the proposed patient safety Bill. Others have been put in place in response to Dr. Scally’s report. Work has been ongoing since December across the range of actions. My Department, the HSE and the National Cancer Registry of Ireland all have important and ongoing work to do.

It is important to say Dr. Scally has, at my request, reviewed the implementation plan for his recommendations. He said publicly that never before had he drawn up a report and then been asked to oversee its implementation. That is how seriously we are taking this issue. He provided a very positive preliminary assessment last November and a more detailed report in February which was published on the website of my Department. He was clear in that report that significant effort and resources were being committed to addressing the problems that had been identified and that the appropriate resourcing and project management structures were in place.

As Deputies will be well aware, Dr. Scally has committed to providing a supplementary report on certain further aspects of the laboratories, including procurement, quality and accreditation arrangements and governance structures. I look forward to receiving and acting on this report in the coming weeks. The report will, of course, be published once it has been shared first with representatives of the 221+ patient support group. The full implementation of Dr. Scally's recommendations will ensure women can have absolute confidence in the cervical screening service. Screening saves lives. It is essential that women continue to use the programme and all of the indications are that they are continuing to use it.

It is important to acknowledge that there continue to be challenges, one of which is lab capacity. As Deputies are aware, following the issues which had emerged with the CervicalCheck screening programme, I made the decision to offer free out-of-cycle smears to any woman who was concerned about her health, where her general practitioner, GP, felt she should have a further test as part of providing reassurance. The reality at the time was that general practitioners, in difficult and pressurised circumstances, were dealing with large numbers of worried patients. GPs needed to be supported while they awaited supporting information to be developed and disseminated by CervicalCheck. Approximately 112,000 consultations were provided by GPs, highlighting the sense of worry in the country, while 57,810 early repeat smear tests were provided between 1 May and 31 December. In other words, about half of the consultations resulted in a smear test, which is very different from how it is portrayed. Some 112,000 women saw their doctor, about 50% of whom decided, in consultation with their GP, that a repeat smear would be beneficial as part of providing reassurance. I trust women and doctors in making those decisions.

Laboratory turnaround times have increased as a result. A backlog of over 80,000 smears had built up to the end of February 2019, a figure that has been well documented. This reflects the 57,000 or so additional smears but also the fact that, thankfully, more women were using the screening programme, including some who had never before engaged with it. The HSE has advised that it has sourced additional capacity internationally and that it is working to agree commercial arrangements and complete quality assurance processes in order to enable it to incorporate this capacity into the CervicalCheck programme. I know that this will be welcome news. It has been welcomed by the patient advocates, many cancer organisations and many Deputies in government and opposition.

The HSE is advising women that the natural history of cervical cancer indicates that the disease normally develops over a period of ten to 15 years. It has stated that, in this context, a delay in the return of cervical screening results is undesirable but not necessarily dangerous and that it poses a very low clinical risk. That is not an excuse for the backlog but an important message for the women of Ireland.

The House will be aware that I have asked the HSE to introduce as soon as possible human papilloma virus, HPV, testing as the primary screening method for the prevention of cervical cancer. This is in line with developments in cervical screening internationally. Ireland will be among the first countries in the world to make this transition. The HSE is engaging with other countries which have already made the switch in order to identify learnings for the project across a range of work streams, including reconfiguration of laboratories, procurement, information and communications technology, ICT, and colposcopy services.

The report on the scoping inquiry led by Dr. Scally outlines the difference between the current testing approach, using the traditional cytology test as the primary test, and the newer HPV test. It states that for every 1,000 women screened, around 20 will have pre-cancerous changes. The traditional test will identify 15 of the women, while the HPV test will correctly identify 18. In other words, it is a more sensitive and accurate test. Funding to implement the switch to HPV screening and, importantly, extend the HPV vaccination to boys, an issue on which I know Deputy Kelly has advocated, has been allocated in budget 2019. Vaccination for boys will be introduced in September.

