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Seanad Éireann debate -
Wednesday, 4 Jul 2018

Vol. 259 No. 5

Civil Liability (Amendment) (No. 3) Bill 2018: Second Stage

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

I welcome the Minister to the House. It is an apt time to take this Bill. I am delighted to open the Second Stage debate. This Bill is about being transparent in healthcare, being protected by law and not being protected by the idea of doing something voluntarily, which is unenforceable. We know that to be the case now. More than that, this Bill is about delivering for the men, women, and children who have suffered as the result of medical mistakes which occurred completely unintentionally, but nevertheless happened and caused much harm and heartbreak.

We should keep those people in mind as we debate this Bill. We should think, especially, of those who died as a result of medical mistakes. I am sure we can all remember some of them. The recent reports into the baby deaths at the Midland Regional Hospital Portlaoise and Portiuncula Hospital are to the forefront of my mind this evening. The practice of keeping quiet when something goes wrong is prevalent in our medical culture and only a statutory duty of candour will address this. That is why we are bringing forward this legislation. The decision by the Government last year, supported by a Fianna Fáil abstention, to make open disclosures voluntary was a grave mistake. They now know how much of a grave mistake that was.

Sinn Féin has always opposed making open disclosure a voluntary concept. Along with independent Members and others in the Lower House, we voted to make it mandatory on 8 November 2017 on Report Stage of the Civil Liability (Amendment) Bill 2017. We were defeated that day, but this Bill seeks to right that wrong. Most recently, the fallout from the CervicalCheck scandal has shown the limitations of a process of voluntary open disclosure. I welcome that the need for mandatory open disclosure with legislative underpinning is now accepted and the passing last month of a Sinn Féin Private Members’ motion in the Dáil calling for mandatory open disclosure. I hope this House will go one better and begin the legislative process to make this a reality.

For open disclosure to work, it must be mandatory and legally binding. As an example, when we passed the Children First Act 2015, we made it mandatory to report child neglect and abuse. That only came into being on 11 December 2017. We know what is needed. We know to protect our children but now we have to protect our health, and the health of all the people on this island, when mistakes are made. Mandatory disclosure is the only show in town. This Bill addresses the problems surrounding the current system and amends the Civil Liability (Amendment) Act 2017 to provide for a mandatory system of open disclosure in our health system. It provides for mandatory open disclosure of a patient safety incident, the introduction of a mandatory requirement that the patient be provided with any and all additional information which later becomes available and, for that purpose, to amend the Civil Liability (Amendment) Act 2017 and to provide for related matters.

Recent scandals have given the impression that there is endless protection for those at the top while no such protection exists for those at the coalface. The actions or omissions of those at a high level in the Health Service Executive, HSE, or the Department of Health can affect more patients than the actions or omissions of those on the front line. We have open disclosure for those on the ward and in the surgery. Surely, there also needs to be accountability and disclosure among individual executives, hospital CEOs, and members of the HSE and the Department of Health. It is a healthy proposition.

I reiterate what I say so often in this House and it comes from my experience. Public participation at all levels of healthcare is vital. If we have more public participation in the top tiers and at the top tables of the HSE, strategy and steering groups, accountability will follow. I ask the Minister to consider this seriously as we deal with the fallout from yet another scandal. The Government is resistant to this Bill. There is a suite of excuses for not supporting it. The Minister might attempt to argue that the current legislation does not allow for voluntary disclosure and that the best practice of mandatory disclosure is being followed, but we have evidence from recent scandals that this is far from the case.

The Minister may reference the recommendations regarding mandatory reporting arising from the Commission on Patient Safety and Quality Assurance or the Madden report. This is good policy, but it does not go far enough because when we talk to the HSE at the various Oireachtas committees, everything has changed. If the Government is wary of voluntary decisions around disclosure, and it is something it denies is happening, then there is no harm in strengthening the legislation to take away the risk. This is about the culture of the HSE, and legislation such as this is the strongest way to change that and provide protection and honesty. The Minister may also reference the recent approval of legislative provisions to provide for mandatory open disclosure through the development of the general scheme of a patient safety Bill. That is with a view to having it brought to the Government for consideration in early July 2018. The Minister stated that it is hoped that it will be possible to commence drafting shortly thereafter.

