Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

(2) Information provided in data referred to in subsection (1) or a clinical audit referred to in that subsection—

(a) shall not constitute an express or implied admission, by a health practitioner, of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission, in the determination of any matter specified in subparagraphs (i) to (vi) of section 10(2)(a), and

(b) are not, notwithstanding any other enactment, admissible as evidence of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission, in proceedings to determine a complaint, application or allegation referred to in paragraph (a).

(3) This section is in addition to, and not in substitution for, any enactment or rule of law relating to the disclosure of information in respect of the provision of a health service.

(4) In this section—

“clinical negligence” has the meaning assigned to it by section 10;

“clinical negligence action” has the meaning assigned to it by section 10;

“medical defence organisation” has the meaning assigned to it by section 10;

“professional indemnity insurance” has the meaning assigned to it by section 10.

PART 7 Amendment of Act of 2007

62. Amendment of section 2 of Act of 2007

62. Section 2 of the Act of 2007 is amended, in subsection (1)—

(a) by the insertion of the following definitions:

“‘Act of 2004’ means the Health Act 2004;

‘cancer screening service’ has the same meaning as it has in section 2 of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023;

‘complainant’ shall be construed in accordance with section 41A(5);

‘health service’ means the provision of clinical care or any ancillary service to a person for—

(a) the screening (other than screening carried out by a cancer screening service), preservation or improvement of the health of the person,

(b) the prevention, diagnosis, treatment or care of an illness, injury or health condition of the person,

(c) the performance or surgery, or a surgical intervention, in respect of aesthetic purposes, or other non-medical purposes, that involves instruments or equipment being inserted into the body of the person, or

(d) without prejudice to paragraph (a), a cancer screening service;

‘medical speciality’ means a medical speciality recognised by the Medical Council under section 89 of the Medical Practitioners Act 2007;

‘patient’ has the meaning assigned to it by section 41A(10);

‘prescribed private health service’ means a health service that is prescribed under section 101A;

‘private hospital’ means a hospital under the management or control of a person (other than the Executive)—

(a) at which—

(i) medical or surgical treatment for illness, injury, disability, palliative, obstetric or gynaecological care, or

(ii) a health service,

is provided to a person which provision of treatment is under the direction of registered medical practitioners from at least 3 different medical specialities who are registered in the Specialist Division of the register of medical practitioners, and

(b) which is capable of accommodating one or more persons in that hospital when providing the treatment under paragraph (a), for a minimum period of 24 hours, but does not include—

(i) a designated centre,

(ii) a centre registered by the Mental Health Commission,

(iii) a service provider to which paragraph (a) of the definition of service provider applies, or

(iv) a hospital which is in receipt of assistance under section 39 of the Act of 2004;

‘register of medical practitioners’ has the same meaning as it has in the Medical Practitioners Act 2007;

‘registered medical practitioner’ has the same meaning as it has in the Medical Practitioners Act 2007;

‘Specialist Division’ has the same meaning as it has in the Medical Practitioners Act 2007.”,

and

(b) by the substitution of the following definition for the definition of “service provider”:

“‘service provider’ means—

(a) a person who enters into an arrangement under section 38 of the Act of 2004 to provide a health or personal social service on behalf of the Executive,

(b) a person who is in receipt of assistance under section 39 of the Act of 2004 in an amount that exceeds an amount prescribed for the purpose of this subparagraph,

(c) a service provider under the Child and Family Agency Act 2013, or

(d) a private hospital;”.

63. Amendment of section 8 of Act of 2007

63. Section 8 of the Act of 2007 is amended—

(a) in subsection (1)—

(i) in paragraph (b)—

(I) in subparagraph (i), by the substitution of “a service provider to which paragraph (a), (b) or (c) of the definition of service provider applies” for “a service provider ”, and

(II) by the substitution of “and advise the Minister, the Minister for Children and Youth Affairs” for “in this section called the ‘services’, and advise the Minister, the Minister for Children and Youth Affairs”,

(ii) by the insertion of the following paragraph after paragraph (b):

“(ba) to set standards on safety and quality in relation to services provided by a service provider to which paragraph (d) of the definition of service provider applies or a person carrying on the business of providing prescribed private health services;”,

