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Seanad Éireann díospóireacht -
Tuesday, 25 Sep 2018

Vol. 260 No. 3

Scoping Inquiry into CervicalCheck Screening Programme: Statements

I welcome the Minister for Health, Deputy Simon Harris. This is the first opportunity I have had to do so as Acting Chairman.

I am very pleased to be back in Seanad Éireann. As Senators are aware, on 12 September I published the report on the scoping inquiry into the CervicalCheck screening programme. I welcome the opportunity to speak to the House about the report. I publicly acknowledge the extraordinary contributions of Ms Vicky Phelan, Mr. Stephen Teap, Ms Lorraine Walsh and many other women and their families who have shared their stories with us.

Through his report, Dr. Scally has brought much needed clarity to the CervicalCheck crisis. Such clarity and understanding are crucial if we are to address what went wrong. We now understand that, at its heart, the crisis is about the failure to tell women about their own medical information - to disclose to them the results of a retrospective audit of their screening history carried out after they had been diagnosed with cervical cancer. The failure to disclose was utterly wrong and unacceptable. Furthermore, the way in which many of those affected were eventually told about the outcome of the audit added to the pain they were experiencing in dealing with the aftermath of a cancer diagnosis.

It is fair to say some of the complexities were not always well understood in recent months. It is clear that some people believed women had not been told that they had cancer. That view was expressed in each of the Houses. Others assumed that a diagnosis of cervical cancer in a woman whose screen had returned a negative result was automatically negligent. Thanks to Dr. Scally’s report, we now have a much greater understanding of the complexities involved in our screening programmes. The report is based on intensive work by him and his team of experts over a relatively short period. While it provides welcome reassurance about the quality and safety of the laboratories being used by the Irish screening service, it clearly sets out the enormous impact the lack of disclosure of retrospective audit results had on those affected. The Government has accepted all 50 recommendations made in the report and I am committed to moving ahead with their implementation. I ask and hope for and I am sure I will receive the support of Members on all sides of the Seanad and the Dáil in putting all of our energy into delivering the recommendations because they will lead to a world class screening programme. If implemented, they will help us to make cervical cancer an extraordinarily rare disease in this country, which must be our aim. When this debacle first broke and I met and spoke to Ms Phelan, she told me, as have others since, that she wanted to know that some good could come out of this awful situation. That good can be to make cervical cancer an extraordinarily rare disease in this country and save women's lives. We must all put our efforts into pursuing these goals.

As an implementation priority, I will work on the establishment of a new independent patient safety council. As its first task, the council will carry out a detailed review of the existing policy on open disclosure. The resulting policy will have legislative underpinning and operate across the health service.

The establishment of a statutory duty of candour is a further key requirement. The Patient Safety Bill is scheduled to undergo pre-legislative scrutiny tomorrow at the Joint Committee on Health. I ask members of that committee to give this issue the priority, attention and time it requires in order to pass this landmark legislation which will make a duty of candour a legal requirement. The Bill provides the legislative framework for several important patient safety issues, including mandatory open disclosure of serious patient safety incidents. I wish to ensure the requirement to disclose or a duty of candour will apply to individuals and institutions, rather than institutions alone, as is the case in certain other jurisdictions.

The Government is committed to the continuation of CervicalCheck, BreastCheck and BowelScreen. We know that screening saves lives. Dr. Scally has been clear that the continuation of the screening programme is crucial. His report affirms that the laboratories contracted to CervicalCheck are providing a quality service. It is very important that this be recognised. Leaving aside whatever else went wrong, charges were made, possibly in this House and certainly in the Lower House, regarding the quality and safety of the laboratories. The number one query I received from women by email, in my constituency office and as I went about my business was whether the laboratories responsible for carrying out screening were safe and whether women could be assured of the quality of the results. Dr. Scally examined the issue and visited the laboratories with three other medical experts, a senior counsel and a barrister at law. They concluded that the laboratories being used by the screening service were safe. That is a very important point for all Members to reiterate.

Crucially, Dr. Scally has found no reason for the existing contracts for laboratory services not to continue until the new HPV testing regime is introduced next year. He is satisfied with the quality management processes in the laboratories and his report presents no evidence that the rates of discordant smear reporting or the performance of the programme fell below what was expected. It is essential that we clearly and emphatically send the message that this is a high quality and effective programme and that screening reduces the risk of developing the disease. I know that some of the women most impacted on by this issue have been very determined that that message is sent clearly.

As Members now know, screening alone is not enough to prevent all women from getting cervical cancer. Sadly, false negative results are inherent in screening programmes. Page 11 of Dr. Scally's report is very revealing in that regard. It states that, for every 1,000 women screened, 20 will have pre-cancerous cells. Screening will detect the pre-cancerous cells in 15 of the women but, sadly, miss them in five of the 20. The good news is that as we move to HPV testing that rate of detection of 15 of 20 will increase to 18 of 20. That is why it is imperative for us to invest in and deliver the HPV testing programme and we are determined to do so. I have given approval for the switch to HPV testing as the primary cervical screening test, which, as I have stated, will reduce the rate of false negatives. Work is under way to progress that change.