However, that is too late. It is early July now and we do not have any time to waste. The Minister cannot tell Vicky Phelan to wait and he cannot tell Emma Mhic Mhathúna to wait. They and many others have lost so much.

The Minister should allow this Bill to proceed to Committee Stage today in order that we can make the changes necessary as soon as possible. It is the right thing to do and I know the Minister knows that too. We cannot suffer in the meantime but many will suffer if the Minister and his Government do not take this opportunity now. I will quote from what the Minister said on this issue in the Dáil last month: “I want to be clear that the Government is committed to progressing, as a matter of urgency, legislation to provide for mandatory open disclosure for patients and mandatory reporting of serious incidents to the relevant regulator”. This has not happened but this Bill will make it happen. It will be a continuation of our journey to honesty and openness. I therefore look forward to this Bill proceeding to Committee Stage with support from all sides of the House.

The Civil Liability (Amendment) (No. 3) Bill is necessary legislation. People who have been deeply impacted by the recent scandals, such as with CervicalCheck, are asking for it now.

Up to the time that Vicky Phelan and Emma Mhic Mhathúna spoke out to tell their tragic stories, very many people were under the impression that they would be told if something went wrong or mistakes were made in respect of their diagnosis or treatment. The hardworking staff of the HSE also need open disclosure. It is more than unfair that they are held responsible for individual actions and decisions at the coalface, while many of those higher up are protected by a culture of cover-up and defence of the organisation.

There is protectionism within the system, something I noticed long before I came into politics as it was blatantly obvious that wagons were circled in such circumstances. Whether in the area of physical health or mental health, this culture exists and until we face up to it we will not change it. This legislation is not about seeking to punish workers in the HSE. It is a genuine attempt to change the culture within that organisation. The benefits that come from a culture of open disclosure between health staff and patients are self-evident and have been proven internationally.

While this Bill seeks to legislate for disclosure at the patient-health worker level, we are clear that this has to extend to the HSE and the Department of Health. If either of these are aware of mistakes, misdiagnoses or any other information that could impact patients, they must make this known. This did not happen in the CervicalCheck scandal. The recent revelation of the deaths of babies at Portiuncula and Portlaoise hospitals and the long, protracted battle by their parents to discover the truth underline the need for this change in culture. Although devastated by the deaths of their children, these parents took on this culture of cover-up because it is vital that bereaved relatives have access to the truth. Anything that we, as legislators, can do to facilitate this should be a no-brainer.

The culture that exists at the moment, where patients effectively have to go to war with the HSE, does nothing to foster a positive relationship between patients and healthcare workers. In the west, we recently learned of up to 50 children who were identified in a HSE review of audiology services as having been misdiagnosed. The families learned of the report's publication through the media and were left waiting until they saw sight of a copy. The children in question were discharged from the HSE audiology service, only later to be diagnosed with severe to profound hearing loss. I know from these parents that there was a complete vacuum in communication where the HSE adopted a "shut down and go away" attitude.

The valproate scandal, caused by the wrongful prescribing of a drug to pregnant women that has led to over 400 children in this State being born with avoidable disabilities, is another example of why we need mandatory disclosure. The Government’s own legislation introduced voluntary disclosure. The only conclusion that can be reached is that in the months since that legislation was enacted, the voluntary model has not worked. It is not robust enough to force a change in culture that will be to the benefit of workers and users of the HSE. Therefore, the real argument here is not whether patients deserve and require candour. It is whether every patient should have that right enshrined in legislation. I urge all parties and none who agree with this basic right to support our Bill tonight on Second Stage.

In no way do we claim that this Bill is a panacea for all faults and mistakes within the health system. Unfortunately, these will always occur. However, a health system that strives to recognise mistakes, informs the patient and attempts to mitigate any future repeat needs legislation like the Bill before us. The current system means that one potential mistake can lead to many more occurring with no checks and balances.

The Minister will say that Government legislation is going through and I know that he recognises much of what we have said in our contributions this evening, but we would be failing as an Opposition were we not to table this legislation. We will work with the Minister and, as my colleague, Deputy O'Reilly, has said in the Dáil, we will work with him in whatever way we can. It is not a competition in which one Bill is trying to be better than another. It is about changing the culture in the HSE. It is for this reason we need mandatory reporting.

I welcome a debate on this matter as it is important that there is open disclosure of any adverse events occurring in medical practice, whether in a hospital, in a voluntary hospital or any medical facility. It is important to recognise we have come a long way. The problem is that our judicial system is an adversarial system and that is not helpful or conducive to all information being given at an early date.