(iii) in paragraph (c), by the substitution of “paragraphs (b) and (ba)” for “paragraph (b)”,

(iv) in paragraph (e), by the substitution of “services referred to in paragraph (b)” for “services”,

(v) in paragraphs (f), (g) and (i), by the substitution of “services referred to in paragraph (b) or (ba)” for “services” in each place that it occurs,

(vi) by the substitution of the following paragraph for paragraph (k):

“(k) to set standards as the Authority considers appropriate for the Executive, the Agency, service providers or a person carrying on the business of providing prescribed private health services respecting data and information in their possession in relation to services and the health and welfare of the population;”,

and

(vii) in paragraph (l), by the substitution of “the Executive, the Agency, service providers and persons carrying on the business of providing prescribed private health services” for “the Executive and service providers”,

and

(b) by the insertion of the following subsection after subsection (1):

“(1A) The Authority may, in setting standards referred to in subsections (1)(b), (1)(ba) or (1)(k), set different standards for different categories of services referred to in those subsections.”.

64. Amendment of section 9 of Act of 2007

64. Section 9 of the Act of 2007 is amended—

(a) in subsection (1)—

(i) by the substitution of “Subject to subsection (1A), the Authority may undertake an investigation as to the safety, quality and standards of any of the services described in section 8(1)(b) or (1)(ba)” for “The Authority may undertake an investigation as to the safety, quality and standards of the services described in section 8(1)(b)”,

(ii) by the substitution of the following paragraph for paragraph (a):

“(a) there may be a serious risk—

(i) to the health or welfare of a person receiving those services, or

(ii) of a failure to comply with the provisions of the Act of 2013,

notwithstanding that such a risk may also exist elsewhere in those services,”,

and

(iii) by the substitution of the following paragraph for paragraph (b):

“(b) the risk may be the result of any act, failure to act or negligence on the part of—

(i) the Executive,

(ii) the Agency,

(iii) a service provider to which paragraph (a) or (b) of the definition of service provider applies,

(iv) a service provider to which paragraph (c) of the definition of service provider applies,

(iva) a service provider to which paragraph (d) of the definition of service provider applies,

(v) the registered provider of a designated centre to which paragraph (a)(ii), (iii) or (c) of the definition of designated centre applies,

(vi) the registered provider of a designated centre to which paragraph (a)(i) or (b) of the definition of designated centre applies,

(vii) the person in charge of a designated centre referred to in subparagraph (v), if other than its registered provider,

(viii) the person in charge of a designated centre referred to in subparagraph (vi), if other than its registered provider, or

(ix) a person carrying on the business of providing a prescribed private health service, and”,

and

(iv) by the insertion of the following paragraph after paragraph (b):

“(c) an investigation may be in the interests of—

(i) improving the safety, quality and standards of the services described in section 8(1)(b) or (1)(ba) which are the subject of the investigation, or

(ii) the provision of health and personal social services for the benefit of the health and welfare of the public.”,

(b) by the insertion of the following subsection after subsection (1):

“(1A) The Authority shall notify the Minister in writing before undertaking an investigation under subsection (1).”,

(c) by the substitution of the following subsection for subsection (2):

“(2) The Minister may, if he or she believes on reasonable grounds that—

(a) there may be a serious risk of the kind mentioned in paragraph (a) of subsection (1), notwithstanding that such a risk may also exist elsewhere in those services,

(b) the risk may be the result of any act, failure to act or negligence of the kind mentioned in paragraph (b)(i), (iii), (iva), (v), (vii) or (ix) of subsection (1), and

(c) an investigation may be in the interests of—

(i) improving the safety, quality and standards of the services described in section 8(1)(b) or (1)(ba) which are the subject of the investigation, or

(ii) the provision of health and personal social services for the benefit of the health and welfare of the public,

require the Authority to undertake an investigation in accordance with this section.”,

(d) by the substitution of the following subsection for subsection (2A):

“(2A) The Minister for Children and Youth Affairs may, if he or she believes on reasonable grounds that—

(a) there may be a serious risk of the kind mentioned in paragraph (a)(i) of subsection (1), notwithstanding that such a risk may also exist elsewhere in those services,

(b) the risk may be the result of any act, failure to act or negligence mentioned in paragraph (b)(ii), (iv), (vi) or (viii) of subsection (1), and

