Patient Safety (Notifiable Patient Safety Incidents) Bill 2019: Second Stage

Minister for Health (Deputy Simon Harris)

I move: "That the Bill be now read a Second Time."

I am pleased to have the opportunity to introduce the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019. On 3 December last, the Government approved the publication of this Bill. I believe strongly that this legislation heralds a new era for the health service. This House will be familiar with some of the issues that have arisen within our health service in recent years that have, quite rightly, led to demands for improvements in patient safety. Any patient safety incident significantly affects patients' lives and impacts on their families. Quite often, that pain is compounded by poor communication.

I think today of people like Róisín and Mark Molloy, incredible patient advocates who lost their baby, Mark, in the Midland Regional Hospital, Portlaoise. They advocated so much for open disclosure. I also think of the incredible Vicky Phelan. These are people who have been kept in the dark about their own healthcare or that of a loved one. They have led us on the road to today and I formally thank them here on the floor of Dáil Éireann today. I also want to send a message to our doctors, clinicians and all those working in the health service. This legislation is not about a blame culture or finger pointing. It is about supporting those people in doing their jobs and about creating a culture in the health service where open disclosure and transparency are the norm. I know there are concerns and I can understand why.

When it comes to open disclosure, we must all become better at responding when things go wrong. Let us be honest. In every health service the world over, things will go wrong. What matters is how the health service responds and deals with situations when those mistakes and errors happen. We have now seen several good examples of responding when things go wrong, but this House and the media must also reflect on our reactions once the news of such incidents breaks. I believe we will succeed in creating the kind of culture we desire, but it will, inevitably, mean that more incidents will be discovered and disclosed. This means a more balanced analysis will be required in future. If mandatory open disclosure becomes the norm, and it will under this legislation, that will mean that, quite rightly, we will be hearing about more patient safety incidents. We need to debate that as an Oireachtas, a country and a health service in a balanced way and in a way that recognises that identifying errors and putting up one's hand and saying "I made a mistake, I got it wrong, I am sorry and here is the learning" is actually a good culture to embed in our health service.

The Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 is part of a programme of legislative changes and policy initiatives being taken by my Department to improve the ability of our health service to anticipate, identify, respond to and manage patient safety issues. I hope the Bill will also change the culture within the health service. This Bill provides for a number of patient safety priorities, including mandatory open disclosure of serious patient safety incidents. It also provides for the notification of those reportable incidents to the relevant regulator, and it is an important point that the regulator has to be notified, the use of clinical audit to improve patient care and outcomes and, importantly, the extension of the remit of HIQA to private hospitals. That is something for which there have been calls for many years and it will now happen in this legislation.

This Bill is divided into eight Parts, with 54 sections and two Schedules. The first Part, preliminary and general provisions, covers sections 1 to 4, inclusive. Section 1 contains standard provisions setting out the Short Title of the Bill and arrangements for its commencement on a phased basis. Section 2 deals with the interpretation of the Bill. It defines the meanings of some of the terms used for the purposes of the Bill, including "apology", "health practitioner", "health service", "notifiable incident", "open disclosure of a notifiable incident", "patient" and "relevant person". Section 3 provides the definition of a "health service provider", which encompasses a wide range of providers of health services, public and private. Section 4 deals with expenses.

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

All notifiable patient safety incidents, whether listed in the Bill or prescribed in regulations, are subject to mandatory open disclosure and must be notified by the health service provider to the appropriate regulator. This section is intended to ensure that the list of notifiable patient safety incidents subject to mandatory open disclosure can, as I have said, be kept up to date on an ongoing basis. The section gives the Minister wide scope to prescribe further patient safety incidents as notifiable incidents, bearing in mind the learning from incidents that have occurred in the Irish health service or internationally, as well as learning from advances in clinical practice.

In prescribing new patient safety incidents as notifiable incidents, the Minister of the day must have regard to a number of matters, including the nature of the incident; the consequences for the patient; and the need to obtain and disseminate information regarding an incident so as to prevent or lessen reoccurrence. Section 9 provides that when a health service provider engages in open disclosure in accordance with the Act, the disclosure, including an apology, shall be treated as an open disclosure of a notifiable patient safety incident.

Section 10 sets out that the information and apology given at an open disclosure notifiable patient safety incident meeting shall not: constitute an express or implied admission of fault or liability; be admissible as evidence of fault; invalidate insurance; constitute an express or implied admission, by a health practitioner of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission in relation to notifying a notifiable patient safety incident.

The purpose of these legislative protections, which are very much in line with international experience and best international practice, is to encourage an environment of open disclosure by ensuring that information relating to notifiable patient safety incidents can be disclosed by health practitioners and health service providers without fear of liability. It is a shame that, on many occasions, in the health service and in many other walks of life when something goes wrong, the first place the public service can run to is a lawyer. That is the culture we are trying to change. We are trying to create a safe space in which somebody can come forward and admit an error happened. As Dr. Scally said in his report, we must acknowledge the error, apologise for it, mean it and learn from it. That is at the core of what mandatory open disclosure has to be about. That is why these protections are in the legislation. The following terms are also defined in this section: "clinical negligence"; "clinical negligence action"; "medical defence organisation"; and "professional indemnity insurance".

Section 11 provides that a health service provider must set out in writing its procedures for making open disclosures of notifiable patient safety incidents to patients. Section 12 addresses openness and transparency and sets out that both health service providers and health practitioners, when making an open disclosure under this Bill, must provide all relevant information to the patient, or his or her relevant person, and, where appropriate, any other health service to address the consequences of that incident.

Part 3 addresses the procedure for making an open disclosure of a notifiable incident. It is one matter to practise open disclosure. How open disclosure happens is equally important. I have met patients who have been openly disclosed to but in a less than satisfactory manner. Section 13 requires that an open disclosure must be made on behalf of the health services provider by the principal health practitioner. If the principal health practitioner is not available, or not in a position to make the open disclosure, the health services provider will identify an appropriate health practitioner to make the disclosure.

Section 14 requires the health services provider to take all reasonable steps to make the disclosure to the patient and-or his or her relevant person as soon as practicable, having regard to the circumstances of the notifiable patient safety incident. Section 15 details matters to be addressed by the health services provider before making the open disclosure of the notifiable patient safety incident. These matters include the appropriate time, given an assessment of the circumstances; to whom the disclosure should be made; the making of an apology; the complexity of the information; the assignment of a designated person to liaise with the patient; and preparing a statement in writing about the incident.

Section 16 provides for the designation by health services providers of a person to act as a designated contact person for the patient or family in relation to the open disclosure. Section 17 requires that the open disclosure meeting will be held in person, unless the patient and-or his or her relevant person requests that it be held by telephone or other method of communication. Again, this shows the patient-centred approach.

Section 18 requires the health services provider to make arrangements for the open disclosure meeting with the patient and-or his or her relevant person. This includes the information that must be given orally at the meeting and in writing within five days of it. This is important as somebody could be at a vulnerable stage of his or her life. The person would be going into a meeting with much information coming at him or her. This measure of a recap of that information in writing is important. This information must include names of the persons present at the meeting; a description of the incident concerned; the manner in which the incident came to the notice of the health services provider; the physical and psychological consequences of the incident for the patient; the treatment and care plan for the patient relating to any of the consequences arising out of the incident; actions, policies or procedures proposed or that have been taken by the health services provider to address the incident; and any apology to be made to the patient.

Section 19 makes it clear that a patient may choose not to participate in the open disclosure of a notifiable incident or may decline to accept written information regarding the incident. However, the patient may change his or her mind within five years from the day of refusal and request the health services provider to make the open disclosure. The provider is also required to keep a record of the refusal.

Section 20 requires a health services provider to take all necessary steps to contact a patient to arrange an open disclosure meeting. If a health services provider is unable to make contact with a patient, it must set out in writing the steps taken to establish contact. If the patient is later contacted, the health services provider must proceed to hold an open disclosure meeting.

