Quarterly Update on Health Issues: Discussion

This is a quarterly meeting with the Minister for Health and the director general of the HSE. The purpose of this meeting is to allow the Minister and his officials and the director general and his staff to update the committee on key healthcare issues. On behalf of the committee, I welcome the Minister for Health, Deputy Simon Harris, who is accompanied by the Minister of State, Deputy Jim Daly, and we may be joined by other Ministers of State during the course of the meeting. I also welcome the director general of the HSE, Mr. Tony O'Brien, and the deputy director general and chief strategy and planning officer, Mr. Dean Sullivan, who are accompanied by Ms Anne O'Connor, Mr. Damien McCallion and Ms Angela Fitzgerald.

I draw the attention of witnesses to the fact that by virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of their evidence to the committee. However, if they are directed by the committee to cease giving evidence on a particular matter and they continue to so do, they are entitled thereafter only to a qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges any person, persons or entity by name or in such a way as to make him, her or it identifiable.

Any opening statements made to the committee may be published on its website after this meeting.

Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make any charges against a person outside of the Houses or an official either by name or in such a way as to make him or her identifiable.

I would like to make a few comments before we start. The director general of the HSE was due to be on annual leave this week but has come back to deal with the cervical screening controversy and, as such, he had not planned to be here this morning, but he has made himself available. I thank Mr. O'Brien very much for coming in. He has a prior engagement later this morning in regard to examining the cervical screening programme, therefore, he will be here for a limited period of time, until 10.30 a.m. or so.

In that regard, this committee is here to establish facts, to examine policy issues, and to hold the Department and the HSE to account, but it is not a forum for making political capital or political statements or for personal commentary on any one individual. I would like the committee members to observe that practice. Bearing that in mind, I call on the Minister, Deputy Harris, to make his opening statements.

I thank the Chairman and committee members for inviting me to attend today. I am joined by my ministerial colleague, the Minister of State with responsibility for mental health and older people, Deputy Jim Daly. I am also accompanied by Mr. Jim Breslin, Secretary General of the Department of Health. I would also like to welcome Mr. Dean Sullivan, deputy director general of the HSE, Mr. Tony O'Brien, director general of the HSE and other officials from the HSE.

The Chairman and the members of the committee asked me here today to brief to them on Sláintecare and I know that they are also interested in hearing about the targets set out in the national development plan and the results of the mid-term review of the capital plan.

However, before I go any further, I would like to say a few words about current events. This has been an intensely difficult time for everyone involved, most importantly the individuals, the women, and their families. The events of the last ten days in relation to CervicalCheck have shaken the confidence of the public and me, as Minister, in the very fundamentals of our healthcare system. Fundamental values of honesty, truth and openness have been questioned. Our commitment to these vital principles and values has rightly been questioned.

We have a long road to travel to restore public confidence but I am determined as Minister to get to the bottom of what happened here and why such a crisis of confidence and trust came to pass. I want to briefly outline for the committee the steps I propose to take, first, in regard to examining issues relating to the CervicalCheck issue itself, and second, in regard to the broader issues of open disclosure, of the approach to medical negligence claims, and of accountability. First, however, I want to put on the record of this committee my thanks and gratitude to Ms Vicky Phelan, who has played a central role in bringing these issues to light. I want to take this opportunity to thank her again for her courage in doing so.

I want to see all issues relating to CervicalCheck examined and dealt with without delay. Accordingly, the Government is establishing two strands of investigation. The first strand of investigation is the scoping inquiry. Yesterday, I announced that Dr. Gabriel Scally has agreed to lead this inquiry. He will be joined by Dr. Karin Denton, who is a leading expert in women’s health. Yesterday I also published the terms of reference for the inquiry. These reflect the cross-party engagement that has taken place. I want at this committee today to thank all the Opposition spokespeople on health for their assistance and constructive engagement on this. I believe that, as a result of that cross-party approach, we have terms of reference that are comprehensive and allow for the full examination of all of the issues arising and the concerns raised by other parties in the Oireachtas and other groupings as well as the concerns of the Government.

However, what is most essential is that the inquiry deals with the concerns of Ms Phelan and the other women affected or their family members. Dr. Scally has already spoken with Vicky Phelan, and will continue to engage directly with her and with other women and their next of kin who are willing to and wish to do so. I anticipate and expect the scoping inquiry to report by the end of June and have asked that it provide a progress update in the first week of June.

The second strand of the investigation is the clinical strand. This is an international clinical expert review to be carried out by a panel established from representatives of the British Society for Colposcopy and Cervical Pathology and the Royal College of Obstetricians and Gynaecologists in the UK. This panel will comprise a full team of senior independent medical experts from outside Ireland. Their review will ensure that each woman with a diagnosis of cervical cancer who had a previous smear through the CervicalCheck will have her case reviewed so that her concerns can be addressed, including in respect of the timing of her diagnosis, the nature of her treatment and the outcome of her care. These two strands of investigation are crucial to, first, establish the facts; second, determine what action is needed to address the issues; and, third, help to restore trust and confidence of women in CervicalCheck. This will lead then to a commission of investigation. I acknowledge that Deputy Alan Kelly pointed out to us the need for this. The Government has committed to that in principle, but it is important that we gather all the facts and the data through the scoping inquiry process between now and the end of June. This is essential because, despite its failings in regard to disclosure, the CervicalCheck programme works and it is important we are clear on this. Since the inception of the programme, more than 1,200 invasive cancers have been detected by CervicalCheck.

In addition, 30,000 low-grade abnormalities have been detected and more than 50,000 women with high-grade abnormalities have been diagnosed and treated, considerably reducing their risk of developing cervical cancer. The incidence of cervical cancer has been falling and there has been an increase in earlier stage diagnoses. We all want this progress to continue.

It is particularly concerning that the events of the past ten days have undermined people’s confidence in the clinical performance of screening programmes. The facts available do not give any reason to believe the screening programmes have operated outside or below international benchmarks for screening programmes. I very much hope that as we move forward with these two strands of independent investigation, led by international experts, women will begin to feel reassured about the programme’s effectiveness. Women can consult with their GPs if they want to discuss their concerns and arrange a repeat smear test if necessary without charge. An agreement has been reached with general practitioners in that regard.

There are a number of broader issues which have come to the fore as part of the CervicalCheck issue. These are, first, open disclosure; second, the way we approach medical negligence claims; and, third, accountability. I believe addressing these issues to ensure that we do as much as possible to improve this system and patients’ experience of it are absolutely essential if we are to restore trust and confidence that has been so badly eroded in recent weeks. I intend to focus on these as a priority.

It is clear that the delayed communication to Vicky Phelan of the results of the clinical audit of her case and the absence of communication of results to many other women following clinical audit is significantly out of step with the standards rightly expected by the public and with best practice in regard to open disclosure. I am pleased that yesterday the Government approved the drafting of a patient safety Bill, which will provide for mandatory open disclosure to patients of those serious events which will be the subject of mandatory external notification. It is part of a major programme of patient safety and patient centred reform under way. It is led by my Department and includes a range of measures to increase openness and transparency, including patient safety statements, annual quality reporting and the national patient experience survey, the second round of which is under way in our hospitals this month. It also includes major legislation to provide for licensing, clinical audit and the extension of HIQA’s powers to the private sector as an important step on the journey to full licensing of our health service.

Our tort laws have rightly been criticised for being adversarial and slow to provide for persons who have suffered harm within the healthcare system and there has been a growing recognition of the need for reform in this area. My Department has collaborated with the Department of Justice and Equality on a suite of reforming legislation including on pre-action protocols, mediation and periodic payment orders. I also intend to engage with the Minister for Justice and Equality, the Minister for Finance and the State Claims Agency on whether further improvements can be made to the legal framework and the management of medical negligence. Such an approach should complement and inform the major programme of patient safety and advocacy under way.

The Sláintecare report placed an emphasis on the need for both clinical and managerial accountability and states:

The Committee strongly believes there is a requirement for clearer clinical and managerial accountability and governance throughout the system. This includes clarity at all levels, from the Minister for Health, the Department of Health, the HSE and healthcare providers.

I intend to bring forward legislative proposals next week to provide for the appointment of a new HSE board. In addition, as part of my Department’s response to Sláintecare, it is proposed to consider how best to further strengthen clinical governance and managerial accountability in healthcare. I mentioned last night in the Dáil that I have met Róisín and Mark Molloy who pointed out what other jurisdictions have done on this, particularly Australia. We need to look at how other jurisdictions have managed to crack this. It is possible to do it. It has happened in other countries.

Returning to business, I will start by talking about an ambition we all share, which is to reform our health service. Among the recommendations put forward in the Sláintecare report are accountability legislation setting out the requirements on the Minister and staff at all levels of the health service; the introduction of a board for the HSE, with the chair accountable to the Minister and the CEO accountable to the board; the development of a strategic national centre complemented by regional integrated structures that would be accountable for delivering integrated care; and the development of a blueprint for clinical governance across the health system, underpinned by legislation which specifies standards and structures. These recommendations are central to delivering meaningful reform of our health service.

I have said it many times in this committee, in the Dáil and elsewhere but it is important to state it for the record again. The Sláintecare report and the cross-party support it enjoys presents us with a unique opportunity to deliver long-lasting reform that will fundamentally change the way we deliver healthcare to provide fairer, better and more accountable healthcare for all our citizens. The Government is fully committed to leveraging the support and momentum of the Sláintecare report to put in place a robust programme of reform and associated implementation arrangements. Just as cross-party co-operation and support was required to bring forward the Sláintecare report, similar cross-party co-operation and the support of all stakeholders will be required to implement the recommendations.

I am pleased to say I have already been able to take action on a number of the recommendations in the Sláintecare report. I have already outlined to the committee the Bill I will bring forward on reinstating a HSE board. I ask for the co-operation, which I know will be forthcoming, of the committee in getting the legislation through the Oireachtas as an absolute priority to send out a very concrete message on accountability. We all agree on the need to ensure more robust and transparent structures of accountability and the appointment of a strong, skills-based board is essential to achieving this. I also prioritised the Sláintecare committee’s recommendation to consider the impact of removing private practice from public acute hospitals. This is a far-reaching, complex reform but, let me be clear, it is absolutely fundamental to achieving a fairer, more equitable health service. I have established, in line with the Sláintecare committee's recommendations, an independent review group, chaired by Dr. Donal de Buitléir, to examine the impact of separating private practice from the public hospital system and to outline the roadmap to follow to bring that about. The group has advanced its work very well and will conclude its work this year. This will provide valuable guidance on how we go about implementing this major, fundamental recommendation and eliminate private practice from our public hospitals on a phased basis.

My Department has also commenced work on the committee’s recommendations on changing the HSE structure itself. As members will be aware, this is an area I addressed when I appeared before the Sláintecare committee. We have a HSE that is overly centralised when it comes to decision-making, responsibility and accountability. With governance too far removed from the front line, the HSE has become too big to fail and too big to succeed. Real accountability requires more local ownership and decision-making. An important component of this will be the development of regional structures to support the delivery of integrated care. The first step in this process is to better align our current regional structures – our hospital groups and community healthcare organisations.

Developing more comprehensive and integrated community care is at the heart of the Sláintecare vision. A public consultation has opened on the geo-alignment of hospital groups and community healthcare organisations. Alignment can go some way to delivering and being a key enabler of delivering integrated care. The role that general practice will play within this is absolutely vital. I have now secured Government approval to move forward with contract negotiations with general practitioners and I expect to see progress on this in the coming months. The engagement has commenced and there is Government commitment to supporting the negotiations with a multi-annual programme of funding. It is a game-changer for delivering identifiable improvements in general practice. It is a different space for me as Minister for Health saying I want to negotiate a new contract because it is backed up with resources from right across Government.

The Government has already committed to the establishment of a Sláintecare programme office and the recruitment process for the executive director of the office has been carried out through a very thorough process by the Public Appointments Service, involving a national and international executive search. I expect to have an announcement on the name from the Public Appointments Service very shortly. The final interviews have concluded.

While all reform is important, we know it must also be matched by increased investment, particularly with regard to capacity. I touched on a number of these issues last night so I do not propose to do so again unless the committee wishes me to do so. They are the capital plan developments; the additional 2,600 hospital beds to replace the failed policy of the past of cutting hospital beds in our health service, long before the troika ever arrived in town; the need for 4,500 more community beds to deal with our older population; the need to build three new elective hospitals, one in Dublin, one in Galway and one in Cork; the need to co-locate all stand-alone maternity hospitals with acute adult teaching hospitals; and the fact that is now funded. In terms of Sláintecare, we are providing €1.6 billion in our capital plan to fully deliver the e-health agenda and the ICT programme. The committee highlighted that it is not a discretionary extra and if we wanted a reformed health service we needed a proper e-health system and an ICT system.

I will conclude on that point. I look forward to having the opportunity to brief the committee further, to hear its views and take any questions.

I call on Mr. Dean Sullivan, deputy director general of the HSE, to make his opening statement.

Mr. Dean Sullivan

I thank the committee for the invitation to attend its meeting this morning. I am joined by my colleagues, Ms Anne O'Connor, national director of community operations, Ms Angela Fitzgerald, deputy national director, acute hospital services, and Mr. Damien McCallion, national director for national screening services. Mr. Killian McGrane from the women and infants programme is also here. The director general is sitting to my right.

I am very pleased to be here today on what is my first appearance before the committee. In preparation for this meeting, the committee requested information and replies to a number of specific questions and it will have received a written response to them. I will therefore confine my opening remarks to the following issues.

First is an update on CervicalCheck. As the committee is aware, there are a number of strands to the work of the serious incident management team which has been working solidly over the past 12 days with the aim of addressing and allaying the concerns that women and the wider public have about CervicalCheck and its audit process.

Regarding our work to make contact with women directly affected by the failure of CervicalCheck to inform all women of the audit process and its findings in relation to their smears, I can confirm that hospitals have been working since the serious incident management team was established to contact all the women affected and to discuss the audit findings with them. To date, 201 women and their families have been contacted. I understand it has not been possible to contact the remaining eight people and their families to date, as some women are not in the country because they are travelling or living abroad, or are uncontactable for other reasons. All 201 women or their families have been offered a meeting at the earliest opportunity with their doctor at a time that is suitable and convenient to them.

I can confirm the National Cancer Registry Ireland, NCRI, is working with the CervicalCheck programme to carefully reconcile data held by the registry and CervicalCheck to ensure that we have identified all women diagnosed with cervical cancer since 2008 who had a screening history with CervicalCheck. We expect to conclude this data reconciliation process over the coming days. The establishment of an expert international review panel, led by the Royal College of Obstetricians and Gynaecologists and the British Society of Colposcopy and Cervical Pathology, will review the results of screening tests of all women, including any additional women identified by the NCRI and CervicalCheck data reconciliation process, who have developed cervical cancer and who participated in the screening programme since it was established in 2008. This will provide independent clinical assurance to all women about the timing of their diagnosis and any issues relating to treatment and outcome.

As members will be aware from the daily reports published by the serious incident management team, we are working to provide call backs as quickly as possible to concerned women who have rung the information line. As of yesterday, 11,982 women have called the line. Of these, 8,150 women have requested a call back, and of these 3,649 calls have been returned. As members will appreciate, the call backs take a period of time, as in those cases where the person has a history of referral for colposcopy treatment or a history of cancer, we are providing a clinical consultation with a clinical staff member with expertise in colposcopy or cancer treatment. Return calls to women have been made throughout the weekend and will continue through this week, with support from staff in health facilities around the country. The clinical advice is that women who have had normal test results in the past can continue to participate in the cervical screening programme according to their normal schedule. We are working to provide information to women across a range of channels to assist those whose query can be answered without the need for them to call the CervicalCheck information line. Since we began measures to provide public information across a range of channels, the proportion of callers having their information needs met and therefore not requesting a call back has dropped significantly.

I would like to put on record my personal apology at the concern and anxiety that has been caused to women and their families and the wider public as a result of the CervicalCheck controversy. It is essential that we learn lessons and re-establish confidence in the screening programme, as the Minister said, which was and is a public health initiative saving literally hundreds of lives. In this regard, I very much welcome the decision announced yesterday by the Cabinet to establish a scoping inquiry into the issues which have recently come to light. I assure members, the women and families affected and the public at large that the HSE will participate and co-operate fully with this process and with the work of the external expert panel to ensure all of the facts surrounding what has occurred will be known, that we can learn from this and importantly that trust and confidence in our national screening programmes will be rebuilt.

Turning to the Portiuncula Hospital report, last week the Saolta University Health Care Group published the report of the External Independent Clinical Review of Maternity Services at Portiuncula University Hospital. The review examined 18 cases from the period 2008 to 2014. I wish to make the following comments in light of the publication of the review. There have been a number of important developments since the initial review into the therapeutic hypothermia cases in Portiuncula in 2014. There is now a strong policy framework in place, with the development of the national maternity strategy in January 2016, the development of the national bereavement standards in August 2016, and the launch of HIQA’s national standards for safer better maternity services in December 2016.

Following on from the policy framework, the national women and infants’ health programme was established in 2017 to implement the strategy, and to provide leadership and governance for maternity, neonatology and benign gynaecology services. During 2017, the programme visited all 19 maternity hospitals and units at least twice; supported the hospital groups to develop maternity networks, and launched the implementation plan for the national maternity strategy. In 2018, an additional €4.55 million in development funding was allocated to maternity services. The key priorities for that include the introduction of foetal anomaly scanning and the appointment of 28 additional sonographers has been approved; and the supporting of new models of care, particularly the supported care pathway, which is a midwifery delivered approach and is a key focus for 2018. To support this, 52 additional midwives have been approved to take forward the pathway in each maternity hospital or unit. A national implementation group has been established to oversee the development.

On quality and safety, the women and infants programme will be supporting maternity networks to develop a serious incident management forum dedicated specifically for maternity services within each maternity network. A key focus of the national infants' and women’s programme will be to develop these new tools with the services and to improve learning outcomes. Finally, on maternity networks, as the Minister noted, effective governance is a core recommendation in the maternity strategy and more generally in the planning and delivery of health and social care services. Managed clinical networks, called maternity networks, are being progressed and should provide the necessary governance, and ensure that smaller units work closely with tertiary units in ensuring that the provision of consistent, high quality, safe care to women and their infants.

The Sláintecare report provides an ambitious vision of a different kind of healthcare system. It signals a new direction of travel in relation to eligibility, delivery, and funding of health and social care in Ireland into the future. It presents an opportunity and, appropriately resourced and governed, it has the potential to transform the health and well-being of the population, and how and where they access services.

As stated in the HSE national service plan 2018, a key priority for the health service this year is to develop an agreed strategic position with the Department, in the interests of building a safer, more sustainable health service, designed to meet the needs of our population. An opportunity to achieve this is presented in the detail of the implementation of Sláintecare. We will continue to work closely with the Department to ensure that we realise this opportunity.

Integrated health and social care is at the heart of the report which would see healthcare delivered at the lowest appropriate level of complexity through a health service that is well organised and managed to enable comprehensive care pathways that patients can easily access and service providers can easily deliver. As members will be aware, the consultation on integrated health and social care, and alignment of CHOs and hospital groups, is currently under way, with a closing date of 23 May. This is an important engagement and we look forward to learning the outcome and participating in consideration of all of the factors involved in any proposals around integration and alignment, as optimised health service delivery is at all levels of delivery is a common aim.

In the national service plan 2018, we highlight four key reform themes; first, improving population health; second, delivering care closer to home; third, developing specialist hospital care networks; and fourth, improving quality, safety and value. These themes line up fully with key strategic actions within Sláintecare and provide the basis of a phased shift within the way we deliver our services, commencing in 2018, which lays a foundation to build on through specific actions which support the implementation of Sláintecare.