We need to change the process for when adverse events occur in the course of medical treatment. We need a totally different system from the adversarial one we have. Last year we paid out over €300 million in claims via the State Claims Agency. If all the claims with that agency were settled in the morning, it would cost the State approximately €2 billion so there must be a better way. As much of the cost of that system is absorbed by solicitors and counsel, we need to look at the system and I welcome the Government's decision to carry out a review.

On open disclosure, not all adverse events have answers which are immediately available when they occur and, while information may be available to medical practitioners, the reasons for how such an event occurred may require further investigation. I am aware of cases where it has been decided to bring in an external person to examine the history of how a patient has been managed but, 18 months later, no agreement has been reached as regards who that person should be.

I had one case where the nurses and doctors on the front line wanted someone appointed immediately, and 18 months later the HSE had not taken a decision about who should be appointed. Cases such as this contribute to the worry and concern and, obviously the immediate impression that something is being hidden, but the people who work on the front line are not the people who caused the delay.

Where there have been very adverse events where deaths have occurred there have been considerable delays in the holding of inquests. This has also contributed to the concern of the families involved that someone is hiding something. In fact, it is beyond the power of the HSE and beyond the power of the front-line nurses and doctors and support staff to dictate when an inquest should be held. As a result, they are the people who seem to be identified as causing the delay when, in fact, it has to do with the system of holding inquests. For instance, there is no requirement for a coroner to hold an inquest within a particular period of time and this needs to be changed. In cases of infant deaths and maternal deaths I have seen a considerable delay in the holding of inquests. As a result it caused the wrong impression. It is important that the information, as soon as it is known, is made available to the people who suffered as a result of the adverse event. Any delay causes confusion, upset and anxiety, outside of the fact that people are going through a very traumatic period of time anyway. It is important that we make some of the changes in that area. Specific time periods for coroners are not covered by the Bill but it is something that should be looked at. In some areas of the country it is extremely good and efficient and coroners deliver very early, but in other areas it seems to be a problem.

The Minister will outline the Government's position on the Bill. We need to make the change in law. We need to make sure people are satisfied that every relevant piece of information about an adverse outcome is available to them and that nothing is kept from them. This is no criticism of the Minister because it happened before he was in office, but I had one scenario where I spent two and a half years getting an order for discovery against the Department and after getting that discovery I got a letter stating 1,100 hours of staff time had been used in assembling the documents for me to inspect. Of course the next line in that letter from the Department's solicitor was asking whether I would like to settle the case. That was after two and a half years of looking for discovery. It justified my persistence in getting it. I should not have had to do it and no one should have to do it with regard to any adverse event. It was not a medical negligence case but it was a case that involved the Department. We have made a lot of changes in the judicial and legal processes with regard to the disclosure of documents rather than discovery, but we still need to do a lot more with regard to how we can make information available so people do not have to be forced into the court system. It is extremely important that we do this. I welcome the debate and I look forward to listening to the Minister and hearing his response on the matter.

I want to clarify something. The Minister has indicated he wants to come in but I want to know who remains to speak.

Is the Minister willing to wait until Senator O'Sullivan has spoken?

I will be replaced by a Minister of State and I was hoping to have an opportunity to outline my position.

We will let the Minister in and Senator O'Sullivan can respond to what he says.

I thank Senator O'Sullivan and the Acting Chairman. I thank the Members of the Seanad for giving me the opportunity to speak this evening. I thank the Sinn Féin Senators for tabling the Bill, which provides me with an opportunity to outline a number of important developments in this area. Let me be very clear at the outset, because I often hear the position of the Government and myself misrepresented in this regard, although not this evening. The Government and I are completely committed to legislating for mandatory open disclosure. We need to legislate for it and I believe there is a consensus in both Houses in this regard. Tomorrow I will go to the Government on this and I will use this opportunity to outline that.

The House is aware that Part 4 of the Civil Liability (Amendment) Act 2017, which was signed into law by the President last November, provides the legal framework to support voluntary open disclosure. The Act applies to all patient safety incidents, including near misses and no-harm events. It provides the scope to create a safe space for staff to be open and transparent with patients when something has gone wrong, so that they may be given as much information about the incident as possible, as early as possible, including an apology where appropriate.