Sections 21 and 22 contain provisions relating to a health services provider holding additional meetings with the patient and-or his or her relevant person to provide information that may not have been available originally. Section 23 provides that a patient, or relevant person, who attended an open disclosure meeting may, at any time, can make a request to the designated person for clarification about the information provided. The clarification should be provided orally at a meeting and in writing as soon as practicable, either by the health practitioner who previously made the open disclosure or an appropriate alternative person, if necessary.

Section 24 sets out that a provider must provide the patient with a written statement on the incident either at the relevant meeting and not later than five days from the day on which the meeting was held. Section 25 details the records that must be maintained by the health services provider about a notifiable patient safety incident. The Minister may also prescribe in regulations the format of records to be kept and maintained.

Part 4 addresses the notification to certain regulatory bodies of notifiable incidents. Section 26 is the interpretation section for Part 4. Sections 27 to 29, inclusive, set out that a health services provider under the remit of HIQA, the chief inspector of social services or the Mental Health Commission, as appropriate, will make a notification as soon as practicable and not later than seven days from when the provider is satisfied that an incident has occurred. The notifiable incidents are those specified in Schedule 1 and those specified in regulations to be made under section 8. The notification must include the name of the health services provider; the type of incident that has occurred; the date the notifiable incident came to the notice of the health service provider; any action that is being taken, or is proposed to be taken, to prevent a reoccurrence, or mitigate the consequences of any similar incident and for the purposes of sharing the knowledge and learning arising from it.

Section 30 provides that the method for making notifications to the bodies will be by means of the National Treasury Management Agency incident management system. Section 31 provides where a notifiable patient safety incident is reported to the relevant regulatory body, the regulator may request further information from the health services provider. Again, we are trying to learn from more than just individual incidents. If HIQA or the Mental Health Commission has to be notified of these incidents, it will create a wealth of information about patient safety standards across our health and social services.

Section 32 provides that the regulatory bodies may share information on these incidents with other health regulatory bodies, as well as with coroners, for the purposes of the safety of patients and if the information relates to the function of the relevant body. Section 33 clarifies that information relating to these notifications, including further information or sharing information, will not constitute an express or implied admission of fault or liability; be admissible as evidence of fault; invalidate insurance; or constitute an express or implied admission by a health practitioner of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission relating to notifying a notifiable patient safety incident.

Section 34 provides, in respect of a notification made under Part 4 to a regulator, that the Freedom of Information Act 2014 will not apply to a record of or relating to that notification. Again, the purpose of these legislative protections, in line with international experience, is to encourage health services providers and health practitioners to comply with this requirement to notify the regulators of notifiable patient safety incidents without fear.

Part 5 addresses clinical audit. Section 35 deals with the interpretation for Part 5 and contains definitions of the terms "clinical audit", "clinical standard", "clinical guideline", "aggregated data" and "clinically-led". Section 36 provides detailed definitions of the terms “clinical audit” and “clinical guideline”. The definitions of “clinical audit”, “clinical standard” and “clinical guideline” are key to this Part in that a health services provider or a health practitioner who undertakes and publishes an audit may only seek protection from the Freedom of Information Act 2014 in respect of a clinical audit that has been conducted in accordance with the definitions in this Bill.

Section 37 details how a clinical audit to which this Part applies should be carried out. It should be collected solely for the purpose of improving patient safety and quality improvement, and published as aggregated information. Section 38 provides that a record of a clinical audit, a component of or information provided in respect of a clinical audit, to which this Part applies, is exempt from the Freedom of Information Act 2014. Section 39 contains legislative protections on clinical audits, in similar terms to sections 10 and 33.

Part 6 deals with the amendment of the Act of 2007 in order to extend HIQA's remit to the private hospital sector, a long overdue measure. Section 40 amends the definitions section of the Health Act 2007 to reflect the requirements of this Bill. Section 41 amends section 8 of the Health Act 2007 to allow for HIQA standards to apply to both public and private healthcare services. Section 42 deals with investigations by HIQA where the agency believes there is a serious risk to the health or welfare of people receiving a particular service. Investigations may be carried out by HIQA on its own initiative or where required by the Minister for Health or Minister for Children and Youth Affairs, as the case may be. This section amends section 9 of the 2007 Act to take account of the investigations into services provided by private healthcare providers.

Section 43 amends section 10 of the Health Act 2007 to enable HIQA to set standards for the private healthcare sector. Section 44 amends section 12 of the Health Act 2007 to include private healthcare providers as being among the bodies which HIQA may require to provide information or statistics in order to determine the level of compliance by these organisations with standards set by HIQA. Section 45 amends section 73 of the Health Act 2007 to also apply to premises owned, used or proposed to be used by a private hospital or a prescribed private health service. Section 46 amends section 78 of the Health Act 2007 so that HIQA may publish a report relating to the monitoring of compliance with standards by private hospitals. Section 47 provides that the Minister may prescribe, by regulation, a health service to be a prescribed private health service for the purposes of this legislation.

Section 48 repeals section 100 of the Health Act 2007, an aspect of the Act that has not proven to be necessary during the period of the Act's operation.

Part 7 addresses the offences and penalties. Section 49 sets out that a health service provider which fails to comply with the obligation to make an open disclosure of a notifiable patient safety incident, without reasonable excuse, shall be liable on summary conviction to a class A fine. A health service provider which fails to comply with the obligation to report a notifiable patient safety incident externally to the appropriate body will be liable on summary conviction to a class A fine. In many situations where patients are harmed, the error or mistake occurred because systems were not in place to support the healthcare practitioner or team in identifying and avoiding that error. For this reason, in this section the consequences for failing to comply with mandatory open disclosure and notification are placed on health services providers.

Part 8 deals with miscellaneous and general matters. Section 50 provides that the Minister for Health may publish guidelines on the operation of, and compliance with the Bill and regulations made under it. Section 51 provides that the Minister has the power to make regulations for any matters prescribed or to be prescribed in the Bill. Section 52 amends section 11 of the National Treasury Management Agency (Amendment) Act 2000 in order that the National Treasury Management Agency may provide the incident management system as the means of making the notification regarding a notifiable incident to the regulatory bodies.

Section 53 provides for the amendment of the Civil Liability (Amendment) Act 2017 in the manner specified in Schedule 2. Section 54 contains the savings and transitional provisions. Where a health service provider makes an open disclosure in accordance with Part 4 of the Civil Liability (Amendment) Act 2017 of an incident which would be a notifiable incident under this Bill before then coming into operation of this legislation, Part 4 of the Act of 2017 shall continue to apply to that open disclosure.

In Schedule 1, Part 1 includes a list of 12 unintended or unanticipated notifiable patient safety incidents that are of a very serious nature and which mostly fall into the category of preventable incidents. In Schedule 1, Part 2 includes a notifiable incident for situations in which a baby is referred for therapeutic hypothermia. This is included as an indicator for neonatal conditions, for example. As outlined, under section 8, the Minister through regulations will have the power to designate, on an ongoing basis, additional incidents as notifiable patient safety incidents for which mandatory open disclosure is required. Schedule 2 deals with amendments to the Act of 2017. This Schedule details the amendments to the Civil Liability (Amendment) Act 2017, in order to align with this Bill.

In the time available I have endeavoured to take Members through as much of this very comprehensive Bill as I could. It deals with a number of important aspects of patient safety priorities, including mandatory open disclosure of serious notifiable patient safety incidents, external notification to the regulator, provisions regarding clinical audit, and for the first time the extension of HIQA's remit to the private healthcare system.

I am confident that the Bill will bring significant improvement in patient safety and quality. I commend the legislation to the House and I look forward to a detailed and robust scrutiny of the Bill, and hopefully its swift passage in coming weeks as we try to finally get this much-needed legislation on the Statute Book.

Deputy Stephen Donnelly

Fianna Fáil will be supporting this long-overdue legislation which underwent scrutiny at the Oireachtas Joint Committee on Health last year. Patients must be able to trust that they are getting from their doctors the full facts about their own medical tests and conditions, including any adverse events and errors that have happened. Those doctors and healthcare professionals must feel free to be able to share this information with patients and to do so without fear of legal consequences.