The independent expert panel review, which is being conducted by the Royal College of Obstetricians and Gynaecologists, RCOG, will provide further clarity and assurance to the women who have consented to take part. I am the first to admit that this has taken longer than expected, particularly due to the necessity of seeking consent from women or their next of kin. However, I am pleased the review is now progressing well, with the transfer of all slides due to complete shortly. Of crucial importance is that the results of the review are disclosed to women in a sensitive and quality assured manner, and work is ongoing to ensure the right process is in place for this to happen.

On 16 April 2019, the Government approved my proposal for the drafting of a Bill to establish a tribunal to hear and determine claims arising from the retrospective CervicalCheck cytology clinical audit and from the expert panel review of cervical screening, in particular in respect of the reading of smears. This arises from recommendations made by Mr. Justice Charles Meenan in his report on an alternative system for dealing with claims arising from CervicalCheck. The proposed tribunal will be chaired by Ms Justice Mary Irvine, a serving judge of the Superior Courts, and will be open to individuals who are part of the 221 group, along with individuals who are identified during the RCOG review, where this review presents findings discordant with those of the original cytology examination.

I am pleased that we have this opportunity to put in place a new process to hear and determine claims for these cases. Mr. Justice Meenan’s report provides a roadmap through a complex legal environment and the tribunal that he proposes is substantially different to anything that has been done before. It has never been done before in our country. Getting this right involves striking a careful balance between several important priorities, including the well-being of women and their families, the continued viability of life-saving cancer screening programmes, and the need to properly hold the State and private operators to account. Following consultation with the office of the Attorney General, the general scheme of the legislation is now available on my Department's website. The Bill has gone for drafting to the Office of Parliamentary Counsel. I have issued a letter to the Chairman of the Oireachtas Joint Committee on Health, Deputy Harty, who is present, to offer a briefing by my officials to committee members. This is complex legislation but it is a priority for the Government. Let me be clear that it is my intention to pass the legislation through both Houses before they rise for the summer recess.

On 11 March 2019, the Government agreed to my proposal to establish an ex gratia scheme for women affected by the non-disclosure of the CervicalCheck audit. The scheme is designed to provide an alternative, non-adversarial and person-centred option for women affected by the CervicalCheck non-disclosure issue. The Government also approved the appointment of an independent assessment panel. I have appointed the other two members of the panel, namely, Ms Brigid Doherty and Dr. Kevin Connolly, along with the judge. The panel has begun its work and held its first meeting on 1 May 2019. The role of the panel is to make a determination as to the appropriate amount of the ex gratia payment. Under the terms of scheme, the same amount will be paid to each woman, or her estate, who is assessed by the panel not to have had appropriate and timely disclosure. All women, or their next of kin, in the 221 cohort identified from the clinical audit as having discordance in their smear test results will be eligible to participate in the scheme and I am pleased that letters of invitations were issued yesterday. The terms of the scheme will shortly be available on my Department's website.

Members can see the considerable focus on the various issues raised over the past year, and the progress that has been made in responding to them. My overriding priority remains public health. The country has the opportunity to drive the virtual eradication of cervical cancer through a combination of screening and vaccination against HPV. Since the inception of the cervical screening programme, the incidence of cervical cancer in Ireland has been falling and we must build on this. This is very much the focus of the work of my Department, the HSE, and the many brilliant patient advocates in implementing the recommendations of Dr. Gabriel Scally, as well as in the important development of extending the HPV vaccine to boys this year. My priorities now are the ex gratia scheme, the Meenan tribunal legislation and ensuring the capacity is in place to reduce the backlog turnaround times.

Each Opposition spokesperson will have six minutes. The first Opposition spokesperson is Deputy Donnelly of Fianna Fáil.

I will share my time with Deputy Murphy O'Mahony. I thank the Minister for his statement. At this stage, we are all acutely aware of the damage that the offer of the free retest caused in terms of the-----

I want to clarify for all Members that I am told this is questions and answers with the Minister.

Can we start again, then?

