Kathleen Funchion (Carlow-Kilkenny, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Amendments Nos. 1, 3 to 12, inclusive, 14, 19, 21, 46 to 48, inclusive, 51, and 71 to 73, inclusive, are related and may be discussed together.

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 1:

In page 5, line 12, to delete “disclosure meeting” and substitute the following: “disclosure meeting; to provide for the mandatory open disclosure, by health services providers, of Part 5reviews carried out in accordance with this Act; to provide, in the interest of the common good, for certain restrictions on the use of the information provided in such disclosures that are made in accordance with this Act and of any apologies made in the course of such disclosures and the use of any other information relating to the open disclosure provided, and apology made, after the Part 5review disclosure meeting;”.

I seek the guidance of the Acting Chair. My understanding is that we should address the amendments to the substantive amendment I have tabled, and then address my amendments. However, if the Acting Chair wishes for me to speak to the main grouping of amendments first, I am happy to do so.

Kathleen Funchion (Carlow-Kilkenny, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I have not received any direction other than that the Minister should speak to the grouping.

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

That is no problem. I thank the Acting Chair.

The overarching intention of the Bill, as colleagues will be aware, is to embed a culture of open disclosure in our health and social services. However, it is fair to say that many aspects of the Bill have been informed by the very serious learnings from what happened with CervicalCheck. This includes the need to ensure accountability by service providers and clinicians in carrying out open disclosure to patients and their families. In that regard, the Bill and its intended outcomes can be viewed as an important part of the legacy of reform and transformation arising from the issues in 2018 and how those issues have been addressed.

I flagged on Committee Stage that I would be introducing an amendment on Report Stage to ensure open disclosure applies to completed patient-requested reviews of cancer screening. The approach we are taking here is based on the report of the expert reference group, published in 2020, into interval cancers. The group was set up following on from the report by Dr. Scally. It was deemed appropriate to follow the group's recommendations in respect of individual patient-requested reviews as providing the basis for open disclosure provisions.

Amendment No. 19 is lengthy, comprising 21 sections. This is necessary to ensure full provision for mandatory open disclosure for patient-requested reviews of cancer screening. The provisions are similar to those already in the Bill in respect of mandatory open disclosure of notifiable incidences. This amendment will ensure that open disclosure applies to completed patient-requested reviews of cancer screening. This is key. It is one of the substantial amendments I am bringing forward on this Stage. I am now proposing that a patient-requested review of his or her cancer screening will be provided for in a new Part 5 of the Bill. This will ensure that current provision for open disclosure of a notifiable incident will be replicated in the new Part of the Bill for open disclosure of a patient-requested review of cancer screening. All reviews will have to be disclosed, irrespective of whether there is a discordance. This is the nub of it. All reviews must be disclosed to the patient where the patient has requested the review. Where there is a cancer diagnosis, all patients will be told the patient-requested review is available to them if they so choose. Our understanding is that in the UK, for example, approximately half of patients choose it. All patients will be informed that this is available to them. If they choose it, all patients will have that disclosed.

Amendment No. 19 provides for the insertion of a new Part 5 in the Bill to provide for the open disclosure of completed patient-requested reviews of HSE cancer screening services. Such a review will be defined in the body of the Bill and will involve statutory requirements similar to those prescribed for patient safety incidences. This includes an obligation to make an open disclosure of a review, procedures for making open disclosures of a completed review by the health service provider, and offences similar to those already prescribed in the Bill for patient safety incidences. Implementing mandatory open disclosure as provided for in the Bill is intended to afford patients and families the opportunity to understand what went wrong, and to receive an apology where appropriate.

Along with colleagues across the House, I have just come from a very useful discussion with officials, including the chief clinical officer. Very reasonable issues have been raised. One of those issues is the question of what would happen in the future in the case of the women affected by what happened with Cervical Check. The answer is that every woman who has a diagnosis of cancer would be informed that a patient review process is available to her should she want it. Every woman would be told. There would be mandatory open disclosure of that review should the woman choose to initiate a review. The reviews have been carefully designed with clinical and international experts, along with patient advocates and representatives. They have designed a review that works for the women, so that every woman will have this option, which was not available previously, available to them. That is the first important point.

A second question being asked relates to programmatic audits. The Madden report, published in 2018, stated that we must have these learning audits in order to be constantly improving the service for patients and constantly improving cancer detection rates. It stated that these learning audits, which need to go on all the time, should be anonymised. There are several reasons they should be anonymised. It is international best practice. It is the recommendation from the expert reference group. We are working closely with the WHO at the moment and expect it to publish a position on this shortly. We expect that it will be in line with anonymised programmatic audits. We have considered practice in this regard in the UK and other jurisdictions and we have concluded that anonymised audits are international best practice. Why is that? First, it means the health service providers have access to all the data. They are used right across the HSE at the moment. They are a really important learning tool in order to constantly improve care. The second reason is that if programmatic audits were done but were not anonymised, what would happen - this is what happened previously - is that a health service provider would be saying it is going to take all of a patient's information without his or her knowledge or consent, and do audits on the identifiable information of the patient without him or her having requested that. We know from the UK that only half of those who are offered it actually want it. Many of the patients did not ask for this, and in many cases did not want it. When discordant results are found, of course they would be disclosed to the patient, as they ought to be.

Kathleen Funchion (Carlow-Kilkenny, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

The Minister will have a further two minutes to wrap up.

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I thank the Acting Chair for her indulgence. I will finish on this. In essence, we are saying that we will have best international practice - anonymised programmatic audits - so that our screening services can get better. Every patient who receives a cancer diagnosis must be offered a review that has been created to work for the patient. The Bill states that the results of that review must be disclosed to the patient. My view is that this works for patients and puts Ireland as one of the few countries in the world that are putting the patient and the patient voice first and centre in terms of these requested reviews.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I thank the Minister for the briefing provided today by his officials. We had a number of conversations on this issue in recent days. I will start with an observation that I have stated privately to the Minister.

It is also important that I put on the record that everybody wants to arrive at the same place. That position is genuinely held by everybody in this Chamber. We all know how emotive the CervicalCheck scandal was and we all want to make sure that duty of candour and open disclosure is what it is. We have arrived, however, at an unsatisfactory place, where we have an important amendment that inserts this Part 5 request into a Bill on Report Stage. There are genuine concerns, which I imagine many of us have, and we now have limited time, even with the additional time that has been allocated, to not just discuss those amendments but amend them, if we want to. It is more difficult on Report Stage to amend. In fact, it might be impossible if a Deputy has not previously raised an issue. We are quite limited in what we can do.

On top of that, stitched into this Bill, as I said privately to the Minister, is an entirely new section relating to the role of the chief officer in inspections of nursing homes. Again, I support this section and much of it is good but we do not have sufficient time to properly interrogate it either. We have arrived at an unsatisfactory position regarding how the Bill is being dealt with. Others may make the same point.

I have an issue with the process, in addition to what is being proposed. In some respects, there is an absence of a statutory duty of candour in the Bill. It also does not provide for an obligation on a provider or clinician to inform a patient of the right to a Part 5 review at the point of diagnosis. When I spoke to the Minister privately, he said that was not in the Bill but it would be in guidelines elsewhere. I would prefer if it was in the Bill. I would prefer that to be a legal requirement of clinicians so that it would be crystal clear that this is a requirement. When the Minister responds, he might explain to us exactly how it will work in practice. That is, again, a legitimate and reasonable request. The Bill does not specify or provide powers to the Minister of the day to prescribe how the review is done. In fact, the section leaves it to the lab itself, as far as I can see from my reading of it - if the Minister wishes, I will read him the section - and that is problematic. We will certainly table amendments to that section when it goes to the Seanad because we think this is unsatisfactory.

The core issue, however, relates to whether the Part 5 review will do what it should do, and whether it will do what Vicky Phelan, all the women, myself, others and the Minister want. No matter what the circumstance, if a discordant slide is found, particularly those horrific ones that we know happened in the past that led to the CervicalCheck scandal, there is no requirement to request a review other than if a request comes from a woman. There is no legal requirement on the lab if it does a look-back, or conducts this programmatic review or audit, to inform a woman of a discordant slide. That is problematic. There is a difference between an obligation on a service provider or clinician to provide information as of right, if that is what a woman wants, as opposed to her having to ask and having to go through what is called a Part 5 process to get information that, I imagine, we all agree should be done as of right. Even if we have an anonymised-type programmatic review or audit, it should still be possible, if there is a troublesome, difficult, discordant slide, to be able to trace that back to a patient and that patient then being informed. The Minister said in response that means information could be used by the lab, possibly against the wishes of a patient. Maybe that is something that could be looked at. When a woman undertakes a smear test or a cervical check screening, she might then agree, as part of qualitative audit look-backs that if a discordant slide is found, she would indicate she wants to know about it. We should give women that choice. That is not the choice they are being given. That is the difference between how I see it and possibly how the Minister sees it.

I understand, from an education perspective, that there is a need to collect data and to do look-backs for all sorts of reasons. My point is, in its simplest form, when we look at everything that happened in the past, no matter what the situation is in the course of a lab's business - it might be in the course of a look-back, audit or other reason - and whatever the circumstances, where a horrific, discordant reading is found, if a woman wants that information to be disclosed to her, it should be done as of right and automatically. It should not be up to the woman or patient to have to request a review. That aspect of the Bill is fundamentally flawed.

Vicky Phelan's file, as the Minister knows, contained information relating to her discordant reading. She picked up the file, read it and found out to her horror, at that point, that there was a discordant reading. That was done as part of a non-anonymised look-back. Under what is being proposed, that would never even have ended up in her file and she would never have known. Even if there was a right to review, how would she have known to seek a review? She would never have guessed or known that there was a difficulty in the first place. That is the flaw in what is being proposed and the difference between how the Minister sees it, I see it and others in the HSE see it.

Other Members want to come in. I will leave it at that. I have concerns about all these matters. If we are to have duty of candour and open disclosure, it has to be an obligation and not simply a right to request. A right to request is important. It is part of this and gives added value, but it cannot be a replacement for placing an obligation on a provider, if that is what a woman signs up to. If a discordant reading is found, in whatever way it is done in the course of a lab's work, a woman should be informed. This section simply does not do that.

Róisín Shortall (Dublin North West, Social Democrats)
Link to this: Individually | In context | Oireachtas source

It is important to note that while there is a lot of focus on the issue of open disclosure, the original, horrific and fatal problems associated with CervicalCheck the last time were to do with poor standards in the labs. That was the fundamental problem. In the past week or two, we read some of the background to that decision taken in 2008 by the then Minister to outsource all of the lab analysis to the US, with no regard to the poor standards that applied. What Dr. Scally came up with in that regard was horrific and shocking. Lessons have to be learned from that both in terms of health services and across the board generally.

The argument that the then Minister made for removing the labs from Ireland - several labs here had dealt with large numbers and there had not been an issue about it before then - taking the work away from Irish labs and outsourcing to those standard labs in the US, which had fatal consequences, was on the basis of saving money. People were told that the Minister was of the view that the cost of outsourcing would be approximately one third of what it cost to do the analysis in Ireland. It has turned out, in human terms originally and primarily, lives were lost unnecessarily. That was a massive price to pay. In addition, for all the other reasons in cost terms, it turned out to be a massive cost. As a result of that, we lost a lot of expertise, corporate memory, corporate expertise and so on, which will be hard to restore to labs in Ireland.

Fundamentally, we have to get a guarantee regarding the standards in labs. While I note what Dr. Scally said about Quest Diagnostics currently, we need to accelerate the programme of developing capacity in the Coombe hospital. Major issues remain regarding the lack of staff, principally, and a lack of forward planning for those qualified staff.

There is also a question about whether recent recruits to the lab have the requisite qualifications. The Minister must get to grips with these issues. He must be in a position soon to give guarantees about the standards that will apply to the analysis of smear tests and the repatriation of those tests to Ireland.

The duty of candour is another key issue. Dr. Scally stated that the duty of candour should come as naturally as breathing, but that has not been the culture within Irish medicine. This issue must be addressed. Discussing legislating for future arrangements is all very well, but one of the key findings in a previous report by Dr. Scally - it may have been the first report - related to the failure of consultants to be candid with their patients and the need to introduce some measure to restore trust, given that trust had been lost. His recommendation was that there be restorative meetings, whereby all of the consultants involved made arrangements to meet their patients to try to restore trust, apologise and provide some kind of acceptable explanation for why the patients were kept in the dark. As far as I am aware, those meetings have not happened to any great extent. It is an outstanding recommendation that needs attention, having received none recently. Will the Minister devote some attention to it?

It is only right that women be able to request a review, and I welcome his proposals in this regard. However, an issue arises concerning the list of notifiable incidents. I spoke to him about this earlier. Dr. Scally was clear on this point and stated:

The limited scope of the Bill is problematic. The Bill only specifies the mandatory requirement for open disclosure in the case of 13 categories of incidents. 12 out of the 13 highly specific incidents where notification would be mandatory relate to the death of a patient. This, under any circumstances, represents a tiny proportion of harm caused to patients through clinical error.

I tabled amendments to include significant harm in those 13 incidents. Unfortunately, they were ruled out of order. That was wrong. The Minister has stated that it is his intention to extend the definition in a Schedule. Will he put on record that he intends to do so? In the past week or so, I have been in touch with the 221+ group regarding his amendments. This matter is one of the group's principal concerns. In fact, it was the only concern the group relayed to me. Will he commit to broadening the scope of the notifiable incidents and set out a timeline for doing so? He has stated that broadening the scope is his intention, which is fine, but who knows who will be the Minister next year or in five year? I ask that the Minister be clear in what he is putting on the record.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I thank the Leas-Cheann Comhairle for the opportunity to contribute. It is good that we are debating this Bill and that we have reached this point. It would be a shame if we did not get it right at the last minute. The question we must ask ourselves is whether the Minister's amendments will live up to what Vicky Phelan and other campaigners would have wanted to be part of the legislation. If the answer is "No", then the Minister needs to recognise that and go back to the drawing board.

All Deputies want to work with him on the Bill and to achieve the same outcome, namely, a service in which women have confidence. I use the CervicalCheck service and want to have confidence in it. I want my daughter and my friends to have confidence in it. I want them to know that, as a right, there is not information about them, their health and their well-being about which they are not aware. Unfortunately, the way the amendment is constructed - and what the Minister has stated - means that every woman will be told she has a right to a patient safety review but she will not be told if there is a discordant slide.

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

She will be told, Deputy.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Speaking as someone who uses the service, I want to know as a right where there are issues.