We are also enhancing our planning, delivery and our accountability roles to support change so that it results in service improvements and better experience and outcomes for people. I very much look forward to the upcoming publication of the Sláintecare implementation plan which will inform our corporate plan for the next three years and be visible in the actions planned through our annual planning process for 2019.

The €10.9 billion capital investment in healthcare infrastructure announced in the recently published Government’s national development plan 2018-2027 is very welcome. It represents a significant increase in capital investment over the next decade compared to the past ten years. This increased allocation will allow the HSE to address the areas of greatest clinical and infrastructural risk including the equipment replacement programme in addition to enabling the HSE to deliver on the current capital programme. This allocation will also allow the HSE to plan, develop and commence a construction programme to meet the additional capacity demands outlined in the recently published health service capacity review 2018. As the Minister noted, the allocation will also allow demonstrable progress to be made with the e-health agenda over the next ten years.

The committee’s invitation letter made specific reference to the availability of Versatis, and a more detailed briefing note on the up to date position has been provided for members. For the purpose of the opening statement, I would just like to reiterate that prescribing patterns for this medication had become grossly out of line with expectations for its licensed indications and usage, and access control measures were necessary to address this for patient safety and cost reasons. Members will note from the details circulated that the medication continues to be available for licensed indications, that is, for nerve pain after a previous shingles infection in adults, and a quick turnaround application and appeals system is operational for unlicensed or exceptional access for individual patients. Latest figures indicate that the medication continues to be reimbursed by the HSE for approximately 3,000 patients.

I would like to make a few brief comments on Storm Emma, which was one of the worst storms to hit the country and severely challenged all front-line services. At this time, when the service is making many headlines for the wrong reasons, and the public's trust is reasonably undermined, it is important to acknowledge when the service gets things right. I am sure committee members will join me in recognising the huge efforts of staff across the service, supported by staff from other sectors, who went way beyond the call of duty in the face of almost impossible conditions to ensure all essential health and social care services continued to operate during that period of particularly severe weather. The values and commitment of healthcare workers were particularly demonstrated during this very testing time.

This concludes my opening statement and my colleagues and I will endeavour to answer any questions committee members may have.

Before we start I welcome to the Gallery Mr. Jack Kavanagh who, unfortunately, suffered a serious neck injury in a surfing accident. He has continued to study pharmacy to masters level and he has come to observe how the Oireachtas works. He is a guest of Deputy John Brassil.

I propose that in the early part of the session the health spokespersons for the Opposition parties and permanent members of the committee will be invited to have five minutes questions and answers between themselves and our witnesses. Mr. Tony O'Brien is here for a limited period of time and he will have to leave in about an hour or so. I want to give the permanent members of the committee an opportunity to engage with the witnesses and Mr. O'Brien if they wish.

I thank the witnesses for coming before the committee. I will begin by directing my comments to Mr. O'Brien. As he may be aware, Fianna Fáil's position is that we would like to see him step back with immediate effect without prejudice. I am very conscious that as spokesperson I have asked for this publicly in the Dáil and in the media but not in a position where Mr. O'Brien has had the chance to respond to it. I would like to put it to him to give him the chance to respond in open session. I take no joy in the call and I am very conscious he has given many years of public service to healthcare.

The reason the party believes that at this point it would be better for the healthcare system and the women affected by the CervicalCheck scandal if he were to step back is that while we must all wait for the investigation to establish all of the facts, it is abundantly clear that he was in charge of the organisation. The Minister in his opening remarks referred to non-disclosure as significantly out of step with public expectation and best practice. This is a very polite way of putting it. It has been a catastrophic failure of governance. Sadly, it has led to a collapse in public confidence in critical screening services. Women across the country and, indeed, men when they meet a consultant will ask whether that consultant is telling them everything and whether the HSE has told their consultant everything. They may question the literature.

We found out at a committee meeting last week that the CervicalCheck literature states the test is not 100% accurate. We found out later in the same session that it is, in fact, 70% accurate, which is a serious error in the accuracy of the information to the women. Yesterday, a High Court judge described as scandal the fact that one in 25 so-called consultants in this country are not in fact consultants as they are not registered. The public may even now be questioning whether the consultant sitting in front of them is, in fact, a consultant. Public confidence is rocked.

Specifically with regard to Ms Phelan's case, there was a failure to anticipate the public concern which has led to such widespread anger and worry, and there was a failure to react quickly enough to it. As of last Saturday, approximately 800 women had had a call back. We know this number has increased considerably in recent days, but the number of women who have had a callback is still less than half. Obviously this case has been known about for some time. These are the reasons. As I said, I take no pleasure in it, but I want to put it to Mr. O'Brien directly in this forum so he has the opportunity to respond to it.

Mr. Tony O'Brien

I thank Deputy Donnelly for the courteous way in which he has addressed the question. I appreciate it. It is correct to say these are significant issues. Last week, the committee heard from all of the other witnesses present who indicated I had not, in fact, been informed of the circumstances of this case and neither did I know it was coming, in circumstances where, in fact, it would have been relatively straightforward for them to get themselves off the hook by stating I had. They had no particular benefit in not doing so. I intend to continue the work it has been agreed with the Minister that I will do to address all of the issues which are of significant concern. I appreciate the Deputy is suggesting I should resign without prejudice. I am not 100% sure what that really means, but I understand it is intended to be polite and intended to be respectful and I do not take that away from the Deputy.

With regard to the operation of the helpline, it is, of course, important to note that while full clinical consultations have not been completed with all of those waiting for them, they are being provided at an accelerated pace with significant commitment from a huge number of medical professionals, most of whom worked throughout the bank holiday weekend and continue to work. It would be wrong to think this means there has not been any follow up. There have been further updates by text and other means to indicate those calls are going to be made. It would be very easy for us to carry out a cosmetic exercise of having an unqualified person make a return call to all of those women, which would be of little or no value. Instead what we are doing is ensuring a meaningful complete clinical follow-up with each person who requested one, which can take half an hour or more to be effective. While clearly it would be preferable if they could all have been done more quickly, as a matter of practical reality that could not be done in a meaningful way which would bring benefits to the women who have requested those calls. While I recognise the concern, I believe the effort under way to address that concern is appropriate and meaningful. I understand the Deputy's point but I respectfully decline to accept his invitation to resign, without prejudice or otherwise.

I thank the Chairman and I welcome the witnesses. Is it correct that we will have an opportunity to ask questions again and that this part of the meeting is just for Mr. O'Brien?

Correct. The questions do not necessarily have to be just to Mr. O'Brien but-----

I understand that.

-----we do want to use his time.

Given that Mr. O'Brien's time is limited-----

I suppose in more ways than one. That was not intended-----

Mr. Tony O'Brien

It was humour, let us be fair.

It was intended to be funny in a situation where probably we should not be.

With regard to accountability and open disclosure, my views and the views of my party on Mr. O'Brien's position are well known and have been well ventilated over a long period of time and I do not propose to rehearse them here. When we were at the committee meeting last week, Mr. O'Brien told us he found out from an app on his phone about Vicky Phelan's case. I am interested to know his views on whether he thinks at this stage, with the full benefit of hindsight, that it was appropriate that as the head of the organisation he was not told about a case such as this, with the massive implications we now see? I am specifically asking because we are discussing whether we need to introduce legislation and whether that legislation would, in fact, have an impact on the culture. To be able to consider whether it would have an impact on the culture we need to understand what the culture is. The culture of the organisation appears to be one whereby people in very senior positions do not feel they need to tell the person who is heading up the organisation a potentially catastrophic piece of information. We all see that it took legs of its own. It is either that as the head he does not encourage people to share that information with him, that the people who are reporting to him think he would not be interested in it, or that the culture of secrecy and cover-up, and all of the other words used, goes right up to the top of the HSE.

With the benefit of hindsight, does Mr. O'Brien now feel that the senior managers should have made him aware and certainly before he found out via an app on his phone?

Mr. Tony O'Brien

I thought I had said last week that I was not at all happy for multiple reasons. The Deputy asked a multilayered question and I will try to give a multilayered answer. The first thing is that I believe that had I been aware of this case in all of its magnitude, it would have been possible for me to put in place a number of steps which, while not taking away from the case itself, would have meant that the organisation was far better prepared to deal with the fall out of it. In other words, if I had become aware in advance that the matters disclosed as a result of discovery indicated that it was far from certain that all the women the programme had set out to tell had been told, it would clearly have been greatly beneficial if all of that communication had been completed so that by the time this came into the public domain, there would have been no woman out there wondering whether she was one of those who should have had that communication. In fact, that is the most important aspect because that is probably the single thing that has damaged confidence in the programme and led to all the calls to the helpline. Had I known and had I been made aware of all of the implications of this - had I been given the information, I would have figured out the implications for myself - I would certainly have put in place a different approach to how the whole thing should have been dealt with. That is the first point.

The second point, and the Deputy asks a fair question, is whether the culture I have attempted to create encourages people to tell these things. Yes, it is. The Minister tells this story sometimes. On the wall in my office is a sign that says "speak truth to power". I put it up the second day I was in the job back in 2012. The reason is because, by statute, the HSE is one of the most hierarchical organisations possible. The role of director general is quite a powerful one in that sense. After a round of meetings and briefings on my very first day, it appeared to me that people were reluctant to tell me stuff so I put this sign up, brought everyone back into the room and had a repeat set of discussions encouraging that this would be a place where everyone could tell me whatever they needed to regardless of whether they thought I would like it. It is not dissimilar to a process that Pat Lamb introduced when he was manager of Connacht - the safe zone. I have encouraged a process of people telling me stuff. Why was I not told about this one? At the moment, it appears that those who should have told me did not see the significance of it but this does form part of the inquiry. Yes, I should have been told and I have sought to create a culture in which I should be told these things and, by and large, I am told about these key issues. I was not told about this issue and I am very concerned about that. The Deputy knows I am on the record as supporting mandatory open disclosure or duty of candour, as it is typically referred in the states that have legislated for it. It would not necessarily change the way people make their judgments but it would bring a sharper edge to the judgments they would make and I would hope that if such a duty existed, I would have known about this case.

Given the time limitations, I will put all this into one comment and two questions, which the witnesses can answer collectively if that is all right. I appreciate that Mr. O'Brien changed my mind and came here today. It was the right decision. Obviously, as the Vice Chairman of the Committee of Public Accounts and the person who will chair the meeting tomorrow, I hope he will consider attending tomorrow as well, particularly in view of the fact that a different dynamic applies at that committee's meetings.

I have two questions for the Minister, Mr. Breslin and Mr. O'Brien. We are now sitting here on the morning of Wednesday, 9 May. Do the Minister, Mr. Breslin and Mr. O'Brien feel there are any major issues or items of information relating to this scandal of which they have not yet been made aware or about which they are concerned they may not have full information? This is an opportunity to say so. Last Tuesday, I described as a bombshell the occasion when the Minister came to the Chamber and revealed that he had just been told about what we now know are 1,621 or 1,624 cases of women who had not been audited. This is a very important question that is addressed to all three. When did they individually or their organisations become aware or find out that National Cancer Registry Ireland was not sharing some data regarding women with cervical cancer with CervicalCheck? If they do not know the answer, could they say so?

May I go first?

I apologise; I was distracted. Could people attend to their phones, particularly if they are located near microphones?

I think Deputy Kelly asked each of us the same two questions, both of which are important. The first question is whether I would be concerned that there could be other issues or scandals of which I have not been made aware. I am not aware of any others. I have put everything I have learned relating to this into the public domain as quickly as I received it and that is the way I intend to continue to operate in respect of this matter. If I had absolute confidence that there were no other such issues, we would not need a scoping inquiry so after the two weeks we have seen, I think it would be foolish to sit here and say I do not have more concerns. I think Deputy Kelly will see in the terms of reference, which we have all discussed collectively, that I am trying to tease out a number of those issues as part of this. I know Dr. Scally's first report is due in approximately three weeks and that his final one is due in six or seven weeks. Until I see the initial report, I cannot go any further because, in the aftermath of what happened in the past two weeks, that is the prudent course for any Minister to take.

In respect of the second question, which concerned when I became aware of the issue regarding National Cancer Registry Ireland not sharing its data with CervicalCheck or the fact that CervicalCheck did not know of all the cases with National Cancer Registry Ireland, I was told by my chief medical officer in the company of the Secretary General and the assistant secretary just before I went into the Dáil on Tuesday last.

Mr. Jim Breslin

In respect of the first question, I am very much with the Minister. The other thing I would say is that I am in the midst of a process of assembling all the records within the Department. I cannot be definitive until I have completed that process. Nothing has arisen in the process to date either in respect of records or asking people in different units that might have information to give me cause to believe there is information within the Department that has been withheld. However, I will complete the process. The process being undertaken by Dr. Scally will be very important in judging the significance of all the information we hold within the Department but at this stage, I do not have anything to tell the committee beyond what that of which it is already aware.

I became aware of the National Cancer Registry Ireland issue last Tuesday, very shortly before briefing the Minister. This was a current issue. Although I was not there, I understand that the briefing that was supplied to the serious incident management team and the Department about National Cancer Registry Ireland over the course of four or five days was inaccurate in that period. We were told one thing at the start of the process and by Tuesday, we were told the opposite. It was a specific cause for concern that we had told the Minister something that turned out to be inaccurate in that very short space of time. I have no information organisationally over a course of earlier periods. I will say that in general, we do know and are working on information governance within the total health system, the unique health identifier and other aspects to try to improve the flow of information between organisations and much more reliable information but I had no personal knowledge of this issue before the past few days.

There was no departmental knowledge of this before last Tuesday?

Mr. Jim Breslin

That is also the process in which I am engaged at the moment. I talked to people in the Department and National Cancer Registry Ireland this morning. I have nothing on that at the moment.

Mr. Tony O'Brien

I believe the serious incident management team, SIMT, has probably uncovered all there is to uncover, although I cannot give an absolute guarantee because the team's work is still in progress. I am not aware of any significant issues that are not in the public domain through the SIMT reporting process, in which there are daily updates.

The totality of the organisation I lead includes CervicalCheck and it is clear there was knowledge within that organisation to the effect that it was not receiving National Cancer Registry of Ireland data and, consequently, that the figure of 1,482 did not include other cancers which occurred in that period.

Was CervicalCheck aware that National Cancer Registry Ireland had not shared its bit?

Mr. Tony O'Brien

Yes.

Was it aware for a period?

Mr. Tony O'Brien

It was aware that the numbers it had audited only included those cancers that had been notified to CervicalCheck through its own process, which relates to gynaecology clinics and colposcopy clinics.

Did it try to get the data regarding other patients?

Mr. Tony O'Brien

I wish to finish this part of the answer and then I will come back to that question.

Mr. Tony O'Brien

There were discussions last Friday week which led to the briefing from CervicalCheck to the SIMT on the day of its establishment but that information was not conveyed. In other words, the understanding was given that the 1,482 related to the totality of the cancers to be audited. That was the basis on which the Minister's officials briefed him and on which my officials briefed me. Last Tuesday afternoon, my chief clinical officer reported that the SIMT had determined that there were other cancers - the National Cancer Registry Ireland cancers. I knew probably an hour before the Minister but I was aware that the Minister's officials were going to brief him immediately.

The Deputy had a follow-up question.

How long did CervicalCheck know that what they were auditing since 2014 was not the totality, and that they had not been given the transfer of patient information from National Cancer Registry Ireland?

Mr. Tony O'Brien

I think they always knew that.

Mr. Tony O'Brien

As far as I know, yes.

We have to move on. Deputy Kelly will have opportunities to come back later on in the morning.

My question is on the communications system between the State Claims Agency and everyone in the HSE. It appears that the State Claims Agency may have been aware of the seriousness of this issue but did not communicate it to people working on the front line. In the current structure, a claim comes in against a medical consultant in a hospital and is passed on to the State Claims Agency. There may be some consultation initially but my information is that the next communication from the State Claims Agency is when the matter comes up for hearing in court. There does not appear to be communication in the intervening period and the seriousness of a claim does not appear to be conveyed back to people on the front line. Are these current structures being reviewed? It is extremely important, especially where there is a series of claims.

My next question is on the general public's understanding of the cervical screening process. There seem to be different views on how accurate and comprehensive the process is. It does not, for example, identify certain cancers. Is anything being put in place to get more detailed information out there to the general public about the programme, what it can identify and what it cannot identify? Some people seem to believe that once they have smear tests, they have the all-clear for the future.

Mr. Tony O'Brien

I indicated last week that I would carry out a case management review, using the management of this case as a learning exercise. I have now directed the HSE's internal audit division to do that. There is a significant potential to improve the process. For example, if different parts of the organisation are involved in a case raised by a plaintiff and handled by the State Claims Agency, a discovery process is followed in different parts of the organisation and two or three parts of the discovery are joined up, but this is done by lawyers in the State Claims Agency and not people in the HSE. I want to put in place a process whereby the discovery is matched up by someone from within the HSE who will be better able to identify the danger signs, the warnings and the risk issues that might be apparent from discovery. In the current case, joining up the two lots of discovery would have made it possible for another part of the organisation to identify the risk around communication without anyone in the programme or anybody involved in it saying it internally. The externalising of the management of these cases, which has served other purposes usefully for the State, has led to a weakness in risk and management control inside the health service which we must now address. The internal audit case management review which I have instigated to look at the failures to escalate this case, and at the fact that the issues were not identified and addressed quickly, will provide a pathway to do that. This is not to criticise the State Claims Agency but to recognise that a lacuna has opened up in processes, which this case has really exposed.

Professor McKenna, who is providing clinical governance for the programme on an interim basis, indicated last week that he will be examining what enhancements can be made to the literature to promote a better understanding of the advantages, the risks, the disadvantages and what the screening programme cannot do. We are moving rapidly towards HPV testing as the primary mode of testing, which will transform the way we do cervical cancer testing in a hugely significant way and is the best way to improve the confidence people have in the programme, with or without the present circumstances.

Senator Colm Burke asked about where we are going now. What happened in the past was referred to but, in light of what has happened in recent weeks, it is important that there is confidence in the CervicalCheck programme. A lot of inroads have been made into treating cancer in Ireland in recent years and it is regrettable that this has caused such damage. There are people working in the service who have given a lot of their time to reducing the impact of cancer on people's lives. There is an opportunity now for a new comprehensive programme for the reduction of the impacts of cervical cancer on people's lives.

One of the things that has led the women of Ireland to have a feeling betrayal is the title of the programme. The term "CervicalCheck" implies something like a car check, where everything is fine when one drives off afterwards but this is not the case and it is not 100% accurate. A combination of HPV testing and the HPV vaccine is the answer.

It is very important to highlight symptom reporting here. It seems to have been almost lost in the whole conversation. A woman's symptom reporting and awareness of her cervical health is fundamental to the outcomes here.

One of the things highlighted last week was the opportunity for reform of the HSE. We were able to home in on that aspect of the structure of the HSE. I think Deputy Kelly said that ten or 15 people, who are allegedly accountable, are involved in management positions. It opened up to many of us, who have worked on developing the Sláintecare report and who are members of this committee, much of what we have been saying for years - that too many people are in charge of areas but nobody is in charge.

That brings me to open disclosure, which seems to be the core part of the terms of reference. Medics, nurses and pharmacists are regulated.

Sorry, Deputy O'Connell has a five-minute window and we need to get questions.

We are talking about open disclosure for medical people. However, fundamentally the people in the organisational structure of the HSE are not bound unless they are a member of a medical organisation. Irrespective of the amount of talk we have about open disclosure, that is to do with the practices in medicine. What about open disclosure when it comes to people in management in the HSE? These people whose salaries are paid by the State are not doctors and therefore the Medical Council, the pharmacy regulator or whatever has no way of bringing them in. How is it proposed to make people in that structure accountable?

