Seanad debates

Tuesday, 7 March 2023

Patient Safety (Notifiable Incidents and Open Disclosure) Bill 2019: Second Stage


Question proposed: "That the Bill be now read a Second Time."

12:30 pm

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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We have a slightly unusual procedural situation as this is very comprehensive legislation with many sections. With any Bill I have ever seen introduced, the Minister obviously goes through all the sections. However, this would take over twice as long as the time I have for my opening statement so, with colleagues' agreement, I will speak very briefly to the totality of the Bill and start to go through the sections. We will have provided printed copies so colleagues will have the full speech covering all of the sections but I do not have time to speak to all of them. I hope it is within procedure for me to do that.

I will start with the objectives of the Bill. The first objective is mandatory disclosure of patient safety incidents. It ensures that the most serious incidents are covered in primary legislation and can be added to. Some of the questions raised previously concerned the Schedule towards the end of the Bill, which lists a relatively small number of incidents that are the most serious incidents. Deputies questioned whether it was intended to leave it at this limited number.I assure Senators that that is not the case. In fact, the reason we have the Schedule at the back is to say that these are incidents that are so serious that it would require a change in the primary Act to remove them as notifiable incidents. It is my intention that the categories of patient safety incidents will be added to significantly. It is important this is done through regulation rather than primary legislation so we can keep apace of changes to clinical practice, new procedures, new services and so forth.

The initial objectives of the Bill, when it was introduced some time ago, were to provide for mandatory disclosure for patient safety incidents; to provide a framework for clinical audit to take place, which is important for getting better at patient care and improving patient outcomes; and to expand HIQA's powers into private hospitals, which is also very important. On Committee Stage, I signalled that there were additional substantial amendments that I would propose on Report Stage in the Dáil. The first was to extend HIQA's powers to investigate patient safety incidents in nursing homes, which it currently cannot do in response to an individual incident. The second was to introduce mandatory disclosure of patient requested reviews. I know there will be some debate on such reviews, which are an innovation that will make Ireland one of the leading countries in the world in terms of patients having control of their own information and a right to a full look-back at their clinical and screening history. The third amendment was to provide for a review of the legislation after two years.

We had a very constructive debate on Report Stage. We adjourned the debate and I recently proposed three additional amendments. The first was to make it mandatory to inform patients of their right to a patient-requested review before or during screening. Second, we made it mandatory to inform patients of their right to a patient-requested review after screening, in other words, they are informed after screening. We also made it mandatory to provide information on a patient-requested review online. We will come back to some of that. We had constructive cross-party engagement in the House and important engagement with patient representative groups, including the 221+ group.

I have given a broad overview of this important Bill, which will mark a fundamental change to a culture of openness and transparency, and much more. I will now go straight to the sections and we will progress through as many of them as possible in the time available.

Part 1 is on preliminary and general provisions and covers sections 1 to 4, inclusive. Section 1 contains standard provisions setting out the Short Title of the Bill and arrangements for its commencement on a phased basis. Section 2 deals with the interpretation of the Bill and defines the meanings of some of the terms used for the purposes of the Bill. Section 3 provides for the definition of a health service provider encompassing a wide range of providers of health services both public and private. Section 4 deals with expenses.

Part 2 sets out the framework for mandatory open disclosure of a notifiable patient safety incident. Section 5 places an obligation on the health service provider to make an open disclosure when satisfied that a notifiable patient safety incident has occurred. Section 6 places an obligation on a health practitioner, where he or she has formed an opinion that a notifiable incident has occurred, to inform the health service provider of that incident. Section 7 is important in that it establishes the obligation of mandatory open disclosure. This section requires that a health service provider must make an open disclosure to the patient concerned where a notifiable patient safety incident has occurred. If the patient has died or there are concerns regarding the capacity of the patent, this section also recognises that it may be more appropriate to make the disclosure to another relevant person.Section 8 is also a key provision and provides for the Minister for Health to make regulations prescribing additional patient safety incidents as notifiable incidents. This is an important function. We do not want to have to go back to primary legislation every time we need to add to the Schedule. Having that flexibility through regulation to revise this list is a practical way of ensuring we can keep the law up to date as health services evolve.

All notifiable patient safety incidents, whether listed in the Bill or prescribed in regulations, are subject to mandatory open disclosure and must be notified by the health service provider to the appropriate regulator. This section is intended to ensure that the list of notifiable patient safety incidents subject to mandatory open disclosure can be kept up to date. The section gives the Minister wide scope to prescribe further patient safety incidents as notifiable incidents.

Section 9 provides that when a health service provider engages in open disclosure in accordance with the Act, the disclosure, including an apology, shall be treated as an open disclosure of a notifiable patient safety incident.

Section 10 sets out that the information and apology given at an open disclosure notifiable patient safety incident meeting shall not: constitute an express or implied admission of fault or liability; be admissible as evidence of fault; invalidate insurance; or constitute an express or implied admission by a health practitioner of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission in notifying a notifiable patient safety incident. The purpose of these legislative provisions, which are very much in line with international experience and best international practice, is to encourage an environment of open disclosure by ensuring that information regarding notifiable patient safety incidents can be disclosed by health practitioners and health service providers without fear of liability.

Section 11 provides that a health service provider must set out in writing its procedures for making open disclosures of notifiable patient safety incidents to patients.