The Minister might clarify, but my understanding is that, if the anonymous programmatic audit he mentioned had been in place in 2014, Lorraine Walsh, Vicky Phelan and all the others would not have been informed of the discordant slides. We need to remember that this situation came about through someone looking at her file. She opened the file, saw something in it and pursued it. That is not the right way to find out such information. The burden should not be placed on the person who has cancer to ask these questions. It would not be fair. The test of this has to be that, if we took ourselves back to that time, there would have been nothing in the file for Vicky Phelan to ask about. I would welcome clarity from the Minister on this point.

As my colleague, an Teachta Cullinane, stated, we are all here for the same reason and we all want the same outcome. We want to ensure that the service is fit for purpose and women have confidence in it. We all acknowledge that, notwithstanding the good work done by the people who provide its services, which are efficient and well run for the most part, confidence in CervicalCheck has been shaken. Work must be done to rebuild that confidence. From speaking to Dr. Scally, he acknowledges this as well. Some of it is down to misinformation and some is down to people misunderstanding. That will always happen when non-medical people interact with medical people. However, some of it has to do with the fact that women wanted to understand a little more about how the system worked. From reading newspapers recently, they would have seen the correspondence that Ms Mary Harney received as Minister pointing out the issues with outsourcing services. This would not instil people with much confidence. I never liked the idea of my slide venturing off to the US or God knows where else to whatever lab - it turns out that no one knew - without the proper checks and balances being in place. I accept that they may be in place now, but it never sat well with me that this was happening. I do not believe it sits well with other people either. When we hear that Ms Harney had been written to and informed in stark terms about issues with outsourcing, it knocks people's confidence.

We are all here for the same reason. We want to be able to walk out of the Chamber tonight knowing that we have done our best and that, as much as we can as non-clinicians, we have given women confidence in their service, including the confidence to know that, if there is a discordant slide, that information will be conveyed to them as a right and they will not have to ask for it. If we provide the right to ask, perhaps people will not exercise it because they are busy or so on. We should not put the burden of asking on the person who might have cancer. The information should be available as a right.

The test of this has to be that if we were to go back to 2014 we would need to know that things would have been different. The way things worked out then was not good. The outcome was catastrophic for many women and their families. We, therefore, must be able to say with confidence that if we hopped in a time machine and went back to 2014, and the amendments, as the Minister has outlined them, had been passed and in place then, what impact they would have had then. If we were to fast forward back to our own time, would we find ourselves talking about this CervicalCheck scandal?

Nobody likes to hear a service they rely on, a really good service, mentioned with the word "scandal" attached to the end of it. CervicalCheck is a good thing. It is something I have always encouraged people to have done. Talk to any of my friends and they would say I told them to get it done. It is not nice, it is not a bit nice, but it is worth having done. It is surveillance. Not everything will be caught, and I understand all that. When I was my party's health spokesperson, I did not appreciate being spoken to by some of the people in the HSE as if I did not understand what surveillance is. I understand it very well. Believe me, when this procedure is being done, you do find out what it is, where it goes and how it is going to impact. We are all here for the same reason and we want to achieve the same goal; we just need to ensure we get it right.

Ruairi Ó Murchú (Louth, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

We are at this point that happens on many occasions. We all want to deliver for the many women who have been failed by what happened in respect of CervicalCheck. The recent death of Vicky Phelan has put this matter at the top of the agenda, as is absolutely necessary. The fact, however, is that we have often had issues in this State where the Government and agencies, especially when we talk about the history of the HSE and other organisations, have travelledl part of the distance but not the entire distance. I sometimes feel we do a grave disservice to those people, and those women in particular, in many cases, who have been wronged. We do not deliver what is necessary.

Deputy O'Reilly put it well regarding the crucial necessity of screening and of CervicalCheck. We want people to have the confidence in the process that has definitely been knocked to a great degree. Part of this endeavour, therefore, is seeing right done for those who were failed. It goes beyond that, though. It is also about ensuring that people have confidence in the system. Deputy Shortall put it very well too. We started out dealing with the initial period of the CervicalCheck scandal. What happened is that we had outsourced laboratory services to America. As people will understand, many politicians in here, including former Deputy Caoimhghín Ó Caoláin, and others, railed against this being done for years. They did that because they could see this was being done not from the perspective of the public and to ensure we were looking after people's safety, but based on saving money. This approach has been disastrous, in the sense that it has brought us to this point.

We are talking about a duty of candour, open disclosure and the necessity of these aspects. We all understand how screening works, that it can be an imperfect science and that mistakes can be made. This point has been put far more eloquently by other speakers before me. The fact remains, however, that we cannot put the onus in this regard on patients who are dealing with cancer and trying to cope with their medical issues. These people are under severe pressure. We cannot put additional pressure on people to request a part 5 review. We must ensure this is down to clinicians and the system. Especially in cases where discordant readings are being dealt with or mistakes that can have a critical impact on people's lives, we must ensure the people concerned are told about this.

I assume the Minister will come back to us - on some level,I think he has already indicated this - regarding how he sees it being possible to find another means by which people will be informed of this type of situation, whether we are talking about guidelines or whatever. It would need to be pointed out to me why we do not just bed down this aspect in the legislation now. As I said, we must ensure we have the entire toolset put in place from the perspective of ensuring we do not allow circumstances to develop again that repeat what happened when Vicky Phelan and others were not given the information they should have. Questions have been also thrown up concerning the anonymised audit system. It has been pointed out that Vicky Phelan, on the basis of this system, even if she got a look at her file, would not have been able to see the pointers to her own situation.

Deputy Cullinane and others spoke about the fact that, if we take the Vicky Phelan case, the system we are putting in place has not actually caught those mistakes in the process. The aspect I cannot get out of my head is that, as I said, we have travelled a significant part of the journey but we have not managed to put in place a process and a system that will protect women from what happened before. It will not ensure that if there is information concerning discordant readings, necessary medical information that these women need to know about, that there will be an onus on the clinicians and the system to ensure this information is given to women to enable them to make the best choices possible.

The unfortunate thing is that at times Irish people are very civil, busy and all the rest of it, and we will not necessarily seek reviews etc. Once again, we must ensure we have a system that is sufficiently robust and that does all that is necessary. I am repeating myself, but I do not get how we got to this point. Working on the basis that we all wanted to deal with the issues that Vicky Phelan and others have put on our agenda and ensure there is a duty of candour, open disclosure and a system to guarantee that everybody, particularly all these women in similar circumstances, would be provided with their necessary medical information, we are now going to put in place a process that will not exactly do this.

Perhaps the Minister will respond to some of the questions put to him, but I cannot get my head around how we would not just deal with all these issues and ensure the responses are embedded in the legislation. We could then do right by those women who have been failed and put in place a system that is fit for purpose. Beyond that, we must get timelines concerning the Coombe hospital and when these lab services will be up and running. Furthermore, we must find out what percentage of lab services will be undertaken there and how many other lab services will be still outsourced?

Catherine Connolly (Galway West, Independent)
Link to this: Individually | In context | Oireachtas source

We have quite a list of speakers, so before moving on, and to ensure the Members know where they are, the next speakers will be Deputies Ó Laoghaire, Kelly, O'Donoghue, Patricia Ryan, Ward, Cronin, Daly and Carthy.

Donnchadh Ó Laoghaire (Cork South Central, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Tá sé seo sách ráite cheana féin ag cúpla Teachta, na Teachtaí Shortall, O’Reilly agus Cullinane ina measc. Cuid bhunúsach den fhadhb ná an tslí inar cuireadh soláthar ar na seirbhísí sna Stáit Aontaithe, in ainneoin go raibh go leor daoine ag rá go raibh baol ann de bharr na gcaighdeán sna labs sin, an osradharc ar na tástálacha sin agus an tionchar a d’fhéadfadh a bheith aige sin ar an gcaighdeán eolais a bheadh muidne, agus na mná, ag fáil anseo. so

Is tromchúiseach an toradh a bhí ar sin agus chonaiceamar go leor cásanna ainnis dá bharr. Is dóigh liom go bhfuil dualgas sách mór orainn é seo a fháil i gceart. Nílimid ag rá nach feabhas é seo ar an rud a bhí ann cheana féin ach níl sé maith go leor go fóill. Cuirim fáilte roimh an gcinneadh tuilleadh ama a chur ar fáil faoi láthair ach nílimid san áit inar chóir dúinn a bheith. Níl an rud a bhí Vicky Phelan, Emma Mhic Mhathúna agus go leor daoine eile ag lorg anseo sa reachtaíocht.

The point has already been clearly made that there is a key lesson here for other public services. It is not the case that nobody warned of the danger of outsourcing and sending these slides to laboratories in the United States where, after some time, it became evident that the standards of the checks were not what they should have been. The implications were enormous. It was clearly raised in correspondence with the then Minister for Health and Children, Ms Mary Harney, and she was aware of it. It was raised by former Sinn Féin Deputy, Caoimhghín Ó Caoláin, and other Opposition Deputies at the time. There is a lesson in that for us but in this particular instance it had very weighty consequences. It led to women not being informed of a very serious health concern and threat to their lives and, unfortunately, several of them died subsequently.

What the Minister has put before us is not so much the issue. We do not have an issue with the Bill or the amendments. It is not that this is not better than the status quo ante. It is an improvement on it but it is not a duty of candour or open disclosure. The definition of "candour" is "the quality of being open and honest; frankness". There is an active obligation on the person who has the information. This legislation is not pushing for any active obligation on the part of the medical practitioner here. The Minister states that he might deal with this obligation in regulations but we are not nailing it down in terms of an obligation to inform people of their right to review. I note the Minister is shaking his head but we are not telling people that they have a right to a review. The Minister can address the issue in a minute, if he wishes, but that is certainly my understanding of the legislation. It is welcome that there is a right to a review, which is better than what was there previously, but it is not the case that there is an obligation to inform people of that review or to inform them that there is a legislative obligation to tell people of a discordant slide.

I emphasise that I am a big believer in screening. It has been a crucial public health intervention, not only in relation to this cancer but in relation to other cancers as well and in other areas of health. It has a crucial role to play. It is vitally important that we ensure there is full confidence in screening but to do that, we need to heal the scars of the past, rectify the failings that occurred and become leaders in this regard.

The Minister will be aware of the scale of screening. How many women go through the screening programme each year? We will take this year as an example. Does the Minister know that figure off the top of his head? In any event, I would expect it to be several thousand. When dealing with that scale, it will include women who potentially have limited English, vulnerable women and women with limited health literacy who are undergoing a crisis of whatever sort and simply want to get out there. Many women will ask for a review. Many will see this debate and become aware that they have that right. That is welcome and it is better than what is there now. However, there are other women who will not have that knowledge, wherewithal or, potentially, the English or communication skills to ask for a review, and it will not occur to them to do so. We have to take into account every category of woman who will potentially go into this programme. The scale is significant. We need to take into account every set of circumstances. That is why it is important that there be a duty on the medical practitioner to inform women of their rights and what they are entitled to know.

Much of this is technical and we could discuss it in detail but, on a fundamental level, it is quite simple. This is the bit I do not understand and for which I have not been given an explanation. I have not seen the Minister, truthfully or in any meaningful way, dispute the fact that there is not an obligation on the medical practitioner. I also have not heard an explanation as to why we are not doing this. Is there a good legislative or constitutional healthcare policy reason we are not doing this because it seems relatively fundamental? Whatever about future guidelines the Minister may issue, we are not making it necessary in law for the medical practitioner to tell women they have a right to a review and that there is a discordant slide. That does not seem to be the case and I do not understand why it is not being done. I would appreciate it if the Minister outlined why that is not happening.

There is a shared desire to rectify this issue, put Ireland in a much better place and make this State a leader in screening. That is laudable. I welcome the additional time for this discussion and the engagement in advance of these amendments. It is clear, however, that this is not what the women, including the late Vicky Phelan and many others, sought. That needs to be addressed and I urge the Minister to do so. I do not understand why we are not simply doing that.

Alan Kelly (Tipperary, Labour)
Link to this: Individually | In context | Oireachtas source

I welcome the fact that this legislation is before us. In fairness, this has gone on for a long time and I acknowledge that the Taoiseach made a commitment when Vicky Phelan passed away that it would be done. I also acknowledge the Minister's officials and the people who work with him. They met us earlier and went through my concerns and those of others and, in fairness, addressed some of them. We should not be here, however. This is so rushed. We got more than 40 pages of amendments on Friday. The more I go into this, the more questions I have. I want to support this Bill. We should not be here doing this like this. Even next week would have been fine because we could have done with more time with the Minister's officials. I have had more questions since I came out of today's meeting. I have spoken to many more people. We should not be here. It is not good practice, particularly on such a sensitive Bill. I am passionate about this Bill for reasons the Minister is well aware of.

This is simply not open disclosure. I will not have enough time to go through all my issues but having reflected on the meeting we had, I understand the balancing act the Minister's officials have. There is a balancing act here. This is highly technical legislation that crosses into many different areas. I understand that. I have sympathy for the Minister and his officials in trying to perform this balancing act, particularly when it comes to screening given everything that has happened and in relation to ensuring we have providers into the future. Dr. Scally, in moments when one talks to him privately, will acknowledge that there was a balancing act and a need to keep the system in place.

I often speak to Lorraine Walsh and Stephen Teap, as the Minister knows. They are very good friends of mine and I have worked with them for many years. They are watching me speak. They do not support this legislation in this format. That is the test for me because, to quote Stephen, it is "not fit for purpose." I will not quote Lorraine because of the way in which she put it.

Others have spoken before me. This does not pass the Vicky test. That is so important to me. It does not pass the test because if Vicky's case was going through this process, there would not be an obligation. This is why we cannot support the Bill as it is drafted. I know the Minister has said that is not the view being taken.

I have a number of other points to make on the way in which the anonymisation will be done. In fairness, the officials have made good inroads in explaining this to me. It is causing real issues. In this scenario women will have to request their files and they will have to know how to do it. I did not come out of the meeting convinced. I knew information would be provided on this, that and the other but I did not come out of the meeting fully convinced that the people who would need to tell the women would legally and morally do so. It is just not there. It is not strong enough for me.

I was told in the meeting that members of the 221+ group were fully consulted on this legislation. I want to ask a direct question. Were they shown the Bill? The Minister might answer that. I know what they were consulted on. Was the 221+ group shown the Bill? Did officials or anybody go through it with the group? That is a very direct question and I would like an answer to it. I think I know the answer but I would like to get it on the record from the Minister to give him an opportunity, to be fair.