Following on from the national maternity strategy, we spoke a lot about the mastership model in this room. It seems clear to me that when the people in charge have no clinical experience and no clinical involvement in the provision of services in a hospital or an organisation, there is a deficit when it comes to being able to relay down to what happens in real life. How do we make people, who are not regulated by an external body, accountable?

Mr. Tony O'Brien

I welcome the Deputy's comments about cancer prevention and so on, and agree with what she has said. The policy on open disclosure is not confined to regulated medical professionals. There is an equal obligation, irrespective of the professional discipline from which a HSE staff member is drawn. The Deputy's central point that members of a regulated or licensed profession are subject to professional disciplinary issue while others are not is a very valid point. In the past I have spoken of this for two equal reasons, one of them being the Deputy's point that it would be beneficial if the profession of health management were to be recognised, both so that it would be valued and so that it would be subject to professional standards and so on.

In other jurisdictions - the Minister has mentioned one or two of them - including jurisdictions not too far from here, there is the notion of the "fit and proper person" test which can be applied at the point of appointment to a senior role. It is not dissimilar from, but not exactly the same as, what has been introduced here in financial services in the past decade. I believe what we somewhat disparagingly used to call health administrators provide a hugely important and central role, irrespective of whether they have a health professional background. There would be value in examining how to regulate that as a professional in terms of the qualifications required, continuing professional development and adherence to standards in the way the Deputy has described.

I thank the witnesses for appearing before the committee this morning. I have many questions on Sláintecare, etc., but given that Mr. O'Brien has to go soon, I will ask about the ongoing saga. I was very interested in hearing about the sign he placed on his wall the day after he took up his new position. I think he will have to agree that the sign did not work. I find it hard to believe that he did not know, but I obviously take him at his word. I have no reason not to do so. However, he should have known; not knowing is nearly as bad as knowing and not doing anything about it. As Deputy Donnelly has said, my party has called for him to step aside. If he decides not to or if he is left in his position, I ask him at least to forego the annual leave he intends taking before he retires to at least see it through and maybe as a goodwill gesture. However, that is up to him.

Do Mr. O'Brien and the Minister think the scoping inquiry is enough at this stage? Should we dig further? As I asked Mr. O'Brien this question last week, perhaps the Minister can answer this week. What can be done to restore the public's confidence in screening in general? I think things were going very well but the public has lost huge confidence in this and it is hard to blame them.

What was called a helpline last week is now being called an information line. "Phoneline" is probably the correct term to use because the feedback I am getting is that it just not working. Maybe something else could be done about that. People are being advised to contact their GPs who are already very much overworked. Is there a plan in place to help them in this?

Is the scoping inquiry enough? No, absolutely not. It has been set up and is independent. We will leave Dr. Scally and Dr. Denton to their work. What I have heard from colleagues from all political parties and groupings and most importantly what I have heard from women who have been impacted by this was that they did not want us to hand this issue over to a commission or something that would go on forever and a day. They wanted us to try to get as many answers as we could as quickly as we could and also identify the other issues that would require a commission. Therefore, the Government decided yesterday that there will be a statutory commission of investigation. The following questions will arise when Dr. Scally's work is concluded. What questions have been satisfactorily answered? What do we know the answers to? What remains to be answered?

I also call it a phoneline. I said this in the Dáil last night and I know Mr. O'Brien has said it here today. There is a view that people are not getting calls back because of resources. That is genuinely not the truth. I have been scrutinising this. Many more people have been trained up to prepare the calls. Women are ringing up with personal information and quite rightly wanting answers to their own clinical situation, which then often requires a clinician going off looking at the situation and then a nurse or doctor coming back. A total of 3,649 of those calls have been concluded in the sense that the information has gone back. Damien McCallion is here today. I heard him give a public commitment that the overwhelming majority of them will be concluded by the end of this weekend and that is still the aim.

While I will not go into it in detail now, the Deputy hit the nail on the head in asking what we can do to build confidence now in a practical sense. I met representatives of the Irish Cancer Society for about an hour last week. They had some very practical logical things that I would like to do with them. I would very much welcome any ideas. The move to HPV testing will provide us with an opportunity to nearly restart the conversation with the women of Ireland. It will also give us an opportunity to reconfigure labs and all of that. Therefore, a big opportunity is coming up later this year.

Mr. Tony O'Brien

The phoneline is clearly a phoneline, irrespective of what we call it. It is currently receiving 900 calls a day. The data indicate they are being answered within 18 seconds on average. Therefore, the phone system is working. The only issue relates to the numbers requiring a detailed consultation by telephone. That is being worked through and the daily statics show that it is progressing, not obviously as fast as we would like, but as well as it reasonably can.

In the issue of whether or not I was called, I want to quote that great philosopher, Deputy Alan Kelly, "It's so bizarre and unbelievable that it must be true." I believe that is what he said on a radio station last week. Indeed he had the opportunity to question all the people whose - to use a Monopoly term - get-out-of-jail-free card would have been to say that they told me, and they did not. I will be going in three months. They have no advantage by protecting my back other than that they are decent, honest people in this regard.

There has been much speculation and discussion and many words said about annual leave. As early as February this year, I put in place deputisation arrangements, as I am required to do under the Act, for the period 1 to 22 July, with a view to my final two working days being 23 and 24 July, the latter marking the official end of my term of office as director general. I have indicated that I intend to push back the start of that period in order that I will definitely be around for the report on the scoping review. However, I have also indicated to the Minister that, given that I will take leave later, it is highly unlikely I will return on 23 and 24 July, just as a matter of practicalities, and that, rather than appointing an acting director general, as the law provides, I will instead invite him, in the interests of the organisation, to appoint an interim director general from that day forward to avoid chopping and changing and uncertainty which the health service does not need at this time. That is the position on my annual leave.

A few things come to mind. As the Minister and the director general know, this is not personal. I have often repeated - in fact, I have said continuously - that I am not happy with the structures in place within the HSE in general, but that is not the fault of the staff. The structures in place are not at all convincing in terms of the chain of command. There is no chain of command, as this incident proves. I presume the National Cancer Registry should be part of the chain of command and report to someone somewhere along the line. Surely the reporting should continue along the line to someone at a senior level. Who are the people at senior level to whom those reporting should report? Why did they not report? If the information was available to them at an earlier stage, why did they not convey it? Furthermore, I still believe - the Minister knows this well from previous debates we have had here - that whatever changes are made as a result of what has happened should lead to the creation of a structure that will be accountable and seamless from top to bottom in order that information will flow immediately in both directions and in order that whoever is the director general or the Minister will be au fait with what is happening and required on the ground. In another context I remember a chief executive who had a sign on his desk that read, "I am part of your team. If someone makes a mistake, tell me. If someone deliberately drops me in it, start running". He conveyed a message to all and sundry about the way the ship was to be run. That is what we are missing. I am not blaming anyone personally, but it is a fact of life that the current structure is unworkable. It operates in watertight compartments. It is the silo mentality. As long as it does not change, women and men who need health services of one kind or another will be put at risk.

I thank the Deputy.

I expect replies to my questions.

Mr. Tony O'Brien

Many years ago I had the privilege to chair the board of the National Cancer Registry Ireland which is a separate State agency. It does not operate within the HSE but is under the aegis of the Department of Health. It does its work transparently, reports well and has done good service. In this instance, there is a data protection issue which has been overcome. The general data protection regulation, GDPR, which will come into force very soon will provide a particular route to overcome data protection issues. The fault is not the National Cancer Registry Ireland's. The issue is that information was given that the audit that had been carried out had involved the totality when it had not. That is the basis on which the Minister was briefed and on which he briefed the House and the Government. He was briefed incorrectly in the way I described when I was here last week. Because it is a very serious matter if a Minister is misled, I made it absolutely clear, on behalf of the HSE, that any onward misleading was not the Minister's fault.

I have had occasion to discuss with the committee and others my views on the creation of the HSE and its structures. I opposed the way in which it was created and worked very hard to keep the part of the organisation that I led out of it, but time caught up with me and it became part of the HSE. The creation of the HSE, despite the many good things that go on within it - members have referred to some of them - was an exercise in how not to do change management. From policy to implementation in 18 months, many of the underpinning factors described in the reports that proposed the creation of the HSE were never acted on and have still not been acted on. I refer to having integrated financial systems and so on. The Minister used the phrase, "too big to fail and too big to succeed". That is right. The notion that one person - me in this case, or my successor; I hope there will be strong competition for the post and I will certainly encourage people to apply for it, although at this points I have doubts about the competition - must be personally accountable for every failure and mistake of the 140,000 individuals who work in the health service is not a basis for accountability. There are strong recommendations made in the Sláintecare report that I have publicly supported in that regard. As I have indicated before, I was appointed to an organisation that was to be wound down in the aftermath of the abolition of its board. Three years in - I had a year before the five-year start - as it was clear that that would not happen, I started on a different course. However, at some point - the fact that there is now all-party consensus proves this - we must have a settled position on the structures of the organisation, but in six years what have we done? We have abolished a board and are now going to recreate one. That is not great progress.

I do not wish to detain people, but because some of the questions refer very much to policy, I should respond to them. The way to view National Cancer Registry Ireland is as a Central Statistics Office for cancer. It is meant to be the body that knows all about all types of cancer and the learnings that can be developed from that information. Deputy Alan Kelly referred to this issue and I want to be very clear on it. How we ever got to a situation where one of our cancer screening programmes did not get its data from the registry but seems to have told some people that it did and this seems to have gone on for years and years is beyond me.

It is absolutely bizarre.

It is and the facts need to be established very clearly as it is not satisfactory.

The director general made an interesting point on the issue of HSE reform. The political system, in all of its party political guises, needs to make a few very key decisions quickly on the structures. We should use what has been an horrific situation for some good, for which I have heard people such as Vicky Phelan call. That is why the HSE board legislation to be brought forward next week is important. To be very clear, Government policy on the structures within the health service is in line with the Sláintecare report, that is, that we keep a leaner central HSE but devolve more to regional integrated structures. That is the policy. By the way, while I believe the concept behind the HSE - having a national body to do all it has done; it has made some progress in a number of important areas - is a good one, the way in which it was set up has meant it has become overly complex and bureaucratic. That is not an insult to people working in it. I think people working in it very readily identify with my comments. We need to make a number of political decisions quickly in the Oireachtas on how we can devolve more to new regional integrated care structures. The geo-alignment consultation process that is under way, details of which are on my Department's website, will guide proposals that I will bring to the Government later this year in that regard.

Our last permanent member in this round of questioning is Senator Rónán Mullen.

In the Sunday Independent I saw the Minister stress the point that the entirety of this scandal concerned people who had already been diagnosed with cancer. That has been the entire focus of our discussion. However, it prompts my thinking about the many women who have had cervical checks and are wondering whether there is information which, because of a lack of test accuracy or human error, all of which will be explored and investigated, has not been made available to them. Is there a cohort of women who have cancer that is as yet undiagnosed but on whom there is information available?

Does Mr. O'Brien know how many of the almost 12,000 women who have called the helpline belong to that cohort? Perhaps I misunderstand the focus of the helpline. What percentage of callers are in the zone which we have been discussing, that of people who have been diagnosed with cancer, and what percentage are just worried? It was stated here this morning that women who have had normal test results can continue to participate in the cervical screening programme according to their normal schedule. There is talk of providing information without them having to call the CervicalCheck information line. That prompts the question as to whether such people are being hived off to the side somewhat or extra resources are being put in place to deal with what must be a very understandable concern among that cohort of people.

Senator Mullen has asked some very important questions. The point I was trying to make in the article to which he referred is that the clinical audit related to people who had already been diagnosed with cervical cancer. That is the message we have been trying to communicate for the past two weeks. I did not want any woman watching these debates while sitting at home or in her workplace and thinking the HSE or CervicalCheck has done an audit on her and knows she has a cancer but has not told her. My comments that the Senator referenced very much related to the fact that the clinical audit was in respect of women who had already been diagnosed with cervical cancer. The question and upset was about their not having been told about their earlier audit.

The Senator touched on the very interesting point of a larger random sample audit of non-cancer cases, as raised by Deputy Kelly and several others in the Dáil last night and which Cabinet colleagues also brought to my attention. We are going to ask the Royal College of Obstetricians and Gynaecologists and the British Society for Colposcopy and Cervical Pathology to come here and I will be guided by them in that regard. My gut feeling is that such blind sample would be worthwhile in terms of providing assurance and that is something I would like to do. I have no information that there is anybody in this country who has a cancer about which the HSE knows but has not told the person. That is the differentiation I was trying to make.

Mr. Tony O'Brien

I can definitively state that the CervicalCheck programme has no knowledge of anyone who has cancer but is not aware of it. I ask my colleague, Mr. McCallion, to address the question on the phone line details.

Mr. Damien McCallion

We have received 11,982 calls, 3,832 of which were dealt with immediately at the point of contact in our centre in Cork. The figures are contained in the daily reports. We triaged the 8,150 women who requested a callback into three categories: those who had a normal smear history; those who have had contact with colposcopy services; and those who have had an abnormal smear history. Those calls are then moved to a number of different centres. As of yesterday evening, 4,501 women were awaiting a callback. It was clear to us last weekend that we would not get through this quickly with the resources and process we had. We set up a centre in Waterford which solely deals with those who have had a normal smear history. Such women still need reassurance and many will have questions and need advice from a person with a clinical background. The second group, those who have had an abnormal smear history, need to talk to someone who has access to the cancer screening system. Two centres to cater for that group have been set up in Dublin and Limerick. The final group, who are probably those with the most questions, are those already in contact with the colposcopy service or who have some form of cancer. We put a system in place with the hospitals such that the colposcopy units are now working with us to contact those women directly. In many cases the units' staff know the women and will be able to give reassurance much more quickly than an operator at a central point who does not know the person could. It also provides access to a pool of specialised resources that would be impossible to try to pull into a small number of sites. As of yesterday, we had dealt with 1,000 callbacks. Prior to last weekend, we had dealt with a number in the low hundreds. Approximately 500 were dealt with on Saturday, 550 on Sunday and 700 on Monday. The numbers are increasing. We are not being absolute in terms of a final point because calls are still coming in. The number of calls varies; there was a low number on Monday and slightly more calls yesterday. That can sometimes be determined by the discussions going on around the cervical screening programme.

The point was made that the calls with women who have had an abnormal history or were in contact with services take time. I have talked to some of the nurses and doctors staffing the helpline and we must give people time to deal with the calls. We have ramped up resources such that we have probably got over 60 to 70 people at different times of the day working through these calls. We must bear in mind that a colposcopy or cancer nurse or a doctor is required to deal with those women who have had contact with the service and we are drawing on the system to try to maximise that. The people who have a normal smear history simply want to talk to someone who has a clinical background and can explain things to them in language that gives them a degree of reassurance. We are continuing to try to get communications out through social media and other channels to give them some level of reassurance to those who have a normal smear history but in the current environment I expect that we will receive a significant number of calls this week.

Mr. Tony O'Brien

That echoes a point made by Deputy O'Connell, that irrespective of whether there has been no previous screening history or one with no abnormality detected, the right course of action for any women experiencing symptoms such as unusual discomfort or bleeding is to seek a medical consultation with a general practitioner, which is likely to lead to a rapid referral to a colposcopy service. In such situations, a clinical examination rather than a smear test would be indicated. That is always true, irrespective of screening history.

What is the breakdown of those three categories among the almost 12,000 calls?

Mr. Damien McCallion

We can circulate the exact figures afterwards but approximately 50% are what I call the normal call volume, those directed to Waterford, with the balance split fairly equally between those who had an abnormal smear history and those with a history of cancer or contact with colposcopy services.

I thank Mr. McCallion. That completes the round of permanent members of the committee. I thank Mr. O'Brien for making himself available this morning. I apologise to Senator Dolan; I thought he indicated that he did not wish to contribute.

I did but I now have a quick question. I acknowledge Mr. O'Brien has left. The reputation of the HSE and the health services are generally on the lower end of the scale. There is a quandary about governance and risk in terms of this issue. There is almost an instinct not to publicise something that has gone wrong because to do so would add to the perception of poor service. However, if the HSE were to admit that something went wrong but that it found out about it and made people aware of that, it could be the genesis of creating confidence. I do not refer to any particular situation in that regard.

Senator Dolan is correct that it is about creating an environment in which candour becomes the norm and the system not just legally but culturally realising the benefit of being honest and upfront with people. I yesterday heard Dr. Gabriel Scally talk of his experience of dealing with people who have been let down by a health service and what such people want. He has much experience of such situations in the UK and Northern Ireland. People often want an admission that something went wrong, an apology and a genuine commitment to working to ensure it never happens again. That is often what people who all present come across in our work want to happen. The Senator is completely correct in what he has said.

I thank Senator Dolan. I now call on Members who are not part of the committee to have a five minute engagement with the HSE and the Department of Health. I call Deputy Ruth Coppinger.

It is a pity that we cannot ask questions of Mr. O'Brien. I was at the meeting of the committee last week and wished to pursue something he stated there. Perhaps one of the other representatives present can answer my query. Many people are talking about the plaque on the office wall at the HSE which is intended to send out a great message to the masses who work for it. As regards speaking truth to power, Noam Chomsky, in a critique of how the system works, said that power already knows the truth and is busy concealing it.

Maybe it is best not to keep that plaque on the wall. I note that while Mr. O'Brien was here, he said that not every case of cervical cancer was referred back to CervicalCheck for audit. To quote, he said "I think they always knew that". However, the Minister was only hit with that news 20 minutes before he got up to speak to the Dáil. Does he still have confidence in Mr. Tony O'Brien and others who are meant to be reporting to him?

I would just like to say that I am all for heads rolling and people being accountable, but there is also a danger that heads can roll while the system remains in place. The questions I am more concerned with are about the system. Yesterday, I asked about the anomalies in some of the lab results. People on the committee will recall that when Mr. O'Brien was here last week, he said that there were two pairs of eyes watching every test. On foot of that, a woman who was subsequently diagnosed with cervical cancer contacted me over the weekend, because she was watching the committee. People are actually watching this. She was particularly interested in that, because she had two negative results, and then a year later was diagnosed with a large tumour. She just found it very difficult to believe, based on what she had experienced, that there were two pairs of eyes looking.

I met a pathologist over the weekend. He ran a cervical screening lab for at least a year. He said that in his experience, each test would take at least ten minutes. Ten to 15 would be the best recommendation. That would mean that every slide in these labs is taking 20 to 30 minutes to be looked at, if we follow Mr. O'Brien's claim. I would have liked to ask him if he still stands over that. Every test is signed off on by a cytologist. Can we check how many were done by each cytologist? Are they within the limit of 12,000 a year that is recommended by CervicalCheck's quality assurance? The quality assurance committee - what were they doing if they were not looking at, for example, what is up on the website now? I think it went up on Saturday evening. In reference to the three labs, A, B and C, people have figured out that B is the Coombe Women and Infants University Hospital, A is Medlab Pathology and C is Quest Diagnostics. There are noticeable differences in the results over the three years. Without blinding people with science, that is particularly so for lower-grade abnormalities. A woman I spoke to-----

We just have five minutes, so Deputy Coppinger has four to ask her question.

Maybe I will just finish on this. Quest Diagnostics diagnosed low-grade abnormalities at 4% in 2013, while the Coombe was finding 11.8% and Medlab was finding 10.7%. Now, how would that be explained? Is the same categorisation of lower-grade and higher-grade abnormalities used? I think this is important for people who have been diagnosed.

The last question is this. Will the document that the Minister mentioned today, the international clinical expert review, include people who were audited as well? Yes? Will their cases also be looked at? I met somebody who was audited. Disclosure was made to them a year after the diagnosis, but they do not feel that this disclosure was a full and frank one. I want to ensure that those people are considered.