The Bill represents a serious, healthy and necessary legal change for the environment in which our healthcare professionals will be working. However, it has taken far too long for the legislation to come before the House and does so in the final few months of this Dáil. In 2016 when the Taoiseach was Minister for Health he said he would not introduce mandatory reporting. This was in spite of his promising in 2015 that he would do so. Until the CervicalCheck crisis arose, the Minister, Deputy Harris, had decided to introduce voluntary open disclosure rather than the mandatory scheme outlined in the Bill. The HSE published its disclosure guidelines in 2012 and its national healthcare charter from that year states: "Patients can expect open and appropriate communication throughout their care, especially when plans change or if something goes wrong."

We are finally debating this Bill four years after the then Minister and now Taoiseach boasted about preparing a wide-ranging package of patient safety measures when it came to disclosure and eight years after the then Minister, Senator Reilly, promised a patient safety authority that was never established. There has been a complete lack of urgency from successive Fine Gael-led Governments when it comes to open disclosure and patient safety.

It is critical that patients know the full facts and we all know this did not happen in the case of CervicalCheck. We have all pointed criticism at CervicalCheck, some of which is very necessary. It is worth acknowledging that no other country even tried to do what CervicalCheck tried to do with its historical audit in looking back at every case and telling the women affected. Ireland is the only country where an attempt was even made to communicate with the women. There was some limited implementation of this in the British National Health Service, NHS, but it does not exist anywhere else.

However, it did not reach the bar it set for itself and as we all know many women were very badly let down. In most cases the information was communicated to the doctors, but for a variety of reasons outlined in the Scally report and through debate over the last year and a half, we know that much of this critical information was not communicated to women or their families. It should have happened and this legislation will help ensure it happens in the future.

We know about the cases from the 221+ group. However, the Royal College of Obstetricians and Gynaecologists, RCOG, review has revealed many more women who did not know. With her permission the case of Ms Bernadette Kiely has been referenced openly in this Chamber previously. In this case a CervicalCheck audit had found discordance. None of this was communicated to Ms Kiely. She was not included in the 221+ group as she should have been. Just as worryingly, when she got her RCOG review results which found the discordance and referenced the CervicalCheck audit, she then approached the HSE and asked to join the 221+ group but was told she could not. She only got her patient files when her solicitor acted on her behalf. Even now they have not been provided with all the relevant files.

I have read through the file in detail and believe she is unambiguously entitled to the ex gratia payment of €20,000. However, when Ms Kiely and her solicitor asked that she be eligible for the payment, she was told by the HSE that she was not entitled to it. She was then told to find whatever receipts she could from her previous medical care, including drugs and that if she could pull these together the HSE would reimburse her. We have a long way to go in full open disclosure and in reacting properly to women who have not received disclosure.

Three days ago, in a clinic in Wicklow I met a lady who was part of the RCOG review and where discordance was found. She came to me because she is still completely at sea. She does not know if she is entitled to the €20,000, which I think she should be. I believe they all should be entitled to that even though we read in the newspapers that they are not. Although she has not been told about any previous CervicalCheck audit, the discordance was found from a 2014 smear test, which indicates to me there probably was an audit. She said she is now required to fill out sheaves of paper and forms and has not got the support she needs.

I am not making any political points here; we all want what is best. However, we need to do much better in supporting these women in open disclosure and critically in supporting them after open disclosure. Over many years we have all dealt with heartbreaking cases of people who have fought the system and, in many cases, lost because the State wields the threat of legal action and legal costs like a weapon against largely defenceless citizens. In denying them access - I have met, as the Minister may have done, parents whose baby died during childbirth. Audits were conducted and there was a thorough look back at what happened. Errors were found but all of this was hidden and kept from the parents.

To this day, those parents are struggling to get justice.

These cases are extraordinary and they are not just on the medical side. In this House, we tend to focus on the medical side but we must take a broader view. For several years, I have been dealing with the case of a social worker employed in child protection who was asked to do something in a case. The expert had clearly said this should not be done and the social worker raised a flag and said he was not comfortable doing it. The HSE set out to destroy this guy. It brought him to the High Court and the legal costs in the case reached the point where he was going to lose his house. He ended up having to leave the service and the country. All he was doing was trying to protect a child and follow the expert advice that had been given. I wrote to the director general of the HSE and said I wanted this case investigated but he refused. I also wrote to the Office of the Ombudsman asking to have the case investigated. It also refused to do so on the ground that it was a child protection issue and informed me that I should contact the Ombudsman for Children. I met the Ombudsman for Children who said the case did not warrant an investigation. The HSE, having destroyed a good man for protecting a child, refused to investigate, as did the Ombudsman and the Ombudsman for Children. This is the reality for those who see something wrong and refuse to act in a certain way because they do not want to create a patient safety incident. The case I raise is a live one. We need to look at our hospitals and medical care and also social care.

It is critical that clinicians feel they are legally protected. Based on the conversations I have had with clinicians, they do not feel protected at the moment. I am aware that amendments will be made to the Civil Liability Act. We must engage in great detail with the clinicians. They must be assured that they have legal protections and we must ensure that resources are in place. This will require training and may require other supports. Counselling may be required for patients and their families and also, in many cases, for the clinicians. These can be very difficult things for people to do.

Whatever process is put in place, it should be at an appropriate level of administration. There is a real fear that clinicians, in trying to comply with this law, will be buried in paperwork and red tape. They need to spend most of their time keeping people well and treating patients who are sick. Of course they must do what is prescribed in the Bill but we cannot bury them in red tape. We need standardised and simple processes where the right information can be communicated to the right people and organisations without giving rise to an onerous burden of red tape.

State agencies will also need additional resources. A great deal of new information will go to HIQA, the Mental Health Commission and perhaps other State agencies. These bodies will have to investigate and get involved, as they should. That is one of the reasons we are doing this. For them to do that, however, they must have additional resources. We cannot have circumstances where sensitive and important information begins to make its way to our regulators and statutory agencies, including safety agencies, if they do not have the professionals they need to go in and investigate and work with our hospitals, healthcare providers and patients to make sure these things are acted upon and improvements are made.

I welcome the additional powers being given to HIQA in respect of private hospitals. By and large, our private hospitals are pretty good. They put in place their own rigorous safety processes and audits, often with independent and international oversight. It is right and proper that the State's regulatory and safety agency can investigate any of the private hospitals in the same way as it can investigate public hospitals.

I do not have a copy of the Minister's speech. With regard to open disclosure, he spoke of clinicians now being able to stand up and say they made a mistake, got something wrong, fell short and apologise for doing so. I encourage the Minister to look to his Government on this and lead by example. The Select Committee on Health met last week when it was asked to approve an additional €338 million for health. We got the relevant information late on the night before the meeting. Members were in the Chamber voting at the time and discussed the Supplementary Estimate at 9 a.m. the following morning. The previous year, we received the information at 10 p.m. on the night before the committee meeting. One of the most important roles of the House is to interrogate money. The reality is that the information we got was not what was needed, did not have the detail we needed and we got it on the evening before a 9 a.m. meeting had been scheduled to discuss it. If we are to have open and full disclosure, we must lead by example. The information has to be given out in a more timely manner. The Minister could also lead by example. The Minister and I had a back and forth discussion in the committee on cost overruns and parliamentary questions. In a non-adversarial way, I put it to him that perhaps he would like to correct the record with regard to responses he had given to Deputy Cowen. He refused do so and ended up having to correct the record in the Chamber.

Deputy Simon Harris

I chose to correct the record in this House.

Deputy Stephen Donnelly

Perhaps we could have a bit more open disclosure from the Government and maybe we could be more accepting of that in this House when Ministers have to come in here to correct the record. The Government must lead by example. All Members must lead by example. If we are to require healthcare professionals across Ireland to stand up and do the right thing, to be honest and to hold their hands up and say they got something wrong, we must also do so.

