Press Release

Minister Harris announces significant Patient Safety Progress – Approval of the General Scheme of the Patient Safety (Licensing) Bill

Minister for Health Simon Harris TD today received Government approval for the drafting of the Patient Safety (Licensing) Bill.   The General Scheme of the Bill is now being referred to the Oireachtas Committee on Health for pre-legislative scrutiny

Speaking today, Minister Harris said “The aim of this licensing legislation is to ensure that hospital providers in Ireland are operating to minimum core standards so that we can all have confidence in the safety, quality and effectiveness of the services that are being provided, whether in the public or the private sector.”

The legislation also responds to the calls for a greater focus on clinical governance contained within the Sláintecare Report. It is part of a phased approach to facilitate a proportionate, outcome focused, consistent and responsive regulatory environment.  It should also provide for a robust and accountable system which has the confidence of the public. As such, the Bill has the potential to significantly enhance the approach to patient safety across the total acute hospital sector, and ensure that best practice standards are applied systematically and system wide.

HIQA will become the licensing authority.  It will process the applications for licenses and monitor the performance of license holders. The Bill allows for Ministerial regulations which providers must meet which will be closely aligned to the National Standards for Safer Better Healthcare (2012).

The move towards the introduction of licensing is part of the broader emphasis which has been brought to bear in relation to the promotion of greater patient safety, a fundamental component of quality healthcare. The increasing emphasis on patient safety by the Department of Health resulted in the establishment of the National Patient Safety Office (NPSO) in the Department of Health in December 2016.

The NPSO is leading a comprehensive approach to the area of patient safety, in relation to legislation, policy, clinical effectiveness and the creation of a surveillance function.


Notes to the Editor

Licensing of Healthcare Providers

  • The National Patient Safety Office (NPSO) launched by the Minister for Health in December 2016 is located within the Department of Health. This Office is leading a programme of patient safety legislation (open disclosure, hospital licensing, mandatory reporting of serious events); extending the clinical effectiveness agenda; developing a patient complaints and patient advocacy policy; publishing the National Healthcare Quality Reporting System, establishing a patient safety surveillance system and developing patient safety policy.
  • It should be acknowledged that the delivery of healthcare is an inherently risky activity and it is inevitable that things will sometimes go wrong. Studies of adverse events worldwide demonstrate that between 4% and 16% of patients admitted to hospital experience one or more adverse events, of which up to half are preventable.
  • The OECD in 2017 estimated that more than 15% of hospital expenditure goes towards correcting preventable medical mistakes or infections that people catch in hospitals across its member countries.
  • While acute public hospitals are currently subject to thematic monitoring by HIQA, the powers of HIQA are limited. The introduction of a system of licensing will ensure that all hospitals, public and private, are operating to appropriate standards and have the requisite governance arrangements in place to enable the delivery of the safest possible service.
  • The Bill will apply to both public and private hospitals, and it will be an offence to operate a hospital without a licence.
  • The Bill will also apply to high risk activities, which will be designated, and which are conducted in other settings, such as private clinics. Such activities may, for example, include the use of general anaesthetic. The activities to be designated will be determined once a full consultation process has been completed in 2018.
  • HIQA will be the licensing authority, processing applications for licences, and monitoring the performance of licence holders.
  • Ministerial regulations will be used to establish the standards which licence holders will be required to meet. These regulations will be enforced by HIQA and ensure a level playing field for public and private service. They will be closely aligned with the existing National Standards for Safer Better Healthcare.
  • Where 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 also have the power to attach conditions to a licence or require improvement plans to be submitted.
    The Bill also provides for a number of offences.
  • In line with the Report by the Chief Medical Officer, “HSE Midland Regional Hospital, Portlaoise Perinatal Deaths (2006-date)” (24 February 2014), a licensed provider must prepare a patient safety statement with information on clinical activity, outcomes and patient safety incidents.   Patient safety statements must be updated monthly and be available to the public.
  • Fees will 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.