Section 12 addresses openness and transparency and sets out that both health service providers and health practitioners, when making an open disclosure under this Bill, must provide all relevant information to the patient, or his or her relevant person, and, where appropriate, any other health service to address the consequences of that incident.

Part 3 addresses the procedure for making an open disclosure of a notifiable incident. Section 13 requires that an open disclosure must be made on behalf of the health services provider by the principal health practitioner. If the principal health practitioner is not available, or not in a position to make the open disclosure, the health services provider will identify an appropriate health practitioner to make the disclosure.

Sections 13 to 25, inclusive, set out detailed procedures for: making of open disclosures; timing of making same; matters to be considered before open disclosure; designated contact persons; in-person meetings, or alternatives where necessary; conduct of open disclosure meetings; procedures where a patient chooses not to participate and the five year period within which they can change their mind; procedures for establishing contact; procedures for additional required meetings and clarifications; and, procedures for written statements and the maintenance of records.

Part 4 addresses the notification to certain regulatory bodies of notifiable incidents. Section 26 is the interpretation section for Part 4. Sections 27 to 29, inclusive, set out that a health services provider under the remit of HIQA, the chief inspector of social services or the Mental Health Commission, as appropriate, will make a notification as soon as practicable and not later than seven days from when the provider is satisfied that an incident has occurred. The notifiable incidents are those specified in Schedule 1 and those specified in regulations to be made under section 8. I will leave it at that for the moment.

Photo of Paul DalyPaul Daly (Fianna Fail)
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I thank the Minister. As he said, this is a comprehensive Bill. He will have ten minutes to sum up at the end and we will get to go through each section in more detail on Committee Stage. I am duty-bound to stick to the schedule here. I am aware that ten minutes is a short time for the Minister in this regard.

Photo of Lorraine Clifford-LeeLorraine Clifford-Lee (Fianna Fail)
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I thank the Minister for outlining this comprehensive Bill. I know he is not finished yet, and that this just gives a flavour of how wide ranging this comprehensive legislation is. It is very significant. It is a major step forward in health services provision in this country and in the interaction the public as with the health service. He has been committed to it since becoming the Minister for Health and I commend him on bringing such comprehensive legislation before us. There was significant debate on the Bill in the Dáil.I look forward to discussing and working with colleagues on this Bill as it progresses through this House. It is so important for people to have faith in the health service. The mandatory disclosure requirements and the notification of serious patient incidences to HIQA are really important and new. This openness and transparency will really help people to have more faith in the health service, which is only a good thing. I look forward to hearing the rest of the provisions, which the Minister will outline at the end of the debate. Hopefully, we can move this as quickly as possible and get the law finished.

Photo of Paul DalyPaul Daly (Fianna Fail)
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The next speaker, representing the Independent Group, is Senator Boyhan.

Photo of Victor BoyhanVictor Boyhan (Independent)
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I welcome the Minister. I grasped his brief overview very quickly. I took the time today to read the record of the Dáil and that is exactly as I understood it. I wish to acknowledge the enormous work the Minister has personally committed to driving this legislation. The Minister also mentioned and acknowledged in his speech to the Dáil the importance of his team in the Department, which I picked up very quickly in the transcript. I also thank the officials. It is a really important Bill. It is complex but it is necessary and important.

The Bill will make it mandatory for patients to be informed of their right to request reviews and that is clearly important. The Bill has been brought forward, of course, as a result of the advocacy work and life experience of Vicky Phelan. It is not only Vicky Phelan, however. There are many other people who quietly went away and suffered. There were many people who fought as best they could but they were too weak to continue to fight. Many of their families continued to fight to take on the broad definition of the establishment; let us leave it as simply as that. They were courageous people who took a stance against the establishment for openness, transparency and truth and, ultimately, some form of accountability regarding their health and that of their families. That must be acknowledged.

It is not an easy journey for people to have to lay bare their vulnerabilities and personal sets of circumstances, but they believed that something needed to be done. I acknowledge all those women. Many of them were public figures, but many others could not go public for various reasons. As I said, they were brave and courageous and they took a journey. Hopefully, this legislation will acknowledge this and provide feedback and a follow-up to their call.

CervicalCheck campaigner Lorraine Walsh of the 221+ group was quite joyous after the legislation was passed in the Dáil and gave a number of statements. She said, "It was an immensely proud day for me and for the other people involved ... to know [that] what happened to Vicky and others, like myself, will not happen again.” I am always interested in the personal testimonies of people who travel a journey, particularly one like this, when they speak words such as these. They said the critical issue for this Bill is the right for patients to be entitled to a review of the diagnosis, which the Minister has clearly laid out as part of the three key messages.

I read with some interest the words of campaigner Stephen Heap. He spoke about how nervous he was in finally looking at the wording of the patients' rights Bill that was agreed by the Minister and his Department. Stephen went on to describe his massive relief at the passing of the Bill and commended all the participants in the Dáil on the tenor of the debate and success of the legislation. Again, this is someone who has gone on a personal journey and told his story. It is the important that we talk about people who have travelled the journey and advocated for this legislation.

I have spoken to others, and I want to say this clearly because it is important to say something and be fair, and they acknowledge the Minister's enormous commitment. It has not been easy. One of the difficult tasks for the Minister of Health is that there are so many demands on his time. However, I have only had positive feedback about his engagement on this issue, publicly and behind the scenes, to bring this legislation to where it is. I want to acknowledge that.