A well organised screening programme, combined with HPV vaccination for boys and girls, can bring us very close to eliminating the disease. I reiterate the absolute importance of the vaccination programme. I noted in horror that some of the Oireachtas Members who were most vociferous on the CervicalCheck screening programme opposed use of the HPV vaccine. The vaccine has saved lives. Some of those Members have written to me questioning the safety of a vaccine which can prevent the death of women from cervical cancer. The HPV vaccine is safe and saves lives. Members need not listen to me. However, they should listen to Laura Brennan, an incredible patient advocate who has cervical cancer and spoken about how she does not want any other girl to find herself in a similar position. If this is about reducing the rate of cervical cancer and saving women's lives, there is a duty on all Members to promote not only the most robust screening programme we can have in this country but also use of the HPV vaccine.

It is appalling that the vaccine's uptake rate had fallen because of the misinformation that was allowed to get out. People need to get their medical information from medical professionals, and www.hpv.ie has factual information for parents to make an informed decision. I want to see the HPV vaccine extended to boys. We are committed to introducing that next year subject to HIQA's report, which is due shortly. I have asked my Department to develop a HPV plan for the reduction of cervical cancers and other HPV-related cancers to the maximum extent possible, building on these changes and optimising uptake of screening and vaccination. It is through screening and vaccination hand in hand that we will eradicate this disgusting and despicable disease from our country.

I do not downplay in any way, shape or form the extraordinarily serious gaps that have been identified in the governance structures of the screening service. They need to be addressed in full through Dr. Scally's 50 recommendations. They must also be considered in terms of how they apply to governance structures in the health service more broadly. I emphasise that Dr. Scally has stated in unequivocal terms that he found no evidence of conspiracy, corruption or cover-up. This speaks to the integrity of civil and public servants, some excellent people who get up every day and go to work to try to build a better health service. Some of the things that were said in the heat of the controversy questioned the integrity of public servants in leadership positions; therefore, it is only right that we now acknowledge the actual position as outlined by the independent expert, who was assigned to establish the facts by those of us in the Oireachtas.

The report examines the provision of briefing notes on screening audit and disclosure to the Department of Health in 2016. These came into the public domain in May. I welcome the clarity provided. The inquiry considers that it would have been unreasonable to expect senior management in the HSE or, even more so, my departmental officials to have intervened on foot of these notes. According to the report, the subsequent problems were significantly associated with the failure to disclose, and it would have been difficult to predict this, given the reassurance that the briefing notes provided.

Dr. Scally has based his findings on careful examination of the contemporaneous records. He has reviewed more than 12,800 files, which is more than anyone in this House has, in order to get all of the facts and information. I fully accept his conclusions in this regard. I am clear that the decision of my officials not to escalate to me was correct in the context of his findings.

Accountability was an issue raised by many women and family members during their engagement with Dr. Scally’s review. He has been clear that the problems he has uncovered represent a system failure. In many ways, it is often more straightforward to receive a report asserting that X or Y individual did something. Sadly, when one reads the Scally report, the situation is far more complex. A whole-of-system response is required. I have already taken some steps, and I look forward to working with Senators on delivering them. For example, I have re-established a board for the HSE. I announced its chair designate only last week. It will provide the foundation for proper governance and accountability. I hope that we can get the Health Service Executive (Governance) Bill passed through the Houses this year in order that the board can take office in January.

The key focus must be on implementation. My Department has already commenced the task of fully implementing the report. The CervicalCheck steering committee, which I established in June, will oversee and direct the implementation of all 50 recommendations. Importantly, the committee will publish its minutes and agenda; therefore, everyone can, via my Department's website, find and track everything that is being done. The Department has established a working group to drive the work of implementation. I have already written to all of the organisations mentioned in the report, including the Medical Council, to ask them to commence preparations for implementation of the relevant recommendations. Questions remain to be answered about how clinicians interacted with patients, in this case women. Some of what women were told is extraordinarily worrying. It is not the first time we have seen women treated like this by the health service. For example, we saw it in respect of transvaginal mesh, sodium valproate and, dare I say, issues related to abortion and reproductive health. Sadly, we now see it in terms of CervicalCheck. I welcome Dr. Scally's recommendations in that regard. There are lessons for the Government, the HSE, clinicians and clinical leadership.