I have an issue with how the audits will work and the process by which the laboratories will behave and the contractual nature of how this will operate. I am not in any way satisfied with the legislation in relation to this. I have a significant issue with regard to a point that is often missed. People forget that we are not doing auditing at present. I know audits are good things. They are good for various reasons such as to learn. We can learn things that go across other programmes, not even in the programme itself. There is a range of reasons it is very good practice. The audits stopped at Vicky's case and they have not begun. I have significant concerns that there will probably be legal issues with regard to the Bill being introduced now and being retrospective from 2017 to now. All of the variables with regard to what happened to Vicky, Ruth Morrissey and everybody else have not changed an iota. That means statistically there have to be other issues. This Bill is going backwards and there will probably be legal issues with it.

I want the Minister to reflect on what has been said tonight. I do not believe the Bill will be finished tonight. The officials and the Department need to reflect, come back and work with us on proper amendments. They need to speak to Lorraine Walsh, Stephen Teap and others in the 221+ group. They need to go through the legislation completely, explain it and address their concerns.

I have a point to make on notifiable incidents. I took from what the Minister said earlier that 12 of the 13 reasons are where somebody passes away. I understand the Minister can extend this by secondary legislation. The Minister needs to say on the record that it is his intention to do this while the Government is in place. This is a significant weakness.

Richard O'Donoghue (Limerick County, Independent)
Link to this: Individually | In context | Oireachtas source

I hope the media are listening to this. I would like the people of Ireland to know what happens following a serious incident or death in a HSE hospital. If someone is unfortunate enough to be injured or if a loved one is injured or, worse, dies under the care of a HSE hospital, this is what happens afterwards. I ask the Minister to give me his attention. A member of staff who has witnessed the incident is supposed to electronically record it locally in the hospital through a system called Q-Pulse. A line manager is then supposed to investigate the incident and speak to witnesses. Details of a serious incident are to be reported to the national incident management system in the State Claims Agency. I have discovered that staff in the HSE often record incidents locally on Q-Pulse but serious incidents are not always reported nationally. Therefore, no national record is kept of incidents related to a certain Department or member of HSE staff in a particular hospital. This leads to the safety of the public being seriously compromised as opportunities are missed to prevent future incidents.

I found an article on the Internet written by a former consultant in University Hospital Limerick, UHL. He refers to 140 incidents he recorded on Q-Pulse in UHL that were never followed up by management. We now have 70 medical professionals who have also stated they have reported incidents in hospitals and nothing was done. This is what the public needs to know. The HSE jointly manages the national incident management system members in conjunction with the State Claims Agency. The HSE is the owner of the national incident management system healthcare data and related patient safety services user incidents. The State Claims Agency has no regulatory function and does not have legal powers to impose sanctions.

It might be decided by the HSE that an independent investigation should be carried out in a serious incident but the investigation team will be made up of past and present HSE employees and will sometimes include a member of staff from the same hospital. The HSE investigation report is then given to the coroner to refer to if there is an inquest into a death. Those who are not happy with how an incident has been investigated can seek help from HIQA but, again, it is made up mostly of past and present HSE employees. A doctor involved in a serious incident may be reported to the Irish Medical Council. Its members are mostly past and present HSE employees.

Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
Link to this: Individually | In context | Oireachtas source

Deputy, you need to indicate how this is connected to the amendments.

Richard O'Donoghue (Limerick County, Independent)
Link to this: Individually | In context | Oireachtas source

I will. The Medical Council then seeks a so-called external expert investigation. This expert is usually a past or present HSE employee. If a serious concern is brought to the national patient safety office in the Department of Health, a past or present member of the HSE is working there and the Minister for Health is the head of the service. The same Minister appoints certain members of the Medical Council. How can this system be fair and just? Where is the natural justice? The HSE investigates itself and has its own members on every health authority. It appears to have total control of incidents and how they are dealt with, including death. The public does not stand a chance.

I am asking for a public inquiry into all serious incidents recorded locally in UHL. The HSE's incident recording system is not fit for purpose. It is dangerous and unreliable. After a public inquiry, I will call for an external body to investigate all serious incidents in the health system in Ireland that does not involve any past or present HSE member.

I have asked the Minister for his help on more than one occasion and I am doing so again. We have serious incidents that are being reported but not investigated.

Serious incidents have been reported and are being looked at by HSE employees even if there has been a death.

After raising the issue of cover-ups in UHL, I was recently asked by reporters if I could send them information I had on this. Here is the piece for the media to understand. I submitted three incidents on UHL more than 12 months ago, and the HSE wrote to ask me if I could disclose the information. It already had it on file for 12 months. We are trying to ensure patient safety. If there are incidents, they should be reported properly and we will try to protect patients in the future. If the Minister is not willing to ask people from outside the HSE network to investigate cases, we will never rectify the problems we have in Ireland. It was done in the UK. Political people pushed for it. Independent investigations were conducted and hospitals were held to account for the mismanagement of incidents that were reported and never dealt with.

I again ask the Minister to investigate UHL using independent people and to hold people to account for mismanagement, which has been raised with the Minister and the HSE by health professionals. We must help them to make sure we can stop the occurrence of future deaths or serious incidents in UHL.

Patricia Ryan (Kildare South, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

The Minister will know Sinn Féin has no issue with the amendments to the Bill, but we have an issue with the process and the absence of a statutory duty of candour. The Bill also fails to specify or provide powers to the Minister to prescribe how the review will be conducted. It is similar to self-regulation. How can we do something in this Chamber and have it looking like self-regulation? It is just not right. The bottom line is that we are not giving people the right to information unless they seek it, and that is very unfair. We should have the right to automatically get this information.

The Government is forgetting that patients are at the heart of this. We must protect the viability of the screening services; we understand that. Approximately 250,000 CervicalCheck screenings will be carried out this year and that has to be welcomed, but it must be a process that is safe and people must get their information. A specialist who provides counselling support for women affected by the CervicalCheck scandal has stated, "I see a state that pays lip service to acknowledge its mistakes and yet the systematic failures are blocking and resistant to change causing ongoing heartache, a trauma without a bottom line that keeps adding to the suffering of women I met."

Deputy Shortall said earlier that there is a lack of forward planning and I totally agree with her. Women must have trust and they do not currently have that. It is up to us as legislators to make sure they get that trust. All Members of the House will continue to say they want to work with the Minister on this, but we have to work in a proper fashion. I also agree with what Deputy O'Reilly said about slides. We should not have them sent to another country. It is a confidence issue. We should be allowed to have slides examined in this country. I was a patient of the gynaecology department in the Coombe hospital and without it I would not be here. The trust of women in the hospital and gynaecologists they attend is vital. I firmly believe we must continue to do this in such a fashion.

I also listen to people talk about the pressure people are under as patients and women. Not only that, but their families are under severe pressure as well. When a loved one is very sick, people are not sure how they will get the results, where the results will go to or what their rights are, so they too are under pressure. They are under pressure when their loved one needs them most. It is very difficult to give a loved one what they need when people are under such severe pressure. That needs to be addressed.

How can we get this right when it so rushed? If the Minister does not get it right this time, he will not get it right at all. The Bill should not be rushed. The Minister needs to get it right and this issue must be addressed.

Mark Ward (Dublin Mid West, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I never met Vicky Phelan but like most of the nation, I felt like I knew her. Those who listened to her or watched her could not help but be struck by her honesty, courage and dedication. She had the courage to fight - the bravest courage of all - for those who would, ultimately, come after her.

I listened to other speakers who knew Vicky Phelan. Deputy Kelly said this Bill does not pass the Vicky test. The Minister has to make time to make the Bill Vicky-proof, and I hope he and his officials can achieve this. As he will know, managing disclosure was one of Vicky's core demands. Managing disclosure means there is a legal obligation on clinicians and healthcare providers to tell a woman if there is an issue with the reading of her cervical cancer screening slides. There was a consensus that the original Patient Safety (Notifiable Patient Safety Incidents) Bill did not provide for this demand.

As a united Opposition, we have said all along that we would work with the Government on this legislation to get it right and over the line. While that remains our position and commitment, the Government amendment does not provide for managing disclosure. There is provision for a right to review, which is welcome. An obligation on a clinician or health service provider to reveal and pass on information and manage disclosure where legal responsibility is on the clinician and organisation is what the women fought for. This was recommended in the Scally report. There is a concern beyond the definition of managing disclosure or the duty of candour about the review process. There is no legal obligation for the women, at the point of diagnosis, to be told she has a right to review.

We have no issue with the Bill. It is better than what was previously proposed and better than the status quo. It is an improvement. We take issue with the process, however, and the absence of a statutory duty of candour in the Bill. It does not place an obligation on the provider or clinician to inform patients of their right, under Part 5 review, at the point of diagnosis. This obligation must be on the clinicians and not the patient.

This is rushed legislation. In my time in the Dáíl, I have Bills being guillotined. Rushed legislation makes bad legislation. We do not want to come back in a year's time to make further amendments to the Bill that we could sort out here and now.

Approximately 250,000 women will go for cervical screening tests each year. This is really welcome and we will encourage it. It is a vitally important tool. As a father of two young girls, this is something I want my girls to be able to access. I also want them to have the confidence that when they go to CervicalCheck screening, their human rights will be catered for and if there are any discrepancies in the results, the clinicians will have a duty of care to inform them straightaway. We have to protect patients' rights. This is the crux of the problem. We cannot expect everything of the person going for the test and nothing of the system. I cannot understand why a duty of candour is not enshrined in the Bill. I hope the Minister will clarify the reason for that because people need that question answered.

Lay people looking at this debate want clarification on why something that could so simply be put into this Bill should not be put in to give people confidence in CervicalCheck going forward. If that were done, those who went before and their families would feel vindicated that they basically got the Bill they deserve.

Pa Daly (Kerry, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Níl fadhb leis an mBille ná leis na leasuithe seo. Tá fadhb leis an próiseas áfach agus leis an easpa dualgais dháiríre atá ann. Níl aon dualgas ar dhochtúirí a rá láithreach go bhfuil ceart ag an othar i leith athbhreithniú Pháirt 5 maidir leis an diagnóis. Ba chóir go mbeadh córas tríd an chlárlann ailse a thugann eolas do dhaoine go bhfuil an ceart acu ag an bpointe seo. Ní thugann sé cumhachtaí don Aire. Léiríonn sé conas an t-athbhreithniú a dhéanamh. Tá sé cosúil le self-regulation. Ní chuireann sé an sampla ailse san áireamh leis an t-othar a chur ar an eolas agus ná bac le conas nó cathain atá an othar ag fáil amach. Ba chóir go mbeadh dualgas dáiríre chun an disclosure sin a dhéanamh mar tá an ceart ag daoine a fháil amach. Is ceart agus is cóir é sin. Dá mbeadh an reachtaíocht seo ann in 2014, bheadh a fhios ag na hothair, na mná sin, an toradh a bhí acu.

We do not have any issue with what is in the Bill. We do not have any issue with the amendments either. Thanks be to God, there is information on other issues going through the system at present, for example through trolley count. I recently dealt with a case in Tralee involving a woman in her late 70s from the north of the county. Families are stressed because there is no isolation room in University Hospital Kerry. This woman was left on a trolley for days. We were able to do something about that because the information from trolley count was there.

We have an issue with the process and with the absence of any statutory duty of candour in the Bill. There is no obligation on a provider or clinician to inform a patient about the right to the Part 5 review. There should be a system through the cancer registry that notifies patients of their right. Ba chóir go mbeadh an ceart ag gach éinne gach eolas a bheith acu ar an gcóras sin. We do not have the discovery of a discordant, erroneous or otherwise inaccurate reading of the cancer screening sample as a notifiable incident. When the system was changed and the outsourcing happened it was Caoimhghín Ó Caoláin, almost alone, who pointed out that this would cause problems. He has not been given enough credit for his foresight on that occasion. If he had been listened to at the time, maybe many of the incidents would not have happened.

There should be a duty of candour and to make a disclosure. It is important to make this point again and again because the patient has the right to know. If this legislation about the anonymous programmatic audit was in place eight years ago, all those women would have been informed of the reading and would have been able to see it in their files. They would never have discovered it until they asked for a review. In the words of another, this legislation would have made sure that nobody would have found out what was going on with CervicalCheck, since people were not given the right to information unless they sought it.

Unfortunately, the Bill does not place an obligation on a clinician or service provider to inform a patient when the error or inaccuracy is discovered. No matter what type of information it is or how severe the misreading is, there is no obligation to tell anyone that something wrong was found. The Government is forgetting that patients are at the heart of this. We must protect the viability of the screening services. There will be about 250,000 screenings this year, which is welcome. We all want to see this grow but we must protect the rights of patients. We must have a national health service, like in England, which is free at the point of access. In the meantime, we must improve and expand medical card access to cover home care and palliative care.

When it comes to who is responsible for a person getting the truth, the burden should not be placed on the person who has cancer to ask. We must acknowledge the mistakes by clinicians and doctors in the past and not stand behind an approach which puts a responsibility on the patient to take the steps while placing no obligation, except after a request, on any clinician to make a proactive, open disclosure, whether about cancer screening or something else. One specialist who provides counselling said they see a State that pays lip service to acknowledge its mistake and that systematic failures are blocking and resistant to change, causing ongoing heartache.

Matt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I am incredibly disappointed that we are at this point. We have a Bill that should be unifying legislation. We support it in principle. Amendments have been tabled that, in and of themselves, are worthy of support. The difficulty is not so much what is in the Bill but what is glaringly missing, particularly the absence of a statutory duty of candour, from the Bill. Before this debate, I read some sections of Vicky Phelan's book, "Overcoming". I will read a short section of that which is from the period when this first came to the corridors of this House, when Vicky Phelan presented at the Committee of Public Accounts. It reads:

A short time later we found ourselves sitting in front of a row of politicians at the Public Accounts Committee. Me, Stephen and my solicitor Cian.

I was invited to speak first. I cleared my throat. 'If I do die, I want it not to be in vain. I want protocols to be put in place and sanctions for people who make mistakes and that the HSE is overhauled from the ground up, so that people are held accountable and that this will never happen again,' I said.

I told them my story, from the beginning, and everything that had happened over the course of the past year. 'The misdiagnosis in my case has cost me my life. I've got terminal cancer,' I said. I took a deep breath. 'I don't believe I'm going to die but I have to fight for my life every day.'

I outlined three issues that needed to be addressed: open disclosure (how could it be left up to individual doctors to decide whether or not to communicate information to their patients?), patient safety (we needed to rebuild trust in the system, to ensure this would never happen again) and responsibility of senior HSE management who approved the communication strategy regarding the audit results and whether patients were to be told about them (who was ultimately responsible for what had happened?).