I also wish to mention Dr. Gabriel Scally and his team for the enormous work they have done in the area. It is important that all the Scally recommendations are fully implemented in time; he did an enormous amount of work. The women who lost their lives as a result of what happened in CervicalCheck and those who were denied the full, open honest account of health scans and their families paid a very heavy price. I would not do it justice by talking at great length about all their experiences. I will just say this is important legislation.I will not be bringing forward any amendments based on the meaningful and constructive engagement in the Dáil, from what I read.

In preparing for today, I read a review by Dr. Gabriel Scally. He was commissioned to do an implementation review report which was published in November 2022 at the Minister's request. Something jumped off the page that was very moving and it crystalises some of my thoughts around this. The foreword of his report contains a piece called "I Deserve" and I will read some of it here.

I deserve not to be treated as the aggressor

I deserve restoration

I deserve fair play

I deserve to speak with the decision makers

To not be dragged through the court procedure

when I placed my trust in the system


That crystalises for me all the issues around this important legislation. It is timely, appropriate and important and I wish the Minister well on the journey bringing the legislation through the Oireachtas.

Photo of Martin ConwayMartin Conway (Fine Gael)
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The Minister is very welcome to the House with what is one of the most important Bills that we will put through during this term. We have had Covid emergency legislation, and that was important, but this is critically important. That there was agreement to change the name of the Bill to the Patient Safety (Notifiable Incidents and Open Disclosure) Bill was very important because the Title of a Bill does matter. A Title of a Bill should clearly state what the Bill means and what its intentions are. The open disclosure element of the Bill is extremely important.

People have paid the ultimate price because there was not open disclosure. Senator Boyhan is quite right when he says that Vicky Phelan did heroic work but there were many more Vickys and there were many Vickys who did not go public and who paid the ultimate prices as well.

There is one person I want to mention in my contribution here today and that is John Wall. I know the Minister will be very familiar with John Wall. He is a good friend of mine. He is from Clare and he is a very capable and competent advocate. And John Wall has made a difference in terms of this legislation and in the advocacy work he does. He will continue to do advocacy work because he sees it as his duty. I commend all those people and the families of the people who we lost for continuing the battle and ultimately getting this result.

There is one politician I want to acknowledge and it is only fair and right that he is acknowledged, namely, Deputy Kelly, for the outstanding campaigning he has done on this issue working with the families and the late Vicky Phelan and others. Alan Kelly's legacy is in this Bill as well. But so too is the Minister's legacy because he had an open mind. He committed many hours. His officials, his team, his adviser, Susan Mitchell, and others, committed many hours to taking on board the concerns and coming back with solutions to the concerns. The Minister is quite right in saying that it is complex, technical and detailed legislation. That makes it good. What also makes it good is its review clause so that two years from the date of commencement of the Act, the Department will review it in terms of its practicality and whether its operation achieves what we all want. If there are obvious elements that are not working before that 24-month period is up, I would urge that the Minister not hesitate to come back in to amend it. Nobody expects anything to be perfect but an enormous effort has been made in this Bill to get it as near to perfect as possible. It just shows that when there is collaboration and when people work together in an honest endeavour, what you can achieve is enormous. The heavy lifting for this Bill has already been done by everyone in Dáil Éireann.We are coming at it when the heavy lifting has been done. Senator Boyhan has studied the Dáil record. I sat in on many of the contributions at the time, two or three weeks ago. I remember meeting the Minister ahead of going in on the final day and having a quick chat with him. I do not think there is anything we can offer. Maybe some colleagues will spot something, and if they do I would urge the Minister to take it on board. Ten minutes was not enough to give the Minister an opportunity to put the details of the Bill onto the record of the House, but his summation was very accurate and fair.

There is a lesson to be learned when Government opens its mind to engaging with the NGO sector and to people who have lived experience. It is exemplified by what we have here today. The 221+ group and Opposition politicians felt that they were being listened to and engaged with, and their advice taken on board and acted upon. That is what happened towards the end with this legislation. It makes the Oireachtas a place that really can work when the Government has an open mind and the Opposition takes a constructive approach.

It is an excellent Bill. We are setting a gold standard internationally that, hopefully, other countries will follow. It is a testament to the people who are no longer with us, and to their families who live on advocating in their memory, that this legislation is before us today.

Photo of Paul GavanPaul Gavan (Sinn Fein)
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On this, the eve of International Women's Day, this Bill presents a timely reminder of the many ways in which the State and the Government have failed ordinary people, and in particular women. However, this Bill also presents an opportunity to put these same women front and centre, and acknowledge the dedication and sacrifices they gave to make Ireland a better place for women in the future. I am conscious in particular of Vicky Phelan. Vicky's refusal to accept the demand for confidentiality opened the door to truth for hundreds of other women, empowered a generation of people to demand better, and forced a fundamental re-evaluation of our healthcare services. It is an enormous tribute to Vicky, and to all those in the 221+ group who have not let this issue rest and have campaigned vigorously to ensure that we do not repeat the mistakes of the past and that we have robust legislation in place. It is also a testament to what can be achieved when the Government actively engages with the Opposition and with expert groups.