I will conclude on a political point. The greatest source of patient safety incidents is not our clinicians but the crises that are unfolding in our healthcare system today. Yesterday, RTÉ reported that two patients had waited three weeks on trolleys at Limerick University Hospital. Elderly men and women are waiting for days on trolleys. Safe staffing levels have not been met. Diagnostic suites are not open when our clinicians need them. Our GPs do not have the resources they need. Our public health nurses are stretched extraordinarily thinly. If we preside over a public healthcare system in which, through no fault of their own, our healthcare professionals are understaffed, overworked and stressed out of their minds, then it is the Government that is the single greatest source of failures in patient safety, not clinicians. While it is not part of this legislation, we should reflect on the fact that while we ask our healthcare professionals to put their hands up and admit errors, perhaps this Government should put its hands up and apologise to healthcare professionals for putting them in that position in the first place.

Deputy James Browne

I welcome the very important Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 or, to put it in layperson's terms, the mandatory open disclosure Bill. It is long overdue but it is now very welcome. I am glad to see that patients will be entitled to get the full facts about their medical tests, conditions and medical information. They need to be able to trust that they will get that information.

The proposed legislation represents a cultural change for the hospital, medical and clinical sectors. It is also a legal change. There needs to be leadership within the HSE to drive this change. Other policies and laws which were changed in the past were not implemented in the manner they should have been.

As Deputy Donnelly stated, in 2016 the then Minister for Health, the Taoiseach, Deputy Varadkar, stated that he was opposed to mandatory reporting. In 2012, the national healthcare charter was published and contained open disclosure guidelines, but it was never properly or fully implemented.

The Bill aims to ensure that the health service learns from its mistakes and errors in order to prevent them from being repeated. It is also about the right of patients to know about their own bodies, medical conditions and bodily integrity. The World Health Organization has stated that one in ten hospital patients experiences harm, but at least 50% of these cases are preventable.

It is questionable whether we would be introducing mandatory open disclosure were it not for the CervicalCheck scandal. In May 2018, the emergence of a failure to disclose to affected women the results of a cervical screening audit led to widespread and very understandable anger. Women had been badly let down. In his report, Dr. Gabriel Scally made clear his view that the system for dealing with medical errors in Ireland was "not fit for purpose". Dr. Scally went on to say that patients in particular were left with no other option but to pursue legal action "to find out the truth of what went wrong". "Until that changes", he added, "we are not going anywhere". Litigation is the only option. As a barrister, I have represented a number of patients in medical negligence cases. I know what it is like, as a member of a small legal team, to go up against the might of the legal apparatus of the HSE. I have seen cases where people who had suffered serious medical negligence in heartbreaking and stressful circumstances were willing to settle their case early because they were simply unable to deal with the stress of a court case.

Yesterday, I said in a discussion on the perjury Bill that the vast majority of people in this country never go to court. The vast majority of those who do go to court find it extremely stressful and do not want to be there. To face the might of those legal teams is quite phenomenal.

Dr. Scally went on to say the current system is deeply flawed. The legal system takes an error and converts it into an injustice and then converts that into a financial sum. Even then, it is for the lucky few who are able to withstand the might of the HSE legal system and can afford their own lawyers or can get lawyers willing to take on the case on a no foal, no-fee basis. Dr. Scally also said the failure to inform patients about errors in their treatment in CervicalCheck were catastrophic and the catastrophe came about when rushed and botched attempts were made to disclose, as some of those disclosures were made in an appalling way.

Today is the UN's universal health coverage day and it calls for all citizens to be provided with affordable and quality healthcare. It is very apt that the Bill is being discussed today because it is about quality healthcare. We cannot have quality healthcare without patients being informed about the healthcare they are receiving.

I want to touch on a very particular aspect that is not specifically dealt with in the Bill, as far as I can see, but it is an important matter in terms of disclosure. We have a record in recent years of appointing unqualified non-specialist doctors to work as consultants who are not trained to take up these roles. They have not taken on leadership training and they are not on the Medical Council's specialist register but they are treating patients who are not aware that the people holding themselves out as consultants are not qualified. The vast majority of patients simply take a consultant at his or her word. When they hear someone is a consultant they believe that person has been through all of the necessary training. Many people would be very surprised, very hurt and very concerned if they realised the consultant treating them was not on the specialist register and had not completed specialist training. As a senior nurse said to me, one day a junior doctor needs a nurse to help him or her put a needle into an arm and the next day that doctor is leading an entire medical team in a hospital. This is simply not acceptable. This is a real patient safety issue. Where a non-specialist doctor is acting as a consultant is it not, prima facie, a safety issue? Under one interpretation of the Bill should those consultants who are not on the specialist register be compelled to inform the patient of this? In December 2017, the Minister said this probably should be the case and I would like to hear his views on it.

I welcome the Bill. It is overdue and I am glad to see it is now happening.

Deputy Martin Kenny

I welcome the opportunity to speak to the Bill. I will speak to the various sections, starting with the overarching agenda of the Bill setting out the legislative framework for reporting notifiable patient safety incidents.

Mandatory open disclosure has been a significant public concern for some time, not least since the CervicalCheck scandal. A policy of mandatory open disclosure of specified serious patient safety incidents should form the cornerstone of our health service. We need a clear and consistent approach to open disclosure for health service providers, for those working in our health service and for patients. Sinn Féin has always been in favour of mandatory open disclosure and has argued in the Chamber and in the committee rooms for legislating for mandatory open disclosure.

In recent years, we have had many instances that have reinforced the need for open disclosure. It is unfortunate that these instances have been the catalyst for this part of the Bill. The CervicalCheck scandal showed the limitations of a process of voluntary open disclosure. Telling the truth where there is a patient safety incident should be mandatory and legislatively underpinned. Nobody believes the health service can be run without error or risk but people demand that it show compassion and be truthful and honest. Oftentimes in the health service this has not happened. It did not happen in the cases of Vicky Phelan, Emma Mhic Mhathúna and others affected in the past. It did not happen in the case of Alison McCormack when she had her breast cancer misdiagnosed. It did not happen when there were errors leading to baby deaths and injuries in Portiuncula Hospital and it did not happen when errors led to the deaths of babies in Portlaoise hospital.

In order for open disclosure to work it must be mandatory and it must be legally underpinned. In the past few decades there has been recognition throughout the world of the importance of open disclosure in medical incidents. Medicine has evolved and so too must the way in which we report harm or error. It can no longer be an act of goodwill; it must become a system of meeting the expectations of transparency and accountability.

In one case of which I am aware, a couple whose baby did not survive had at least a dozen meetings with personnel from the HSE to try to get answers. In the end, they met with what they felt was such stonewalling that they went to a solicitor, who told them the only way to ever get answers is to go the legal route. This is a very poor reflection of the health service. These people were not interested in that. They just wanted to know why there had been no 20-week scan and why the woman was not treated appropriately when she was sent to a Dublin hospital. They just wanted answers but those answers were never given. The only way they could try to get answers was to go down the legal route. This is a very unfortunate reflection. This is what has been happening in the past 12 months. We do not have to go back years to find such a case. It is here and now and we must recognise this.

In the British system, driven by events such as those which occurred at the Mid-Staffordshire NHS Foundation Trust from 2013, new standard NHS contracts require all NHS and non-NHS providers of services to NHS patients to comply with a duty of candour in reporting patient safety incidents. In 2007, New South Wales Health in Australia defined open disclosure as the process of providing an open, consistent approach to communicating with the patient and the patient's support person following a patient-related incident.

While the Bill will entail mandatory open disclosure, it is important that we reinforce or help cultivate a culture in the health service where admitting something has gone wrong is not considered a sign of weakness or an admission of guilt. This is the most important part. Human beings make mistakes. The biggest problem we have is that every time there is a small incident there is an immediate rush to cover it up, then a rush to cover up the cover up and then to cover up that cover up with another cover up. This has been the systemic problem we have had not just in our health services but our justice system. It is in so many places and in so many parts of our Government structures throughout the State. A notion almost prevails in all professions that we are better off ignoring or denying our mistakes or errors and living in the hope that no one notices. This belief, if such a culture exits in our health services, needs to be countered right now. This is not about admitting guilt or weakness; it is about doing the right thing.

