Dr. Tony Holohan:

I thank the committee for the opportunity to discuss this legislation. I am joined by Dr. Kathleen MacLellan, director of the patient safety office, and Mr. David Keating, principal officer in the patient safety office.

The legislation has been developed to facilitate the creation of a comprehensive, far reaching system of regulation to oversee all hospitals in the State, public and private, as well as providing the Minister for Health with powers to designate certain activities as carrying a sufficiently high risk as to warrant their providers also coming within the ambit of the new regime.

The committee's agreeing to undertake pre-legislative scrutiny will contribute significantly to our progression of this important legislation. As the committee is aware, the health service has been striving in recent years to place the safety of patients at the forefront of the work that is done. There have been a number of initiatives in this regard over the past decade, including the creation more than ten years ago of HIQA, which is also represented here this morning, and the updating of much of the legislation on the professional regulation of healthcare workers across individual professions. There is, however, something of a lacuna at present, whereby no specific legislation is in place on the operation of hospitals or other health service entities to minimum standards of clinical governance. The proposed legislation seeks to rectify this.

The Bill has been developed over the past number of years by officials in the Department and a working group made up of key stakeholders from the HSE, HIQA, the Private Hospitals Association and the Forum of Professional Regulatory Bodies. The introduction of a licensing system along the lines envisaged in the Bill was a key recommendation of the Madden report in 2008. While acute hospitals are currently subject to thematic monitoring by HIQA, the powers of HIQA in this regard are limited. The introduction of a system of licensing, however, will ensure that all hospitals, whether they are public or private, will operate to appropriate standards and will have the requisite governance arrangements in place to enable the delivery of the safest possible service. We will, therefore, be able to have assurances, which we cannot fully have at present, on the patient safety operating frameworks that will need to be in place in all hospitals. Such a framework will require management support and buy-in, a critical element of patient safety as the committee is aware, as well as patient engagement and accountability. Clinical audit, as well as implementation of clinical guidelines, will be regarded as an integral part of this overall approach.

It should, however, also be acknowledged that the delivery of healthcare is an inherently risky activity and it is inevitable that things will go wrong. As we say, the science is not perfect, the people are not perfect and the processes are not perfect so risk is part of the everyday delivery of healthcare. For example, studies of adverse events worldwide have demonstrated that between 4% and 16% of patients admitted to hospital may experience one or more adverse events, up to half of which may be preventable. In work published last year, the OECD estimated that more than 15% of hospital expenditure goes towards correcting technically iatrogenic, or preventable, medical mistakes or infections that people catch in hospitals across its member countries. Expenditure in this country in excess of €350 million is attributed by the State Claims Agency to healthcare patient safety claims for the years from 2012 to 2016.

The ability of the Irish health service to learn from mistakes and system errors also requires improvement. We have, as the committee is only too well aware, seen similar issues emerge across many hospitals after an incident has occurred, often related to weaker than desired governance and leadership. This legislation is part of our system-level efforts to respond to this situation but on its own it will not be enough, and in and of itself it will not provide an immediate solution to some of these issues. In considering this, it is important to recognise it is part of a wider programme of reform, being driven primarily by the patient safety office in the Department of Health, which I mentioned.

There are a variety of other initiatives in this regard, including the publication of monthly patient safety statements by all hospitals in the State, which started originally as patient safety statements relating to maternity services, the establishment of a national patient advocacy service, the introduction of what we call a patient safety surveillance system, the measurement of national patient experience, the extension of the clinical effectiveness agenda comprising clinical audit and implementation of national clinical guidelines, the roll-out of a code of conduct for health service staff, the publication of annual reports of the national healthcare quality reporting system the next report of which is imminent, and the planned creation of a national advisory council for patient safety.

In addition, as the committee is aware, Government approval has recently been secured to prepare a new patient safety Bill that will provide for mandatory open disclosure of serious reportable events. The Bill will also legislate for mandatory external notifications of incidents to the appropriate regulatory body for clinical audit, as well as the extension of HIQA's remit to the private hospital system. This legislation will build on the Civil Liability (Amendment) Act 2017, enacted towards the end of 2017, which will provide a framework for the operational delivery of open disclosure, the regulations of which will be signed before the end of June.

As I have mentioned, the licensing Bill will apply to both public and private hospitals. It will be an offence to operate a hospital without a licence. Concerns have been expressed in the recent past about some private providers of cosmetic surgery services, for example. We have had some direct experiences with providers that may not be operating to the expected standard. This legislation will give us the capacity to respond to such situations. We have simply not had that capacity up to now. As I have said, the Bill will apply to designated high-risk activities which are conducted in other settings, such as private clinics. The nature of the activity, as opposed to where it takes place, will determine the requirement for the licence. Such activities might include the use of general anaesthesia. As a result of recent experiences, screening services will also be included. While such activities do not carry significant risks in and of themselves, we are aware from what has happened with the CervicalCheck programme that the highest standards must apply. The activities to be designated will be determined after a full consultation process has been completed. That will be subject to change on a continuing basis, given the powers that the Minister will have conferred on him through this legislation.

HIQA will be the licensing authority. It will process applications for licences and monitor the performance of licence holders. Regulations to be signed by the Minister will be used to establish the standards that licence holders will be required to meet. The regulations will be enforced by HIQA. This will ensure a level playing field across public and private services. They will be closely aligned with the existing national standards for safer and better healthcare. Where it is necessary in the interests of public safety, HIQA will have at its disposal a series of measures, up to and including the cancellation of a licence, which can be utilised. HIQA will have the power to attach conditions to licences and to require improvement plans to be submitted. The heads of the proposed Bill provide for a number of other offences and for the imposition of fines or terms of imprisonment, or both, depending on the nature of the offences. In line with the recommendations in my 2014 report on the deaths of babies at Portlaoise hospital, a licensed provider must prepare a patient safety statement with information on clinical activity, outcomes and patient safety incidents. Such statements must be updated monthly, published and made available to those who use these services. Fees will be set by the Minister and will be payable with licence applications and applications to remove or vary a condition of the licence. An annual levy is also proposed, with the intention that the system will be self-funding to the greatest extent possible.

The aim of the licensing legislation is to ensure health providers in Ireland are operating to minimum core standards so we can all have confidence in the clinical governance, safety, quality and effectiveness of the services being provided in the public and private systems. As a key element of the wider patient safety systems approach we are bringing forward, we will look to have a greater degree of awareness of issues that arise within the system. We will seek to provide assurances that patients are being informed of errors as they arise and that such errors are being reported appropriately to regulators. Improved complaints and advocacy processes are being developed to assist patients who are unsatisfied with their experiences. Ultimately, all the data generated through these activities should be used to provide insights for managers and clinicians within the health service regarding how to improve their own services before the cycle begins again. I hope the committee will welcome this initiative. I will be very happy to take any questions that members may have.