We still have to accept that we have a long way to go on many of the issues Dr. Scally recommended. Several of the recommendations contained in Dr. Scally's report have still not been implemented. I am particularly concerned by the inability of people to make a complaint about clinical decisions. I accept that it is a difficult and complex area, but we need to have further discussion on it. We cannot skirt our responsibilities simply because of the complexity of the issue. We have a duty to have these conversations and to fully tease out these complex issues.

Dr. Scally also criticised the Bill's failure to require a greater duty of candour in healthcare. Again, I accept the complexities of legislating for such. We had discussions with the chief clinical officer, Chief Medical Officer and chief nursing officer, where they made sound clinical arguments on why this may not be possible. However, the reality remains that we have an independent report from Dr. Scally that made recommendations, not all of which are dealt with in this Bill.

As we seek to honour Vicky and all those who have got us to this point, I am reminded of Vicky's own words after the death of a fellow cervical cancer sufferer, Ruth Morrissey: “I don't want your accolades or your broken promises. I want action. I want change. I want accountability.” This Bill is an important first step in that process.

Photo of Annie HoeyAnnie Hoey (Labour)
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I thank the Acting Chairman, and welcome the Minister for Health to the House. As my Labour Party colleague, Deputy Alan Kelly, noted when speaking about this legislation in the Dáil, this Bill is Vicky Phelan's legacy, and the legacy of all the women who lost their lives due to this scandal. I want to join others in recognising the work that has been done on this matter by Deputy Kelly - I refer in particular to the commitment and promise he made to Vicky - and by all of the women and those involved in the 221+ group to ensure that this Bill got to where it needed to be.I acknowledge the Minister has been working intensely with both Deputy Kelly and the 221+ group to get this to a place where people felt this legislation would do exactly what it is meant to do and that Vicky's legacy would live on in this. She made this legislation front and centre of everything she wanted to achieve. It was core to everything she did and it was incredibly important to her and I know that Deputy Kelly spent some time, particularly towards the end of her life, really listening to her and committing to her that he would do everything and anything to make sure this legislation got to where it needs to be because it is so incredibly important.

It is significant that this legislation is here today which is the day before International Women's Day. It stands as a legacy achievement for Vicky Phelan and a political success for the women who lost their lives as a result of what happened with CervicalCheck and those whose lives have been turned upside down but who have survived. I think of the family, friends, and very often the children whose lives also have been turned upside down. I am thinking of Stephen Teap and his wife Irene and many of the very vocal campaigners on this issue.

I know there was great accolade when this Bill went through the Dáil and it was passed and done with but it must come through the Seanad also. It is significant for Lorraine Walsh, Stephen Teap and the 221+ group who have done an extraordinary job in campaigning and advocating on this and will no doubt continue to do so. The critical issue for this Bill is the right of patients to be entitled to a review of their diagnosis and as Lorraine Walsh stated:

It just means that you can actually find out the truth. It is so important to everybody to know the truth in relation to your history in relation to your health and be able to, at least, have peace.

Now at least everybody will have an opportunity to request a review and it is mandatory that the agency will have to tell patients about the review process when they enter a screening programme. I thought it was important to use Ms Walsh's own words and it is important that patients are informed of their right to make requests for a Part 5 review and that patients must be told this at the point of screening or even before that.

While there are still parts of the Scally report that remain to be implemented, we have to acknowledge the work he did. His report and its recommendations are part of the reason we are here today. We still have a long way to go in terms of many of the issues Dr. Scally recommended, particularly the issue of making a complaint on clinical judgement. The Bill has obviously gone through rigorous examination in the Dáil with very long debates, amendments to amendments, and I think amendments to amendments to amendments at one point. It was a robust process and exactly what these Houses are for. The legislation is important but other issues remain that we cannot put on the long finger. We have done so much regarding human papillomavirus, HPV, screening and testing and bringing laboratories back but there is a little bit more still to do. It has taken far too many scandals for this legislation to come about but this legislation is an important step in the right direction. I attended a women's health forum in Galway last week and we talked about different things about women's health, from Savita Halappanavar all the way to Vicky and a point really struck me in the room. I was incredibly honoured to have met Vicky many times, speaking at women's health events, and I remember her immense wit and fun. However I should never have had to meet her. I should never have known who Vicky was unless she was running for political office or making her name in another way. While I am incredibly honoured I got to meet her and to know her and I am incredibly proud of the legacy she has left for Ireland and hopefully for women coming forward, I am sad we ever had to know her in that way. Senator Gavan used her words about how she did not want our accolades or broken promises, that she wanted action and wanted change.It is important that while we do remember her and the great legacy she left, including in this Bill, it is tinged with great sadness that we ever had to know her in this way and that this became her defining feature, as opposed to the funny, smart, quick-witted woman that lots of people got to know. As I said, this Bill has gone through a fairly rigorous process in the other House and I very much welcome that we have this Bill today and hopefully some justice and some righting of wrongs will now be done for those women who were affected, and for their friends and families.

Photo of Robbie GallagherRobbie Gallagher (Fianna Fail)
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I welcome the Minister to the House and at the outset, I would like to give credit to him for this legislation and I am delighted to speak on behalf of the Fianna Fáil group, along with my colleague Senator Clifford-Lee. Fianna Fáil believes in the delivery of fundamental public health services to the highest standard through investment, innovation and reform. It is critical that when things go wrong, patients are compensated and reforms are made so that the same harm does not occur again. This Bill would not exist without the tireless work and advocacy of Ms Vicky Phelan and her friends. We have now tragically lost Vicky. Patients like her and others who were harmed deserve justice and all patients deserve access to information about potential errors in their care.