The Act provides legal protections for the information given following a serious patient safety incident and for any apology. The apology cannot, for example, be interpreted as an admission of liability and neither can it be used against the provider in clinical negligence actions. It is about providing a safe space for someone to say something went wrong, here is what happened and to say he or she is sorry. Neither can the information and apology constitute an admission of liability in fitness to practise proceedings. However, it is important to note that the protections provided in the Act do not provide protection for incompetent, negligent or other unprofessional patient care. This is very important. Patients will, of course, also continue to be able to use their medical records in litigation.

An open and just culture for patient safety balances the need for a mandatory, open and honest reporting environment and quality healthcare with accountability for individuals and organisations. Sinn Féin has brought forward a Private Members' Bill that would amend Part 4 of the Civil Liability (Amendment) Act 2017. The effect, however, of these amending provisions, which aim to introduce mandatory open disclosure, would alter the intent of the Bill and are, in my view, most likely to prove unworkable. In contrast, the forthcoming patient safety Bill, which has been under preparation by my Department for some time, and which I am pleased to inform the Seanad will be considered by the Government tomorrow morning, will deal with these issues in a full and comprehensive manner, including the issue of mandatory open disclosure. I hope that after tomorrow's meeting I will be in a position to send the patient safety Bill, which will legislate for mandatory open disclosure, to the health committee for its immediate consideration.

Notwithstanding my concerns with regard to this particular Private Members' Bill, I recognise the overriding priority of patient safety and quality in the delivery of health services. I agree with Senator Conway-Walsh's bipartisan remarks on the need to work together on this. I have been engaging with Deputy O'Reilly in this regard. I do not think we are divided on the need to legislate for mandatory open disclosure. We might have different views on it but we all share the aim of making sure we get it right.

The Government always has been and remains fully committed to open disclosure. At a non-political and political level, the Department has a track record in driving openness in order to ensure patient safety. I believe that all staff must be open and honest with patients. There are also the clear current requirements of the medical practitioners' code of conduct, which sets out that all clinicians have a duty to support a culture of candour, and open disclosure is the clear requirement of the HSE open disclosure policy. I do not want to pre-judge the various inquiries going on now or that will go on in the future, but it is interesting to note that although the medical practitioners' code of conduct is already so clear on this we know disclosure did not happen in so many cases. What is written down in black and white for our clinicians to follow clearly was not followed in the overwhelming majority of cases. This should be a cause for concern and shows the need for us to legislate.

Open disclosure should also happen in the right way and in every circumstance in which it applies. Patients simply must be informed. However, this can be a challenge for the medical profession. The Department’s legislative approach in the Civil Liability (Amendment) Act 2017 is to encourage this cultural change and encourage our clinicians to do the right thing in circumstances where disclosure is required. Through this Act, passed last year, which covers all patient safety incidents including near misses, any fears that doctors may have had with regard to being open and apologising to patients have been taken away. Put very simply, there is no longer room for excuses in this regard. The patient has a right to know and the patient must be told. I am pleased to advise the House that yesterday I signed the Civil Liability (Amendment) Act 2017 (Part 4) (Commencement) Order 2018. The Civil Liability (Open Disclosure) (Prescribed statements) Regulations 2018 to accompany the Act have now been finalised. These regulations provide the form of the statement to be given to the patient at the open disclosure meeting.

The regulations set out the information to be included in the statement about the patient safety incident - what happened, how it happened, the consequences for the patient, treatment and clinical care, actions taken by the provider to address knowledge from the incident and any apology made. The role of the statement is to set out the facts of the meeting in writing, to ensure there is clarity on all the information given at the meeting. This is an important point. I met a patient advocate last week, not concerning CervicalCheck but concerning another matter. On paper, they had been openly disclosed to. They certainly did not feel that the process had been in any way adequate, and they certainly felt that the person sitting on the other side of the table did not think so either. Open disclosure, mandatory or otherwise, cannot just be a box-ticking exercise. It is important that it be done in a compassionate, empathetic, truthful, honest and wholesome way. That is the purpose of this statement, as well as what open disclosure is meant to constitute.

In addition, the 2017 Act requires the health service to designate a liaison person. To comply with the Act, the HSE must prepare a statement in writing of the procedure for making an open disclosure of a patient safety incident and the manner in which the restrictions on the use of information provided applies.

