Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

The Minister would be disappointed if I was not giving out.

Surveys consistently show that health care professionals support open disclosure after a safety incident. A survey of US and Canadian physicians revealed that disclosure attitudes were similar in both countries, with 98% agreeing that serious adverse events should be disclosed and 78% supporting the disclosure of minor adverse events to patients. In another study, 99% of paediatricians endorsed reporting serious adverse events to patients' families.

Despite this, evidence from the UK and the US has shown that before open disclosure policies were introduced, only around one-third of harmful events were disclosed to patients. Evidence from a study in the UK which examined what has happened there since it introduced a legal duty of candour found broad support among those interviewed. One doctor said:

I have learned that being open is also quite a self-preserving thing to do. The worst thing is if the patients get it into their heads that there is some sort of cover up going on, then they get the bit between their teeth and solicitors get involved and it is all very difficult.

Another doctor put it this way:

If you are very honest and straightforward and treat the patients right, then often they take a generous view towards the mistake as opposed to getting very litigious about it which, I think, they are more inclined to do if there is a big cover-up and people are not honest.

With mandatory open disclosure for serious incidents, everybody wins. It is better for health care staff, patients and the health service as a whole. It would very likely reduce costly and drawn-out litigation. It will not place too heavy a burden on health care staff particularly if, as we are told, the HSE and NPSO are committed to training and encouraging a culture of openness without blame. Health care providers should have nothing to fear from a system of mandatory open disclosure if our amendments are accepted, but they will have everything to gain.

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Have the other amendments in the group been moved or discussed?

Pat Gallagher (Donegal, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

They are being discussed together, but they cannot be moved until we deal with each one in numerical order.

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I want to refer to the extensive debate on this issue on Committee Stage. The House will be aware that Part 4 of the Bill, as initiated, provided for the voluntary open disclosure of patient safety incidents and that an amendment was made to section 12 on Committee Stage in the Dáil on 29 June last to instead provide for mandatory open disclosure.

Amendment No. 31 seeks to return to the original intent of voluntary open disclosure in this Bill. The set of new amendments brought forward by Deputies Daly and Wallace for consideration today clearly recognise the burden that would be placed on the system by making all patient safety incidents, including near-misses, the subject of mandatory open disclosure. The amendments seek to change the definition of a patient safety incident and introduce a significant modification to the approach to open disclosure, creating a two-tier system in respect of patient safety incidents.

Category A incidents which result in the death of a patient, major or moderate harm or prolonged psychological harm to the patient would be subject to mandatory disclosure provisions.

Category B incidents relate to incidents that have caused less serious harm, which is defined as harm which does not meet the criteria for major harm, moderate harm or prolonged psychological harm. Category B incidents also include no-harm incidents and near misses. Category B incidents would be subject to voluntary disclosure provisions.

The amendments are extensive and detailed, and they reflect the attention and commitment that Deputies Daly and Wallace have brought to open disclosure as a critical patient safety issue. More time is needed, however, to consult on the changes to the meaning of "patient safety incident". Creating a two-tiered system of patient safety incidents for open disclosure in the health service without having fully explored the implications of the definitions proposed creates a real challenge for assurance of implementability of the legislation. Moreover, time is needed to consider the legislative implications that may arise in the open disclosure provisions of the Bill as a consequence to the amendments. I say with the greatest respect to the Deputies opposite that the last thing any of us want is legislation that is open to challenge. It appears, with the import of these amendments, that not only would the legislation be open to challenge but it is wide open. This would defeat the joint aim that we all have to promote open disclosure and learning from patient safety incidents when they occur.

The Minister for Health has given serious reflection to the Deputies' proposals and agrees there are merits in progressing legislation regarding mandatory open disclosure for a defined set or list of serious events. The Minister's view is that a reasonable approach at this time is to proceed with voluntary open disclosure in the Civil Liability (Amendment) Bill as initiated. Provision for mandatory reporting of serious events to the appropriate external agency is already included in the general scheme of the health information and patient safety Bill. He is proposing a rescoping of these approved patient safety elements to provide for an addition of mandatory open disclosure to accompany the list of reportable serious patient safety events in the health information and patient safety Bill. At this stage, and subject to Government approval and legal advice, it is envisaged that such a list would be the subject of ministerial regulations and could be tested and amended as necessary.

The Minister would welcome the opportunity to work with Deputies Daly and Wallace, as well as other Deputies and stakeholders in the preparation of these legislative proposals. My colleague, the Minister for Health, also commits to examining all options to expedite the patient safety provisions currently within the health information and patient safety Bill. With this commitment in mind, I am proposing amendment No. 31, which amends section 12 of the Bill, to provide for voluntary open disclosure as was the original intent of the legislation when published and debated.

It is important to provide some further context but we can come back to it. The goal of the Minister for Health from the outset has been to create a safe space where there can and should be full disclosure of the facts surrounding a patient safety incident and the implications, if any, for the patient’s care and treatment. There has been considerable deliberation of the advantages of a mandatory or voluntary open disclosure framework. That took place before the Minister for Health came to the view that a voluntary approach offered the best way forward in this Bill.

There are issues of real significance here within my remit and that of the Minister for Health, who proposes we return to the original wording of section 12. I ask the Deputies to appreciate and understand why we should accept amendment No. 31. I am not in any way questioning the sincerity or the desirability of the proposals from the Deputies opposite. I am very concerned about the import of this legislation should we go down the road of making these amendments as they are proposed.

Jack Chambers (Dublin West, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I have a few questions, further to the Minister's clarification. Will the Minister make the exploration of the impact of a potential mandatory open disclosure or will it be the Minister for Health? Will it be a combined effort? Is there a timeline for it? When Deputy O'Callaghan met officials from the Department of Justice and Equality, they said work would be ongoing. I would like to have a timeline.

I suppose there is a contradiction as the Minister mentioned a potential challenge. At the justice committee earlier today we heard about a definite challenge to another general scheme of legislation that the Department appeared to reject. Both Mr. TJ McIntyre and Mr. Simon McGarr mentioned a definite challenge to a general scheme, having challenged the legislation previously. A potential challenge should not be the simplistic factor given by the Minister for rejecting what are constructive amendments from Deputies Wallace and Daly. They are trying to go beyond a cultural change by putting forward a practical framework they feel would go further. It would bring what Deputy Wallace has stated are changes with the studies, surveys or scientific approach that have brought a positive outcome internationally around mandatory open disclosure. The Department and the Minister have serious concerns about the legislation with amendments as currently proposed. When will this proposed legislation come about? Will the Minister outline some of the concerns submitted to the Minister and the Department? Before discussion of these amendments on Committee Stage, was there an intention to go further than voluntary open disclosure? Will the Government park the disclosure issue at the proposed amended position. It is important for us to know.