The amendment to the Health Act 2007 to extend HIQA's remit to private hospitals is eminently sensible, and like all sensible matters in our health service it should have been done long ago. HIQA's healthcare team already does a great deal of work in promoting quality in healthcare services in our public and voluntary hospitals. Private hospitals provide a significant amount of healthcare in the State and, therefore, it is important that HIQA can inspect them to ensure they meet the same national standards.

There are aspects of the Bill that will have to be teased out and will need further work and some amendments on Committee Stage. We hope the Minister will attend and work constructively with all members of the committee when that time comes. I am sure he will, as will all members.

Deputy Bernard J. Durkan

I am delighted to have an opportunity to speak on this very important legislation. I hope it serves the purposes for which it is intended. I hope it will improve the standard of care and attention available to all of our constituents throughout the country, that it will safeguard hospital staff themselves and protect them so that mistakes that might be made and things that might have been overlooked will not be overlooked in future, and that the quality of services provided will be acknowledged and universally applied, without exception.

I am a Member of the House and I was a member of a health board and hospital visiting committees. Over the years, we have all seen incidents that could have been prevented. We have also seen very expensive cases that end up in court where it is alleged, and proved in some cases but not in others, that something went wrong and a mistake was made.

It is important that a mistake is acknowledged, but that does not always address the impact of the mistake on the victim, in particular where a victim has died. As I said, this is important legislation. It is important to acknowledge that one can err but in these circumstances the error can be serious and have long-lasting or permanent consequences for the victim.

Reference was made to accident and emergency departments throughout the country. I agree that they are not operating satisfactorily and are not sufficient to meet market requirements. The population of Ireland has increased by 500,000 over the past ten years, be that through immigration or emigration. All of these people require services of one kind or another and, thus, there is an additional burden on the system. Demand has increased and our health service is demand-led. It is unacceptable to say that demand was anticipated to be X, Y or Z at a particular time of the year but that, unfortunately, it turned out to be greater than anticipated. We must properly anticipate demand. We have no choice but to do so. As I said, our service is demand-led and, as such, we have to make provision for it.

At a meeting of the Joint Committee on Health earlier this week, I made the point that it is incumbent upon us when identifying the budget for the health services to also predict what contingency might be required. We know that a contingency will be required so we make provision for it. If the contingency is not spent it can be carried forward to a subsequent year to the benefit of patients and the quality of their treatment. It is distressing for patients admitted to hospital to be on hospital trolleys for lengthy periods. Obviously, patients who are admitted are unwell. A person who is fit and waiting for minor medical attention in an emergency department for a long time will find the experience extremely boring, annoying and distressing but for the person who is ill, the experience is ten times worse.

In terms of recovery, the health service still has a way to go. I do not apportion blame for this to any particular Minister. I deal with opposition in committee as it arises, and I do so on a fairly regular basis. It must be recognised that there are some things we cannot do without advance monetary provision. Whether we do so, however, is up to us. There is a hue and cry when it comes to over-expenditure. The modern way is to criticise over-expenditure and so on. That is unfair. There is no need for over-expenditure if the level and extent of funding required for the service throughout the year is properly identified. This is how expenditure was managed previously. It is only in recent years that the sticking plaster came on stream. It is a bit like a footballer clearing a ball that is about to go into the net into the feet of an incoming forward who buries it in the back of the net. Nowadays it is an emergency reaction all of the time, which does not make for good, quality services.

At a meeting earlier this week, we heard about constant queues and confusion in waiting areas in a number of hospitals. There are beds available, adjacent to and within those hospitals. In some cases, there are wards that have been closed and beds decommissioned. This should not be tolerated at a time when patients are waiting lengthy periods for treatment. By way of example, a child with autism, who is volatile and whose reaction can be sudden, injured himself during a breakdown and was taken to the local emergency department. One does not have to be a medical professional to know that the child required immediate medical attention but despite having waited some time in a very crowded area, he was left untreated and the parents took him home and returned the following day, when they again had to wait for a lengthy period to have him seen. This is the daftest situation I have ever come across. There is no excuse for it. Service providers operating at the coalface and presented with such a situation must have the means to deal with it properly, effectively and efficiently to the satisfaction of the patient. In the case of a patient who has a condition that renders him or her incapable of understanding what is happening, we have a special responsibility. As politicians we need to ensure that such cases are dealt with not when people have time but immediately. We need to ensure that provision is sufficient to ensure that when such cases arrive at emergency departments they are dealt with immediately.

I hope that this legislation will have an impact on the way in which we deal with those cases and that it will enhance and give prestige to our health service. We have some of the best medical professionals in the world in this country but we do not appear to be able to retain them. The more we criticise the service, the worse it gets. When staff are demoralised they question being asked to perform tasks for which they do not have the resources. It is easy for the system to blame others. It needs to look inwards and determine what is required in monetary terms to do the job. In regard to the overcrowding in our emergency departments countrywide, perhaps a troubleshooter should be appointed to identify and investigate the bottlenecks and logjams in terms of throughput of patients, the cause of the slowdown in the system and how it can be addressed. It is possible to do all of this, but it is not being done. There is passive acceptance of an inferior service which is threatening patient safety.

In regard to mental health patients, there is need for an awakening to their plight and for them to be attended to efficiently as they may not always understand what is happening to them.

In some cases it may be their first experience or they may have had many experiences. If we do not do something about it, then the good name of the hospital, the institution, the GP or whatever it is, is in danger of being damaged.

Many medical professionals from all over the world are willing to come here if we want them but we will have to pay a price. We do not have to pay New York prices every time. There are those who say that we do but that is not necessarily the case.

We have to be inventive in the way we deal with the throughput. This has to be done quickly and safely.

The other issue, which is main purpose of this Bill, is to admit our mistakes and to make a decision. We often hear of a case being settled without acceptance of liability. That may well be the case. It is very easy for me to criticise a medical professional in a crisis moment and to say it should not have happened. We know it should not happen but whether my criticism will solve the problem remains to be seen. What I do know is that insofar as we can, we have to be open with the public. When we know that something has gone wrong, we have to be willing to say we are sorry, this did happen and should not have happened, and we admit it. Failure to admit in those circumstances only drags on and multiplies the legal costs many times. That should not be allowed to happen because it is not in the interests of the services, the institutions involved, or our staff.

We have much to do in this particular area but we can do it if we apply ourselves to it.

I will also mention the alacrity with which it is generally accepted, in Murphy's law, that if it can go wrong it will go wrong. It does not have to be that way, as long as we are absolutely certain that we have done the best we can and have put in place, as best we can, the necessary resources to deal with the situation. That also eliminates from the whole scenario the fact of there being mitigating factors, what they were, and was it because we did not have resources. There should never be an accident or incident in a hospital where the resources were inadequate. We cannot provide a health service on that basis. We have to provide a health service that is reliable, that protects people's health, the public, the institutions and the State, all of which have a common interest in this particular situation.

I am aware of situations in the past where patients have not been given the information or where the relatives and family have not been given the information and where they had to fight for it. That should not be the case any more than the CervicalCheck system should not have been the way it was. I am aware there were mitigating factors, in that it was not a diagnostic system but was a system that had a 70% to 80% accuracy rating. It was held afterwards in court that women should have been told at an earlier stage and if they had been told at an earlier stage, there might have been the possibility of a different outcome. This is always very hard to determine but it is not very helpful to the patients and their families. It is not very helpful if there is a doubt about it. It is the doubt that undermines the integrity of the system. That doubt should not be there. It is important for us all remember that we can criticise those working in that system as much as we like, but if the system itself has only a 70% to 80% accuracy rating, then we need to acknowledge that from the outset. We must recognise that it is not a gold standard and was never going to be one. The presumption that it was a gold standard is wrong. It may be convenient for us at a given time to say that X, Y and Z took place and should not have taken place. We know that things happened that should not have happened. The system, however, was in operation for quite a while. The Minister, the staff, and the clinics have been blamed. This has happened, however, with the benefit of hindsight. Remember, the system has been in operation for several years and without a doubt identified and averted the deaths of hundreds of women. The issues involved were identified long beforehand in order to be able to take corrective action. This could only be done with a 70% to 80% accuracy rating. That does not change. It could be 90% one day in one group of patients, depending on their particular state and the degree to which their system was coping with what was an onslaught. The incidence of cancer-creating conditions might never be detected and there have also been situations where that has happened.