Dr. Scally's 50 recommendations are important and their breadth reveals the complexity involved. We must now begin the hard work of implementing each and every one of them. This is what will improve the quality of the screening programme. I propose to meet the patient representatives, including Vicky, Stephen and Lorraine, in the coming days to speak with them about the next steps and how to ensure their involvement. I propose to take Dr. Scally up on his offer to stay involved for the next 12 months and externally oversee the recommendations. This is not a report that he has written just to head back to the UK. He wants to oversee its implementation externally. I want him to appear before the Joint Committee on Health to update the Houses and the public on how he is getting on with delivering the recommendations. There will be a need for further inquiries - he has already pointed to a number of areas that require further examination - but we must also reflect on his views as to how best to go about that. Crucially, we must take on board the views of Members in both Houses and those who have been impacted on.

We have a great deal of work to do, but Dr. Scally's report brings us to a place where we can approach it in an evidence-based fashion, focusing on implementation and delivery in order that we can ensure lessons are learned and lives are saved in the future.

I thank the Minister. Since we are tight on time, I will hold rigidly to the times allocated. I would appreciate it if Senators finished ahead of time so that all speakers can contribute.

Like everyone else, I was horrified when the facts of this scandal unfolded over a number of weeks. As a woman, they were horrific to hear. I have had a number of smear tests over the years and have been grateful for the screening programme, as have been the many hundreds of thousands of women who have gone through it and received results, be they clear or indicative of a need for further testing. It is a good screening programme, but our belief in the system was rocked to the core.

As the Minister stated, this occurred at a time when we were debating the eighth amendment, which was a women's healthcare issue. It raised questions about how women's healthcare had been sidelined and neglected over the years. It was an extremely emotional time for me, listening to Emma Mhic Mhathúna on the radio and the testimonies of Stephen Teap, Vicky Phelan and many others who had been badly affected by this scandal.

I welcome the Scally report, which is comprehensive. I would like its 50 recommendations to be implemented immediately. Have funds been set aside in the upcoming budget to provide for this?

I pay tribute to Vicky Phelan, whose bravery and refusal to be bullied into signing a non-disclosure agreement, NDA, brought all of this to light. She has done women, this country and the health service an enormous service. She risked everything in refusing to sign that NDA and her bravery should be acknowledged.

The Scally report is excellent, in that it records the testimonies of the women affected and their families. Their testimonies are vital. I am glad that Dr. Scally gave them and their families that time. Their voices need to be listened to where the commission of inquiry is concerned. They are undergoing a period of reflection, which they should be allowed the time to take. We should all then reflect on their decision and allow them to direct the outcome.

I was taken aback by the statements about how the women were dealt with by the mainly male practitioners in the health service and the paternalistic and misogynistic attitudes that were displayed. The medical community needs to reflect on how it deals with women. Perhaps it can examine why women are not progressing up through its ranks and why there is a male-heavy medical profession in certain sectors. This matter needs to be considered. All of this ties into the gender pay gap and other issues. There is a reason for female medical students not becoming consultants, particularly in this area. Perhaps the Minister's Department needs to examine this matter.

The Minister referred to the lack of gravity attributed to women's healthcare down the years. It was a significant point. I was in Buswells Hotel today to attend the pre-budget submission of the National Women's Council of Ireland. From speaking to those present, it has some excellent proposals on women's healthcare, to which I would like the Department to give consideration. I back the council's call for the establishment of a women's health action plan, particularly given the report's finding that, since 2010, CervicalCheck has not had on a full-time basis an accountable senior person responsible for the programme's delivery.

That is absolutely shocking and horrendous and needs to be addressed immediately. This needs to be addressed in the overall context of women's healthcare being neglected down through the ages in this country. It is about time that women and our healthcare are taken seriously. There is perhaps a disconnect between these Houses and the medical profession and the 51% of the population. I look forward to seeing some progress. I am dismayed with a lot of the information in the Scally report, but it has not come as a total shock because we have seen it time and time again. I do not want to be standing up in this or any other chamber discussing the next scandal in women's healthcare. I look forward to significant progress on this over the coming weeks. I reserve my position on the commission of inquiry until I hear what the women and the families have to say about it.

I want to thank the Minister for coming and giving a comprehensive overview of this terrible saga. I also acknowledge Ms Vicky Phelan, Mr. Stephen Teap and Ms Lorraine Walsh who, with so many others, were so courageous and brave. It is never easy to go out into a public space and to talk about one's own personal life, but also to talk and share that on the national airwaves, and tell one's personal story, in front of one's own children, one's loved ones, knowing that one's own health is at stake. They paid a terrible price and are continuing to do so. I thank them, because it is important that we acknowledge and thank them.

I thank Dr. Scally, the scoping inquiry and all of the people who supplied information and the personal accounts and the advice to the inquiry. They too are brave and courageous. It took brave people to put their head over the parapet and say, "Enough is enough and we are not accepting what the Government and the Department were saying. We are not going to be dragged through the courts having to fight and fight all the time."