We are all very aware of the implications and damage that the offer of the free smear test caused-----

I am sorry for interrupting. Six minutes for questions and answers is not practical. I was not told this. Was Deputy Donnelly aware of this?

Was Deputy Funchion aware of the six minutes?

I was not and I am-----

I want to point out this is not a direction from the Chair. It was agreed by the Business Committee-----

Fine but it seems tokenistic-----

I can sympathise with Deputy Kelly's point-----

-----to have six minutes for questions and answers on a subject such as this.

I sympathise with Deputy Kelly's point but that is what has been agreed by the Business Committee.

Deputy Donnelly will have to start for the third time.

That is okay. We might start the time again, if that is possible.

The offer of the free smear test contributed greatly to the HPV vaccine roll-out being delayed and to the backlog for women waiting for their smear test results. Back in February, the health committee was told the backlog had increased. We were all expecting it to have reduced considerably. From memory, it increased from approximately 78,000 to approximately 81,000. The Minister referenced February's figure. Given that it is May, what is the figure now? Does he at least have a date for when the HPV test should go live?

Obviously, I do not agree with the Deputy on the free repeat smear test but in the interests of time, I will not rehearse the argument we have had many times. In my opening statement, I outlined why I believed it was the appropriate action to take. I do not have any more up-to-date figures available to me now but I am checking whether we can get them. If we can do so during the debate, I will make them available to the Deputy and the House. If not, I will make them available to the Deputy in writing, ideally today. I will certainly seek them for him.

What I can say, and the Deputy knows it - and it has been welcomed by the Marie Keating Foundation, the 221+ group and many others - is that the agreement we now have in place with MedLab, which is the laboratory that has the largest backlog, means it is expected the backlog will be significantly reduced over the summer months. Many women receive their results within three weeks or within nine weeks. The specific challenge has been with MedLab, where the time is approximately 33 weeks. The fact that MedLab is now focusing on its backlog will see it reduced significantly.

What about the HPV test?

It is still my intention for the HPV test to be introduced by the end of the year. We have reached an agreement with MedLab whereby it already uses the HPV test with regard to its backlog, which is an important point.

I thank the Minister. I accept his bona fides in stating he will get us the information but, with respect, these are Dáil statements on CervicalCheck. The backlog is one of the most pressing issues. The latest data we received was in February. The Minister should have the figures at his disposal for the Dáil this morning on what the backlog is because we need to know whether it is in increasing, decreasing or stationary.

In the interests of time I will put my other questions together. I welcome the movement on the ex gratia payment but by the time it is implemented it will probably have been a year since Dr. Scally recommended it. Why has it taken so long to do something that seems to be fairly straightforward?

My next question is related to CervicalCheck. It is very important and probably deserves more time in the Chamber. It relates to the court ruling in the recent case on screening, which has sent a shockwave through all screening programmes. Senior doctors are speaking to me about the possible implications of having to shut down entire screening services in the country. Is the Minister able to give a brief response on what actions the Government is taking on this front relating to CervicalCheck?

I ask, with the agreement of the House, that we show each other a bit of flexibility because when a major question such as this is asked I will not rush my words because it is important. I am happy to be flexible.

On the ex gratia payment I take the Deputy's point. My position is that the scheme is very much under way and the letters of invitation issued to women yesterday. With regard to the recent court judgment I am limited in what I can say because the House should not discuss cases that are still technically before the courts. What I will say in light of the public and medical concern that has been expressed and articulated by the Deputy is that this is a judgment that needs to be considered carefully. The Taoiseach and I have asked the Attorney General to consider the implications of the judgment. I do not mean the implications regarding Ms Morrissey. Everybody is pleased she has received justice and that she has received an award in this regard and I wish her and her family well. I am speaking about the broader implications regarding the phrase "absolute confidence" and the broader implications regarding the primary liability lying with the State and what that liability is for. We have often been criticised for knee-jerk reactions on this issue. The State does not intend to have a knee-jerk reaction but to allow the Attorney General consider the implications of it for the wider health service. After I have been legally advised on it, I will be happy to brief Opposition spokespersons or come back before the House.