I will start and I will ask Mr. Sullivan to come in on some bits. On the issue of confidence, I think everybody's confidence has been shaken over the last several weeks. How could it not have been? If the Deputy's question is whether, in my judgment, it is better that Mr. O'Brien serves out his remaining number of weeks and continues to do what we need him to do, to help get the answers, I say yes it is. That is my judgment. In relation to-----

Are money or legal issues involved if he has to go?

I am not going to discuss somebody's contract here, because I would not discuss the contract of employment of anybody, but I mean-----

Deputy Coppinger has submitted her questions. The Minister must have an opportunity to answer.

People are wondering that, though.

The truth is what I have just said, that I believe that he is best placed to provide answers, help the scoping enquiry and help the process that CervicalCheck needs to undergo over the next few weeks. On the issue of the labs, Deputy Coppinger has been asking a lot of questions, and I am not suggesting that they are not important. They are important questions. The Deputy also made a detailed submission to me about the terms of reference. I have tried to capture that in item f. of the terms of reference, whereby we have asked Dr. Scally and Dr. Denton, who know a lot about this as opposed to me as a non-clinician, to "examine the tendering, contracting, operation, conflict of interest arrangements, performance information and performance management, accreditation and quality assurance of contracted cytology laboratory services by CervicalCheck from initiation of the programme".

All of those issues, the operation of each of those labs and how it relates to the programme will be looked at to provide answers. I will ask Mr. Sullivan if there is anything I need to add in relation to the comment that the director general made about two pairs of eyes. In response to the Deputy's question and the woman she met who was looking for assurance that her case would be looked at again, we are asking the Royal College of Obstetricians and Gynaecologists to review all of the known cervical cancer cases in Ireland. Now, obviously, not all cases will have a screening history. We are seeing this with the National Cancer Registry. Nonetheless, we are asking them to look at all of them, which will be in and around 3,000 cases. So yes, it will be looked at again.

Mr. Dean Sullivan

Just to pick up on the issue of the review of smears, I have been advised that each smear, every single one, is subject to a full read by a cytologist and then to a second review by a separate cytologist. That is my understanding of the position across all the labs across the full life of the screening programme since 2008.

One probably takes a minute or something like that. There is no way 20 minutes are being spent on each of those.

Mr. Dean Sullivan

I can only guess that it takes as long as it takes to do properly, but my understanding is that the second is certainly a quicker process than the first. It is a full, thorough review by the first cytologist and a quicker second check by the second cytologist. Crucially, it is by two different people, and the slides-----

The Minister should know that the woman I met has not been contacted by anybody since this began. She does not know if she is one of the 209 or not.

I see Mr. McCallion had to go back to CervicalCheck. What we can categorically say this morning is that all of the 209 or 208 women have been contacted. The director general said earlier that with eight women, there seems to be great difficulty in making contact. If someone has not been contacted now, and they are contactable, they are not one of the 201. However for all 3,000 women, that work will get under way when the Royal College starts its work in the next couple of weeks. That work has not yet begun.

I welcome the opportunity to contribute briefly. My first comment is that I think we should never miss the opportunity to get some benefit from this crisis. There is an opportunity here, because what has become apparent and blatant in the last few days is that the culture of non-disclosure and covering up is never acceptable and is never the right option. I think that message has to go very clearly to all employees in the HSE. If something goes wrong, they should put their hands up. The outcome of that will always be better than pretending that it did not happen. In future, if every arm of that organisation operates on that basis, issues such as this, while they will always be difficult, will always be dealt with in a far more progressive manner.

I have just a couple of specific questions. There is talk of a new, more accurate human papillomavirus, HPV-based screening technique. When will that be available instead of what is there at the moment? I am just wondering whether, if there is a more accurate and better test, it would be better to concentrate on that rather than continuing what we have, which has a degree of uncertainty about it. With regard to patients who have had previous high-risk or non-clear tests, is there a targeted campaign to contact those women to say they should be tested again or are we leaving it up the women themselves to come back and say that they want to be re-tested? My opinion is that we should target them as opposed to waiting for them to come to us, because people's nature is to hope that there is no problem, to turn a blind eye and hope it goes away.

There is an onus on us to contact any potentially high risk patient and to ask her to come back in for another look.

Last night I raised the issue of the succession of the CEO of the HSE. In his contribution just five minutes ago, Mr. Tony O'Brien said that he doubted there would be much interest or uptake by anybody because of the nature of the organisation and the difficulties around the role. It would, however, be nice to know a month or two before the current director general leaves if there is interest in the job. If there was no interest then what could be done to attract people and what head hunting would be required? By the time we find somebody and by the time he or she gives notice, we are certainly looking at a six-month period. There is a lesson to be learned in that. This applies not only to the recruitment of CEO positions but across all positions in the HSE. There should be a much better succession planning system in place when trying to replace administrators, doctors, consultants and nurses. That clearly is not there. There is a lesson to be learned in trying to improve this process.

I take Deputy Brassil's point on the last issue. As I tried to outline to the Dáil last night work has begun, through the Public Appointments Service, in identifying an executive search. My Department is in contact with the Public Appointments Service and I expect the advertisement to be placed very shortly. It will become apparent in due course that there has been a body of work to try to align this post with the Sláintecare reforms. I heard a Deputy suggest last night that we should leave the post vacant until all the Sláintecare legislation is in place. I do not believe we can do this but we are moving from a role of director general into a CEO role. I take the point and the advertisement will be placed very shortly.

Reference was made to retests and targeting that group of women. I will refer this directly to CervicalCheck and to Damien McCallion. I will ask him to come back to the committee directly on that. The Deputy has made an important point but I would rather the committee received an expert view on it rather than my view. The plan is to move towards HPV testing around October this year. In February this year I approved the introduction of primary HPV screening for cervical smear samples. I did so on the basis of a HIQA health technology assessment, which found that women would benefit by making the screening process more clinically effective and by reducing unnecessary tests for women. This would be a more effective system that would need to test women less often. This will be beneficial all around. I have asked how quickly can we get there and I have been told that October is as ambitious as we can possibly be. I continue to scrutinise that situation because the quicker we can get there the better. Ireland will be one of the first countries in the world to move to introduce this type of testing. This is some positive to come out of a very bad situation.

Mr. Jim Breslin

I wish to make a point outside of the cut and thrust of the controversies over the last week. It relates to the degree of interest in our health services by everyone in this committee room and on the question of the successor to the director general, who will be the new chief executive. I have worked in different parts of the public service but I deeply believe that of all the parts of the public service, healthcare is the most meaningful and impactful role any public servant can play. There are people within our health service, within other sectors and within other jurisdictions who will find the meaning in this role to be absolutely rewarding and personally satisfying especially when added to the opportunity that has been created - including through the work of many people in this room - which provides a clear vision around where we want to get to over the next ten years. We have €10.9 billion in capital to try to bring this about. We have €1.9 billion for a CT strategy and we will soon have a fully-funded Sláintecare implementation plan. I believe this is an exciting role and it should attract anybody who has the essence of public service in their makeup. They could come from any sector but as long as they have that value at heart then we could be successful in recruiting really good candidates to these positions.

I agree with that. It has been said that the HSE is too large to fail but too big to succeed. I accept that it is too large to fail but I do not accept that it is too big to succeed if we have the right structures in place. There are companies that are much bigger than the HSE with very successful organisational groups and they work perfectly well. It can succeed if the structure is in place to make it succeed. I agree with Mr. Breslin's comment. We should be going out there and looking positively for someone. With the blueprint of the Sláintecare report we can show him or her there is a real opportunity to make a positive impact, to make this organisation work and to give us the healthcare service we deserve.

I want to discuss mandatory disclosure and especially the decision by the Government in November to include the amendment on the advice of the HSE. This amendment would mean that disclosure was voluntary rather than mandatory. Who within the HSE gave this advice to the Minister?

I do not believe that advice was given by the HSE. It is advice that was given by the Chief Medical Officer, which was also advice given at this committee by the Chief Medical Officer. It was accepted by this committee in a report that was produced, and which the Taoiseach has referenced on the floor of the Dáil. I want to be very clear with the Senator that this issue was scrutinised in detail and in a very constructive way by this committee. It produced a very fine report that found in line with the Chief Medical Officer's view.

The Minister obviously did not have that. Even though he gives the impression in the committee that he had cross-party support for it being voluntary rather than mandatory, and while it might have been discussed at the committee, the recommendation from the HSE was that it would be voluntary.

I do not mean to correct the Senator, but in the interests of fairness to everyone, it is the Department of Health and the Chief Medical Officer rather than the HSE.

Did the HSE give any opinion at all on it?

Not that I am aware of.

The Chief Medical Officer is-----

Dr. Tony Holohan.

-----and he is not connected to the HSE.

No. He is in my Department.

This is part of the problem; "it is not him it is me or it is the State Claims Agency" and it is bound up-----

Only if it is made a problem.

It is a problem in terms of transparency. Would the Minister admit now that it was a serious error of judgment last November to follow that advice?

No I would not. I welcome the back and forth but perhaps the Senator will allow me to answer the question. The Chief Medical Officer is the medical adviser to the Minister for Health. I do not believe there is any confusion or lack of transparency about that. The Chief Medical Officer's name is Dr. Tony Holohan and he is very well known to Members of these Houses. Dr. Holohan gave a view to me, to my predecessor and to this committee around how we could best implement open disclosure. I am not speaking for Dr. Holohan but my interpretation of the advice was that open disclosure should be in place right across the health service, that it is already the policy of the HSE since 2013 - but I fully accept that clearly it has not been implemented.

The advice included that we should underpin it in a voluntary nature in the Civil Liability (Amendment) Act but that we should make it mandatory for serious events in the health service by legislation. This has not just come about now. I am using the current situation as momentum to get the legislation passed. I corresponded in writing with Deputy Clare Daly, who has done great work on this, in November of last year to give her an assurance that we were going to legislate for mandatory disclosure. My understanding of the advice was to bring in open disclosure for all of the health service but to make it mandatory for serious incidents.

Who defines if something is a serious incident or not? Yesterday we spoke to the State Claims Agency and it was obvious that Vicky Phelan was just another run-of-the-mill case and there was no need to report it to anybody or to do anything else. Who defines what is a serious incident and at what point?

There will be a list of definitions in the Act, and it is a really important job for this House to do that. I have already said very clearly that as a result of Vicky Phelan's case, screening will be clearly identified in the definitions of serious. There will be a list of definitions.

If the Government welcomed mandatory reporting why did the Minister still find it necessary to include the amendment? I cannot understand it. It is not just about mandatory reporting of serious incidents; it is about having a culture of mandatory reporting within the system.

I followed the advice. It was justice legislation, the Civil Liability (Amendment) Act. The Government's intention for the legislation was, as I have outlined, to have open disclosure for everything; involuntary for some and mandatory for serious incidents.

Deputy Daly produced an amendment on that issue that was out of kilter with this approach. The Joint Committee on Health considered the matter and produced a report that is available for all to see. The Government and the Oireachtas, which voted on it, took the decision that it was better to have mandatory reporting in separate legislation.

Yesterday, I got permission to draft the patient safety Bill. That will make it mandatory and bring in mandatory reporting.

I very much welcome that, but even in that sense it speaks to something of the question of who is in control.

I wish to move on because my time is limited. I wish to ask about the redress scheme. Can the Minister explain why a redress scheme cannot be set up with an inquiry? I am concerned that if a redress scheme does not come about until after the inquiry then there will be problems with people accessing it. Perhaps the Minister has new information on the matter or information I do not have.

The Taoiseach gave a commitment in the Dáil last week that there will be redress by the Government. The Government has had some initial conversations on the matter but has yet to make a decision on what the scheme might look like. The Taoiseach outlined in the Dáil yesterday that he believed it was sensible to establish all the facts first. I have heard some of the women impacted say that as well. A scoping inquiry has been established.

In fairness, I credit the Sinn Féin health spokesperson, Deputy O'Reilly, and others for their engagement on this matter. The structure being set up will produce answers and a report quickly. Dr. Scally will report in three weeks' time – during the first week in June. His final report will be submitted by the end of June.

We need to get this right. We need to identify exactly the number of women who were impacted. We need to establish what the redress is for and where the liability might be for the State, whether legal or moral liability. We also need to establish where the liability might be for a laboratory. We have seen the two of these interact already in the Vicky Phelan case.

Will the Minister speak to the question raised by my colleague, Deputy Doherty, yesterday with the State Claims Agency? It relates to the agency taking control such that we do not have a situation whereby we have the women versus the two laboratories. Does the Minister support such a move by the State?

I will answer with the caveat that I am not a lawyer and I am not the Attorney General. The idea that the State should not be in conflict with the women who it wishes to help absolutely makes sense. What is the best mechanism to do that?

What if the liability rests with the laboratory? I know we might have privilege at this committee but I have no wish to say anything that poses any difficulty for any woman in her legal interactions. One idea is that there may be liability with a laboratory in some cases. The idea that we would help to support women in those cases rather than be in an adversarial situation is one the Government wants to realise. The Taoiseach has asked the Attorney General to work with the State Claims Agency and report back to Government. Instinctively, I believe the suggestion put forward by Senator Conway-Walsh is sensible. Whether it is workable legally is something we need to deal with.

I believe it is important. Many profit-driven organisations will not be driven by fairness and the ethical stance that would, I hope, be taken by a state agency.

We are going to move into our second round of questioning. We are going to repeat the process of bringing in the Opposition spokespersons first. We are going to extend the amount of time to seven minutes, if that is okay. However, contributors need not necessarily use all seven minutes if they do not desire it. Deputy Stephen Donnelly is first.

I am keen to make some quick points on CervicalCheck. Then I will move on to a question on non-registered consultants. Yesterday, a High Court judge described that situation as scandalous.

I wish address the issue of CervicalCheck first. I believe there is an opportunity to be proactive in identifying high-risk women. We have been speaking to general practitioners throughout the country. The point was made to us that the inverse care law may apply here. In other words, those most likely to contact the centre and go for further screening are not necessarily those most likely to need it. In one conversation relayed to me a general practitioner talked to women in his practice who he believed should have repeat screening. They said they were fine and that the GP should not worry about it. There is an opportunity to identify and target higher-risk women and proactively reach out to them. The idea is not simply to have a woman contact her GP and self-select or contact the helpline. We should be more proactive about it.

Will the Minister tighten up the guidelines for GPs? I have been contacted by several GPs. They say the information they have to date is insufficient. They have been told to use their clinical judgment. That is fine but I believe many of them are looking for a little more in terms of when it is appropriate or otherwise when it comes to different types of clinical advice.

I wish to address the preliminary investigation. I did not put this point in my submission to the Minister. I am suggesting something new. It relates to the fact that the investigation will be looking at the activities of the Department of Health and the Minister. My understanding is that it will include the period from when the Department knew about Vicky Phelan's case and sent the memorandum to the Minister and so forth. There is a clear conflict in reporting into the Minister or the Department on that basis. Will the Minister consider a reporting line into the Department of the Taoiseach? I appreciate that I should have raised the matter before the Minister brought it to Cabinet, but I will leave it with the Minister.

It would be useful to get a report on laboratory accuracy. There is considerable concern that the US laboratories may have been substandard and that the Irish laboratories were substandard. The HSE has released documentation. The HSE released it on Saturday but with insufficient explanation on the values. For example, if we use positive predictive value, it would appear that in two of the years the Irish-based laboratory was the least accurate. If we use the number of anomalies detected, it would appear the same laboratory was the most accurate. I am seeking expert advice on the matter myself but I believe a clarifying note from the Department or the HSE would be useful.

This is a political point for the Minister and for the Taoiseach as well. There is still considerable confusion as to the link between non-disclosure and clinical outcomes. I am talking to women who still believe that the issue of non-disclosure has led to women's deaths. My understanding from talking to consultants is that while that cannot be ruled out, in fact it is not the case.

When Storm Ophelia arrived, every time I turned on the television the Taoiseach was on the screen flanked by soldiers and rescue workers. He has not been out in the same way on this. This is a national emergency just like Storm Ophelia in terms of the level of fear and misunderstanding. Will the Minister talk to his boss and suggest that he show the same zeal for communicating with the public on this? Perhaps he does not believe it would be as good a photo opportunity to be standing beside the HSE officials at the moment. I am being somewhat tongue-in-cheek but there is a marked difference between how much he appeared on our television screens during Storm Ophelia and how we are seeing him on this issue.

Either the Minister can or cannot respond to any of these questions. I am making them as points so the Minister can feel free in that regard.

I want to ask the Minister on an issue described by a High Court judge yesterday as scandalous. There are well in excess of 100 doctors in Ireland working as consultants but who are not in fact consultants. It amounts to approximately one in 25 doctors in consultant posts in the country. On top of the CervicalCheck scandal, which has obviously shaken confidence, we have an issue described as scandalous by the courts. It seems a patient may not know whether the consultant he or she is seeing is in fact a registered consultant. What is the Minister's view on that? Does he believe it is acceptable? My understanding is that this has been going on for some time. We got evidence last week at committee that there is genuine clinical risk attached to this practice. What is the Minister's view on it? What, if anything, does the Minister intend to do to stop this practice?

I thank Deputy Donnelly for his questions. I will try to rattle through them and take them in the order in which they were put.

Deputy Donnelly has made an important point about high-risk women and how we can ensure that we specifically target groups of women most at risk. I will certainly pass that on to CervicalCheck and to the Royal College of Obstetricians and Gynaecologists representatives when they arrive. I do not have the statistics to hand but I know that we have a good track record compared to other countries in terms of reaching women across various demographic measurements and social classes and so on. We need to ensure that does not fall off as a result of this. Deputy Donnelly has made a valid point in that regard.

The GP guidance was produced on 2 May by Dr. Peter McKenna, the clinical director of the national women and infants health programme. We will certainly reflect back to Dr. McKenna to see if any further guidance can be produced.

We reached agreement with GPs last Friday on how they will be paid and resourced for taking on this extra work. I want to acknowledge on the record of this committee that the IMO and the NAGP were supporting the idea of carrying out repeat smears and were seeking to do so. I think they were getting worried that women would turn up in their clinics looking for repeat smears and they would not know what to do. If there is a need for more guidance in this respect, I will ask Dr. McKenna about that.

In that regard, will there be anything to prevent CervicalCheck from doing these smears out of turn? GPs often do smears outside the three-year cycle only to find that CervicalCheck will not process them.

I do not believe there is any difficulty there at all.

I think Deputy Donnelly made a fair point on the issue of laboratory accuracy. It is difficult for those of us who are not clinical experts to interpret the data that is being produced. I take assurance from the chief medical officer's statement that "none of the evidence that we have available to us at this point gives us any reason to have any concern about the quality assurance of the performance of the screening programme". Obviously, there is a reason we are having an independent scoping inquiry. It is important not to pre-empt that. I am not suggesting that Deputy Donnelly is doing this. The evidence available to us now is that the screening programme is safe and is working in line with international norms. The Deputy's final point on this issue was a political one. I will tell the Taoiseach that the Deputy enjoys seeing him on the television and would like to see more of him on television. I assure the Deputy that the Taoiseach, in his position as head of Government and as a doctor, has been extremely supportive of me in a hands-on way as we have been dealing with this difficult situation. I do not have any concerns in that regard.

I asked the Minister whether it would be possible for the investigation to report to the Taoiseach because of a potential conflict of interest.

I took a note on that question, but then I could not read my writing. I do not have any difficulty with working out a mechanism for that to happen. Maybe the Taoiseach and I could get the report at the same time. As Minister for Health, I have duties to discharge. The concern, health and well-being of women in Ireland is one of my main priorities. It is my main priority as a result of this. I have no difficulty with the idea that the Taoiseach would get the report at the same time as me. I will discuss it with him. I am aware that Deputy Donnelly's party leader has raised this matter with the Taoiseach. I will revert to him on this question. I have no difficulty in principle with his suggestion. Like him, I want the facts to be established as quickly as possible so that we can bring assurance to people.