'At least I'm still here to tell the tale and that's why I'm fighting with everything in my being ... I swear to God, over my dead body I'm going to keep at this. Simple as that.'

Cian O'Carroll, my solicitor, spoke of the 'coordinated, premeditated plan to deny patients the information'. 'Not in total,' he added. 'The documentation suggests that it was envisaged that some patients would be told of the audit, albeit quite late in the day.'

Those are the words of Vicky Phelan. They are the first challenge that she brought to this House, when she first presented at the Committee of Public Accounts. We have all spoken of our admiration. I do not believe that people of different political parties have any more or less admiration for what Vicky Phelan did in refusing to sign a non-disclosure agreement despite the strong pressure put on her to settle her case. The fact that she refused to do that is commendable. It is still a scandal that there has never been accountability for anybody who tried to force her to sign that non-disclosure agreement in the first place.

She set out, time and time again, what needs to happen, which is clear. In the cases of those people who are the victims of mistakes or whatever else might have happened, the clinician or service provider must be obliged to inform the patient of where an error, mistake or inaccuracy is discovered. It is as simple as that. We have listened to those people who are directly affected by these scandals and hear from them that the amendments the Minister has tabled do not resolve their concerns. He is continuing to tell everybody else they are wrong in their interpretation. It points to a fundamental problem that we have with accountability, transparency and appropriate communications with the people who are at the coalface of mistakes made by the HSE and the health services.

I appeal to the Minister to listen to what is being asked of him. Do not listen to us, since we are only politicians reciting what people have said to us. I ask the Minister to listen to them directly and to please make the necessary provisions so that we can have a Bill we can say, with hand on heart, will actually make a difference. It would have made a difference if it had been in place at the time when Vicky Phelan and others were so badly let down by the State. I make that appeal to the Minister once again because the rights of patients have to be paramount. Of course we understand that there has to be a layer of protection for the services, but there must be also a layer of protection for patients when they are failed. Otherwise, as history has shown us, when one allows a culture to exist which has no accountability for failures, they will continue to repeat themselves.

Before I came into the Chamber this evening, I met some parents who were affected by the organ retention scandal. Daily and weekly, we meet with families and individuals who have been badly let down by our health services. In some cases, it involved simple mistakes, gross errors in others, and extreme gross negligence in others. In all cases, it is hard to pinpoint where anybody is held accountable or where the necessary changes have been made without resistance from the powers that be. I ask the Minister to change that and to write a new chapter tonight by working with the Opposition to ensure we have a Bill we can all be proud of, that this House can be proud of, so that we can collectively say to Vicky Phelan and all those other brave women who told their stories that we heard them, listened, and acted accordingly. Nothing less will be sufficient.

Pat Buckley (Cork East, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I suppose the Minister is black and blue from listening to it, but I will cut straight to the chase. The duty of candour has to be put on a statutory footing. In the short few years I have been here, we have scandals including CervicalCheck, vaginal mesh, mother and baby homes, the mental health system and the disability system. It comes down to oversight, accountability and responsibility.

We are all working on this Bill together. That is the agreed basis. The Minister has heard most of us talk about it. If we cannot keep the onus on the service provider or the clinicians we are going back to where we started before. We will have nothing. People will lose faith in the screening services and we do not want that.

I will not mention any names but the patients are really at the heart of this. As I was listening to the debate I was saying to myself that we should not even be here. How hard is it to do the right thing? Let us break the status quo. Why is the Government so frightened? If we put the duty of candour on a statutory footing we will be nailing down accountability, responsibility and the oversight. It does not matter how big the mistake was or how far the actual incident had gone, it is about having the cojones to stand up and say we made a mistake and this person needs to be told the truth today. It is ludicrous that people are waiting on their screens to come back. I do not even think people are aware they actually have to ask for their results and whatever. If there is something wrong a person should be automatically told.

I worked on the protected disclosures legislation and one of the big changes in the Act that will be coming into force in January is the reversal of the burden of proof. Where somebody in a whistle-blowing situation made a protected disclosure, the person it was made to had no obligation to prove the whistle-blower was actually telling the truth. I raise that because with the duty of candour we are not forcing but putting it into law and doing the right thing by stating that people have a responsibiltiy in their jobs, whatever it is, and they will be held accountable. It is very easy to see when somebody is taking on this job that it is not a quick flip for money. I still cannot understand why we even outsourced these services when we have plenty of people well capable of carrying this out. It has been said many times that there is nobody on this side of the House, or any side of it, who has issues with the Bill, except for this one little thing. Paper never refuses ink, so the Minister still has an opportunity to change things and change them for the right. We cannot bring back any family members or anybody who has unfortunately passed but we can certainly take a giant step forward in doing the right thing. We can say we as a collective body passed legislation that had the core principles of proper oversight, proper accountability and proper responsibility, but with the responsibility on the service providers as well as on the patients.

I was reading though one of the notes, from which I will quote, "It was described by a survivor as like the tribunal all over again, nothing would be changed and we would have to look for it. That is not what we want, that we would actually have to look for our information". I appeal to the Minister. As I said, paper does not refuse ink. He can change things here. If we can nail down that duty of candour we will have done something right. My wife uses the services, as does my daughter. We want faith in them. You do not want something hanging over you just because of a technical glitch or because it was another word that was absent from this legislation. I appeal to the Minister. At the moment a service provider or clinician can sit back and say that if a patient does not ask them, they do not have to tell the patient. That is not proper legislation. There is a duty to say hold on, something is wrong here and to let that person or family know. It sounds like common sense but sometimes common sense - not even in inverted commas - comes into the House. It drives me bonkers and drives me mad. It is like self-regulation. If the Minister has the HSE investigating the HSE, we are not going to get accountability. We are not going to get proper oversight. I appeal to the Minister, if it is the only thing he can do, to ensure the duty of candour is on a statutory footing and that everybody involved moving forward will be held accountable if they do not do their job properly. Surely everybody should be responsible for what they do?

Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

As many Deputies have joined us, I advise amendment No. 1 to amendment No. 14 is also being discussed. It is in the name of Deputies Duncan Smith and Kelly. Amendment Nos. 1 and 2 to amendment No. 19 are in the name of Deputy Shortall and are included in this grouping. That is for the information of Members as it is not on the groupings list that has been sent around.

Darren O'Rourke (Meath East, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I welcome the opportunity to speak on this group of amendments and on this legislation. One of the central findings of the CervicalCheck scandal was showing up in lights the paternalistic nature of medicine and healthcare in Ireland. Ireland is not unique in that regard but we have a particular history, especially when it comes to women, poor people and people who are disadvantaged. In response to that, there are clear asks to address it. One of the things I took from the Scally report and this whole dreadful experience is there is a need for a culture shift. There is a need to address that information imbalance that exists between doctor and patient. It was at the heart of the CervicalCheck scandal and how these women were failed.

The absence of the statutory duty of candour is a glaring omission that does not address the key issue at the heart of the scandal. The question of whether we can go further and do better must be asked. We all appreciate these are complex issues, that there are considerations, that no two cases are the same but after everything that has gone on, after all the dreadful experience, this is a unique opportunity and we in these Houses are uniquely placed to respond, to address those failings and to introduce legislation and a process that is fit for purpose and at its heart constantly shows people their information is their information. It is about saying that exchange or transaction, for want of a better word, between a person and their clinician is an equal transaction. The person is not a part of a broader system. Their sample, their cells, their biopsy or tissue material is not in a system for the sake of developing and improving a system but is instead a central part of that transaction between patient and doctor.

At the heart of this is the need to ensure confidence in CervicalCheck. Central to the lack of confidence, or the hollowing out of confidence, is the experience of the scandal. Related to that was the decision to outsource cervical screening. I worked in our hospital laboratory system in advance of that decision. Through my role as a union representative, I , along with other medical scientists, could see clearly what was going to happen with cervical screening if it was outsourced. We also saw the motivation. It was a cost-saving exercise. Of course, the HSE had alternatives. It could have resourced cervical screening in Ireland but it did not. It was part of a broader strategy. At the time, we invited those private laboratories that we outsourced cervical screening to into Ireland. It was not just cervical screening that our Fianna Fáil and Progressive Democrats Government wanted to give them. It wanted to give them hospital and GP diagnostics as well. They now have facilities out on the M50. They did not come here to do private testing; they came to do public testing, and a Fianna Fáil-PD Government wanted to give it to them. It outsourced cervical screening, with detrimental impacts. Thankfully, thanks to the efforts of union representatives and workers, it did not outsource the public and GP work.

We need to re-establish confidence in the cervical screening programme by investing in and resourcing our laboratories. We need to repatriate cervical screening and bring it back. We need to do it in accredited labs. I recall the shock when people learned that many of the labs that cervical screening was outsourced to, and subsequently outsourced from the outsourced laboratories, were not accredited, but many of the laboratories in Ireland are accredited only on a voluntary basis. They are not supported or resourced adequately to be accredited. That needs to be addressed. We need to train up cytologists and we need to bring that work back to Ireland to give people confidence in it. We also need to establish this legislation and the process, to ensure that women can have confidence in the process so they know that when their cells and samples are in the system that they will have as much access to the information as their clinicians. To do that, we need a clear statutory duty of candour in the Bill.

Duncan Smith (Dublin Fingal, Labour)
Link to this: Individually | In context | Oireachtas source

Deputy Alan Kelly set out our position on a number of elements of the Bill, including notifiable incidents, anonymisation, lack of consultation with the 221+ group on the Bill itself and auditing. I will speak to amendment No. 14, which is in my name and Deputy Kelly's.

The Bill is trying to make open disclosure of certain incidents around patient care mandatory, but the quid pro quofor this open disclosure, such as it is, is that information or an apology given at an open disclosure meeting will be made inadmissible in any subsequent legal proceeding. That is a big element of the Bill. There may well be legal proceedings following on from open disclosures set out under the Bill and the use of open disclosure should not become a bar to legal action if harm has been done. As Deputy Kelly said, we cannot assume that everything is okay now. There will always be risks and people let down. That is why we need strong legislation and strong systems. We also need to ensure that open disclosure, such as it is outlined in the Bill, does not become a bar to legal action. Hence, our amendment is intended to make clear that the provision of information under the Bill to a patient who has suffered actionable harm would not become a bar to that information being admitted to a court in later legal proceedings if the information can otherwise be obtained in the ordinary way litigants use the rules of court in discovery of documents. I am interested in the Minister's response to our amendment. It is vitally important that this be accepted. This is one of many changes we think should be made to this Bill.

I turn to the duty of candour. In Dr. Scally's final report, published last month, there is a quote that has been repeated in this Chamber and elsewhere. He states: "The right of patients to know the truth about their health should be at the heart of all the interactions between health services, health professionals, and patients ... for a health professional, telling the truth to patients should be as natural as breathing." Those are the words he used in his final report. He went on to say that it was difficult to see how this Bill, as written a month ago, which is more or less how it is written now, subject to the amendments the Minister has tabled, would change things. Even with those amendments, that would not change. The duty of candour is not going to be delivered in this Bill. That fundamental cultural shift that is required to make disclosure as natural as breathing, which requires a strong legislative underpinning, will not be delivered in the Bill, with or without the Minister's amendments. That is why the Bill, unfortunately, is not fit for the purpose for which it is intended.

Chris Andrews (Dublin Bay South, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I certainly believe the Minister is working exceptionally hard. Every Minister works hard but the Minister for Health goes above and beyond in his commitment. I support the Bill. There are good things in it and it is an important Bill. However, it will not build trust in the health system, where trust is in short supply. It will not build trust in the cancer screening process or the CervicalCheck system. It will not build trust in any of those. As has been said previously, we have no issues with what is in the Bill or the amendments but we have an issue with the process and the absence of a statutory duty of candour in the Bill. There has to be transparency. Patients have to be at the centre of this legislation, and the health system. Patients are vulnerable by their very nature and they need to be supported. Patient rights are a crucial human right. Patient rights are essential pillars in providing good healthcare and promoting good medical practices.

A core element of patient care is to allowing patients to make decisions about their own care. To do that, they need all the information, whether it is good or bad, and they should not have to request that. There needs to be more clarity around the process. Patients are vulnerable; they are not well. They may have little family support. In my experience, particularly recently, I have found that medical practitioners can be quite dismissive of patients, particularly older patients. I have a letter from a woman who wrote to me who is in her mid-80s. In the late 1970s she went for a tubal ligation in a Munster hospital; one would imagine that this would have been a pretty standard operation. A number of years later, she found out that menopause was hastened due to the operation. She found out when she got the menopause that she had a" full ovary removal" in her words. She is still traumatised by it. At the time, she got on with it. She had young children and was under a lot of pressure. Even now, when she reflects on her life, she is traumatised by it. The fact that this happened without her knowledge was devastating and had a huge negative impact on her life. She wants to know what happened; she is still not sure. She is looking for that information.

This is replicated throughout the health system, which is why confidence in it is low. This lady was let down by the health system. She should have been told automatically. She should not have possibly found out by mistake years later. It is unacceptable. The Bill is being fast-tracked. I accept there is a time and place to fast-track legislation but this is not one of those Bills. We need to ensure that patient safety and information are prioritised. This is an important Bill. It does not place an obligation on a provider or clinician to inform a patient of the right to a Part 5 review at the point of diagnosis. This can and needs to be done; it is essential. If we are going to rebuild confidence in the health system and the cervical cancer screening system, this information must be automatic and there must be a process by which people can get information. It does not matter how this or any woman discovers that there was a mistake or a procedure was carried out without their knowledge. Patients need to be told. It is completely unacceptable. In the words of a survivor, this legislation would have made sure that "nobody would have found out what was going on with CervicalCheck".

The bottom line is that this is not giving everyone the right to information, unless they seek it. It does not place an obligation on a clinician or a service provider to inform a patient when an error, mistake or inaccuracy is discovered. Whether that is minor, within the margin of error or a severely negligent misreading, there is no obligation on anybody to tell anyone that they found something wrong. This is self-regulation. It will not work in the health system, which has been proven in the past. Self-regulation generally does not work and it certainly does not work in the health system. The right to information needs to be introduced.

Sorca Clarke (Longford-Westmeath, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

We have a number of opportunities here, which could not be any clearer. We have an opportunity to guarantee that we as legislators do all in our power to ensure that the cervical cancer scandal is never repeated; to introduce and provide true accountability and real transparency; and to give the 750,000 women who will have smear tests this year confidence that their needs, concerns and, in some cases, fears, have been addressed and that at no point in the future will there be another scandal. It is not only the women and families of today that need to have that confidence and trust but it is our daughters, nieces and the young girls whose mammies are sick or whose mammies have passed. Will this Bill give them that trust? Without the duty to report, I fear it will not. Nobody in this House wants any screening programme to be undermined.