(c) an investigation may be in the interests of—

(i) improving the safety, quality and standards of the services described in section 8(1)(b) or (1)(ba) which are the subject of the investigation, or

(ii) the provision of health and personal social services for the benefit of the health and welfare of the public,

require the Authority to undertake an investigation in accordance with this section.”,

(e) by the insertion of the following subsection after subsection (3):

“(3A) Where an investigation under this section is being undertaken in respect of the services specified in section 8(1)(b) or (1)(ba), the Authority shall—

(a) give notice in writing to the relevant person of the matters to which the investigation relates, and

(b) give the relevant person a copy of any document which in the reasonable opinion of the Authority is relevant to the investigation.”,

and

(f) in subsection (6), by the insertion of the following definition:

“ ‘relevant person’ means a person or body referred to in subparagraphs (i) to (ix) of subsection (1)(b) ;”.

65. Standards set by Authority

65. (1) The Act of 2007 is amended by the substitution of the following section for section 10:

“10. (1) The Authority shall, prior to submitting a draft standard to the Minister for approval, publish a notice on the website of the Authority stating that—

(a) it proposes to set a standard,

(b) a draft of the proposed standard is available on that website for the period specified in the notice, and

(c) submissions in relation to the draft standard may be made in writing to the Authority on or before that date.

(2) Subject to subsection (3), the Authority may consult with such other persons on the draft standard referred to in subsection (1), as the Authority thinks fit.

(3) The Authority shall notify the Minister and the Minister for Children and Youth Affairs, where appropriate, before undertaking a consultation under subsection (2).

(4) After considering any representations made to it under subsection (1) or (2) on the draft standard and making any changes to the draft standard that the Authority thinks fit in view of those representations or otherwise, the Authority shall submit the draft standard to the Minister for approval and, where the standard relates to services provided under the Child and Family Agency Act 2013, the Minister shall not approve the draft standard without the prior consent of the Minister for Children and Youth Affairs.

(5) Where the Minister approves a standard under this section, he or she shall cause a notice of the approval to be published in Iris Oifigiúil and the notice shall specify the date from which the standard shall come into operation.

(6) Subject to subsection (7), the Authority may revoke or amend a standard approved under subsection (5).

(7) Subsections (1) to (5) shall, with all necessary modifications, apply to a standard that the Authority proposes to amend or revoke under subsection (6) as those subsections apply to a standard that the Minister approved under subsection (5).

(8) In this section, ‘standard’ means the standards set by the Authority under section 8(1).”.

(2) Notwithstanding the amendment of section 10 of the Act of 2007 by subsection (1), a standard set by the Authority before the coming into operation of subsection (1) and which is in force immediately before that commencement shall continue in force after such amendment unless revoked or amended by the Authority.

66. Provision of information to Authority

66. The Act of 2007 is amended by the substitution of the following section for section 12:

“12. The Authority may require—

(a) the Executive,

(b) the Agency,

(c) a service provider, or

(d) a person carrying on the business of providing a prescribed private health service,

to provide it with any information or statistics that the Authority needs in order to determine the level of compliance by the Executive, Agency, service provider or the person carrying on the business of providing a prescribed private health service, as the case may be, with the standards set by the Authority in accordance with section 8(1).”.

67. Amendment of section 41 of Act of 2007

67. Section 41 of the Act of 2007 is amended, in subsection (1), by the insertion of the following paragraph after paragraph (c):

“(ca) undertake reviews in accordance with section 41A,”.

68. Review of specified incident by chief inspector

68. The Act of 2007 is amended by the insertion of the following section after section 41:

“41A. (1) This section applies where it appears to the chief inspector that a specified incident has occurred, following—

(a) the receipt by the chief inspector of a complaint in relation to the specified incident concerned,

(b) the notification of the specified incident concerned to the chief inspector by a relevant entity, or

(c) the chief inspector otherwise becoming aware of the specified incident concerned.

(2) Subject to subsection (4), the chief inspector may undertake a review of the specified incident where he or she considers it appropriate to do so, having regard to all of the circumstances, in order to—

(a) identify, in so far as possible, how the specified incident concerned occurred, and

(b) make any recommendations of a general character arising out of any findings under paragraph (a) that can be implemented to reduce risk and to improve the safety, quality and standards of services provided by the relevant entity or relevant entities, as the case may be, where the specified incident occurred.