I take the Minister's word around voluntary open disclosure and he has said it is the appropriate position now but without future legislative proposals and a timeline for that, the matter is really being kicked to touch. I do not want to see that because a cultural change will not happen without a strong legislative framework to drive the process. It would be better for the patient, the health service and the health care profession to have open, honest and transparent disclosures of whatever an incident might be anyway. Leaving this parked as a voluntary process for the long term would not achieve the cultural change we all want to see in this House. I would like the Minister to answer those questions.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

There are a couple of issues.

The Minister said we were introducing a two-tier system. That was not our choice. We succeeded in getting an amendment passed which meant that all reporting was mandatory. We believe this is absolutely necessary to guard against the cultural deficit that exists inside the HSE in particular. However, having met officials from the Department of Health, who had concerns about the impact of that, we agreed at their behest that we would adopt the British model and zone in on the more serious incidents. It is disingenuous to use a gesture that we made in order to deal with the Department's concerns as a reason for saying our amendments are not fit for purpose.

It is also illustrative that we were contacted by the Department yesterday, who said that the definitions we had were quite good and that there was nothing wrong with them per sé but that our proposal would be moved in a different piece of legislation. I have a couple of problems with that. The idea of what we are proposing being open to challenge was not introduced previously. This is a new argument. Departmental officials agreed with us. It was an amicable meeting and there were no hard and fast sides to the debate, but rather there was an agreement that what we should be striving towards is a position of the best open disclosure possible. The departmental officials agreed with us that the evidence was not there to support the contention that it is game over in terms of voluntary disclosure. On the other hand we have good examples of mandatory reporting in other jurisdictions. The Minister, at the eleventh hour, is saying the Department of Health will introduce legislation in the future. The problem we have is that five months have passed since Committee Stage. We made ourselves available at every turn to meet the Department. There is no meat on the Minister's proposals for how this will be dealt with. It is civil service time, and we have lost a valuable opportunity. While I am not in any way questioning the Minister's bone fides, the problem is that the only amendment to the legislation before the House is to remove the one change made on Committee Stage. That does not signal an intent to work together.

Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

The Minister took issue with the fact that our definitions of the different kinds of harm have not been exhaustively tested and that his preference is for those definitions to be provided for in regulations. We say that the definitions brought forward here are reasonably broad and detailed, but not exhaustive. However, it is open to the Minister, should he wish to provide more exhaustive details on each category of harm at a later date, to do so. Our definitions do not have to be the final word on this, nor did we ever anticipate they would be. Regulations exist to provide the detail that does not sit well in primary legislation.

Another concern is time. As Deputy Daly has said, five months have passed since this was passed on Committee Stage. Everything moves slowly. The chances of the present Government arrangement even being in place by the time an alternative emerges are probably slim. Paddy Power would give a good price on it. Everything takes so long in here. Today we have an opportunity to do something really good for our health service, for patients and for healthcare workers, and I believe we should take it. It was passed on Committee Stage with the support of Fianna Fáil, and I sincerely hope it has not changed its tune because of the so-called confidence and supply arrangement. We are hoping it will do the right thing and support us on this.

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I wish to assure Deputy Chambers that the Minister for Health will progress the legislation. He will immediately examine how the patient safety elements of the Health Information and Patient Safety Bill will deal with the points at issue. I again stress the importance of amendment No. 31 and want to state that what we are doing here is returning to the original wording of section 12. The Minister for Health is proposing that mandatory open disclosure for a defined list of serious incidents would be progressed through the patient safety provisions of the Health Information and Patient Safety Bill. I can assure Deputy Chambers that I will bring the urgency and importance of advancing these issues to the Minister for Health's attention immediately.

The Minister for Health acknowledges the commitment to open disclosure of Deputies Daly and Wallace. I know they have given the issue serious consideration in the amendments, but I believe this is an issue for the Department of Health. I understand the rationale for the amendments, but I cannot support them. It is important that we proceed along the lines of voluntary open disclosure and that is the best, most opportune and clearest way to proceed with this legislation at this point. I hope that in these circumstance the Minister for Health's amendment can be accepted.

If there are two parallel pieces of legislation we will create a complex and detailed area of uncertainty. This legislation is now extending far beyond the parameters for which it was originally designed. I ask the Deputies opposite to give due consideration to that, along with my commitment on the part of the Minister for Health.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

This is an incredibly serious issue. The Minister says it is more suitable for the Department of Health, and that may be the case. We respect that. However, this is the legislation before us now and it is the only legislative provision this Oireachtas will have the chance to consider in its lifetime. That is fair to say, based on the length of time it takes to get anything moving in here. The issues are far too serious when we consider some of the catastrophic incidents which have occurred in our health service, and the appalling pain and extra hardship that was put on families in trying to get access to information.

The Minister said that voluntary disclosure is the best way to deal with open disclosure. That viewpoint is not supported by evidence. It is an opinion, and the Minister is entitled to that opinion. There is a substantial body of evidence to say that in places like the UK the mandatory reporting mechanism has been successful. In the face of an organisation that is culturally challenged and instinctively covers up problems, I believe reporting has to be mandatory.

The Minister said that the Department of Health will immediately examine it. My response to that is that if it is so important and such a priority for the Department, why has that not been done already? These issues are not new. This legislation has been before the Houses for a long time now. There is a lethargy and a delay factor here, and in the years it will take to get the alternative legislation in place many people who could have benefitted from our proposals will miss out.

I return to the point we made that we met the Department in good faith. It was not acrimonious; there was a rational discussion between adults where we acknowledged that there is no magic wand and that our viewpoints were perfectly valid. There was no feeling that this would be subject to challenge so it could not be done. The Department said the committee had made the provision too broad and that we needed to distinguish between the incidents. That is what we have done. Our definitions are clear. They are linked to other HSE definitions and they are not definitive. The Minister would be still able to bring in regulations, so we will definitely be supporting the committee's original view. We are hoping that Fianna Fáil is still with us in this regard. It is very important.

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I am precluded by the rules of the House from responding, but Deputy Daly is mistaken when she refers to other jurisdictions. Mandatory disclosure for such a breadth of events would be challenging. It is not in place in any other country. This is not in place in England or in any other common law jurisdiction such as Canada, Australia or the US. In fact, there is no other country with such a breadth of arrangements.

Pat Gallagher (Donegal, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I cannot open the debate.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

Our definitions are entirely based on the UK model and the HSE's definitions.

Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

We changed it so it would be in line with the English model.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 6:

In page 17, between lines 33 and 34, to insert the following:" "Category B safety incident" shall be construed in accordance with section 9;".

Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 7:

In page 20, between lines 11 and 12, to insert the following:" "less serious harm" means harm which does not meet the criteria for moderate harm, major harm or prolonged psychological harm;".

Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 8:

In page 20, between lines 11 and 12, to insert the following:" "major harm" means a permanent lessening of bodily, sensory, motor, physiological or intellectual functions, including removal of the wrong limb or organ, that is related directly to a safety incident and not related to the natural course of the patient’s illness or underlying condition;".

Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 9:

In page 20, between lines 13 and 14, to insert the following:" "moderate harm" means—

(a) harm that requires a moderate increase in treatment, and

(b) significant, but not permanent, harm;".

Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 10:

In page 20, between lines 13 and 14, to insert the following:" "moderate increase in treatment" means an unplanned return to surgery, an unplanned re-admission, a prolonged episode of care, extended time in hospital or as an outpatient, cancelling of treatment, or transfer to another treatment area (such as intensive care);".

Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 11:

In page 20, line 25, to delete "shall be construed in accordance with section 8;" and substitute the following:"means both—

(a) a Category A safety incident construed in accordance with section 8, and

(b) a Category B safety incident construed in accordance with section 9;".

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 12:

In page 20, between lines 29 and 30, to insert the following:" "prolonged psychological harm" means psychological harm which a patient has experienced, or is likely to experience, for a continuous period of at least 28 days;".

Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 13:

In page 21, between lines 16 and 17, to insert the following:“Meaning of “Category A safety incident”

8. In this Part, “Category A safety incident”, in relation to the provision of a health service to a patient by a health services provider, means an unintended or unanticipated incident that occurred in respect of a patient in the course of the provision of a health service to that patient which has caused—

(a) the death of the patient, where the death relates directly to the incident rather than to the natural course of the patient’s illness or underlying condition, or

(b) major harm, moderate harm or prolonged psychological harm to the patient.”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 14:

In page 21, line 18, to delete “patient” and substitute “Category B”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 15:

In page 21, to delete lines 20 to 22 and substitute the following:“(a) an unintended or unanticipated incident that occurred in respect of a patient in the course of the provision of a health service to that patient which has caused less serious harm to the patient,”.

Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 16:

In page 21, line 23, after “an” to insert “unintended or unanticipated”.

Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 17:

In page 21, line 25, to delete “injury or”.

Pat Gallagher (Donegal, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Amendment No. 18 arises out of committee proceedings. Amendments Nos. 18, 19, 21 and 22 are related and may be discussed together.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 18:

In page 21, line 26, to delete “the health services provider has” and substitute “there are”.

Many of these proposals are simple and straightforward and we think they would strengthen the Bill. We do not see them as controversial at all. This group of amendments relates to section 8 of the Bill. It aims to take the power to judge whether a patient was placed at risk or could have been injured out of the sole hands of the health service provider. That is all that these amendments seek to do. In the original general scheme of provisions on open disclosure, a patient safety incident was defined as either an incident in which a patient was harmed where there was reasonable grounds to believe that, during the provision of a health service to the patient, the patient was placed at risk of injury or harm; or an incident where, but for timely intervention, the patient would have been harmed. The definition of a patient safety incident is important as these incidents will be subjected to open disclosure in the Bill. In the Bill before us, the provisions in the general scheme have been changed such that an incident will now only qualify as a patient safety incident if the health service provider has reasonable grounds to believe the patient was at risk or to believe that, but for a timely intervention, the patient would have been placed at risk. In our opinion this puts far too much power in the hands of the service provider.

We know from both broader global literature on open disclosure and from our own experience of our health service that fostering a culture of openness and transparency within a health service is a very difficult thing to do. We know from the brutal experience of the HSE that the first impulse when something goes wrong is to pull up the drawbridge, fortify the barricades, deny all and circle the wagons. In this sense, we do not think it makes sense to leave the final word on whether a patient was placed at risk with the health service provider alone. They will certainly be in a good position to judge whether this was the case, and our amendment does not preclude them from making that decision. It just means that they are not the only ones who can decide what is a patient safety incident.

We would hope that, if the amendment was passed, in the vast majority of cases the health service provider would hold up its hands, admit a patient was placed at risk, and try to make it right. In reality, in many cases only the service provider will have this knowledge. We accept that is the case. If patients were put at risk, for example, during surgeries or scans and so on, the patient would obviously be none the wiser as to whether he or she was placed at risk. There would be some instances in which the health service provider would be the only one to know. These amendments deal with the small minority of cases in which the patient knows and the health service provider does not own up. It allows scope for a patient, or somebody connected to him or her, such as his or her family or a loved one, to rely on the legislation and to have what happened to him or her classified as a patient safety incident, thereby granting him or her access to open disclosure of all the circumstances around how and why he or she was placed at risk.

Information is power. Quite often what patients or their families want is reassurance that what happened to them will not happen to somebody else. That is why it is very important for our health service to learn from those situations. We believe that, as with open disclosure generally, allowing patients this scope, if they spot something which they believe put them at risk, should actually help hospitals, which often have a deep cultural aversion to accepting errors and to learning that the sky does not fall in when they do so. It will also help hospitals to put measures in place to ensure that mistakes are not made again with possibly more serious consequences. We think this is only a good thing. It is a relatively minor thing and we hope that the Minister agrees with us.

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

I had not intended to speak on this amendment but, such is its importance, I want to actively support my colleague, Deputy Daly, in respect of it. One thing I have learned in my professional life and on a human level is that institutions simply cannot be trusted. No institution can be trusted. If he looks at the record of the HSE in Galway city, the Minister will see that, on every single occasion on which there was crisis, the reaction was to close ranks in a most effective manner. The unfortunate case of Savita Halappanavar only came to light because of the persistence of a journalist. If that tells us anything it is that we cannot trust institutions. Since then there have been a number of other inquiries in Galway, which I will not go into, but in which I have some personal involvement. From my personal experience I see absolutely no commitment from the HSE or from institutions in general to learn from mistakes, to acknowledge them and to actively involve the patient or the patient's family. I find this particularly unacceptable given that, in the end, a lot more of taxpayers' money is spent on inadequate internal investigations, inadequate external investigations, investigations which pretend to be independent and, finally, the appointment of independent people.

8 o’clock

That has been my experience, both professionally and personally, over my lifetime. Unfortunately, I have not seen any inclination on the part of institutions to learn. Therefore, I support the amendment. I hope the Minister considers it and accepts it in the spirit in which it is meant. The result would be to make an institution healthier, and there would be less litigation, not more. Ultimately, everybody makes mistakes, including institutions. A problem arises only when the institution does not admit a mistake. This costs the taxpayer more money in the end. Most people are not litigious. Most simply want to be part of a system, learn and have mistakes acknowledged.

Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

I wish to follow up on the comments of Deputy Catherine Connolly. I am a great believer in trusting everyone until they prove unworthy of it. I raised yesterday with the Taoiseach the case of a woman called Jane Johnstone, who was having an horrendous time with the HSE in Wexford owing to her having had the audacity to stand up for herself and her two autistic children. I wish it were otherwise but the HSE has not earned our respect with its behaviour. As Deputy Clare Daly said, the tendency just to circle the wagons whenever a problem arises and to enter the zone of denial is rampant within the organisation. Perhaps Wexford is particularly bad but we have had such an horrendous experience with the HSE there for so long over a number of issues. All we are recommending tonight is the introduction of best practice to change behaviour. The idea that behaviour will change if we leave it to the institution is not valid because our experience has taught us otherwise.

The English have mandatory reporting of serious incidents. Their problems with the National Health Service are probably not quite as bad as our problems with the HSE. The English have found mandatory reporting to be positive. Introducing rules and regulations that guarantee better practice represents a common-sense way forward and it is not revolutionary. It is common sense because we want better practice from the HSE and a better service for the people who engage with it. What we are asking for is not in any way extreme.

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

These amendments relate to section 8, the section that defines the key concept of what constitutes a patient safety incident. It is an important definition based on the World Health Organization international classification for patient safety. That definition covers three concepts: incidents that caused unintended or unanticipated injury or harm to the patient; incidents that did not result in injury or harm at all, known as no-harm incidents; and incidents that were prevented from happening by timely intervention or by chance, commonly described as "near misses". In the case of no-harm incidents, section 8 refers to the health service provider having reasonable grounds for believing the incident placed the patient at risk of unintended injury or harm. Similarly, in the case of near misses section 8 refers to the health service provider having reasonable grounds for believing that, in the absence of the incident being prevented, injury or harm could have occurred to the patient.

The intention behind these amendments is to cover any no-harm incident or any near miss where any person has the reasonable belief that the patient was put at risk. It would usually be the provider that would have the knowledge that a no-harm incident has occurred, or that there has been what can be described as a "near miss". The Minister for Health appreciates that the intention behind the amendments is to cover where the patient or family believes a no-harm incident or near miss has actually happened. His view, however, is that it is the provider which makes the disclosure of the no-harm incident or the near miss, and it should therefore be because the provider reasonably believes the patient had been placed at risk or that an incident had been averted, rather than because somebody else has that belief. If a patient or his or her family has a concern that a no-harm incident has happened or that there has been a near miss, they could, of course, make the provider aware of the concern, and the provider could then look into the issue. If the provider came to the conclusion that there had been no harm incident or a near miss, it could make the open disclosure then. Therefore, I do not intend to accept the amendments.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

As I stated at the start, we acknowledge this involves a relatively small number of cases. Few as they may be, they are important nonetheless. We do not have a problem with the definition of the patient safety incident per se. The difficulty we are trying to deal with, however, is that it is only the health service provider which will decide whether it is the case. We accept that, in the overwhelming majority of cases, the health service provider will be the one that will know this, but the Minister said that if the patient or patient's family becomes aware of something, they can tell the health service provider, and that if the provider then decides it is a patient safety incident, the legislation will offer protection. However, this is missing the key point, namely, that in this scenario we are dealing precisely with an institution that does not accept responsibility and whose tendency is to circle the wagons. It does not preclude the health service provider from making its decisions or from having information referred to it by patients or their families but I am referring to the cases where this does not happen. All the amendment does is make what I propose possible where the patient or his or her family have clear grounds for believing the patient was placed at risk. An example could be where a doctor or nurse fills an intravenous antibiotic bag with penicillin even though the patient is allergic to it. The patient might shout "Stop" before the line goes in. This could be regarded as a patient safety incident even if the doctor or management swore blind it never happened or that, even if it did, there were no reasonable grounds for believing the patient was at risk.

We accept there is a small number of cases but if we are trying to change an embedded culture, we need to put everything into the hands of the patient, where possible. What we propose is not onerous, or anything like it; it is simply catering for the minority of cases in which a patient may have access to information on an incident and the health service provider may be in denial that the person has the opportunity to avail of the protections of this legislation. We do not see it as a big deal at all. It would help to develop trust and a better way of viewing our health service.

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I repeat that if a patient or any member of the patient's family has a concern that a near miss has occurred or that a no-harm incident has happened, it is quite logical, reasonable and, dare I say, obvious that he or she would make the provider aware of it and that the provider, having been made aware of it, would examine the issue.

In the event then that the provider forms the view that there had been a no-harm incident or near miss there would be an open disclosure on the part of the provider. In the circumstances, that is what I think is the way to deal with it. I believe it is important that the provider who makes the disclosure of a near miss would do so on the basis that there is a reasonable belief that a patient had been placed at risk and it is the provider that forms that view rather than anybody else.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

That is precisely the problem we are trying to highlight. It is the health service providers, the person or organisation potentially responsible for the near miss or that created the patient safety incident that are the sole people who decide whether an incident is subject to the provisions of this legislation. Our amendments do not preclude what the Minister outlined. It does not stop the health service providers from being the main determinant in the majority of cases or for patients or their families referring a case on to them for them to investigate. What it deals with is the small minority of cases where they do not accept responsibility and it allows for the possibility of not just them deciding that there was an incident but that the family could do so as well.

Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 19:

In page 21, line 27, to delete "placed the patient at risk of unintended or unanticipated injury or" and substitute "the patient was placed at risk of".

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 20:

In page 21, lines 30 and 31, to delete "an unintended or unanticipated injury, or harm," and substitute "harm".

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 21:

In page 21, lines 32 and 33, to delete "the health services provider has" and substitute "there are".

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 22:

In page 21, line 34, to delete "could have resulted in such injury, or harm, to the patient" and substitute "such harm to the patient could have resulted".

Declan Breathnach (Louth, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Amendments Nos. 23 is being taken with amendments Nos. 29, 51, 52 and 56 to 62, inclusive. Is that agreed? Agreed.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 23:

In page 22, line 22, to delete "where" and substitute "when".

This has been a long day. This group of amendments is essentially about the same issue, namely, making it mandatory for service providers to apologise at an open disclosure meeting. At present it is up to the service providers if they want to say sorry when something goes wrong. We do not think that is good enough. We had a really long discussion on the matter on Committee Stage. However, I did not find the Minister's objections to be satisfactory. He mainly said that if one made it mandatory they would only apologise begrudgingly and sure that is no good at all. I do not accept that logic. It is clear from the definition of a patient safety incident in the Bill that it means something went wrong. The Bill provides for an optional apology by a provider for something that went wrong. I find that utterly bizarre. The open disclosure meeting would not take place at all if an incident had not happened in the first place. In that sense, we do think it is dangerous to make an apology optional because we are creating a situation whereby health service providers can say to a patient that they hurt them, this is how it happened and that is the end of it, that they are not going any further on that. That is wrong. Even a gritted-teeth apology is better than no apology.

