Dr. Tony Holohan:

I thank the Chairman and the committee for the opportunity to come before you today on the legislative provisions proposed within the general scheme of the Patient Safety Bill. I will keep this statement short and I am happy, as we all are, to reply to any questions.

As the Chairman has said, I am joined by Mr. David Keating and Ms Elizabeth Adams from the patient safety, policy and advocacy unit in the Department of Health.

The Government directed the Department to undertake the development of the Patient Safety Bill in May of this year. This Bill incorporates the patient safety elements of the Health Information and Patient Safety Bill which introduces a requirement for external notification of patient safety incidents to the appropriate regulator and to the State Claims Agency. It also empowers the Minister for Health to issue guidance with respect to clinical audit and extends the remit of HIQA to private hospitals on top of HIQA's existing statutory powers.

These elements in fact previously underwent pre-legislative scrutiny in January 2016 when consideration was given to the full Health Information and Patient Safety Bill. In addition, the Patient Safety Bill now also provides for mandatory open disclosure of serious reportable events. That is the added part since the pre-legislative scrutiny in January 2016. As such, this legislation complements the measures contained within the justice legislation, the Civil Liability (Amendment) Act 2017, which was passed by the Houses last year and which provides protections from liability for clinicians engaging with open disclosure and important elements of that were commenced in the early part of this week.

I wish to alert the committee to an additional aspect that has emerged since the Government approved the Bill. Earlier this month, the High Court overruled the Minister's decision to require HIQA to undertake a section 9(2) investigation into the circumstances surrounding the death of Mrs. Malak Thawley at the National Maternity Hospital in May 2016. This judgment has revealed that there may be a need to enhance powers in relation to section 9 of the Health Act 2007. This may require amending legislation. While the Department is still in the process of considering how best to address this, it might be that some modifying provisions will be brought forward within this Bill and that is under consideration.

I now turn to the primary elements of the Bill before us, beginning with open disclosure. Creating a culture of open disclosure and learning from things that go wrong is the bedrock of making services safer. In line with the long-standing approach of the Department on this issue, open disclosure should be an open and consistent approach to communicating with patients and their families when things go wrong in healthcare. This includes expressing regret for what happened, keeping patients informed, providing feedback on investigations and the steps taken to prevent recurrence of adverse events.

I would like to recall that, last year, the Houses of the Oireachtas provided protections, as I have briefly mentioned, from liability for clinicians making a disclosure through the Civil Liability (Amendment) Act of 2017. During the passage of that Act, a number of Deputies sought to amend the legislation to provide for a mandatory approach. As that legislation was extremely broad and applicable to a wide variety of health and social care settings, it was ultimately decided by the Oireachtas not to be the appropriate vehicle for mandatory open disclosure. The Minister for Health did, however, undertake to bring forward legislation to provide for a mandatory duty to disclose at an early opportunity and hence the Bill that we have before the committee today for its consideration.

It should be noted that, with the commencement of part 4 of the Civil Liability (Amendment) Act, the regulations arising from it and their provision for a framework to support openness, transparency, timely disclosure and an apology for unintended or unanticipated injury have come into effect earlier this week.

Mandatory open disclosure is about building patient and public trust in the health system. The recently published report of Dr. Scally's scoping inquiry provides a clear analysis of the system failures that occurred in CervicalCheck, based on patient and family accounts of their experiences. We must now ensure that the learning from this report is used to drive the changes we want to see so as to ensure that patient safety is a primary element driving and shaping policy for the health service.

I would like to reassure the committee that the Department has taken close note of Dr. Scally's findings and, in particular, regarding the primacy of the right of patients to have full knowledge as to their healthcare as and when they wish. While the current approach to disclosure within the health service has had positive impacts within and across the service, the Scally report has identified significant issues which now need to be remedied and this Patient Safety Bill, while in development prior to the receipt of the Scally report, will now be one of the primary means for responding to important aspects of his report and will provide the legislative underpinning for mandatory open disclosure.

Fundamentally, the Bill will introduce a requirement for disclosure of serious patient safety incidents. The definition of a serious patient safety incident includes the death of an individual; a permanent lessening of bodily, sensory, motor, physical or intellectual functions; and, harm which is not severe but which otherwise results in, for example, an increase in the requirement for treatment or a requirement for treatment to prevent death or injury.