The HSE has been asked to build capacity and expertise within the organisation nationally, regionally and locally to be prepared in advance for the requirements of the Civil Liability (Amendment) Act 2017 and for the forthcoming mandatory open disclosure included within the draft general scheme of the patient safety Bill. I have also committed to an early evaluation of the implementation of these regulations.

During the Dáil and Seanad debates on open disclosure last year I listened to the concerns voiced by many Senators and Deputies around the need for mandatory open disclosure of serious patient safety incidents. I committed to examining other legislation to provide for mandatory open disclosure for serious events. Events over the past few months have further reinforced my belief that mandatory open disclosure for certain serious patient safety incidents, including incidents related to screening, is absolutely necessary. At its meeting on 8 May, the Government approved that my Department would undertake the development of a new patient safety Bill. This Bill incorporates the patient safety elements of the health information and patient safety Bill dealing with the external notification of patient safety incidents, clinical audit and extending the remit of the Health Information and Quality Authority, HIQA, to the private health service, in addition to making provision for mandatory open disclosure. I will bring the general scheme of this Bill to Cabinet tomorrow.

Importantly, the patient safety Bill provides for mandatory open disclosure of serious patient safety incidents to the patient concerned, or to their next of kin or guardian where appropriate. The provisions will apply to all health service providers, public and private. That is an important change we are making. The provisions include private healthcare facilities as well as public healthcare facilities. The requirement extends wherever our citizens interact with any element of healthcare.

A patient safety incident is defined as an unintended or unexpected incident of harm that occurred in the provision of a health service. The Bill enables the Minister for Health of the day to prescribe those serious patient safety incidents that are to be subject to mandatory open disclosure. Among others, examples of such incidents include wrong site surgery, patient death or serious disability associated with a medication error, a diagnostic error or a serious error that could emerge in screening programmes. These provisions are in line with the UK duty of candour legislation. I have heard that many people want to know that we have mandatory open disclosure in line with the UK duty of candour legislation, and that will be the case. However, I am pleased that we are not going to stop there. Far be it from me to critique another country's legislation, but from reading quite a bit about this I know that there was a lot of disappointment with that legislation among some patient advocacy groups in the UK. The duty of candour introduced there only applied to organisations and not to individual professionals. I assure Members that after listening carefully to Senators, Deputies and patient advocacy groups, I have taken the decision that not only must the duty of candour provisions apply to the organisation as a corporate entity, they must also apply to the individual person. There has to be collective organisational responsibility, but also individual responsibility and accountability. In the proposed patient safety Bill which I will bring to the Government tomorrow, we will go beyond other jurisdictions like the UK in that regard.

I would like to acknowledge the work that Sinn Féin Senators have put into the Civil Liability (Amendment) (No. 3) Bill 2018, which seeks to amend Part 4 of the Civil Liability (Amendment) Act 2017 to provide for mandatory open disclosure of a patient safely incident. I have considered these provisions carefully and can appreciate their intentions. I do not believe we differ on the intention. However, in many ways the effect of these amending provisions would be to make the Act unworkable. If applied to every incident regardless of seriousness, even where a near miss or no harm has occurred, this would result in huge operational implications and could serve to suppress the appetite among staff working on the front line for the cultural change that we clearly need to make.

As I outlined earlier, I am convinced that the forthcoming patient safety Bill will deal with these issues fully and comprehensively. I would be delighted to work on this on a cross-party basis in Seanad Éireann and Dail Éireann. I have made that clear in my correspondence with Sinn Féin's health spokesperson in the Dáil. This important new legislation will provide in law for mandatory open disclosure in respect of serious patient safety incidents and will complement the legal protections for clinicians engaging in open disclosure that were introduced through the Civil Liability (Amendment) Act 2017.

The proposed patient safety Bill will empower the Minister of the day to prescribe by regulation those serious patient safety incidents that are to be subject to mandatory open disclosure. The process set out within the Civil Liability (Amendment) Act 2017 is relatively onerous, requiring the arranging of meetings between health service staff and patients and the production of written records in the format prescribed by the legislation. This is to be expected when legal protections are being granted around serious patient safety incidents. However, the adoption of such an approach for every error that occurs during the delivery of a health service, as proposed in these amendments, would be entirely unworkable.