I reiterate we have no issue with this Bill or with the amendments. The issue is with the process and the absence of a statutory duty of candour in the Bill, which does not place any obligation on a clinician to inform a patient of their right to a Part 5 review at the point of diagnosis. Let us imagine for one second a woman being told she has a cancer diagnosis and then imagine expecting that person to be in a frame of mind to request a review without that option being clearly put in front of her. It does not include the discovery of a discordant, erroneous or otherwise inaccurate reading of a cancer screening sample as a notifiable incident. It does not matter how it was discovered, when it is discovered or what difference, if any, it would make to a patient's condition; there should be a duty of candour and a duty to make a disclosure because the patient has a right to know. The bottom line is that this is not giving everyone the right to information, unless they seek it. It does not place an obligation on a clinician to inform a patient of an error or mistake or even an inaccuracy. Whether it is minor, within a margin of error or negligent, there is no obligation on anyone to say anything. "We can be asked", is a very different starting point from, "We must tell".

We have to protect the rights of the patients, which we see being eroded the length and breadth of our health service every day. There is doubt the Minister sees more than we do in his job. That is to our great shame and this country's great shame. When it comes to those with responsibility, it is on them to ensure the patient gets the truth. The burden cannot and should not be placed on the patient to ask that vital question at that moment in time. One cannot expect everything of the person who has been told she has cancer and nothing on the system. I ask myself if this Bill had been in place back in the day, would it have prevented the cervical smear scandal? I do not think it would have. I fundamentally disagree with the Minister on that. I do not believe it would have. Open disclosure is vital. We do not need another system that compounds hurt. We have the obligation this evening to do the right thing and ensure that no deaths, loss or suffering have been in vain.

Rose Conway-Walsh (Mayo, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I was glad to hear Sinn Féin party leader, Deputy McDonald, say this morning that she would work with the Minister in every way to get this Bill right. We have an opportunity and a grave responsibility to get it right. As everyone has said, there is no issue with the Bill itself and I welcome the amendments that have been tabled. Everyone across this House is attempting to do the right thing. We cannot leave this Bill without doing the right thing.

The question which seems to be glaring is: why is the system fighting against transparency and truthfulness? If there is one thing we can inject into the health service, it is that transparency. We have to get away from the position where the system is being protected and the patient does not come first. This has happened in so many matters. We have an opportunity and a responsibility to insert the duty of candour into the Bill. We cannot have self-regulation of issues and we cannot put the responsibility on patients to come forward all the time. We cannot expect the person to do everything and the system to fail them time and again.

I wish to speak to the wider issue of protected disclosures. This morning I raised the matter with the Taoiseach of protected disclosures that are in at the moment relating to the Western Care Association in County Mayo. Current and former staff within that organisation were brave enough to come forward to express concerns they had about the services. I wrote to the Minister some time last week. These matters arrived on my desk after I had read about them on the front page of The Mayo News. There are serious issues that need to be addressed. The reply I received to the parliamentary question that I tabled on the protected disclosures states: "The HSE does not share protected disclosures with the Department, therefore I am referring this to the HSE." I am concerned about that because we have to have accountability. We have to address these issues and give reassurance to families, service users and patients around how things will be handled. This afternoon I asked for a number of things to be done. I want to acknowledge the great work that is done by people in the HSE across the board and people within the Western Care Association. There are some excellent people who go above and beyond to protect the rights of those for whom they care. I have seen them do that throughout Covid-19 and outside of Covid-19. We have to have confidence in the system that if people working within that system see something wrong that they come forward. We have to change the culture of protecting the system. We must encourage people to come forward.

I want the Minister to guarantee that nobody will lose his or her job, that nobody will be exiled for coming forward with concerns and that families are not going to be disadvantaged by it, not only the families of the service users but also the families waiting to access the individualised services within the Western Care Association who desperately need those services. I am concerned that there is not an immediacy and there is not a completely independent and transparent process that can be taken up straightaway. However, this is not new. When the Wolfe report was done on the Western Care Association, one of the recommendations was to escalate individualised services to the organisation risk register. It pointed out significant risks. That was two years ago. The problem is that things are not done in a timely manner. I am still concerned that things do not happen. I need somebody to deal with this, to put up their hand and say, “I will deal with that”. The buck stops with the Minister and the Minister of State, Deputy Rabbitte, on this. I just want them to be open and transparent and for us in Mayo to have confidence in a service and an organisation that does so much good work. When matters are brought to our attention, we all have a duty of care. When they arrived on my desk I had a duty of care. I do not like doing this because of all the workers who are there but I have a duty of care to do that.

Does the Minister know that the same thing happened regarding the Valproate issue? I thank him for announcing the inquiry, for which we were grateful at the time. However, it is two years he announced there would be an inquiry as to who knew what, when they knew it and why nobody did anything about it when women were prescribed Epilim when there was a tonne of evidence to say what the impact would be on their unborn children. Hundreds of children and families throughout the State have been impacted by this. Children have been born with disabilities. The terms of reference for the inquiry have been agreed. We have one Cabinet meeting remaining. I ask the Minister to bring this to Cabinet to get that inquiry up and running. These are all examples of cases where nobody shouted “Stop”. Harm is being done. We have to stop harm being done in the health system. This is one such opportunity where we can stop harm being done by getting this legislation right. If we fail to get it right it will be a case of shame on all of us. I ask the Minister to listen. I do not always agree with Deputy Kelly but he said it is not fit for purpose and that it does not pass the Vicky test. I did not know Vicky Phelan but I do not think that this passes the Vicky test either. We have to honour her name and her courage by getting the Bill right and ensuring these things never happen again. That way the Minister would be acknowledged for doing that within the system and for being the one Minister for Health who shouted "Stop".

Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

We should not be here discussing this. That is how bad society is that we cannot take it as a given that when somebody, whether a clinician, a medic or even a company, discovers an error or misreading of such a vital test as a cervical smear test that they would immediately inform the patient. That there was an immediacy about that. The problem as we know far too well, and some people know to their detriment, is that there have been failures in the system not just here but abroad when we relied on public or private companies but even moreso when we relied on private companies and outsourced the smear test analytics, especially to companies that had been found guilty of fraud in the past. Back in 2008 I had the argument with the then Minister for Health, Mary Harney, opposing the outsourcing and the undermining of public laboratories in this city, and how that very move would undermine our ability to ensure testing would be carried out at the highest possible level. What was worse at the time was that the company that was granted the contract at the time, Quest, had paid out and was to pay out after that quite substantial amounts in a variety of fraud cases that it faced in America, some of which were because it defrauded the American State itself. Mar atá sé ráite ag daoine eile romham, níl fadhb againn leis an mBille seo nó leis na leasuithe. Táimid ag caint faoi bhfadhb bunúsach, sé sin an dualgas a bheith oscailte, agus nach bhfuil sé seo ar fáil sa Bhille. Mar a dúirt mé ansin, níor chóir go mbeadh muid ag déileáil le seo nó go mbeadh muid ag plé rud a ghlactar leis gur chóir a bheith uathoibríoch. It should be automatic that when an error is spotted in a medical procedure, it is immediately notified and, in particular, notified to the patient. That is what we are talking about. That is who we are talking about in the first instance. As others mentioned, self-regulation does not work. It has not worked.

We were here last night talking about self-regulation in the construction industry and we have seen the cost that has led to for the State. It is not the same cost as in this case, where it can be fatal, or while construction defects can also be fatal, these issues can be fatal very quickly. Patients need to know as quickly as possible what medical care they need, whether they need a new test, whether they need a course of medication and if that medication addresses the cancer. We are always told that the earlier a cancer is identified, the greater the chances are. If there is any delay or any hiding of results or mistakes in tests, as would be the case given the Minister is adamant about an anonymous programme audit, that could make the issue worse because we would not identify where the errors are, or we might identify errors but not the person who was the subject of the error.

As I said, the information should be immediate. We should expect nothing less, given what Dr. Gabriel Scally’s report, the survivors and those who are no longer with us outlined as they watched this issue unfold over recent years.

Mar a dúirt mé ag an tús, caithfidh an dualgas a bheith orthu siúd atá ag obair sna labs ar fad thar lear, agus fiú amháin orthu siúd atá ag obair anseo in Éirinn sna hoifigí leis na comhlachtaí atá ag próiseáil na dtrialacha nó na dtorthaí sin. Is orainn ar fad a bheith oscailte nuair atá botúin déanta. Tá níos mó measa ag daoine orainn nuair a dhéanaimid é sin agus sa chás seo is é an rud atá á dhéanamh ná an rún diamhair nó an rún féin a chothú sa phróiseas atá leagtha amach anseo, i dtreo is nach mbeidh muinín ag daoine sa chóras atá os ár gcomhair. Beidh botúin eile ann, beidh míchruinneas, agus b'fhéidir go mbeidh mná ag casadh ó na trialacha seo a fháil toisc nach bhfuil muinín acu iontu.

One of the key things we need to ensure is that those who are going for cervical smear tests have confidence and if there is anything that will undermine that confidence, we need to address it. I believe that, without the duty of candour, the proposal before us will undermine the confidence of women who are going for these tests. We need to address that and make sure they have full confidence that where errors, mistakes or missed readings are identified, they will be informed straightaway. If there is any doubt of that, or if that does not happen, confidence erodes and the whole system based around cervical smear tests begins to erode and fail.

Seán Crowe (Dublin South West, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Most fair-minded people do not believe that doctors are infallible and they accept that mistakes are made. They are made every day, as we know, but doctors do not only make mistakes, and they make positive calls in regard to diagnosis in the majority of cases. What is galling for many people and what they do not accept is that the truth behind mistakes being made is denied to them. That is the nub of the issue for many of us in the Opposition.

The real fear I have about the legislation is that we are cementing a system that allows errors and inaccurate readings to be swept away and never disclosed to patients. It locks in a system that was already in place in 2014 when the CervicalCheck smears were missed. Under this Bill, as I read it, there will be no obligation on anyone to disclose that they ever made a mistake. Maybe I am wrong on that, but that is my reading of it. What are survivors saying about the Bill? They are not expressing confidence in it, that is for sure.

The question I am asking is whether we have learned anything. Patients could be left for years not knowing what is wrong with them or why they are feeling unwell. I can talk about my own situation. I knew at one stage that I was not well. I went into the medical system and I was told that clear was white, cancer was black and, in my situation, I was grey. For many years, that is what I was told by the system. I went for an MRI at one time and I was told not to worry and to come back in 12 months. I still knew there was something wrong and I knew my own body, so I went to try to get a second opinion. I went for another biopsy. When I was getting the second biopsy, which I did not particularly want as it was very uncomfortable, I was told that I would not get a second opinion. Lo and behold, after that biopsy it turned out I had cancer, and that is when my story began. Mistakes were made along the road but I do not think anyone ever came to me and said they made a mistake on that. Clearly, the MRI was read wrongly and if I had accepted that, I probably would not be here to speak tonight. Mistakes are made.

The waiting list crisis is such that if someone has a misread or erroneous scan, it will take months or even years to secure another one. I can give an example of someone I know who was in the hospital system. He had worked all his life. He had what they called a broken back and he was in extreme pain and on morphine-based medication which he tried to come off. He learned two years later that he was supposed to get pain injections and due to an oversight, he never got them. Again, mistakes are made.

Half of cancer treatment is learning to live with cancer, the effects on the body and how to fight the worst of its effects. The big journey for a lot of people is getting that news and how they respond. It cannot be said often enough that patients need absolute candour from the medical professionals who are in charge of their care. Real harm is done in the absence of candour. The question we are asking is why we are going down this path. The system does protect itself. It is hard to get one doctor or clinician to go against another, as we know. In many cases, people have to go to Britain or abroad to get one to give evidence against the other, and there is a cost involved in that.

We heard this week of the fear that some clinicians have about litigation and being sued, and we know how much the State Claims Agency pays out each year. The question is whether we are bound by that. Is that the reason we are not opting for absolute candour? As I said, the system protects itself. The system can afford the best of lawyers. There is no balance in regard to the people taking those cases because the power is on the side of the State. Is it the case that candour has been put on the back burner in regard to this legislation? If so, we are forgetting that patients’ needs must also come first. I do not understand how this Bill serves those needs. It may be better than nothing but there is a great deal that can be done to improve it. That is why we are all here tonight.

The House is split on this issue. I believe many on our side of the House and on the Minister’s side share these concerns. While we might say patients can always ask for a review, why is the burden placed on the cancer patient to ask the questions of their doctor or consultant? When many people hear they have cancer, they cannot think of anything else and their mind goes blank. When people are landed with a cancer diagnosis, who is going to be thinking about a Part 5 review or anonymous audits? Patients need to have full confidence in the medical system. They need to have faith in our doctors, nurses and consultants.

I do not believe the Bill gives anyone confidence. What has changed? That is the question hanging over us tonight. What have we learned? I am sure there are people at home watching these proceedings who are asking the same. It is a fair question.

Martin Browne (Tipperary, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Have the Minister and others on that side of the House already forgotten about Vicky Phelan and the statements we all made in this Chamber when she died? We talked about what would happen and what would be done for women. The Minister has a unique chance to bring in legislation that covers all situations. I have no doubt he would have the backing of all Deputies on this side of the House if he did so.

I listened to most of the debate from my office. It has been repeated all evening that no one has an issue with the Bill or the amendments. The problem is the way the Minister is dealing with the Bill, as well as the absence of a statutory duty of candour. That can be changed very easily. It can be changed tonight by the Minister. The Bill places no obligation on a provider or anyone else to inform a patient of his or her right to Part 5 at the point of diagnosis. There has to be a system for notifying patients of their rights. That could be done through the National Cancer Registry.

The Bill does not specify that the Minister should prescribe how the review is done. It is like self-regulation. The Government does not need to be reminded by Members on this side of the House where self-regulation got it with housing, banking and all that. The last thing we want in this situation is for self-regulation to lead us down a road down which no one wants to take. The Bill does not even include the discovery of something having gone wrong or an inaccurate reading of a cancer screening sample as a notifiable incident. The Minister might be able to explain to us why that is so. How or when it is discovered should not matter in this context, although it might make a difference to a patient's condition.