Voluntary apologies are all the more bizarre when we look at the very strong protections that exist for apologies in the Bill. The entire Bill is crafted in a way in which any apology given is not an admission of liability. It cannot be entered as evidence of liability in court so even if our amendments in regard to information provided in the course of open disclosure being admitted are accepted, apologies would still be protected by this legislation so there is nothing to fear here. We drafted our amendments to section 10 in the way we did precisely because apologies are so important to people. It touches on a point made by Deputy Connolly earlier. This would save the State money because people do not want to turn to litigation. Quite often all they want is an acknowledgement that people are sorry for the wrong that was done to them.

I wish to make two points about open disclosure. One is that there should be a full explanation of all the circumstances in terms of what went wrong and joined to that would be an apology. To acknowledge the fact and not to apologise for it is like a double insult. It is leaving open the possibility of people going into incredibly stressful incident meetings and open disclosure meetings where they are hurt, confused and probably fuming. It is fundamentally accepted culturally that when one hurts someone, one should say sorry. The only people who do not believe that are psychopaths. It is a normal way of good human interaction. When a patient hears that the health service provider has wronged and hurt him or her and then shrug its shoulders and does not take it any further, I believe some patients would be so incensed by that that they would launch civil suits that they would not otherwise do when all they were looking for was an apology in the first place. I think it leaves us open to more costly civil action – costly for the patients to be fair but also costly for the State. That will leave us with a lot of hurt and angry people, which is not what we are supposed to be doing. The Bill is supposed to engender confidence in the health service.

My final point on the issue of mandatory apologies is the following. I am sure the Minister will say that in the vast majority of cases the health service providers will apologise. That is great. Perhaps they will but perhaps they will not. Let us even say they will. We would be happy with that, but the problem in leaving an apology as an option in the Bill is that we are explicitly giving service providers moral cover if they do not apologise. I think that, perversely, will make apologies less likely. In fact, by not making it mandatory and given all the protections that exist for apologies we are undermining the confidence of health service providers in the strong protections for apologies that already exist in the Bill. They will rightly wonder if an apology is not an admission of liability and, if they cannot be admitted as evidence of such, why they are optional. Any basic, decent human being would say that if one does something wrong one should apologise. I think we are leaving a gap of doubt from which uncertainty would flow and that is just not good enough for the service providers or the patients.

The Minister used an example on Committee Stage. He reminded us of when we were children and our parents would tell one's brother to apologise if he hit his sister and he reluctantly said sorry. In the case of bad behaviour from a brother, should a parent say a child should not apologise? Is it not the case that the next time such an incident occurred the brother would know he had to apologise or he would be embarrassed in front of his sister by his parents giving him a clip around the ear and making him apologise? It is part of learning. We have a dysfunctional health service that needs to learn. The fact that it must learn to apologise is pretty sickening to be honest but I think it is a reality and we should train it because the health service is like a delinquent child and it needs a lot more intervention than most children in the State do to correct its defective behaviour and to make providers behave like decent human beings with compassion and empathy. If it is the case that they will all apologise anyway, that is great, but the amendment is for the cases where they do not.

Sadly, the experience of all Deputies who have had constituents come to them about this is that many elements of our health service providers do not do that.

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

This issue was the subject matter of debate on Committee Stage. Deputy Daly is right. I do not believe we should read section 10 in isolation. Section 15 deals with matters to be addressed by the provider before making open disclosure of an incident. It is in this context, perhaps, that the issue of the apology would be best framed. I say as much because open disclosure is fundamentally about communicating with patients and their families when matters go wrong.

We referred to the issue on Committee Stage as being a human experience for everyone concerned in the context of open disclosure and a consequent or subsequent apology. Since then, serious thought was given to whether an apology should be an automatic consequence of open disclosure. The Bill, along with the Health Service Executive policy on open disclosure and the Medical Council code of conduct, takes the approach that where an apology is appropriate to the specific circumstances of the incident, then of course it should be given. Section 15 sets out what the provider must do before the making of an open disclosure. The provider must make an assessment of all the circumstances of the patient and the nature of the incident itself. At this point while considering the matters to be addressed before an open disclosure is made a decision should most likely be made in respect of an apology.

I believe it is reasonable to form the view that an apology should be a meaningful exercise and that it should be something more than simply a box-ticking exercise. It has to be more than a question of the provider making an apology and then moving on. It has to be more than a question of whether the provider considered an apology and whether it was forthcoming. I do not believe an apology should be given simply because the provider is told to apologise. It should not be mandatory for an apology to be forthcoming.

We should be mindful of the fact that it is not possible to predict every situation. We propose that each patient safety circumstance should be treated individually. Then, if the decision is to be made on the matter of an apology, it should be made by the provider taking into account all the circumstances of the case, including the health, capacity and form of the patient at the time of and after the incident in question. I believe it is eminently reasonable to form the view that an apology needs to be appropriate to the particular circumstances of the case.

The object of the exercise is to ensure we can create the best circumstances for open disclosure to take place having regard to the fact that this will be a human experience for everyone involved. Otherwise, the apology will simply become a matter of form, indifference or something less than substantial - a box-ticking exercise. I do not believe this is the intention of Deputies Daly and Wallace in the context of these amendments. Of course there will be circumstances where an apology is absolutely necessary. However, I believe the best time and place to deal with these is when the pre-open-disclosure issues are taken into consideration under section 15.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

The Minister did not make the point that I had thought he would make. I am actually more shocked now – perhaps it is the lateness of the hour or maybe I gave him surplus credit. I assumed he would say an apology would happen anyway and the provider would apologise, so there would be no need to make him or her apologise. Instead, the Minister's explanation has been rather shocking. He said that it is up to every individual provider to decide whether he or she apologises. He said they should make the decision and that it is eminently reasonable for them to look at it in the context of the circumstances.

The circumstances of an open disclosure meeting are precisely that something has gone wrong and the patient has been impacted. In that scenario, if there are providers working in our health service who do not believe it is appropriate to apologise or who believe they need to individually assess whether to bother giving an apology, I do not believe they should be clinicians in our health service. In any sphere of life it is part of the A,B,C of our culture and interaction as human beings that if someone does something wrong, that person apologises.

I agree with the Minister that the apology should be meaningful - of course it should. The Minister said that if we make providers do it, it will not be genuine. I do not believe that. We are dealing with a dysfunctional organisation that needs to be trained and told. It is regrettable that this is the case. Is it not utterly shocking that we have to tell those involved that this is the case? In any event, that has been the experience of people the length and breadth of the country. In their experience, providers do not want to apologise because they are afraid of litigation and of being held to account. We specifically kept in provisions that protect apologies from litigation and any malpractice cases and so on. The health service providers have nothing to fear by this and everything to gain by improving their relationships with their patients. Then, when something goes wrong they should say they are sorry. They may do it first time around and not like it because they do not have the humility to admit they were wrong, but the circumstances are that the meeting is being held to admit that they were wrong. If the provider cannot offer an apology, the best thing is to train him or her to do so by making it mandatory.