Regarding the issue of consultants who are not on the specialist register, I note the comments made by the president of the High Court yesterday. Sadly, this is not a new issue. We have been discussing it at this committee for quite a period. I am assured by the HSE that the number is declining. The HSE has asked Professor Frank Murray to do a discrete piece of work this year to work through how this situation can be regularised. I am told that some of it relates to people who may never have joined the specialist register of the Medical Council, but may be well qualified to do so, which is completely unacceptable. I ask Mr. Sullivan to update the committee on what exactly the HSE plans to do about this.

Mr. Dean Sullivan

I will replay some of the headlines around this issue, about which Ms Rosarii Mannion and Professor Frank Murray spoke to the committee on 2 May last. Since 2008, the HSE has required consultants to be on the relevant specialist division of the Medical Council's register of medical practitioners. This is a means of ensuring consultants in Ireland have the necessary training, skills, competencies and qualifications. As of April 2018, the position with regard to what the Deputy has asked about is that 4.3%, or approximately one in 25, of the 3,000-strong consultant workforce in the South is not on the specialist register. Of the 127 individuals who are not on the register, 52 relate to the period before the requirement was introduced in 2008 and 75 relate to the period after 2008. As the committee discussed last week, processes are ongoing to identify the consultants who were in their posts before 2008 and who have the necessary skills to be on the relevant register but have not yet chosen to put themselves forward for inclusion on it, and to encourage them to do so. Processes are also in place to upskill, as required, those other pre-2008 consultants to bring them to the necessary standard. I hope Professor Murray has given the committee further details in that regard. The process for post-2008 individuals is largely a consequence of the inevitable delays that are experienced when we try to fill posts within the system, whether on the hospital side of the house or on the mental health side of the house. Those delays are probably - almost certainly - too long at the moment.

Professor Murray will work with relevant colleagues in relevant agencies to look at options to reduce the amount of time it takes to fill a post after it is created as a new post, or becomes vacant and is identified as needing to be filled. This will remain an issue in light of the pattern of services we have in Ireland at present. There are some posts that are difficult to fill, unfortunately. This becomes one of the symptoms of that challenge. I am from the North, where we have exactly the same difficulty because certain posts at some of the smaller sites are harder to fill. As I alluded to in my opening remarks, one way of beginning to provide additional assurances in this respect and getting around the recruitment difficulty is to provide for better networking when smaller sites are joined into the smaller sites. In cases in which we have difficulties because of individuals in posts who are not on the specialist register, I assure the committee that appropriate assurances and governance arrangements are in place in community healthcare organisations and hospital groups to provide the necessary scrutiny of their day-to-day practices.

I thank Mr. Sullivan. As we have been sitting for more than two hours, I am obliged to tell anyone who wishes to take a five-minute break that we can accommodate that. Are the witnesses happy to continue?

Mr. Jim Breslin

I am happy, subject to the return of the Minister.

We will continue.

The Minister has had his five-minute break.

Before I ask my questions, I want to refer to the posters that went up in the Minister's constituency yesterday, as we all saw in the media. I do not propose to speak for the committee, other than to say we all hope we will have a respectful and reasoned debate. I am speaking for myself when I say that such posters are deeply unhelpful and, to be fair, quite disgusting. That is my personal opinion.

I will move on to my questions. Can the Minister tell the committee how many of the 209 women who have been identified are terminally ill? We understand that they are ill, but how many are terminally ill?

I would like to ask about the information that was communicated to the HSE by the State Claims Agency. I understand that at yesterday's meeting of the Joint Committee on Finance, Public Expenditure and Reform, and Taoiseach, the State Claims Agency advised that all ten cases were known to the HSE and that there is some way in which quarterly reports are given. The Minister might tell us how all of this slipped through the net. Are there quarterly reports? If so, who gets them and where do they go? When I listened back to the proceedings of the joint committee, it was not clear to me how that would be communicated.

In Sinn Féin's submission regarding the inquiry, we suggested that while the non-statutory inquiry is under way, the time available could be used to work on reforming the legislation that governs commissions of inquiry to make it more fit for purpose. This is needed to give us the capacity to put together a bespoke inquiry that might get some answers.

My view of the impact of outsourcing on quality is well known. As a result of how seriously people in the trade union movement have taken the issue of outsourcing, a clause in the public service agreement, with which I am sure everyone present is familiar, requires consultation. The Minister might give his view on what is happening in the Mater Hospital at present with regard to the central sterile services department. It is particularly unfortunate that this issue has arisen at a time when we are facing the spectre of outsourcing and the potential that it might not have delivered for patients. I do not say that to scare anyone, I say it because the potential is there. It might not have served patients well.

It strikes me as somewhat counter-intuitive that there is a headlong rush into outsourcing, contrary to the term of the PSSA.

Last week, we discussed consultants. I have no sense that the HSE is doing anything other than counting and trying to reclassify them. As we sit here, a consultant somewhere who is probably not entitled to be on the specialist register is drawing down specialist wages and about to embark on his or her journey towards a contract of indefinite duration. I do not think anyone in the HSE is trying to stop that. As part of the recruitment process, is the HSE actively trying to recruit people from the specialist register or is it happy to allow the practice to which I refer continue? I do not see it diminishing.

My final question relates to the Central Mental Hospital, CMH, a place which is well known to me for work reasons rather than any other, I hasten to add, and the practice of clients of the hospital going directly from court to it when they have been found not guilty by reason of insanity. The CMH does not have the required staff. Can our guests provide an indication of the number of people who have been turned away and who should have been provided with places in the CMH for specialist treatment? Can they give us an idea of what services within the HSE those people are availing of and whether they are out on bail at the moment?

I will start. I noted seven questions. If I missed any, I ask Deputy O'Reilly to let me know. I will ask the HSE to start with most of them.

The Deputy raised the issue of posters. I thank her for her comments. The Deputy and I obviously have the same view on this issue - heaven forbid we might have the same view on any other. Largely speaking and regardless of one's view on the issue, the campaign had been pretty civil. There are a few cases where that has not been the case. What happened in my constituency with my image yesterday and the posters placed around my office and near my home and my family's home was a very low blow and kind of disgusting. It was very upsetting for parents and families. I do not think it is a fair reflection of the decent people who will be voting "No" or "Yes". It was disgusting and should be condemned by everybody. I regret that, so far, it has not been and I would like visible condemnation of it from all sides because we do not need the final two weeks of the campaign on this very sensitive and important matter to be dogged by such issues.

When we engaged last week, the Deputy asked me about the terms of reference for the scoping inquiry and reforming current legislation to examine how we could have what the Deputy called a bespoke inquiry or investigation. I have raised the matter with colleagues. The legislation resides in justice. I have made a couple of initial inquiries about whether a commission can hold any of its hearings in public. There seems to be a viewpoint that the commission possibly can do so at the discretion of its chair. We have a few weeks between now and the end of June before we get into a commission of investigation and I will use that time to work with the Opposition. It is obviously outside my direct ministerial remit, but I will work with Government colleagues to see what a bespoke investigation could look like.

I certainly do not wish to speak for everyone, but my sense is that we are all agreed that we do not want to go down the road of a big tribunal which will go on for ever and which involves very sick women. That is not appropriate. The commission of investigation could produce a much quicker outcome in that regard, but it needs to be modular. Deputy Kelly reminds me of that all the time and we have included the word "modular" in the terms of reference of the scoping inquiry. We also need to see whether people who want to give testimony in public can be facilitated. We need to tease out a few issues in that regard. I will keep in touch with the Deputy and the Opposition.

There are people who should give evidence in public who may not want to do so. That is where the focus should be.

At the moment, there is a legislative conflict. A tribunal is very public and no one really wants a tribunal. A commission of investigation is generally not public but it is quicker. I am happy to engage on whether there is a way to align the two.

Mr. Dean Sullivan

I will respond to the elements the Minister did not pick up on. On how many of the 209 cases involve women who are terminally ill, the communications arrangement and the State Claims Agency, I will come back to members with further detail on those issues. I would not wish to mislead the committee.

What is the timeframe within which we will hear back?

Mr. Dean Sullivan

It will certainly not be longer than a week. I am not sure what a normal timeframe would be.

I would have thought it is the kind of information the HSE could put its hand on immediately.

Mr. Dean Sullivan

I hope it would be. We will do our very best.

Okay. We can expect to hear that information. It is important. If it is not known or available to the HSE quickly, that would worry me.

Mr. Dean Sullivan

I will ask Ms Fitzgerald to deal with the central sterile services department at the Mater Hospital and Ms O'Connor to comment on the issue relating to the CMH.

On consultant recruitment, we are not seeking to admit anyone who is not on the register to any permanent consultant post on a permanent basis. That is not to say that people who are not on the register are not being put into those posts on a temporary basis. That comes back to the issue I mentioned in the context of facing a cliff edge. In some cases, one could wander into the challenges of being able to maintain a particular service if certain post could not be filled. There could be difficulties in maintaining out-of-hours cover if a particular post could not be maintained or filled. Sometimes we have no choice. It is not what we would wish to do, but it is what we are doing. I refer to the governance arrangements I mentioned and the efforts of Professor Murray, along with Ms Mannion, being taken forward to minimise the length of time it takes to recruit consultants. There are some hard to fill posts out there.

One minor question, Deputy O'Reilly.

Under the law, consultants are perfectly entitled to be recruited on contracts of indefinite duration from the start. My sense is that there is no plan. I understand what happens when someone cannot be recruited. Someone who does not have the required qualification is then brought in. Should that not be on the proviso that the person concerned will attain the necessary qualification, particularly as we all know that the recruitment processes are not exactly shining lights? People recruited under that system are accruing an entitlement, as they should, under a contract of indefinite duration. That is how many consultants are being recruited. I do not get any sense that there is any will to tackle this issue.

Mr. Dean Sullivan

That could happen, but we are talking about individuals and their choices. Some people may choose not to be on the register. That has consequences for them in terms of their employability, the different types of roles they can undertake and so on. Where we have a choice of not filling a post at all or filling it with someone who, for whatever reason, is not on the register, we need to put in place extra governance arrangements around that. I will check with Professor Murray and Ms Mannion this afternoon about that, as well as the first two points the Deputy raised.

We have to move on.

A number of my questions were not answered. Mr. Sullivan referred to Ms Fitzgerald and Ms O'Connor.

We have a time limit. I am afraid we have to move on.

Based on that, do not respond to my questions. I want the delegation to take them on board. I will not ask any questions about what Portiuncula Hospital and we are going to deal with that during a specific session. I have lots of questions relating to that.

I take a particular interest in eHealth Ireland. I ask Mr. Sullivan to break down the proposed spend for that over the coming years. I understand acute hospitals are being prioritised.

There are issues relating to paediatric services in Dublin, particularly in Tallaght. The paediatric emergency service area has been taken over. The provision of beds for paediatric patients is not what it was. I understand that there are other issues in terms of elective surgery for paediatric patients. I know of one 13 year old boy who has Down's syndrome and who has been in desperate need of a hip replacement for two years. He has begged me to help him. His family have asked for my help. The young lad is in serious pain. There has been messing around going on for a significant period, which leads me to think that there are issues there. I have been in touch with the general manager. Are there broader issues with paediatric services?

On cervical screening, I thank the Minister for taking what I said on board. Random sampling is necessary given the scale of the issue and concern in order to give a quick follow through in terms of public confidence.

With regard to the HTA for the HPV for boys, HIQA needs to come through ASAP. The third thing is that I believe the HPV process relating to the new screening needs to be brought forward as quickly as possible and to deal upfront with the issues relating to laboratories and IT because they are the issues that would hold it up.

I attended a meeting of the Oireachtas Committee on Finance, Public Expenditure and Reform, and Taoiseach yesterday where the State Claims Agency told us that unless the laboratories give indemnity on these ten cases, and there will be more, the agency has no choice but to continue as part of the process of pursuing these women. This may require emergency legislation to allow the State Claims Agency to change tack because it is actually confined in what it can do. Will the Minister bring that to Cabinet and consider an emergency change? I am sure all of us would help him to change that to ensure the State Claims Agency does not have to be part of pursuing these women.

I return to my main issue. We know that last week, 1,482 cases were reviewed as part of CervicalCheck. We also know that there were issues with scans in 209 of those, of which 162 were not notified. We know that as a consequence, unfortunately, 17 women died. We now know that 100,621 cases from National Cancer Registry Ireland were not given to CervicalCheck. We now know from Tony O'Brien that this was known for years. I understand that National Cancer Registry Ireland has been writing to the Department for years. There are two critical questions that need to be answered immediately. We need to find out when the Department knew this and if or why it did not do anything. The real issue was if it was 14, 82, 209 and 17, when will we know the proportionality regarding the number of cases? I accept the number will be smaller because it probably involves older women, many of whom may not have been screened, although many of whom were. What proportion of women have been not told? What is the comparable figure to 2009 for these women? Unfortunately, women's lives were put at risk. It correlates. Women's lives were put at risk so the bottom line is the fact that National Cancer Registry Ireland, which I believe is a good organisation, requested or tried to transfer these cases to CervicalCheck and was unable to do so probably because of data protection rubbish. CervicalCheck was trying to get these cases from National Cancer Registry Ireland. A total of 1,621 cases were not part of the audit. As a consequence of that, we do not know how many of those cases had issues with the way in which they were surveyed and smeared and we also do not know how many of those cases jeopardised women's lives and potentially, women who passed away. Can I say this-----

Give the Minister a chance to respond.

For me, that is a scandal and I will not stop until we get to the bottom of why this information was not transferred. To be fair, I do not believe the Minister knew. Given what we know now, women's lives were put at risk and, we do not even know yet, some women may have died.

Could the Minister respond in as short a time as possible?

I get the impression that the Deputy is happy for us to come back on the other matters so I will get a note for the committee on e-health spending. We will ask the HSE to respond directly on the paediatric services in respect of electives and beds. In respect of the cervical screening issue, I will seek an urgent update from HIQA as to how soon the HTA for HPV for boys will be done. I have already answered about the HPV testing. I am as eager as the Deputy is to get that in quickly.

I heard some of the State Claims Agency's evidence to the Oireachtas Committee on Finance, Public Expenditure and Reform, and Taoiseach yesterday. I will listen to its evidence before the Committee of Public Accounts tomorrow. It seems that the State Claims Agency believed - and I have no reason to doubt it as I presume it is telling the truth because why would it not tell the truth? - that it had all been disclosed to women. The agency seemed to be as shocked as everybody else. I doubt that this is just confined to health. The idea of the State Claims Agency, which has delegated functions but is somewhat out there as an orbit, is something at which we need to look. I appreciate that the Deputy acknowledges that I did not know. I am with the Deputy that we should not rest until we establish this answer. If the Deputy's assertion is that it was known that National Cancer Registry Ireland could not transfer cases to CervicalCheck for many years-----

(Interruptions).

You are correct. Mr. O'Brien alluded to that today. We need to know how that was known, who knew it and why they did not do something. I have asked the Secretary General, and in fairness, he acknowledged it this morning, to examine whether there is any evidence in the Department that the Department knew going back a number of years. I will ask him to comment on that. The Deputy asked an important question when he asked what proportion of that number of women could have been audited. The indication I have been given from the strategic incident management team is that it is quite a small proportion. That does not make it right. However, many women, perhaps the overwhelming majority, may not have had a relevant screening history for a variety of reasons.

I accept that.

All of the cases, even the cases of women who do not have a screening history, will now go to the Royal College of Obstetricians and Gynaecologists for full clinical review. I will ask Mr. Breslin to talk about the Department and the work he will do.

Mr. Jim Breslin

We will complete the record check and be definitive regarding the information that is held in the Department. As I said earlier, we have conducted some preliminary inquiries with people involved. I do not have detailed information to give the Deputy. I do not have corroboration of what the Deputy is saying to me. If I do have it, I will place it in the public domain.

Tony O'Brien-----

Mr. Jim Breslin

The director general said it had been known over the years that this is not where the cancer information that CervicalCheck used for its audit came from. That is what he said.

Which means it did not transfer the information.

Mr. Jim Breslin

The Deputy has suggested that there was an issue that had arisen between National Cancer Registry Ireland and CervicalCheck and nothing was done about it. That is a separate question.

With the Department.

Mr. Jim Breslin

Absolutely. I will seek to try to establish that. Importantly, it is not in the same category as the 209 women.

I accept that. That does not make it right.

Mr. Jim Breslin

The cancer registry data is about women who have been diagnosed with cervical cancer. It runs down every last trail to try to establish that. It works with private hospitals, the Coroners Court and everywhere to try to get us the best population data possible. By definition, those cases that were with National Cancer Registry Ireland but were not with CervicalCheck were not audited. The core problem relating to this, on which Dr. Scally will have to put perspective, is the audit having taken place, the information not being disclosed to the women.

I accept that.

Mr. Jim Breslin

The question of National Cancer Registry Ireland data is completely separate.

But it still put women's lives at risk.

Mr. Jim Breslin

I do not understand that.

It is a scandal even if it is one woman, two women or ten women.

Mr. Jim Breslin

The Deputy will have to explain that to me further because I do not understand the sequence the Deputy is putting on that.

He has asked the question of me so I want to clarify. It is a request for me. I did not ask the question. It is very simple. In respect of National Cancer Registry Ireland, I think the Minister gave a figure of 1,621 cases. Of those, a large proportion probably got cancer directly and were not part of the screening process. There is also a proportion that was part of a screening process or some process through various other pathways and avenues. The fact that this information was not part of the audit meant that if there were issues, and proportionately we must work off the other set of figures, some of those women may have had issues relating to screening which as a consequence were not being picked in the subsequent audit and did not get interventions so their lives were put at risk.

Mr. Jim Breslin

I do not understand that. I am not being disingenuous. Those women were in treatment. The audit was not about prescribing them treatment. The audit was about examining whether something was missed in their screening history.

I know but we do not know if they were told about all of their issues at the time.

I understand the discrepancy. There will be clarity on it.

I have a few questions for all of the witnesses so will I put them all together?

The first few are for the Minister of State, Deputy Finian McGrath. I know we have spoken about waiting times for the assessment of need many times before but I am very concerned, particularly given the importance of early intervention.

In west Cork, people are currently waiting 23 months instead of the six months promised under the Disability Act 2005. I would like to hear the Minister of State's comments. I acknowledge the work that he plans to do in respect of respite, with extra houses being built, etc. Is there anything else he can do? There is a particular need for respite for people over 18 years of age who have special needs. I acknowledge the work done by carers and family members.

I had a question for the Minster of State, Deputy Jim Daly, on the fair deal scheme, but I will talk to him later about that. I agree with Mr. Sullivan's comments about front-line workers during Storm Emma. I also acknowledge, however, people like Dr. Jason van der Velde in west Cork. Has Mr. Sullivan heard of him? The "Jeep for Jason" fundraiser was organised by local people. It shows that there is a need for more front-line workers. If Mr. Sullivan is praising such workers, he might also mention the volunteers who helped during Storm Emma.

My final question is for the Minister. Many people, including GPs, are concerned about the practicalities of what will happen if the "Yes" vote is successful in the referendum. The health system is already stretched, as are GPs. Is it all going to happen in hospitals? Are there going to be clinics? Will the Minister confirm that he will be debating all of this with the "No" side? He committed to that before. When does he plan to do it?