The spirit of the Bill is noble and it is crucial that patients be informed of their right to have their screenings reviewed. It is equally crucial that there is open disclosure of errors that put patients in harm’s way. However, I have concerns that the Bill does not go far enough in protecting patients and I would welcome the Minister's comments on these concerns.

My first concern is about when a patient requests a review of their screening. The Bill should require that an independent practice complete the review in order to ensure that the same doctor or person who did the initial test is not the one who completes the review. The patient warnings are also not sufficient. The Bill only requires that patients be told once, likely at their first screening. In the case of a cervical cancer screening, women may receive their first screening at a very young age and may not be at risk of developing cancer until many years later. The burden is on patients to remember their rights years later and they are further burdened by a requirement that their request for review be made in writing.

The second concern I have is about the standards for notifying a patient after an independent audit. If an audit discovers that a patient’s test was misread, even the smallest error should be made known to the patient, no matter if that mistake has already resulted in death or severe injury. In the worst-case scenario, a patient may have cancer or another illness completely unbeknownst to them, and being notified of even a small error in an earlier test could spur them to seek further testing. It should be up to the patient whether an error is large enough to be concerned about. The old adage, a stitch in time saves nine, springs to mind here. The Bill only requires disclosure when an error results in death or severe injury, and only then if the harm resulted directly from the care provided. This standard is subjective and the maximum fine is a mere €5,000.

Furthermore, any disclosures of errors made cannot be used in legal proceedings as evidence or in a civil suit. For example, in a road traffic accident, if X drives on top of me and causes me harm and at the scene X says that he was at fault and takes complete responsibility, that can be used as evidence in further litigation, but not in this case. If this Bill were law when Ms Vicky Phelan was fighting her case, it is possible she would not have learned of the mistakes made reading her scans because discordant cytology is not considered an unintended or unanticipated incident under the Bill. Ms Phelan's poor care would not qualify as an incident worthy of alerting patients or regulators. Furthermore, the way that records are sealed under the Bill would have made it much more difficult, if not impossible, for her to access the notes on her 2011 screening.

While the spirit of the Bill is noble, I believe there are amendments that would potentially firm it up. I would welcome the Minister's thoughts on the matter. I hope the response I receive will bring clarity to the genuine concerns I have outlined.

Photo of Seán KyneSeán Kyne (Fine Gael)
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I welcome the Minister and acknowledge his interest and dedication in engaging with the concerns the Opposition has raised during the course of debates on this legislation. It is always a testimony to a good Minister that he or she is willing to accept that things can be improved and to engage with issues that are raised in the Houses of the Oireachtas.I also acknowledge Vicky Phelan and all the campaigners who have advocated for and on behalf of the Bill and those in the Oireachtas, including Deputy Kelly and others across the political spectrum, who supported and pushed for this important legislation.

It goes without saying open disclosure in all aspects of medical care is important. Open disclosure is also important to all aspects of other types of engagement with the State. I acknowledge the amendments the Minister has tabled to enhance the Bill. The expansion of HIQA powers to cover private hospitals is welcome. I have no reason to believe that private hospitals are other than of the highest standard but where issues arise, it is important HIQA can and does have the powers to investigate. Mandatory disclosure of patient-requested reviews is also very important, as is the patient's right to a full look-back at a review before and after screening. These are all very important parts of the Bill.

There are obligations on the health practitioner, when he or she has formed the opinion that a notifiable incident has occurred, to inform the health service provider of it and, under section 7, which, as the Minister said, is an important section, establish the obligation of mandatory open disclosure. "Notifiable incident" relates to those issues listed under Schedule 1, in addition to the regulations that will be made under section 8. As others said, Schedule 1 relates to obligations where a fatality has, unfortunately, occurred across a wide range of areas. Some 12 notifiable incidents are listed under that Schedule, ranging from surgery "performed on the wrong patient ... [or] ... on the wrong site ... [or performed on a patient] ... resulting in an unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition ... Unintended retention of a foreign object in a patient after surgery resulting in an unanticipated death ... Any unintended and unanticipated death occurring in an otherwise healthy patient undergoing elective surgery in any place or premises in which a health services provider provides a health service" and a series of other provisions. These are all comprehensive in respect of patients who have passed away. Section 8 concerns what the Minister may prescribe as a notifiable incident and includes:

an incident which has occurred in the course of the provision of a health service; ... an incident which, having regard to developments in clinical practice, healthcare and patient safety, may occur; ... an incident which, having regard to such developments internationally, has occurred or may occur. Regulations under this section shall only be made where the Minister is satisfied that ... the incident was or would be an unanticipated and unintended outcome of the health service provided.

All these are important in ensuring full confidence in the provision of healthcare and, where some patients may be incapacitated, that their next of kin or those responsible for them have the same rights to full disclosure. That is also highly important.

I acknowledge the work that has gone into the Bill. The Minister's openness to engagement with campaigning groups and individuals, their families, and people who have suffered and been bereaved in the past regarding issues of healthcare, and reacting to those requests, is testament to a Minister who is engaging and listening on a particular issue. I thank him for that.