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I do not believe it is possible to make an accurate or concrete prediction regarding every situation and all the circumstances of every case. Each case will have differences and peculiarities. Of course I accept what has been said to the effect that the reality of the situation is that in most circumstances an apology will be necessary and, having regard to the necessity for that apology, it will be forthcoming. When a patient safety incident is due to an identified error, omission or failure in the delivery of care, of course there always should be an apology. However, that should be a meaningful and substantial apology with due acknowledgement of the failures in the delivery of care. However, I do not believe we can allow a situation whereby it becomes merely a routine or box-ticking exercise. I believe it is not unreasonable that each case should be treated on its own merits rather than have a mandated or routine apology, as proposed by the Deputy in the amendments.

Declan Breathnach (Louth, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Amendments Nos. 24 to 28, inclusive, are related and may be discussed together by agreement.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 24:

In page 23, to delete line 14 and substitute “incident.”

This large and important group of amendments deals with information being admissible in court and the issue of apologies. I will address the first issue and Deputy Wallace will discuss the latter issue.

Section 10 requires substantial amendment and we were disappointed that the amendments we proposed to the section on Committee Stage were defeated. The section holds that neither information provided nor an apology made during open disclosure will be admissible as evidence in court in regard to any action that arises from the patient safety incident that has been disclosed. It also holds that information provided and any apology made will not be admissible as evidence of any professional malpractice or misconduct in a professional misconduct investigation. As we stated on Second Stage, the idea that factual information provided at an open disclosure meeting would later be denied in court by a health service provider is ludicrous and contrary to the principles of natural justice. As the Medical Injuries Alliance pointed out: "It would be abhorrent to the administration of justice if a Court were precluded from considering all existing information necessary to establish relevant facts which are or may be in dispute, before making a decision which determines disputed facts."

Another major issue arises with the proposal to prevent a patient from being able to rely on any information provided during an open disclosure process. Rather than diminishing mistrust, this provision is likely to breed more distrust. If, for example, a patient is provided with a clear and frank explanation of how an adverse incident occurred and the very same facts and version of events are subsequently denied in court by the service provider, how will this build trust in the health service?

We have less difficulty with the proposition that information provided pursuant to the legislation cannot be deemed to constitute an admission of liability in the legal sense. We have not proposed to remove this provision in section 10(1) because we do not have a problem with it. Our amendments would also retain the protections for apologies currently provided for in the Bill and apologies could not be submitted as evidence of liability. Deputy Wallace will elaborate on that point in a moment.

The purpose of the amendment is to emphasise that where there is a dispute regarding liability, it is essential that the court is able to consider all factual evidence gathered on foot of the incident in question, including any facts obtained during open disclosure and all records created for the purpose of making that disclosure. We must view this issue in the context of court proceedings. Allowing information and records provided as part of an open disclosure process to be entered as evidence in court proceedings does not necessarily mean the court proceedings will succeed. All the legal safeguards that normally operate in such circumstances will apply in any case because even if the information and documentation gathered as part of the disclosures process were admissible as evidence of fact, the patient would still be required to establish liability, absent a formal acknowledgement or admission of same. As such, the question of liability still has to be determined.

We are providing only for access to factual information. This offers ample protection for the service provider, particularly when one considers that the burden of proof a patient must discharge in any civil action is set very high. It must be proved that a doctor has been guilty of a failing for which no other reasonable doctor of like skill or experience would be guilty. That is a high threshold.

Another significant issue is that if information gathered or provided as part of the disclosure process cannot be admitted as evidence in court, it will result in court cases becoming much longer and more expensive. Dr. Tom Ryan of the Irish Hospital Consultants Association, in his submission to the Joint Committee on Health's pre-legislative scrutiny hearings, stated: "When litigation does occur, it is preferable for it to be conducted speedily." The State spends tens of millions of euro fighting damages claims, as do the individuals involved in making such claims. It is a shocking fact that the State spends more on fighting clinical damages claims and paying out damages than it spends on maternity services. If the current provisions on open disclosure are allowed to stand, it is likely that litigation costs will increase because if one party to a civil case has access to relevant factual information and the other party is denied access to this information, legal battles will become more hard fought, lengthy and costly. In addition, one has the emotional and psychological damage done to those who are already victims in these types of cases.

If the amendments are not accepted and in the absence of being able to use the independent factual information to which I referred, patients will be forced to pay for and obtain their own independent medical experts to give the expert evidence needed to substantiate or establish that their care was substandard as well as causation. Given that this will have already been established through the open disclosure process, they should not be forced to shoulder this additional burden to obtain this information. The system is highly deficient in this regard.

Similar provisions apply in respect of information in professional misconduct hearings. Again, factual information should be provided at such hearings, which are not as onerous as cases involving civil actions. There is no reason this information should not be provided.

The Francis report in Britain led to the establishment in the United Kingdom of a statutory duty of conduct. The Queen's counsel who produced the report, Robert Francis, made the reasonable point in regard to professional misconduct proceedings that professional regulators would be far more lenient on those who owned up to errors with a serious effect on patient safety than they would be with those who denied it or tried to cover it up. Mr. Francis stated: "We need a situation where the legal advice is going to be, "I know this is unfortunate, but you are going to be better off by telling them about it and being honest and open about it than not"." He is exactly right on that point and we have a long way to go before we reach anywhere near that stage. Denying people taking civil proceedings access to factual information that they were given previously in an open disclosure process later is an incredibly serious flaw in this Bill.

Mick Wallace (Wexford, Independent)
Link to this: Individually | In context | Oireachtas source

I will address the amendments in the group which deal with apologies and the provision that an apology shall not constitute an admission of liability. This is a crucial issue. As noted in the discussion on the second group of amendments, apologies are one of the most important aspects of any open disclosure process. The Australian Commission on Safety and Quality in Health Care reviewed this matter and reported that a full and sincere apology following an adverse event is a key element of successful disclosure and that, for patients, an apology is the most valued part of open disclosure and fundamental in the reconciliation process.

There is evidence to suggest that apologies assist the recovery of harmed patients, promote forgiveness and the early resolution of disputes and reduce litigation and legal costs. That is why we propose to retain the provision that apologies should not count as an admission of liability and cannot be submitted as evidence of liability in court. We want to encourage apologies and health care providers to be comfortable giving them.

