Mr. Phelim Quinn:

On behalf of HIQA, I thank the committee for the opportunity to address it. I am joined by Ms Mary Dunnion, who is the chief inspector of social services and director of regulation; and Dr. Máirín Ryan, who is the deputy chief executive and director of health technology assessment. We are pleased to be here to discuss the general scheme of the patient safety (licensing) Bill. HIQA has 11 years of experience of regulating and monitoring Ireland's health and social care services. Over that time, we have developed our knowledge of systems and models of international best practice. Therefore, we are well placed to provide observations and advice on the significance of this legislation.

Before I discuss the main provisions of the general scheme, it is important to explain HIQA's current role in the healthcare sector. Although HIQA is known as the State's health and social care regulator, we do not have the power to regulate public or private hospitals. Our remit does not extend beyond monitoring the safety and quality of HSE-funded hospitals against the national standards for safer and better healthcare. We monitor a number of key areas of risk, such as medication safety, antibiotic resistance, infection prevention and control, nutrition and hydration. We have conducted full service reviews against the national standards. Under section 9 of the Health Act 2007, we can conduct statutory investigations if there is a concern about the health and welfare of people using health and social care services. Similar to our monitoring function, the recommendations HIQA issues on completion of investigations are not legally binding. We do not have the power to oversee or insist on the implementation of our recommendations which, in the past, have gone unheeded.

I emphasise that HIQA has no role in the monitoring or regulation of the private healthcare sector. In effect, there is no statutory oversight of private hospitals in Ireland. Any organisation or individual is free to establish a private facility without restriction. Last month, the Government approved a different patient safety Bill - based on a previous Health Information and Patient Safety Bill - which will extend the remit of HIQA to private hospitals and provide for mandatory notification of serious patient safety incidents to HIQA or the Mental Health Commission, as appropriate. It is important to be clear that even under the provisions of this new Bill, HIQA will not have any enforcement powers, which will make Ireland an outlier in healthcare regulation internationally. The new patient safety Bill will simply extend to the private sector our current powers to set standards, monitor compliance and undertake investigations. My concern is that when this legislation is enacted, the public may be of the impression that the private healthcare sector is now regulated and, as a result, they, as patients, are protected. Interestingly, a Red C poll conducted for HIQA last year showed that 83% of people believe private hospitals in Ireland are already subject to regulation.

I will discuss the general scheme of the patient safety (licensing) Bill as it relates to HIQA. The Bill sets out the legislative framework for the introduction of a mandatory system of licensing for public and private hospitals and other providers of high-risk healthcare activities, which are known as "designated activities". Under the Bill, as the licensing authority HIQA will process licence applications, monitor the performance of licence holders against regulations and standards and take enforcement measures to address non-compliance where there is a risk to the health or safety of the public. Under the proposed scheme, HIQA will grant a licence to an applicant when a number of criteria have been satisfied. When HIQA is considering a licence application, it will assess whether the licensed provider and the person in charge are fit and proper persons. Persons in charge are nominated by the licensed provider and are described in the general scheme as the person with responsibility for managing the service on a day-to-day basis. While HIQA must be satisfied that the person in charge is a fit and proper person for this role, the Bill does not explicitly outline the specifics. It appears that this judgment is to be made at HIQA's discretion. In the absence of any statutory underpinning of hospital groups, the licensed provider in a statutory hospital will be the HSE or a voluntary organisation funded under a section 38 arrangement. In the case of private hospitals, it is likely that the licensed provider will be the body corporate - the legal entity that owns the hospital. We understand that in situations of sustained non-compliance in an individual public hospital, enforcement will centre on the HSE directorate as the licensed provider. Therefore, clarity on the status of the legal entity to be licensed is essential.

When determining whether a licensed provider of a private facility is a fit and proper person, HIQA will need to assess the character and competence of the licensed provider as well as all of its principal officers. Principal officers are defined as directors, secretaries or members of the management committee. This reasonable measure is broadly in line with how HIQA currently assesses the fitness of providers in designated centres. However, the Bill explicitly precludes the regulator from assessing the character and competence of the principal officers of the HSE or voluntary hospitals. This means HIQA will assess the fitness of the HSE or the voluntary organisation as a whole and will not be required to assess the character and competence of its principal officers. In effect, this approach will treat private providers differently from public or voluntary providers and will limit the regulator's power to assess the fitness of individual managers in public hospitals. It could result in circumstances in which the oversight of governance arrangements and competence of decision makers in public or voluntary hospitals is less rigorous. Clear lines of accountability are essential to ensure hospitals, which are large and complex organisations, are well governed and provide good-quality and safe care to the public. Our experience has shown that many failures in the provision of health and social care can be traced back to poor governance and a lack of accountability.

Applying different approaches to the regulation of private versus public and voluntary providers, specifically in terms of governance and financial capability, could lead to a lower standard of care in public and voluntary hospitals compared to private hospitals, and could be open to legal challenge by private providers and patients.

An additional point to note in this context is the requirement to assess the financial viability of the service provider. According to the Bill, licensed providers will be required to submit evidence of their financial capability to carry on the business of a hospital. The Health Information and Quality Authority, HIQA, will assess the ability of the intended licensee to meet the costs of carrying on the hospital or the designated activity and also the licensee’s insurance indemnity provisions and other financial assurance instruments to cover liabilities.

HIQA welcomes this measure, and it is something we advocated for in our discussions with the Department of Health. However, this test of financial capability only applies to private providers, not to Health Service Executive, HSE, and voluntary organisations. There may be an argument for excluding the HSE from such a test as it is fully funded by the State; however, it would be prudent to require voluntary providers to also prove their financial capability.

In this context, it is crucial that legislators recognise that healthcare is continually evolving and that current service models may not be suitable in the future. We believe reform of the way HIQA registers and regulates services is needed to respond to the various existing and emerging models of care in Ireland.

I am sure many members would question the readiness of the acute hospital sector to meet the regulations and standards that will arise from the proposed licensing system. When independent regulation was introduced into the social care sector, significant investment in many nursing homes and residential centres for people with disabilities was required to make them compliant with the regulations. It is reasonable to expect that the hospital sector will be no different.

I note that the Department of Health proposes to carry out a regulatory impact assessment, RIA, to examine the costs and benefits of introducing a licensing framework. The results of this RIA must be examined closely as it is likely to give an indication of the level of public investment needed to bring the hospital sector up to the required standards.

There has been a good deal of discussion in recent years about reforms to our health service. The Sláintecare report and the health service capacity review both looked at our future needs and, if implemented, will require significant levels of funding. This level of investment, coupled with the resources required to meet licensing regulations, could represent a massive commitment of public funds.

Based on our research on healthcare regulation internationally and our experience of social care regulation, HIQA strongly supports the proposal to introduce a system of licensing to the healthcare sector to bring Ireland in line with our OECD peers. HIQA’s experience in the social care sector has shown that regulation drives improvement, and we welcome the proposals contained in this Bill. Retaining the status quois simply not a viable option. Nonetheless, a number of issues still need to be ironed out. Clarity on the legal status of the licensed provider is necessary, as is a greater emphasis in legislation on effective governance and clear accountability at the level of the provider.

The Department of Health must be realistic about resourcing HIQA as the regulator of hospitals and other designated activities. Hospitals and clinics providing healthcare services are complex organisations, different from the types of services HIQA encounters in social care regulation. The proposed model of regulation will require competent and robust assessment by an adequate, skilled and knowledgeable workforce, not only in the area of front-line inspection but also in terms of managerial, administrative and technical support.

I wish to thank members of the committee for inviting us here this morning. We would be happy to answer any questions they may wish to ask.