(3) The chief inspector may decide not to undertake a review under this section, or decide to discontinue such a review, if—

(a) subsection (1)(a) applies and the chief inspector believes on reasonable grounds that the complaint is frivolous or vexatious,

(b) the specified incident, the subject of the review concerned, has already been subject to a review under this section,

(c) the chief inspector believes on reasonable grounds that the incident the subject of the review concerned is not a specified incident,

(d) the chief inspector believes on reasonable grounds that, the subject matter of the review concerned has already been resolved or substantially resolved,

(e) the subject matter of the review concerned is the subject of criminal proceedings, or

(f) the review concerned is the subject of an investigation by An Garda Síochána.

(4) The chief inspector shall not undertake a review of a specified incident under subsection (2)—

(a) where subsection (1)(a) applies, after the expiration of one year from the later of the following dates:

(i) the date on which the specified incident occurred;

(ii) the date on which the complainant knew or could reasonably be expected to know that the specified incident occurred,

or

(b) where subsection (1)(b) or (c) applies, after the expiration of one year from the date on which the specified incident occurred.

(5) Without prejudice to Part 9 of the Health Act 2004, each of the following persons may make a complaint to the chief inspector in relation to a specified incident, and where he or she does so each such person shall, in this section, be referred to as a ‘complainant’:

(a) the patient;

(b) a parent, guardian, son, daughter, spouse or civil partner (within the meaning of the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010) of the patient;

(c) a person who is cohabiting with the patient (including a cohabitant within the meaning of section 172 of the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010);

(d) any person who, by law or by appointment of a court, has the care of the affairs of the patient;

(e) any legal representative of the patient;

(f) any other person, with the written consent of the patient.

(6) Where a review under this section is being undertaken in respect of a specified incident, the chief inspector shall—

(a) give notice in writing to the relevant entity concerned of the matters to which the review relates, and

(b) give the relevant entity concerned a copy of any document which in the reasonable opinion of the chief inspector is relevant to the review.

(7) A review of a specified incident undertaken under subsection (2) shall not—

(a) consider or determine fault, or assign civil or criminal liability,

(b) consider or determine whether any action should be taken in respect of an individual by any panel, committee, tribunal or professional regulatory body, or

(c) be admissible as evidence of fault or liability in a court in relation to the specified incident, or a clinical negligence action which arises (whether in whole or in part) from the consequences of that specified incident.

(8) Nothing in this section shall be construed as preventing a relevant entity from undertaking a review of a specified incident that may have occurred.

(9) The chief inspector shall ensure that a review under this section does not interfere, or conflict, with the functions of any statutory bodies.

(10) In this section—

‘complaint’ means a complaint, in any form, made by a complainant in relation to a specified incident that may have occurred during the provision of a health service by a relevant entity to a patient;

‘patient’ means a person to whom a health service is, or has been, provided by a relevant entity;

‘relevant designated centre’ means a designated centre to which paragraph (c) of the definition of designated centre in section 2 applies, that is registered in accordance with section 49 and includes—

(a) a designated centre whose registration has been cancelled under section 51 where an appeal against the cancellation has been made and has not been determined or withdrawn or in respect of which an appeal has been made under section 62 and that appeal has not been determined or withdrawn, and

(b) a designated centre in respect of which an application was made to the District Court under section 59 and the application has not been determined or withdrawn or in respect of which an appeal has been made under section 62 and that appeal has not been determined or withdrawn;

‘relevant entity’ means—

(a) a service provider to which paragraph (a), (b) or (d) of the definition of ‘service provider’ in section 2 applies,

(b) a relevant designated centre that is not a service provider referred to in paragraph (a),

(c) a person carrying on the business of providing a prescribed private health service, or

(d) the Executive;

‘specified incident’ means an incident that occurs on or after the coming into operation of this section—

(a) that may have resulted in the unintended or unanticipated death or serious injury of a patient, and

(b) that has occurred in the course of the provision of a health service to that patient by a relevant entity, where some or all of that health service was provided in a relevant designated centre.”.

