Brian Lenihan Jnr (Dublin West, Fianna Fail)

The Health Bill 2006 is a central element of the Government's reform programme for the health service, as well as meeting commitments made in Quality and Fairness — A Health System for You and Towards 2016. The measures proposed in the Bill, in particular the establishment of the Health Information and Quality Authority and the Office of the Chief Inspector of Social Services, will bring about a safer health and social services system which will entrench quality at all levels and in all settings.

The Bill was framed with the central purpose of creating a new standards-based approach to health care services. Patient safety and quality of services are the key principles underpinning the arrangements set out in it. In many respects, the Bill represents a new and radical departure for the health system and the changes it introduces are fundamental to delivering a better health system in Ireland.

The Bill will create a national body, the Health Information and Quality Authority, often referred to as HIQA. The purpose of the authority is to set quality standards and secure compliance with those standards in an open and transparent way. In line with the national health information strategy, the new body will also have a vital role in developing, evaluating and improving the gathering and use of health care information. It will also ensure emerging health care technologies are independently and objectively assessed to benefit both patients and taxpayers.

The functions of the authority will be to set standards of safety and quality for all services provided by the HSE and service providers on behalf of the HSE, as well as private nursing homes, with the exception of mental health services which are covered by the Mental Health Commission and the Inspector of Mental Health. It will monitor compliance with the standards it sets and advise the Minister and the HSE on the level of compliance. It will undertake, on its own initiative or at the request of the Minister, investigations into the safety, quality and standards of services where it believes there is a serious risk to the health or welfare of a person receiving services. It will carry out reviews to ensure best outcomes and value for money for the resources available to the HSE and operate accreditation programmes for health and personal social services in both the private and public health sectors. It will also carry out assessments of health technologies, including drugs and medical devices and perform a range of information related functions with regard to health services and the health and welfare of the population, including evaluating existing health information, identifying deficiencies, advising the Minister and the HSE on those deficiencies, setting information standards and advising the Minister and the HSE on compliance with those standards.

The Bill also establishes the Office of the Chief Inspector of Social Services as an office within the authority with specific statutory functions. The chief inspector will be an employee of HIQA with independent statutory functions which include the Social Services Inspectorate's current inspection work, namely, conducting inspections into children's residential services run by the HSE, as well as the important new functions of registering and inspecting residential services for those with disabilities and older people, including private nursing homes.

In line with guidelines on regulatory impact assessment, a public consultation process on the legislative proposals was undertaken last year. More than 70 submissions were received and the proposals to establish HIQA and the Office of the Chief Inspector of Social Services were generally welcomed. The key features of the Bill reflect the outcome of these consultations and I am confident the Bill was strengthened as a result. Discussions took place with the interim HIQA board and the social services inspectorate on the Bill. Much preparatory work has been carried out by the interim HIQA board to ensure it can use its statutory powers as quickly as possible.

The Bill honours a commitment made by the Minister for Health and Children last year to provide for protected disclosures, more commonly known as whistleblowing, in the health service. It does this by inserting a new part into the Health Act 2004 covering a range of circumstances. The effect will be to create a structure within which protected disclosures can be properly made and investigated and to provide appropriate protection for the persons making such disclosures in good faith and in accordance with the provisions of the legislation.

I now turn to how the system of standards, registration and inspection for all designated centres will work together to create a fully independent and robust registration and inspection system. These centres will be inspected against standards set by HIQA and regulations made by the Minister. The chief inspector will have extensive powers to carry out inspections and may enter a centre, examine any records, take copies of documents, inspect and remove other relevant items and interview residents and staff in private. I should make clear that the registration and inspection requirements will apply to Health Service Executive residential centres, centres operated by agencies funded by the HSE and private nursing homes. This will guarantee that the public, voluntary and private sectors providing residential services will be required to meet the same standards of care. The chief inspector will also be responsible for overseeing the Health Service Executive's performance in complying with regulations and standards in foster care for children, pre-school services and what is called in law the "boarding out" of older people where they reside in someone's home. Residential centres covered by the Bill may not operate unless they have been registered by the chief inspector and it will be an offence to operate without registration. A centre must be in compliance with the conditions of its registration. Registration details will be available to the public on the Internet. The chief inspector can cancel a registration if the residential centre fails to meet standards.

Where necessary, the Bill provides for action to be taken quickly to protect service users. This includes provisions for the urgent deregistration of centres where the chief inspector, on application to the District Court, believes there is a risk to the life, or a serious risk to the health or welfare, of people resident in a centre. Accordingly, issues will no longer arise about the legal capacity to deal with failing nursing homes or residential care centres. If necessary, they can be closed down.

Senators are aware that the Minister for Health and Children established a commission on patient safety and quality assurance to examine and make recommendations on a system of licensing for all public and private providers of health care. This will include public, private and voluntary hospitals. We have general agreement that this is the direction we must take to give patients the greatest possible assurances of safe and quality care. The Minister asked the commission to report to her within 18 months of its establishment last December. The commission established a subgroup on licensing which may be in a position to come forward with recommendations in advance of the commission's report. The subgroup proposes to invite private health care providers to consult it as part of the process. The commission also plans to advertise for submissions on the various areas it will address as part of its work.