Photo of Aisling DolanAisling Dolan (Fine Gael)
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I thank the Minister for coming to the House to speak on powerful legislation that will change patient safety. It is about patient rights. It is crucial legislation. He acknowledged the work of Vicky Phelan has been a key driver for this legislation on behalf of women and as part of that group.

The key thing we want of the legislation is culture change in the hospital environment. We are changing that culture in order that people can come forward with disclosures. That is what is key to this. It is about legislation, and a Bill of 100 pages the Minister spoke about, to change a culture within our hospitals so we are in a better place, which is what we want to see. We want to be in a better place as regards health outcomes and rectifying issues.It is about acknowledging the issues in the first place and action then being taken quickly. In the context of looking back at some of these incidents, it is about action, responsibility and accountability.

A few other issues relating to patient rights have been highlighted to me recently. The patient advocacy service is source of independent, free and confidential advice for patients in respect of making a complaint. That is crucial. Additional supports have been provided to the group. I do not know if the Minister can comment further in that regard. That service is there for people who wish to discuss what may be significant issues for them. The patient councils in hospitals work with clinical staff to improve patient care. That can be seen in local hospitals. I want more people to get involved in respect of the care patients receive - being proactive and taking action. This is a further step towards the Minister doing that as well.

I appreciate that the Minister has taken amendments on board, as he stated in his opening remarks. He acknowledged the right relating to the mandatory disclosure of patient review results. In addition, he highlighted the necessity for HIQA and the chief investigator to look into incidences in nursing homes. That has been very relevant in the past two or three years. Supports for nursing homes are crucial.

I appreciate that the Minister indicated there will be a review in two years' time. Who will be involved in that review? The Minister did not state that in his remarks, although it may be in the detail of the Bill.

When it comes to women's health, under the Minister's tenure and in recent years we have repeatedly seen that it has not been to the fore or a priority. It has not received the attention required in recent years, although I acknowledge the Minister has made many changes. I would like the Bill to be another step forward in that regard in so many areas, such as patients' rights within hospitals, but, in particular, in the context of cancer screening.

I appreciate and welcome the Bill. I highlight the role of patient advocacy and patients' rights and the crucial nature of the Bill in the context of rights or supports that should always have been there.

Photo of Tom ClonanTom Clonan (Independent)
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I thank the Minister for coming to the House. I came here to listen to the contributions because it is an historic moment. On the day before International Women's Day, I, like my colleagues, remember Vicky Phelan and the contribution she made. As an observer of this process, it is great to see the collaboration between different parties in our Parliament - those in opposition and those in government. That spirit of collaboration in the public interest and for the public good is welcome, particularly given the polarity that is now emerging in parliaments and legislatures throughout the world.

The relationship between medical professionals and patients is such an important social contract because it is built on trust. It is a unique professional relationship. Being able to learn from misadventure and mistakes is what makes medicine possible. This legislation reinforces and supports that bond of trust; that social contract patients have with medical professionals.

I commend the Minister on the legislation and thank him for bringing it forward. I hope he does not mind me saying that when I first met him in here, he told me there would be good days and bad days. This is one of the good days. I appreciate his leadership and work on this issue.

Photo of Paul DalyPaul Daly (Fianna Fail)
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As there are no other Senators offering, I will return to the Minister. As the debate is scheduled to conclude at 4.45 p.m., I am offering him 1 hour and 10 minutes. One has to be careful what one wishes for around here.

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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I will see if I can talk for an hour and 45 minutes. At this point, I probably do not need to read into the record the rest of the sections, given that colleagues have the full intended speech which covers all of that. We will go through the Bill section by section on Report Stage, if that is okay with colleagues.

I would like to start with a few thank yous. I thank Senators for their contributions today. I also thank patient representatives. This obviously includes Vicky Phelan. Her legacy is broader than this Bill, but it is part of her legacy. As Senators have said, many other patient advocates have worked in the public sphere and more privately over the years to push for these kind of changes. Different patient groups have been involved, including the 221+ group. Without that advocacy I do not believe we would have the Bill we have before us today. We owe a debt of gratitude to patients and patient advocates, in particular. I have worked with quite a number in opposition and in office and they are fearless but are also dealing with very serious medical issues.

John Wall was referenced. John and I worked together closely to bring about an extension to the medical card scheme to make it available to people with a terminal diagnosis for up to two years. John had campaigned tirelessly and I was delighted to be able to introduce that. Not only was John dealing with that, but he was also dealing with the most serious prognosis himself. We owe a real debt of gratitude to the patient advocates who have, over many years, given so much of their time at a time when their health is compromised. I want to acknowledge that.

Senators referenced the Department of Health and the HSE. They come in for a certain amount of criticism, as do I and governments. A little over two and half years into my time in the Department of Health, it is my experience that it is populated by people who care passionately about health care and patients. Does the Department or any of us get it right all the time? We do not, but the overarching philosophy is better and better health care for patients and a strong public health service. The officials who worked on this Bill have put a huge effort into it.

It is also important to acknowledge the work of our healthcare professionals within the HSE. There was a lot of criticism of how certain things were done in response to CervicalCheck. I do not know if all of it was warranted, but a lot of it certainly was. I have had a lot of engagement with screening services and the people involved in CervicalCheck on the mandatory open disclosure parts of the Bill, including Dr. Colm Henry, the chief clinical officer. This is a group of healthcare professionals who dedicate their lives to making things better and better for patients and providing better and better healthcare. The Bill constitutes a significant shift in the culture of our healthcare services, and is one that the clinical leadership has embraced and championed. I want to acknowledge that.