There should be a duty to make a disclosure. All the women to whom we have spoken have the right to know that information. There should be no question about that. If this legislation was in place in 2014, Lorraine Walsh, Vicky Phelan and all the other women would not have been informed of any wrong that was done or any wrong reading. They would not have been able to see it in their files. It would not have been discovered until they asked for a review. Has the Minister not listened to any of the survivors? They have said it is like the tribunal all over again for some of them. Nothing will change. They would have to look for a review. That is not what they want. They have made that clear to us over here and I am sure they have done likewise to those on the other side of the House. In the words of another Deputy, if this legislation had been in place in 2014, nobody would have found out what was going on with CervicalCheck. The bottom line is that it is not giving patients the right to information unless they seek it. That should not be the case. The last thing on the mind of patients who get that sort of diagnosis is to ask those kinds of questions. The Bill does not place an obligation on a clinician or providers to inform patients when an error has been made or discovered. They should be big enough to bring that information forward straight away, and the legislation should be there to ensure that happens. It should not matter whether it is a minor error within a particular margin of error or a severe negligent misreading. If there is no obligation on anybody to reveal that they found something wrong, nothing will change and we will have the same conversations over and over again. The biggest scandal is that if we do not introduce regulations now to ensure the information has to be given to patients, we will finish up back here again.

The Minister can argue that the anonymised audit means it is not possible to identify a patient whose slide reading is discordant, but that would be possible if the system was designed to allow for it, especially in the case of a severe misreading that is outside the acceptable margin of error.

Patients have to be at the heart of this. I agree that we must protect the viability of some of the services. There will be approximately 250,000 CervicalCheck screenings this year, and that is welcome, but the rights of patients have to be protected and that has to come across in the legislation with which we finish up. The burden of responsibility for ensuring the patient gets the truth should not be placed on the people who have cancer. They should not have to ask those kinds of questions. The burden must be placed on the clinician and providers to produce the evidence to the patient.

I am not going to say much more because I am only repeating much of what has been already said. In the words of a specialist who provides counselling and support for women affected by the CervicalCheck scandal, the State pays lip service to acknowledging its mistakes, yet systematic failures are blocking and resisting change, which is causing ongoing heartache and trauma. The bottom line is that it keeps adding to the suffering of the women they meet. It is in the power of the Minister to ensure that this legislation is done as Vicky Phelan and others asked for it to be done and that no other woman goes through what she did. She fought right to the end for herself, and especially for others in the system. The Minister has a chance to change the Bill and to do the right thing by these women. I appeal to him not to let them down, as previous Ministers have done. I ask him to ensure that a statutory duty of candour is included in the Bill. This is his opportunity to make a good statement, one that can be supported by all on this side of the House.

Pauline Tully (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

As many of my colleagues have stated, this is not about the Bill - there is no issue with the Bill - or the amendments. It is about transparency and ensuring mistakes of the past are not repeated. A doctor or clinician should be obliged to inform a patient of the right to a Part 5 review at the time of diagnosis, but that is not the case under the Bill. The Bill does not provide for a statutory duty of candour. It does not place an obligation on the doctor to inform the patient where an error was made or an inaccuracy discovered. It does not matter how big or small the error is; every woman has the right to know that information about a test result. We want to encourage as many women as possible to undergo smear tests and avail of screening but those doing so need to have confidence in the system. They have rights, and those rights must be protected. If mistakes are made by a doctor or service or the system, there must be a forthright acknowledgement of those mistakes.

It is not fair to put the responsibility on the patient but place no obligation on the clinician or service to make an open disclosure where a mistake has been made. That applies to all screening services or tests of any sort, whether cancer screening or otherwise. The onus should not be on the patient to request a review, reply or explanation. It should be her right to receive that. The Minister argues that the anonymised audit means it will not be possible to identify a patient where a slide reading is discordant, but the system could be redesigned to allow for that, especially in the case of severe misreadings that are outside the accepted margin of error.

So many people have been failed by the health service. The biggest hurt of all is the failure of the health service - the HSE or individual hospitals - to acknowledge mistakes, give people answers or issue an apology. Instead, people are being forced to go to court to get the truth. They are put through a lengthy legal process, often at a great financial cost but a bigger emotional toll, to get truth about an issue that affects them or their family. I have heard from families who lost children in childbirth or whose child is severely disabled due to mistakes made at the hospital. As well as dealing with the loss of a child in some cases, they are dealing with a wall of silence in respect of what happened. That forces them to go to court. The same is true for families whose members had organs retained without their knowledge or agreement. Again, they receive no answers. It is just not fair.

There is a need to pass the Bill but we, as legislators, must ensure it is thorough before doing so. That will ensure the mistakes of the past cannot be repeated. We need a better system going forward and we need to give people confidence that the health system will be better in the future than it was in the past. Mistakes will be made, but they must be acknowledged, owned up to and explained to the people.

Mary Lou McDonald (Dublin Central, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

As has been said by others, it is very important that we get this legislation right. It is important legally that we have clarity and we are clear procedurally that what we are agreeing to will work. This is because, of course, women and their families have had the awful experience of the CervicalCheck scandal but as my colleague, Deputy Tully, referred to, that is not the only scandal, and the only hardship and heartbreak, that has emerged as a result of the resistance of the system or systems to simply provide information.

I recall that this legislation is all about the provision of information. It is not about malpractice, or establishing negligence or any of those things, which require separate legal processes, as the Minister is aware. In that spirit, we need to come at this looking to maximise information flow and access to information for the woman and the patient. I say that because, culturally, within the system the reflex action is not to tell. We have all of the evidence of that. I do not know whether the Minister agrees with that assessment but the evidence shows us that the system is conservative or anxious to protect itself, to protect its staff and not to tell. Furthermore, even when mistakes are established, the system's next reflex is to fight those odds, very often through the courts. The women and their families have had that experience. Indeed, some will go into court tomorrow on this. I understand Stephen Teap, the widower of the late Irene Teap, is in court tomorrow. Such legal action is the second instinct. We have to be very real in formulating this legislation. We have to provide the legal basis and the procedural certainty but we also have to be real about the culture in which this legislation will operate.

The reason we are zoning in on this legislation and taking the Minister through his paces on it is simply that we want to be sure that we get it right. There are several parts of this legislation we do not believe that he has right yet. We want to work with the Minister to correct that. A positive duty of mandatory disclosure and candour places the onus and burden of responsibility on the system, clinician and service provider. That is what it does. If it simply places an onus or burden on the woman, or the patient in the case of other screening services, what is that? Not just legally but operationally, what does that say to the system?

The right to review, which I acknowledge was widely consulted on and this is the advice the Minister has been given, is an excellent opportunity for women and patients. However, it is problematic that the legislation does not state, as a matter of obligation, that the woman or patient must be told and informed of their right to that review. The Minister should correct that in the legislation. His proposal to move to an anonymised - I struggle to say that word - look-back or audit is also problematic. If we think about it, in legislation and a system that is all about recognising the right of individuals - not numbers or statistics but real women and real patients - to their information, is there not something kind of ironic and almost inappropriate in anonymising, in totality, that process? That is a mistake. In fact, if we think about Vicky Phelan's experience, and her name echoes throughout this debate, had the look-back been anonymised at that stage and, of course, it was not, would the information regarding the error in reading her slide ever have found its way onto her medical records?

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

If she had wanted it to.

Mary Lou McDonald (Dublin Central, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

No. She was entirely unaware. That review process is a separate issue. In an anonymised scenario, would that information have found its way onto her files? The answer to that question is "No".

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

It is not.

Mary Lou McDonald (Dublin Central, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

The answer to that question is "No".

If there is concern around an entirely anonymised system, a halfway house can be found on that. The Government can give women and patients choice in respect of any future look-backs as to whether their sample or slide would be anonymised. I suggest, and my instinct is, that most people, when we talk about information, clarity, transparency and accountability, would prefer that the system not be anonymised. I am not convinced by the argument, and I have heard it rehearsed, that if the look-back is not anonymised it will collapse the whole screening system. I do not buy that because I remember a time when all the controversy, and the women speaking out and defending their corner, was also cited as a potential danger, menace or jeopardy to the entire screening system. Not alone did that not prove to be the case, as a matter of fact, and the data reflected it, more not less women went for screening. All of us on all sides of the House, and Deputy Tully said it very clearly, want people to avail of the screening services.

I hope the Minister will agree to further amendments to this legislation. I do not think he has got it to a point where we could, hand on heart, say this does the job. I had the opportunity to talk to some members, though not all, of the 221+ group. They share many of the concerns, and more concerns than I have expressed, in respect of this legislation. I appeal to the Minister to open his mind and move to correct the deficiencies in the legislation.

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

My understanding is I have two minutes to respond. I acknowledge that is a constraint we have on Report Stage. Obviously, two minutes are not sufficient to address all the very reasonable issues raised. As I heard it, broadly, many different issues have been raised about many different parts of the Bill. I will confine my comments to Part 5, referenced in this amendment to the Bill, which we are speaking to.

Essentially, what I think I heard expressed, maybe not by everybody but from colleagues around the House, is there is broad support for the Bill and the amendments. That has been stated repeatedly. Members do not have an issue with the Bill or the amendments. Two additional issues are being raised. One is around the programmatic audit and whether it should be anonymised or not. The second is around an obligation within the Bill, as opposed to an obligation within standard operating procedures of the HSE, to inform a patient - a man or a woman because this will apply to all screening services - of his or her right to a patient requested look-back, for which there has been broad support. I will try to deal with those issues. With the Acting Chair's indulgence and the agreement of the House, I will take a little longer-----

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Agreed.

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

-----if that is okay, to address these issues because I cannot do so in two minutes. With regard to the look-back, the advice to Government and the Government position is being led by many years of domestic and international expertise, which indicates that programmatic audits are learning audits. We know they are now used all over the HSE in all manner of clinical areas every day.

They are used by clinicians to get better at identifying patient safety issues, detecting cancers and so forth. They happen every day. At an informal meeting of the health committee today, there was a briefing at which Dr. Colm Henry, the HSE's chief clinical officer, made the point that anonymised audits were used as standard practice in health systems around the world. The Madden report in 2008 stated powerfully that our public health service had to have these learning or programmatic audits and that we always had to be improving what we were doing. It recommended anonymising audits. We have covered some of the reasons for that.

I accept that there is no perfect answer to this situation and that reasonable points have been made across the floor. The advice at the time was to anonymise the audits. Importantly, the expert reference group that was set up following Dr. Scally's report strongly recommended anonymisation of the audits. The view of the UK's National Institute of Clinical Excellence, NICE, which is held in high regard internationally in this respect, is that audits should be anonymised. I asked officials to examine other countries around the world that were considered to be good at this. What I have heard back from country after country and institute after institute is that these audits should be anonymised.

Probably of most importance is the fact that the WHO will publish a view on this matter early in the new year. Ireland and many other countries are involved in its work. We will wait to see what the WHO says, but the indication I have from my Department is that the WHO will also be suggesting that the audits be anonymised because they are learning audits. We have discussed several reasons for doing this, one of which is that clinicians need access to all of the data. They use aggregated data. Dr. Henry stated that people used a great deal of different information. It may be information that no one sought consent for or information that we do not need today but clinicians decide in five years' time is useful. It means that the people running the audits and our doctors have access to the widest possible amount of information so that they can provide the best quality service for patients.

There are other reasons. Deputy Shortall asked whether we had a sense of whether patients who were given the choice in the UK actually wanted a review of their slides. I believe the officials stated that approximately 40% to 50% of women said "Yes". Critically, the other 60% or 50% did not. If we conduct audits on an ongoing basis - they should be done across the system every day - and we do not anonymise them, the patient must be told if discordance and errors are found. However, approximately half of those patients might never have wanted to know that information. This is something that we must balance. There is no perfect answer, but the answer is to put it entirely in the power of the patient.

Everyone has supported the patient review process that is in place. There has been a reasonable request that we amend the Bill to make that mandatory. We do not normally legislate at that level of operating procedure, but we are all aware that there is a unique context to this.

Various Deputies referenced the culture. It is changing. Deputy McDonald asked whether I have faith in a culture of open disclosure. I believe that many important changes have been, and are being, made. In terms of open disclosure and culture, for example, we have this Bill. It will not answer everything, but it plays an important part. Once the Bill is in place in January, the HSE will publish a new national framework. Ms Noeline Blackwell is chairing and leading that work. The HSE's open disclosure policy will be updated in line with the framework and the framework will be cognisant of this Bill. There is a national open disclosure office now when there was none previously. There is also mandatory open disclosure training within the HSE now. I am happy that more than 90% of clinicians have undergone this training, but that figure needs to be 100%. The professional bodies-----

Marc Ó Cathasaigh (Waterford, Green Party)
Link to this: Individually | In context | Oireachtas source

I am mindful that we are well over time on this grouping, but I am agreeable to allowing more time if Members wish to permit some leeway. Is that agreed? Agreed.

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

The professional bodies have their own guidelines. In his latest report, or perhaps it was in a conversation I had with him before he published that report, Dr. Scally stated that some of those guidelines should be better and tighter. This is another matter that can be examined.

HIQA's standards are being updated with a view to the new national framework. We have the patient advocacy service, which Deputy Cullinane references in some of his amendments. This service is being invested in more and its remit is expanding. Yesterday, Dr. Henry launched a new HSE process, entitled "Better Together: The Health Services Patient Engagement Roadmap", which is concerned with creating a culture within our public health service whereby our healthcare professionals work hand in hand with patients. Is all of this perfect and has everything been done? No, but I hope that colleagues will agree that it represents a real effort by the HSE to do things differently and to acknowledge the shortcomings of the past.

This brings us back to an earlier point. Given the circumstances, I would be open to amending the Bill to make it an obligation that the patient be told. While I accept there are different views on programmatic audits, the Bill's provisions will at least address the fact that such audits are for learning. We can have different views on whether they should be anonymised. For every discordance, all patients on every screening programme would be told that this appropriate process, which they were in control of, was available. Part 5 would make it mandatory that the results be disclosed to the patients.

We are on Report Stage. I have had a quick chat with the officials about whether we can make a simple amendment or if it will require something more complex. I would need a little time - I do not know how much yet - to discuss this matter and for the Department to work through it. One option might be to amend the Bill in the Seanad, after which it would return to the Dáil. Another option might be to amend it next week in the Dáil. With the best will in the world, and if we were all agreeable to making such an amendment, my sense is that it would probably push the Bill's final stages and its signing by the President into January. We could do it quickly. I would be curious to know what Deputies think.

No one is trying to play politics this evening. We have to get this right. We cannot do everything that everyone wants - various Deputies have been clear on what they believe and we have heard the views of patient advocates - but there may be ways of amending the Bill to reflect some of what people have called for. However, I will not reflect calls where the international expert advice I have states that the patient safety call means anonymised audits.