I will start with that question. It is a stretch in terms of the remit of this committee but I am happy to answer it. I love debating this issue. It is an important issue and it is vital that we get the facts and the information out. There is no need - when I am in the middle of dealing with a cervical cancer scandal and trying to reassure women - for people to turn up with an empty podium outside Leinster House and ask where I am and why have I not turned up for the debate. People might be aware that there was quite a lot on last week. I had other priorities relating to women's healthcare, but I look forward to debating. Our national broadcaster has scheduled a number of debates over the next couple of weeks. I will take part in at least one of them, subject to being invited and that the broadcaster is happy I am not representing the "Yes" campaign. There are many people in many political parties and many civil society groups and campaigns. I very much welcome the opportunity to debate. I say this in all sincerity. The tone of the debates I have seen so far have been respectful and, hopefully, informative for people. I hope we continue in that vein.

The Deputy makes an important point on the issue of the GP service. If the people of Ireland vote "No", nothing changes. We understand that. If the people of Ireland vote "Yes", the Protection of Life During Pregnancy Act 2013 will remain the law of the land until new legislation is introduced. I have published the heads of a Bill as to what I propose putting to the Dáil. There will be a period during which my Department will engage with the Irish College of General Practitioners, ICGP, and the Institute of Obstetricians and Gynaecologists, as would normally be the case. Both of those institutions will draw up clinical guidelines. The Deputy and I have a different perspective on this. I respect that. I note that many GPs are also in favour of this issue. I know some are not but-----

It is all about the practicalities-----

-----whether people are for or against, I have no doubt that GPs will, as they and all in our health service have always done, abide by the law of the land. There will be conscientious objection. That is in the law and we will have plenty of time to engage with general practice and with the institute should the issue arise if there is a "Yes" vote.

I thank Deputy Murphy O'Mahony for her questions. Before I go into the assessment of needs and the respite care services, I want to be associated with what many of my colleagues said in respect of the poster put up outside the constituency office of the Minister. That was appalling and disgraceful behaviour and it does not have any part in any campaign. I offer my support to the Minister. From a personal and family point of view, what happened was totally out of order.

On the assessment of needs, as the Deputy correctly stated, there is a provision in this regard in the Disability Act 2005. We accept that the HSE figures show there has been a huge increase in the number of applications. I think it is in the region of 6,000. We accept that we are facing huge challenges in meeting the statutory timeframes. That is the reality. We have also come across very complex cases. We have, however, started acting in respect of the delays.

We are doing three major things. We are putting in place a comprehensive plan of individual measures in each community healthcare organisation, CHO, area. We are also putting in place a new standard operational procedure for the assessment of needs. That is being implemented and is ongoing. The objective is to improve the efficiency and operation of the assessment of needs process and the position with regard to compliance rates. On the broader issue, reconfiguration of the disability services is taking place as part of the progressing disability services for children and young people programme. We also have integrated teams that are operating well and the assessment of needs process runs more smoothly in that situation. Finally, because of the problems we are having, we are also carrying out a policy review of the assessment of needs process. I intend to report back to the committee in future on this issue. That to which I refer is something we have done in respect of this issue and I intend to focus on it the context of the Estimates for 2019.

On respite, as has been acknowledged, we managed to secure an extra €10 million. The work in this regard has already started. I opened a beautiful respite house beside the sea in Balbriggan last week. The staff there are great. In the context of the funding, €8 million will be used to provide nine new dedicated houses for respite in each community area. The remaining €2 million will be used for respite based on home-sharing and also for day options for respite services for people with special needs. We will also be adding the option of home support services for respite. Some families have told us that because of the high level of need experience by children or young adults with disabilities, rather than sending them, it is easier to have the respite care provided in their homes and then their family members take a break.

A wide variety of respite services are on offer. I thank the Minister for his great support on this. A couple of months ago, we listened to people, we talked to families and we accepted that there was a crisis in the context of respite. We had to get an additional €10 million to deal with that. The work has started. In the negotiations that will take place during the summer months and in the debate on the Estimates, it is essential that we deal with the issue of supporting children and adults with disabilities, whether in the context of the assessment of needs or the provision of quality services.

As regards broader disability services, we already have €1.772 billion going into social care services. We have seen massive increases in services. We accept, however, that we have a long way to go but we have started the process. Two years ago, I had three central objectives: first, to reform the services; second, to invest in the services; and, third - the new dimension and in line with the UN convention - to put people with disabilities at the centre of the services. That work has begun and we are gradually making progress.

I thank the Minister of State. Everybody is enthusiastic to contribute. I am trying to be as fair as possible. I invite Senator Dolan to speak and then, once his questions have been answered, I will call Senator Colm Burke.

I welcome the Minister for Health and the teams that are present. I have four questions. The first one is on the funding that organisations get. Many organisations are almost 100% funded. My point is that a culture can develop of "We are paying you and we own you". That is putting it very bluntly. I thank the Minister for his earlier reply. I asked a question about the protocols and steps that are in place within in the HSE to mitigate the risk of that to which I refer happening. Is there full governance respect for organisations with which the HSE has service level agreements?

The reply set out many of the things relating to legal contracts and the Department of Public Expenditure and Reform statement and circular. I do not get a reassurance or a sense that the response has struggled with the question of what protocols are in place to protect against that happening. I will leave it at that. However, I am in close contact with the organisations and I know that when they read this, they will not feel reassured by it. They will say that they know there are service level agreements and so forth but that is about compliance and the sense that there is a lived respect for the autonomy of the organisations. As charities, they are public benefit organisations and they are first cousins to their public sector counterparts. However, the attitude is, "Look, you are getting the money from us and whatever". It is a quandary but I would like the Minister and his Department to respond further on this.

My next question relates to employment retention. I am very annoyed about this and about the section 38 and section 39 organisations. The Department and the HSE knew about this issue well over a year ago when the organisations were trotting to the Workplace Relations Commission one by one. Union representatives were there sitting beside the employers and the question being asked was, "Where is the money?". There is an issue, and on some occasions the HSE was dragged into some of those discussions. I raised this matter a year ago at this committee and I also raised it in the Seanad with the Minister for Public Expenditure and Reform, Deputy Donohoe, at the same time. Last January, we received confirmation that an exercise was being undertaken by the HSE with a number of the organisations. What is the current position and will there soon be a satisfactory solution? The only figure I have been given is that 50 of the grant-aided organisations are involved. A questionnaire was sent out to the organisations and it was to be returned by the end of March, which is six weeks ago. What is happening now? When will the exercise be concluded?

The core issue is that I can name two organisations, one a section 38 organisation and one a section 39 organisation, that are working in the same county and with the same client group. As regards section 38 organisations being different from section 39 organisations, they are in the way they are constructed under the Act but it is very hard to see a difference in the way they are providing services and support. One of the organisations I mentioned is now acting as a cheap recruiter and trainer for the other and the staff are being churned and moved around. This must be resolved. I am getting a strong sense of it being put on the long finger and I am not happy about that.

My next question relates to personal assistance. The Minister of State, Deputy Finian McGrath, and I have had the abacus out on a number of occasions to break down the hours and so forth. The HSE is clearly stating what was a matter of fact - from the figures it had in any event - which is that the average number of hours per week is less than 12. That is an average of one hour and 42 minutes per day. The definition we have been given is that the role of the personal assistant is to assist an individual with a disability to maximise his or her independence through supporting him or her to live in an integrated setting and to access community facilities.

I ask the Senator to concentrate on the time.

I am on my third of four questions.

Yes, but we need to have the answers as well within the seven minutes.

Go raibh maith agat. The definition being used in 2016 was that it was to enable the person to live an independent life. How in the name of God can the Minister of State deliver on that definition, even if he calls it in-home support, if the person is getting an average of less than two hours per day? It is impossible. It is not personal assistance and it is a lie to present it as such. Some 2,000 of the 2,500 are getting less than an average of 20 hours per week. For God's sake, call a spade and spade, go back to the drawing board and develop a personal assistance. How many people are on the waiting list?

My final question relates to regulatory compliance. I will be brief. There have been some increases in funding, but they are modest in terms of what needs to happen. The Minister admits this. The Charities Act, HIQA and a range of other things, none of them to be decried, were put in place during the recession, which is interesting. However, there has been no extra funding. Along with taking cuts, organisations were told to ensure that services were not reduced. They were told that they must hold the line. The Department made a cut of 5% in 2010 and told the organisations to get on with it and maintain the same level of services. That is a fact. Increased compliance has been shoved in there as well, which is another bubble. There is no acknowledgement of that in terms of the reasonable costs that are involved in it.

I accept that the Minister and others will not have time to respond fully on my questions, but I would like to have further engagement on this.

I will deal with the personal assistance hours. First, I accept that Senator Dolan has a strong point but it is important to recognise the reality that approximately 2,500 people are getting personal assistance hours.

My point is that they are not getting personal assistance.

The aim is to maximise the independence of the person with a disability. It works out at 1.46 million hours per year for services. On the question of the 12 hours, that is an issue. The Senator is correct that the average is 12 hours per week. However, I know many people with physical disabilities who are getting more than 12 hours per week. However, the HSE figure is the average, which is 12 hours per week. I am trying to increase this.

There are 67 getting 40 hours per week.

There are 1.46 million hours this year. There has been an increase in the disability budget. Incidentally, it is wrong to say that organisations did not get an increase in money this year-----

I did not say that. I said the increase was modest.

Many of the organisations that approached me seeking extra funding got the extra funding. Some of them received increases of €5 million to €10 million in their budgets, so it is wrong to say that.

For the record, Chairman, I did not say that.

The overall spending for disability services has increased and, as I said earlier, my ambition is to increase and develop it further. To return to the point about the personal assistance hours, we got 1.46 million hours, which is an extra 100,000 hours on last year. Do I want more? Yes. Will is try for more in the negotiations? Absolutely. I believe in the independence of a person with a disability and I believe that person should be supported as much as possible in the community. That is my vision and my plan. However, it is a step-by-step approach and I will do my best for those people.

On the section 38 and section 39 organisations, the opening point made by Senator Dolan about the relationship between the State and the voluntary sector is very important. He will recall that I established the Dr. Catherine Day group, which is doing very good work. Dr. Day is very eminent in her understanding of governance structures and the like, and she is ably assisted by Professor Jane Grimson and Professor Deirdre Madden. I expect the group to report this year. It will give us an interesting roadmap for what the relationship should be between the voluntary sector and the State sector in terms of health and social care services in the 21st century. I am looking forward to receiving that body of work.

The Senator does not need me to use up time explaining the difference between section 38 and section 39 organisations. He understands it very well.

We have put in place a process to develop a deeper understanding of the funding position of these grant-aided organisations. The HSE has been asked to engage with section 39 organisations to establish in the first instance the facts regarding what cuts were applied and how and when they were implemented. They are not all the same; that is the challenge. Representatives of section 39 organisations will tell one different things. Some will say they made the cuts from their own resources while others will say they did not. Some have very genuine and real challenges with recruitment and retention in a more competitive employment market. We are expecting an interim report from the HSE very shortly. This will inform the Government's thinking and possible solutions.

Before the summer?

Yes, before the summer.

Mr. O'Sullivan referred to the anomaly scans and the extra people employed in that area. I wish to flag with him that I have been made aware that medical consultants in the smaller units are being advised they will not be given an opportunity to look at the scans before they are sent to the central unit for review. I am talking about the smaller maternity units around the country. The consultants are expressing concern that although their names are on top of the charts, they will not have the opportunity to review the scans. They are now asking that their names be removed from the charts. Even though the patients are assigned to the consultants, the consultants are not being given the opportunity to review the scans before they go to the central unit. Will that issue be dealt with? The delegates might not be aware of it but it is an issue in the smaller maternity units around the country that are joined to bigger maternity units that are in charge of rolling out the system for the anomaly scans. The consultants want to be involved but they are being excluded from the process, yet their names are on top of the patients' charts.

My second issue, concerning the State Claims Agency and claims, follows on from the issue raised by Deputy Alan Kelly. I understand that, without legislation, the State Claims Agency could reach a solution in regard to some claims but still step into the shoes of the claimant and go after the company that represents the laboratory. Might that be addressed? Deputy Kelly raised a very valid issue in this regard. I am not clear that it requires a change to legislation as there may be a process available already.

The third issue I want to raise concerns consultant recruitment. It is a significant issue concerning planning. In the reply to a question I tabled on the number of consultants in place, the number of vacancies and the need for planning, I was advised that approximately 59 consultants are expected to retire over the next 12 months. That is an underestimate. I am saying that because, if there are 2,930 consultants and the average consultant stays in the system for around 20 years, and even if there is a 5% reduction every year, 146 will retire naturally every year. I am wondering about the planning process. It is very difficult to get consultants and we are not advertising many positions until they become vacant. I have raised this consistently over the past three to four years in respect of planning. The HSE's estimate that 59 will retire is an underestimate, and we are not on top of this issue. For a recent obstetrics and gynaecology position advertised in Portiuncula Hospital, there was no applicant. Therefore, we really need to plan. We are not doing enough. The estimate of 59 is wrong. An average of 150 will retire every year. We need to fast-track the process to address this because services will fall down unless we are able to plan.

The other issue regarding consultant contracts concerns the terms being offered. We are now competing with all the other jurisdictions not only in regard to what we are offering, but also in regard to a tax system. In the United Kingdom, for instance, one can earn up to £45,000 before being taxed at the higher rate. In Ireland, the figure is between €34,000 and €35,000. Therefore, one is competing with other jurisdictions on different issues. We need to be conscious of that aspect.

The only other issue I want to raise concerns the GP contract negotiations and whether we have now started the process in regard to them. Have we set targets for making some progress on this matter? In fairness to GPs, they are now stepping into the breach and providing considerable backup support in regard to the cervical screening process. We need them on board. I am wondering how fast we can expedite this issue.

I will start and Mr. O'Sullivan might take questions that relate to the HSE.

On the State Claims Agency issue, the point the Senator makes is exactly the sort of point we need to be teasing through. The Taoiseach has asked the Attorney General to do a body of work on this. It is a question of how we can get ourselves to a position whereby liability rests in the correct place legally and the State does not end up in an adversarial position in relation to women in this country. We do not want to be in that position. That is what the Government is teasing its way through.

With regard to the GP contract, engagement has commenced. I have said on a number of occasions, and must state again, that I do not intend to provide a running commentary on this, although I am not suggesting the Senator is asking me for one. We would be the worst negotiators in the history of the State if we were to give one. There are many millions of euro extra that the Government wants to spend in general practice that I have agreed with the Minister for Finance, Deputy Paschal Donohoe, and the Taoiseach. We would like to commence some of the additional expenditure this year and we would like to increase significantly the expenditure for 2019, 2020 and 2021. The Senator knows the issues that need to be examined are manifold. I know that from the perspective of those in general practice, it involves the issue of FEMPI. I heard that very loudly and clearly at the IMO conference. I heard it from the National Association of General Practitioners also. The engagement is under way very actively.

With regard to the timeframe, I do not wish to state one publicly because that weakens the hand of those in the room acting on behalf of the State but we are very eager to make progress very quickly. Rather than having the long processes of the past that were not backed up with resources — I concede this was a cause of frustration for GPs — I believe having a period of really intensive engagement on both sides could yield the result that would be to the satisfaction of patients and doctors.

I believe the rest of the questions were for the HSE.

Mr. Dean Sullivan

There was a couple of questions for us. I will ask Mr. McGrane to address the issue of the anomaly scans and the associated governance arrangements.

On the consultant recruitment issue, which the Senator is raising again, I can see he did the mental arithmetic. There is a workforce of 3,000 and one can see the estimate of 59 looks low given the average career span of a consultant. I will certainly follow that up with colleagues after today. What I would say, however, is that there will not be an exact science whereby X divided by Y equals Z; it will be a question of considering individual consultants who are coming to the end of their working lives.

Mr. O'Sullivan might obtain the average number who have retired over the past three years, for instance. I guarantee him that the number is far higher than 59.

Mr. Dean Sullivan

We will both be looking at that together then, and we will see what the numbers indicate. We will certainly aim to get information back to the Senator quickly if it is any different from what he has been advised in terms of the retirement number of 59.

The Senator's point on recognising the importance of predicting and planning for retirements is well made. That takes us back to the discussion we were having earlier on recruitment processes and the centrality of Professor Murray's rule in terms of trying to speed things up a little. If we know a post is going to become vacant because of a retirement on date X, we really should be working backwards from that to ensure the gap is a small as possible. That is related to, but different from, the workforce planning issue. Clearly, we can fill posts from within the local workforce. In that regard, we need to have coming off the training conveyor belt enough new registrars to become consultants and so on. We also need to try to fish in other ponds. The Senator highlighted some of the challenges in that regard. We will examine the retirement numbers and share them with the Senator. We will double-check them as quickly as possible.

I have a question for the Minister on the GP contract. I declare that I am a GP. I have spoken to the Minister about this on many occasions and do not expect him to negotiate the GP contract on the floor of the health committee.

I will provide the legal advice.

We have a GP, a Minister and a legal adviser.

Yesterday I met with eight trainee GPs who are about to graduate this summer. If the contract negotiations are about adding extra money or services to the existing contract, none of those GPs is going to sign it. It is not about the money, it is about the conditions of service, and I think that is the critical point when the Minister is engaging with the organisations. Of course money is important, as is unwinding the Financial Emergency Measures in the Public Interest Acts, FEMPI, but the conditions of the contract are critical to attracting new GPs into the service. I wished to piggy-back on Senator Burke's comments in that regard.

I appreciate the Chair saying that on the record of this committee, because I think it is really important. I wish to reassure him that from the State's perspective, the GP contract negotiations will be what I have described as Sláintecare-friendly, and aimed at recognising that we need GPs to work in what will be a radically different health service.

I raised the anomaly scan issue.

Mr. Kilian McGrane

There are two elements to Senator Burke's question. If a woman is identified with an anomaly, then she needs or may need foetal medicine expertise. That may or may not be available in one of the smaller units. If not, there is a referral to a tertiary unit where that expertise or a consultation can be provided, in which case there is no transfer of care for the woman from the smaller unit to the larger unit. In the event that the anomaly is severe and she needs tertiary level expertise, then there may be a transfer. If that happens, the care should absolutely be transferred from the local unit to the senior unit.

That is not the issue. The issue is that when the anomaly scan is done, the consultants in the smaller units are being advised that they will not have an opportunity to look at those scans. They will be sent to the main unit on day one. They are concerned that issues which they could deal without sending on with may be missed. That is the concern that they have.

Mr. Kilian McGrane

Senator Burke might approach me on that offline, and I will come back to him with answers to the specific queries he has raised.

I wish to follow on from Senator Burke's comments. My understanding is that in Portiuncula there is no proper 3-D scanning unit, or whatever it is called. I refer to the fancy scan a woman gets at 20 or 22 weeks. About a year ago this committee heard from Professor Louise Kenny from University College Cork. She outlined that the anomalies pop up in the population group where one would not expect them. From memory, I think she said they emerge at a rate of about one a week. Conditions that one would not associate with a 28-year-old mother, for example, happen at about that rate. There is no way of detecting them if there are no machines to do so. Do the witnesses get what I am saying? I would like to make that point. If a woman is never scanned, she will never know, and it is only when the baby starts coming out that the doctor realises the problem.

While I am commenting on Portiuncula, I note that the report is shocking. I am not too shocked by it, because I know of a number of cases in that part of the country. I would like to ask whoever is in charge, perhaps Mr. Sullivan at this moment, if they would be happy for any member of their family to have a baby in Portiuncula hospital. The impact of catastrophic events at birth extend a long way beyond the impact on the baby. There tends to be an emergency section. There tend not to be ideal circumstances for a section to be carried out. It tends to be a large section; it tends to have repercussions when it comes to women's health thereafter, including both forms of incontinence, adhesions, and impacts on people's personal lives, sex lives and relationships. I have not read the report yet because I have been too busy with other things. However, I have heard statements here this morning. Looking at it as a woman who has been engaged in the maternity services for the last ten years, I am concerned about any babies being born under these circumstances and any woman presenting themselves. I wonder if Mr. Sullivan or whoever would be happy for somebody belonging to them to be born there.