Let us put this matter in context. The people concerned met block walls for a long time. Only when the media sat up and took an interest and suddenly when the people concerned gave their true story, their testimony to their lives and their experiences, we all took this issue on board. Great thanks are due to the media and journalism that helped them to tell their story.

The Scally report achieved a remarkable task, under very difficult circumstances, with clear dedication and genuine concern for the women involved. This is clear to anyone who has read the report. There were difficult issues in terms of cervical screening and he has shone a light on a very dark place. We have to be careful, however, about what he said. It was a very measured report and brought a sense of measure to the whole matter. It was interesting, for instance, to note that he is not recommending that we go ahead and have a full commission of inquiry. However, the Taoiseach gave a commitment that we will have a full commission of inquiry, and I want the Minister to return to this issue.

What Dr. Scally said in his report was profound. He stated:

The current policy and practice in relation to open disclosure is deeply contradictory and unsatisfactory. In essence, there is no compelling requirement on clinicians to disclose. [...] It is left up to their personal and professional judgement.

That is a direct quotation from the Scally report. He goes on to say there is some reluctance on the part of the Government - there was reluctance on the part of the Government in the past - to embrace the issue of mandatory open disclosure. I do not want to rehearse all of that here in front of the Minister, because I do not believe in laying blame on anyone. We got a glance back but we look forward and need to get on with the job. I take on board what the Minister is saying.

Clearly after what the Scally report has stated, this puts an end to that argument. We have got to embrace without any ambiguity the absolute need for mandatory open disclosure. It is important to acknowledge and to say that there are many dedicated people in the health screening sector. It is right and proper that we support them and that we advocate for good health screening. It makes absolute sense. The Scally report also went on to state this.

I am saying I would like the Minister to clarify what the Government's intention is and he may need more time to reflect on this. Clearly, we need to talk to the victims. I have spoken to a number of these women. They have not fully made up their minds yet whether they want a full, sworn commission of inquiry. Time is running out for many of them. We have to respect and not rush to any judgment. I can only take the Taoiseach at his word, that he will have a full commission of inquiry, which I believe is important.

The leaking of the report was ultimately disturbing. I took the time to quote and look at the Taoiseach's responses to it. I too want to share his revulsion, disappointment and hurt that he referred to in his own statement when the leak was brought to his attention. I would like some clarification as to whether this has been investigated and, if so, what sanctions are going to happen. I would sack someone that leaked an important report before the people got it. That should be addressed. As to this issue of leaks being investigated, that was no good to the people on the night when Dr. Scally had to go out and talk to people and give them some comfort a day in advance. It was grossly irresponsible, not good enough, and the Taoiseach should continue to investigate how that report was leaked. I urge him to take appropriate action that is right and consistent with his statement.

I hope the Minister will continue to pursue the 50 recommendations. That is important. We should have regular updates on these 50 recommendations. I acknowledge the great thanks that we, the State, owe to these courageous and brave women. I acknowledge the work of Dr. Scally and am particularly pleased to hear today from the Minister that Dr. Scally wants to remain involved. That is welcome and should be encouraged.

I call Senator Colm Burke who wishes to share time.

Yes, I will share time with Senator Kieran O'Donnell.

I welcome and thank the Minister for making his presentation on the report. It is important to acknowledge that what occurred was wrong in a sense of the non-disclosure to women when the results of this audit were published. It was a retrospective audit on people who were in a programme of treatment. This information was important to them and should have been disclosed to them when it became available. I pay tribute to the women, in particular Ms Vicky Phelan, for coming forward and taking on the system and making sure the information was in the public domain. We would not have this report only for her coming forward and bringing her information into the public domain.

I have read the report substantially and marked and flagged various areas in it about which I have concerns. The report is a very good study of all of the issues in this area: what was not working properly; what could have been done a lot better; how people felt about the way they were treated; and how this was managed.

Dr. Scally's team had to examine a great amount of documentation. There were over 12,000 documents; 6,958 from the Department; the HSE provided 4,994; and there was documentation provided by the State Claims Agency and the National Cancer Registry of Ireland. We need to look at the whole governance structure that was there regarding CervicalCheck and the disconnect in getting the information out and a disconnect about the management of the structure. For instance, the programme established a system of governance on 1 January 2007. The national screening service had a board which was abolished on 1 April 2010.

It was absorbed into the HSE. There seems to have been a problem regarding everyone working together and communicating. Important decisions were not taken when they should have been. For example, there was no one person in charge. Instead, there was a clinical director and a programme manager. Technically, there were two people in charge but there is the question about responsibility.

The report also refers to people within the cervical screening programme not having job descriptions, not knowing what their job responsibilities were and certain individuals having responsibilities that were not contemplated by their job descriptions. This problem of governance leads on to bad management and a systems failure. There was a systems failure, which added to the problem.