In the interests of time, I will group my few questions together. I am the first female Deputy ever elected in Cork South-West. I am the only female Oireachtas Member from County Cork.

I stand before the Minister this morning to say how sad and let down I feel on behalf of the women of Ireland at the way the CervicalCheck saga has played out. I am tight for time but I must say how awful it is. I acknowledge that the Minister knows of the pain and worry of women who continue to wait for results but I want to get it across to him how awful it is.

What is the Minister going to do to restore confidence? It is essential that the women of Ireland go ahead with this and any other screening process that is available. What will the Minister do to restore confidence in health checks in general and CervicalCheck in particular? Was the Minister advised not to go ahead with the free or out-of-schedule smear tests? How can the Minister stand over the fact that if one pays for a result, one can get it faster than if one does not? That is still the case. Can poor people not be sick? Why do poor people have to wait for a result? There are so many calls on people's money now. Why must they wait for a result and worry for the duration of the wait while people with a few bob for results can get them faster? How can the Minister stand over that?

It was exactly because of the Deputy's last point that I decided to bring in a free repeat smear test. People on a TD's income and the like could have afforded to go to the doctor and pay for a repeat smear test. Some of the Deputy's constituents would not have been able to do that, however, and I was not going to allow an apartheid to exist in relation to reassurance. The circumstances of the free repeat smear test have been well documented but the Deputy and I have a different view despite the fact that many Members across the House called for its introduction at the time. Such is political life.

The Deputy asked what I am doing to restore confidence in the screening programme. The clinical audit did not happen during my tenure as Minister for Health, nor did many of the challenges arise. However, the issue blew up during my time but it is my job to fix it and to work with the Deputy in that regard. We are going to eradicate cervical cancer in our country within a generation. That is not pie in the sky, it is something that has been done effectively in other jurisdictions. It will be done in Ireland through screening, HPV testing, the introduction of the HPV vaccination for boys, the promotion of vaccination by all Members of the House and, hopefully, the end of the silly nonsense and scaremongering of some Members against the life-saving vaccine and CervicalCheck. We are implementing the recommendations of the Dr. Scally report, namely the 120 actions which - I accept Deputy Murphy O'Mahony's bona fides and passion on the issue - will genuinely give us a world-class screening programme which will continue to build on the progress CervicalCheck has made since its introduction in 2008 on foot of a brave decision by Fianna Fáil in government which has helped to save lives.

My first question is on Dr. Scally. His first report was in September. Where is his second report? I am becoming very concerned about this. Something does not add up, as I have been saying now for months. Let us go back to the meeting of the health committee of 13 February 2019. At that meeting, I asked where the second report was. We know there are issues around outsourcing and I am very confident that there are further issues in that regard which were not found in the first report. We know also that there are huge issues in relation to quality assurance. The second phase of reporting on the part of Dr. Scally relates to contracts and quality assurance and all related issues. At the meeting of 13 February, I pressed the Secretary General of the Department of Health on when the second report would be forthcoming. I spoke to him about the issues I have just set out. He told me he believed the report was due imminently. I asked how soon and whether it would be that week and he replied that it potentially would be that week. That was 13 February. What is after happening? Is there a misunderstanding between the Department of Health and Dr. Scally regarding the terms of reference for phase 2? In fairness to the Minister, he published the terms of reference. I am not trying to catch him out. I just want to know what has happened. From September last year or the exact point at which the terms of reference were agreed and sent to him, Dr. Scally has been working on the terms of reference as written by the Department. I want an assurance this minute that this is the case and that his work did not change as a consequence of what happened at the health committee meeting of 13 February 2019. I cannot understand how the Secretary General could say the report was imminent and potentially due that week when it is still not done in the second week of May. What is going on? That is the first question.

I thank Deputy Kelly for the questions. I have no knowledge that-----

Something does not add up.