I also note the absence of any enforcement provisions in this Bill for cases where there has been a failure to disclose. In contrast, I want to be clear that in the patient safety Bill I will bring to Government we will introduce a strict enforcement mechanism relating to open disclosure. There must be sanction where people refuse to comply with the law of the land where mandatory open disclosure is concerned.

Furthermore the provision in the proposed amendment to include a patient safety incident that has occurred in the previous five years is provided for under section 23(2) of the Civil Liability (Amendment) Act 2017, which states: "Where a patient safety incident occurred, or came to the notice of a health services provider, before the day on which this Part comes into operation, a health services provider may, on or after the coming into operation of this Part, make an open disclosure of that incident in accordance with this Part." I consider the Current Civil Liability (Amendment) Act 2017 to provide adequately for the provision of additional information for the patient or relevant person.

I would also like to underline the wider reform programme being driven by my Department, of which providing for open disclosure is one important element. The National Patient Safety Office, established in my Department in December 2016, is charged with delivering a programme of policy and legislative changes to improve the ability of the health service to anticipate, identify, respond to and manage patient safety issues. Progress to date includes the general scheme of the patient safety (licensing) Bill, which was approved by Government in December 2017 and referred to the Oireachtas. The Joint Committee on Health has now commenced pre-legislative scrutiny of the measure. This is vital legislation that I hope we can work on a cross-party basis to pass. Licensing our healthcare facilities will give the Minister of the day, and, therefore, the State and the citizens, a power that we do not have today. This requirement will also apply to private practice. Where somebody does not comply with the best practice we expect, the Bill also creates the ability to revoke that licence.

We have also introduced Part 4 of the Civil Liability (Amendment) Act 2017, which provides the legal framework to support open disclosure: oversight of the publication of monthly patient safety statements by all maternity hospitals and maternity units in the State and hospital patient safety activity reports by public acute hospitals; an annual National Healthcare Quality Reporting System, which published its fourth report today; and progression of the development of a new national patient safety complaints advocacy service, which will commence later this year. This last measure is really important. Senator Devine has mentioned public participation, which is an important point. I am committed to the idea of having advocacy voices and patient voices embedded within our system and I welcome Members' views on that. We will commence that new advocacy service this year.

Further to this, we have seen quality assurance by the national clinical effectiveness committee of 17 clinical guidelines and one audit, including those on sepsis management early warning systems for both adults and children; in collaboration with the Department of Agriculture, Food and the Marine, Ireland’s first ever national action plan on antimicrobial resistance, which was approved by Government in July 2017; and the establishment of the annual national patient experience survey that is administered by HIQA on behalf of the Department of Health, the Health Service Executive and HIQA. I cannot understand how up until recently we used to survey everybody and hear everybody's views except the patient's. We now publish an annual patient survey, for all to see what the patient experience is in our health service, warts and all.

The establishment of a patient safety surveillance system has also commenced. We have also rolled out a code of conduct for all health service staff, which sets out the principles which all staff are expected to adhere to with regard to patient safety. I also look forward to going to Government shortly, hopefully this month, with the HSE board legislation, which will improve accountability. I can give a commitment that a patient advocate will be on that board to make sure that the patient's voice is embedded from a patient safety perspective.

In addition to this, I want to pick up Senator Burke's point. As a Government, it is important that we look at how to resolve issues regarding clinical medical negligence claims. The current system is far too adversarial. The State Claims Agency, SCA, does its very best to resolve issues in a non-adversarial way, and I welcome that they are attempting to mediate in clinical negligence claims. However, it is important that as a country we examine best practice in other jurisdictions, and consider alternative methods to the courts process for resolving clinical negligence claims.

Last week at Cabinet I received Government approval to establish a new expert group in this regard. This is a joint initiative by the Minister for Justice and Equality, the Minister for Finance and me. The group will be chaired by the eminent High Court judge, Mr. Justice Charles Meenan, who has significant experience in the area of clinical negligence. It will provide an interim report after three months and a final report within six month from its establishment date.

This group will examine how we can deal more sensitively and in a more timely fashion with issues, such as catastrophic birth injuries, certain vaccine damage claims and claims where there is no dispute about liability from the outset, yet the cases seem to trundle on for far too long. The group will also examine whether an alternative dispute resolution mechanism or a no fault system, which we see in other jurisdictions, would be effective. This follows on from a commitment in the programme for Government.