For me, it was important that we arrived here with as much cross-party support as we could get. We worked hard through Committee and Report Stages in the Dáil. There is an openness here. Given the context of the Bill, it is important that a unified message goes out from the Oireachtas that Dáil Éireann and Seanad Éireann stand behind this important change to our health service. I want to thank colleagues for that.

The Bill applies to a much wider context than cancer screening and cervical cancer services. It applies across the health service, including public and private services.However, the genesis of it was what happened in the cervical cancer services and the response from patients, patient groups and the Oireachtas. When we talk about cervical screening and cervical cancer services, it is important to say that this is one important part of a much broader response. Since the cervical screening issue arose, HPV screening has been brought in. It is significantly more accurate than what was being used before. It is going to save yet more lives and is an important addition. We have HPV vaccines. Our colleagues will be aware that we recently launched the Laura Brennan HPV catch-up programme, which is for boys and girls in school who missed the initial offer of a vaccine, and women up to the age of 25. That is in place. A new laboratory in the Coombe hospital is scaling up and has started processing CervicalCheck screening samples. As it scales up its workforce, it will do more and more of that. This state-of-the-art facility is another important step forward.

In regard to informing patients after screening, this is a broad Bill dealing with nursing homes, private healthcare and mandatory open disclosure. For obvious reasons, there has been a great deal of focus on the patient-requested reviews, the clinical audits and the provisions on cancer screening. I will speak specifically to this. The 221+ group wrote to me on the morning we were scheduled to proceed with Report Stage in the Dáil. I was not sure whether we would proceed with Report Stage until I got that letter. The group wanted it to be clear and on the record that the obligation is on the health service provider to inform patients of their right to a patient-requested review. It happens during screening, as it should and patients should know ahead of time. However, we have amended the legislation to provide that patients will essentially get a reminder and that will be a mandatory reminder. My objective and that of the 221+ group is that this will occur after a diagnosis. Exactly when and how is being designed with patient bodies, including the 221+ group. That is being designed in a way that works for patients. Critically, it is intended that the reminder will be sent after a cancer diagnosis, which is when it is probably most important. The process for the design of this ongoing patient-requested review and the detail will be done in collaboration with patient groups. I am writing to the HSE to that effect.

Senator Gallagher sought clarification on various questions. I will run through them now. Will the patient-requested review by done an independent group? Yes. Clinicians will not review their own work. When will patients be reminded of a right to a review? I have just addressed that. The schedule of incidents is not the intended full schedule. Those are the incidents that no Minister for Health can decide to change. The actual schedule will be much broader and will be introduced through regulation in order to keep pace with changes in healthcare, essentially. This means a Minister can add, take away or adjust various incidents as appropriate but does not have the discretion to take from the schedule in the Bill. That would require legislative change. Would apologies through this process of mandatory disclosure be used in litigation? No. This is what we see throughout the world. It is considered best international practice because while everything we are doing starts and finishes with the patient, as it must, we also have to provide a space for clinicians in which they can safely engage and speak with their patients.We talk about a duty of candour. It is important that clinicians can engage with their patients and speak with them openly, without fear of litigation and having to watch what they say. We do not want a situation where a clinician, in good faith, gives a full account of what has happened, and perhaps apologises for that, only for a lawyer then to say “Aha, gotcha, I will use that in court to sue you.” The best international practice in everything starts and ends with the patient but we must create a safe environment for clinicians as well to be open.

As colleagues will be aware, clinicians have become more and more concerned with the increase in medical litigation. We have seen a significant increase in the amounts of money being paid out. Dedicated clinicians are telling me that they are now practising defensive medicine. They do want to do so, but there is now a tangible fear of litigation. It has crept more and more into our healthcare service. We are looking at that and at non-litigious ways of patients being able to be recompensed and so forth. That is the philosophy there. We also have an obligation to clinicians to create a space where they can speak freely.

Would the Bill cover the situation as it pertained to Vicky Phelan and, indeed, to many other women involved in CervicalCheck? The answer is “Yes”. What will happen under this Bill, which would never have previously happened, is whenever there is a diagnosis, the patient will be told they have a right to a review and it will be done in a way that is designed to work for the patient. A patient at that stage may say that they do not want a review. They may say that perhaps they want one in a year or five years but at that moment they need to deal with their health and the cancer diagnosis. The information we have from the HSE is that about half, perhaps 40% to 50%, of patients in the UK say they do not want to know. A patient can change their mind. They can come back to it after a month, a year or three years if they want.

The next question is whether you tell them anyway. Do you have non-anonymised audits? The clear expert advice we have on the clinical audits is to keep them anonymised for this. There are audits done all over the healthcare system all the time, in trauma, cancer services and many other services. All of those reviews are published, which is very important. However, they are anonymised. The advice we have is that in order to have the best learnings and, therefore, the best clinical outcomes for patients, audits have to be anonymised. Some people talked about semi-anonymised audits. However, the advice we got back is that there is no such thing. You can either identify the patient or you cannot. It is quite binary.