-----Dr. Scally is working to anything other than the terms of reference. I cannot remember the date but I told Deputy Kelly in the House on a previous occasion, when he put the proposition to me, that additional laboratories had been identified which had previously been used in our screening programme but which were not, to the best of my knowledge, still in use. Dr. Scally provided me with an assurance that nothing he had found should concern me in relation to the safety of the laboratories being used today but he said he would require more time to look into some of the issues he had found regarding some of those laboratories. Deputy Kelly has always been responsible on this and it is important to say Dr. Scally provided me with an assurance on the safety of the laboratories we are using today, albeit he said it would take him longer to do his work. I believe it is nearly complete and I expect to receive it in the coming weeks. I cannot be more specific as Dr. Scally is independent in his work.

I have no issue with waiting. I want him to be thorough. I just want to know why, all of a sudden and in the middle of all this, Dr. Scally had a conversation. I would have presumed the Department and Dr. Scally were hand in glove. I cannot understand how a Secretary General would say it was imminent and potentially due that week when we are still waiting for it. That does not suggest a hand-in-glove relationship. Rather, it suggests a hands-off relationship and a not-in-control relationship. I want dissection of what went on historically. I appreciate what was in the first report and that we have to go through quality assurance and so on in the laboratories and in the contracts. Something here does not add up because it has changed since 13 February.

My second question relates to the decision of the judge in Ruth Morrissey's case. I heard what the Minister said earlier about that and I wish her all the best. She is an amazing woman. There is an opportunity here. We all know, albeit the Minister will not admit it for reasons I respect, that what the Taoiseach promised on "Six One" was unachievable. It was scandalous to do so. He overpromised something the Government could never do which was to say it would chase the laboratories and that the women would not have to go through the courts. Ruth Morrissey spent over 35 days in court and it is a national scandal that she had to do so. The judge has made his decision. While I respect the fact that the Minister needs to get an opinion on it, the Government now has an opportunity to settle with these women and for the laboratories to be pursued separately. The Taoiseach is so out of touch that last week he did not know what he was talking about a second time. He said women would not now have to go through the process of giving evidence. The only difference, which I acknowledge is unique, is the proposal following Mr. Justice Meehan's report that the press will not be involved. The press has been very important in revealing every issue in relation to this scandal. Women will still have to give evidence. The Minister has an opportunity based on last week's decision to create a process to settle with these women. All of these women and their families have the process of going through the High Court and they will have the process of going through the tribunal following this legislation. However, there is a third way. Many of the patient advocates believe there is a third way. Will the Minister look at this third way to settle with the women and their families? In his deliberations with the Attorney General, I ask the Minister on behalf of many people, to whom the Minister knows I speak, to seek advice on whether there is a third option, namely to mediate and settle with them to shorten the process for these women, many of whom do not have time on their side.

As the Deputy has acknowledged in his comments, I am not going to pre-empt the Attorney General's consideration of what the legal landscape looks like-----

I just want the Minister to add to it.

-----but I hear the point made by the Deputy. As Minister for Health, I have a number of priorities here and I need to make sure they are complementary and not competing. The first is to make sure we are looking after women who were wronged and the second is to make sure we protect our screening programmes. I am aware that the Deputy is also passionate about that.

The impact of the judgment on our health service will need to be considered very carefully. It has been acknowledged by many patient advocates and some of their legal teams that not all of the cases will be negligent. How one proves negligence is an issue with which many of us have been grappling.

There is an important point to be made with regard to the Meenan tribunal legislation. It does not say that the cases must be held in private. The Meenan tribunal legislation has indicated that it is the woman's choice. If a woman wants to have the hearing held in public then that can happen, absolutely. If a woman wants to have it heard in private then she also has that right, which she does not currently seem to have in the courts.

This is once it passes in legislation.

Yes. Once we pass the legislation. We have seen the waiver of pre-legislative scrutiny and I believe we can pass that legislation before the summer recess.

I am very conscious of the seriousness of the matter and as the Minister has said I do not want to prevent people from making their points. We are running slightly over but as there is just a certain period of time allowed, I would appreciate Members keeping their contributions reasonably within the timeframe.