All of a sudden, we became 100% accurate, and on that basis everybody is condemned. I am fully aware of the fact that people who worked in that system became extraordinarily frustrated because no matter what they did, they could not do anything right. Day after day, something else popped out of the woodwork to prove that they were wrong again. As long as we go down that self-righteous road in the health services in the determination of what is right and what is wrong, we always will have that problem. Misdiagnosis is one thing but a system that has only a 75% to 80% accuracy rating is a totally different thing. It is not a firm diagnosis at all. As a result, we need to be cautious about who we blame and how we blame them.

We must also acknowledge the benefits accruing to the health of the women of the country from that system, even though there were some tragic oversights leading to loss of life and serious illness that did occur and perhaps should not have occurred. Hopefully, the revised system will address that to a far greater extent and we will not have to revisit this.

In the short time remaining to me, I will mention another matter. We all deal with cases of emergencies, and for some unknown reason, the public believes that we have a responsibility in the matter and should respond to some things from time to time about which people are not getting a resolution from the system. We should do this and be doing that on a fairly regular basis. In order to keep in touch with the issues that affect those who are patients, medical professionals, coming through the system, or whatever, we need to be regularly involved. It is only then that we will know what we are talking about.

We will learn, as time goes by. The one question that is put again and again to politicians is whether they are medical professionals, having expounded on a theory with which somebody may disagree. My response to that question is that I am not, but that I do not have to be to be able, within reason, to identify something obvious, as any human being can. I may say there is something wrong with that unfortunate person and we need to do something about him or her. If something is not done and something goes wrong, it will be asked of me why I did not do something about it and did not respond. I will be asked why did I not stand up and take my responsibilities seriously. Incidentally, I am not touting for business, but in 90% of the cases of that nature that I have dealt with, I was right.

There is a need to be vigilant at all times. I am not criticising the medical profession or any of the other professions but it must be always remembered that when a member of the public, a patient in these circumstances, feels that something is wrong, they usually know. The response will depend on the way they describe it and hopefully, if the member of the public describes it well and we respond to that, then something can be done about it.

Deputy Michael Harty

On the mandatory open disclosure of specified serious patient incidents, we should add other patient safety incidents by regulation. It is important that we separate serious and less serious, or minor, incidents. Notification can be made to HIQA, the chief inspector of social services and the Mental Health Commission. In that regard, there should be a common database among the three of them in order that each can see what the others have been notified of. It is important that specific regulations and sections on clinical audit have been included. We will discuss many such issues in detail on Committee Stage early next year.

It is essential that open disclosure be mandatory, as was identified in A Programme for a Partnership Government. The Civil Liability (Amendment) Act 2017 maintained voluntary disclosure and the Joint Committee on Health accepted the advice of the Chief Medical Officer at the time that it was the most appropriate course of action, even though it was in contradiction to the programme for Government. It is essential that we are moving to a mandatory process, which has come on foot of Dr. Gabriel Scally's report on CervicalCheck and the deficiencies in the CervicalCheck audit process. It will put an additional onus on health professionals and health service providers, which is only right, and I am glad that it will include private hospitals as well as public, voluntary and HSE-run hospitals. It should be extended to other healthcare facilities, which could be added by regulation. Many other healthcare facilities should be included in the Bill, given that they have great potential to harm patients if they are not properly regulated. There need to be clear guidelines on how mandatory disclosure will operate and a comprehensive training process within the HSE and for health professionals - doctors, nurses and other allied professionals - on how open disclosure is to be delivered. There needs to be appropriate governance of how all of that is managed. It is important that patients and the medical profession have confidence in the process and that they believe that mandatory open disclosure will not expose them to unnecessary risk.

On the definition of serious incidents, I acknowledge there will be many types, most of which will have caused harm but others may not. They may have been near misses, or may have had the potential to cause harm but did not do so, or may have been averted before harm could develop. It is important that the health service and health professionals learn from such incidents too, and I hope to explore that on Committee Stage.

The disclosure of a serious incident should not apportion blame or guilt. Many issues are multifactorial, and while they relate to health professionals' actions, many other factors can affect adverse incidents. They may relate to excessive workload, the hours that doctors, nurses or other health professionals work, or the supports they are offered within the health structure. Such factors also need to be recognised within the legislation.

If a health professional has acted negligently, the matter cannot be decided by open disclosure but rather by the regulatory body that regulates the profession or it will be up to the courts to decide. There are protections in respect of open disclosure whereby information delivered within the process is not admissible in legal proceedings. That is important to give health professionals the confidence to engage in open disclosure. Serious adverse incidents are often a failure of a team, management or the structure of the HSE, and are not necessarily solely attributable to the health professional involved.

Doctors and patients must have confidence in the system and each health group, following the HSE's devolution through Sláintecare, should have a dedicated open disclosure unit that would involve the appropriate people - perhaps the CEO and certainly the clinical director of the hospital group - if adverse incidents happen within the community. There should be a clear line in the Bill on responsibility and on who is to make the open disclosure, to give clarity. The issue came starkly to light in respect of CervicalCheck, where there was a failure to identify who was responsible for making the open disclosure to the women being audited. That was the failure of CervicalCheck, as Dr. Scally identified. There needs to be specific training of HSE management and clinical directors on how to deliver mandatory open disclosure. It should be integrated into undergraduate training because few health professionals will get through their career without being involved in an adverse incident in some way or another. It is important that they recognise that it has happened, their responsibility for it and their responsibility to make a mandatory disclosure about it. It should be ingrained in our educational system.

There need to be supports not only for patients and their families in respect of open disclosure but also for health professionals who may have been involved in an adverse incident. In many such incidents, it is not the case that there has been negligence but it can be a career-defining moment for many health professionals. Being involved in an adverse incident may end their career or give them serious psychological issues to deal with, for which supports are needed. I mentioned excessive working hours, poor working conditions, a lack of staff, overcrowding and excessive workload, all of which are part of our health system. We need to recognise that and take it into account in respect of adverse incidents. Management should also be involved in taking some responsibility for them, not least if there are shortcomings such as those I outlined.

The current system of litigation following adverse incidents is not appropriate. There needs to be a move towards no-fault compensation within our health system, especially when it relates to audit or vaccination, where healthy people are asked to get involved in a health service for their own good. Should there be an adverse incident in either such scenario, a no-fault compensation scheme is important to remove the adversarial blame culture that has built up within the health system. Patients want an explanation and recognition for what has happened, to ensure that it will not happen to anybody else, to get reasonable compensation if they have been damaged, which is where the no-fault compensation scheme would apply, and to avoid adversarial, lengthy, stressful proceedings, which can take years, do not do anybody any good and cost a fortune. It is important that we do not fall into an element of defensive medicine and the medical profession should not be forced into it. We have to guard against that in respect of open disclosure. There has been a definition of absolute confidence. Medicine is not an exact science and it is difficult to be absolutely confident in every decision one makes. Following agreed protocols gives the health professional some protection but he or she must nonetheless deliver a service on clinical judgment. In my experience, the act of making an apology is empowering for the professional.

It is important to the person who has been damaged, but it is empowering for the professional because it takes pressure off them. It also takes pressure off the patient who has been adversely affected. I think it is part of what we should be educating our medical and nursing students for.