Part 1 of the Bill, comprising sections 1 to 5, inclusive, contains standard provisions dealing with the Short Title, interpretation, commencement, establishment day and expenses. Part 2, sections 6 to 12, inclusive, makes provision for the establishment of HIQA, details its functions which I outlined and contains provisions required for its operation and other matters. In line with arrangements for other statutory agencies responsible for setting standards and monitoring compliance, section 10 provides that standards set by HIQA must be approved by the Minister. Section 11 provides that the standards will be admissible as evidence in court proceedings, while section 12 allows the authority to require information from the HSE and service providers. Under the regulations, the Minister will be able to set out the procedures to be adopted by the authority in setting standards. This is to ensure the appropriate statutory bodies will be consulted before standards are drawn up.

Part 3, comprising sections 13 to 20, inclusive, provides for the establishment of the HIQA board and related matters. The board will have 12 members. Part 4, comprising sections 21 to 25, inclusive, covers standard provisions dealing with the appointment of the chief executive officer. Part 5, comprising sections 26 to 28, inclusive, contains standard provisions dealing with the recruitment of employees and advisers.

Part 6, comprising sections 29 to 39, inclusive, deals with the accountability and funding of the authority. It includes provisions allowing the Minister to give HIQA general directions to ensure ministerial policy will be clear. It contains provisions requiring the authority to draft codes of governance and a five-year corporate plan for ministerial approval. It also allows HIQA to charge, should it deem it appropriate, for any services it provides, except those it provides for the Government, the HSE or public service providers. There is also provision for the Minister to determine the authority's net annual expenditure and a requirement for the authority to submit a business plan to the Minister on an annual basis.

Part 7, comprising sections 40 to 45, inclusive, deals with the Office of the Chief Inspector of Social Services. Section 43 provides for the appointment of inspectors to staff the inspectorate. I should mention at this stage that section 72 allows HIQA, at the request of the chief inspector, to appoint qualified persons to assist the chief inspector and inspectors in the inspection of residential centres. Section 44 deals with the corporate and business plans for the office of the chief inspector and their inclusion in HIQA's corporate and business plans.

Currently, the HSE carries out inspections of voluntary children's residential centres and private nursing homes. The legislation provides that these will become a statutory function of the chief inspector. Section 45 provides that the Minister may require the HSE to carry out such inspections on behalf of the chief inspector. This is intended as a temporary arrangement to facilitate the continued inspection of these facilities pending a transfer of staff and resources to the authority. Such inspections must be carried out in the manner specified by the chief inspector and in accordance with standards set by HIQA and regulations made by the Minister.

Part 8, comprising sections 46 to 69, inclusive, deals with the registration of designated centres. Under section 46, a person shall not carry on or manage a designated centre unless it is registered and the person is the registered provider. A person is prohibited from managing a designated centre if the centre is not registered. Under section 47, any person applying for registration or renewal of registration is prohibited from giving misleading or false information. Sections 48 and 49 deal with requirements in regard to applications for registration and the details to be included by the chief inspector in the registers he or she maintains. The registration of a designated centre is for three years.

Section 50 provides for the granting or refusing of applications for registration. The chief inspector will grant the application if satisfied that the registered provider and any other person involved in the management of the centre is a fit person and the centre complies with standards set by HIQA and regulations made by the Minister. If the chief inspector is not satisfied on these counts, the application will be refused and conditions may be attached to registration.

Under section 51, the chief inspector can cancel a registration, vary a condition of registration or impose new conditions in certain circumstances. These circumstances are where the registered provider or other person involved in the management of the centre is convicted of particular offences or is not a fit person, or where the centre is not meeting its regulatory requirements. Under section 52, registered providers may apply to the chief inspector to vary a condition of registration.

Sections 53 and 54 provide for notification by the chief inspector of proposed decisions and the right to respond. The chief inspector must give notification of proposed decisions to refuse or cancel registration, vary or attach conditions of registration or impose new conditions. Time is allowed for the making of written representations. Section 55 provides that when the decision is made by the chief inspector, the person is informed in writing of the decision.

Section 56 sets out certain requirements and prohibitions in regard to designated centres, while section 57 provides for the right of appeal, on the part of a registered provider or applicant, against a decision by the chief inspector to the District Court. Appeals must be brought within 28 days after receipt of a written notice from the chief inspector. Section 58 provides that the chief inspector can apply to the District Court for an order enforcing certain decisions.

The Bill provides for the urgent cancellation or varying of conditions of registration where the chief inspector believes there is a serious risk to the health or welfare of residents. Sections 59 to 61, inclusive, set out the procedures and arrangements in this regard. The chief inspector must apply to the District Court for an order in regard to the registration and this application may be made ex parte and without notice to the registered provider. An ex parte interim order may be granted by the court if it considers it necessary or expedient to make the order immediately in the best interests of the residents. The chief inspector may apply to the court for a final determination. Notice of this application must be given to the person who was the registered provider at the time of the ex parte application. Under section 62, the Bill provides for the appeal of District Court decisions to the Circuit Court, while section 63 provides for the chief inspector to be a party to any court proceedings under this part of the Bill.