69. Amendment of section 72 of Act of 2007

69. Section 72 of the 2007 Act is amended, in subsection (1)—

(a) by the insertion of “or a review referred to in section 41A” after “section 41”,

(b) in paragraph (a), by the insertion of “referred to in section 41, or an inspection relating to the review referred to in section 41A, as the case may be” after “the inspection”, and

(c) in paragraph (b), by the insertion of “referred to in section 41, or to the review referred to in section 41A, as the case may be,” after “the inspection”.

70. Amendment of section 73 of Act of 2007

70. Section 73 of the Act of 2007 is amended—

(a) in subsection (1), by the substitution of the following paragraphs for paragraphs (i) and (ii):

“(i) owned or controlled by the Executive, the Agency, a service provider, or a person carrying on the business of providing a prescribed private health service, or

(ii) used or proposed to be used, for any purpose connected with the provision of services described in section 8(1)(b) or (1)(ba).”,

(b) by the insertion of the following subsection after subsection (2):

“(2A) If the chief inspector considers it necessary or expedient for the purposes of a review referred to in section 41A, the chief inspector may enter and inspect at any time any premises—

(a) owned or controlled by a relevant entity within the meaning of section 41A, or

(b) used or proposed to be used for any purpose connected with the provision of a health service by a relevant entity within the meaning of section 41A.”,

(c) in subsection (3)—

(i) by the insertion of “or a review referred to in section 41A” after “section 41”, and

(ii) in paragraph (b), by the insertion of “in the case of an inspection referred to in section 41, or any premises referred to in subsection (2A) in the case of a review referred to in section 41A” after “subsection (2)”,

(d) in subsection (4)(a), by the substitution of “a service provider, a person carrying on the business of providing a prescribed private health service,” for “a service provider”,

(e) by the insertion of the following subsection after subsection (4):

“(4A) A chief inspector, in respect of premises referred to in subsection (2A), may—

(a) inspect, take copies of or extracts from and remove from the premises any documents or records (including personal records) relating to the services provided by a relevant entity within the meaning of section 41A,

(b) inspect the operation of any computer and any associated apparatus or material which is or has been in use in connection with the records in question,

(c) inspect any other item and remove it from the premises if the chief inspector considers it necessary or expedient for the purposes of a review referred to in section 41A,

(d) interview in private any person—

(i) working at the premises concerned, or

(ii) who at any time was or is in receipt of a service at the premises and who consents to be interviewed,

and

(e) make any other examination into the state and management of the premises or the standard of any services provided at the premises.”,

(f) in subsection (5)—

(i) by the insertion of “or (2A)” after “subsection (2)”, and

(ii) in paragraph (ii), by the substitution of “section 41, or of a review referred to in section 41A” for “section 41”, and

(iii) by the insertion of “or to the review” after “is relevant to the inspection”,

(g) in subsection (6), by the insertion of “or (2A)” after “subsection (2)”, and

(h) in subsection (8)—

(i) by the insertion of “or (2A)” after “subsection (2)”,

(ii) by the substitution of “an inspection referred to in section 41 or a review referred to in section 41A” for “an inspection under this section”,

(iii) by the substitution of “subject of the inspection or review” for “subject of the inspection”, and

(iv) in paragraph (b), by the insertion of “or review” after “the inspection”.

71. Amendment of section 74 of Act of 2007

71. Section 74 of the Act of 2007 is amended by the substitution of the following subsection for subsection (1):

“(1) In this section, ‘dwelling’ includes—

(a) any part of a designated centre occupied as a private residence by the registered provider of the designated centre or by a member of the staff of the registered provider, and

(b) any part of the premises of a person carrying on the business of providing a prescribed private health service occupied as a private residence by that person or by a member of the staff of that person.”.

72. Amendment of section 75 of Act of 2007

72. Section 75 of the Act of 2007 is amended—

(a) in subsection (1), by the substitution of the following paragraph for paragraph (b):—

“(b) in relation to any premises referred to in section 73(2) or (2A), the chief inspector conducting an inspection referred to in section 41 or a review referred to in section 41A,”,

and

(b) in subsection (2)(a)—

(i) by the insertion of “or, in the case of a review referred to in section 41A, section 73(2A)” after “section 73(1) or (2)”,

(ii) in subparagraph (i), by the substitution of “section 8(1)(d),” for “section 8(1)(d), or”

(iii) in subparagraph (ii), by the substitution of “subsection 41, or” for “section 41,”, and

(iv) by the insertion of the following subparagraph after subparagraph (ii):

“(iii) the chief inspector considers it necessary to inspect for the purposes of a review referred to in section 41A,”.