Deputy Denis Naughten

As I am the final speaker before the Minister brings this debate to a conclusion, perhaps I can be facilitated with a new slot rather than having to share Deputy Harty's slot. I do not intend to speak for much more than ten minutes, but it might be best to make arrangements just in case.

Acting Chairman (Deputy John Lahart)

We can be flexible.

Deputy Denis Naughten

On 18 January 2016, to the shock of many people, myself included, the then Minister for Health and current Taoiseach, Deputy Varadkar, issued a statement to the effect that it would be counterproductive to enshrine open disclosure to patients in legislation. This was the position of the then Minister and of the Department of Health. It represented a major U-turn on the policy that had been pursued up to that point by the then Minister and his predecessor, Senator James Reilly. On 27 January 2016, in response to that announcement, I dusted off a Bill I had been working on and introduced it in the Chamber on First Stage as the Health Disclosure Bill 2016. The aim of the Bill was to provide for mandatory reporting of patient safety incidents. The introduction of legislation in this area was one of my key demands during the negotiations on a programme for Government later in 2016. Forty-four months later, after a lot of persistence, the Minister, Deputy Harris, has brought the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 before the House. In fairness to the Minister, I must acknowledge his support.

I put it to those who have often criticised the usefulness of new politics, and indeed the usefulness of the participation of Independent Deputies in government, that this legislation is one of many examples of the real difference that many of us have made over the last four years. This legislation will make a real and fundamental difference to the delivery of our health service and the impact of that service on patients. Open disclosure will be embedded in legislation and will become the bedrock of patient safety. I was determined to change this law because, in my dealings with my constituents, I had come across many cases of people being treated appallingly by the health profession. In the four years since I proposed the Health Disclosure Bill 2016, the cervical cancer scandal has reinforced the fundamental need for laws of this nature.

When I was introducing the Bill in question in January 2016, I referred to a recent - at that stage - "survey of doctors conducted by the Medical Council [which] showed that only half would report instances of significantly impaired or incompetent colleagues". I suggested that this was "a damning indictment of the profession and of the culture" that existed in the profession at the time. I continued:

Where there has been irreversible health damage, we need to admit mistakes. We need to outline what we can do to alleviate or rectify the problem and to ensure that if compensation is required, this compensation is paid over without this policy of defence and denial, which exists within our medical profession at the moment.

Sadly, we have seen a reflection of that policy in the cervical cancer scandal. Dr. Gabriel Scally has described the culture within the medical profession. The failure to tell patients the whole truth in a timely manner can be attributed, at least in part, to an attitude of "doctor knows best". During the cervical cancer scandal, there were disgusting attempts to play down the seriousness of the debacle that was unfolding. All of this can be attributed to the culture that existed within the medical profession.

Neither medicine nor midwifery is an exact science. Sometimes the professional judgment of a doctor or a midwife is wrong. This does not mean a person is a bad doctor or a bad midwife. It means that he or she called it wrong. The nature of medicine means that it involves judgment calls. When a mistake is made, it does not necessarily mean that there is negligence. I remind the House that every three minutes, a patient is injured in our health service. This equates to 438 patients a day. A small fraction of these incidents - approximately 60 - end up with a complaint to the HSE and far fewer end up in litigation.

This legislation will radically change the culture within our health service. It is about doctors telling patients that there has been an unexpected outcome and explaining the reasons for that outcome. I know from my dealings with families and patients that it is important for them not just that the mistake is admitted, that an apology is made for it and that measures are put in place to rectify it, but also that they are told what steps will be taken to make sure no one else goes through a similar experience and the mistake is not repeated.

Section 18 of the Bill before the House sets out the structure within which notifiable incident disclosure meetings will be performed. I suggest it is imperative that every patient will have an opportunity to bring a third party with him or her. This needs to be written into the legislation. It is not provided for in the Bill as it stands, but it must be provided for. Section 18 provides that the health services provider will set out the relevant information in a manner that it "considers appropriate". The person or patient may not have the understanding to appreciate the significance of what is being said to him or her. It should be possible for such a person to have someone else with him or her. It is imperative that this is enshrined in law.

I would like to mention something that will be important during the enactment of this legislation, which I warmly welcome. I welcome the broad thrust of it and the detail of it. This Bill is very similar to the legislation I outlined in 2016. I fully support it. I would like the change I have mentioned to be made on Committee Stage. That is one side of it. The other side is the follow-through. We will apologise to patients. We will tell them what has gone wrong. We will tell them what we intend to do to ensure this does not happen again. We will report it to the authorities. However, what will we do to rectify the situation?

I will give the Minister an example that pertains to the Department of Health. He is well aware of this situation. In fairness to the HSE, when a mistake was brought to its attention, it held up its hands and issued an apology to the families of 49 children who were misdiagnosed by the audiology service in counties Roscommon and Mayo. Credit is due to the health service, the Minister and the HSE for contacting those involved to apologise to them. The difficulty is that the system has fallen down with the follow-through on that. That is the next issue that will need to be addressed. In fairness to the HSE, it has now put in place all the health support services that the families of these children have sought. However, the ongoing battle faced by the families as they deal with the Department of Education and Skills on this matter is horrendous. The Department is not providing anything in addition to what is provided to every other child. It is not prepared to make a special case for these 49 children.

I would like to elaborate on the frustrating thing about all of this. Not one of the parents with whom I have been dealing wants to submit a claim. The parents just want the cases of their sons and daughters to be rectified. I have advised them to go through the State Claims Agency because the system we have at the moment sadly means that this is the only way they will be able to move these cases along. For the life of me, I cannot understand why we cannot put a small amount of money aside to provide the intensive support needed by these 49 children now. The State Claims Agency approach that is being pursued instead involves not admitting anything and getting others to prove their case in court. The families in counties Roscommon and Mayo will prove their case in court.

When these children are aged 17 and 18 years, they will receive substantial funds and compensation because of what has been done to them, but that is not much good to them if they cannot function in society. Does it not make much more sense to put a small amount of money aside now and provide the intensive support to those children so that they can fully function in our society in coming years rather than waiting until the end of a long and protracted legal process?

The Minister will know that I must raise the matter of no-fault compensation schemes. It has been ongoing, like medical disclosure, for a long time. It is another commitment that is enshrined in the Programme for a Partnership Government. Deputy Harty has already raised it specifically in relation to vaccinations. There is a culture of denial in this country that vaccines in a very small number of cases will cause a severe adverse reaction, yet the State is not yet prepared to acknowledge and accept that even though every other member state in the European Union has such a compensation scheme in place, while we do not. We are forcing those families to go through the legal process to prove beyond reasonable doubt that their child has been damaged by the administration of a particular vaccine. This failure and gross negligence on the State's part in this area is undermining the credibility of our vaccination programme. We are not prepared to admit that there will, in a very small number of cases, be a severe adverse reaction to the administration of a foreign body into a child. By admitting that we can at least move forward and explain to parents that there is a small risk but that there is a far greater risk if they do not vaccinate their child. It is very hard to make that argument when the State continues to bury its head in the sand, as does the medical profession, and they claim that it is 100% safe. No foreign body injected into any human being is 100% safe. It cannot be. Just like the issue before us, it is not that doctors are negligent, it is that adverse reactions happen for one reason or another with the very best medical professionals in the world. Let us accept that it happens and move forward from there. We are doing it with doctors here now, but not with vaccines and that has to change. The matter is exposed by this Bill.

I acknowledge a significant inclusion in this legislation. Private hospitals now come under the remit of HIQA. This was a gaping hole in the regulatory regime here. Sadly, there were incidents in the past relating to private hospitals. Their inclusion in this legislation is very warmly welcomed insofar as it goes. It is very comprehensive. The one weakness that I want to see changed in it is that relating to a patient advocate.

I reiterate that we must introduce a no-fault compensation scheme for the administration of vaccines and end the situation where the families of children affected are forced to go through the courts. The State has admitted liability in the past. Dr. Michael Woods in 1982 offered £10,000 to 16 families where, on the law of probability, someone was damaged by the three in one vaccine. We were able to do it in 1982 but since then we have brushed it under the carpet and denied it ever happened. That must change.