The importance of apologies in medical practice is reflected in the fact that many jurisdictions have passed so-called apology laws. These laws provide that apologies by health practitioners do not constitute an admission of liability and they exist to encourage health practitioners to say "Sorry" when things go wrong. Such laws are in place in many US states and Canadian provinces. Crucially, what all these apology laws have in common is that they only indemnify apologies and do not have anything to say about information gathered during open disclosure or other forums. Our amendments are essentially modelled on this concept. An apology is not a legal admission of liability and should not be treated as such. Information and facts about an incident are information and facts and should be treated as such, not excluded from evidence in subsequent proceedings.

My final point in regard to this group of amendments is that in the UK a mandatory statutory duty of candour was introduced in 2014 after the Mid-Staffordshire health care scandal on the recommendation of the Francis report. The UK duty of candour has nothing to say about protection from liability. All it says is that if something goes wrong and a patient is harmed, the health care provider has to own up to it, provide full information on the incident, say "Sorry" to the patient, provide the patient with help if he or she needs it, and tell the patient when further inquiries are undertaken into the incident. Liability is not mentioned.

I note the following in the review of potential costs conducted by the British Government before the UK brought in its 2014 duty of candour regulation. One of the most commonly cited barriers to providers being candid is the fear that being candid and providing more up-front information about patient incidents can lead to a risk of increased litigation and that offering an apology might be interpreted as an admission of liability. On the other hand, it has also been suggested that being candid can reduce litigation costs as often the main motivation for bringing about a medical negligence claim is to seek more information about mistakes in care or due to a perceived failure of the provider to apologise.

Overall, the evidence on the likelihood of litigation is unclear. Despite this, the Bill seems to be built on the presumption that openness with information and apologies will inevitably lead to more litigation and more pay-outs, but the evidence for that does not exist. There is no evidence to say that it does that is not contradicted by other evidence to say that it does not. The British review referred to is almost painful in its Tory focus on the potential costs of open disclosure in terms of increased litigation sidelining the moral and ethical obligation of openness to a significant degree. Even they could not come up with any evidence of litigation increase.

We are at nothing in legislating for open disclosure if we do not in every way encourage openness. We are doing a massive disservice to patients and we are standing in the way of improving the health service.

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

The Deputies will agree that this is groundbreaking legislation. It may well be overdue but it is appropriate and novel.

The important aspect of section 10 is that we ensure that there will be cultural buy-in to this new legislation. In this regard, the Bill provides for certain protections for information given to the patient at an open disclosure meeting, including that the information and written statement given to the patient are not admissible as evidence of fault or acceptance of liability regarding the patient safety incident or in any subsequent medical negligence action that might arise from the consequences of the incident. I will briefly set out why the provisions were included.

It has been said before that the perceived fears of medico-legal consequences of open disclosure can act as an obstacle to that disclosure. This was recognised by the Commission on Patient Safety and Quality Assurance in its report, Building a Culture of Patient Safety. The commission recommended that legislation should ensure that open disclosure, which is undertaken in compliance with national standards, cannot be used in litigation against the person making the disclosure. The HSE evaluation of the national open disclosure pilot also identified what can be described as a perceived fear of medico-legal consequences as presenting a difficulty, challenge or obstacle.

I want, and I am sure the House needs, to ensure cultural buy-in to the concept of open disclosure. I might add that, in its pre-legislative scrutiny report on the open disclosure provisions, the Oireachtas Joint Committee on Health stated it was sympathetic to claims on the part of stakeholders that cultural buy-in to open disclosure is necessary to ensure its success.

The purpose of the open disclosure provisions in the Bill is to create a framework in which this can be brought about. The Bill is clear on the detailed information to be given to the patient. It is equally clear that the legal protections will only apply when the disclosure is made in accordance with the legislation.

It is important that the input of my colleague, the Minister for Health, in this Bill be recognised, particularly in the context of the Report Stage amendments that we have been dealing with this evening, all of which refer to the health service providers' liability in the area of health and patient care. In this regard, the Minister for Health believes that the Bill will bring benefits to patients, with the supports for open disclosure in the Bill helping to ensure that patients will get the information they want in a timely manner following an incident. It is important to say that patients will, of course, have access to their medical records and that this legislation does not impact in any way on the use of these records by the patient.

Having regard to the fact that what we need is to ensure that we have a climate for cultural buy-in and that the Bill works well to the benefit of the person in receipt of the service, I am not in a position to accept the Deputies' amendments.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

In some ways, we are going around in circles. We believe that this is genuinely bizarre, if we are talking about changing culture, etc. We accept the idea that the information would not be admissible as evidence of fault or liability, and our amendments do not remove any issues in terms of liability.

What we are talking about is information regarding the facts. We are talking about an open disclosure meeting where the person is told what went wrong. If the person decides to take a civil action later on, he or she still has to go to court. That evidence will be produced. It will be up to the court to determine whether liability is with the health service provider or whatever. The case still has to be heard. As far as we are concerned, the idea that somebody would be given factual information that later would be contradicted and the person could not say anything about that, is ridiculous. It neither negates the protections that are there for apologies nor amounts to an admission of liability.

Such laws in other states only indemnify an apology. They do not say anything about the information gathered in the course of an open disclosure. What we are talking about here is the information gathered in the course of an open disclosure. As it stands, without our amendments, the patient or his or her family would be prevented from relying on that information in civil proceedings later on. There is no guarantee they would win the proceedings or anything like that, but the idea that they would go in with only half the information when they know, having been told at a meeting a couple of months beforehand, what actually happened and not be able to use that, is incredible. It is mad. It would breed substantially more distrust. It will undermine the value in this legislation.

It is regrettable that the Minister has not taken on board these amendments. Not only would we be saving people emotional damage, we would be saving the State a lot of money if we brought in these amendments.

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I am sure the Deputy will agree that the objective here is to ensure that the patient acquires the appropriate information, receives an apology and that a process of redress is initiated. The facts of the patient safety incident will, of course, be recorded in the medical record file of the patient in any event. These facts will be there. It is important that we would consider a process that will ultimately lead to what we would regard as the best outcome for patients. It seems to me that section 10 provides an appropriate level of impetus for the cultural change to which I referred earlier. It facilitates the acquisition of information on the part of the patient after the incident. Presumably, that will be accompanied by an apology and will be followed by an appropriate process of redress, often without any need to resort to the courts at all.