73. Reports of Authority or chief inspector

73. The Act of 2007 is amended by the insertion of the following section after section 77:

“77A. (1) The Authority or the chief inspector may prepare and publish a report relating to the functions and activities of the Authority, or the chief inspector, as the case may be.

(2) A report prepared under subsection (1) may include information on—

(a) the monitoring of compliance with standards under section 8(1)(c),

(b) any investigation carried out under section 9, and

(c) any review carried out under section 41A.

(3) Where preparing a report providing information in relation to subsection (2), the Authority or the chief inspector as the case may be, shall give to the Executive, the Agency, a service provider, a person carrying on the business of providing a prescribed private health service, or the registered provider of a designated centre or the person in charge of that designated centre if other than its registered provider a draft of the report (in this section referred to as a ‘draft report’) along with a written notice stating that the person may, not later than 21 days from the date on which the notice was received by him or her, or such further period as the Authority allows, make written submissions to the Authority or the chief inspector on the draft report.

(4) In the case of a report which includes information on a review referred to in subsection (2)(c), the chief inspector shall also give to the patient and, as the case may be, the complainant to whom the review relates an extract from the draft report which relates to the review concerned along with a written notice stating that the person may, not later than 21 days from the date on which the notice was received by him or her, or such further period as the chief inspector allows, make written submissions to the chief inspector on the extract from the draft report.

(5) As soon as practicable after the expiration of the period referred to in subsections (3) and (4) and, having considered any submissions made pursuant to those subsections, the Authority or the chief inspector as the case may be, may amend the draft report and, prior to publication, shall furnish the final report to—

(a) the Executive,

(b) the Agency,

(c) a service provider,

(d) a person carrying on the business of providing a prescribed private health service,

(e) the registered provider of a designated centre or the person in charge of that designated centre if other than its registered provider, or

(f) in the case of a report which includes information on a review referred to in subsection (2)(c), the patient and, as the case may be, the complainant.

(6) Without limiting the generality of section 78, the Authority or the chief inspector is not liable in damages arising from any report or communication made in good faith for the purposes of, or in the performance of, the functions under this section.”.

74. Amendment of section 78 of Act of 2007

74. Section 78 of the Act of 2007 is amended, in paragraph (ii), by the insertion of “or section 41A” after “section 41”.

75. Prescribed private health services

75. The Act of 2007 is amended by the insertion of the following section after section 101:

“101A. (1) Without limiting the generality of section 98, the Minister, having consulted the Authority and any other person as he or she considers appropriate, may prescribe a health service to be a prescribed private health service for the purposes of this Act.

(2) For the purposes of subsection (1), the Minister shall have regard to the following matters:

(a) whether the service is provided on an in-patient, day-patient or out‑patient basis;

(b) whether the service is provided in a hospital (other than a private hospital) where medical or surgical treatment for illness or injury, disability, palliative, obstetric or gynaecological care is provided;

(c) whether a general anaesthetic is administered to a patient in the provision of that service;

(d) whether the service is provided in a hospital (other than a private hospital) where the provision of the service is under the direction of registered medical practitioners from at least 3 different medical specialities who are registered in the Specialist Division of the register of medical practitioners;

(e) whether the service that is being provided is arranged by the National Treatment Purchase Fund Board under the National Treatment Purchase Fund Board (Establishment) Order 2004 (S.I. No. 179 of 2004);

(f) whether the service that is being provided includes the performance of surgery, or a surgical intervention, in respect of aesthetic purposes, or other non-clinical purposes, that involves instruments or equipment being inserted into the body of the patient.

(3) When prescribing a health service to be a prescribed private health service under subsection (1), the Minister shall not prescribe health services provided—

(a) at a designated centre,

(b) at a centre registered by the Mental Health Commission, or

(c) at a retail pharmacy business.