The next question arises. If a patient clearly says at that point that they do not want to know, even if you did the non-anonymised audits - which we should not do, but even if we decided to do that - should you then ignore the patient’s wishes and tell them anyway? First of all, you will not know because the audits are anonymised. Certainly, in the meetings I had with patient groups, they were very clear. They said, “If I tell you, as my health service provider, that I do not want to know at this time, then do not go and check, come back and tell me.” We have to respect the patient and what the patient wants. That is why they can come back at any time if they are in space where they want to know and want a patient-requested review.

Essentially, this part of the Bill has two objectives. The first objective is full empowerment and choice for the patient. That is what the patient-requested review will be. I am advised that we will be one of the only countries in the world that does anything like this. The second objective is the best clinical outcomes for patients, which is the programmatic, large-scale audits. That is exactly what we are trying to do here – what is best for patient empowerment, patient transparency and also patient outcomes. Hence, the anonymised programmatic clinical audits and patient-requested reviews.

I think that covers the various issues. Senator Dolan asked who will do the review at the end of two years. That will be up to the Minister, a bit like the termination of pregnancy reviews. For those, I set the terms of reference - do it in a collegiate manner, obviously, if you have any sense - appoint a chair, generally appoint a secretariat and then let them get on with that. Senator Dolan and others mentioned that tomorrow is International Women's Day. In that regard, this is a timely session for a debate on the Bill. It is also Women's Health Week in Ireland, and a lot of important progress is being made. Yesterday, I visited Tallaght University Hospital, where a new specialist endometriosis service is in place. It is part of a new national model of care for endometriosis that has been rolled out over the past 12 months or so. One in ten women will become symptomatic with endometriosis, and until recently, there was next to no care for them. Staff at the hospital told me yesterday that of the women who present to their GP with symptoms of endometriosis as needing care, up to now half of them present ten times to their GP but get no referral. We are working, therefore, with GPs and the Irish College of General Practitioners, ICGP, to put in place training and quick reference guides, just as we did for the menopause. There will also be the five regional hubs for secondary care and the two national hubs, in Dublin and Cork, for specialised care. The Bill is clearly an important part of that.

We will launch something on gestational diabetes later this week. It was a key ask of the Women's Health Group and the Diabetes Society of Ireland that pregnant women would have the availability of retinol scanning for gestational diabetes, and that is something we are putting in place as well. Later this week, we will move on with another phase in the communications and awareness campaigns regarding menopause. A lot is going on and that is one of the positives. It has been supported broadly across the political parties and among Independents. The feedback I received yesterday in Tallaght from the healthcare providers, who were dealing with both endometriosis and the see-and-treat gynaecology clinics, suggested it is having a tangible impact on women's physical and mental healthcare services, waiting lists and so forth. It has been good to see. I thank colleagues for referring to it.

As I said on Report Stage in the Dáil, we are on a journey and the Bill is part of that journey. During its passage through the Houses, there has been robust but important debate, and I echo the remarks about the Senators' Labour Party colleague, Deputy Kelly, who has played an important part in that. He clearly cares passionately about the Bill and is close to those involved. Ours was a useful collaboration.

Today is an important step but it is only one step in getting us where we want to be. Ultimately, the goal is universal healthcare. Test number one will be driving down costs for patients. This morning, I got agreement from the Government to bring a Bill to both Houses in the coming weeks that will abolish adult inpatient hospital charges, which is another important step.

The second test will relate to access. I brought the waiting list action plan for this year to Cabinet earlier today. Good progress is being made. We are all signed up to the Sláintecare targets, essentially that no patient will wait more than ten or 12 weeks for care. Last year, we saw an 11% reduction in the number of people waiting longer than those targets. That equates to approximately 56,000 men, women and children. We have seen a 24% reduction since the peak of Covid, so there has been a large reduction in the number of patients waiting for longer than the ten- and 12-week targets we have set, and our intention for this year is to push that further. Access is far from perfect but it is getting better and we are moving in the right direction.

Critically, the third test will be a great healthcare service, and there are two aspects to that. The one most of us focus on is clinical outcomes, but the second is patient experience, which gets less attention. Typically, modern health services are pretty good at patient outcomes and at applying medicine and science. They are not always as good at the patient experience bit and at recognising that this too is important.That is what this Bill is mainly about. The clinical audit aspect of it is about better patient outcomes but this Bill is focused on the patients in our health service. It is focused on making sure they are listened to and on making sure they are dealt with in an open and transparent way. Inevitably, unfortunately and with the best will in the world, sometimes things go wrong but the Bill seeks to ensure that in those instances there is a mandatory obligation that patients are told about that and that they are told in an appropriate way. The Bill involves one of the elements of universal healthcare that gets less attention, namely, patient experience during our time within our healthcare services. On that, I thank colleagues again for their support and comments.

Question put and agreed to.

Photo of Paul DalyPaul Daly (Fianna Fail)
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When is it proposed to take Committee Stage?

Photo of Seán KyneSeán Kyne (Fine Gael)
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Next Tuesday.

Photo of Paul DalyPaul Daly (Fianna Fail)
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Is that agreed? Agreed.

Committee Stage ordered for Tuesday, 14 March 2023.

Cuireadh an Seanad ar fionraí ar 3.57 p.m. agus cuireadh tús leis arís ar 4.45 p.m.

Sitting suspended at 3.57 p.m. and resumed at 4.45 p.m.