It is important that when we provide healthcare, we recognise that when, for example, a person is first diagnosed with cancer, it is a really traumatic experience. It affects him or her directly but it also affects his or her immediate family. There is the worry of long-term treatment, there are financial management worries for the family and there is concern about the young children in the family. In this instance, we find that the programme and the system of governance relating to it are not really functioning properly. The latter leads, as in this case, to a fairly problematic system. The lack of accountability between the HSE and the cervical screening programme seems to be accepted within the executive to a large extent. People are moving within jobs and nobody is actually accountable. We need to tackle this. In fairness, Dr. Scally refers in his report to a clear pathway in how we should reform and deliver the service and how to manage it into the future. I welcome the Minister of State's comments that Dr. Scally staying on for another 12 months. We should learn from this to make sure there is never a repeat of what occurred in this case. I welcome the comprehensive report but it is important that we now implement the recommendations contained in it.

I welcome the report of the scoping inquiry into the CervicalCheck screening programme. I compliment Dr. Scally on the report. The most important people in this are the women themselves. My main concern was to wait and see how the women who have been impacted upon felt about the report. I listened intently to my neighbour Vicky Phelan, Stephen Teap and others. They welcomed the report. That the report was leaked was reprehensible. That should not have happened. This is about women's lives and about how those lives have been impacted upon. I got to know Vicky Phelan at the start of the year. She is an extraordinary person. Ruth Morrissey is another neighbour of mine and another extraordinary lady. Both of them happen to live quite close to each other. When we consider the others who have also been affected by this directly and indirectly, people such as Stephen Teap and Lorraine Walsh, there is admiration for what they have come through. In the case of Vicky Phelan, this came about through a failure to disclose to people information they are entitled to. The key issue now is that this will never happen again. It is imperative that Dr. Scally stays on - and he has indicated that he will - because he has the trust of the women involved. It is important that we introduce a regime of HPV testing as quickly as possible. It is absolutely imperative that all of the report's recommendations are implemented. I welcome that the Minister is to meet Vicky Phelan, Stephen Teap and Lorraine Walsh shortly. It is imperative that this vital screening programme continue and be improved.

Fáilte arís a Aire Stáit. I thank Dr. Scally and his team and, in particular, the women who contributed to the report. Their evidence and testimony were invaluable to this process, as well as to the final conclusions contained in the report. The women were beyond brave and have done a great public service by sharing their experiences. The past and present scandals of the State, which seem to be for ever unfolding, are discussed and uncovered by the bravery of people such as Catherine Corless, Vicky Phelan, Emma Mhic Mhathúna and Stephen Teap.

Women's health in Ireland has a history of shame. It is not just about the treatment of women socially, it is also in the context of healthcare and treatment. These women, however, refused to be bought off. They were defiant and they refused to be silent. We all owe them so much and I thank them. I urge women to stay engaged with the screening programme and to have their smear tests. Screening saves lives. We must never lose an opportunity to remind women that, notwithstanding what they read in the press, they should engage with the service.

Dr. Scally states the biggest failure that he identified in his four-month review was the non-disclosure of information from CervicalCheck audits to the patients. This is the most important finding and it should now be legislated for. Just prior to the recess, I introduced the Civil Liability (Amendment) (No. 2) Bill in respect of mandatory disclosure. Unfortunately, it was defeated by Fine Gael by a single vote. Always opposed to making open disclosure a voluntary concept, we have attempted to bring legislation through this House on several occasions. I very much look forward to working with the Minister to finally have his patient safety legislation enacted.

I thought we had entered the age of enlightenment. I thought we had moved away from superstition. It was a throwback to when I was a very young woman and I worked part-time in Our Lady's Hospice. Not one of the patients there were told they were dying, but if a person went to the hospice he or she knew it was a place to die. People were not told what they had, be it cancer or whatever. Shamefully, one was to say prayers for them. That was the treatment; prayers. Medication that might ease a painful death was withheld. As a young woman, I found this incredible. A painful death was supposed to give a person an advancement in Heaven. I thought we had come through the enlightenment and I thought we had got through those days but it is still the case that patients are not involved in their treatment or care plans and nor are they allowed to lead matters and state what they want to do. These are seriously ill patients. Many of them are dying and they do not know why that is the case. I find it incredible that nobody would talk to such a patient about his or her end of life. Even for the 18 women that we have lost through this scandal, there was nobody talking about end of life and it was kept quiet. I had hoped that we had moved a lot further.

On foot of the Scally report, we know that one of the laboratories, Clinical Pathology Laboratories, CPL, outsourced part of its work to four other laboratories that were not accredited or certified to the standards demanded by CervicalCheck. In the context of the outsourcing of contracts, questions arise regarding the rollover of tenders and procurement. This is an aspect which, I am sure, the Committee of Public Accounts will examine. I also echo the call of my party colleague, Deputy Louise O'Reilly, that HIQA should have an oversight role in respect of any laboratory involved.