Under section 64, the chief inspector must notify the HSE immediately when registration is cancelled and the executive must make alternative arrangements for residents. Section 65 requires a registered provider to furnish the chief inspector with such information as he or she may require. Sections 66 to 68, inclusive, are technical provisions dealing with the closure of designated centres and the appointment of persons by law to take charge of a centre. Section 69 sets out the transitional arrangements for existing designated centres to allow them to operate pending registration for a period of not more than three years.

Part 9 deals primarily with investigations by HIQA and inspections by it for the purposes of monitoring compliance with standards set. It also deals with inspections of designated centres by the chief inspector. Section 70 allows HIQA to appoint persons known as "authorised persons" to monitor compliance with standards set and carry out investigations where the Minister believes there is a serious risk to the health or welfare of a person receiving services. Section 71 provides that the HSE may appoint persons to examine designated centres operated by service providers for certain purposes. For example, this may be to establish whether centres are complying with the terms of any funding given to them by the executive.

Sections 72 to 77, inclusive, deal with the right of entry for authorised persons to relevant premises owned or controlled by the HSE or service providers. This deals with the inspection and taking of copies of relevant documents and contains standard provisions that apply to procedures of this type. The chief inspector, in respect of inspections of designated centres, has precisely the same powers as authorised persons. In addition, under this Part, a warrant may be obtained from the District Court if an authorised person or the chief inspector, where appropriate, is prevented from entering premises or believes there is a likelihood of being prevented from entering premises. In these circumstances, an authorised person or the chief inspector may be accompanied by a member of the Garda Síochána. It will be an offence to refuse, obstruct or give false or misleading information to an authorised person or the chief inspector. Provision is also made for entry to a private residence, if necessary. Section 78 provides for qualified privilege for the reports of the chief inspector or authorised persons.

Part 10, comprising sections 79 and 80, provides for the offences under the Bill and the proceedings for summary prosecutions. A person guilty of a summary offence is liable to a fine of up to €5,000, a term of imprisonment of up to 12 months or both. A person guilty of an indictable offence is liable to a fine of up to €70,000, a term of imprisonment of up to two years or both.

Part 11, comprising sections 81 to 85, inclusive, contains the standard provisions for board members, employees and advisers on standards of integrity, codes of conduct and prohibition against unauthorised disclosure of information and the standard disqualifications from board membership and employment.

Part 12, comprising sections 86 to 97, inclusive, provides for the dissolution of the Irish Health Services Accreditation Board and the interim Health Information and Quality Authority and the transfer of their employees to HIQA. Part 13, comprising sections 98 to 102, inclusive, provides for the general power to make regulations and specific powers to make regulations regarding registration arrangements and standards in designated centres. Under section 8, regulations may also be made on the procedures to be followed by HIQA in setting standards.

Part 14 amends the Health Act 2004 by inserting into that statute a provision dealing with protected disclosures in the health service. This is an important innovation and it is important it should be featured in the Bill which is essentially about standards for patient care and safety. The concept of a protected disclosure, as set out in the Bill, is framed on the basis that the disclosures are made in good faith and on reasonable grounds. The type of disclosure that will attract protection includes disclosures about actions that put the health or welfare of those in receipt of services or the public generally at risk. Employees making protected disclosures will be required to follow set procedures, established by the HSE or their employers, except, for example, where urgency is a consideration. If the person making a protected disclosure is an employee, it safeguards him or her from workplace victimisation. Furthermore, any person making such a disclosure will have immunity from civil liability, except where he or she recklessly communicates an opinion or makes a false, misleading, frivolous or vexatious allegation or gives information which he or she knows to be incorrect. It should be noted that if a person makes a report that is false or misleading, he or she may be prosecuted for committing an offence under this Part.

There are detailed redress procedures involving access to the rights commissioner service and, on appeal, the Labour Court for employees who believe they have been victimised for making disclosures. The terms "employee" and "employer" have been specifically adapted to cover any entity which provides a health service inside or outside the remit of the health legislation. Employees in private sector health facilities will also be covered by the protections in this Part where they report a matter to a professional regulatory body. Any person who reports to a professional regulatory body will be covered by the protected disclosure provisions.

Part 15, comprising sections 104 and 105, provides for consequential amendments to other legislation. Schedule 1 deals with the repeals and revocations of relevant orders, while Schedule 2 sets out the precise amendments to other legislation. One of these amendments is to the Civil Registration Act 2004 and arises from the urgent need to continue to facilitate the marriage of seriously or terminally ill people who, by reason of their illness, are unable to travel to a public venue for their marriage.

I know Senators will agree experience shows that the case for a standards-based approach is indisputable. There is an imperative for change and a new approach based on high threshold standards that are rigorously monitored and consistently enforced. By establishing and empowering robust and independent structures in HIQA and the Office of the Chief Inspector, this Bill will help ensure the necessary change happens. I commend the Bill to the House and look forward to hearing the views of Senators.