The Minister for Health will prescribe the specific incidents to be disclosed in secondary legislation under the powers conferred upon him in this legislation. This definition is in line with recent legislative definitions incorporated in Scotland in their Act of 2016 which, in turn, builds on the duty of candour arrangements in operation in England since 2015.

The Bill provides the legislative framework for a number of recommendations of the Scally report on placing a statutory duty of candour on individual healthcare professionals and healthcare organisations.

The Bill provides that it shall be an offence for a health service provider to fail to make a mandatory open disclosure or notify a reportable incident to the external authority. A registered health service provider guilty of an offence will be subject to penalties in the form of a fine or imprisonment. It is similar to the approach of the UK, where the duty of candour regulation seeks to hold providers and directors to account. It is a mechanism to hold the owner, management or board of an organisation to account and ensure that the individuals at the top of the organisation are invested in quality and patient safety.

Regarding individual health practitioners, the policy is to distinguish between genuine unintentional acts of omission or commission that can lead to harm and the much rarer acts of wilful negligence or deliberate breach of acceptable practice. In the drafting of the Bill, the inclusion of a defence will also be incorporated.

In terms of the notification of reportable patient safety incidents, the report of the Commission on Patient Safety and Quality Assurance - the so-called Madden commission report - recommended that provision should be made for the mandatory reporting to the appropriate regulatory body of adverse events that resulted in death or serious harm. The commission also recommended that provision be made on a voluntary basis for other less serious, as it were, adverse events and "near misses". The commission concluded that a mandatory system would improve patient safety and ensure greater accountability by requiring specific reports of serious injury to be made by healthcare organisations, with disseminating lessons to be learned throughout the health system. The Bill provides for mandatory notification of serious patient safety incidents to a number of bodies, including the State Claims Agency, HIQA and the Mental Health Commission, depending on the nature of the incident.

Regarding clinical audit, it would be helpful in the first instance to give some definition of what we mean. In this context, clinical audit is a clinically-led quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit standards and acting to improve that care where these standards are identified as not having been met. Defining clinical audit in legislation recognises the need to have a standard definition and associated methodology to ensure that there is consistency of approach across the health system. The Madden commission advocated building a positive culture of participation in clinical audit that would benefit patients and the health services as a whole, and recommended that legislation be introduced providing for: exemptions from freedom of information, FoI, legislation for records arising from clinical audit activities and related activities; and protections for these records from admissibility as evidence in civil proceedings. It was envisaged that certain legal privileges would be granted if guidance on governance, methodology and clinical standards for clinical audit was followed by the individuals undertaking the clinical audit activities. This Bill will enable the Minister to issue such guidance, subject to public consultation. Where clinical audit is carried out in accordance with that guidance and aggregate results are published, any record created solely for the purpose of the clinical audit will not be admissible as evidence in civil proceedings and the FoI legislation will not apply to that specific record. This part of the Bill will therefore support those who use clinical audit to improve the quality of care provided.

Of course, such protections do not exempt healthcare organisations or health professionals from their responsibilities where a serious patient safety incident has been discovered during the audit process. Where any serious patient safety incident is so discovered, mandatory open disclosure would clearly apply. The governance framework, methodology and reporting of clinical audit will all be incorporated into the Minister's guidance on clinical audit that will be developed by the national clinical effectiveness committee, which operates to and through the Department.

The Oireachtas committee will recall that we appeared before it recently when it examined the patient safety (licensing) Bill, which will provide HIQA with full regulatory responsibility for all hospitals, public and private. In advance of that, the Bill before us today will provide for the extension of HIQA's existing powers in respect of the setting of standards, monitoring of compliance and undertaking of investigations to the private hospital sector. It is a step along the road towards licensing. Extending these powers will ensure that all defined private and public health service activities will be subject to the same standards and be monitored by the same authority, with the exception of those that fall under the remit of the Mental Health Commission.

In conclusion, I would recall that the scoping inquiry - the Scally report - has identified what those involved in a patient safety incident want: to be told what happened and why, that is, the truth; for someone who was involved to say he or she is sorry and to mean it; and to be assured that this will not happen again to anyone else. Through this legislation and other policy and legislative steps that the Department is taking, that is exactly what we are trying to achieve.

We are happy to take whatever questions members might have.