(4) In this section, ‘retail pharmacy business’ has the same meaning as it has in the Pharmacy Act 2007.”.

76. Repeal

76. Section 100 of the Act of 2007 is repealed.

PART 8 Offences and Penalties

77. Offences

77. (1) A person who fails to comply with section 5(1) without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.

(2) A person who fails to comply with section 19(9) without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.

(3) A person who fails to comply with section 20(5) without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.

(4) A person who fails to comply with section 27, 28 or 29 shall be guilty of an offence and shall be liable on summary conviction to a class A fine.

(5) A person who fails to comply with section 37(1) without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.

(6) A person who fails to comply with section 50(9) without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.

(7) A person who fails to comply with section 51(5) without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.

(8) In proceedings for an offence under this Act, it shall be a defence for a person against whom such proceedings are brought to show that the person made all reasonable efforts to ensure compliance with such provisions of this Act as are alleged to have been contravened.

(9) Where an offence under subsection (1), (2), (3), (4), (5), (6) or (7) is committed by a body corporate and it is proved that the offence was committed with the consent or connivance, or was attributable to any wilful neglect, of a person who was a director, manager, secretary or other officer of the body corporate, or a person purporting to act in that capacity, that person shall, as well as the body corporate, be guilty of an offence and may be proceeded against and punished as if he or she were guilty of the first-mentioned offence.

(10) Where the affairs of a body corporate are managed by its members, subsection (9) applies in relation to the acts and defaults of a member in connection with his or her functions of management as if he or she were a director or manager of the body corporate.

PART 9 Miscellaneous and General

78. Guidelines

78. (1) The Minister may, after consultation with the Authority, the chief inspector (within the meaning of Part 4), the Commission and the State Claims Agency (within the meaning of Part 4), and such other persons as he or she considers appropriate, prepare and issue guidelines for the purpose of providing practical guidance as regards the operation of, and compliance with, this Act and any regulations made under it.

(2) The Minister shall publish guidelines made under this section.

79. Regulations

79. (1) The Minister may by regulations provide for any matter referred to in this Act as prescribed or to be prescribed.

(2) Regulations under this Act may contain such incidental, supplementary and consequential provisions as appear to the Minister to be necessary or expedient for the purposes of the regulations.

(3) Every regulation made by the Minister under this Act shall be laid before each House of the Oireachtas as soon as may be after it is made and, if a resolution annulling the regulation is passed by either such House within the next 21 days on which that House sits after the regulation is laid before it, the regulation shall be annulled accordingly, but without prejudice to the validity of anything previously done thereunder.

80. Review of operation of Act

80. (1) The Minister shall, not later than 2 years after the coming into operation of this section, carry out a review of the operation of this Act.

(2) In carrying out a review under subsection (1), the Minister may consult with such persons as he or she considers appropriate.

81. Amendment of Act of 2000

81. The Act of 2000 is amended by the insertion of the following section after section 11:

“Notifications under Act of 2023

11A. (1) The Agency may provide the National Treasury Management Agency incident management system (within the meaning of the Act of 2023) as the means for making a notification under section 27, 28 or 29 of the Act of 2023.

(2) Subsection (1) shall apply whether the health services provider (within the meaning of the Act of 2023) making a notification referred to in that subsection is a State authority or otherwise.

(3) In this section, ‘Act of 2023’ means the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023.”.

82. Amendment of Act of 2017

82. The Act of 2017 is amended in the manner specified in Schedule 2.

83. Savings and transitional provisions in respect of open disclosure under Part 4 of Act of 2017

83. (1) Where, before the coming into operation of this section, a health services provider had, under, and in accordance with, Part 4 of the Act of 2017 made an open disclosure of an incident (within the meaning of the Act of 2017) that is a notifiable incident specified in Schedule 1, that Part of the Act of 2017 shall continue to apply to that open disclosure of that incident.

(2) Where, on or after the coming into operation of section 8, a notifiable incident is specified in regulations under that section and a health services provider had, under, and in accordance with, Part 4 of the Act of 2017 made an open disclosure of an incident (within the meaning of the Act of 2017) that is a notifiable incident specified in those regulations made under section 8, that Part of the Act of 2017 shall continue to apply to that open disclosure of that incident.