Scandalously, the report was leaked before the women involved could be properly briefed and prepare themselves. I am aware that the Minister agrees with this sentiment. In the Dáil he stated he hoped the Taoiseach would investigate the leak. I wonder if we can get an update in that regard. It is morally and absolutely wrong.

The responsibility was shirked by the Department and by the media, which was disrespectful. It was grabbing headlines and doing other nefarious things the Department wanted done in order to take the shine off it. I am not too sure why that was done, but obviously there were other issues around at the time. In the latter part of the report Dr. Scally also mentioned the glaring lack of grace and compassion. We should dare to believe that it is possible to possess grace and compassion. I hope misogyny is not endemic in the health services, but this has unfortunately come to light in the treatment of women with cervical cancer and, perhaps, women with other health difficulties when they attend.

I reiterate what I say so often in this House, which comes from my experience on the ground as a nurse; public participation at all levels of healthcare is vital. If we have more public participation in the top tiers and at the top tables of the HSE and of the strategy and steering groups, accountability will follow. It is welcome that the Minister will meet those affected by this report and that he has committed to this ethos throughout the implementation of all 50 recommendations. Dr. Scally has offered to continue to work for the next 12 months on the delivery and to oversee the delivery from an external point of view. That is also to be welcomed. Citizens and women demand assurances that this will not happen ever again.

The Institute of Obstetricians and Gynaecologists is due to publish its report soon. We will we be led by this report and by the victims themselves if they believe that a commission of investigation is warranted. The Minister of State spoke about the HPV vaccine, which is slightly off-topic but it saves lives by preventing cases of cervical cancer. I have always been an advocate of this science, which will protect our young women and men. The uptake has increased significantly over the period of this scandal, which has raised awareness. We need herd protection and to get the uptake back up to 90% or so. Now that the schools are back for the new term, will the Minister of State come back to us with details of the percentage of our young people who are taking up the HPV vaccine?

I have great empathy with the women concerned about and affected by the recent issues relating to CervicalCheck. I know the emotion associated with not being told something. I fully believe in the principle and practice of open disclosure. My brother died unexpectedly at the age of 19 after a routine appendix operation and my family never got answers. That still hurts and bothers us as a family. Regarding cervical screening in Ireland, we need to focus on the future. I agree with Dr. Scally. I am not in favour of a commission of investigation. That would not be the best way to proceed. We need to put our energy into the implementation of the 50 recommendations.

Let us remember that cervical screening is screening. It is not diagnosis. It is about population health rather than about individuals per se. There will be false negatives in screening programmes. For women's health it is important to have both cervical screening and breast screening. The move to the new approach of also screening for HPV will significantly improve the accuracy of the screening process, increasing the chances of more cancers being prevented due to the detection of early changes. From a review of every 1,000 women screened, of the 20 women identified with pre-cancerous changes, the HPV test will correctly identify 18 but will still miss two. The current pap test will identify 15 women, but will still miss five. There will always be false negatives in any screening process. We need to remember that as we make the changes we need.

Dr. Scally speaks of a realistic prospect of the virtual elimination of cervical cancer in Ireland in the coming decades. That is a prize worth fighting for and worth keeping to the fore in our deliberations this evening rather than establishing a commission of inquiry. Cervical cancer is the fourth most common cancer in women. Cervical screening has saved lives. According the Scally report, in 2015 the lifetime risk of getting cervical cancer was one in 135 as against one in 96 in 2007. As a result of screening, the odds of developing cervical cancer have drastically reduced. The NHS screening service states that it is estimated that cervical screening prevents 75% of invasive cervical cancers. Dr. Scally states unequivocally that, in the case of cervical cancer, there is clear and undisputed evidence that properly run screening programmes are of substantial benefit to the female population of the State. Dr. Scally also states that he is satisfied with the quality management in the current laboratory sites. That is very reassuring.

While there are issues to be addressed in order to ensure we have in place a properly run cervical screening programme in which women as a population and women as individuals can have confidence, there is much on which we can build. Public understanding of what screening is and what it is not is critical. Understanding the concept of sensitivity, that is, the ability to correctly detect the condition in people who have it, and the concept of specificity, that is, the ability to correctly identify people who do not have the condition, is really important. The Minister of State said that in his statement and we need to get that message out. There is no screening test yet developed that can deliver 100% sensitivity. It is important that is understood by those of us participating in screening programmes.

