Simon Harris (Wicklow, Fine Gael) | Oireachtas source

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 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 concerning 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 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 revolve 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.

Taken in the round, 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.