I apologise to Deputy Funchion because I had not realised she was standing in for Deputy O'Reilly. I should have come to Deputy Funchion second. It is now her turn.

That is fine. We had not realised that the format of this debate was questions and answers but this is okay. Some of the points already have been raised and I echo the comments of Deputy Murphy O'Mahony who made an excellent contribution on behalf of all the women of Ireland and in particular those who have been affected by this matter. Deputy Donnelly raised the issue of the backlog, which is one of our questions. Exactly how long have people been waiting? We are aware that at one point it was 27 weeks.

I will group my questions together but there are two main questions as well as the issues already raised. We welcome the fact that people can have their hearing in public or private. It is very important for women that their wishes are respected in that manner. Women who may already have received a court settlement, however, are not to be allowed to give evidence to the tribunal. While it is totally understandable that a person cannot have a second claim in this regard, it is important that all those who have been affected are allowed the opportunity to give evidence to the tribunal to help it in its deliberations. Will the Minister confirm that women who have already received an award are barred from giving evidence? I would welcome if that is not the case but I would appreciate clarity on it. If it is the case, why would women be stopped from giving evidence? They would not be seeking a second award.

Reference was made to the recent judgment on absolute confidence in screening programmes. What are the views of the Minister and what are the assessments of the chief medical officer and the Attorney General on this ruling? Where lies the future of screening programmes as a result of this judgment?

I thank Deputy Funchion for grouping the questions. The Deputy has made a fair point about the Meenan legislation. The Deputy has quite rightly indicated that people cannot, nor would they wish to, have two claims or go through two processes. I believe Deputy Funchion is asking me whether it is possible for a woman who had gone through the courts to have her experience documented by the tribunal, if she so wished. The Bill is at the general scheme point of preparation at present but I understand the legislation is currently silent on that matter. It is a provision we probably could accommodate. I am happy to work with the Deputy and her party spokesperson as we progress the legislation on how we could advance that.

On the recent legal case, I do not have anything further to add to what I have already said other than the ruling is going to require very careful consideration by the Attorney General. We need to look at the impact not merely in relation to the individual case. We have been very clear and are unified as a House in wanting Ms Morrissey to be supported, for her to receive the compensation the court has awarded to her and for her to be able to enjoy time with her own family, as she outlined after the court case last week. There may be broader issues for the health service on which we will need clarity. Today we are at the stage where the Attorney General is considering these matters and he will then revert to the Taoiseach and to me. In due course we will consider how best to get that clarity. As Deputy Donnelly has rightly said, many medics are now asking what are the implications for screening and for other elements of the health service? We are duty bound to answer this question. In the coming period we will consider how we will answer this in a way that does not adversely affect Ms Morrissey but provides legal clarity.

Will the Minister also provide information on the current backlog and the waiting times? A 27-week wait is the equivalent of maternity leave. It is a huge length of time for a person to wait while wondering every day if a letter or a phone call is going to come. It would help if we had the information on the backlog.

I have no difficulty whatsoever in making that information available. The work we have been undertaking, which has been welcomed by patient advocates, doctors, cancer groups and others, is to now try to have a really intensive focus on the backlog. The Deputy has not said it, but it is not true to suggest that everybody has been waiting a very long time. Far too many, however, are waiting a long period of time. When one consider the three laboratories involved, the Coombe laboratory has a turnaround time of approximately three weeks, Quest Diagnostics has a turnaround time - from my memory - of approximately seven to nine weeks and MedLab Pathology had a much longer turnaround time. MedLab is now focusing on its backlog, is now using HPV testing and is prioritising tests, which is a good development. I expect that the backlog will substantially reduce over the summer months.