I know that Mr. O'Brien has left now, but when he came before the committee he mentioned difficulties with one person being at the head of the service. I do not want to misquote him. He did not think it was possible, or thought that people would not apply for the job. My understanding is that Mr. O'Brien has been in that job for six years. I am wondering if the Department has any correspondence from Mr. O'Brien, or if anybody has such correspondence, where he indicated that he did not think it was possible for one person to do the job. It seems to me that we heard that today, in light of all that has come out, but he did apply for a job that he deemed himself qualified for. Somebody gave him the job. I do not want to misquote him, and we can go back and check the record. However, what I took from what he said was that this is too big a job for one person. When he referred to what a big job it is for one person, was he referring to the management of the organisational structure of the HSE, or is he talking about the population it is in charge of? I would like to remind Mr. Sullivan that the population of Ireland is comparable with that of Manchester. How could anyone say that it is too big to manage when it happens in other countries? I am quite concerned about those statements this morning, in light of Mr. O'Brien's six years in the job. If someone came into a job said that it was too much after six months, I could understand it. However, it seems a bit confusing at this point in the conversation.

I wish to return to the issue of open disclosure, with reference to the cervical screening situation. Mr. O'Brien referred to the open disclosure practice of the HSE non-clinical staff. Is there any letter or any record of any non-clinical staff member being told that open disclosure would apply to them? Regarding the health administrator role being subject to regulation, which I spoke about in my first contribution, has this just started today, or is it in train? I refer to health administrators or whatever we want to call them, non-clinical people who are in a position of authority. Is it envisaged that the regulation would be on a statutory footing? Doctors very much do not like going in front of the Medical Council. It tends to be quite complex and can be very difficult for people. If we are going to make people accountable, are they actually going to be properly accountable? Will it be on a statutory footing, and will it have real teeth?

Regarding the terms of reference, I refer to part f. I went through these in detail last night. Term f. seems to have an awful lot of stuff shoved into one term of reference. It deals with tendering, contracting, operation, conflict of interest arrangements, performance information, performance management, accreditation and quality assurance. An awful lot seems to be contained in term f. To me, it is really important going forward, as opposed to looking back, that the data we are getting back from places is of value to us when we are studying our population data.

Finally I wish to raise the plan for human papillomavirus, HPV, testing that the HSE already had before this happened. Will the HSE now look at the HPV plan with a new lens in light of what has happened? Are we now looking at a new way of going about this, and when will we have a picture of what sort of plan that will be?

On the topic of Portiuncula, from my reading of the report I would firstly sympathise with the families who have been tragically impacted by this, many of whom I have heard comment in the media, and all of whom I know were offered briefings in relation to this piece of work, to look into what went wrong in Portiuncula. I think it is important to say, however, for women who may be using our maternity services today, that objectively a lot has changed since then. I welcome the fact that the Chair might do a separate engagement on this, because there is a lot that we could discuss. If one looks at the number of consultants, non-consultant hospital doctors, NCHDs, nurses, or midwives in Portiuncula, one sees they have all significantly increased. There was no director of midwifery, assistant director of midwifery or national maternity strategy. There now is. That is not to suggest in any manner or means that the job is done. Deputy O'Connell knows the area of our national maternity strategy very well. However, I would point out that a lot of the recommendations made in the Portiuncula report are already very much under way.

I took some assurance that from a great tragedy, and a failure, very positive, concrete actions were taken.

I am not going to speak for the director general or offer an interpretation of what he said today. I believe the way the HSE was established was not appropriate. It seems that is acknowledged by everybody in these Houses now, and by most people in the HSE. What are we going to do to fix it? If we bring forward the HSE board legislation next week, it will be a start. We then need to move as quickly as possible to the roadmap for these regional integrated structures, or whatever they will be called. We need to see the community health organisations and the hospital groups working together. There has to be a couple of them around the country, with the country divided up into several areas which have local accountability and devolved structures. That is where we need to get to, and I expect to be in a position to bring that roadmap to Government this year so that we can actually map it out.

On the issue of accountability, I have heard it from many people - Ms Róisín Molloy has said it to me previously - that if something goes wrong in the health service, the doctor is accountable to the Medical Council. Nurses are accountable at the Nursing and Midwifery Board of Ireland, NMBI, but to whom is the manager accountable? Accountability does not mean that heads must roll, but it means professional development and regulatory structures. I believe that many people working in the HSE would welcome that, but how that is legislated for is something with which we will have to grapple. I started a piece of work on this issue a couple of weeks ago, before the latest CervicalCheck situation arose. I know that this committee is very busy, but I would welcome any input it might have as to what accountability legislation looks like. I am aware that the Sláintecare report calls for it to be implemented, as do I, but what does it actually look like? How would it actually work?

Term F is extensive, but it can be summed up by saying that it is about the laboratories. It addresses the entirety of the laboratory issue, from the decision to outsource to how they work now and how they will work in the future, and their accreditation. It is important that it is there.

On HPV testing, it has been said to me and in public that the women of Ireland need to see not just that we have responded to a terrible situation and are trying to deal with it, but that we have gone above and beyond that by saying that women in this country were let down and making clear the steps we are taking to ensure not just that they will not be let down again, but also to make sure that the health services are improved. HPV testing is a real way of doing this as it would provide more accurate tests and a reduced requirement for smear tests. Ireland would be one of the first countries to move in this direction. I do not want to make any commitments that I cannot stand by, but at the moment I am told that HPV testing will be introduced in October. I will scrutinise that further and revert to the committee.

I will refer to some items already raised but look at different aspects of those issues. How committed to open disclosure are people working the system? What is the immediate reaction when something goes wrong? I recognise that there must be a "for and against" aspect to this; all parties are entitled to defend their views and do not have to automatically capitulate. However, an alarm bell must sound somewhere if the same issue arises on more than one occasion at the same location. How long do we wait before the alarm goes off and someone decides that the issue has to be looked at immediately?

On the question of the combative nature of the system in this country, why is it necessary to fall into legal combat? It puts a distance between the two sides and puts them on notice. Is it not possible to investigate individual situations with a view to finding out whether there is substance to the case or not and come to a conclusion? In the event that there is clear evidence of negligence, surely there should be a system where an offer is made, or some ex gratia payment offered in recognition of the suffering the patient went through, with a view to short circuiting the case.

On the Portiuncula Hospital report mentioned by my colleague, how was the system activated? We have a report because there was a series of events that were not in accordance with what we expected. Was the system activated at some point down the road? Why did we have to wait? Why was it not possible, in the interests of public health and safety, to put measures in place to investigate thoroughly the issues that arose in the initial stages? If more than two, three or four cases began emerging from the same location, I would become very suspicious.

I am not just referring to this because it is a current news story, but over the years various procedures carried out on women in maternity hospitals, and in some general hospitals, were peculiar. A series of events happened in rather strange circumstances which would lead me to ask why certain practices were continued. They have since been discontinued, thankfully. These practices were appalling and went on for many years without being checked. I cannot understand why they occurred. Notwithstanding all that has happened, and the lack of accountability for the various scandals that have taken place, can we rest assured now that there are provisions in place which mean that we do not have to wait for an inquiry before it dawns on someone that something must be done about a particular issue?

Mr. Kilian McGrane

In Portiuncula, a number of babies were referred for cooling. It was picked up within the Saolta hospital group towards the end of 2014 after six babies had been referred. It is very hard to know, considering international evidence, what is the tipping point. The Deputy has made very valid points. We were here in February and spoke about the need to implement serious incident management forums for maternity services only. Had they been in place in the Saolta hospital group at the time, there is a very good chance that some of these issues would have been picked up earlier. There was a comprehensive review carried out by Saolta long before Professor Walker's report was commenced. It identified almost all of the issues, and Professor Walker's report confirms that point. Most of those things have been implemented at this stage or are in the process of being implemented.

The core point the Deputy is making is absolutely valid. We need specific focus on maternity services in terms of incident reviews, but the broader issue is the governance of maternity services, which involves the maternity networks. We are absolutely committed to achieving that. It is being progressed in the Saolta group, which is moving from what it currently has to what it is describing as clinical business units. It is the same concept; a clinically managed network that ensures that the smaller units do not operate in isolation but rather work in collaboration with the bigger units. One of the developments Saolta has come up with is the creation of an integrated unit between the site at University Hospital Galway and the Ballinasloe site. On Deputy O'Connell's point about the safety of the unit, safety is one of the core elements. Professor Walker was at pains last week to stress that developments on the Portiucula site are significantly different, and that for normal risk women - I appreciate that it is very hard to define a normal risk woman - Portiuncula is appropriate and safe. Professor Walker appeared before the committee last week. We have done many of the things we needed to do in the last period.

The core point made is very valid about how we trigger something before it becomes a major issue. We have the tools available to us, and we need to make sure they are fully implemented.

Mr. Dean Sullivan

I want to build on Mr. McGrane's contribution, and return to Deputy O'Connell's earlier point around structures and the comments the director general has made. Ireland is a relatively small country of 5 million people, which is equivalent to Manchester in England. It is apparent, within Ireland and other jurisdictions, that the idea that a set of measures or indicators can be put in place from the centre that will wave a red flag to tell us when something has gone passed tipping point at a particular service or particular site is bonkers.

No one in the world has designed anything like that. The only way of getting to the place to which we would all like to get, where we minimise levels of risk - one can never eliminate risk as this is a human-delivered service - where staff at the front line are empowered to manage the service and where appropriate governance arrangements are in place at the front line is to have a culture that encourages the sharing of issues when they occur at a local level, that learns from them at a local level and that, as appropriate, escalates them through systematised arrangements to national level where there is national learning to be had. We are on a journey in this regard, and it is the same journey that many other countries are on.

Regarding the issue of medical negligence and so on, I will be very brief but I just wish to make the point that we have taken a number of steps as an Oireachtas and a Government in recent years, the Mediation Act being one such example, whereby there are now tools at the disposal of the State that do not involve bringing a woman, or indeed any other person, who has been through an issue of medical negligence or upset or trauma in our health service to the courts. I know the State Claims Agency has spoken about this already, but it is a tool at its disposal. Whether we need, as we have, a Personal Injuries Assessment Board, a medical injuries assessment board or something similar to move such cases completely out of the courts is something that warrants significant consideration as well. We need to find a system that is less adversarial in getting to the bottom of these things. Open disclosure helps, absolutely, but even after open disclosure there needs to be a mechanism to try to provide people with supports or financial compensation.

I do not wish to delay proceedings but I just want to say one thing. I deal with a good number of queries, like every other Member of the Oireachtas, I am sure, that allege medical negligence. I have come across quite a number of such cases in which nothing ever happened, despite the fact that an incident took place and there was clearly a need to address the issues concerned. I dealt with one case not so long ago in which a member of another profession became hysterical when I probed why the matter was not progressing because there needed to be a response, not in five or ten years' time, but soon.

I thank Deputy Durkan.

I must move on to Senator Mullen. I am sorry-----

I wish to comment on something Mr. Sullivan said in reply about the red flag. This is important. Is he telling me that in Portiuncula Hospital there is no system to the effect that there are data every year that show, say, 100 babies born, five gone for cooling, three mammies dead and five babies dead. Are there no such data annually to flag issues? This seems fairly basic.

Mr. Dean Sullivan

No, that is absolutely not what I am saying. I refer back to the comments the director general made earlier and what he meant when he spoke about the challenge of one person trying to do things with the structures that exist within the HSE at present. What I am saying is that at the centre, one is trying to run effectively 17 provider organisations, and a health business service, and a screening service - and, and, and. This is not a model that is set up to be particularly effective. It is just too broad a scope. The point I was making is that one needs layers to all of this. There is a level of scrutiny that clinical teams within the maternity networks that are putting it in place will have, really drilling down into the detail and the things that will set off warning bells for them. The further up, the more we rely on the cascading upwards of issues and learning. That is the point I was making, not that there cannot be appropriate flags and signals. What we cannot do right at the very top of the organisation is have all of that coming in because we would drown and it would just be a lot of noise. It must then be pushed into the system in order that the professionals on the front line, supported by managers, look at these data on an ongoing basis.

The common structure is not conducive to-----

I am sorry, Deputy, but we will have to move on because we are running out of time.

Mr. Dean Sullivan

That is all right. That is fair.

I wish to return to the CervicalCheck scandal and then I have two questions on abortion prompted by the Minister's comments. To go back to the issue of mandatory disclosure first, I was particularly impressed by an article by Pat Leahy in The Irish Times last week, which the Minister may have seen, in which Mr. Leahy gives some deserved criticism of us all as a political class about the failure to face down establishment opposition to mandatory disclosure, whose time seems to have arrived as an idea. One person I know who has direct experience of the problems surrounding mandatory disclosure says not disclosing information about one's institutional or personal professional failing is like driving away from the scene of an accident. Has the Minister formally, intellectually and politically committed to mandatory disclosure? If so, when did he mentally and publicly commit to it first? If I am on the right track about the change in thinking, if it is a good idea now, why was it not a good idea before now?

Regarding the issue of abortion, the posters and what the Minister himself said, I have always opposed the public use of graphic images of abortion because it is disrespectful to the dignity of the unborn child whose death is so graphically depicted for one thing and, second, I worry about its impact on children and other vulnerable people. However, I would like a precise answer to this question: does the Minister not think there is something of a disconnect or double standard if, on the one hand, there is outrage on one's own behalf or other people's behalf about such graphic images and, on the other, a lack of empathy towards the child whose death is depicted, however graphically? I am just asking the question.

I wondered why the Minister appeared to laugh at Deputy Murphy O'Mahony's question about what debates he will do and when. I would have thought it is part of his ministerial stewardship and his duty, if he is leading the Government's campaign to make a very significant change to our law on a life-or-death issue which will have far-reaching effects, to be out there publicly. I know he is a busy man, but he has quite a phalanx of people, including party-political people and civil servants, behind him to help him do his job. I would have thought it is very legitimate to ask him the precise detail of what he will debate and when. There is a tendency across Government to use press releases, press conferences and other situations whereby Ministers and powerful political people are unchallenged. He has been out very little on the abortion question in any circumstance in which people can respectfully challenge him. Frankly, there are big questions, and Deputy Murphy O'Mahony is right to ask about GPs. The Minister is proposing a far-reaching law providing for abortion up to 12 weeks gestation on demand and up to six months gestation effectively on demand because that is how it works in Britain, where abortion is available on a mental health ground. GPs do not have scanning equipment. People are entitled to know whether we are looking at a future in which abortion clinics will be established in this country. Regardless of what side of the issue he is on, does the Minister not think he has a duty to be out debating this issue soon, often and in circumstances in which he can be respectfully challenged on detail? What we are not getting is detail on what will happen if people repeal the eighth amendment and give politicians full power to legalise abortion. I agree with his empathy for women in crisis pregnancy. I am asking him why I neither see nor hear any empathy for the children who will be aborted if our law changes. Very specifically, I am asking him for detail as to when he will debate this issue respectfully, one on one or in circumstances in which he can be challenged honestly, and how many times he will debate. He is no doubt talking to his advisers about when he will debate these matters, so we are entitled to some detail.

To be very clear, the reason I laughed was that I recalled the image last week, in the middle of a cervical cancer scandal, when we were trying to reassure women about their own health, a responsibility with which I, as Minister for Health, was charged, of a photo shoot outside Leinster House with a podium with my name on it asking where I was. I think it was very evident to pretty much every citizen in this country exactly where I was. I will debate. This has become a straw man argument. Debates will be decided not by the No campaign or the Yes campaign, certainly not by Senator Mullen or me, but by broadcasters. They have a number of debates scheduled, I believe, and I hope to be invited to participate in one. If I am invited to participate in one, I will be there. I think the Senator has known me long enough to know, whether he agrees or disagrees with my views on issues, that I do not shy away from articulating them, or indeed from having-----

I do not know. The jury is out on this one. We have not heard from the Minister yet. It is not just broadcasters who decide, by the way.

There has not been any-----

The Government solicits coverage for issues, sometimes at taxpayers' expense, as we all know from the recent debate. It is not just broadcasters who decide.

The other issue is that the Senator said I am heading up the Government campaign. To be very clear - and I do not mean to be pedantic - obviously, there is no Government campaign because that would be illegal.

There is a proposition-----

No. The spending of money would be illegal.

There is no-----

There could well be a Government campaign, and there certainly is.

Senator, please, give the Minister an opportunity to respond.

This is the way the debate is going to go.

The Minister is wrong on facts.

It will not inform anybody if every time I say a few words-----

It is respectful challenge. That is all.

I did not interrupt the Senator. I am a proponent of the changes. I passionately believe we need to repeal the eighth amendment but so, too, does the leader and the health spokesperson of Sinn Féin, the leader and the health spokesperson of Fianna Fáil, the leader and the health spokesperson of Labour, Deputy Coppinger, my colleagues here, Deputy O'Connell and Deputy Durkan, and, if I am not misquoting her, Senator Conway-Walsh. Many people in the political establishment believe it. Politicians have a role to participate in that debate. I am one of them. Also, civil society - women, doctors and lawyers - all have a role. I am not speaking for the Yes campaign but we will not be dictated to by the No campaign as to who speaks for us. We will put forward people to best articulate the reason we believe we need to repeal the eighth amendment. I do not believe there is any disconnect whatsoever. I did not quite hear Senator Mullen condemn the use of those posters but I believe he does, and I respect the fact that he does not-----

I will tell the Minister what I said. I have always disapproved of such posters but I am asking him if there is a disconnect between disapproving of the posters and being in favour of the killing of children in that way.

The phraseology "killing of children" really is-----

Is that not what happens?

It is in your opinion, but not in-----

Senator Mullen, I understand the issue was brought up-----

The Senator's is one view.

-----but the issue is not substantive to this meeting-----

-----which is to review the health service.

There is nobody-----

With respect, Chairman, I would have thought it is part of the Minister's brief to give an account of his stewardship, including the Government's participation in campaigns to change the law. However, I am happy to leave it at that. I would like an answer to the question about the precise debates that will happen, and also to my question about mandatory disclosure. I am conscious that other members want to come in.

On the issue of debates, we are not scheduling one here and now. This is the Oireachtas health committee, but I look forward to debating and participating fully in the campaign.

I completely disassociate myself from the Senator's language regarding killing babies. This is about accepting a reality that Irish women face. Nine women will leave our country today to have a termination. At least three will take the abortion pill today. I am not willing to ignore those realities. I have heard from doctors. I have heard from the Institute of Obstetricians and Gynaecologists, which has a position on this issue. It believes the eighth amendment needs to be repealed.

Dr. Mary Holohan has a position too.

That is what I believe as well. I will campaign vigorously with colleagues on a cross-party basis and with civil society to bring that about. I hope those who disagree with my position will also campaign and put their views forward but will not put pictures of miscarried babies with my image around my office and near my house with a view to intimidating and upsetting my family, my friends and my constituents.

We are in agreement about those pictures, but I would have to say that miscarried babies suggests an element of denial.

Sorry, Senator, but I have to wind down that section of the questioning.

Regarding mandatory open disclosure, my understanding is that it is a commitment in the programme for Government. I have always been in support of mandatory disclosure since becoming Minister for Health and taking up this responsibility. I would have publicly communicated that to Deputy Clare Daly last November, but the suite of measures was always to give a legal underpinning to voluntary open disclosure, through the Civil Liability (Amendment) Act, to the Minister for Justice and Equality and follow on with a patient safety Bill with mandatory open disclosure. It is fair to say, and there is no denying this, that there has been a momentum to get this law in place-----

Is it not a pity that it takes that?

It is fair criticism of the political system as a whole that this has not been in place before now. I will work with the Senator and everybody else to try to get this law passed as quickly as possible.

I thank the three visitors to the committee for their patience. I will call them in the following order: Deputy Ruth Coppinger, Senator Rose Conway-Walsh and Deputy David Cullinane.