We need to ensure that we have legislation that will bring about a cultural change from the current deficient situation and also ensure that there will be an appropriate level of buy-in, without which this legislation will be a disappointment and will not work to the benefit of those at whom it is directed.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

In fairness, the people at the coalface of these issues who actually deal with litigation would very much dispute that argument. Sadly, this legislation has been very much framed in the context of supposedly protecting establishments from liability rather than proactively empowering patients to get information about incidents that happened to them. What we are putting forward should actually embolden health service providers to properly and openly disclose with no fear of litigation at all but the legislation seems to be framed around that.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

9 o’clock

I move amendment No. 25:

In page 23, line 15, to delete “(b) shall” and substitute the following:

“(2) An apology, when it is made at an open disclosure meeting in respect of a patient safety incident, shall”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 26:

In page 23, to delete line 31 and substitute “safety incident.”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 27:

In page 23, line 32, to delete “(c) shall” and substitute the following:

“(3) Information provided, and an apology when it is made, to a patient or a relevant person (or both of them) by a health services provider at an open disclosure meeting in respect of a patient safety incident, or pursuant to the provisions specified in subsection (6), the statement referred to in section 16(5)and the statements referred to in the provisions specified in subsection (6), shall”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 28:

In page 24, to delete lines 25 to 28 and substitute the following:

“(3) An apology, when it is made at an open disclosure meeting in respect of a patient safety incident is not, notwithstanding any other enactment, admissible as evidence of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission, in proceedings to determine a complaint, application or allegation referred to in subsection (4).”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 29:

In page 25, line 25, to delete “any” and substitute “the”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 30:

In page 25, line 34, to delete “patient” and substitute “Category A”.

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 31:

In page 25, line 35, to delete “the health services provider shall make,” and substitute “the health services provider may make,”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 32:

In page 25, line 36, to delete "patient" and substitute "Category A".

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 33:

In page 26, line 2, to delete "patient" where it secondly occurs and substitute "Category A".

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 34:

In page 26, line 7, to delete “patient” and substitute “Category A”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 35:

In page 26, line 12, to delete “patient” where it secondly occurs and substitute “Category A”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 36:

In page 26, line 16, to delete “patient” and substitute “Category A”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 37:

In page 26, between lines 17 and 18, to insert the following:

“Voluntary open disclosure of Category B safety incident13.Where a Category B safety incident occurs in the course of the provision by a health services provider of a health service to a patient, the health services provider may make, in accordance with this Part, an open disclosure of the Category B safety incident to—

(a) the patient concerned,

(b) a relevant person where—

(i)in the opinion of the health services provider, having had regard to the age, capacity or health of the patient who is the subject of the Category B safety incident, it is appropriate that the open disclosure of that incident is made to a relevant person,

(ii) the patient has died, or

(iii) the patient has requested the health services provider to make the open disclosure of the Category B safety incident to the relevant person and not to the patient,

or

(c) both the patient and a relevant person where—

(i) in the opinion of the health services provider, having had regard to the age or capacity of the patient who is the subject of the Category B safety incident, it is appropriate that the open disclosure of that incident is made to both the patient and a relevant person, or

(ii) before the open disclosure meeting is held, the patient has requested that the health services provider makes the open disclosure of the Category B safety incident to a relevant person as well as that patient.”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 38:

In page 27, line 3, to delete “desirability, subject to paragraphs (b)and (c), of making” and substitute “requirement, under subsection (2), to make”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 39:

In page 27, lines 13 and 14, to delete “Having considered the appropriate time for making the open disclosure of the patient safety incident, the” and substitute “The”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 40:

In page 27, line 15, to delete “following that consideration”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 41:

In page 27, line 26, after “shall” to insert “, having regard to paragraph (a) of section 14(1)”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 42:

In page 27, to delete lines 27 to 29.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 43:

In page 27, line 30, to delete “(i) make” and substitute “(a) make”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 44:

In page 27, line 32, to delete “(ii) consult” and substitute “(b) consult”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 45:

In page 27, lines 32 and 33, to delete “subparagraph (i)” and substitute “paragraph (a)”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 46:

In page 27, line 38, to delete “paragraph (a)(i)” and substitute “paragraph (a)”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 47:

In page 27, line 40, to delete “paragraph (a)(ii)” and substitute “paragraph (b)”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 48:

In page 28, to delete lines 1 to 3.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 49:

In page 29, line 13, after “12(b)(iii)” to insert “or section 13(b)(ii) or 13(b)(iii)”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 50:

In page 30, after line 41, to insert the following:“(i) a statement as to what further enquiries, if any, into the patient safety incident the health services provider believes are appropriate and which it proposes to undertake;”.

It is implicit in section 18 that health service providers will make additional inquiries into a safety incident if necessary after an open disclosure has been made. The amendment aims to codify that in the Bill by adding to the list of things which a service provider has to tell a patient at a disclosure meeting and a statement as to what further inquiries into the incident the health service body feels are appropriate and which it will be undertaking. We think it is pretty reasonable and cannot see any reason why the Minister would not support it.

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

As outlined on Committee Stage, the proposed amendment is superfluous. Legal advice was sought on this matter. The firm view is that the Bill already covers such further inquiries as proposed by Deputy Clare Daly. I do not propose to accept the amendment

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 51:

In page 31, to delete lines 8 to 12 and substitute the following:“(4) The health services provider shall, at the open disclosure meeting, make an apology to the patient or the relevant person (or both of them) in respect of the patient safety incident.”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 52:

In page 31, line 19, to delete “where such apology was made”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 53:

In page 31, line 33, to delete “applies” and substitute “or section 13(c)apply”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 54:

In page 32, line 16, after “section 12(c)” to insert “or section 13(c)”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 55:

In page 33, line 7, to delete “may” and substitute “shall”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 56:

In page 33, line 17, after “an” to insert “additional”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 57:

In page 33, line 17, after “and” where it secondly occurs to insert “additional”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 58:

In page 33, line 26, after “an” to insert “additional”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 59:

In page 33, line 31, after “and” to insert “additional”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 60:

In page 35, line 25, after “an” to insert “additional”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 61:

In page 35, line 28, to delete “, if any”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 62:

In page 35, line 31, to delete “, if any”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 63:

In page 38, line 32, after “section 12(a)” to insert “or section 13(a)”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 64:

In page 39, line 5, after “section 12” to insert “or subparagraph (i), (ii)or (iii)of paragraph (b) of section 13”.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

I move amendment No. 65:

In page 39, line 16, to delete “section 12,” and substitute “section 12 or subparagraph (i)or (ii)of paragraph (c) of section 13,”.

Declan Breathnach (Louth, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

When is it proposed to take Fifth Stage?

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Now.

Charles Flanagan (Laois, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I thank Deputies for their contributions on all Stages of the Bill. I acknowledge the constructive debate on all sides and trust that the legislation can now proceed for signature by the Present at the earliest opportunity. It will first go to Seanad Éireann.

Declan Breathnach (Louth, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

The Bill, which is considered to be a Bill initiated in Dáil Éireann in accordance with Article 20.2.2° of the Constitution, will now be sent to Seanad Éireann.