I thank the Minister for giving us the opportunity to discuss the subject this morning. Cervical screening is not a diagnostic test and this is where a lot of the issues have arisen. No screening programme can identify 100% of the abnormality that it is looking for. In this case the screening programme looks for pre-cancerous changes, which have a huge spectrum of change from zero to invasive cancer. The programme attempts to deliver population health versus individual health. Up to 2008 it was random screening of cervical smears and then the population health directorate introduced the national screening programme, which has delivered a huge amount of success in identifying women who had pre-cancerous changes. Unfortunately, because the programme has inherent difficulties - all screening programmes have inherent difficulties - the judgment that was delivered last week on absolute confidence really misunderstands what screening programmes are all about. It is not attainable or available to any screening programme to achieve 100% success. Right across the world this is not possible. Medicine is an uncertain business and one tries to confirm in an area of uncertainty. Screening tries to improve population health. Will the Minister tell the House if the judgment will put other screening programmes in doubt, has it put other diagnostic tests in doubt and has it put the future of cervical screening in doubt? I understand there was a high-level meeting between CervicalCheck and departmental officials some days ago to discuss this very issue. Has the judgment really damaged the future of all screening? I believe there will be an appeal of the judgment. Will the Minister comment on that?

HPV testing has been promised for a year. It was to come in last October and it is now promised for before the end of this year. What are the barriers to introducing HPV testing before the end of this year? Is it dependent on clearing the backlog or is it dependent on finding a laboratory that will provide the new level of testing?

My third question relates to MedLab's coverage. The smears that are sent to MedLab are usually from the regions outside the Dublin area. I believe that MedLab is no longer accepting new smears since 1 July. Those smears are now being stored pending access to new laboratory capacity, which has not been attained yet. Will the Minister confirm if this is true?

Earlier I made a suggestion for dealing with the substantial backlog, for which the last figure we had was 80,000 smears. Is there some merit in suspending the screening element of CervicalCheck until that backlog is cleared?

Women are now being asked to attend for smears but they might not get a result for up to 33 weeks, which negates the benefit of getting an early result from screening and undermines confidence in the screening programme. Has the Minister or CervicalCheck considered a temporary suspension of the screening arm of CervicalCheck to allow for the backlog to be cleared?

I thank the Deputy for his questions. I very much appreciate the points he made, as a medic and a public representative, in regard to reminding this House that screening is not a diagnostic test and that there will, therefore, always be false positives and false negatives in any screening service in any country. While the HPV test, when introduced, will lower the numbers of false positives and negatives, some will remain, as I outlined in my opening statement.

I said - I do not wish to go any further - that I am aware of the concern over the judgment among the medical community. I have heard many of them articulate it publicly in recent days. My suggestion, which is prudent and sensible, is to consider the implications in a calm and rational manner and then decide what action, if any, is required, either by these Houses or the Government in regard to seeking legal clarity on the impact of the judgment beyond any individual case.

I am not a legal expert by any stretch but I would make the point that the judge states in his judgment that the United Kingdom has some of these tests in place. The UK has a very robust screening process and, therefore, I call for calm and for us to allow the Attorney General to advise the Government. On the basis of that advice, I ask that we stand in support of screening and take whatever action is necessary and appropriate, should any be required, in regard to screening or wider implications for the health service.

With regard to the introduction of HPV as the primary method of testing - it is already in place in some cases, particularly regarding MedLab and the backlog - it is a good development. The HSE has been engaging with other countries that have made the switch, including the Netherlands and Australia, and countries that are preparing to do so. We are learning from their experiences. We have provided funding to make the switch. A clinical advisory group has been set up in the HSE and it is currently reviewing quality assurance guidelines. Colposcopy capacity planning is under way through the national women and infants health programme. This is required to support the introduction of HPV testing. This includes reviewing current operational pressures for all colposcopy units, in addition to the impact of the introduction of primary HPV testing and the review of the RCOG. That is also nearing completion. The HSE has advised that the majority of planned site visits have now taken place, and the plan is to have the remaining visits in the coming weeks. We will manage to introduce the system by the end of this year.