Minister for Health (Deputy Simon Harris)

I thank Members for their comprehensive contributions and the wide support for the legislation. There will be detailed scrutiny of it at the Select Committee on Health in the new year and there will be an opportunity to fine-tune the legislation and tease out, discuss and debate a number of the issues. It is heartening for patients and staff across the health service to see that cross-party support for the Bill, which I genuinely think is landmark legislation. That is a phrase we use a lot in this House but I believe it is true of this Bill. It is an issue which Deputy Denis Naughten has championed for many years. He and Deputy Harty made very strong representations on it during the negotiations for the Programme for a Partnership Government, but before that there was his own legislation, so I thank him for helping us get to this point.

I am taken with the comments of many Members, including Deputies Harty, Naughten and Browne, on the Bill being very welcome but also on the need to see it alongside significant reform that is necessary in the legal area. We know our system is far too adversarial at the moment and that far too many people end up on the steps of the High Court who have no wish to be there. They are often people who have been victims of something that went wrong in the health service, they have been traumatised, they or their loved one is in pain or sometimes they have been bereaved. Generally, they want answers, open disclosure, which this legislation provides, but they also want, where necessary, a mechanism to be supported or compensated in a way that does not involve lengthy trips to the High Court where the only people who benefit are the legal professionals. It is very costly for the Exchequer, and can be very difficult, painful and lengthy for the citizen and every day solicitors and barristers get wealthier on the back of it. That needs to change. I have some good news to share with the House. Deputies will be aware that Mr. Justice Charles Meenan has been doing some work on tort reform to fulfil the commitment in the programme for Government. We set up a group to review the area and examine the idea of a no-fault scheme. The initial report is due to me very shortly. I will definitely receive it this side of Christmas. I cannot pre-empt its contents but I am very hopeful and expect to be in a position to bring forward proposals to act on its recommendations early in the new year. I would be happy to provide a briefing to Members of this House once I have received the report.

I very much take the point made by Deputy Harty and others on the importance of resourcing and training our staff, clinicians and the people on the front line, as well as our health service managers on this legislation. It has been a policy of the health service for many years, definitely since 2013, to have open disclosure yet as we know it has not happened. It is not that those working in the health service are bad people but legal protections were necessary. Also, we need to train, support and resource people in doing that. We will have a chance to tease it through and discuss how the legislation should be implemented in a very practical sense on Committee Stage. The Deputy is correct that, as we set up the structures to deliver Sláintecare, there is a chance to embed the legislation as core business of the health service, which it is. One of the very appealing things about the way we have drafted the legislation is the fact that there is such a clear obligation on the health service provider in reporting and ensuring the open disclosure takes place. What it will mean in a practical sense is that for the hospital manager or CEO it will be a very important part of their day-to-day job, and as important as finances or access issues in the hospital, because if something goes wrong, they are the people who will be directly answerable under the health service providers' obligations under the law.

Deputy Durkan raised a wide range of issues relating to the health service, particularly around the need to recruit and retain more doctors. I fully agree with that. Yesterday, at the Joint Committee on Health, I said that I had no confidence in some of the work practices in place. I was returning to a phrase used by Deputy O'Reilly when questioning me. She was putting the words of the Irish Hospital Consultants Association, IHCA, to me.

I wish to make clear that I have every confidence in our brilliant doctors, who work extremely hard. However, it is and will remain my view that we cannot be confident that some of the work practices we see as part of private practice in public hospitals are serving patients well, nor indeed the clinicians who are dedicated to the public health service. I intend to bring forward proposals shortly which will offer to pay consultants an awful lot more to work in the public health service, the key point or rub being that it must be in the public sector. I stand over my comments that in a situation where our public hospitals are under pressure, it is inexcusable that we would allow public beds to be used for private medicine. It is an issue we need to work on and there is a near cross-party consensus on which we can base that work. It is a thorny and difficult issue but one we must tackle.

Deputy Browne and others asked about the specialist register and the safeguards that will apply. The HSE has put in place arrangements to manage and supervise consultants who are not on the specialist register and ensure that any such appointments occur only where they are critical to support the delivery of essential services and with the approval of senior HSE management. That has been necessary in certain instances to fill vacant posts and ensure service delivery. The HSE has established a medical workforce and patient safety oversight group to agree and oversee implementation of a number of actions relating to this issue. I will keep interested Deputies up to date on that.

Reference was made to the Civil Liability (Amendment) Act 2017. That legislation was designed to facilitate a voluntary approach, but the word "voluntary" was used with reference to whether clinicians choose to avail of the legal protections offered by the Bill. I am conscious that the chief medical officer is not here and cannot speak in this House. I wish to make clear on his behalf that it was never his view that disclosure should be voluntary. Deputy Harty acknowledges that much work was done in considering and scrutinising these issues. During the passage of that Bill, which was prior to the emergence of the CervicalCheck debacle, I undertook to return to the House with legislation to provide for mandatory open disclosure in line with the programme for Government. That undertaking is realised in the legislation before the House today.

Deputy Naughten made a valid point, which he has raised in reference to several Bills, about the importance of people being able to take somebody with them to meetings at which important matters are being discussed. I will reflect on his comments. My understanding, from engaging with my officials, is that this matter is covered by the relevant person clause in section 5(1) of the Bill. The relevant person may be a family member and it is a patient's choice as to whether he or she will have such a person in attendance. However, if there is a need to make the position clearer, I am happy to work with the Deputy to ensure it is explicit, in accordance with the expressed intention of the legislation.

Deputy Naughten referred to audiology services and acknowledged the work that has been done in this area. I will convey in the clearest possible terms the issues he vocalised in regard to the education part of those supports to the Minister for Education and Skills. I understand the Deputy has been in contact with the Minister on this matter. Either the Minister, Deputy McHugh, or I will revert to him as soon as possible.

This is significant legislation and its significance becomes more apparent when it is considered alongside the range of measures that have been taken in recent years to improve patient safety. The establishment of the national patient safety office in my Department is one such measure, and that office is now playing a key role in ensuring patient safety issues are constantly on the agenda when new policies and legislation are brought forward. The new system of publication of maternity reports on a monthly basis is helping to give a more transparent picture of what is going on in our maternity services. This is particularly important given the tragic issues that arose in the past. Last month, Ireland's first ever national patient advocacy service was established, funded through my Department but entirely independent in its functioning, and offering a website and dedicated helpline. It allows people with a complaint about the health service to access a qualified person who will advocate on their behalf and steer them through what can sometimes be a confused complaints system by making it simpler and easier to navigate. Notwithstanding these developments, we have much more work to do in this area.

Finally, I thank the patient advocates who have agitated in a positive way on this issue, in some cases for many years. I think of Róisín and Mark Molloy who came to see me when I became Minister for Health and with whom I have since met on several occasions. They had already been to see several previous Ministers at that stage. They are incredible people in terms of their kindness and their desire for improvements in the system. They have played a constructive role in that regard despite the huge adversity they faced and the personal trauma and devastation of losing baby Mark.

Deputy Denis Naughten

Hear, hear.

Deputy Simon Harris

They know the importance of mandatory open disclosure. I think of people whose names are familiar to us all, such as Vicky Phelan, Lorraine Walsh, Stephen Teap, the people involved in the 221+ group, and the many others whose names are not known publicly but who have come to see us at our clinics and in our offices over the years to make the case for changes in this area. There is an onus on us, early in the new year, to get the Bill to Committee Stage, under the chairmanship of Deputy Harty, and through all Stages. Whatever length of time this Dáil has left, we should embrace the new politics and try to get this legislation onto the Statute Book.

Question put and agreed to.

Dáil Éireann díospóireacht - Thursday, 12 Dec 2019

Patient Safety (Notifiable Patient Safety Incidents) Bill 2019: Second Stage

Dáil Éireann díospóireacht -
Thursday, 12 Dec 2019