It is getting very late and I am sure the people from the Health Service Executive, HSE, must be very tired after almost four hours. I have two brief questions and one substantive one; I will try to rush them. The first one is on scoliosis, about which there was a good deal of publicity recently but which appears to have fallen off the agenda. I know many families personally affected by this issue and I want the witnesses to clarify the four-month target in terms of a waiting list. Where is that? How are the plans going to recruit three additional surgeons - two in Crumlin and one in Temple Street hospitals - because from what I am hearing, the waiting lists are still extremely long?

The second question is on the issue of the legislation post the referendum, if it is passed, and this other issue that has arisen. I agree that the Minister and the Department of Health should answer misinformation if it is in the public domain. I have said that previously. That does not involve spending money. It involves the Department of Health answering basic questions. We need basic biology lessons for a number of people about the abilities of foetuses and otherwise to speak and what they can do, what is proposed in the legislation and what 92% of abortions would actually look like at six months gestation, which is not what is being displayed on poles. Approximately 0.1% of abortions that took place in Britain last year are being presented as the common, everyday abortion. I urge the Department to intervene because these notions that are going around are very dangerous.

Lastly, on the broader issue of cervical cancer and also Portiuncula Hospital, one would not have to be too bright to notice that there is a pattern in this State of women and women's health not being taken very seriously. We have the hepatitis C issue, the Savita Halappanavar case and many other examples. I wonder if the HSE or the Government intend to look into the reason that is the case. I have my own ideas about the history of misogyny in this country but, internationally, is the HSE aware of gender bias in the delivery of health care? There have been many studies done on that, for example, a study called The Gender Pain Gap by Crook and Tunks. They studied accident and emergency departments when women and men attended reporting roughly similar levels of pain and found that men were treated within 49 minutes and women were treated within 65 minutes. It is not just men, although I cannot fail to notice the male line-up among the HSE witnesses. There are two women but they have not spoken yet. There are more women now who are general practitioners, GPs, and who are studying medicine. That does not mean they do not also have a gender bias. Another study on gender stereotyping in nursing care was done which showed nurses different symptoms and before they knew who they were attributed to, the nurses responded differently if they were male or female.

There is an inherent assumption, which runs through literature and culture, that women are hysterical, emotional and not rational and therefore are not as likely to be believed. For example, one in ten women suffers from endometriosis but, in general, it takes seven or eight years for it to be diagnosed. The symptoms are severe, chronic pain. Why is that? All of this has to be considered by the HSE. In the case I highlighted earlier, the woman was telling her GP about symptoms and was being fobbed off because of the two clear smear tests. This culture of not listening to women and not believing them is extremely unhealthy and should be examined.

In Portiuncula Hospital, the fact is that a couple had two children who died. I was not there and I have not looked at the medical records but in the second case, when that woman showed up, she was not believed in terms of the critical nature of her previous pregnancy. She was not taken as seriously as she should have been.

We are talking about plaques on walls. There is a saying in the Bible, "Onto the woman I will greatly multiply thy sorrow and thy conception". That seems to be carried over as gospel into the health service as well.

I am sure the Deputy did not mean it like this but the only reason the two female members of our delegation have not spoken is because none of the questions has been directed to community services or acute hospitals.

Were they, they would be the people best placed and most able to answer the questions here. I just wanted to acknowledge that.

On the issue of scoliosis, can I send the committee a detailed note as to where we are at? The bottom line is around the co-designed plan, working with patient advocacy groups, consultants and the children's hospital group to develop a sustainable service which can, ultimately, treat all children here in Ireland within the four-month target where clinically appropriate. A huge investment has gone into it this year. The best part of €10 million has been spent and recruitment is under way. I will send members a detailed note on it.

On the issue of gender bias, I have not read about the gender pain gap, but I will now. It is an interesting point. We must all be aware of gender bias continually. I point out, however, that we have the first-ever national maternity strategy. It is a bit weird in some ways that it is the first national maternity strategy. We never had one before but we have one now. We have seen, notwithstanding the terrible things that have happened in relation to cervical cancer and screening, that the rate of that cancer has fallen in Ireland each year since the programme was introduced. We have seen progress in breast cancer also. I do not know if colleagues in the HSE want to add anything on that. We should always challenge and be challenged to ensure that our systems are not biased. However, I do not see any policy being pursued by the Irish health service that is biased on a gender basis.

Mr. Dean Sullivan

I agree with the Minister's point. Notwithstanding the fact that we do not see it, we need to be aware of the risk that it is there and seek positive assurance that it is not happening. In the development of the service plan for 2019, inequalities and the potential for those in respect of access to services or outcomes from services will be key things for us to look at. Endometriosis is a key thing affecting far more women than is generally understood. One of the difficulties is that it is not generally understood, including in GP-land. Sometimes, people are slow to pick up on it and refer the lady in question for more specialist care within gynaecology. Certainly, that is an area on which we need to work.

On scoliosis, I note that Ms Angela Fitzgerald and Ms Anne O'Connor have not had much opportunity to speak yet. Angela may wish to say anything to supplement this. My briefing is that we are on track to achieve for 2018 the four-month target, albeit it involves, as the Minister alluded to, services outside the South for this year. We are seeking to put in place an arrangement which will sustainably deliver services for children within the island in due course. Does Angela wish to add anything?

Ms Angela Fitzgerald

I do not want to speak for the sake of speaking or being the token woman, which I think is what was implied, but on the specific issue of scoliosis, the number of children currently waiting is 141. There are 20 children who have been waiting for over a year and who were offered a number of options, but whose families chose to have the children treated in Ireland despite the delay. The priority is to get those children treated as soon as possible. For the remaining 121 children, our objective is to work within the four-month target. To clarify matters for families, the four-month target period runs from the time the child is deemed to require the surgery. Obviously, there will be some variation because children are still in growth patterns. However, the four-month target has been set explicitly and we intend to work within it.

It is worth saying at the committee that the feedback from those children who opted for overseas options has been extraordinary and the subject of much discussion. I have met a number of the families with the Minister and I understand the anguish they experience watching their children, not only in pain, but also with the disabling effect of the condition. Being able to offer choice was significant in the circumstances. With specific reference to Crumlin, the objective is to increase its capacity to five days. It is important to acknowledge, however, the efforts by Cappagh and Temple Street hospitals, which are now hitting the targets. I was talking to a neighbour recently whose child was seen two weeks ago and is now being listed for surgery in August during her summer holidays. She will be able to go back to school fully recovered. Compared with where we were last year, we have made significant inroads. We are not there yet but we expect to meet the target by year end.

To clarify, I never said the women that were here were token; far from it. I mentioned simply that we routinely see a lot of men presenting to committees. Housing and health are no different.

I am conscious of time and will bring in Senator Conway-Walsh and then Deputy Cullinane. We need to vacate the room as the Committee on the Future of Mental Health Care is meeting here at 1.30 p.m.

I have a series of questions and will be brief as I want to hear the answers to them. I submitted a question on the number of legal cases against the HSE regarding misdiagnosis, how many were currently in process and how much compensation had been paid out in the past ten years. I have not been furnished with answers and will await replies from the State Claims Agency. However, I find it mind-boggling that the information is not to hand; not for me, but for the Minister. Does the Minister not receive regular reports on the clinical incidence and number of misdiagnoses? This would all feed into the issue of unqualified consultants. Does the Minister see dangers around that and a risk of escalation? There were 34 cases of clinical incidence and 575 cases resulted in claims against the HSE. In most incidents where there is misdiagnosis, people will not bother taking cases. However, my question is about reporting to the Minister himself and whether he will change anything in that regard following the situation with Vicky Phelan.

What plans does the Minister have in place to address spinal surgery waiting lists? I know people who have been waiting several years for spinal surgery. Can these patients go abroad? If they are to be told it will be three years before they get spinal surgery in the State, can we facilitate and pay for them to go abroad to have that where they identify a surgeon somewhere else?

I do not accept the answer I have been given on Translarna. The reason I do not is because the European situation was cited, whereas we know it can be approved conditionally and has been in most EU member states. As such, this does not stop countries facilitating the provision of this treatment. Why are we not doing that here? On the price, the Minister knows the €300,000 per patient quoted is a public price. It is not a negotiated price. That really concerns me because it is untrue. Is it not the duty of the HSE to negotiate the price? As to a timeline, if the drug company submits more or new information, how long will it take before approval is given?

I will ask the Minister about Versatis again. I thank him for the answer he has given but it means there are still 23,000 patients who were on Versatis. I take the Minister's point on overprescribing but I ask him specifically whether he is monitoring how many extra patients are using morphine patches as a result of the withdrawal of Versatis. When will he conduct a post-decision analysis on that? Will he meet the people who intend to gather outside Leinster House on 30 May and who were in chronic pain to tell him about the impact this awful decision has had on them?

I ask the Senator to finish up.

When can we expect the transition to personal budgets for people with disabilities? I have numerous other questions. Overall, I note that the answers I am getting from the HSE in reply to the questions I submit are not at all satisfactory. I have another question on GPs charging for blood samples, which is a continuing practice. When will that be addressed? Is it going to be addressed within the GP contract? It is absolutely wrong that it continues to be done, in particular for people on extremely low incomes.

I will try to go through the questions very quickly and we can come back on further detail. To start from the last question, the blood sample issue will be addressed as part of the GP contract. There needs to be a consistent approach to this and it needs to be fixed.

On the issue of legal cases, reporting to Ministers, the State Claims Agency, SCA, and reporting into Departments there will have to be significant learning as a result of the scoping inquiry. As the members have heard from the SCA, the Department, the HSE and other Departments there is no reporting mechanism at the moment. The SCA is an arm of the National Treasury Management Agency, NTMA, and sits under the Department of Finance. I expect recommendations will come from that and we will need to act on them.

I do not have the figures for spinal surgery here. Ms Fitzgerald might comment if she has any data. We are investing a lot in the National Treatment Purchase Fund, NTPF, so people can go abroad once their consultant recommends it, and the treatment is recognised as an appropriate one here. Ms Fitzgerald might say more about that.

Ms Angela Fitzgerald

I do not have the information here but I can get it for the Senator. We have taken two or three measures in the past 12 months and more than 100 patients from Tallaght were treated under the NTPF in the last quarter of last year, using an outsourced arrangement. In addition, the arrangements for scoliosis have made provision for the transfer of services from Tallaght to the Mater which frees up services in Tallaght and allows adolescents and adults who need deformity surgery to be treated in the Mater. That service has worked very well. Our objective in working with NTPF this year is to target a further 100 to 150 patients to be treated with spinal surgery. We can provide the most recent update on the particular challenges and where we expect to be over the coming months.

The taskforce on a personalised budget was in the programme for Government. It did amazing work over the past 12 months under the chairmanship of Christie Lynch, with many disabled people and several disability advocates. It involves controlling and accessing health and social services and reflecting the UN convention to respect the person with a disability and give them more autonomy to make decisions. The good news is the taskforce has finalised the report. I have had it on my desk for the past two weeks. I am finished with it now and hope to bring a memo to Government in the next week or two. The taskforce has focused on adult services and HSE funded services and the idea is to give control to the person with a disability. I think people will be very happy with this. It is a start but we have a long way to go.

Mr. Dean Sullivan

I note the members' comments on some of our responses. If they need more clarification on anything they could follow up with us and I would be happy to give that.

In my opening remarks I mentioned Versatis and will not go over that again but that intervention was being very heavily used in Ireland, at a level comparable with Britain which has ten times the population. It is appropriate that within the context of very scarce resources within health and social care, where every euro spent on something that is less------

Mr. Sullivan's post-decision analysis is important.

Mr. Dean Sullivan

The arrangement was only introduced last September so we have moved from a position where many people were receiving this intervention inappropriately to one where we have cut the annual spend of €36 million to €4.5 million, significantly aiming resources at those individuals who are truly going to benefit from this and ensuring that other individuals have access to other appropriate interventions that are relevant to their needs. We will continue to monitor that as arrangements go forward. There are no plans for a formal evaluation but I can follow up with colleagues to seek additional assurance on that.

Translarna came across my desk in the North as well. It is a very expensive drug which was assessed for cost-effectiveness in Ireland. A conclusion was reached that it was not cost-effective in terms of the benefit that it offered patients.

Did the HSE negotiate the price?

Mr. Dean Sullivan

The HSE is involved in price negotiations on all of the drugs. That is part of the arrangement. Cost-effectiveness is a combination of those two dimensions. There are two ways a drug can become more cost-effective - either more evidence will emerge as to the impact it is having on patient outcomes and-or the pharmaceutical company can reduce the price. We have left both of those options to the relevant pharmaceutical company in this case that if additional evidence can be brought forward about effectiveness and-or a lower cost per patient we would consider this again.

Of questions 7 to 10, two referred to cardiac services at University Hospital Waterford and two to the national review of specialist cardiac care. Questions 7 and 8 are specifically about interim measures which were to be put in place to support cardiac care at University Hospital Waterford. When Professor Herity published his report he recommended that the capacity of the existing single laboratory be increased by 20%. The Minister is aware of that.

That did not happen. We are 20 months down the road since Professor Herity made his recommendation and not one minute of additional time has been put in place. We are hearing that there are difficulties in respect of recruitment.

Why does it take so long for that information to get to us and to patients? Why would it take 20 months for this to go on with no resolution? It is breathtaking that it would take so long.

The second question was whether a modular lab would be put in place. I was one of several Oireachtas Members who met with the general manager of the hospital and I have met with the lead cardiac consultants. They tell us that increasing the hours at the existing lab will not make much difference, it is throwing good money after bad and is not really what is required. What is required is a modular lab. In his response the Minister says the Department is examining proposals at his request. Four months ago the group of Oireachtas Members met the Minister and the modular lab was discussed. We last met two months ago and proposals are still being examined. Why does it take so long for that to be examined? Can the Minister commit to deploying a modular lab and if he cannot, why not? Whatever about the national review being a matter of policy underpinned by clinical and medical evidence, which will take considerable time, it would not be a fundamental policy shift to deploy a modular lab because there is a mobile lab there at the moment. That has reduced waiting times for diagnostic angiograms but the effect is that the wait time for interventions has risen considerably because 30% of those diagnosed will need an intervention. We are solving one problem but creating another problem. It makes sense to put in a modular lab that can perform interventions and diagnostic angiograms. There is no good reason that cannot be done. I do not understand why it has taken so long to get to the point where we cannot get a commitment from the Minister.

I asked specifically about public consultation in the national review. It states that public consultation will start in June, and will last two months. What exactly does that mean? Will the Minister explain it for people who would be interested in this and would want to make submissions? When will the information be available? When will the public be told when and where they can make their views known?

The national review is scheduled to take 18 months. A commitment was given to Oireachtas Members in the south east if it could be done in 12 months. In his written response the Minister notes that all the key targets have been met to date. Is that an indication that we could have a report sooner than 18 months?

I will take the national review first. It is independent and the Deputy would rightly criticise me if it was not.

I will, though, convey to the professor the need for an update that I can furnish to the Deputy and other representatives about concrete measures for the public consultation. My understanding is that it will begin next month and the means by which his constituents and others can make their views known on it will be advertised and publicised. Professor Nolan was eager that the review would be truly national and that all the meetings would not be held in Dublin. The review group will travel around the country to meet interested stakeholders. Its membership includes patient representatives from the Irish Heart Foundation. It is a different model from that we have previously used. I wrote to the chairman outlining that he or she had 18 months but we would be pleased if it could be done quicker. I am conscious of speed and accuracy working side by side. If the review could be completed within 12 months, I would be delighted but the group has 18 months to conclude its work.

With regard to the interim measures, some of the Deputy's comments are fair and legitimate. I made a decision to deploy a mobile laboratory and he acknowledged the progress that made in respect of one element of the waiting lists. I then made another decision to extend the deployment of the mobile lab and I have since extended it further. I am a little frustrated that I have had to do that because I would rather have done what the Deputy suggested, which is provide the additional hours that Professor Herity recommended in his report and which we have funded through the Estimates process in order that the existing cath lab could be open for longer.

Has the Minister spoken to management at the hospital and consultants who provide this service? The lead cardiac consultant is saying that extending the service in the existing lab by a few hours a day will not make a material difference to waiting times.

Does that not tell us something? If we are to recruit more people into the health service based on an independent clinical report, that is what we should follow. We have an independent report done by an eminent professor. The people of the south east do not agree with it in respect of the 24-7 provision but to decouple that issue, he referred to the existing cath lab having better equipment and opening longer. That is surely something these people would welcome and the Deputy has made that point. It is a source of frustration that the recruitment process has not progressed satisfactorily and I have asked the HSE to talk to the hospital and outline why that is the case.

I am giving the issue of a modular lab serious consideration. I see the logic in it but it is not as quite as straightforward as the Deputy, understandably, presented it on behalf of his constituents.

I will give the Deputy three reasons. First, other parts of the country do not have cath lab facilities even of the standard in Waterford. If we establish a modular lab in Waterford, what about other parts of the country that have longer waiting lists? How can we tell people in the north west that they should wait until the national review has been completed but people in the south east can have a modular lab in the meantime? I need to analyse the issue and examine the facts. I have my Department doing some work on that.

The second issue is staffing. Can the modular lab be staffed? This is a legitimate issue.

The third is the turnaround time for putting a modular lab in place. The indications I have heard from some local representatives do not tally with the timeline I am hearing from the HSE as to how long it would take to put a modular lab in place. I will give the Deputy a commitment that I will in the next few weeks arrange to meet representatives of the south east.

I thank the Minister for his response. He may be correct on the turnaround for a modular lab but it is 20 months since Professor Herity made his report. The Minister referred to his recommendation for additional hours and said he is frustrated that the additional capacity has not been provided. That turnaround time has not been impressive. When patients in the south east hear the Minister saying there may be a difficulty putting a modular lab in place because of the turnaround, they know it has been 20 months without progress on the additional hours. If the decision has been taken four months ago to do this, we would have been four months ahead of ourselves. The problem is the Minister has not made the decision. It is only at the point he makes the decision that there is a possibility of a turnaround. There is no possibility at the moment because no decision has been made. Has he made the decision to deploy one?

The Deputy knows I have not. I have just explained why not.

Then how can there be any problems with a turnaround?

The Deputy is conflating two issues. The criticism would be valid if I had done nothing in the 20 months, and if Professor Herity had reported and the report gathered dust on a shelf. That is not what has happened.

He did not recommend a mobile lab.

It has resulted in a national review, which all representatives in the south east have bought into on a cross-party basis, and a mobile lab being deployed and staying much longer than was intended due to the recruitment challenges. It is now resulting in me bottoming out the issue of a modular lab. I understand and share the frustrations of the people of the south east. I will meet representatives on a cross-party basis in the next few weeks by which stage I will have tried to bottom out this issue.

I had many questions for the Minister.

I can imagine. The Chairman has been patient.

I have reduced them to one. The Minister committed to a Government response to Sláintecare "before December", "early in the new year", "before Easter", "after Easter" and "soon". Could he give a commitment regarding when the Government's response will be approved?

It is a fair point and I detect the Chairman's palpable frustration on this. We have been extraordinarily preoccupied with a live situation for the past few weeks regarding CervicalCheck but it is still my intention to bring forward the draft implementation plan, which I have shared with the Departments of Public Expenditure and Reform and Taoiseach and for which I need cross-Government buy-in, by the end of May or the first or second week of June.

This year?

On behalf of the committee, I thank the Minister and his departmental officials, in particular, Mr. Jim Breslin, and the HSE officials, including, in particular, Mr. Tony O'Brien. I also thank the Ministers of State. I am sorry we did not get an opportunity to grill Deputy Catherine Byrne.

The joint committee adjourned at 1.25 p.m. until 9 a.m. on Wednesday, 16 May 2018.