This group will examine tort law as it currently applies to personal injuries arising in the healthcare context and consider options for reform of relevant tort law. It will also examine whether clinical claims management systems are adequate and whether there may be an alternative mechanism by which claims could be managed and determined more efficiently and effectively from the perspective of the person who has made the claim and the culture of patient safety. This is a very important piece of work for patients and the whole health service. It is a really exciting piece of work and if we get this right, we can radically improve the experiences of people who encounter an adversarial system that seems to go on far too long when it comes to the issue of clinical negligence.

I appreciate and share the genuine concerns of Seanad colleagues on the lack of provision for mandatory open disclosure in the Civil Liability (Amendment) Act 2017. I believe the approach taken in that Act is correct but I believe there is a need to bring forward further legislation to legislate for mandatory open disclosure in both our public and private health services, to go further than the UK in this regard in terms of ensuring that the individual as well as the organisation is covered.

I want to be very clear that any fear that anybody working in our health service may have had with regard to being open and apologising to patients in the past, should be gone now with the passage of the Civil Liability (Amendment) Act 2017. There is no room for any excuses in that regard. We must now build on what we have done. There is clearly a need to do more. I think we all agree on that. The reality is that serious patient safety incidents, including some that we have seen in recent weeks and months, absolutely require mandatory open disclosure. There is the forthcoming patient safety Bill, and I look forward to bringing the general scheme of the patient safety (licensing) Bill to Government in the morning which provides for mandatory open disclosure and importantly the mandatory reporting of these incidents to HIQA or the mental health commission, which ever is appropriate. It is important that the regulator gets automatically notified of these.

I am confident that this patient safety Bill in conjunction with the Civil Liability (Amendment) Act is the correct approach. I will be very happy to work on a cross-party basis to seek the speedy passage of the patient safety Bill. I thank the House for the opportunity to outline my position.

I thank the Minister. Does Senator Grace O'Sullivan wish to contribute?

I waive my right to speak to allow Sinn Féin to come back in.

When is the debate concluding?

Once Senator Devine speaks, nobody can speak after her.

I will be brief so as to ensure that there is adequate time for Senator Devine to come back in.

I support this Bill. It was unfortunate that when the Civil Liability (Amendment) Act 2017 passed through these Houses more recently that the change was made at that time to go from "shall" to "may". I appreciate the Minister's sincerity and I believe he is serious about engaging with and looking at this issue. I also note that a patient safety Bill will come before us. That will be a Government Bill and no doubt it will have the potential to pass out and overtake this Bill. I think we would all be very happy to see that. Having the pressure point of this very useful, practical and reasonable amendment Bill on the books can only add an appropriate impetus to the patient safety Bill to ensure its speedy passage and to ensure it is given the priority that is needed.

The recent tragic and unacceptable and outrageous situation on cervical cancer, which others have touched on, and screening is just one example of the importance of taking very seriously what we do in terms of ensuring patient safety. There are three strands to the process: the work of prevention; the work of information; and the work of reparation. I appreciate that the civil liability Act was designed to take that work of reparation and place it in a slightly different place to ensure that the important work of information was not compromised in any way. I hope to bring forward legislation later in the year on prevention, looking at the issue of how we issue contracts and the importance of quality in all public procurement contracts on health.

This Bill focuses on that crucial issue of information which states that people "must" be informed of key issues of interest to them. The question of what might be serious or not serious is ambiguous. I think it is appropriate that this Bill is enacted to put pressure on the patient safety Bill. Having worked in a completely separate but parallel area of data protection, namely, data breaches, I was concerned about the large number of exceptions under which Government and public bodies allowed themselves to not have to disclose to people where their personal data had been breached.

The devil is in the detail in determining what may or may not be considered serious in respect of a data breach and much more vitally in this area in regard to patient health safety. The seriousness cannot be underestimated. The seriousness may not be known because those who are determining whether it is a serious enough breach do not know the circumstances of the individual. They do not know the decisions that a person might be making without information and might make blind decisions in ignorance of an issue that deeply affects him or her.

This is a very positive Bill. I think we should accept it. I note the concerns raised by Senator Colm Burke that sometimes the process is very long in terms of the full exposure and the full investigation of an issue, but this is provided for by the initial information of the safety concern. There are also proposals that additional information should be given to them, and that may be two or three years later. The fact that all the information is not in place at once does not stop an initial disclosure. That is provided for separately.