I am curious about colleagues' opinions. While we may get the Bill through next week, that may not be possible, given the timelines. We have all made commitments. When Deputy McDonald asked the Taoiseach, he gave a commitment. He took it seriously, which is one of the reasons we are debating the Bill now and are scheduled to debate it again next week. If we all agreed it would be okay to move the Bill to January, we should consider doing so.

Róisín Shortall (Dublin North West, Social Democrats)
Link to this: Individually | In context | Oireachtas source

Before the Minister sits down, perhaps he will clarify something. It could be significant.

Marc Ó Cathasaigh (Waterford, Green Party)
Link to this: Individually | In context | Oireachtas source

Deputy, the Minister will contribute again later.

Róisín Shortall (Dublin North West, Social Democrats)
Link to this: Individually | In context | Oireachtas source

Given that this is potentially quite significant, I ask the Minister to clarify the area in which he is prepared to consider an amendment.

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

The ask would be that it would be an obligation within the Bill, on a statutory basis, for patients to be informed that this patient-requested review is available to them. I think this is what is being requested. We would also-----

Róisín Shortall (Dublin North West, Social Democrats)
Link to this: Individually | In context | Oireachtas source

Informed rather than-----

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Exactly.

Marc Ó Cathasaigh (Waterford, Green Party)
Link to this: Individually | In context | Oireachtas source

The Deputy will have a further two minutes and the Minister will have another chance to respond at the end. I call Deputy Cullinane.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

The very fact that we are now looking at an amendment which might take some time to be crafted is a vindication of what we have been saying, which is that we need to go through this legislation properly and thoroughly and get it right. I welcome the fact that there has been movement on this issue. This makes sense because it places a legal obligation on the clinician to inform a woman who is diagnosed with cancer - which would involve trauma for any woman, or for any patient for that matter - that there is now this entitlement. This is an important amendment and we would support it. If it takes until January to do it, then the women, and patients generally, would say it would be better to get this right rather than rushing it through now. My view is that if this is what it takes, this is what we should do. It is unsatisfactory that we are in this situation and that I have just two minutes to respond. We are all limited in our time because this is Report Stage.

To return to the anonymised audit, it seems we are not going to agree on this. The Minister said that up to 50% of women may not want to know if there is a discordant reading. He may be correct; I do not know. I imagine it may be higher in Ireland because of what happened in CervicalCheck. Whatever the percentage, there are some women who may not want to know if there is a discordant reading. For this reason, it would be wrong to have an unanonymised system. The opposite of this, however, concerns the question of what happens in the case of the 50% of women who want to know. We are not giving them a choice other than through this patient-initiated system. There is no automatic obligation on the system to inform women if there is a discordant reading. I have spoken to the Minister about what I think is a logical system. We can create whatever system we think is best for us, including a bespoke system that creates a choice to opt in or to opt out. If there is a discordant reading and the system comes across it, for whatever reason, whether as part of a look-back, an audit or a lab coming across an error in any other part of its work, the question asked would be whether the patient wishes to be informed. This would give the women a choice and it would have been a better system. It is regrettable that the Minister is not minded to accept this suggestion. However, I acknowledge that the amendment the Minister is proposing is one we would support.

Róisín Shortall (Dublin North West, Social Democrats)
Link to this: Individually | In context | Oireachtas source

How long do I have? Misinformation was circulated earlier about-----

Marc Ó Cathasaigh (Waterford, Green Party)
Link to this: Individually | In context | Oireachtas source

We will have a second round and the Deputy will be allowed two minutes.

Róisín Shortall (Dublin North West, Social Democrats)
Link to this: Individually | In context | Oireachtas source

Yes, but my amendments were not included in the grouping in the first advisory we got. This had to be corrected well into the debate.

Marc Ó Cathasaigh (Waterford, Green Party)
Link to this: Individually | In context | Oireachtas source

The speaking lengths for Report Stage are seven minutes in the first round and two minutes for the second round-----

Róisín Shortall (Dublin North West, Social Democrats)
Link to this: Individually | In context | Oireachtas source

I was not informed that my amendments were being taken.

Marc Ó Cathasaigh (Waterford, Green Party)
Link to this: Individually | In context | Oireachtas source

-----regardless of whether the amendment is in the name of the Deputy.

Róisín Shortall (Dublin North West, Social Democrats)
Link to this: Individually | In context | Oireachtas source

I do not think that is correct. All this debate and the discussion earlier at the briefing indicate that this is an exceptionally complex matter. It is, literally, one of life and death. It goes to the heart of some significant issues within healthcare, the right to know and the duty of candour. It underlines how inappropriately this has been handled in the sense of being rushed and all these amendments being supplied to us at the last minute, with no briefing and no pre-legislative scrutiny.

I have two amendments in this grouping, which are somewhat different, but I would like to add my voice to the statement that it is more important for us to get this right than to do it quickly. If the Minister is proposing opening this legislation up again and allowing for proper interaction, perhaps outside this House, by way of briefings etc., or perhaps in the Joint Committee on Health, that would probably be a better way to tease out the implications of the legislation, with a view to getting it passed by January. I am certainly in favour of that approach.

Regarding my amendments to the Minister's amendment No. 19, concerning the statement in respect of the procedure for open disclosure under Part 5, where section 41(2), without prejudice to the generality of section 76, states now that the Minister "may" make guidelines, I am proposing that the "may" be changed to "should". Similarly, regarding section 51(1), concerning the review information, where the text reads that a health service provider "may" at any time during the holding of a Part 5 review provide information on the guidelines, my amendment would change this to "should". I propose that these two changes be made to put the onus on the healthcare provider, rather than leaving it open where it may be argued. This is also vague, and there should be no place for vagueness in this legislation.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I welcome the Minister being open to amending this legislation. Without meaning to point fingers, or anything like that, this may be some acknowledgement that a bit more time is going to be needed to get this right. I am minded to recall what was said earlier regarding Stephen Teap and Lorraine Walsh. They have said that this legislation does not pass what was referred to as the Vicky test. If it is the case that we are agreed that we can work together, and it was said I do not know how many times during this debate that nobody wants to get this wrong and that we all want to get it right, I am still reminded of the debate on the termination of pregnancy legislation, which the Minister might well remember. We all came under tremendous pressure then to get it done, get it in and do it quickly. Now, we are returning to the legislation to talk about safe access zones. I submitted an amendment on safe access zones which we did not get to and which was not discussed. Indeed, we were pressured by outside organisations, as was the Minister, that quite disgracefully encouraged and urged us and twisted our arms up our collective backs to withdraw amendments we knew were good ones and represented the right thing to do. We are now back again to try to legislate for safe access zones. We need to dispense with the practice of trying to rush Bills through at the end of every year, even if what we are dealing with concerns good and worthwhile projects and everybody wants to get them done.

We need to take time to reflect on this legislation, to get things right and to be mindful of what Lorraine and Stephen are saying concerning what they want, because they have been through this. They are the people, as well as the medical and legal experts, who must be our guiding lights in this process. If we are recognising that a bit more work needs to be done, then this is welcome. Everybody here has, I think, indicated they are willing to work with the Minister. I am very much conscious that we attempted to make amendments to legislation previously and now these amendments have to be revisited. This is happening now, when we could and should have done this earlier and taken the time to get it right.

Ruairi Ó Murchú (Louth, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

It is fair to say this is far from the perfect circumstances in which to deal with an issue such as this and the gravity relating to it. In fairness, Deputy O'Reilly has stated that where mistakes have been made previously, there is no room for shortcuts. We must ensure we deliver on the promise we owe to Vicky Phelan and to many others who have been failed. We must also ensure that we instil some level of confidence in the necessity of having the CervicalCheck programme and cancer screening in general. Like everybody else, I welcome the Minister having come part of the road by accepting that we need to lay down in the legislation that there is an obligation on the clinician, or the system, at the point of a cancer diagnosis to ensure patients will be told. There should be no doubt whatsoever that it would be a necessity for patients to be told that the option of a Part 5 review is open to them. In fairness, Deputy Cullinane has dealt with the point that we are still not particularly happy regarding the anonymised audits. I understand the point the Minister is making concerning the necessary lessons to be taken on board by the system and by wider systems. We are talking about data analytics that are absolutely necessary.

It is far from impossible, however, that anywhere between 40% and 60% of women who use these services might be quite happy and might want to get the details of results, even regarding the terrible news of a discordant reading. If we are going to take the time, and the necessary time, to ensure we have a fit-for-purpose system, we must look at all the questions which exist. We owe this to the many women who have been failed over many years. We must ensure we deliver a system that is fit for purpose. I welcome that we are somewhat further along the journey now than we were earlier.

Donnchadh Ó Laoghaire (Cork South Central, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

It is, unfortunately, all too rare that debate changes opinion in this House but I welcome the fact that the Minister is listening on this occasion and has moved to an extent. It has been clearly a worthwhile endeavour to have the additional time to debate and tease this out.

The Opposition has had an opportunity to clearly articulate the position and the reservations that exist. I suppose it is not only this one reservation; there are several others and we will return to some of them. The Minister has comprehended that and is reacting. We will have to see in black and white exactly what that means and how that will work through the process.

In relation to the point about the anonymised and semi-anonymised audits, if we are moving to a greater element of candour at one end, we need to make sure the system is fully geared towards that at the back end as well. The semi-anonymisation is more in keeping with the spirit of that but it is preferable in more practical terms too.

The other point I would make - the Minister has acknowledged it to some extent in the context of the first proposed amendment he is considering - is that the circumstances here are different than they would be in other places. The public confidence issues are significant but within that, there is scope for this jurisdiction to be a leader. The Minister has expressed that desire on numerous occasions. We want to make sure that our learnings from everything that happened to the late Vicky Phelan, the late Emma Mhic Mhathúna and their families gives us the platform to have one of the best systems. In any decision that we are making, of course we need to be conscious of international evidence, etc., but we should also be conscious of our ambition for the screening programme.

Patricia Ryan (Kildare South, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Everybody who spoke earlier had an issue around the absence of a statutory duty of candour in the Bill. I am asking that this be addressed also. What I really want to say is there should be an obligation on the provider clinician - I am glad that the Minister has mentioned that - to inform a patient of her right to a Part 5 review at the point of diagnosis. We owe it to Lorraine Walsh and Vicky Phelan, and all those other women, to do the right thing. We cannot expect everything of the person with the cancer and nothing of the system. The responsibility is to ensure the person gets the truth. We must ensure we do that. We are elected to this House by people who want us to do a job. By sitting here and not getting this legislation right, we are doing the electorate a disservice. We cannot continue to do this. We cannot continue to rush through legislation for the sake of rushing it through and not get it right. I welcome what the Minister stated about the obligation.

Marc Ó Cathasaigh (Waterford, Green Party)
Link to this: Individually | In context | Oireachtas source

I am trying to following the initial order as closely as I can. Did Deputy Carthy want to contribute?

Matt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Yes.

Marc Ó Cathasaigh (Waterford, Green Party)
Link to this: Individually | In context | Oireachtas source

The Deputy would be next on my list, in that case. I can come back to the Deputy, if he needs a moment.

Matt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Yes.

Marc Ó Cathasaigh (Waterford, Green Party)
Link to this: Individually | In context | Oireachtas source

That is fine. In that case, I call Deputy Buckley.

Pat Buckley (Cork East, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I, too, welcome this debate. It was not too long ago we were arguing about the duty of candour. I recognise that the Minister will look at the Part 5 review and strengthen that. What this House is about is debating it. We are all trying to sing from the same hymn sheet here.

I was a little surprised when the Minister was on about the 50:50 for yea and nay on the audits. That is something, I suppose, that can be tweaked.

One of the other speakers mentioned going back to the Select Committee on Health with some of this. The Minister said he is worried about the timeframe. It is a sensitive Bill but if it needs time, we should treat it with that respect.

As I said, my big bugbear here is still whether we can put the duty of candour on a statutory basis. We need this Bill to be as strong as possible. As I stated previously, there is very little oversight within the HSE. There is very little responsibility. If something goes wrong, nobody is held accountable. We need that accountability. We need that strength in the background.

As I said at the start, I am looking forward to the debate so that we can get something right. If we get this wrong, it is a legacy that all of us will have to live with. I would much prefer if we tweaked this out a lot more and continued the discussion. Hopefully, this Bill will come out as one of the best Bills that ever came out of the House and serve the people of this country. That is what we are supposed to do.

Darren O'Rourke (Meath East, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I welcome the points that have been made in terms of the engagement, the movement on behalf of the Minister and the need, if required, for additional time. I welcome that there seems to be some movement on the part of the Minister but the devil will be in the detail. Programmatic audits are not a new concept in the HSE or elsewhere. The question is what those programmatic audits trigger. When individual errors or issues are identified, what does that trigger? We need to be careful to recognise that these audit processes are not a new concept. They have been designed and used for the development of learning organisations, and for the improvement of systems, screening programmes or whatever else it may be, but we want a cultural change here. We want to ensure that at the heart of those system decisions is a recognition that there is a human there - a patient who is an individual - and it is her information as much as it is the learning system's information.

There is work to be done. It would be some progress to see an automatic need to notify people but we need to stress-test that with those people who have direct dreadful experience of the existing system. I hope the Minister will be open to that type of discussion in the time ahead.

Duncan Smith (Dublin Fingal, Labour)
Link to this: Individually | In context | Oireachtas source

We welcome what the Minister has said in terms of moving on a duty of candour. It is interesting that the Minister has moved in the past couple of hours when he should have moved much earlier. As I said in my earlier contribution when I mentioned the final Scally report, this has been well flagged as a serious and fundamental ask of this legislation. We are happy to give it extra time in order to get it right. We are talking about going into January. What does that mean? What are the modalities of how we go from this moment to getting this right? Is it going back to committee? Is it coming back here?

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

It can be done in the Seanad.

Duncan Smith (Dublin Fingal, Labour)
Link to this: Individually | In context | Oireachtas source

Okay, it will be done there. If we are going to January, the Minister must mean January. The Minister must see this being done by the end of January. He will have time over the Christmas period to get this right. In his final summing up, if the Minister could expand on how this will get from here to where it needs to go, we would appreciate that.

Seán Crowe (Dublin South West, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

It is a little unsatisfactory. The way we do our business in this House is unsatisfactory at the best of times.