I have some observations. What we need for the reform of cervical cancer screening in Ireland is clarity about the task, as well as the governance and management of screening. Chapter 5 of the Scally report goes into this issue in some detail. The governance and management of the cervical screening programme looked a bit of a mess. I ask the Minister of State to look at the organogram I am holding up. He need look no further to know that a recipe for disaster was contained in this organogram. One does not even have to have a degree or an MBA, as I have, to know that was a recipe for disaster. There was chopping and changing in the cervical screening programme. It was subject to the vagaries of political and departmental expediencies and decisions. There was no HSE board and then there was. There were abolitions, amalgamations, absorptions and financial constraints. I give all credit to the staff who kept CervicalCheck going in the middle of all of this. If one looks at the organisational chart on page 26, as I said, it is a recipe for disaster. There is no single line of accountability and no clear answer as to who is in charge, as Senator Colm Burke said. There is no way for people to know who their boss is or what their role is. There are no job descriptions. It is no wonder recruitment and retention issues exist for CervicalCheck, an issue which is not helped in any way by the fetid atmosphere of public outcry and media heat.

In order to succeed, any organisation has to be clear about its primary task and its governance, management, and division of labour. This is especially true of health organisations and it is often sadly lacking with catastrophic consequences. As the Minister moves to put in place properly run cervical screening systems and, indeed, systems for Sláintecare, I recommend he take stock of the John Carver policy governance model, Brian Dive's model for decision making accountability and Henry Mintzberg's reflections on health systems and their organisations. All of these need to be taken on board as we move forward.

There are many people involved in the cervical screening process, including the woman herself, the clinician doing the smear test, the people in the laboratory reading the slides, those involved in any audit and those who care for the person in the long run, that is, the nurses, consultants and GP. All of these need to be clear about their roles and responsibilities, particularly in respect of open disclosure. Each person involved needs to be very clear about open disclosure in the context of a screening, as opposed to a diagnostic process, and in the context of the chill factor and the threat of being sued for large payouts as a result of medical negligence. Any reform of cervical screening must have these clarifications at its heart. There also needs to be clarity about process, including about audits and their purpose. There are blind audits and biased audits and there are consequences arising from each. Dr. Scally's report, while commending the intention to audit, was critical of how aspects of how previous audits were undertaken. The Minister must ensure that audits or reviews are properly designed with clinicians having input in the design, though obviously not in the audit or review processes themselves. That also needs to feature in the reform of cervical screening. Above all the person, in this case women, must be front and centre.

I ask the Minister of State to take my observations on board to achieve the prize of which Dr. Scally spoke, namely, a properly run cervical screening service in which women have trust and confidence, one with engaged and motivated - not scapegoated - clinicians, scientists and managers, all working towards the virtual elimination of cervical cancer in Ireland in the coming decades. That is the priority, as highlighted in this most useful report by Dr. Scally.

I am conscious we have limited time and that the Minister of State will want to respond and he needs to respond to some of the remarks made by colleagues.

Only a few short months ago the names of Vicky Phelan, Lorraine Walsh and Irene and Stephen Teap probably did not trip off the tongues of anyone other than the people in their own networks, families and communities. I am sure that is the way they would have preferred it to stay but we know now that they were propelled into the public realm as a result of failings of governance and responsibility in aspects of our health system. We would all acknowledge they have been let down by the State. I pay tribute to their individual and collective strength and the fact that they, under very difficult circumstances, picked up the cudgels and were prepared to advocate and campaign for a better way of doing things in this country.

I acknowledge also the public work and bravery embodied in some of the work done by a very good friend of mine from Drogheda, Rosie Condra. That name may not be familiar to many of those present but Rosie is one of the women affected by this issue. From the start, she embodied what this process was all about and what it should be about. She is a trade union activist and health professional who understands the health system inside out and naturally felt very let down by what happened. For her and all of the women involved and their families, this is not about them but about rebuilding trust, the rights to access information and to full disclosure, and doing our best to make sure the systems we operate are accountable.

I acknowledge also the sterling work that has been done by my colleague, Deputy Alan Kelly, in the context of the CervicalCheck screening programme. He worked at all times on the basis that we wanted to get to the truth. It was never about political point-scoring. He wanted the truth and to work with Ministers and others with responsibility for this matter to create a better situation for those affected and improve systems in this country.

The women affected and their families contributed enormously to the Scally review and have done the State a great service. The review is excellent. Does the Minister of State accept that it will be judged on the success of the implementation of its 50 recommendations? I and my Labour Party colleagues fully support the recommendations. It is important to stress that we also fully support the screening programme, which will continue to save lives.

It is crucial that the HPV test is fully rolled out. It will boost accuracy rates in the screening programme and lead to far fewer false negative results. My good colleague and friend, Senator Kelleher, expertly analysed the difference between screening and diagnosis. It is important that people understand that and do not misrepresent the position. It is also essential that take-up rates for the HPV vaccine increase. I am glad they have increased among young women in recent months. Deputy Alan Kelly has led the way in campaigning for the extension of the vaccination programme to boys. This is a matter of national urgency, as the Minister understands.

Dr. Scally must be kept on board to try to complete the job and I am very pleased the Minister has reported that he is prepared to do so. That will come as a source of great relief to the women and their families. He has established a bond of trust with them, the political system and, I imagine, senior civil servants, with whom he will need to work to ensure the implementation of this report and all its recommendations.