A very constructive use of language is moving from "at any time" - which is quite vague - to "as is reasonably practicable". That recognises that there will be times when one is waiting for information, when reports need to come back when an expert has been brought in, but it still keeps a clock moving to ensure that things are moving towards getting the patient that information and there is a very reasonable test of "as is reasonably practicable" that is running underneath the process. For all of those reasons I strongly support the Bill, which is very constructive. While I welcome everything else the Minister is also doing, we should vote in favour of the Bill today.

Does Senator Devine wish to conclude?

I welcome the Minister for Health, Deputy Harris, to the House. I am delighted the Minister is going to the Government tomorrow about the Patient Safety (Licensing) Bill which he put on the agenda yesterday. Perhaps the Civil Liability (Amendment) Bill 2018 will give an impetus to the patient safety legislation. Before he left, the Minister rounded off a very decent and in-depth proposal for this patient safety legislation by saying, "I am confident that this patient safety Bill in conjunction with the Civil Liability (Amendment) Act 2017 is the correct approach." I agree with him and I think it would be even more correct when this House passes the amendment to it to include mandatory disclosures. We need to be seen to be acting.

In fairness the HSE acted quite fast but it took us a long time to get there. We need to be seen to be taking this issue seriously. I commend the Minister on the patient safety legislation, but I believe we now need to insert the word "mandatory" into the Civil Liability (Amendment) Act. We realise that it needs a great deal of work and we are willing to work with both Bills together.

The Minister ended his contribution by saying, "I am confident that this patient safety Bill in conjunction with the Civil Liability (Amendment) Act is the correct approach." However, mandatory reporting must be put in the Statute Book tonight.

When is it proposed to take Committee Stage?

I am sorry, Acting Chairman. That is not agreed.

It has been agreed that Committee Stage is being taken next week.

It is not agreed. That is my instruction.

When is it proposed to take Committee Stage?

My understanding is I said, "Not agreed".

That was to a different proposal. The proposal is that Committee Stage be taken next Tuesday. It will be on or after Tuesday. It will not necessarily be on Tuesday.

My understanding is that we are not agreeing to the Bill going to the next Stage. The Minister has announced that he is doing a new Bill and he is bringing it to the Cabinet tomorrow.

On a point of order, Second Stage is through.

It is not through. I said, "Not agreed".

Senator Burke missed out. He did not come in in time.

I said, "Not agreed".

There is no dispute about it. It is not agreed.

I will repeat the question as something was a little lost in translation.

I appreciate that we are putting the question again and that is fine, but it will be interesting to look back on the transcript because there was some lack of clarity. I have had amendments that I did not get to vote on because I was not quick enough. That is fine.

I will put the question again. In fairness, Senator Burke said he did say it but perhaps I did not hear him. My decision as Chair is to put the question again, which I think is fair.

Question again put:
The Seanad divided: Tá, 18; Níl, 19.

  • Clifford-Lee, Lorraine.
  • Conway-Walsh, Rose.
  • Craughwell, Gerard P.
  • Devine, Máire.
  • Dolan, John.
  • Gavan, Paul.
  • Higgins, Alice-Mary.
  • Horkan, Gerry.
  • Leyden, Terry.
  • Mac Lochlainn, Pádraig.
  • Nash, Gerald.
  • O'Sullivan, Grace.
  • Ó Domhnaill, Brian.
  • Ó Donnghaile, Niall.
  • Ruane, Lynn.
  • Swanick, Keith.
  • Warfield, Fintan.
  • Wilson, Diarmuid.


  • Burke, Colm.
  • Burke, Paddy.
  • Butler, Ray.
  • Buttimer, Jerry.
  • Byrne, Maria.
  • Coghlan, Paul.
  • Conway, Martin.
  • Feighan, Frank.
  • Hopkins, Maura.
  • Lawlor, Anthony.
  • Lombard, Tim.
  • McFadden, Gabrielle.
  • Mulherin, Michelle.
  • Noone, Catherine.
  • O'Donnell, Kieran.
  • O'Donnell, Marie-Louise.
  • O'Mahony, John.
  • O'Reilly, Joe.
  • Richmond, Neale.
Tellers: Tá, Senators Máire Devine and Fintan Warfield; Níl, Senators Gabrielle McFadden and John O'Mahony.
Question declared lost.