The Minister was given additional time to explain his thinking within two minutes. He got another two minutes but it is still a bit unclear. I welcome the fact the Minister moved on the candour issue and that it will go to the Seanad. Like everything else we would like to see what wording or what way the Minister will bring the candour issue. When I spoke earlier, I make the point that this is not only about the past. It has to be about the future and how we do things. It is about people trusting the system, trusting those working within the system and making sure that if people make a mistake they can admit to it. I opened by saying that I do not think anyone believes doctors are infallible, including doctors themselves, although we would imagine that some clinicians believe that they are the centre of the universe and they know everything. Most patients look at this fairly. They believe that mistakes can be made. If mistakes can be made people should be able to admit to them within the system and put up their hands up and say so. People mentioned the litigation route that some patients have gone down. Most people I have spoken to who went down that route may have been satisfied that they won the case but there is no real satisfaction at the end of the day. They are still left with the life-changing injury, the loss of a loved one or on medication for the rest of their lives. It is clear the system is broken and needs to be fixed. This is what the legislation is about. I welcome the fact the Minister has listened to us tonight and moved on this.

Matt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

This is incredibly important legislation. It is extremely important that we get it right. It is welcome that the Minister has expressed willingness to engage and hear the concerns that have been raised. I have to say this has been too long coming. Regardless, we should all accept that if this takes an extra number of weeks to get a Bill that will pass unanimously through the House with the enthusiastic and full backing of all Members this is what we should absolutely do.

I have to say I never had the privilege of meeting Vicky Phelan but her legacy is phenomenal. Her name has been referenced many times this evening, including by a number of Members who knew her personally and who are deeply affected by her loss. In many ways, the Bill is a testament to her. Her legacy is ensuring that we are raising concerns not only for her but for all those who follow and all those who may have been impacted. This is very powerful and I hope it comes as some solace to those who knew and loved her and to all of those who have campaigned and brought what it is a deeply personal and tragic set of circumstances into the public domain, not for themselves but for others. It is a very powerful statement of intent.

As I said earlier, I hope our deliberations this evening will force a rethink on the part of the HSE at long last. There are multiple areas in respect of which scandals have yet to be uncovered. Where scandals have been raised the HSE's instinctive reaction at every occasion is to delay, frustrate, hide and block. This needs to change. It can only change with political determination at Government level.

Alan Kelly (Tipperary, Labour)
Link to this: Individually | In context | Oireachtas source

I welcome the Minister's change of tack. It does not happen often, so fair play to him. One issue has been raised this evening that I raised on a previous occasion. I refer to anonymisation. I have spent hours outside of the Chamber because I have been speaking to people trying to get some sort of compromise. Politically, it would be the best if we could all sign up to this. I am sure everyone agrees. We need to reach a compromise on this. From conversations I have just had, I think we could come up with a process for anonymisation but we need time to agree something. I do not have the time to get into it here. It is very technical. I would like for us to deal with anonymisation and the process for it. I get what the Minister is saying about auditing, the data process and the requirement to have a full picture. I get that. It is about knowing that women will get the information to which they are entitled. I have spoken about this previously.

We need to do something about notifiable incidents. I trust the Minister on this issue. I believe he will do something on it. The process by which the laboratories provide information is a concern. Another issue I keep raising is the audits done from January 2018 until now. These involve 1,500 women. We must remember that no variables have changed. In view of the level of analysis, therefore, this means that some women have passed away.

The House is willing to facilitate this legislation. People do not mind if it goes into January as long as it is better and good legislation. The Minister mentioned the Seanad. I am not sure that is the right way to do this.

Deputies:

Hear, hear.

Alan Kelly (Tipperary, Labour)
Link to this: Individually | In context | Oireachtas source

To be fair, the House has a responsibility to get this right. Amendments in the Seanad involve a different process. We need to do it here. I am asking that even if we do not deal with the matter next week, we take time and allow for consultation with people to provide proper amendments that will help the Minister. I would rather the Bill go into January and get it right than bring it back next week. I do not believe doing it through the Seanad is the right way to go. The Minister might advise us.

Chris Andrews (Dublin Bay South, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I welcome the Minister's movement on some issues. I also welcome his candour. It is clear that the Minister is listening. With regard to anonymisation and having listened to Deputy Kelly, regardless of whether that it is to be done here or in the Seanad, we have to take another step and ensure that people can sign up to what is in the Bill. That is very important. The whole debate is very important. It is very important that the Bill is right. Families will understand if it takes a bit longer as long as we get it right. This is key. The devil is always in the detail. It is important that the Minister spells out the detail relating to anonymisation. Patients need to be elevated above the processes. As I mentioned earlier, the public does not have confidence in the health system, the cancer screening process or the CervicalCheck process. There is a serious lack of confidence among the public in this regard. This is why it is very important that the details of the Bill are done right.. I mentioned earlier a woman who wrote to me about finding out about what was done in the operation she had. We cannot allow this to happen again in any area of the health system.

Mary Lou McDonald (Dublin Central, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I thank the Minister for this constructive approach.

It is much appreciated and I acknowledge this, as others have. I again appeal to the Minister to at least keep an open mind on a programmatic audit. He does not need to convince anyone here on the learning, educational value or the need for metadata. We could have a much more progressive and nuanced approached to this in which the need to use the data speaks to a consent issue for patients and women, which can be catered for but, critically, there must be an element of choice. There are people who do not wish to know should an error be discovered, and that is fine. An opt-out clause could be included. As a person who uses the CervicalCheck service, I would want to know and I would not like the idea that I would be prevented from the opportunity of knowing because the system is anonymised. I know the legislation is silent on this issue but collectively we need to do a bit of work on that too. As Deputy Kelly said, and this has been my experience, there is unease on this issue to say the very least. We are grateful for a meeting of minds on the need to have a positive legal obligation in terms of the patient-triggered review.

It is important the amendment on this is brought forward and we do not believe the Seanad is the right forum for that. We have proposed this matter be adjourned. We know the Minister cannot tell us now across the floor, but we ask that he establish with his officials how long it will take for the relevant amendment to be tabled. It would then be the job of this House, in the first instance, to get this matter dealt with. Even though we are talking about January, I would hope we are not talking about dragging this on unnecessarily. We have made good progress this evening and there is more work to be done, but we are not in favour of passing this up. The Dáil needs to get it right.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Hear, hear.

Emer Higgins (Dublin Mid West, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I agree. It is welcome we have such collaboration on this important issue. Vicky Phelan will have a long and lasting legacy in Ireland and we will have a long and lasting legacy in our Statute Book. I agree with many speakers that if we have to slow things down to get this right, then let us get it right. This is about re-establishing trust and confidence in our healthcare system and, ultimately, saving lives.

Pearse Doherty (Donegal, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Unfortunately, I was dealing with another Bill that was on Committee Stage and therefore missed part of this discussion, but I have listened keenly to the Minister's concluding remarks. I acknowledge and welcome the fact he has accepted the need to amendment the Bill at this late stage and to ensure women are informed of their right to seek a review. Others across the House have said that this does not normally happen in respect of legislation and debates, but this is a very different debate and we all understand this. We have a significant responsibility and burden on behalf of everyone who was wronged and those who have gone before us to make sure this is right. That is the key issue. We need to get it right and we have an opportunity here to do right.

There has been a huge amount of campaigning and personal sacrifice which has led to these moments, so I strongly urge the Minister to listen to the proposals that have been put forward. The Dáil is the place to deal with this. There are people here who have the expertise and have been involved in campaigning on this issue for many years. That is no reflection on the Seanad. The Seanad will deal its issues. We need to ensure the amendment on informing of the right to a review, which the Minister intends to bring forward, is appropriate in the first instance. There is another issue. When we pare all of this back, at the end of the day, even with that amendment, which is welcome and we have argued for it, it still places the responsibility on the individual, and that is a serious issue. When this was announced several weeks ago, after the death of Vicky Phelan, everybody believed it was important we get this right and there would be transparency and a duty of candour, but I never thought it would be a case of, "If you ask, we will tell you." If there is an identifiable misreading of a test, through a programmatic audit or otherwise, that information should be provided to the individual, and that is the core we need to get to. We need to make sure information that could be provided to the individual is not being withheld. Unfortunately, even with the advancement of this amendment, that would be the case. Individuals would only be informed that there has been a misreading of their test if they seek the review.

Unfortunately, cancer has touched so many of our lives. We do not know how the process by which that information will be provided. Will it be as people are sitting down to be told of their diagnosis and in the middle of their world collapsing around them that they are told? That puts a responsibility on individuals. There should be an onus to tell, to inform, to be transparent and to disclose provided for in the legislation. The onus should not be on the patient to request this. While making sure the review is provided for, which we acknowledge is an advancement and we welcome it, it does not take away from the fact there must be an onus to inform. I strongly urge the Minister, in the spirit in which he has accepted the arguments put forward by my colleagues on the Opposition benches on the right to review and to be informed of that right, to look at this, as the debate has evolved, in terms of being patient and individual-centred and stepping into their shoes.

In terms of programmatic audits, we can design the types of audits that will allow anonymised audits, but it is to be able to trace where a mistake has been identified and to inform the individual. I take the point that some people may not want to be informed, and that is why the argument for an opt-in system is very simple, to tick the box when asked whether a person wants to be informed if it were the case. The information that is accessible at a point should be divulged to the individual. I always understood, along with those who have campaigned and argued for this, the concept would be that of open disclosure. It would not be open disclosure if an individual has to request a review and perhaps is told at a traumatic and difficult time. We still do not know how an individual would be informed, whether it would be by letter or as part of the consultation. The key issue is that responsibility needs to be on the system and not on the individual patient. I strongly urge the Minister to deal with that second matter.

Rose Conway-Walsh (Mayo, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I acknowledge the Minister has moved on some of this and his tone in this regard is the proper way to deal with this. I also acknowledge the co-operation from across the House. Everyone who speaks on this subject is very genuine in wanting to get this right.

On the issue of anonymisation, I am a woman and I would want to be informed. I absolutely do not want to be a dot on a scatter plot nor a confidence interval. I do not want to be a statistic. I would want to know. Other women may not. It is very important this is dealt with, and dealt with in the Dáil and not in the Seanad. I was a Member of the Seanad and I mean no disrespect, but we cannot pass the buck on this occasion. The Minister has the co-operation to be able to deal with all these issues.

We need a health service we can be proud of. What Vicky Phelan did in the courage and bravery she showed permeates through the cancer services that are offered.

We have the most brilliant people in the world with regard to dealing with cancer. While I am speaking, I will acknowledge and send solidarity from this House to all of the people who are undergoing treatment for cancer at present. We are lucky enough to have good outcomes in many areas. We need to talk about regional outcomes on another occasion but we have expertise here that is second to none. We are lucky to have it but we have to get this legislation right because patients deserve to have and are entitled to their own information.

The Minister has a responsibility and we have a responsibility. We have an opportunity this evening and, even if it takes a couple of extra weeks, we have a responsibility to get this right. It can permeate across the whole system and instead of having a situation in which we are protecting the system, we can put the patient front and centre once and for all. This has gone on for too long. I spoke to the Minister earlier about the valproate situation. I ask the Minister to bring it to the last Cabinet meeting next week to resolve the issues or, at least, to have an openness and transparency in how we deal with them.

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I thank Deputies for their contributions. I will try to address them quickly. With regard to the process, yes, we can go back to the Dáil. Normal process would be for the Bill to go the Seanad after Report Stage where it would be amended and come back here anyway. However, colleagues are keen for the debate and the changes to be made here. My understanding of procedure, on which I am open to being corrected, is that we will adjourn at approximately 9.20 p.m. We can adjourn at that time until January, which gives time to craft and table the amendments. I will ask my departmental officials to engage with colleagues through that time in order that we understand what amendments are being brought forward. We are all talking about January for the right reasons but to be clear, there are only six sitting days in January. We do not want this to go on and on. We all want this done as quickly as possible but let us all be clear. I think we are back on 18 January and there are six sitting days. We will prioritise the Bill, obviously.

The second issue is one Deputies Kelly and Shortall had asked me to raise and I had not yet had the opportunity to do so. Deputy Kelly referenced it again. The issue is with regard to the rest of the Bill, rather than Part 5, but I committed to put on the record the patient safety incidences referenced in the Schedule, which make up a very small list of a very serious number of incidences. I was asked would I, as Minister for Health, add to that list. The intention is for those to be the ones no Minister could ever take out. The legal advice we have is that in order to make it as easy as possible for patients, the more specific those incidences are either in the Act or regulations, the better. It is in the interest of patients. Those are the incidences no Minister could ever take out without amending the Act. I absolutely commit we will add more to the list. Colleagues will be aware the relevant section in the Bill provides for a very broad range of incidences with regard to the parameters which could be covered.

A question was asked about patients who wish to avail of the patient requested review going back to 2018. That will be available for them which is important. Finally, to go back to the issue of substance, while I acknowledge and respect all views, there is no perfect answer to this but let us put aside the audit for a minute. What is being proposed is an obligation in every diagnosis of cancer among men and women, where the screening services are involved, for the man or woman to be told a patient-requested review is available. If the patient chooses, there would be a mandatory obligation to disclose the results.

Colleagues have said they would wish to know and men and women may wish to know. Leaving the audit aside entirely, the mechanism proposed will make sure every single patient is given the choice. As colleagues have said here, they would wish to know. I think I probably would too. However, the UK evidence suggests many patients do not. Every patient would have the opportunity to find out. The flipside of that if a patient says "No" - as we are told approximately half of patients in the UK say - the audit was non-anonymised and a discordance was found, the patient has clearly said he or she does not wish to know. There would now be an obligation to tell the patient even though the patient had said he or she did not wish to know. We need to reflect on that. We will work with officials to find wording and with colleagues across the House to find an amendment that reflects an obligation to inform of the right to a review.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

On a point of order, given the Minister has committed we would adjourn at 9.20 p.m., it would be better were the Minister to adjourn it now and were we to come back in January. We have an agreement on how an amendment might look. There is disagreement on the anonymised system. We will continue to have discussions on that. We have not reached agreement and we still hold hope there will be movement. However, it would be better were the Minister to adjourn it now, if that is within the rules.

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

That is a good question. We should really ask the Whips, because the Dáil business has been scheduled for 9.20 p.m. We have a voting block coming up. We were scheduled for four hours here.

Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I suggest we suspend.

Róisín Shortall (Dublin North West, Social Democrats)
Link to this: Individually | In context | Oireachtas source

Suspend.

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

We could suspend proceedings and see how the Whips wish to proceed. We can continue. We could move the amendments in Part 5. I do not really mind what way we do it. If the House was ready to move on, we could certainly adjourn. Otherwise, I am more than happy to continue the debate on the amendments. Do you wish to suspend for a few minutes, Chair?

Alan Dillon (Mayo, Fine Gael)
Link to this: Individually | In context | Oireachtas source

We will suspend briefly, pending clarification.

Ruairi Ó Murchú (Louth, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

If we seek clarification, it will be 9.20 p.m.