Senators, Deputies and members of the public often speak about institutional failure. It is people, often in teams, who make decisions, not institutions or systems. I say that not to apportion blame - I always try to avoid doing that - but with the intention of getting to the truth and determining how and why the systems we had in place failed these women. We must learn from this experience. I reiterate that this is not about apportioning blame but about trying to figure out what precisely went wrong to ensure we avoid it happening again in the future.

I am also interested in getting to the bottom of the decision by the main laboratory, CPL, to subcontract work to other laboratories, an issue raised by Senator Devine. When a laboratory is involved in these types of work, systems and contracting, it leads almost inevitably to difficulties around governance, management systems and accountability. Again, I say that not to apportion blame but to try to get to the bottom of what can often go wrong in circumstances such as these and which contributes to misgivings and a lack of trust and confidence.

I look forward to seeing the first part of Mr. Justice Meenan's work. Notwithstanding the assurances given by the Taoiseach in the national media, with the best will in the world, I do not believe it will be possible for every woman affected by this crisis to avoid adversarial court hearings, which are often deeply harrowing and invasive. We would all like the women to avoid that scenario, if at all possible. Whether that is legally or constitutionally possible, I do not know. I am interested in seeing what will emerge from that element of the process. I am not an expert but I have reservations about the promise, if I can put it that way, made by the Taoiseach, possibly under pressure. I am sure he and the Minister will reflect on this.

I request that the women affected, their families and the group established to support them are given all necessary support and resources to enable them to support one another and to advocate and campaign for better services and access to the kinds of services they need or may need in the future. I am sure the Minister of State will agree that is the very least we owe them.

The Minister of State has the floor. As time is tight, he has a maximum of five minutes.

I will be as brief as possible.

To return to the question of open disclosure, it is clear that the lack of disclosure and the way disclosure eventually took place had a major impact on the affected women and families. Their experience is reflected eloquently in their own words, which are threaded through Dr. Scally's report. The Scally report underlines that disclosure is not just about legislation and procedures, but also about culture, as many speakers acknowledged, and core values such as openness, honesty, trust and confidence in doctors. The vast majority of doctors and the medical profession in general hold these values very dear in the care they provide. The dedication and commitment of the entire range of health professionals, including doctors, are among the key assets of the healthcare system. While, understandably, patients and society generally can ask questions arising from Dr. Scally's findings, the questions can only be answered effectively by the medical profession. The Minister has said he looks forward to seeing constructive engagement on these issues from the medical profession. The Chief Medical Officer has commenced engagement with the leadership of the medical profession on these issues and I know that the Minister intends to meet it also.

I emphasise again that Dr. Scally has found no reason the contracts with the current laboratories should not be extended to cover the period until primary HPV screening is introduced. This provides reassurance to women that they can continue to attend for screening. I thank those Members who spoke about the positives and the necessities of screening and also Senator Kelleher for her insightful description of the difference between diagnosis and screening.

Significant work continues on many of the issues raised by the CervicalCheck crisis. A supplementary report from Dr. Scally will deal with a laboratory that is no longer providing services for CervicalCheck and related accreditation and procurement matters. The independent clinical expert review to be carried out under the auspices of the Royal College of Obstetricians and Gynaecologists will examine the screening history of up to 1,850 women diagnosed with cervical cancer who had previously been screened. A process of seeking consent from women to participate in this review is ongoing. This will provide further information for women about their screening history.

Mr. Justice Meenan has been tasked by the Government with identifying further mechanisms to avoid adversarial court proceedings, specifically for the women and families affected by the CervicalCheck controversy. He has confirmed that his work is under way and will be completed in October. This reflects the fact that while the Government and the State Claims Agency are committed to using mediation, where possible, to settle cases in a sensitive and compassionate manner, mediation involving multiple parties and disputed facts has presented real difficulties in achieving successful resolutions in some cases.

The report and the implementation of the necessary changes present a very significant challenge for policymakers and healthcare professionals in the years ahead. However, with the report, we now have the framework to ensure that women can once again trust the national cervical screening programme as safe, effective and, above all, patient-centred.

There will be funding to implement these recommendations. As regards the commission of inquiry, the Minister will meet the women involved and their representatives in the next week and that decision will be taken. I have noted Senator Kelleher's comments on that issue. That is a decision yet to be taken and will be further developed in the coming weeks.

Senator Devine asked about figures for the HPV vaccine. I will pass on those comments to the Minister as I do not have the figures to hand. Senator Nash also referred to the uptake of the HPV vaccine now that the schools are back.

I hope I have addressed all of the issues raised.

I thank the Minister of State. When is it proposed to sit again?

At 10.30 a.m. tomorrow.

The Seanad adjourned at 7.30 p.m. until 10.30 a.m. on Wednesday, 26 September 2018.
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