The Deputy asked about current capacity within the screening programme and whether I considered a suspension. I will group the questions in the interest of time. Had additional capacity not been sourced, the proposition the Deputy highlighted might well have become a reality but the HSE has been undertaking a global search for laboratory capacity. As he will be aware, it has not been easy to do so. The HSE has advised that it has sourced additional capacity internationally. It is working to agree commercial arrangements and to complete the quality assurance process while remaining conscious of Dr. Scally's findings. The process is at a very sensitive stage. I expect it to be concluded very shortly. I expect this will provide us with enough capacity to continue to run the screening programme, to continue to invite women to attend for screening after appropriate regular intervals, and to address the backlog.

I assure women today that the HSE is fully focused on ensuring the necessary screening capacity remains in place and that there will be capacity to process all the slides that have been taken so far.

I seek clarification. The Minister said the HSE has sourced additional capacity internationally. Is it the case that it is not in place yet?

Yes. The commercial negotiations are very much nearing conclusion.

Is it the case that smears that normally would have gone to MedLab from 1 July do not have a laboratory to go to at the moment?

Yes, it is the case but they are being stored safely and will be processed. I cannot go further than that. I know the Deputy would not want me to jeopardise what is going on at the moment but I assure the House that additional capacity is coming on stream, which will ensure the slides are processed safely. I can give women that reassurance.

I seek a little more clarity on that. There are cervical smear takers around the country who are taking smears at present but there is nowhere for those smears to go. They are being stored pending the HSE's sourcing of additional capacity. Is that the case?

It is the case that the finalisation of the commercial arrangements in regard to the additional capacity is ongoing. The process is very much nearing completion. This will provide the additional capacity to ensure our screening programme operates at 100% capacity and can address the backlog. There will also be other significant benefits to the screening programme, which I would be more than happy to discuss at a meeting of the health committee in great detail once the commercial negotiations are concluded. I believe I am due to appear before it on 22 May for our quarterly meeting. I can reassure women that the smears being taken today will absolutely be processed. I expect the commercial negotiations to conclude very shortly.

Since some Members were tied up at committee meetings this morning and could not get here, there is a little time remaining. If Deputies Funchion, Donnelly and Harty wish to ask any other brief questions of the Minister, I will allow them before he responds. I am sure that is acceptable to the Minister.

We are good at this stage.

In that case, I ask the Minister to conclude. He has five minutes.

I do not wish to take up the time of the House unnecessarily other than to emphasise again that a significant body of work is ongoing in regard to CervicalCheck. I sincerely acknowledge the positive and constructive role the health committee is playing in overseeing this and in continuing to monitor the implementation of the recommendations. I assure Deputy Harty of the ongoing co-operation of my officials and those of the HSE in appearing before and updating the committee he chairs. There will be a number of appropriate and important occasions when this can be done, particularly in regard to HPV testing and processing the legislation on the new tribunal.

I am pleased we now have a very robust implementation plan in place. I am pleased Dr. Scally is pleased because he is the independent arbitrator who rightly has the confidence of citizens at large and certainly of patient advocates. I am satisfied now that some of the supports regarding the ex gratia scheme are being processed and that the invitations to women to participate have been issued. The HPV vaccine will be introduced for boys this year, in September. As I outlined in answering the final round of questions from Deputy Harty, substantial progress has been made as we prepare for HPV testing.

I thank HSE staff, particularly Mr. Damien McCallion, who has done Trojan work on behalf of our country in trying to ensure the continuance of screening and the sourcing of additional capacity. I am pleased that while we have experienced genuine challenges in this area, Deputies and patient advocates continue to support screening and call on others to support it. As challenges emerge and as we deal with ongoing challenges and consider the legal implications of court judgments, I am pleased that there seems to be a bipartisan and constructive approach to this issue. I look forward to making progress on that basis.

That concludes the debate. I thank the Minister and his officials. I thank all the Deputies, whom I believe contributed in a very sincere way to the debate, which touches every one of us. I thank the officials of the House for their help.

Sitting suspended at 10.20 a.m. and resumed at 10.30 a.m.